Table of Contents

ii List of tables, figures, forms and annexes

vi Abbreviations and Acronyms

9 Chapter 1
Introduction

21 Chapter 2
Case Finding

35 Chapter 3
Case Holding

76 Chapter 4
Community-based Care

81 Chapter 5
MDR-TB and Palliative Care

85 Chapter 6
Prevention of Drug-Resistant TB and
Infection Control

92 Chapter 7
Recording and Reporting

106 Chapter 8
Logistics Management

118 Chapter 9
Pharmacovigilance
Active Drug-Safety Monitoring Management

122 Chapter 10
Health Promotion

135 Chapter 11
Monitoring, Supervision and Evaluation

142 References

145 Annexes
 List of Tables
Table No. 1 Diagnostic Facilities
Table No. 2 Treatment Providers
Table No. 3 PMDT Services
Table No. 4 Roles and Functions of Health Workers
Table No. 5 Presumptive DR-TB
Table No. 6 Xpert MTB/RIF Results and Interpretation
Table No. 7 Anti-TB Drugs Recommended for Treatment of Rifampicin-
Resistant and Multi-Drug Resistant TB
Table No. 8 Steps in Designing Conventional Treatment Regimens for DR-TB
Table No. 9 Dosages of the Anti-TB Drugs in the Standard Short Treatment
Regimen According to Weight Category
Table No. 10 Schedule of Clinical and Laboratory Baseline and Follow-up
Examinations for DR-TB Patients during the Intensive Phase and
Continuation Phase of Treatment
Table No. 11 Adjustment of Anti-TB Drugs in Patients with Renal Insufficiency
Table No. 12 Safety of Anti-TB Drugs in Pregnancy according to US FDA
Classification
Table No. 13 Severity of Adverse Events
Table No. 14 Guide on Deciding Appropriate Treatment Regimen based on
LPA or DST Result
Table No. 15 Steps in Managing Treatment Interruption
Table No. 16 Treatment Outcomes for RR-TB/MDR-TB/XDR-TB Patients
Table No. 17 End of Life Support Measures
Table No. 18 Timeline of Reporting
Table No. 19 NTP Recording and Reporting Forms
Table No. 20 Health Promotion Plan of Activities
Table No. 21 Matching Health Promotion Strategies and Implementation with
TB Program Objectives
Table No. 22 Matching Health Promotion Activities and Key Messages with
Specific Target Audiences
Table No. 23 Program Indicators
Table No. 24 Position, Qualifications and Responsibilities of Each Member of
the National TB Medical Advisory Committee
Table No. 25 Position, Qualifications and Responsibilities of Each Member of
the National TB Medical Advisory Committee
 List of Figures
Figure No. 1 Implementing arrangement of PMDT
Figure No. 2 Trend of enrollment of DR-TB patients, 1999 – 2016
Figure No. 3 Trend of interim treatment outcome of cohort of patients 2009 to
2015
Figure No. 4 Trend of Final Treatment Outcome of patients, 1999-2013
Figure No. 5 Current Diagnostic Algorithm Using Xpert MTB/RIF Test
Figure No. 6 Approach to Nausea and Vomiting secondary to Anti-TB Drugs
Figure No. 7 Approach to Drug-induced Hepatitis
Figure No. 8 Approach to QT Prolongation secondary to Anti-TB Drugs
Figure No. 9 Transition from Intensive to Continuation phase for patients on
SSTR
Figure No. 10 Management Component and Responsible Units for managing
NTP Products
Figure No. 11 Engagement of Regional Warehouses
Figure No. 12 Delivery direct to the Treatment Facilities

Annexes
Annex A List of Forms
Form 1. Presumptive TB Masterlist or Referral Logbook
Form 2a. NTP Laboratory Request and Result Form
Form 2b. NTP Laboratory Result Form for HIV testing
Form 2c. NTP TB Culture Result Form
Form 2d. NTP Drug Susceptibility Testing Result Form
Form 2e. NTP Line Probe Assay Result Form
Form 3a. Laboratory Register (Microscopy and Xpert MTB/RIF
Form 3b. NTP Laboratory Register (TB Culture and DST)
Form 4. TB Treatment/IPT Card
Form 4b. Drug-resistant Treatment Card
Form 5b. Drug-resistant TB Patient’s Booklet
Form 6b. Drug-resistant TB Register
Form 7. NTP Referral Form

Annex B List of Patient Management Forms

DR-TB Screening Form
DR-TB Case Presentation Form
TB Medical Advisory Committee Masterlist
Patient Progress Report Form

Annex C List of Administrative Forms

TB Laboratory Specimen Receiving Form
TB Laboratory Results Releasing Form
Quarterly Laboratory Report Attachment Form
Solid TB Culture Workbook
Laboratory Solid TB DST Workbook
Liquid TB Culture and DST Workbook
 Stock Cards
Temperature and Humidity Monitoring Log
Drugs and Supplies Receiving Form
Expired/Damaged Drug Disposal Report Form
NTP Standard Monitoring Tool

Annex D List of Reports

Report 1a. Quarterly Report on TB Microscopy and Xpert MTB/RIF

Laboratory Examination
Report 1b. Quarterly Report on TB Culture and Performance Indicator
Report 1c. Quarterly Report on 1st Line Solid and Liquid DST
Report 1d. Quarterly Report on 2nd Line DST
Report 1e. Quarterly Report on Line Probe Assay – 1st Line for TB
Report 1f. Quarterly Report on Line Probe Assay – 2nd Line for TB
Report 3b. Quarterly Report on All DR-TB Cases
Report 4b.Quarterly Report on Drug and Supplies Inventory and
Requirement for SLDs and Supplies
Report 4. iDOTS/Treatment Site Requisition Form
Report 5b. Quarterly Report on Treatment Interim Outcome of DR- TB Cases
Report 5c. Annual Report on the Treatment Outcome and Post-
Treatment Follow-up of DR-TB Cases
FDA Suspected Adverse Reaction Form

Annex E Paunawa Form

Annex F DR-TB Treatment Information Form
Annex G Procedures on Collection and Transport of Specimen
Annex H TB Medical Advisory Committee Guidelines
Annex I WHO recommended Weight-based dosing for Adults under the
Conventional Treatment Regimen
Annex J Department Memorandum No. 2015-0228 Expanded List of PMDT
Ancillary Drugs
Annex K Community-based PMDT Care Commitment Form
Annex L Assessment Checklist for Healthcare Facilities and other Congregate
Settings
Annex M Patients Charter for TB Care
 Abbreviations and Acronyms
ADR - Adverse Drug Reactions
aDSM - active Drug Safety Monitoring and Management
AE - Adverse Events
ALT - Alanine aminotransferase
ART - Anti-retroviral Therapy
AST - Aspartate aminotransferase
BC - Bacteriologically Confirmed
BDQ – Bedaquiline
BHW - Barangay Health Worker
CBC - Complete Blood Count
CBO - Community-based Organization
CD - Clinically Diagnosed
CDC - Center for Disease Prevention and Control
CHO – City Health Office
ComCare – Community-based Care
CPT – Co-Trimoxazole Preventive Therapy
CSF – Cerebro Spinal Fluid
CTP – Community Treatment Partner
CTR – Conventional Treatment Regimen
DLM – Delamanid
DOH – Department of Health
DQC – Data Quality Check
DRS – Drug Resistance Survey
DR-TB – Drug-Resistant Tuberculosis
DSM - Drugs and Supplies Management
DSSM – Direct Sputum Smear Microscopy
DST – Drug Susceptibility Testing
DS-TB – Drug Susceptible Tuberculosis
ECG - Electrocardiogram
EP-TB - Extrapulmonary Tuberculosis
FDA - Food and Drug Administration
FIFO - First In, First Out
FLD – First-Line Anti-TB Drugs
GF – Global Fund
GLC – Green Light Committee
HIV – Human Immunodeficiency Virus
iDOTS – Integrated DOTS
IEC – Information, Education and Communication
ITIS – Integrated TB Information System
KMITS – Knowledge Management and Information Technology Service
LCE – Local Chief Executives
LED FM – Light Emitting Diode Fluorescence Microscopy

6
LFT – Liver Function Test
LGU – Local Government Unit
LPA – Line Probe Assay
LTFU – Lost to Follow-up
LZD – Linezolid
MDR-TB – Multi Drug-Resistant Tuberculosis
MSE – Monitoring, Supervision and Evaluation
Mtb – Mycobacterium Tuberculosis
Mtbc – Mycobacterium Tuberculosis Complex
NGO – Non-governmental Organization
NOSIRS – National Online Stock Inventory Recording System
NSAIDS – Non-steroidal Anti-inflammatory Drugs
NTP – National Tuberculosis Control Program
NTRL – National Tuberculosis Reference Laboratory
N-TB MAC – National Tuberculosis Medical Advisory Committee
PAS – Para-AminoSalicylic Acid
PHO – Provincial Health Office
PICT – Provider Initiated Counselling and Testing
PIR – Program Implementation Review
PLHIV – People Living with HIV
PMDT – Programmatic Management of Drug-resistant TB
PNF – Philippine National Formulary
PPRF – Patient Progress Report Form
PSG – Patient Support Group
PTB – Pulmonary Tuberculosis
PTOU – Previous Treatment Outcome Unknown
PViMS – PharmacoVigilance Monitoring System
QAS – Quality Assurance System
QTc – Corrected QT Interval
RHU – Rural Health Unit
RO – Regional Office
RR – Rifampicin Resistant
R-TB MAC – Regional Tuberculosis Medical Advisory Committee
SACCL – STD/AIDS Cooperative Central Laboratory (Philippines)
SAE – Serious Adverse Event
SLI – Second-Line Injectable Drugs
SSTR – Standard Short Treatment Regimen
STC – Satellite Treatment Center
TALF – Treatment After Lost to Follow-Up
TAT – Turn-Around Time
TB – Tuberculosis
TC – Treatment Center
TSH – Thyroid-stimulating Hormone
WHO – World Health Organization

7
WRD – WHO-recommended Rapid Diagnostic Test
XDRTB – Extensively Drug Resistance TB

8
 CHAPTER 1

INTRODUCTION
Basic Facts about the Multi Drug-Resistant TB (MDR-TB)

Tuberculosis (TB) is caused by a bacterium called Mycobacterium tuberculosis which

is transmitted through coughing, sneezing and talking. TB is diagnosed through direct
sputum smear microscopy (DSSM), rapid diagnostic tests and chest-ray examination.
Drug Susceptible-TB (DS-TB) patient has to undergo at least six months treatment of
first line anti-TB drugs (FLD) to be cured.

Multi Drug-Resistant TB (MDR-TB) is when a TB patient is infected with strains that

are resistant to at least Isoniazid and Rifampicin in vitro. Resistance to FLDs is
detected through conventional culture and drug susceptibility testing (DST). Rapid
molecular (genotypic) tests such as Xpert MTB/RIF assay detect resistance to
Rifampicin while line probe assay (LPA) detects resistance to both Isoniazid and
Rifampicin.

There are two major causes of Drug-Resistant TB:

1. Acquired Drug-Resistant TB- may result from inadequate dosages and incomplete
intake of anti-TB drugs, by taking anti-TB drugs of poor quality or due to
malabsorption among others.
2. Primary Drug- Resistant TB- will result if a person is infected with drug-resistant
TB strain. Transmission could be facilitated by impaired immune system of the
patient or through environmental factors such as overcrowding, poor ventilation,
poor infection control, and congregate settings. Currently, fifty (50%) percent or
more of the MDR-TB cases are considered as primary DR-TB.¹

MDR-TB patient has to take second line anti-TB drugs (SLDs) for at least 9 months of
treatment.

Magnitude of MDR-TB

Tuberculosis (TB) is a major public health problem in the Philippines. It is the 8 th

leading cause of mortality and morbidity among Filipinos.² Based on the World Health
Organization (WHO)-issued Global TB Report for 2016, the country is one of the 30
with high TB and MDR-TB burden countries. By 2015, it has the following magnitude:
TB incidence is 322/100,000; TB prevalence is 417/100,000 and TB mortality is
14/100,000. Although significant achievements in TB control have been made since
the introduction of the DOTS strategy by the National TB Control Program (NTP) in
1996, there are still many challenges. One is a growing concern in the emergence of
MDR-TB.

The latest Drug Resistance Survey done in 2012 showed a decrease in the prevalence
of multi drug-resistance among new cases from 4% in 2004 to 2% in 2012. However,
there was no change in the prevalence of multi drug-resistance re-treatment cases
which remained at 21%.³ WHO estimated that the prevalence of rifampicin resistance

9
(RR)/MDR-TB among notified new TB cases is 2.6% and 29% among notified
retreatment TB cases.⁴ This translates to about 15,000 DR-TB patients in 2015.

Past efforts to address MDR-TB in the Philippines

 In 1999, Tropical Disease Foundation (TDF), in collaboration with the

Department of Health (DOH), started providing diagnostic and treatment
services to DR-TB patients.

 In 2000, this was continued through a Green Light Committee-approved DOTS-

Plus Pilot Project with 200 patients in National Capital Region.

 In 2003, the Global Fund to Fight against AIDS, Tuberculosis and Malaria
(Global Fund) initiated giving financial support to the country to expand services
for MDR-TB patients. This led to the increase in the number of GLC-approved
cohorts of patients to be treated.

 By 2008, five (5) TB culture laboratories had been operationalized namely, the
National Tuberculosis Reference Laboratory, Cebu TB Reference Laboratory,
Lung Center of the Philippines, Philippine Tuberculosis Society, Inc. and
Tropical Disease Foundation, Inc. Two (2) treatment centers were established
in Regions 4A and 7.

 On May 26, 2008, DOH issued Administrative Order No. 2008-

0018,“Guidelines for the Implementation of the Programmatic Management of
Drug-Resistant Tuberculosis” mandating the treatment of MDR-TB all over the
country and providing for the PMDT policies and procedures

 In April 2010, the management of PMDT was transferred from TDF to the Lung
Center of the Philippines (LCP). In the same year, there were 10 operational
PMDT treatment centers.

 In 2011, the concept of satellite treatment centers (STC) was introduced. The
first operational STCs were Dr. Elvira M. Lagrosa Health Center, Gat Andres
Bonifacio Memorial Medical Center, Tondo Foreshore Health Center,
Moonwalk Health Center, Batasan Hills Super Health Center, and Grace Park
Health Center from the National Capital Region (NCR) and the Bicol Medical
Center from Region 5. In the last quarter of the same year, the country started
adopting molecular (genotypic) test, the Xpert MTB/Rif, by initially establishing
16 Xpert sites which provide rapid screening test that can detect rifampicin
resistant strains of TB bacilli in just two (2) hours compared to conventional
DST with a turn-around time of 9 weeks.

 In 2013, PMDT key policies and guidelines were incorporated into the revised
NTP Manual of Procedures, 5th edition with the aim of incorporating DR-TB care
in the general TB care.

 In 2014, PMDT was transferred from LCP to the Infectious Disease Prevention
and Control Division of the Disease Prevention and Control Bureau of DOH
(IDPCD-DPCB). It is in the same year that all regions of the Philippines have at
10
 least 1 PMDT treatment facility and the concept of integrated DOTS or iDOTS
was introduced and piloted in NCR. Community-based PMDT care or
ComPcare was also pilot-tested in Caloocan City and Laguna.

 In July 2015, the program initiated the 9-month treatment regimen operational
research in 10 study sites. LPA was used in the research to detect resistance
to second-line injectable (SLI) drugs and fluoroquinolones. Resistance to SLI
and/or fluoroquinolone is an exclusion criterion in the study.

 In June 2016, the program introduced Bedaquiline (BDQ), a novel anti-TB drug,
under operational research and was implemented in 10 study sites.

 As of mid-2016, there are 20 TCs, 127 STCs, 525 trained iDOTS facilities, 185
Xpert sites, 25 TB Culture Centers and 4 DST centers.

On September 23, 2016, DOH issued the Administrative Order 2016-0040

“Revised Policies and Guidelines on the Implementation of the Programmatic
Management of Drug-resistant TB”.⁵

Programmatic Management of Drug-Resistant TB (PMDT)

Implementing arrangement

The National TB Control Program (NTP) of the Infectious Disease Prevention and
Control Division of the Disease Prevention and Control Bureau of DOH (IDPCD-
DPCB) leads in the implementation of PMDT in the country. The DOH Regional Offices
(RO) through their Regional NTP teams, oversee the PMDT implementation at the
regional level while the Provincial Health Offices (PHO) and City Health Offices (CHO),
through their provincial/city TB teams are responsible for DR-TB control efforts in
provinces. The current PMDT implementing arrangement is shown below.

11
Figure No. 1 - Implementing arrangement of PMDT

12
Treatment and diagnostic facilities involved in PMDT are listed at the right side of Figure
No. 1. All DOTS facilities are conducting presumptive DR-TB identification and referral.

The following health facilities are directly providing diagnostic and treatment services for
DR-TB patients:

Table No. 1 - Diagnostic Facilities

Facility Description Services
offered
TB - Provide quality-assured TB sputum microscopy services DSSM
Microscopy using light or LED – fluorescence microscopy for diagnosis
Laboratories of bacteriologically-confirmed TB and monitoring of
treatment
- Mainly lodged in Rural Health Units/Health Centers
Xpert Sites - Provide diagnosis of bacteriologically-confirmed TB Xpert
through cartridge based nucleic acid amplification test MTB/RIF
(Cepheid GeneXpert MTB/RIF) with coverage for detecting
rifampicin resistance.
- Mainly lodged in PMDT treatment facilities (TC, STC)
TB Culture - Provide quality assured solid or liquid TB culture services TB
and Drug for diagnosis of bacteriologically-confirmed TB including Culture
Susceptibility phenotypic drug susceptibility testing to first line and and DST
Testing second line anti-TB drugs and monitoring of treatment
Laboratories response or sputum conversion.
- Mainly lodged in the Regional TB Laboratories
LPA - Provide rapid diagnosis of bacteriologically-confirmed TB LPA
Laboratories using molecular methods wherein DNA is amplified and
hybridized. Genotypic drug susceptibility testing results are
also provided for first and second line anti-TB drugs.
- Mainly lodged in the Reference Laboratories

Table No. 2 - Treatment Providers

Service Description Services offered
providers
TC/STC - Cater to a bigger catchment area compared - Screening, diagnosis
to iDOTS and treatment
- Mainly lodged at the regional/tertiary
hospitals, provincial/ district hospitals, RHUs
and health centers
- Referral centers for patients with DR-TB who
have clinical management issues
iDOTS - Cater to both DS and DR-TB patients - Screening, diagnosis
- Are linked to TC/STCs and Xpert sites and treatment
- Mainly lodged in RHU’s and health centers

13
 Community- - Daily supervised treatment of DR-TB patient - Community or home-
based detected and initiated treatment by iDOTS based supervised
through community treatment partners treatment
- Contact Tracing

Table No. 3 – PMDT Services

Case finding and Case holding activities Service providers
Identify presumptive DR-TB and referral for Xpert DOTS facilities/ iDOTS
examination STC/TC
Conduct Xpert examination, culture and DST Xpert site, culture/ DST centers
Provide counselling to confirmed DR-TB TC/STC/iDOTS
Conduct baseline and follow-up laboratory / Hospitals/diagnostic centers linked
diagnostic tests to TC/STC/iDOTS
Initiate treatment and register TC/STC/iDOTS
Conduct contact investigation TC/STC/iDOTS/CTP
Conduct supervised treatment TC/STC/iDOTS/CTP
Monitor treatment TC/STC/iDOTS
Assess treatment outcome TC/STC/iDOTS
Conduct post-treatment follow-up TC/STC/iDOTS

14
Functions of Health Service Providers

At the service delivery points, each of the different types of health workers from physicians
to barangay health workers contribute to PMDT implementation. Below are the specific
functions of each type of health worker.

Table No. 4 – Roles and Functions of Health Workers

Physician  Organize planning and evaluation of DR-TB control
activities in the DOTS facilities
 Ensure that all staff are trained on PMDT
 Supervise staff to ensure proper implementation of
PMDT policies and guidelines
 Screen presumptive TB for DR-TB
 Ensure that all presumptive DR-TB are systematically
screened using the recommended rapid diagnostic tool
 Prescribed appropriate treatment
 Manage moderate, severe, life threatening or serious
adverse events
 Present difficult cases to the TB Medical Advisory
Committee.
 Provide continuous patient information and counselling
to all DR-TB patients under treatment
 Refer DR-TB patients to other health facilities if needed
 Conduct home visit to DR-TB patients who failed to take
supervised treatment for more than 2 days
 Encourage community and family support to DR-TB
control
 Mobilize and utilize resources in the area for DR-TB
control
 Analyze and discuss the quarterly reports with the staff
Nurse  Manage the process of screening presumptive DR-TB
in coordination with other staff
 Inform presumptive DR-TB and referring
physician/facility of the screening result
 Facilitate conduct of baseline and follow-up clinical
evaluation, laboratory and diagnostic tests
 Assist the physician in counselling and initiating
treatment of DR-TB patient
 Accomplish the DR-TB treatment card
 Agree with DR-TB patient the mode of supervised
treatment including the treatment partner
 Supervise intake of anti-TB drugs
 Manage mild adverse events

15
  Refer patient with moderate, severe, life threatening or
serious adverse events to physician for evaluation and
management
 Conduct contact tracing, home visit and interrupter
tracing
 Supervise support staff and community treatment
partners to ensure proper implementation of PMDT
 Maintain and update the Presumptive TB Masterlist or
Referral Logbook and DR-TB register
 Facilitate requisition of anti-TB drugs, ancillary drugs,
laboratory supplies and forms
 Maintain records on logistics and ensure proper storage
of drugs
 Provide continuous patient information to all DR-TB
patients
 Facilitate conduct of patient activities in coordination
with other staff
 Conduct orientation of community treatment partners
 Prepare, analyze, and submit the quarterly reports
Support Staff  Under the supervision of the nurse, do the following
o Identify presumptive DR-TB and ensure proper
collection and transport of sputum specimen/s
o Refer all diagnosed DR-TB patients to physician
and nurse for clinical evaluation and initiation of
treatment
o Maintain and update Presumptive TB Masterlist
or Referral Logbook, DR-TB register and DR-TB
treatment card
o Conduct contact tracing
 Implement supervised treatment with community
treatment partner
o Provide continuous patient information
o Supervise intake of anti-TB drugs
o Collect sputum for follow-up examinations
o Report and retrieve treatment interrupter within
2 days
o Refer patient with adverse events to nurse for
evaluation and management
o Supervise and mentor community treatment
partners
Community Under the supervision of the nurse and/or support staff to do
Treatment Partner the following:
 Supervise intake of anti-TB drugs
 Collect and ensure transport of sputum specimen
 Keep and update a copy of the DR-TB treatment card

16
 Update the DR-TB booklet of the patient
 Report and retrieve treatment interrupter within two
days
 Conduct contact tracing
 Attend regular consultation with the health staff
together with patient
 Refer patient with adverse event to the health staff for
evaluation and management
 Provide health education to the patient, family members
and the community

17
 PMDT Performance

The number of enrolled drug-resistant tuberculosis (DR-TB) cases continuously

increased from 15 cases in year 2000 to 5,334 cases in year 2016 for a cumulative total
of 21,316.

Figure No. 2 - Trend of enrollment of DR-TB patients, 1999 – 2016

25000
20000
15000
10000
5000
0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
New Patients 7 15 86 56 22 99 191 134 315 530 569 870 2569 2056 2390 2010 4063 5334
Cumulative 7 22 108 164 186 285 476 610 925 1455 2024 2894 5463 7519 9909 11919 15982 21316

However, the unfavorable treatment outcomes have increased as shown by Figures 3 and 4.
Figure No. 3 – Trend of interim treatment outcome of cohort of patients 2009 to 2015
100%
7.90% 9.30%
90% 14.20% 14.40% 15.60% 15.00%
4.10% 18.70%
6.80%
9.60% 8.50% 8.60% 6.50% 6%
80%
13.10% 8.20% 9.00%
6.40% 8.30% 9% Lost to Follow-up
70%
8.20% Died
60% Not Done
50% Contam
40% MOTT
78.40%
69.20% 66.10% 67.8% 68% 69% Pending
30% 59.50%
Negative
20% Mtb
10%
0%
2009 2010 2011 2012 2013 2014 2015

Figure No. 4 - Trend of Final Treatment Outcome of patients, 1999-2013

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
1999-
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
2000
Lost to Ff-up 9% 14% 23% 23% 15% 13% 18% 20% 25% 33% 38% 44% 36% 31%
Died 9% 15% 11% 5% 8% 12% 17% 11% 10% 9% 14% 12% 13% 12%
Failure 18% 14% 7% 0% 4% 1% 2% 4% 1% 2% 2% 2% 1% 1%
Success 64% 57% 59% 73% 73% 74% 63% 63% 64% 57% 46% 41% 49% 54%

18
 Current challenges in PMDT mainly based on Joint Program Review done in
March 2016.⁶

a) The number of previously treated TB cases who had Xpert tests was not
captured routinely by NTP to date.

b) The proportion of MDR-TB cases detected is 27% of the estimated 15,000 MDR-
TB in 2015.

c) The gap between diagnosis cohort and treatment cohort widened from 5% in
2013 to 12% in 2015, likely indicating increased initial loss-to-follow-up among
RR/MDR-TB cases.

d) The outcome of MDR-TB treatment was not satisfactory. The proportion of

treatment success was 74% in the 2005 cohort, which decreased to 49% in the
2012 cohort, mainly because the proportion of loss-to-follow-up increased from
13% in 2005 to 36% in 2012. Main reasons are ADRs, financial/geographical
barriers and personal.⁷

e) Management of adverse drug reactions largely depends on nurses at S/TC who

may seek support of clinicians. However, clinicians at PMDT treatment facilities
may not be available at all times to provide support in an efficient manner.

f) In the era of decentralization of PMDT, provincial and city NTP teams have not
yet been active in supervision, monitoring and evaluation of PMDT at DOTS
facilities.

g) Implementation and scaling-up of PMDT heavily depends on external funding

and project-hired staff. The budget for PMDT mainly comes from the Global Fund
(GF).

PMDT Plan and Targets

For PMDT, the main targets of the 2017-2022 Philippine Strategic TB Elimination
(PhilSTEP1) Plan are Treatment Coverage of 90% and Treatment Success Rate
of at least 85%.

To attain these, the following are the key strategies:

a. Enable ROs and LGUs to formulate plan to address DRTB through multi-
sectoral collaboration
b. Build capability of human resources to manage PMDT, to provide diagnostic
and treatment services, to promptly identify and properly manage adverse
events, and to provide palliative care
c. Continue to provide free ancillary drugs to combat adverse events
d. Expand quality-assured laboratory facilities supporting PMDT
e. Integrate PMDT services with DOTS services

19
 f. Empower patients and communities, and strengthen the community-based
treatment strategy involving former patients and community members as
treatment partners
g. Enhance supply chain management to ensure uninterrupted supply of quality
NTP products
h. Implement preventive and infection control measures
i. Increase investments of DOH, LGUs and PhilHealth for PMDT
j. Continue to provide support to reduce financial barriers of patients
k. Utilize data from ITIS and researches to provide evidence on future policies
and encourage operational researches among MDR-TB clinicians and nurses
to improve management of DR-TB patients, increase private sector
involvement in the care and support of DR-TB patients

Funding of PMDT

It is estimated that the program cost to diagnose and treat one DR-TB patient for at least
18 months is around P250, 000.00. Currently, DOH lacks the resources to fully support
the implementation of PMDT. Hence, most of the program’s resource requirements are
from Global Fund. DOH and other partners provide limited support for some activities
like advocacy, capacity-building and monitoring. Some LGUs assist patients through food
supplementation, transportation and temporary shelter.

For sustainability, NTP is looking into the following: (a) seeking higher budget from the
national government, (b) advocating for an MDR-TB outpatient benefit package from the
Philippine Health Insurance Corporation, (c) increasing support from LGUs and other
government agencies, and (d) developing business models specially patients from the
private sector.

20
 CHAPTER 2

CASE FINDING

I. Introduction

Early identification of presumptive DR-TB should be a priority for every health-care facility.
This allows for the early detection of drug-resistance and the use of appropriate treatment
regimens for patients to prevent further transmission or deaths, which have impact on TB
elimination.

Tubercle bacilli from people with pulmonary TB can be detected by sputum-smear

microscopy. However, drug-resistance cannot be diagnosed with sputum-smear
microscopy. This is because a positive smear of DR-TB looks the same as a positive
smear of drug-susceptible TB. They are caused by the same organism, Mycobacterium
tuberculosis.

A definitive diagnosis of DR-TB requires that Mycobacterium tuberculosis bacteria be

detected and resistance to anti-TB medicines determined. There are two ways of
detecting drug-resistant TB, (a) phenotypic – this can be done by isolating the bacteria
by culture, identifying it as belonging to the M. tuberculosis complex (MTBc), and
conducting drug-susceptibility testing (DST) for both first line and second line anti-TB
drugs using solid or liquid media, or (b) genotypic – this is done by performing a WHO-
recommended rapid diagnostic test (WRD) to detect the MTBc DNA and mutations
associated with resistance in tubercle bacilli. Currently, the WHO-endorsed available
diagnostic tests in the country are Xpert MTB/RIF that detects rifampicin resistance and
Line Probe Assay (LPA) for first and second line anti-TB drugs. Specimens from all
presumptive DR-TB must therefore be tested using rapid molecular tests. Specimens
from confirmed RR-TB must be cultured, and undergo DST to confirm whether multi drug-
resistance or any other type of resistance is present.

II. Objectives

The objectives of case finding are to promptly and correctly identify and diagnose DR –
TB cases using various available TB diagnostic tools under the NTP.

III. Definition of Terms

Close Contact⁸ – A person who shared an enclosed space, such as the household, a
social gathering place, workplace or facility, for extended periods within the day with the
index case during 3 months before commencement of the current treatment episode.

Intensified Case Finding – Conduct of active case finding among individuals belonging
to high risk groups (i.e. contacts of DR-TB) and vulnerable populations (e.g. jails/prisons).

21
 Active case finding is a purposive effort to find TB cases in the community or among those
who do not consult in a DOTS facility.

Non-engaged Health Care Provider – A public or private health care practitioner, facility
or institution that is not linked with NTP to provide TB services based on the NTP policies
and guidelines.

NTP Laboratory Network – Is composed of laboratories (public and private) that provide
various TB diagnostic tests organized at different levels of the health system and follows
NTP protocols.

PMDT Treatment Facility – A health care facility, whether public or private, that provide
PMDT services in accordance with the policies and guidelines of NTP, DOH. This refers
to Treatment Centers, Satellite Treatment Centers, and iDOTS facilities.

Presumptive TB – Any person whether adult or child with signs and/or symptoms
suggestive of TB whether pulmonary or extra-pulmonary, or those with CXR findings
suggestive of active TB.

Systematic Screening - Is the organized identification of people presumed to have DR-

TB using rapid molecular diagnostic test (i.e. Xpert MTB/RIF).

IV. Policies

1. New WHO-recommended rapid diagnostic tools shall be adopted in accordance with

national health policies and capacity. Xpert MTB/RIF test shall be the primary
diagnostic tool for all presumptive DR-TB. TB culture and DST for FLD and SLD shall
be done when rifampicin resistance is detected.

2. All presumptive DR-TB whether pulmonary or extra-pulmonary shall be

systematically screened.

3. Pulmonary and extra-pulmonary specimens shall be transported to the nearest Xpert

site while specimens that require special handling (i.e. maceration of tissue sample)
shall be transported to the TB culture laboratories.

4. All laboratory results shall be issued within the prescribed turn-around time. Results
from other laboratories outside the NTP laboratory network with quality assurance
shall be accepted by PMDT treatment facilities.

5. All public and private laboratories within the NTP laboratory network shall participate
in the Quality Assurance (QA) system of the National TB Reference Laboratory
(NTRL).

22
6. Children with active TB who are contacts of DR-TB and cannot expectorate/produce
specimen for diagnosis shall be diagnosed as DR-TB.

7. Intensified case finding shall be implemented by all PMDT treatment facilities. Priority
shall be given to contacts of DR-TB.

V. Procedures

A. Identifying Presumptive DR-TB

1. Initially identify if the patient is presumptive TB, assess patient for clinical signs and
symptoms, and ask for chest X-ray result or film, if any. Inquire for detailed history of TB
treatment and risk factors for DR-TB. Note the patient’s general information on the
individual treatment record or patient’s chart.

2. Identify if the patient is a presumptive DR-TB based on the table below:

Table No. 5 - Presumptive DR-TB

History of Definition
Treatment
A patient who has been previously treated with anti-TB drugs for at
least one (1) month in the past.

This includes the following cases:

Retreatment  Relapse
 Treatment After Failure
 Treatment After Lost to Follow – up (TALF)
 Previous Treatment Outcome Unknown (PTOU)
 Non – converter of Category II
A patient who has never had treatment for TB or who has taken
anti-TB drugs for less than one (<1) month but has the following
risk factors for DR-TB:
New  Contacts of confirmed DR-TB cases
 Non – converter of Category I
 People living with HIV with CXR suggestive of TB or any of
the four symptoms: cough of any duration, fever, weight loss,
night sweats.

All listed above are considered high DR-TB risk thus proceed to screening the
presumptive DR-TB for Xpert MTB/RIF test. Patients shall not be directly referred to Xpert
site.

3. Record the patient in Form 1. Presumptive TB Masterlist or Referral Logbook (Refer

to Annex A List of Forms on page 145-146).

23
4. For referrals from non-engaged health care provider, assess the patient and manage
according to NTP protocols.

B. Sending of specimen for Xpert MTB/RIF

1. Discuss with the presumptive DR-TB patient the processes of ruling out DR-TB using
the Paunawa Form (See Annex E on page 200).

2. Collect one (1) sputum specimen for Xpert MTB/RIF test (See Annex G on page 206-
207 for the Procedures on Collection and Transport of Sputum Specimen).

The following are the accepted specimens for Xpert:

• Pulmonary specimens including expectorated, or induced sputum; broncho-
alveolar lavage fluid; bronchial washings; bronchial biopsy specimen and
gastric aspirates
• Extra-pulmonary specimens such as Cerebrospinal fluid (CSF).
• Tissue samples obtained through biopsies such as lymph nodes, pleura and
others.

Other extra-pulmonary specimens such as blood, urine, and stool are still not being
accepted for processing. Pleural fluid will be accepted but yield is low.

3. Fill out Form 2a. NTP Laboratory Request and Result Form, either in paper or
electronically through ITIS, and indicate Xpert MTB/RIF as the test requested. (See
Annex A List of Forms on page 147)

4. Fill out 2 copies of the TB Laboratory Specimen Receiving Form and send to the
Xpert site together with the filled – out Form 2a. NTP Laboratory Request and Result
Form (See Annex C List of Administrative Forms on page 171).

Possible modes of specimen transport:

a. Hand carried by health care provider
b. Hand carried by patient, relative or significant others
c. Courier funded by LGU or other donors

5. Send extra-pulmonary specimens that require special handling to NTRL or other

Culture Laboratories using the same processes above.

6. The Regional Office shall regularly disseminate the updated list of Xpert Sites and
PMDT treatment facilities.

C. Receiving and Processing of Specimen and Releasing of Xpert Results

1. Upon receipt of specimen/s, compare TB Laboratory Specimen Receiving Form with

Form 2a. NTP Laboratory Request and Result Form. Inspect for completeness and
consistency of forms and quality of specimens.

24
2. Acknowledge receipt by signing TB Laboratory Specimen Receiving Form and
sending back one copy to requesting facility.

3. Record in the Form 3a. Laboratory Register (Microscopy and Xpert MTB/RIF)
(See Annex A List of Forms on page 151)

4. Process specimen according to protocol.

5. Record results in Form 3a. Laboratory Register (Microscopy and Xpert MTB/RIF) and
ITIS.

Xpert MTB/RIF results are recorded as follows:

Table No. 6 - Xpert MTB/RIF Results and Interpretation

T MTB detected, Rifampicin resistance not detected
RR MTB detected, Rifampicin resistance detected
TI MTB detected, Rifampicin resistance indeterminate
N MTB not detected
I Invalid/ no result/ error

If rifampicin resistant, promptly notify the referring facility through SMS, e-mail,
phone call or new technologies.

6. If the Xpert MTB/RIF test results are MTB detected, rifampicin resistance
indeterminate or Invalid/no result/error, contact DOTS/PMDT treatment facility to
advise patient for repeat sputum collection immediately. The result of the second test
will be the basis for diagnosis.

7. Fill out 2 copies of the TB Laboratory Results Releasing Form and send to the
DOTS/PMDT treatment facility together with the results in the Form 2a. NTP
Laboratory Request and Result Forms. Release results only to the requesting facility
within three (3) working days (See Annex C List of Administrative Forms on page 172).

8. The DOTS/PMDT treatment facility promptly informs the patient of the Xpert result.

D. Deciding based on Laboratory Results within NTP Laboratory Network

1. Acknowledge receipt by signing TB Laboratory Results Releasing Form and sending

back one copy to the Xpert Site.

2. Update the Form 1. Presumptive TB Masterlist or Referral Logbook for the results of
the Xpert MTB/RIF test.

25
3. Manage patient according to result. Refer to diagnostic algorithm below.

a. If rifampicin resistant and with high DR-TB risk (presumptive DR-TB), start
treatment if facility has PMDT services. If none, promptly refer to a PMDT
treatment facility for initiation of treatment. Fill – out Form 7. NTP Referral
Form and attach a copy of Form 4. TB Treatment/IPT card for the latest
anti-TB treatment and copies of Form 2a. NTP Laboratory Request and
Result Form for the result of the DSSM and Xpert MTB/RIF done (See
Annex A List of Forms on page 164 and 153). If rifampicin resistant and with
low DR-TB risk, repeat Xpert MTB/RIF test and follow result of the second
test.

b. If MTB detected, rifampicin susceptible, start treatment based on MOP.

Culture and DST may be requested if resistance is highly suspected. The
patient may be registered as clinically diagnosed DR-TB and managed
correspondingly even if Xpert result does not show rifampicin resistance.
This case shall be referred to the TB Medical Advisory Committee for review
and final decision.

c. If final result is rifampicin resistance indeterminate, further assess patient

for other clinical conditions. Patient may still be initiated DR-TB treatment
depending on signs and symptoms, other laboratory test results and
chest x-ray. This case shall be referred to the TB Medical Advisory
Committee for review and final decision.

d. If MTB negative, put patient under surveillance. Culture and DST may be
requested if resistance is highly suspected.

4. For extra-pulmonary cases, manage according to result of Xpert or culture and DST.

E. Deciding based on Laboratory Results from Other Laboratories not Part of

the NTP Laboratory Network

1. Accept all Xpert MTB/RIF results from other laboratories (within and outside the
country) not part of the NTP Laboratory Network and manage in accordance with NTP
policies.

2. Accept culture and DST results from laboratories with quality assurance based on the
annual list issued by NTRL at the start of the year.

26
 Figure No. 5 - Current Diagnostic Algorithm Using Xpert MTB/RIF Test

Presumptive Drug-resistant TB
(Relapse, Treatment After Lost to Follow-up, Treatment After
Failure, Previous Treatment Outcome Unknown, Non-converter Cat
1, contacts of DR-TB)

Xpert MTB/RIF Test

MTB Detected MTB Detected MTB Detected

MTB Not Detected Rifampicin Resistance Rifampicin Resistance Rifampicin Resistance
NOT Detected Detected Indeterminate
Invalid/ Error/ No result

Reassessment

High DR- Low DR- Repeat

New Retreatment Xpert
TB Risk TB Risk
MTB/RIF
Test

Second line anti-

TB treatment Follow result
nd
of 2 test
First line anti-TB
treatment
27
F. Classifying DR-TB Cases⁹

If patient is eligible for DR-TB treatment, classify patient based on bacteriologic status,
anatomical site, history of treatment, and drug susceptibility test.

a. Classification based on bacteriologic status

i. Bacteriologically – confirmed – A TB patient from whom a biological
specimen is positive by smear microscopy, culture or rapid diagnostic
tests (such as Xpert MTB/RIF).
ii. Clinically – diagnosed – A TB patient who does not fulfill the criteria
for bacteriological confirmation but has been diagnosed with active TB
by a clinician or other medical practitioner who has decided to give the
patient a full course of TB treatment. This definition includes cases
diagnosed on the basis of CXR abnormalities or suggestive histology,
and extra-pulmonary cases without laboratory confirmation. This is
highly relevant for the very young and PLHIV.

b. Classification based on anatomical site

i. Pulmonary TB (PTB) – Refers to a case of tuberculosis involving the
lung parenchyma. A patient with both pulmonary and extra-pulmonary
TB should be classified as a case of pulmonary TB.
ii. Extra-pulmonary TB (EP-TB) – Refers to a case of tuberculosis
involving organs other than the lungs (e.g., larynx, pleura, lymph nodes,
abdomen, genitourinary tract, skin, joints and bones, meninges).
Histologically-diagnosed EPTB through biopsy of appropriate sites will
be considered clinically-diagnosed TB. Laryngeal TB, though likely
sputum smear-positive, is considered an extra-pulmonary case in the
absence of lung infiltrates on CXR.

c. Classification based on history of previous treatment

i. New case – A patient who has never had treatment for TB or who has
taken anti-TB drugs for less than one (<1) month. Isoniazid preventive
therapy or other preventive regimens are not considered as previous TB
treatment.
ii. Retreatment case – A patient who has been previously treated with
anti-TB drugs for at least one (1) month in the past.

d. Classification based on drug susceptibility testing

i. Mono-resistant TB – Resistance to one first line anti-TB drug only
(except resistance to Rifampicin).
ii. Poly-resistant TB – Resistance to more than one first line anti-TB drug
(except resistance to rifampicin).
iii. Rifampicin-resistant TB (RR-TB) – Resistance to rifampicin detected
using phenotypic or genotypic methods, with or without resistance to
other anti-TB drugs. It includes any resistance to rifampicin, whether

28
 mono-resistance, multi drug-resistance, poly-resistance or extensively
drug-resistance.
iv. Multi drug-resistant TB (MDR-TB) – Resistance to at least Isoniazid
and Rifampicin with or without resistance to other anti – TB drugs
v. Extensively drug – resistant TB (XDR-TB) – MDR-TB with resistance
to any fluoroquinolone and to at least one of the three second line
injectable drugs (Capreomycin, Kanamycin, and Amikacin).

e. Specific Classification based on Bacteriological Status for Recording and

Reporting Purposes¹º
i. Bacteriologically-confirmed rifampicin-resistant TB (BC RR-TB) –
A patient with sputum from pulmonary site or biological specimen from
extra-pulmonary site that is positive for MTB complex using rapid
diagnostic modalities (e.g. Xpert MTB/RIF) with resistance to rifampicin
from a Xpert machine regardless of date of collection, with or without
radiographic abnormalities. If patient had previous successful treatment,
resistance should be from specimen collected after successful
treatment.
ii. Bacteriologically-confirmed Multi Drug-resistant TB (BC MDR-TB)
– A patient with sputum from pulmonary site or biological specimen from
extra-pulmonary site that is positive for MTB complex with resistance to
at least both Isoniazid and Rifampicin from an NTP-recognized
laboratory regardless of date of collection, with or without radiographic
abnormalities. If patient had previous successful treatment, resistance
should be from specimen collected after successful treatment.
iii. Bacteriologically-confirmed Extensively Drug-resistant TB (BC
XDR-TB) – A patient with sputum from pulmonary site or biological
specimen from extra-pulmonary site that is positive for MTB complex
with resistance to any fluoroquinolone and to at least one of three
second line injectable drugs (Capreomycin, Kanamycin and Amikacin),
in addition to multi drug resistance, from an NTP-recognized laboratory
regardless of date of collection, with or without radiographic
abnormalities. If patient had previous successful treatment, resistance
should be from specimen collected after successful treatment.
iv. Clinically-diagnosed Multi Drug-resistant TB (CD MDR-TB) – A
patient with at least one of the following:
- Specimens tested in an NTP-recognized laboratory that is negative
for MTB Complex but with clinical deterioration and/or radiographic
findings consistent with active TB, or
- Specimen/s with other resistance pattern (e.g., Mono-resistant or
Poly-resistant) with clinical deterioration and/or radiographic findings
consistent with active TB, or
- Laboratory diagnosis not done due to specified conditions but with
clinical deterioration and/or radiographic findings consistent with
active TB, or

29
 - Diagnosis showing resistance to both Isoniazid and Rifampicin from
a non-NTP-recognized laboratory;
and there has been no response to a course of empiric antibiotics and/or
symptomatic medications; and who has been decided by the TB Medical
Advisory Committee to have TB disease requiring a full course of
second-line anti-TB chemotherapy similar to BC MDR-TB.

v. Other TB on Second Line Anti-TB Drugs (Other TB on SLD) – The

following are considered as Other TB on SLD:
 Monoresistant-TB – Resistance to one first line anti-TB drug
except Rifampicin whether bacteriologically-confirmed
(regardless of date of collection, with or without radiographic
abnormalities) or clinically-diagnosed (e.g., severe adverse drug
reaction to anti-TB drugs except Rifampicin) and who has been
decided by the TB Medical Advisory Committee to have TB
disease requiring a course on mono-resistant TB regimen
 Polydrug-resistant TB – Resistance to more than one first line
anti-TB drug, other than both Isoniazid and Rifampicin, whether
bacteriologically-confirmed (regardless of date of collection, with
or without radiographic abnormalities) or clinically-diagnosed
(e.g., severe adverse drug reaction to anti-TB drugs except
Rifampicin) and who has been decided by the TB Medical
Advisory Committee to have TB disease requiring a course on
poly-resistant TB regimen
 Serious adverse drug reaction to Rifampicin – A patient with
at least one of the following:
i. Positive for MTB complex but no resistance to any anti-TB
drugs, or
ii. Negative for MTB complex but has been decided (either by
the physician and/or the TB Medical Advisory Committee) to
have TB disease and has serious adverse drug reaction to
Rifampicin thereby requiring a full course of second line anti-
TB chemotherapy similar to BC MDR-TB

G. Ensuring Quality Assurance of TB Laboratories

1. Xpert
a. Xpert site staff shall notify Regional Office if the Xpert machine is due for
annual calibration. Regional Office shall notify NTRL.
b. RO/NTRL shall monitor Xpert machines due for calibration.
c. NTRL, or any authorized office, shall provide calibration kit to the Xpert site.
d. Xpert site shall conduct calibration of the Xpert modules.
e. Xpert site shall keep a calibration schedule report.
f. NTRL shall keep a calibration schedule record of all Xpert machines in the
country

30
 g. Xpert site staff shall also ensure that the error rate is not more than 5% of
the total test run.

2. Culture
a. Culture laboratory staff shall monitor quarterly the laboratory performance
indicators (contamination rate, recovery rate and non-recovery rate).
b. NTRL shall implement the Equipment and Facility Maintenance.

3. DST (including LPA)

a. DST laboratory staff shall participate in annual proficiency testing given by
the supranational laboratory.

4. Feedback on the result of the QA shall be provided to the concerned laboratory

and proper action shall be undertaken.

H. Assessing DR-TB in Children¹¹

Drug-resistance in children shall be suspected in the following conditions:

 there is contact with known DR-TB
 there is contact with suspected DR-TB, i.e., source case is a treatment failure or a
retreatment case or recently died from TB
 a child with TB not responding to first line therapy despite adherence
 a child previously treated for TB presents with recurrence of disease

Every effort should be made to obtain sputum sample from the child that can be sent for
Xpert MTB/RIF.

For patients below 15 years old and cannot expectorate and produce specimen, diagnose
as DR-TB if the child has active TB (letter a) and letter b or c:

a. Diagnose active TB in a child using the MOP guidelines of 3 out 5

criteria:¹²
i. Positive exposure to an adult/adolescent with active TB disease;
ii. Positive signs and symptoms suggestive of TB: at least three (3)
of the following clinical criteria;
 Coughing/wheezing of 2 weeks or more, especially if
unexplained
 Unexplained fever of 2 weeks or more after common
causes such as malaria or pneumonia have been
excluded
 Loss of weight/failure to gain weight/weight faltering/loss
of appetite
 Failure to respond to 2 weeks of appropriate antibiotic
therapy for lower respiratory tract infection
 Failure to regain previous state of health 2 weeks after a
viral infection or exanthema (e.g. measles)

31
  Fatigue, reduced playfulness, or lethargy (e.g. child has
lost his/her normal energy)

iii. Positive tuberculin skin test (a positive TST confirms TB infection

after exposure);
iv. Abnormal chest x – ray suggestive of TB;
v. Laboratory findings suggestive or indicative of TB.
b. Positive exposure to an adult/adolescent with active DR – TB disease
c. Failure to improve clinically with first line anti-TB treatment despite
adherence

I. Conducting Intensified Case Finding

1. Screening of close contacts of DR – TB cases

a. Once a DR – TB case is registered for treatment, interview the index case

and explain the importance of contact investigation.
b. Ask for the name of all close contacts, regardless of age, and list them in
the Form 4b. DR – TB Treatment Card (See Annex A List of Forms on
page 154-159).
c. Instruct the index case to bring all close contacts to the DOTS/PMDT
treatment facility. Close contacts should be evaluated within seven (7) days
from treatment initiation of the index case to ensure prompt diagnosis. If the
patient is unable to bring along all his/her contacts within 7 days,
DOTS/PMDT treatment facility staff should conduct home visit to collect and
transport sputum specimens for Xpert testing.
d. Close contacts are considered presumptive DR – TB and shall be evaluated
based on the PMDT case finding procedures. Test all contacts using Xpert
MTB/RIF.
e. Record all contacts in the Form 1. Presumptive TB Masterlist or Referral
Logbook.
f. For contacts not initiated on treatment, conduct surveillance (symptom
assessment every 6 months for 2 years).

2. Screening in Congregate Settings¹³

a. TB case finding activities among inmates should be implemented during

routine procedures that inmates undergo:
i. Upon entry to the jail or prison;
ii. During detention through cough surveillance;
iii. Prior to transfer of inmates to another jail or prison; and,
iv. Prior to release of inmates back to the community.

The specific procedures are outlined and discussed in the policies and
guidelines of the Bureau of Jail Management and Penology and the Bureau
of Corrections.

32
 b. For other congregate settings, follow procedures on screening of close
contacts of DR-TB cases.

J. Preventing Initial Lost to Follow-up

a. Health care provider shall give enough time to clearly explain to the patient the
contents of the Paunawa form. Involve the family and significant others as well.
Provide IEC material.

b. Promptly inform patient through various means once the result of Xpert
examination has been received. If patient does not arrive in the facility a day after
he/she was informed about the result, this should serve as a signal to the health
care provider to immediately contact the patient and document the reason why
he/she did not come to the facility for initiation of treatment. If patient is not enrolled
within 2 days, this should serve as an alert to the health care provider. A home visit
shall be conducted by the PMDT treatment facility staff or by the nearest DOTS
facility staff. If patient is not enrolled after 2 days, this should serve as an alarm to
the health care provider. Coordination with RHUs, and LGUs shall be done to
convince the patient and provide support. If patient still is not enrolled after 3 days,
this shall be elevated to ROs for further action.

c. If patient could not come due to financial and geographical constraints, health care
provider shall reiterate to patient the options for treatment locations (facility or
home based) or provide enablers.

d. If patient prefers to be treated by another facility, prepare all necessary documents

and coordinate with the receiving health facility.

e. If the patient still refuses to be treated despite all efforts, document reason/s of
refusal and action/s taken (infection control, palliative care).

33
 Summary of Procedures

A. Identifying Presumptive DR – TB

B. Sending of specimen for Xpert MTB/RIF

C. Receiving and Processing of Specimen and Releasing of Xpert Results

D. Deciding based on Laboratory Results within NTP Laboratory Network

E. Deciding based on Laboratory Results from Other Laboratories not Part of the
NTP Laboratory Network

F. Classifying DR-TB Cases

G. Ensuring Quality Assurance of TB Laboratories

H. Assessing DR-TB in Children

I. Conducting Intensified Case Finding

J. Preventing Initial Lost to Follow-up

34
 CHAPTER 3

CASE HOLDING
I. Introduction

Case holding is a set of procedures which ensures that all DR-TB patients are promptly
initiated on treatment and are successfully treated. While first and second line anti-TB
drugs are available in the country, there are still many DR-TB patients who have not been
cured or who have not completed treatment because they are lost to follow-up. This can
lead to more extensive pattern of drug resistance, may lead to eventual death of the
patient or may potentially infect other people. Therefore, it is vital that patients with DR-
TB take all medications in the regimen correctly and regularly in order to increase the
probability of being cured and minimizing the risk of relapse.

Treatment of patients with DR-TB in the country generally lasts 9-11 months or 20-24
months and the duration may be modified according to the patient’s response to therapy.
Once patients have been diagnosed with DR-TB, uninterrupted treatment represents the
best opportunity for them to be cured.

II. Objective

To ensure prompt, quality, complete and effective treatment of all DR-TB patients.

III. Definition of Terms

TB Medical Advisory Committee – Also known as Consilium; Is a case management

committee composed of health care providers with expertise in managing DR-TB who
reviews and approves the cases presented for empiric treatment, and provides
recommendations on difficult cases.

Drug Ramping – The approach of slowly escalating drug dosage of oral second line
anti-TB drugs (Prothionamide, Cycloserine, PAS) over a 3 day period.

Empirical Treatment – Used in case the treatment has to be initiated prior to the
determination of a firm diagnosis of DR-TB after thorough evaluation of clinical, radiologic
and other data.

IV. Policies

A. All confirmed DR-TB patients (also known as patients suffering from DR-TB) shall
be assessed by a physician trained on PMDT for proper management.

B. The patients shall be promptly provided with quality, adequate and effective
treatment regimen within one (1) week from time of diagnosis.

35
C. The prescribed standard short treatment regimen shall be the primary regimen of
choice unless contraindicated or otherwise specified. All confirmed rifampicin
resistant (RR-TB) or MDR-TB patients, without suspected or confirmed resistance
to any fluoroquinolones and/or any one of the three second line injectable anti-TB
drugs, the prescribed standard regimen shall be provided. For patients with
extensive pattern of resistance, conventional or individualized regimen shall be
given.

D. The 9-month treatment regimen shall be adopted by the Program following WHO-
recommendations after all the necessary health system requirements have been
put in place.

E. Treatment regimen shall follow the age and weight-based dosing of anti-TB drugs
based on the latest WHO recommendations. Medically significant conditions (e.g.
renal insufficiency, pregnancy, psychiatric illness etc.) shall be considered for drug
dose adjustment.

F. All enrolled DR-TB patients shall undergo baseline and follow-up laboratory, ECG,
and other diagnostic tests to monitor treatment response.

G. All enrolled DR-TB patients shall be offered HIV Counselling and Testing (PICT)
upon enrolment. DR-TB patients with HIV co-infection shall be referred to HIV
treatment hub for co-management.

H. Ambulatory treatment (facility or community based) shall be the preferred mode of

care except for patients with life – threatening conditions, wherein hospitalization
shall be recommended.

I. DR-TB treatment shall be done through a patient-centered approach. DR-TB

patients shall be allowed to choose where to receive treatment among PMDT
treatment facilities (TC, STC, iDOTS facility), including option for Community-
based PMDT care. Patients needing close monitoring shall be offered an option to
relocate near the PMDT treatment facility. Treatment shall be carried out in settings
that are most accessible and acceptable to the patient daily (7 days a week).

J. Only trained community treatment partners shall be involved by PMDT treatment

facilities to implement the case holding of DR-TB patients for Community-based
PMDT Care.

K. Treatment response of DR-TB shall be monitored through DSSM, TB culture and

clinical signs and symptoms.

L. All PMDT treatment facilities shall comply with the current national policy and
program on Pharmacovigilance and rational use of anti-TB drugs by FDA. All
serious adverse events shall be reported using the official reporting form of the
FDA (Refer to Chapter 9 – Pharmacovigilance on page 119).

36
M. All PMDT treatment facilities shall ensure that tracing mechanisms are in place for
patients who interrupt treatment (with special emphasis on the role of the health
center/rural health unit in interrupter tracing).

N. Patients shall be provided with psychosocial support and enablers in coordination

with the LGUs, NGOs and other organizations to improve treatment adherence.

O. All patients who are successfully treated shall be followed-up every 6 months for
2 years by checking for recurrence of symptoms, TB culture and DST (if needed)
and chest X-ray.

P. All patients shall be given palliative care, especially those who failed or refused
further DR-TB treatment (See Chapter 5 - MDR-TB and Palliative Care on page
80).

V. Procedures

A. Preparing for Initiation of DR-TB treatment

1. Counsel patient including family and significant others regarding DR-TB. For patients
less than 18 years old, mentally incapacitated or those who cannot make their own
decision, discuss with the parent/guardian regarding the need for the patient to undergo
treatment.

2. Administer the “DR-TB Treatment Information Form” (See Annex F on Page 201-
205).

3. Confirm that the patient agrees to undergo treatment for DR-TB and ensure that the
patient understands that this requires:
- Daily treatment for 9-11 months or 20-24 months (7 days a week)
- Consultation and assessment by a physician at least once a month
- Monthly follow-up DSSM and culture examinations
- Regular monitoring of laboratory and other diagnostic tests
- DOT can be done in the following settings by a trained treatment partner:
 PMDT treatment facility
 DOTS Facility
 Nearest public hospital
 Other accredited clinics
 Home
 Other mutually- agreed location
- DOT can be provided by:
 Intensive phase of treatment: Health care provider and trained
community treatment partner who is allowed to administer injections
(e.g. Doctor, Nurse)

37
  Continuation phase of treatment: Health care provider and
community treatment partner

4. Determine the appropriate treatment regimen for the patient.¹⁴

4.1. Assess if the patient has the following:

a. Confirmed or suspected resistance to second line injectable agent and/or

fluoroquinolone
b. Exposure to > 1 second line drugs in the shorter MDR-TB regimen for >
1 month
c. Intolerance to > 1 drugs in the shorter MDR-TB regimen or risk of toxicity
(e.g. drug-drug interactions)
d. Pregnancy
e. TB Meningitis, Osteoarticular TB, Disseminated TB
f. At least one medicine in the shorter MDR-TB regimen not available in the
program

4.2. If the answer is NO to all criteria, initiate Standard Short Treatment Regimen
(SSTR) which consists of:

4-6 Mfx – Km – Pto – Cfz – Z – E – Hʰ /5 Mfx – Cfz – Z – E

4.3. If the answer is YES to any one of the criteria, initiate Conventional Treatment
Regimen (CTR).

4.3.1. Identify the appropriate treatment regimen depending on the DR-TB

case. The anti-TB drugs are classified into four (4) groups as enumerated
in Table 7. This grouping is intended to guide the design of conventional
regimens.

38
 Table No. 7 - Anti-TB Drugs Recommended for Treatment of Rifampicin-Resistant
and Multi-Drug Resistant TB

A. Fluoroquinolones1 Levofloxacin Lfx

Moxifloxacin Mfx
Gatifloxacin Gfx
B. Second-line injectable agents2 Amikacin Am
Capreomycin Cm
Kanamycin Km
(Streptomycin)3 (S)
C. Other core second-line agents Ethionamide/Prothionamide Eto/Pto
Cycloserine/Terizidone Cs/Trd
Linezolid Lzd
Clofazimine Cfz
D. Add-on agents Pyrazinamide Z
(not part of the core MDR-TB D1 Ethambutol E
regimen) High-dose Isoniazid Hʰ
D2 Bedaquiline Bdq
Delamanid Dlm
p-aminosalicylic acid PAS
Imipenem-cilastatin Imp
D3 Meropenem Mpm
Amoxicillin- Amx-Clv
clavulanate4
(Thioacetazone)5 (T)

1
Drugs in Group A are shown by decreasing order of usual preference for use subject to other considerations
2
Drugs in Group B are shown by decreasing order of usual preference for use subject to other considerations
3
Resistance to streptomycin alone does not qualify for the definitions of extensively drug-resistant TB (XDR-TB)
4
Carbapenems (Imipenem, Meropenem) and clavulanate are meant to be used together, clavulanate is only available in
formulations combined with amoxicillin
5
HIV-status must be tested and confirmed to be negative before thioacetazone is started

39
 Adapted from the WHO Treatment Guidelines for Drug-resistant Tuberculosis 2016 Update

4.3.2. The treatment regimen for the patient should consist of at least four
(4) effective anti-TB drugs that have not been used before and/or are
susceptible by DST, taking into account DST reliability and cross-
resistance. Design a treatment regimen following the steps described
below:

Table No. 8 – Steps in Designing Conventional Treatment Regimens for DR-TB

Step 1: Review patient’s clinical history and DST.

Review patient’s DST and confirm the patient’s history of anti-TB treatment to
determine if a drug has certain or almost certain effectiveness. If evidence about the
effectiveness of a drug is unclear, the drug may be included in the regimen but it should
not be counted as one of the four core drugs.

Step 2: Select one later – generation fluoroquinolone from Group A.

For MDR-TB, this is will be considered as one of the effective drugs. For XDR-TB,
fluoroquinolones will not be counted as one of the effective drugs due to possibility of
cross-resistance.

Step 3: Select one injectable agent from Group B.

Always use one (1) group B agent during the intensive phase which should last at 4-6
months for SSTR and about 8 months for the conventional treatment regimen (CTR).
For MDR-TB, this is considered as one of the effective drugs but not in XDR-TB due to
possibility of cross-resistance.

Step 4: Select other SL drugs from Group C.

Add two (2) or more anti-TB drugs among Group C until you have at least four (4)
second line anti-TB drugs likely to be effective.

Step 5: Select add-on agents from Group D.

Select additional anti-TB drugs among group D only if the core regimen of four reliable
anti-TB drugs cannot be formed from Group A-C because of resistance, previous use,
or adverse events. For group D1, use Pyrazinamide and evaluate the use of Ethambutol
but neither should be considered as one of the four effective drugs.

5. DR-TB patients receiving SLDs in the past or contacts of pre-XDR and XDR-TB shall
be referred to the TB Medical Advisory Committee for proper management.

40
6. For mono – and poly – resistant TB, these cases will be presented to the TB Medical
Advisory Committee for proper management.

7. For clinically diagnosed DR-TB, empirical regimen may be provided based on the
successful regimen that is curing the index case, if known.

8. Determine the dosage of the anti-TB drugs based on the weight. For SSTR, refer to
the table below for the weight-based dosing.

Table No. 9 - Dosages of the Anti-TB Drugs in the Standard Short Treatment
Regimen According to Weight Category
Drug (dose in 1 tablet for oral Weight group
drugs) <33 kg 33-50 kg >50 kg
Kanamycin *
(15 mg/kg, max 1000 mg)
Clofazimine (100 mg)
50 mg 100 mg 100 mg
Moxifloxacin (400 mg)
400 mg 600 mg 800 mg
Ethambutol (400 mg)
800 mg 800 mg 1200 mg
Isoniazid (300 mg)
300 mg 450 mg 600 mg
Pyrazinamide (400 mg)
1000 mg 1500 mg 2000 mg
Prothionamide (250 mg)
250 mg 500 mg 750 mg
* In case of resistance to Kanamycin and susceptibility to Capreomycin, replace Kanamycin with Capreomycin at the same dose
(15 mg/kg, max 1000 mg).

For dosages of the anti-TB drugs in CTR, refer to Annex I on page 218-224 for the
weight-based dosing recommendation of WHO.

B. Conducting Pre-treatment Evaluation

1. Do baseline examinations.

A. The collection date of the sputum specimen should be done within 30 days prior
to initiation of treatment or 7 days after the start of treatment. Any examination
done within these periods are considered baseline examination.

B. Do the following examinations:

- Collect two (2) sputum specimens for DSSM, TB culture, and DST
- For all confirmed RR-TB, collect another sputum specimen for Line Probe
Assay (LPA)
- Chest radiograph (CXR)

41
- Blood chemistries:
a. Glucose (FBS)
b. Uric Acid
c. Kidney function (BUN & Crea)
d. Electrolytes (K, Ca, Mg)
e. Liver Function Test (SGPT & SGOT)
f. TSH (if regimen contains Pto, PAS or both)
g. Albumin (if regimen contains Delamanid)
- Pregnancy test for all women of childbearing age
- Complete Blood Count (CBC)
- Audiometry
- ECG
 If patient is receiving QT prolonging anti-TB drugs such as
Moxifloxacin (Mfx), Clofazimine (Cfz), Bedaquiline (Bdq), Delamanid
(Dlm), other frequently used drugs such as Metoclopramide,
Ondansetron, macrolides, Domperidone and risk situations like
hypothyroidism and hypokalemia. Note: Levofloxacin (Lfx) may also
cause QT prolongation but to a lesser extent compared to Mfx.

- Visual acuity if regimen contains E or Lzd

- HIV Rapid Antibody Test

42
Table No. 10 - Schedule of Clinical and Laboratory Baseline and Follow-up Examinations for DR-TB Patients during the Intensive Phase and Continuation Phase of
Treatment
Intensive Phase Continuation Phase
SSTR: 4 months (may be extended SSTR: 5 months
up to 2 months) CTR: 12-14 months
CTR: 8 months
Test/Examination Baseline M1 M2 M3 M4 M5 M6 M7 M8 M9
Clinical Evaluation by the PMDT Physician including weight          
for all and height for children
Mycobacteriological Tests
Direct Sputum Smear Microscopy (DSSM) 6          
TB Culture (TBC)7          
Drug Sensitivity Testing (DST)8 
Line Probe Assay (LPA) 
Diagnostic Tests
Audiometry9     
Chest X-ray (CXR)10 
Electrocardiogram (ECG)11          
Visual Acuity12          
Blood Chemistry/Hematology/Immunological Tests
Alanine and Aspartate Transaminase (ALT/AST) 13     
Albumin If regimen contains Delamanid: Baseline and Quarterly
Calcium, Magnesium (Ca, Mg)14 
Complete Blood Count (CBC)15 
Creatinine16     
Fasting blood sugar (FBS) 
HIV Rapid Antibody Test 
Lactic Acid Indicated for work-up of lactic acidosis in patients receiving Linezolid
Lipase (or Amylase) Indicated for work-up of abdominal pain to rule out pancreatitis in patients receiving Bedaquiline
Potassium (K)17     
Pregnancy Test 
Thyroid Stimulating Hormone (TSH) If regimen contains Prothionamide or Para-aminosalicylic Acid: Baseline, Semi-annual
If regimen contains both Prothionamide and Para-aminosalicylic Acid: Baseline, Quarterly
Urea Nitrogen 
Uric Acid 

6
Two (2) sputum specimens required for baseline
7
For conventional treatment regimen, TB culture shall be requested every 3 months during the continuation phase of treatment
8
Repeat DST if month 4 sputum specimen is positive for TB or anytime during the continuation phase
9
Audiometry shall be performed monthly if regimen contains injectable agent
10
CXR shall be repeated at the end of the intensive phase
11
ECG shall be done monthly if patient is receiving any QT prolonging drugs (e.g. Moxifloxacin, Clofazimine, Delamanid, Bedaquiline)
12
Visual Acuity shall be performed monthly if regimen contains Ethambutol or Linezolid
13
ALT/AST shall be requested monthly during the intensive phase
14
Repeat Ca, Mg anytime if there is hypokalemia
15
CBC shall be requested monthly if regimen contains Linezolid
16
Creatinine shall be requested monthly if regimen contains injectable agent
17
Potassium shall be requested monthly if regimen contains injectable agent or Bedaquiline

43
 C. Provider Initiated Counselling and Testing (PICT): Offer counselling and
testing for HIV to all registered DR - TB cases 15 years old and above upon
enrolment.
-Do pre-test counselling.
-If the patient consents to testing, refer the patient to a proficient medical
technologist for testing.
-If the patient does not consent to testing, offer testing again in the
subsequent visits.
-Results of HIV screening will be written in Form 2b. NTP Laboratory
Result Form for HIV testing and sent to the physician (See Annex A
List of Forms on page 148).
-Do post-test counselling.
-All patients with reactive results shall undergo confirmatory testing. This
shall be coordinated by the proficient medical technologist to SACCL.
-Once confirmed to have HIV, immediate referral for co-management to
HIV treatment hub shall be done. PMDT treatment facility staff shall
ensure initiation of ART within 8 weeks from start of anti-TB treatment
as well as the provision of Co-trimoxazole Preventive Therapy (CPT).

2. Determine whether there are special conditions and situations that affect the
regimen. Assess and address all co-morbidities. Refer patients to appropriate
specialists or health institutions for any needed interventions not available in your
facility (e.g. anti-retroviral therapy (ART), diabetes control, smoking cessation, visual
or hearing acuity tests, monitoring of liver enzymes, etc.).¹⁵

HIV infection

Patients who have TB and HIV, and particularly patients who have DR-TB with
HIV co-infection, present a challenge for treatment due to compounding
adverse drug reactions brought about by ART and anti-TB drugs. The likelihood
of dying from TB greatly increases if PLHIV with TB is not supported by ART.

HIV-positive DR-TB patients should be started on ART within the first eight
weeks of starting DR-TB treatment regardless of CD4 count. DR-TB patients
who are already on ART should continue it. The ART regimen prescription shall
come from the treatment hub/private health care provider. There must be a
proper coordination between the treatment hub/private health care provider and
PMDT treatment facility, specifically to discuss potential drug-drug interactions
between anti-TB drugs and ART.

Substance dependence¹⁶

Substance or alcohol abuse may be encountered among DR-TB patients.

Alcohol abuse was recorded at a significantly higher frequency among DR-TB
LTFU patients compared to patients who completed or were continuing DR-TB
treatment.

Patients with substance-dependence disorders should be referred for therapy

in specialized institutions. Strongly encourage patients to completely abstain
from alcohol or other substances, although active consumption is not a

44
 contraindication for DR-TB treatment. Special caution should be considered in
patients taking Cycloserine due to higher incidence of adverse effects like
seizure.

Psychiatric disorder

Patients with DR-TB have high rates of depression and anxiety due to chronicity
of the disease and socioeconomic stressors.

Patients with psychiatric disorder should undergo psychiatric evaluation prior to

start of DR-TB treatment. Special caution should be considered in patients
taking Cycloserine but the use of Cycloserine is not absolutely contraindicated.
Family members or significant others should be educated about Cycloserine
toxicity and instruct to contact the health care provider for any change in
patient’s behavior. Individual or group therapy session, and treatment with
psychiatric medication may be necessary to manage patients with psychiatric
condition or neurotoxicity brought about by DR-TB treatment. Pyridoxine
(Vitamin B6) 50 mg is indicated for every 250 mg of Cs.

Liver disorder

Patients with liver disorder are at increased risk of hepatotoxicity due to anti-TB
drugs. Of the first line anti-TB drugs, Isoniazid, Rifampicin and Pyrazinamide,
are associated with hepatotoxicity. Second line anti-TB drugs, specifically
Prothionamide/Ethionamide, PAS, Bedaquiline, can also be hepatotoxic.

Patients with a history of liver disease can receive the usual DR-TB regimens
provided there is no clinical evidence of chronic active liver disease, acute viral
hepatitis or excessive alcohol consumption. Otherwise, avoid pyrazinamide and
use of other drugs known to cause hepatotoxicity with caution. Liver enzymes
should be monitored monthly while on DR-TB treatment.

Seizure disorder

Second-line anti-TB drugs, specifically Cycloserine and high dose Isoniazid,

can cause seizures. The risk of seizure from these medications is higher in
patients who have pre-existing seizure disorder.

Avoid Cycloserine and high dose Isoniazid in patients with active seizure
disorders that are not well controlled with medication. However, in cases where
Cycloserine or high dose Isoniazid is a crucial component of the treatment
regimen, it can be given and the seizure medication adjusted as needed.

Chronic Kidney Disease

Anti-TB drugs that are excreted by the kidneys can accumulate to toxic levels
in patients with renal dysfunction.

45
 Renal function should be estimated by calculating the creatinine clearance in
all patients receiving DR-TB treatment.
Creatinine Clearance (Estimated Glomerular Filtration Rate)

Constant
= weight (kg) x (140 - age) x ____________________
Creatinine (umol/L)

Considerations for the computation of creatinine clearance:

Constant:
 Men= 1.23
 Women= 1.04
If creatinine is reported in conventional unit (mg/dL), this can be converted
to
an SI unit (umol/L) by multiplying 88.4.
Normal value for serum creatinine:
 Men= 60-110 umol/L
 Women= 45-90 umol/L

Table No. 11 – Adjustment of Anti-TB Drugs in Patients with Renal

Insufficiency
Drug Recommended Dose and Frequency for Patients
with Creatinine Clearance <30ml/min or For
Patients Receiving Hemodialysis (Unless
Otherwise Indicated Dose After Dialysis)
Group A
Levofloxacin 750-1000 mg per dose three times per week
Moxifloxacin No adjustment necessary
Group B
Kanamycin 12-15 mg/kg per dose three times per week
Capreomycin 12-15 mg/kg per dose three times per week
Group C
Prothionamide No adjustment necessary
Cycloserine 250 mg once daily, or 500 mg/dose three times a
week
Linezolid No adjustment necessary
Clofazimine No adjustment necessary
Group D
High dose Isoniazid No adjustment necessary
Pyrazinamide 25-35 mg/kg per dose three times per week
Ethambutol 15-25 mg/kg per dose three times per week
Bedaquiline No dosage adjustment is required in patients with
mild to moderate renal impairment (dosing not
established in severe renal impairment, use with
caution)

46
 Delamanid No dosage adjustment is required in patients with
mild to moderate renal impairment (dosing not
established in severe renal impairment, use with
caution)
Para-aminosalicylic 4 gm/dose, twice daily maximum dose
Acid
Imipenem/cilastatin For creatinine clearance 20-40 ml/min dose 500 mg
every 8 hours; for creatinine clearance <20 ml/min
dose 500 mg every 12 hours
Meropenem For creatinine clearance 20-40 ml/min dose 750 mg
every 12 hours; for creatinine clearance <20 ml/min
dose 500 mg every 12 hours
Amoxicillin/Clavulanate For creatinine clearance 10-30 ml/min dose 1000
mg as amoxicillin component every 12 hours; for
creatinine clearance <10 ml/min dose 1000 mg as
amoxicillin component once a day
Adapted from the Companion Handbook to the WHO Guidelines for the Programmatic Management of
Drug-resistant TB, 2014, pp. 112-113

Patients with renal dysfunction require close supervision and modification of the
doses of certain drugs. Monitor serum creatinine and electrolytes every 1–2
weeks while the patient is on the injectable agent.

Diabetes mellitus

The presence of diabetes mellitus may multiply the adverse effects of anti-TB
drugs, especially renal dysfunction and peripheral neuropathy.

Monitor creatinine and potassium concentrations more frequently than usual,

preferably weekly during the first month of treatment and at least every three
months thereafter depending on the clinical status of the patient and based on
physician’s discretion. Patients should have regular monitoring of blood glucose
level and other important parameters for diabetes management. Oral
hypoglycemic agents can be used during DR-TB treatment but may require
dose adjustment due to drug-drug interaction. Some experts recommend the
use of insulin for tight blood glucose control. Ethionamide or Prothionamide may
make it more difficult to control insulin levels.

Children

The basic principles of regimen design for children are the same as those for
adults with DR-TB. The dose of anti-TB drugs should be administered
according to the child’s weight. Weight and height should be monitored monthly
and doses adjusted as the child grows and gains weight. A pediatric patient
may have a negative culture, and regimens can be designed only on the
contact’s DST results and history of exposure to anti-TB drugs. There is no
anti-TB drug that is absolutely contraindicated in children, including the
fluoroquinolones, whose benefits outweigh their risks. Second line injectable
agent may be excluded from the conventional treatment regimen for children

47
 with mild form of disease (without cavitary lesion and involves only one (1) lobe
of the lungs).

Breastfeeding

Most anti-TB drugs will be found in concentrations equal to only a small fraction
of the therapeutic dose used in infants. Although the effects of such exposure
on infants are not well established, breastfeeding is not contraindicated but
infection control measures must be in place. When mother and infant are
together, their time should be spent in well-ventilated areas or outdoors and
mother should be advised to wear mask.

Use of oral contraception

Patients generally have no problems in continuing to use oral contraceptives

unless they vomit within 2 hours after taking the contraceptive. This may lead
to poor absorption of the contraceptive and decreased efficacy.

Pregnancy

Treatment for DR-TB is not contraindicated during pregnancy. However,

pregnancy should be avoided while patient is undergoing DR-TB treatment
because some of the second line anti-TB drugs may cause birth defects. It is
necessary to determine the severity of the TB disease as this will guide the
decision whether to postpone the start of treatment. Since there have only been
a limited number of studies on the effects of second line anti-TB drugs on
pregnant patients, and particularly on the fetus, treatment of pregnant patients
who are clinically stable and with mild disease may be postponed until the
second trimester as most teratogenic effects occur during the first trimester.
However, if the mother’s DR-TB is severe or life threatening, treatment should
be started sooner. The decision whether to start or postpone treatment shall be
agreed upon by the patient and physician after the risks and benefits of initiating
DR-TB treatment have been discussed thoroughly.

All female patients of child bearing age shall be assessed for pregnancy upon
initial evaluation (last menstrual period and pregnancy test). The regimen for a
pregnant patient should include three to four oral medicines deemed to be
effective but exclude the following:

- Injectable agents (Group B), because they are particularly toxic to the
developing fetal ear (ototoxic), specifically during the first trimester, but
Capreomycin may be used from the 2nd trimester onwards.

- Prothionamide (Group C), because of an increased risk of nausea and

vomiting, and possible teratogenic effects.

48
Table No. 12 – Safety of Anti-TB Drugs in Pregnancy according to US FDA
Classification
Safety Class Safety Class Interpretation Anti-TB Drug
A Safety established using human ---
studies
B Presumed safety based on E
animal studies
C Uncertain safety, no human H, R, Z, FQs, Cm, Eth/Pto, Cs,
studies, animal studies show an PAS, Cfz, Lzd
adverse effect
D Unsafe , evidence of risk that S, Km, Am
may be justifiable under certain
clinical circumstances

The proposed regimen for pregnant patient shall be presented to the TB

Medical Advisory Committee for approval.

C. Initiating Treatment and Registration

1. Enroll the DR-TB patient at the PMDT treatment facility.

- Open and accomplish completely and accurately the Form 4b. DR-TB
Treatment Card and Form 5b. DR-TB Patient’s Booklet and keep up to date
throughout treatment. Provide a copy of the Form 4b. DR-TB Treatment Card
to the community treatment partner (See Annex A List of Forms on page 160-
161).

-The health care provider together with the patient shall decide who will be the
most appropriate treatment partner and where the treatment will be
administered if it is not possible to receive treatment at the PMDT treatment
facility.

-Treatment can be done in any accessible and convenient place for the patient
(e.g. treatment partner’s house, patient’s place of work, or patient’s house) as
long as the treatment partner can effectively ensure the patient’s intake of the
prescribed drugs and monitor his/her reactions to the drugs. Any of the following
could serve as treatment partner: a) DOTS facility staff, such as the midwife or
the nurse; or b) a trained community member, such as the BHW, local
government official, co-worker, or a former TB patient.

2. Supervise patient on intake of initial dose of medication (Drug Ramping)

- Most drugs should be started at full dose, except Cs, Pto and PAS, in which
case the dose of the drug can be increased over a three-day period.
- Doses given during drug ramping shall be considered as effective doses,
hence, shall be included in the total number of doses taken by the patient.

3. Acknowledge the treatment administered under direct observation by affixing initials

in the treatment card and booklet.

4. Register the patient in Form 6b. DR-TB register. Assign a DR-TB case number
and update the IT IS (See Annex A List of Forms on page 162-163).

49
D. Supervising Daily Treatment

Conduct the following activities daily:

1. Review and update patient’s booklet and treatment card to assess compliance.
2. Assess the patient for any problems or concerns regarding the treatment
3. Document all problems and concerns in the Patient Progress Report Form
(PPRF) and manage accordingly (See Annex B List of Patient Management Forms
on page170).
4. Prepare drugs and ensure correct drug and dosage as prescribed.
5. Administer patient’s medicines.
6. Consider patient absent if dose is missed.
7. Appreciate the patient for continuing treatment and remind him to return for the next
dose.
8. Document intake of patient on Form 4b. DR-TB Treatment Card and Form 5b. DR-
TB Patient’s Booklet.

E. Monitoring of Treatment

1. Monitor for occurrence of clinical problems during treatment.

Monthly Monitoring:
- Clinical assessment (symptom screening and physical examination) by
the
Physician
Daily:
- Manage adverse events and drug reactions and document in the PPRF
(See Annex J on page 224-225 for D.M. 2015-0228 - Expanded List of
PMDT Ancillary Drugs).

General strategies for managing adverse drug reactions:

a. Conduct patient information and counseling.

b. Provide psychosocial support.
c. For mild adverse events, this can be managed by nurses by
reassuring patient and providing supportive measures. For moderate,
severe, life-threatening or serious adverse events (SAEs), these shall be
evaluated and managed by the physician. (Note: All SAEs shall be
presented to the TB Medical Advisory Committee (Refer to Annex H on
page 208- 216 for The TB Medical Advisory Committee Guidelines).

Table No. 13 - Severity of Adverse Events¹⁷

Grade Severity Description
1 Mild Asymptomatic or mild symptoms; clinical
or diagnostic observations only;
intervention not
Indicated
2 Moderate Minimal, local or noninvasive intervention
indicated; limiting age-appropriate
instrumental ADL*.

50
 3 Severe Medically significant but not immediately
life-threatening; hospitalization or
prolongation of hospitalization indicated;
disabling; limiting self care ADL**.
4 Life-threatening Urgent intervention indicated
5 Death
*Instrumental Activities of Daily Living refer to preparing meals, shopping for groceries or clothes, using the
telephone, managing money, etc.
**Self care Activities of Daily Living refer to bathing, dressing and undressing, feeding self, using the toilet,
taking medications, and not bedridden.

d. Adjust drug dosages.

e. Modify the regimen.
If there is a need to stop one of the anti-TB drugs included in the
SSTR due to severe or serious adverse drug reaction, the
following modifications are allowed:
 INH: discontinue without replacement; treatment duration
is the same (9-11 months)
 E: discontinue without replacement; treatment duration is
the same (9-11 months)
 Z: discontinue without replacement; treatment duration is
the same (9-11 months)
 Mfx: replace with high dose Lfx; prolong the treatment
duration to 12 months; if high dose Lfx still not tolerated,
use Bdq, if not contraindicated; or use Lzd instead and
prolong the treatment duration to 12 months
Note: Bdq or Lzd shall be given for the entire treatment
duration.
 Km: shift to Cm for mild adverse events; for moderate to
severe adverse drug reactions, replace Km with Lzd if the
patient is still on the first 3 months of treatment; discontinue
Km if patient is already on his 4rd month of treatment in the
presence of smear conversion; treatment duration is the
same (9-11 months)
Note: Lzd shall be discontinued after the duration of the
intensive phase of treatment.
 Pto: replace with Cs; treatment duration is the same (9-11
months)
 Cfz: discontinue without replacement; prolong treatment
duration to 12 months

f. Refer to a specialist for concomitant co-morbidities.

g. Request for special diagnostics test as needed.
h. Perform laboratory and other diagnostic tests as stated in Table 11.

51
Management of Common Adverse Drug Reactions to FLDs and SLDs
A. Rash, allergic reaction, anaphylaxis
Grade
Adverse 1 2 3 4 5
Event Mild Moderate Severe Life-threatening
Allergic Transient Intervention or infusion Prolonged (e.g., not rapidly Life-threatening Death
reaction flushing or rash, interruption indicated; responsive to symptomatic consequences;
drug fever <38 responds medication and/or brief urgent intervention
degrees C promptly to interruption of infusion); indicated
(<100.4 symptomatic recurrence of symptoms
degrees F); treatment (e.g., following initial
intervention not antihistamines, improvement;
indicated NSAIDS, narcotics); hospitalization indicated for
prophylactic clinical sequelae (e.g.,
medications renal
indicated for <=24 hrs impairment, pulmonary
infiltrates)
Anaphylaxis - - Symptomatic Life-threatening Death
bronchospasm, consequences;
with or without urticaria; urgent intervention
parenteral intervention indicated
indicated; allergy-related
edema/angioedema;
hypotension

Possible anti-TB drug causes: Any drug

Suggested Management Strategy:
1. Evaluate for signs of severe rash, including involvement of mucous
membranes, angioedema and skin necrosis.
2. Review the patient’s record to check for history of drug allergy.
3. Check for other potential causes of allergic reactions (concomitant
medications, food, scabies, or other environmental allergens).
4. For mild allergic reaction: continue treatment and provide ancillary drugs to
the patient:
 Antihistamines (Cetirizine 10 mg/tablet 1 tablet daily,
Diphenhydramine 50 mg/capsule 1 capsule 3x a day)
 Prednisone in a low dose of 10-20 mg per day for several
weeks in refractory cases
5. For moderate to severe allergic reaction: stop all anti-TB drugs pending
resolution of the reaction and provide ancillary drugs. Hospitalization for
severe reaction is indicated. In case of anaphylaxis, manage the patient with
standard emergency protocols.
6. Once rash resolves, re-introduce anti-TB drugs one at a time starting with
the least likely drug to cause the reaction at a small challenge dose. The
dose is gradually increased over three (3) days. If there is no reaction after
the 3rd day, add the second drug at a small challenge dose. The procedure
is repeated, adding in one drug at a time and gradually increasing the dose.
A reaction after adding in a particular drug identifies that drug as the one
responsible for the reaction. Consider not reintroducing in the challenge any
drug that is highly likely to be the drug culprit.¹⁸
7. Stop permanently any drug identified to be the cause of a severe reaction
and this may be replaced by another anti-TB drug.
Note:
 Flushing reaction to Rifampicin and Pyrazinamide is usually mild and
resolves with time. Antihistamines can be used.

52
  Hot flushes, itching, and palpitations can be caused by combining
Isoniazid and tyramine-containing foods (cheese, red wine). If this
occurs, advise the patient to avoid foods that precipitate the reactions.
 Dry skin is common and significant problem with Clofazimine. Liberal
use of moisturizing lotion is recommended.

B. Gastrointestinal: Nausea and Vomiting

Grade
Adverse 1 2 3 4 5
Event Mild Moderate Severe Life-threatening
Nausea Loss of appetite Oral intake decreased Inadequate oral caloric - -
without without or fluid
alteration in eating significant weight loss, intake; tube feeding,
habits dehydration or malnutrition TPN, or
hospitalization indicated
Vomiting 1 - 2 episodes 3 - 5 episodes (separated >=6 episodes (separated Life-threatening Death
(separated by 5 by 5 by 5 consequences;
minutes) in 24 hrs minutes) in 24 hrs minutes) in 24 hrs; tube urgent
feeding, intervention
TPN or hospitalization indicated
indicated
Possible anti-TB drug causes: Pto/Eto, PAS, H, E, Z, Cfz, Lzd, Imp/Cln, Bdq
Suggested Management Strategy:
1. Check for signs of dehydration, electrolyte imbalance, hepatitis or even
pregnancy.
2. Patients with dehydration should be treated with oral or intravenous rehydration
therapy immediately to correct volume status. Electrolyte disturbances should
be corrected.
3. For mild nausea and vomiting, advise the patient to take a light meal before
drug intake. Adjust timing of anti-TB drug dosing, if possible.
 Give Prothionamide or PAS at night
 Give Prothionamide or PAS twice daily
 Give Prothionamide or PAS 2 hours before intake of other anti-TB drugs
4. If there is no improvement despite the above intervention, or if the patient has
moderate to severe nausea and vomiting, provide ancillary drug to the patient
starting with Metoclopramide 10 mg/tablet 1 tablet 30 minutes before intake of
anti-TB drugs (maximum dose is 30 mg daily).
5. If nausea and vomiting persist despite intake of Metoclopramide, give
Ondansetron 8 mg/tablet 1 tablet 30 minutes before intake of anti-TB drugs.
This can be given every 8 hours alone or in conjunction with Metoclopramide.
6. Decrease dose of the offending drug if this can be done without compromising
the regimen. If not possible, stop permanently any drug identified to be the
cause of the severe nausea and vomiting not responding to ancillary drugs.
This may be replaced by another anti-TB drug.
Note:
 Ondansetron can prolong the QT interval. Caution should be taken when
concomitantly administered with QT prolonging anti-TB drugs such as
Bedaquiline, Moxifloxacin, Clofazimine, etc.

53
 Figure No. 6 - Approach to Nausea and Vomiting secondary to Anti-TB
drugs
Patient has nausea and vomiting

Check for signs of dehydration, electrolyte imbalance, hepatitis or even pregnancy

Treat dehydration and correct electrolyte disturbances.

Mild Moderate to
Severe

Advise the patient to take a light meal before
drug intake
Adjust dose of anti-TB drug dosing, if possible
Provide Metoclopramide 10 mg/tablet 1 tablet 30
minutes before intake of anti-TB drugs (max. daily
dose: 30 mg)
Note: Hospitalization may be indicated for severe
cases.

Persistence of
nausea and vomiting
If with persistence of nausea and vomiting,
give Ondansetron 8 mg/tablet 1 tablet 30
minutes before drug intake (alone or in
combination with Metoclopramide)

Decrease dose of suspected drug if this can be done

without compromising the regimen. If not possible, Persistence of
discontinue suspected anti-TB drug. This may be nausea and vomiting
replaced with another anti-TB drug. Resume all other
anti-TB medications.

For SSTR: replace Pto with Cs

54
C. Gastrointestinal: Gastritis and Abdominal Pain
Grade
Adverse 1 2 3 4 5
Event Mild Moderate Severe Life-threatening
Gastritis Asymptomatic; Symptomatic; altered GI Severely altered eating Life-threatening Death
clinical or function; medical or consequences;
diagnostic intervention indicated gastric function; TPN or urgent operative
observations only; hospitalization indicated intervention
intervention not indicated
indicated
Abdominal Mild pain Moderate pain; limiting Severe pain; limiting self - -
Pain instrumental ADL care ADL
Possible anti-TB drug causes: PAS, Pto/Eto, Cfz, FQs, H, E, Z
Suggested Management Strategy:
1. Abdominal pain may be an early symptom of severe adverse effects such as
pancreatitis, hepatitis or lactic acidosis. If any of these is suspected, request for
appropriate laboratory tests to confirm the diagnosis and suspend the offending
the drug.
2. Consider other possible causes of gastritis and abdominal pain. Stop any
NSAID that the patient is taking. Diagnose and treat Helicobacter pylori
infections.
3. For mild gastritis and abdominal pain, advise patient on dietary modifications.
4. For moderate gastritis and abdominal pain, provide ancillary drug to the patient:
 Lansoprazole 30 mg/capsule 1 capsule daily
5. For severe gastritis and abdominal pain, stop suspected agent(s) for short
periods of time (one to seven days). Provide ancillary drugs. Hospitalization is
indicated.
6. Decrease dose of the offending drug if this can be done without compromising
the regimen. If not possible, stop permanently any drug identified to be the
cause of the severe abdominal pain and gastritis. Replacement with another
anti-TB drug may be needed.
Note: Severe abdominal pain has been reported with the use of Clofazimine.
Although considered rare, if this occurs, Clofazimine should be suspended.

D. Gastrointestinal: Diarrhea
Grade
Adverse 1 2 3 4 5
Event Mild Moderate Severe Life-threatening
Diarrhea Increase of <4 stools Increase of 4 - 6 stools per Increase of >=7 stools Life-threatening Death
per day day per day consequences;
over baseline; mild over baseline; moderate over baseline; urgent
increase in increase in ostomy output incontinence; intervention
ostomy output compared to baseline hospitalization indicated; indicated
compared to severe
baseline increase in ostomy
output
compared to baseline;
limiting self care ADL
Possible anti-TB drug causes: PAS, Pto/Eth, FQs, Amoxicillin/Clavulanate
Suggested Management Strategy:
1. Check for signs of dehydration and electrolyte imbalance. Dehydration and
electrolyte disturbances should be corrected.
2. Consider other possible causes of diarrhea (bacterial infections, parasitic
infections, lactose intolerance). Request for fecalysis.
3. For mild diarrhea, encourage fluid intake and dietary intake of banana, rice,
apple and crackers.

55
 4. For moderate to severe and uncomplicated diarrhea (no fever and non-bloody
stool), give Loperamide 2 mg/capsule 2 capsules initially, then, 1 capsule every
after each loose stool to a maximum of 16 mg per 24 hours.

E. Gastrointestinal: Hepatitis
Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
ALT (SGPT) >ULN - 3.0 x ULN >3.0 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN -
AST (SGOT) >ULN - 3.0 x ULN >3.0 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN -
Total Bilirubin >ULN - 1.5 x ULN >1.5 - 3.0 x ULN >3.0 - 10.0 x ULN >10.0 x ULN -
Possible anti-TB drug causes: Z, H, R, Pto/Eth, PAS, Bdq
Suggested management strategy:
1. Check for other potential causes of hepatitis (viral hepatitis, alcoholism,
concomitant medications).
2. For mild to moderate elevations in the ALT, AST, TB and patient is
asymptomatic, continue anti-TB treatment. Repeat liver function tests (LFTs)
weekly.
3. If enzymes are more than 5x the upper limit of normal (grade 3-4), or more than
3x the ULN but Total Bilirubin is more than 2x the ULN and patient is
symptomatic, stop all anti-TB drugs and other hepatotoxic drugs. Repeat LFTs
after 3 days.
4. If LFTs are less than 3x the ULN, resume all non-hepatotoxic drugs (for the
SSTR: resume Mfx, Km, Cfz, E). Repeat LFTs after 3 days.
5. If repeat LFTs show improvement in the result or are stable, reintroduce
remaining anti-TB drugs one at a time starting with the least hepatotoxic drug
at a small challenge dose. The dose is gradually increased over three (3) days.
In the case of SSTR, start reintroducing Pto over 3 days (Pto + Mfx, Km, Cfz,
E).
6. Repeat LFTs after 3 days prior to reintroducing the next drug. If LFTs are stable,
the next drug to be reintroduced under SSTR is high dose H (H + Pto, Mfx, Km,
Cfz, E).
7. Repeat LFTs after 3 days prior to reintroducing the next drug. If LFTs are
stable, the next drug to be reintroduced under SSTR is Z (Z + H, Pto, Mfx,
Km, Cfz, E).
8. Consider suspending the most likely offending drug permanently. This may be
replaced by another anti-TB drug.

56
 Figure No. 7 - Approach to Drug-induced Hepatitis
Patient presents monthly Patient has any of the following signs or symptoms:
o for routine follow-up nausea, vomiting, abdominal pain, yellowish
discoloration of the skin and sclera, dark urine, pale stool

Check AST, ALT

Check AST, ALT, total bilirubin

Normal Elevated <5x ULN Elevated >5x ULN ALT, AST Elevated >5x ULN; ALT, AST
>3x ULN but total bilirubin >2x ULN

Continue routine Stop all anti-TB drugs and

monitoring other hepatotoxic drugs
Check for other potential
causes of hepatitis
Check for other potential causes of
Request for additional tests:
elevated liver enzymes
hepatitis profile
Continue anti-TB medications
Repeat LFTs weekly until normal
or stable
Repeat ALT, AST after 3 days

Repeat ALT, AST after 3 days

prior to reintroducing the next drug ALT, AST <3x ULN

Improvement in the result or stable Resume all non-hepatotoxic drugs

For SSTR: Mfx, Km. Cfz, E

Reintroduce the next anti-TB drug at a small

challenge dose. The dose is gradually increased Repeat ALT, AST after 3 days
over three (3) days. Repeat ALT, AST after 3
days prior to reintroducing the next drug. If there
is improvement in the result or stable, repeat the Improvement in the result or stable
procedure, adding in one drug at a time and
gradually increasing the dose
For SSTR: the next drug is H, then Z
Reintroduce remaining anti-TB drugs
one at a time starting with the least
hepatotoxic drug at a small challenge
Consider suspending the most dose. The dose is gradually increased
likely offending drug permanently over three (3) days.
Replacement with another anti-TB For SSTR: start with Pto
drug may be needed

57
F. Musculoskeletal: Arthralgia
Grade
Adverse 1 2 3 4 5
Event Mild Moderate Severe Life-threatening
Arthralgia Mild pain Moderate pain; limiting Severe pain; limiting self - -
instrumental ADL Care ADL
Possible anti-TB drug causes: Z, FQs, Eth/Pto, Bdq
Suggested management strategies:
1. Check for presence of acute swelling, redness and warmth in a joint. If present,
consider aspiration for diagnosis of gout, infections, autoimmune diseases, etc.
2. For mild arthralgia, encourage fluid intake. Apply hot and cold compress on the
affected joint and light massage.
3. For moderate to severe arthralgia, give any of the nonsteroidal anti-
inflammatory drugs:
 Mefenamic Acid 500 mg/capsule 1 capsule 3x a day
 Indomethacin 25 mg/tablet 1 tablet 2 to 3x a day
 Celecoxib 100 mg /tablet 1 tablet 2x a day
4. Decrease dose of the offending drug if this can be done without compromising
the regimen. If not possible, stop permanently any drug identified to be the
cause of the severe arthralgia if this can be done without compromising the
regimen. This may be replaced by another anti-TB drug.
Note:
 Uric acid levels may be elevated in patients on Pyrazinamide. If gout is
present, initiate treatment with Allopurinol.

G. Renal: Electrolyte Abnormalities

Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Hypokalemia <LLN - 3.0 <LLN - 3.0 mmol/L; <3.0 - 2.5 mmol/L; <2.5 mmol/L; Death
mmol/L symptomatic; hospitalization indicated life-threatening
intervention consequences
indicated
Possible anti-TB drug causes: Cm, Km, Am, S
Suggested management strategies:
1. Check for signs of dehydration in patients with vomiting and diarrhea. Start oral
or intravenous rehydration therapy immediately until volume status is normal.
2. In any case of hypokalemia, also check the magnesium and calcium, if possible.
Hypokalemia may be refractory if hypomagnesemia and hypocalcemia are not
corrected.
3. For any hypokalemia, encourage dietary intake of potassium such as bananas,
oranges, tomatoes, etc. Replete potassium by providing oral potassium
supplement. The dosage depends on the level of potassium.
 Oral Potassium Chloride 750 mg/tablet: contains 9.8 mEq of potassium
 Oral Potassium Chloride 600 mg/tablet: contains 8 mEq of potassium

58
 Potassium Level Daily Dose Frequency of
Monitoring Serum
Potassium
3.3 - 3.5 mmol/L 40 mEq per orem Monthly
2.9 – 3.2 mmol/L 60 – 80 mEq per Weekly
orem
2.7 – 2.8 mmol/L 60 mEq per orem 3x One to two days
a day
2.4 – 2.6 mmol/L 80 mEq per orem 3x Daily
a day
<2.4 mmol/L 10 mEq/hr IV and 80 One hour after
mEq per orem 3 to infusion, every six
4x a day hours with IV
replacement
The normal preparation of a potassium chloride infusion is 40 mEq in 200 ml of normal
saline. Do not exceed an infusion rate of 20 mEq/hr (100 ml/hr).

4. For severe hypokalemia, hospitalization is indicated.

Note:
 The amount of potassium is different from the tablet size. Oral potassium
can cause nausea and vomiting. Oral magnesium can cause diarrhea.
Oral potassium and magnesium should be administered either 2 hours
before or 4 to 6 hours after intake of FQ as they can interfere with FQ
absorption.
 Magnesium replacement therapy
Magnesium Level Total Daily Dose Monitoring Frequency
1.5-1.9 1000 mg-1200 mg Monthly
1.0-1.4 2000 mg One to seven days
<1.0 3000 mg-6000 mg Daily
Quantities greater than 2000 mg are usually given by IV or intramuscular (IM). The
normal preparation is magnesium sulfate 2 g in 100 ml or 4 g in 250 ml of 5% dextrose
or normal saline. Do not exceed an infusion rate of 150 mg/min (2 g in 100 ml
administered over one to two hours, 4 g in 250 ml administered over two to four hours).

H. Renal: Nephrotoxicity (Acute Renal Failure)

Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Acute Kidney Injury Creatinine level Creatinine 2 - 3 x Creatinine >3 x baseline or Life-threatening Death
increase of >0.3 mg/dL; above Baseline >4.0 mg/dL; hospitalization consequences;
creatinine 1.5 - 2.0 x indicated dialysis indicated
above baseline
Possible anti-TB drug causes: S, Km, Am, Cm
Suggested management strategies:
1. Check for other causes of acute renal failure (prerenal, renal, postrenal). One
of the common causes is hypovolemia due to dehydration from nausea and
vomiting as adverse drug reactions to anti-TB drugs. Initiate oral or intravenous
rehydration therapy immediately to correct volume status. Electrolyte
disturbances should also be corrected.

59
 2. For mild acute renal injury, encourage fluid intake. Check the weight of the
patient and ensure that dose of injectable agent is computed at 15 mg/kg/day.
Consider using Capreomycin if an aminoglycoside had been the injectable
agent in the regimen.
 If there is already smear conversion, the frequency of Cm may be
reduced to 3x a week. Repeat creatinine determination weekly.
3. For moderate to severe acute renal injury:
 If the patient is still on his first 3 months of treatment, replace injectable
agent with Lzd.
 If the patient is already on his 4th month of treatment in the presence of
smear conversion, stop the injectable agent. No need to replace with
another anti-TB drug.
 Repeat creatinine weekly until it has returned to normal or has stabilized.
4. For severe acute renal injury, stop all anti-TB drugs. Hospitalization is indicated.
Repeat creatinine after 1-2 days. If the creatinine level has returned to normal
or has stabilized, resume treatment with anti-TB drugs (without injectable
agent) at normal doses. If the creatinine level has not returned to normal or has
not stabilized (creatinine clearance is <30 ml/min), resume anti-TB treatment
as well but the dose of other renally excreted anti-TB drugs and concomitant
medications should be adjusted.
Note:
 Smear conversion: smear is considered to have converted to negative when
two consecutive smears, taken at least 30 days apart, are found to be
negative.

I. Neurological: Ototoxicity (Hearing Loss or Vestibulopathy)

Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Hearing Impaired Adults enrolled on a Adults enrolled in Adults enrolled in Monitoring Adults: Decrease -
Monitoring Program (on Monitoring Program (on Program (on a 1, 2, 3, 4, 6 in hearing to
a 1, 2, 3, 4, 6 and 8 kHz a 1, 2, 3, 4, 6 and 8 kHz and profound bilateral
audiogram): Threshold audiogram): Threshold 8 kHz audiogram): Threshold loss (absolute
shift of 15 - 25 dB shift of >25 dB averaged shift of >25 dB averaged at 3 threshold >80 dB
averaged at 2 at 2 contiguous test contiguous test frequencies HL at 2 kHz
contiguous test frequencies in at least in at least one ear; and above); non-
frequencies in at least one ear. therapeutic servicable hearing.
one ear. Adults not enrolled in intervention indicated. Pediatric:
Adults not enrolled in Monitoring Program: Adults not enrolled in Audiologic
Monitoring Program: hearing loss but hearing Monitoring Program: hearing indication for
subjective change in aid or intervention not loss with hearing aid or cochlear implant
hearing in the absence indicated; limiting intervention indicated; and additional
of documented hearing instrumental ADL. limiting self care ADL. speech-language
loss. Pediatric (on a 1, 2, 3, 4, Pediatric (on a 1, 2, 3, 4, 6 related services
Pediatric (on a 1, 2, 3, 6 and 8 kHz audiogram): and indicated.
4, 6 and 8 kHz Threshold shift >20 dB 8 kHz audiogram): hearing
audiogram): Threshold at 4 kHz and above in at loss sufficient to indicate
shift >20 dB at 8 kHz in least one ear. therapeutic intervention,
at least one ear. including hearing aids;
threshold shift >20 dB at 3
kHz and above in at least
one
ear; additional speech-
language related services
indicated
Possible anti-TB drug causes: S, Km, Am, Cm
Suggested management strategies:
1. Check for other causes of hearing impairment (impacted cerumen, infections,
etc.)
2. For mild and moderate hearing impairment, consider using Capreomycin if an
aminoglycoside had been the injectable agent in the regimen. Decrease the

60
 frequency of Capreomycin to 3x a week if there is already smear conversion.
Repeat audiometry weekly until hearing impairment has resolved or has
stabilized, then, perform audiometry monthly.
3. When thresholds ≧40dB at 4000-8000 Hz or severe hearing impairment, stop
the injectable agent. This may be replaced by another anti-TB drug.
 If the patient is still on his first 3 months of treatment, replace injectable
agent with Lzd.
 If the patient is already on his 4th month of treatment in the presence of
smear conversion, stop the injectable agent. No need to replace with
another anti-TB drug.
Note:
 Tinnitus and dizziness are early symptoms of ototoxicty.

J. Neurological: Peripheral Neuropathy

Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Peripheral Asymptomatic; loss Moderate symptoms; Severe symptoms; Life-threatening Death
Sensory of deep limiting limiting self care ADL consequences;
Neuropathy tendon reflexes or instrumental ADL urgent intervention
paresthesia indicated
Possible anti-TB drug causes: Cs, Lzd, H, S, Km, Am, Cm, FQ, Pto/Eth, E
Suggested management strategies:
1. Check for other causes of neuropathy (diabetes, HIV, alcohol use, vitamin
deficiencies). Correct any vitamin or nutritional deficiencies.
2. For mild peripheral neuropathy, increase pyridoxine to the maximum daily dose
of 200 mg per day.
3. For moderate to severe peripheral neuropathy, initiate therapy with ancillary
drugs:
 NSAIDs
 Gabapentin 100 mg/capsule 3 capsules once to thrice a day.
4. Decrease dose of the offending drug if this can be done without compromising
the regimen. If not possible, stop permanently any drug identified to be the
cause of the moderate to severe peripheral neuropathy. This may be replaced
by another anti-TB drug.
Note:
 Patients taking Cs, Lzd should receive prophylactic pyridoxine.

61
K. Neurological: Depression
Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Depression Mild Moderate depressive Severe depressive Life-threatening Death
depressive symptoms; limiting instrumental symptoms; limiting self care consequences,
symptoms ADL ADL; hospitalization not threats of harm to
indicated self or others;
hospitalization
indicated
Possible anti-TB drug causes: Cs, FQ, H, Pto/Eth
Suggested management strategies:
1. Check for other potential causes of depression. Assess and address underlying
psychosocial stressors.
2. Assess the degree of depression.
3. For mild depression, initiate individual or group therapy session. Maximize dose
of pyridoxine to 200 mg/day.
4. For moderate to severe depression, initiate therapy with antidepressant and/or
refer for psychiatric consultation. The available antidepressant in the ancillary
drug list is Sertraline HCl 50 mg/tablet.
5. Decrease dose of the offending drug if this can be done without compromising
the regimen. If not possible, stop permanently any drug identified to be the
cause of the severe depression. Replacing the offending drug with another anti-
TB drug may be needed.
Note:
 Tricyclic antidepressants and selective serotonin reuptake inhibitors should
not be taken concomitantly and should not be given to patients taking Lzd.
SSRIs can also prolong the QT.

L. Neurological: Headache
Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Headache Mild pain Moderate pain; limiting Severe pain; limiting self - -
instrumental ADL care
ADL
Possible anti-TB drug causes: Cs, Pto/Eth, Bdq
Suggested management strategies:
1. Check for other more serious causes of headache.
2. For mild pain, encourage fluid intake. Maximize dose of pyridoxine to 200
mg/day for patients with Cs.
3. For moderate to severe pain, initiate therapy with NSAIDs.

62
M. Neurological: Psychosis
Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Psychosis Mild psychotic Moderate psychotic Severe psychotic symptoms Life-threatening Death
symptoms symptoms (e.g., paranoid; extreme consequences,
(e.g., disorganized speech; disorganization); threats of harm to
impaired reality testing) hospitalization self or others;
not indicated hospitalization
indicated
Possible anti-TB drug causes: Cs, H, FQ, Pto/Eth
Suggested management strategies:
1. Check for other potential causes of psychosis.
2. For mild psychosis, initiate individual or group therapy session. Increase dose
of pyridoxine to 200 mg/day. Ensure that patient gets enough rest and sleep.
3. For moderate to severe psychosis, stop Cs and INH, and initiate antipsychotic
therapy and/or refer for psychiatric consultation. Available antipsychotic drugs
in the ancillary drug list are Haloperidol 5 mg/tablet and Quetiapine Fumarate
25 mg/tablet.
4. Decrease dose of the offending drug if this can be done without compromising
the regimen. If not possible, stop permanently any drug identified to be the
cause of the psychosis. This may be replaced by another anti-TB drug.

N. Neurological: Seizures
Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Seizure Brief partial Brief generalized seizure Multiple seizures despite Life-threatening; Death
seizure; no loss of medical intervention prolonged
Consciousness repetitive seizures
Possible anti-TB drug causes: Cs, H, FQ
Suggested management strategies:
1. Evaluate other potential causes of seizure. Check serum electrolytes.
2. For any seizure, hold Cs, H, FQ. For SSTR, continue Km, Pto, Cfz, E, Z.
Increase pyridoxine to maximum daily dose of 200 mg/day. Refer to specialist
for further evaluation and management.
3. When seizure has resolved, reintroduce H and FQ one at a time. For SSTR,
restart FQ over 3 days (FQ + Km, Pto, Cfz, E, Z) followed by H (H + FQ, Km,
Pto, Cfz, E, Z).For regimen containing Cs, it should not be restarted unless it is
absolutely essential in the regimen. In this case, the anticonvulsant therapy
should be continued until DR-TB treatment is completed or until the suspected
drug is discontinued.

O. Neurological: Optic Neuritis

Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Optic Neuritis Asymptomatic; Limiting vision of the Limiting vision in the Blindness (20/200 -
clinical or affected affected or worse)
diagnostic eye (20/40 or better) eye (worse than 20/40 but in the affected eye
observations only better than 20/200)
Possible anti-TB drug causes: E, Pto/Eto, Lzd, Cfz. H, S
Suggested management strategies:
1. For any sign of optic neuritis, stop Ethambutol or Linezolid immediately.
2. Refer patient for ophthalmologic consultation.
Note:

63
  Optic neuritis is commonly caused by Ethambutol. Symptoms of
Ethambutol-induced optic neuritis include blurred vision, central scotomas
and loss of red-green color vision.
 Patients should be screened monthly for signs of optic neuritis by using
simple tests (Snellens chart and Ishihara).

P. Endocrine: Hypothyroidism
Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Hypothyroidism Asymptomatic; Symptomatic; thyroid Severe symptoms; limiting Life-threatening Death
clinical or replacement indicated; self care ADL; consequences;
diagnostic limiting instrumental ADL hospitalization urgent intervention
observations only; Indicated indicated
intervention not
indicated
Possible anti-TB drug causes: Pto/Eth, PAS
Suggested management strategies:
1. For mild hypothyroidism, repeat TSH after 1 month.
2. For moderate to severe hypothyroidism, initiate therapy with Levothyroxine:
 Young healthy adults: start at 75 to 100 mcg daily
 Older patients: start at 50 mcg daily
 Patients with significant cardiovascular disease: start at 25 mcg daily
 Children (4-15 years): 4 mcg/kg/day (maximum dose is 200 mcg)
 Infants (1-3 years): 10-15 mcg/kg/day (maximum dose of 200 mcg)
3. Monitor TSH monthly and increase dose of Levothyroxine by 25 to 50 mcg until
TSH is in normal range. Adjust dose more slowly in the elderly and patients with
cardiac conditions.

Q. Metabolic: Lactic Acidosis

Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Lactic Acidosis Asymptomatic or Moderate; minimal, local or Severe or medically Life-threatening Death
mild symptoms; noninvasive intervention significant consequences;
clinical or indicated; limiting age but not immediately life- urgent intervention
diagnostic appropriate instrumental threatening; hospitalization indicated
observations only; ADL or
intervention not prolongation of existing
indicated hospitalization indicated;
disabling; limiting self care
ADL
Possible anti-TB drug causes: Lzd
Suggested management strategies:
1. Check serum electrolytes and renal function, arterial blood gas, and lactate
levels in patients with possible lactic acidosis.
2. Patients are most likely to present with signs and symptoms of lactic acidosis
such as nausea, vomiting, abdominal pain, lethargy, etc. at the time of
suspecting lactic acidosis. Stop Linezolid and provide supportive care.

64
R. Cardiovascular: QT Prolongation
Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Electrocardiogram QTc 450 - 480 ms QTc 481 - 500 ms QTc >= 501 ms on at least QTc >= 501 or >60 -
QT corrected two separate ECGs ms change
interval prolonged from baseline and
Torsade de
pointes or
polymorphic
ventricular
tachycardia or
signs/symptoms of
serious
arrhythmia
Possible anti-TB drug causes: FQ, Cfz, Bdq, Dlm
Suggested management strategies:
1. For mild to moderate QTcF prolongation, check other possible causes of QTcF
prolongation (electrolyte imbalances, concomitant medications, etc.). Continue
anti-TB treatment. For mild QTcF prolongation, repeat ECG weekly until normal
or stable. For moderate QTcF prolongation, repeat ECG more frequently (2-3
days) until normal or stable.
2. For any QTcF prolongation of >500 ms, repeat ECG and confirm the
prolongation.
3. If QTcF >500 ms has been confirmed, evaluate other possible causes of
prolonged QT. Stop all QT prolonging drugs.
4. Repeat ECG daily until below 500 ms.
5. Discontinue suspected anti-TB drug. This may be replaced with another anti-
TB drug. Resume all other anti-TB medications.
6. Repeat ECG weekly until QTc becomes normal or stable.

65
 Figure No. 8: Approach to QT Prolongation secondary to Anti-TB drugs

Patient presents monthly for routine Patient has any of the following signs or symptoms: dizziness,
follow-up lightheadedness, syncope, fainting, non-mechanical fall, loss of
consciousness, palpitations, fast heart rate

Measure the QTc with 12 lead ECG

Normal QTc QTc 450 ms to 500 ms QTc >500 ms

Continue anti-TB Continue anti-TB treatment

treatment and routine Repeat ECG
Check for other causes of s/s and
monitoring QT prolongation
Check for other For mild QT prolongation: Repeat
causes of s/s ECG weekly until normal or stable QTc prolongation
For moderate QT prolongation: confirmed
Repeat ECG more often (2-3
days) until normal or stable

Repeat ECG daily until below <500 ms Stop all QT prolonging drugs (anti-TB
drugs, concomitant medications)

Check for other causes of QT

prolongation (electrolyte imbalances,
Discontinue suspected anti-TB drug and may be replaced hypothyroidism, etc)
with another anti-TB drug. Resume all other anti-TB
medications. Repeat ECG weekly until QTc becomes If symptomatic or with other risk factors,
normal or stable. consider hospitalization

For SSTR: replace high dose Mfx with 400mg Mfx, if

patients cannot tolerate Mfx 400mg, try high dose Lfx; if
still not tolerated, replace high dose Lfx with Lzd and
prolong the treatment duration

Note:
 The QT interval must always be corrected for heart rate.
 Normal QTc: males = <450 ms; females = <470 ms
 The QT interval in an ECG is measured from the start of the Q wave to the
end of the T wave (see diagram below).

66
  The preferred way to calculate the QTc is the Fredericia method (QTcF),
which is derived by dividing the QT interval by the cubed root of the interval
in seconds
between the peak of two successive R waves (RR) read from the ECG strip:

S. Hematological: Anemia or Pancytopenia

Grade
Adverse Event 1 2 3 4 5
Mild Moderate Severe Life-threatening
Anemia Hemoglobin (Hgb) Hgb <10.0 - 8.0 g/dL; Hgb <8.0 g/dL; <4.9 Life-threatening Death
<LLN - 10.0 <6.2 - 4.9 mmol/L; <100 - mmol/L; consequences;
g/dL; <LLN - 6.2 80g/L <80 g/L; transfusion urgent intervention
mmol/L; <LLN - indicated indicated
100 g/L
Platelet Count <LLN - 75,000/mm3; <75,000 - 50,000/mm3; <50,000 - 25,000/mm3; <25,000/mm3; -
Decreased <LLN -75.0 x 10e9 /L <75.0 -50.0 x 10e9 /L <50.0 -25.0 x 10e9 /L <25.0 x 10e9 /L
White Blood Cell <LLN - 3000/mm3; <3000 - 2000/mm3; <3.0 <2000 - 1000/mm3; <2.0 - <1000/mm3; <1.0 -
Decreased <LLN - 3.0 x 10e9 /L - 2.0 x 10e9 /L 1.0 x 10e9 /L x 10e9 /L

Possible anti-TB drug causes: Lzd

Suggested management strategies:
1. Perform additional laboratory tests to assess potential cause of anemia (mean
corpuscular volume, reticulocyte count, LDH, bilirubin).
2. For mild anemia or pancytopenia, repeat CBC weekly.
3. For moderate anemia or pancytopenia, reduce dose of Linezolid to 300 mg
daily. Repeat CBC weekly.
4. For severe anemia, stop Linezolid and other drugs that are likely to cause the
anemia. Blood transfusion is indicated.
5. If Lzd is essential in the regimen, it may be reintroduced at 300 mg daily once
anemia has resolved.

T. Other rare adverse drug reactions:

1. Tendon rupture secondary to FQs: The FQ is considered as the most
important drug in the treatment of MDR-TB. Stopping the FQ may not be the
best option. However, Bdq may be used to replace FQ. The suggested
management strategies are the following:
 Initiate therapy with NSAID
 Avoid physical activities. Rest the joint.
67
  Discuss with patient the possible risk of tendon rupture and the
possible risks and benefits of continuing the FQ

2. Pancreatitis associated with the use of Lzd, H. Bdq: This is considered severe
and can be life-threatening. A full description of management is outside the
purview of this guide.

U. For other possible adverse drug reactions to Eth/Pto such as alopecia,

gynecomastia and dysgeusia (metallic taste), encourage the patient to tolerate
these side effects. Sucking candy or chewing gum can be helpful in disguising the
metallic taste. Resolution of these occur after treatment is stopped.

2. Treatment response of DR-TB patients shall be monitored through the following:

- Ensure collection and submission of sputum specimen as scheduled for DSSM and
TB culture. Request DST if culture positive 4 months after the start of Intensive Phase
(amplification is suspected), or if culture negative becomes culture positive at any
stage of continuation phase.

- Perform physical examination and monthly weight check. Include height assessment
for children.

- Ensure that other laboratory and diagnostics tests are followed as scheduled.

3. Interpret results and decide necessary interventions based on monitoring of

treatment.

A. Once the LPA and/or DST result is/are available, the PMDT treatment facility staff
shall review the result and take appropriate measures accordingly as follows:

68
Table No. 14 - Guide on Deciding Appropriate Treatment Regimen based on LPA
or DST Result
Baseline LPA Result Clinical and Programmatic Action
FQ susceptible Continue SSTR
SLI susceptible
FQ resistant Shift to CTR
SLI susceptible Continue dose count
FQ susceptible Continue SSTR but replace SLI with Lzd
SLI resistant Continue dose count
FQ resistant Shift to CTR
SLI resistant Effective dose will start from the new regimen
Outcome is “excluded”
Assign a new registration number
Negative or Continue SSTR while waiting for the conventional
Invalid or DST result
Error

Conventional DST Result Clinical and Programmatic Action

Lfx susceptible Continue SSTR
Km susceptible
Cm susceptible
Lfx resistant If the patient has good response to treatment and/or
Km susceptible with sputum conversion, continue SSTR
Cm susceptible
Lfx susceptible If the patient is in the intensive phase of treatment:
Km resistant Replace SLI with Lzd but continue SSTR
Cm resistant If the patient is in the continuation phase of
treatment: continue SSTR
Lfx susceptible If the patient is in the intensive phase of treatment:
Km resistant Shift Km to Cm but continue SSTR
Cm susceptible If the patient is in the continuation phase of
treatment: continue SSTR
Lfx susceptible Continue SSTR
Km susceptible
Cm resistant
Lfx resistant Shift to CTR
Km resistant Effective dose will start from the new regimen
Cm resistant Outcome is excluded
Assign a new registration number
Negative or Continue SSTR
Contaminated or
Not done

69
B. Decide whether to shift to continuation phase.

Standard Short Treatment Regimen (SSTR)

Total Treatment Duration: 9-11 months
IP: minimum of 4 months, maximum of 6 months
CP: 5 months

Figure No. 9 - Transition from Intensive to Continuation phase for patients on

SSTR

Smear result at Month 4 Negative Proceed to Continuation

Positive Phase

Extend intensive phase by one

month

Negative
Smear result at Month 5 Proceed to Continuation
Phase
Positive

Extend intensive phase by one

month

Smear result at Month 6 Negative Proceed to Continuation

Phase
Positive

If based on clinical and

bacteriological evidence, failure is
unlikely, proceed to Continuation
Phase;

Otherwise, refer to TB Medical

Advisory Committee for treatment
decision

Conventional Treatment Regimen (CTR)

Total treatment duration: 20-24 months
IP: about 8 months
CP: 12-16 months

- The injectable agent shall be discontinued four months after culture conversion.
- Does not show any sign of clinical deterioration (weight, signs and symptoms, CXR).

70
4. Decide whether the patient is no longer infectious.
-For bacteriologically confirmed patients on SSTR- after 1 month of continuous
treatment, with negative follow-up DSSM result and with clinical improvement
-For bacteriologically confirmed patients on CTR- after 1 month of continuous
treatment, with negative follow-up DSSM result and with clinical improvement

-For clinically diagnosed patients- after 2 weeks of continuous treatment, there is

clinical improvement, or no clinical deterioration.

5. Assess patients when treatment failure is suspected.

A. Any patient who do not culture convert, clinically improve, or worsen after initial
improvement after four months of treatment, shall be considered high-risk for
treatment failure.
- Review patient records to assess adherence and occurrence of ADRs.
- Look for undetected comorbidities
- Review the bacteriological data
- Review the DST
- Review treatment regimen

B. Decide whether to suspend current treatment.

If the patient continues to deteriorate despite interventions implemented, treatment
failure shall be considered and individualized regimen should be designed on the
following conditions:

- Lack of culture conversion by the end of the intensive phase (about 8 months)
for conventional treatment regimen
- Bacteriological reversion of culture in the continuation phase after conversion
- Evidence of additional acquired resistance to fluoroquinolones and/or second
line injectable drugs
- Severe drug intolerance that does not respond to all existing measures and
requires permanent regimen change by adding two or more drugs

C. Document all the results of monitoring of treatment in Form 4b. DR-TB Treatment
Card.

71
F. Managing Treatment Interruption

The following steps shall be taken for patients showing any signs of possible poor
adherence:

Table No. 15 - Steps in Managing Treatment Interruption

Treatment Definition of Actions to be taken Person
Interruption Treatment responsible
Category Interruption
Category
Signal One missed dose Immediately follow-up PMDT
patients who missed a treatment
treatment through phone facility staff
calls (3 attempts) within the
day followed by SMS.
Document the reason for
treatment interruption.
Conduct home visit, if
feasible.
Alert Two missed doses Home visit shall be done DOTS facility
either by the PMDT staff
treatment facility staff or by
the nearest health facility
staff. Conduct counselling to
patient and significant
others. As much as possible,
provide supervised
treatment during home visit.
The health facility staff shall
provide feedback
immediately, but PMDT
treatment facility staff shall
also be proactive in soliciting
feedback from the health
facility staff. Document the
steps taken and the reason
for treatment interruption. If
feasible, decentralize the
treatment.

Alarm Three missed Coordinate with LGU LGU

doses (PHO/CHO/MHO) to assist
in convincing the patient to
resume treatment and to
possibly provide additional
support to patient.
Decentralize treatment at
location that is most
convenient to the patient.

72
 Crisis Four missed doses If still patient did not resume RO
treatment, this shall be
reported to RO for further
action. The PMDT treatment
facility staff shall still get in
touch with the patient and
convince him/her to resume
treatment as soon as
possible. Decentralize
treatment at location that is
most convenient to the
patient.

The following steps shall be taken as soon as the patient reports for treatment:
- Do counselling to patients and family members.
- Manage adverse events and adverse drug reactions.
- Assess and address barriers to treatment adherence, psychosocial issues
such as substance dependence and economic problems in collaboration with
the LGUs, NGOs and other partners. Patients belonging to the catchment area
of a DOTS facility will be closely followed up by the latter to ensure patient’s
treatment adherence.
- Decentralize treatment at location that is most convenient to patients
whenever it is feasible.

The following additional steps shall be taken for patients with frequent absences:
- Home visit by the physician is recommended.
- Decentralize treatment at location that is most convenient to patients
whenever it is feasible.
- Coordinate with PHO/CHO.

G. Ensuring Patient Adherence to Treatment

1. Definition of roles & responsibilities of the team by the physician

2. Home visitations to know the patient’s circumstances
3. Usage of IEC materials
4. Provision of enablers and psychosocial support (including counselling)
5. Involvement of Patient Support Group
6. Provision of patient-centered care (time, cost, distance, provider behavior);
Decentralization of treatment at location that is most convenient to patients
whenever it is feasible
7. Collaboration with other agencies to address patient’s needs
8. Prompt identification and interventions for adverse events
9. Provision of rewards and recognition for health care providers
10. Improvement of the working environment (infection control measures)

73
H. Determining Treatment Outcome

1. Determine the treatment outcome of patients based on completion of treatment

regimen, sputum follow-up results and clinical improvement or lack of clinical
deterioration.

Table No. 16 – Treatment Outcomes for RR-TB/MDR-TB/XDR-TB Patients

OUTCOME DEFINITION
Cured A patient with bacteriologically-confirmed RR-TB/MDR-
TB/XDR-TB who has completed the recommended duration
of treatment without evidence of failure AND three or more
consecutive cultures taken at least 30 days apart are negative
after the intensive phase
Treatment A patient who completes the recommended duration of
Completed treatment without evidence of failure BUT no record that three
or more consecutive cultures taken at least 30 days apart are
negative after the intensive phase.
Treatment Failed Treatment terminated or need for permanent regimen change
of at least two anti-TB drugs because of:
 Lack of conversion* by the end of the intensive phase,
or
 Bacteriological reversion** in the continuation phase
after conversion* to negative, or
 Evidence of additional acquired resistance to
fluoroquinolones or second-line injectable drugs, or
adverse drug reactions (ADRs).
Died A patient who dies for any reason during the course of
treatment.

Lost to follow-up A patient whose treatment was interrupted for 2 consecutive

months or more.
*Conversion (to negative): culture is considered to have converted to negative when two consecutive cultures,
taken at least 30 days apart, are found to be negative. In such a case, the specimen collection date of the first
negative culture is used as the date of conversion
**Reversion (to positive): culture is considered to have reverted to positive when after an initial conversion, two
consecutive cultures, taken at least 30 days apart, are found to be positive. For the purpose of defining Treatment
Failed, reversion is considered only when it occurs in the continuation phase.

2. For cases not satisfying the above definitions, refer to TB Medical Advisory
Committee for review and outcome determination. For Failed cases, refer to
TB Medical Advisory Committee the proposed treatment regimen.
3. Note that the outcome “Cured” is restricted to pulmonary bacteriologically-
confirmed TB cases only.
4. The date of last intake is noted as the date of outcome (except for died).
5. Record the outcome in Form 4b. DR-TB Treatment Card, Form 6b. DR-TB
register and ITIS.
6. Regional NTP will do a Mortality Audit for all DR-TB patients semi-annually.

74
I. Conducting Post – Treatment Follow - up

1. Schedule patient for post-treatment follow-up every 6 months for 2 years.

2. Provide patient education for post-treatment follow-up.
3. Do the following procedures for every post – treatment follow – up visit:
- Clinical assessment
- Sputum collection for DSSM, TB culture, and DST (if positive TB
culture)
- Chest x – ray
4. If patient is assessed as presumptive DR-TB during post treatment follow –
up, do screening procedures for presumptive DR-TB.
5. For DR-TB patients who have no more treatment options left, refer to Chapter
5 on MDR-TB and Palliative Care.

Summary of Procedures
A. Preparing for Initiation of DR–TB treatment

B. Conducting Pre-treatment Evaluation

C. Initiating Treatment and Registration

D. Supervising Daily Treatment

E. Monitoring of Treatment

F. Managing Treatment Interruption

G. Ensuring Patient Adherence to Treatment

H. Determining Treatment Outcome

I. Conducting Post – Treatment Follow - up

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 CHAPTER 4

COMMUNITY-BASED CARE

I. Introduction

Community-based care (ComCare) is one of the strategies to address the growing

concern of increasing lost to follow-up among enrolled DR-TB cases. Through the
years, there has been an increasing rate of lost to follow-up from 13% in 2005 to 36%
in 2012. Based on data gathered, most of the patients are lost to follow-up in the first
six (6) months of treatment, and that one of the reasons identified is accessibility of
PMDT treatment services. This leads to increasing cost for the patient in terms of cost
of travel, relocation and loss of income leading to lost to follow-up.

ComCare will provide a venue for DR-TB treatment that is more accessible, more
patient-centered, flexible to the needs of the patients and tailored to the community. It
hopes to provide more options for access to treatment and encourage treatment
adherence. Countries such as Peru, Bangladesh, and Lesotho have shown increasing
successes in the implementation of a community-based program.¹⁹ Hopefully, this will
contribute to decreasing patients being lost to follow-up, more patients successfully
treated, thereby reducing stigma and transmission in the community.

II. Objective

To ensure successful treatment of DR-TB patients by allowing DR-TB patients to

receive treatment in their community/home/workplace.

III. Policies

1. ComCare shall be implemented in a community, which includes the patient’s

home and workplace.

2. The DR-TB patient is an integral part of the decision making process and
implementation of the ComCare.

3. The case holding of DR-TB patients under ComCare shall be implemented by

community treatment partners (CTPs).

4. Management of DR-TB patients under ComCare and monitoring and

supervision of CTPs shall be done by the PMDT treatment facility staff.

IV. Definition of Terms

Community Treatment Partner – a volunteer treatment supporter who is motivated

to provide supervised treatment, and other form of support to DR-TB patients.

76
V. Procedures

A. Selecting patients

1. Decide when to offer ComCare to DR-TB patients. This can be done before
initiating treatment, when a patient is enrolled, when the patient is in the
continuation phase or even when the patient starts to interrupt treatment.

2. Prioritize patients for ComCare.

Priority should be given to the following patients:
a. with geographical or financial problems in accessing the PMDT
treatment facility
b. physically weak, either due to their disease, co-morbidity or ADRs
c. who have conflicts in schedule of supervised treatment such as those
working, studying or providing care to other family members (e.g. nursing
mothers, parent taking care of his/her children)
d. have identified a community treatment partner

3. Explain to the patient options for accessing treatment whether facility-based or

community-based.

4. Seek patient’s decision whether to deliver treatment facility-based or

community-based.

B. Selecting Community Treatment Partner (CTP)²º

1. Help the patient choose a suitable treatment partner. The following can act as
treatment partners:
a. PMDT treatment facility staff
b. Treatment partners from the community: staff of the rural health
unit/health center/barangay health station, health care providers
who are part of the DOH Deployment Program, barangay health
workers, community health teams, cured TB patients, physician
or nurse in the company/school clinic, or volunteer health worker
in the community or in the barangay where the patient is residing

2. Meet the community treatment partner to determine if he/she has fulfilled the
profile of a CTP.
a. At least 18 years old and not too old to work
b. Not immune-compromised
c. Has basic literacy skills (able to read and write)
d. With experience in DOTS
e. Preferably residing within the same barangay as the patient
f. Available to do supervised treatment every day and weekends
g. Can observe confidentiality of patient’s records
h. Is motivated to care for DR-TB patients
i. Is committed to support the patient for the entire duration of
treatment

77
 3. Explain the importance of supervised treatment, tasks of a CTP, how long the
CTP is needed, support and supervision that shall be provided and incentive
mechanism, if available.

4. If the individual is suitable and agree to be a CTP, ask him/her to sign the
Commitment Form (See Annex K on page 226).

5. Confirm if identified CTP is acceptable to the patient.

6. Help the patient and CTP agree on the time and place that they shall meet daily
for supervised treatment.

C. Orientating Community Treatment Partner (CTP)²¹

1. Orient the CTP by utilizing the ComCare job aid. Ensure that the following
information are provided:
 Basic information about DR-TB
 Roles and responsibilities of the CTP
 How to give supervised treatment
 About common side-effects, how to identify them and how to record in the
patient progress report form (PPRF)
 How to encourage the patient to adhere to treatment
 How and when to make referrals for medical evaluation
 What to do if the patient misses a scheduled treatment
 What to do if the patient or CTP must be away for a few days
 When to send the patient back to the PMDT treatment facility for follow-up
 Importance of monthly sputum examination and regular blood tests
 Infection control at home, including universal precaution
 How to conduct contact tracing
 Patient rights and patient confidentiality

2. Demonstrate to the CTP how to give supervised treatment, including actual

marking of records (patient booklet and treatment card).

3. Ask the CTP to do a return demonstration of providing supervised treatment,

including actual marking of records, for the next patients.

4. Let the CTP observe the other activities in the PMDT treatment facility.

D. Providing tools and drug supply to CTPs

1. Prepare a kit for each CTP to include but not limited to the following:
a. Patient records: patient booklet, Patient Progress Report Form
b. Rubbing alcohol
c. Hand disinfectant
d. Umbrella
e. Community bag
f. Medicine cup
g. Ballpen

78
 h. Notebook/journal
i. Surgical mask (for patient’s use)

2. Provide a copy of the patient’s DR-TB treatment card.

2.1. Copy all the information from the patient’s treatment card and update up to
the last DOT taken. The duplicate card will be given to the CTP to keep and
update.
2.2. Keep the original copy in the PMDT treatment facility.

3. Provide drug supply to the CTP.

3.1. Dispense allocations of oral and injectable drugs to the CTP preferably
weekly in the form of daily packs per patient. Daily drug packs shall be
equivalent to 7 days of supervised treatment with 1 day buffer based on the
latest regimen of the patient.
3.2. Instruct the CTP to store the drugs in a cool, dry, secure place and away
from direct sunlight. Keep in mind that for patients with PAS, the drug may be
stored inside a refrigerator.

E. Providing Community-based Treatment

CTP shall do the following every supervised treatment:

1. Meet the patient at home or at a mutually agreed location.
2. Greet the patient.
3. Ask patient for any complaints.
4. Check the drugs and doses to be sure that they are correct.
5. Watch the patient swallow all the drugs. Injectable agent shall be given by a
CTP who is allowed to administer injections (physician, nurse).
6. Record the supervised treatment in the patient booklet and treatment card.
7. Record any complaint in the patient progress report form and refer patient’s
case to the PMDT treatment facility staff through text or phone call, if necessary.
8. Respond quickly if the patient misses a scheduled treatment.
9. Provide regular reminders/messages on:
 Importance of treatment adherence
 Importance of sputum, blood test, diagnostic test monitoring
 Recognizing adverse drug reactions
 Counselling of patient and family
 Prevention of transmission of TB, including TB screening among
contacts
10. Accompany the patient to the PMDT treatment facility for consultation, or for
regular follow-up.

F. Monitoring and Supervising Community Treatment Partners

Perform ad hoc visits.

1. Observe actual administration of DOT.
2. Check the patient’s records (patient booklet, treatment card and PPRF).
3. Ask patient about the CTP (e.g. Does the CTP work around the patient’s
schedule? Is the CTP prompt or on time? Does the CTP have a good attitude?).
4. Address any treatment-related concern of the patient.

79
5. Check the number of pills per drug pack. If there is an extra or missing pill, seek
an explanation from the CTP.
6. Interview the CTP, discuss any issue, and reinforce key reminders/messages.

Summary of Procedures
A. Selecting patients

B. Selecting Community Treatment Partner (CTP)

C. Orienting CTPs

D. Providing tools and drug supply to CTPs

E. Providing Community-based Treatment

F. Monitoring and Supervising CTPs

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 CHAPTER 5

MDR-TB AND PALLIATIVE CARE

I. Introduction

Management of DR-TB in the Philippines remain to be a challenge due to long

duration of treatment, adverse effects of second line anti-TB drugs, stigma and other
psychosocial factors. Based on the DR-TB analysis of cohort from 2007 to 2012, 20-
44% of patients discontinued treatment and 1-4% of cases did not respond to available
DR-TB treatment. These patients continue to experience symptoms of TB and will
become potential source of infections in the community. Though they are not
candidate for being cured, care still needs to be given to ensure quality of life not only
for the patient but also for the people around them.

The World Health Organization defines palliative care as "an approach that
improves the quality of life for patients and their families facing the problems
associated with life-threatening illness, through the prevention and relief of suffering
by means of early identification and impeccable assessment and treatment of pain
and other problems, physical, psychosocial and spiritual".²² TB and DR-TB is a chronic
disease that poses varied challenges to patients. These challenges can be social
stigma, physical symptoms brought about by the disease and medications, feeling of
worthlessness and loss of hope.

In November 19, 2010, a declaration on Palliative Care and MDR/XDR-TB was

done in Geneva. It was emphasized that (1) access to palliative care for individuals
with MDR-TB/XDR-TB is a human right and promotes dignity, and (2) palliative care
in the context of MDR/XDR-TB should be integrated into the management of
MDR/XDR-TB from the time of diagnosis until patient reaches cure or the end of life.
Palliative care should start as soon as the patients present for care and should
emphasize on maintaining quality of life at any age and stage of illness. Care for
patients with TB and DR-TB requires a spectrum of care delivery ranging from primary
care to specialized team that will focus on addressing symptoms, treating the disease,
and alleviating symptoms at the end of life.

Palliative care focuses on empowering patients on their preferred type of care.

It also focuses on encouraging patients to express their perception and feelings on the
disease process so that the palliative care team will be able to address possible
misperceptions and fears. By doing this, we will be promoting adherence to treatment,
thereby increasing treatment success. For those who are no longer qualified for active
treatment and those who are not candidate for being cured, they must be permitted to
live out their life with minimal suffering and loss of dignity. Palliative care approach is
an essential part of patient centered care approach in DR-TB management.

81
II. Objectives

To ensure quality of life of patients with DR-TB by:

a. Ensuring that patients and their families are given holistic management
during DR-TB treatment to attain treatment completion
b. Empowering patients to participate in the management of TB/DR-TB
c. Ensuring that patients and their families will not be abandoned even if cure
is not anymore possible

III. Policy

Palliative care shall be integrated in the management of DR-TB.

IV. Procedures

A. Providing Care for Relief of Symptoms

All patients diagnosed to have DR-TB must be provided care to alleviate

symptoms. The health care provider shall:

1. Counsel and educate patient and family about TB disease and enjoin him/her
to participate in the management of his disease (e.g. decision on where to seek
treatment, decision to faithfully adhere to treatment, etc.)
2. Monitor adverse events, counsel and give ancillary drugs to control adverse
events
3. Instruct patient and his/her family members to implement infection control in the
household and community.

B. Managing Patients who refused and are not responding to available DR-
TB treatment

1. Plan on how to approach patient, his/her family and significant others in

disclosing the plan to suspend anti TB treatment and other options if treatment
will not be initiated.
2. Discuss with the patient and family the management plan to alleviate symptoms
of TB and to ensure that respiratory infection control is in place.
3. Offer options to control patient’s symptoms to maintain quality of life and dignity
when giving anti TB treatment is not an option. The following are the end of life
support measures:

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Table No. 17 – End of Life Support Measures²³
End of Life Support
Relief of Dyspnea
Relief from pain and other symptoms
Infection control Measures
Nutritional support
Regular Medical Visits
Continuation of ancillary medicines
Provision of psychological support
Other supportive care
Management
 Give Oxygen support
 Give Morphine according to
established clinical protocols in
literature
 Give Paracetamol, or codeine with
paracetamol, gives relief from
moderate pain. If possible, stronger
analgesics, including morphine,
should be used when appropriate to
keep the patient adequately
comfortable
 Refer to WHO-developed analgesic
guides, pain scales and a three-step
‘ladder’ for pain relief for further
guidance.
 Continue infection control practice
with reinforcement on environmental
and personal measures including the
use of N-95 mask for caregivers.
 At the end of life, give small and
frequent feeding. It is expected that
intake will reduce as the patient
deteriorates.
 Treat nausea and vomiting that
interferes with nutritional support.
 Visit patient to address medical needs
and to ensure that infection control is
being followed.
 Give butamirate citrate, morphine,
codeine to control cough.
 Give metered dose inhalers to control
bronchospasm
 Manage anxiety and depression
 Provide counseling to patient and
family to assist in planning for
decisions related with end of life and
provide emotional support especially
in which strong stigma is attached to
the disease
 Give oral care
 Prevent bedsores among bed borne
patients
o Advise use of egg crate
mattress
o Change position of patient
regularly
o Keep the bed dry and clean
83
 Respect for patient’s beliefs and values
during treatment, and especially at the
end of life
Hospitalization, hospice care, or nursing
home care
 Respect patient’s belief, values and
practices and avoid imposing personal
views that prevent the patient to seek
and find comfort in the services
delivered by faith-based organizations.
 Refer to palliative care specialist/team
for further care.

C. Implementing Palliative Care

1. Organize a team to provide palliative care.

2. Train staff to promptly identify and address adverse events due to first and second
line anti-TB drugs and due to complications of advanced TB disease and other co-
morbidities.

3. Train staff in counseling to address the psycho emotional and spiritual needs of the
patients and their families.

4. Provide free ancillary drugs and other regulated drugs such as opioids (e.g.
Morphine), benzodiazipines, antipsychotic (e.g. haloperidol) drugs.

5. Secure an S2 license to have access to regulated drugs.

Summary of Procedures
A. Providing Care for Relief of Symptom

B. Managing Patients who refused and are not

responding to available DR-TB treatment

C. Implementing Palliative Care

84
 CHAPTER 6

PREVENTION OF DRUG-RESISTANT
TUBERCULOSIS AND INFECTION CONTROL
I. Introduction

Drug-resistant tuberculosis is transmitted in the same manner as drug-susceptible

tuberculosis. Based on a systematic review and meta-analysis on the “Yield of Contact
Investigation in Households of Patients with Drug-resistant Tuberculosis” conducted
by Shah, et. al., the majority of secondary cases were detected within 1 year of the
source case’s diagnosis. About 8% were diagnosed to have active TB and 47% were
found to have latent TB during contact investigation. More than 50% of the diagnosed
cases has the same drug susceptibility pattern as the index case.²⁴

According to WHO, the following are the key interventions to prevent drug-resistant
TB: a) early detection and high quality treatment of drug-susceptible and drug-resistant
TB, b) infection control, c) health system strengthening and regulation, and d.)
addressing underlying risk factors and social determinants. Disease prevention
policies for both drug-susceptible and drug-resistant TB go hand in hand. However,
the treatment and management for DR-TB pose more challenges requiring stringent
measures of preventing disease transmissibility.

II. Objective

To effectively implement DR-TB preventive measures at the PMDT treatment facilities,

TB laboratories, workplace, community, and household level to prevent the
development and spread of drug-resistant TB.

III. Definition of Terms

Administrative Controls – Measures that will reduce risk of TB transmission by

preventing the generation of droplet nuclei or reducing exposure to droplet nuclei. This
type of control has the greatest impact on preventing the spread of TB.

Close Contact – A person who shared an enclosed space, such as the household, a
social gathering place, workplace or facility, for extended periods within the day with
the index case during the 3 months before commencement of the current treatment
episode.

Contact Investigation – Is a systematic process intended to identify previously

undiagnosed cases of TB/ DR-TB among the contacts of an index case.

Environmental Controls – Measures that will reduce the concentration of infectious

droplets in the air especially in areas where contamination of air is likely.

Fit Test – Is used to determine which respirator fits the health care provider adequately
and to ensure that the health care provider knows when the respirator fits correctly
and comfortably. Fit testing uses a test agent, either qualitatively detected by the

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wearer’s sense of taste, smell or involuntary cough (irritants smoke) or quantitatively
measured by an instrument, to verify the respirator’s fit. (CDC)

Managerial Activities – Essential separate set of measures to facilitate the smooth

implementation of the three (3) components of TB IC: administrative, environmental,
and respiratory protection controls.

Respirator – A special type of closely-fitted mask with the capacity to filter particles
to protect users from inhaling infectious droplet nuclei

Preventive Therapy – Is an intervention aimed in preventing TB latent infections from

progressing to TB disease in close contacts of drug-susceptible TB.

Respiratory Protection Controls – Measures that involve selection and proper use
of respirators to protect one from inhaling droplet nuclei.

TB Infection Control (TB IC) – Are specific measures and work practices that reduce
the likelihood of spreading the TB bacteria to others.

IV. Policies

A. All health care providers shall ensure prompt identification, initiation, and
completion of treatment of all TB cases.

B. TB prevention and infection control measures shall be implemented in all health

care settings.

C. All PMDT treatment facilities shall implement TB infection control according to

the “Guidelines on Infection Control for Tuberculosis and Other Infectious
Diseases” issued in 2011 by DOH.

D. Close contacts of confirmed DR-TB patients in household and congregate

settings shall be prioritized for systematic screening.

E. Preventive therapy shall not be given to close contacts of DR-TB patients.

F. If without active TB disease, all infants shall be given a single dose of BCG
except those who are known to be HIV positive, those whose HIV status is
unknown but who are born to HIV-positive mothers and those whose symptoms
are suggestive of HIV.

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V. Procedure

Based on WHO, the 4 key interventions to prevent drug-resistant TB are:

A. Detecting early and providing high quality treatment of drug-susceptible

and drug-resistant TB
1. Improve accessibility to TB diagnostic and treatment services
2. Monitor treatment adherence and manage adverse events
3. Strengthen the implementation of quality assurance programs
4. Conduct contact tracing among close contacts of patients
o Children aged under 5 years and anyone with HIV infection are at the
highest risk when exposed to sputum smear-positive TB cases and
should therefore be prioritized for screening.

B. Implementing Effective Infection Control Measures

1. All PMDT treatment facilities shall implement TB IC interventions, following

in order of hierarchy: administrative, environmental and respiratory controls
through managerial activities. Specific guidelines should be adopted according
to the “Guidelines on Infection Control for TB and Other Airborne Infectious
Diseases”.

1.1. Administrative Controls are the first line of defense, and the most
important level in the hierarchy of TB IC. It is the first priority regardless
of available resources.
Administrative control measures include:
1.1.1. Promptly identify people with TB symptoms (triage),
examples
are:
i. Place notices that one must immediately inform staff
about cough of any duration
ii. Assign staff to screen persons with cough and to collect
sputum
1.1.2. Separate or isolate infectious patients
i. Designate waiting areas for presumptive TB/DR-TB or
patients with TB/DR-TB
ii. Inform patients, staff and visitors by placing visible
signage on restricted areas (e.g., “you are entering an
infection precaution area”)
iii. Segregate physically or by scheduling positive and
negative smear/ culture, and DS and DR-TB
1.1.3. Control the spread of pathogens
i. Place signs and posters about cough etiquette
ii. Provide tissue papers, disposable surgical masks or
ordinary cloth face masks to coughing patients and
infectious TB/DR-TB patients
iii. Provide daily health education on cough etiquette

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 1.1.4. Minimize the time spent by patients in health care facility
i. Manage patient flow by moving presumptive DR-TB to
the front of the waiting queue
ii. Minimize time spent receiving services by giving patients
specific time slots or additional staff during busy
days/hours.
1.1.5. Reduce diagnostic delays
i. Use of rapid diagnostic tests when available
ii. Reduce turn-around time for DSSM and other diagnostic
tests
1.1.6. Prompt initiation of treatment
1.1.7. Provide a package of prevention, treatment and care
interventions for staff (e.g. regular screening for symptoms of
active TB disease, CXR at baseline and as part of biannual
physical examination, bacteriological studies for staff with
symptoms), including HIV testing and counselling, anti-retroviral
treatment and IPT for HIV positive staff²⁵
o HIV-infected health care providers should not work in
settings where the risk of TB transmission is high.
o Pregnant health care providers should not be exposed
to contagious patients.
o HIV-infected or pregnant health care providers should
be assigned to work areas that have the least risk for
TB transmission

1.2. Environmental control includes technologies for the removal or

inactivation of airborne infectious droplet nuclei. It is considered as the
second line of defense for preventing the spread of TB and, in
combination with the right administrative controls, will reduce the risk of
infection. Cost-effective environmental control measures that could be
used at the health facilities are natural ventilation and mixed mode
mechanical ventilation (i.e., use of fans together with natural ventilation).
For health facilities, the following are practical and simple measures that
could be adopted:
1.2.1. Use natural ventilation by opening windows and doors or
using tents
1.2.2. Evaluate and document direction of airflow daily in high-risk
areas within the health facility. Use smoke test (incense sticks or
mosquito coil) to visualize air movement
1.2.3. Place or re-arrange furniture and seating such that staff-
patient interaction occur with airflow passing from health worker
to patient or between health worker and patient, rather than from
patient to health worker (i.e., airflow from “clean to dirty”)
1.2.4. Ensure that fans are clean and working properly

1.3. Respiratory protection control is considered the last line of defense.

1.3.1. Based on the IC assessment, identify who among the staff
will wear respirators, where and when respirators will be used
1.3.2. Perform fit test every six months or as needed

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 1.3.3. Train staff on how to wear, care for, maintain and dispose
of the respirator

2. Managerial activities will ensure the smooth and effective implementation of

the administrative, environmental, and respiratory protection control measures.
This includes:
a. Organize the infection control committee or team who will be
responsible for the implementation of the TB IC plan. Assign an infection
control officer
b. Develop a facility TB IC plan
c. Perform IC assessment of health care facilities (See Annex L on page
227-229 for the Assessment Checklist for Healthcare Facilities and
Other Congregate Settings)
d. Rethink the use of available spaces and considering the renovation of
existing facilities or construction of new ones to optimize implementation
of controls
e. Conduct on-site surveillance of TB disease among health care
providers
f. Monitor and evaluate the set of TB IC measures

3. All patients with DR-TB and close contacts shall be educated and
encouraged to do the following TB IC measures:
3.1. The importance of early detection and treatment of TB and DR-TB,
and prompt screening of contacts
3.2. Methods to reduce exposure
3.2.1. Cough etiquette (i.e., covering mouth and nose when
sneezing or coughing)
3.2.2. Minimizing time spent by patients with infectious TB in
crowded public places
3.2.3. Opening windows and removing any obstruction to
ventilation in rooms where TB patient sleeps or spends much time

C. Strengthening and Regulating Health Systems

Health system strengthening involves assessment of barriers and providing

interventions not just only to TB-specific programs but also to programs beyond
NTP. This provides an opportunity for integration of service delivery, sharing of
resources, capacity building, and drug management with other public health
programs. Two health system elements which are important in prevention of
DR-TB include regulation of drugs and proper TB surveillance.

1. Regulation of diagnostics and drugs

o Ensure that international standards are followed for patient
treatment and care.
o Apply existing national regulatory mechanisms for rational use
of drugs
o Determine the criteria for a patient to be eligible to access
drugs.
o Define and apply the ethical standards that will protect
patients, ensure equity and promote human rights.

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 o Monitor the implementation of the program to identify areas in
need of adjustments in order to increase coverage, improve
the care being delivered and increase impact.
o Private and public providers not linked to NTP providing DR-
TB diagnosis and treatment can be engaged through public-
private mix approaches, allowing access to free quality-
assured TB medicines upon adherence to national guidelines.
o Quality and availability of both first and second line drugs shall
be assured.

2. Make TB a notifiable disease

o Ensure proper surveillance to identify where TB (including DR-
TB) is being diagnosed and managed. This will help in the
assessment of treatment outcomes in the whole health
system.

D. Addressing underlying risk factors and social determinants

Drug-resistant TB can be prevented with quality diagnosis and treatment,

however, there are also other factors and social determinants which have an
impact on the management of DR-TB. Some of these include social and
financial barriers to access and adherence to health care services. These
factors shall be addressed to reduce the risk of poor treatment outcomes
leading to acquired/amplified resistance and transmission of drug-resistant TB.
It should be noted that the program cannot address these alone but instead
should be a combined effort from organizations within and outside the health
sector with emphasis on the role of the local government units.

Ways to address financial and social barriers to treatment adherence:

o Provide access to free TB diagnostic and treatment to patients
o Reduce the cost for other related clinical services such as
management for comorbidities
o Minimize indirect cost of care (e.g. transportation expenses,
loss of income)
o Encourage patients to stop or decrease the use of drugs or
alcohol if it interferes with treatment adherence.
o Involve the family as a source of psychosocial support.
o Involve community/religious leaders if there are social issues
such as stigma towards DR-TB is present in the community.
o Manage side effects
o Counsel patients regarding their perspective on treatment
regimen as compared to traditional medicine

E. Conducting Other Interventions

1. Conduct contact tracing

1.1. Identify close contact
1.2. Collect one sputum specimen for rapid diagnostic test
1.3. Perform other laboratory diagnostic test if needed to support
diagnosis of TB

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 1.4. Do surveillance of all household contacts with presumed latent DR-
infection every 6 months for 2 years by symptom screening
o Treatment of latent infection in household contacts of DR-TB
patients is not recommended
o Manage all household contacts who develop symptoms
suggestive of TB according to the case finding policies and
procedures

2. Administer BCG vaccination at birth. Procedure for the administration of

BCG vaccine is discussed under the Expanded Program on Immunization.

Summary of Procedures
A. Detecting early and providing high quality treatment of
drug-susceptible and drug-resistant TB

B. Implementing effective infection control measures

C. Strengthening and Regulating Health Systems

D. Addressing underlying risk factors and social

determinants.

E. Conducting other interventions

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 CHAPTER 7

RECORDING AND REPORTING

I. Introduction

Recording and reporting are important in the implementation of a successful TB control

program. Availability of records ensures provision of appropriate and effective care for
patients. Through efficient recording, health care providers can monitor that each
presumptive DR-TB case is examined and promptly initiated on treatment, monitored,
and cured. Records, therefore, should contain accurate, complete, and up-to-date
information on patient’s diagnosis, contact investigation, treatment, follow-up
examinations, treatment outcome, and post treatment follow-up. Aside from
information on patient’s coverage and care, reports also provide information to
improve program efficiency and effectiveness, including ensuring availability of drugs
and other supplies at the PMDT treatment facilities.
Meanwhile, an electronic information system, the Integrated TB Information System
(ITIS), was developed to enhance recording and reporting of the NTP. ITIS is a web-
based system and a tool for data collection, processing, reporting, and use of the
information necessary for improving TB control effectiveness and efficiency. ITIS
incorporates the requirements of the DOH in the management and/or implementation
of the NTP, in accordance to WHO standards. ITIS is being developed and moderated
by the DOH-Knowledge Management and Information Technology Service (KMITS).
Major advantages on the use of ITIS are:
• Centralized access of information and record keeping
• Ease of tracking users’ actions
• Ease of doing backup of information
• Integration of TB database to other DOH information systems such as
PVIMS, ClinicSys, HOMIS and NOSIRS
• Ease of generating reports including graphical representations
• Eliminate duplication of data in reports
• System generated printable forms
• For online users, real-time access, feedback and use of evidence for
decision making
This section only discusses general guidelines on recording and reporting including
general description of forms and procedures on ITIS implementation and data quality
checks. Detailed instructions on accomplishing the forms will be discussed during
training. Procedures on analysis of data can be found in the chapter on Monitoring,
Supervision and Evaluation
II. Objectives
The objectives of recording and reporting are to:

 Document patient and program information that would ensure high-quality

patient care, a continuum of care among referred DR-TB cases, and information
sharing among health care providers
 Provide tools to help staff in providing adequate services to individual patients

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  Allow program managers at different levels of the health care system in the NTP
to monitor and evaluate program performance in a standardized and
internationally comparable manner.

III. Definition of Terms

Access Level - The type of access given to a user such as encoder, validator or
viewer

Encoder – A type of IT IS access level given to any NTP personnel designated to

perform data input.
Integrated Tuberculosis Information System (ITIS) - An electronic information
system that will be used to collect, consolidate, and report TB data coming from all
health facilities managing TB cases under NTP.
User Account - The information of the user such as name and password
Validator – A type of ITIS access level given to any personnel designated to perform
data validation. Data validation is the process of checking the completeness, accuracy
and consistency of the encoded information prior to making it as a reportable case. A
validator can also perform both viewing and encoding functions.
IV. Policies

1. PMDT data shall be collected, analyzed and utilized to ensure provision of

quality and adequate services.

2. All diagnostic and treatment facilities providing PMDT services shall follow NTP
standard recording and reporting. PMDT recording and reporting shall include
all DR-TB cases, classified according to internationally-accepted case
definitions.

3. The Integrated TB Information System (ITIS) shall be the official electronic TB

information system. All PMDT reports (including laboratory reports) shall be
submitted through ITIS following the prescribed timeline.

4. Data quality check activities shall be done at least biannually at all levels of
implementation.

5. Feedback on the submitted reports shall be provided following the prescribed

flow of reporting and timeline.

6. Confidentiality of patient records shall be observed at all times.

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Recording and Reporting

General Steps

The facility head shall ensure that all PMDT health care providers are capacitated in
accomplishing PMDT forms. The physician or immediate supervisor shall be
responsible in ensuring accuracy and consistency of data recorded and report
submitted.

1. Document properly all procedures in appropriate forms to record action taken.

2. Use red ink for positive DSSM, Xpert and TBC result, and resistance to FLD or
SLD. Use blue ink for transferred-in patients. Use black ink for all other records.

3. Cross out wrong or outdated information and write the correct or updated data.
Countersign the corrections with initials and date.

4. Maintain PMDT records for at least 7 years from the time of creation of the
record in a secure place that only authorized personnel can access.

5. Follow the flow of NTP reporting and timelines. However, Culture and DST
Laboratories shall directly submit reports to the RO.

Table No. 18 - Timeline of Reporting

Level Timeline of Reporting
st
PMDT Treatment Facility and Xpert 1 week of the month following end of quarter
Site
PHO/CHO 2nd week of the month following end of quarter

RO 3rd week of the month following end of quarter

DOH-NTP 1st month of the following quarter

Feedback on submitted reports shall follow the reverse flow within 3 months from submission.

6. Analyze the data. The physician/ immediate supervisor shall conduct analysis
of data together with all heath care providers in the facility, and program
managers at all levels.

Recording and Reporting Forms

Below is a summary of the required recording and reporting forms for PMDT. This
section will describe their major contents, purpose, timing of administration and
updating, data source, person responsible in accomplishing and filing. Detailed
instructions on accomplishing these forms are not discussed in this section and will be
taken up during training.

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Table No. 19 – NTP Recording and Reporting Forms
Records Reports
1. Form 1. Presumptive TB Masterlist or 1. Report 1a. Quarterly Report on
Referral Logbook TB Microscopy and Xpert
2. Form 2a. NTP Laboratory Request and MTB/RIF Laboratory
Result Form Examination
3. Form 2c. NTP TB Culture Result Form 2. Report 1b. Quarterly Report on
4. Form 2d. NTP Drug Susceptibility Testing TB Culture and Performance
Result Form Indicator
5. Form 2e. NTP Line Probe Assay Result 3. Report 1c. Quarterly Report on
Form 1st Line Solid and Liquid DST
6. Form 3a. NTP Laboratory Register 4. Report 1d. Quarterly Report on
(Microscopy and Xpert MTB/RIF) 2nd Line DST
7. Form 3b. NTP Laboratory Register (TB 5. Report 1e. Quarterly Report on
Culture and DST) Line Probe Assay – 1st Line for
8. Form 4b. DR-TB Treatment Card TB
9. Form 5b. DR-TB Patient's Booklet 6. Report 1f. Quarterly Report on
10. Form 6b. DR-TB Register Line Probe Assay – 2nd Line
11. Form 7. NTP Referral Form DST for TB
7. Report 3b. Quarterly Report on
Patient Management Forms All DR-TB Cases
1. DR-TB Screening Form 8. Report 4b. DSM Report and
2. DR-TB Case Presentation Form Requisition Form
3. TB Medical Advisory Committee Masterlist 9. Report 4c. iDOTS/ Treatment
4. Patient's Progress Report Form Site Requisition Form
10. Report 5b. Quarterly Report on
Administrative Forms Treatment Interim Outcome of
1. TB Laboratory Specimen Receiving Form DR-TB Cases
2. TB Laboratory Result Releasing Form 11. Report 5c. Annual Report on
3. Quarterly Laboratory Report Attachment Form the Treatment Outcome and
4. Solid TB Culture Workbook Post-Treatment Follow-up of
5. Laboratory Solid TB DST Workbook DR-TB Cases
6. Liquid TB Culture and DST Workbook 12. FDA AE Reporting Form
7. Stock Cards
8. Temperature and Humidity Monitoring Log
9. Drugs & Supplies Receiving Form
10. Expired Damaged Drug Disposal Report
Form

A. Recording Forms

Form 1. Presumptive TB Masterlist or Referral Logbook

The Presumptive TB Masterlist or Referral Logbook is a listing of all presumptive

TB, including presumptive DR-TB, seen at the DOTS facility. The register shall
serve as tracking list for diagnosed TB and DR-TB cases to ensure that all cases
are started on treatment, whether in the same facility or not. The form shall contain
patient demographics, contact information, source of referral, and risk factors for
DR-TB, diagnostic examinations requested and results, and actions taken. The
form shall be accomplished by the health care provider upon identification of the
presumptive TB/DR-TB and updated upon availability of results of diagnostic

95
examinations and decision. This form shall be kept at the DOTS/PMDT treatment
facility. The form shall be the source of reports on screening and diagnosis.
Form 2a. NTP Laboratory Request and Result Form

The NTP Laboratory Request and Result Form shall be used by DOTS/PMDT
treatment facilities and trained health care providers to request for DSSM, Xpert
MTB/RIF, TBC, DST or LPA. It shall also be the result form for DSSM and Xpert
MTB/RIF. Results of TBC, DST, and LPA shall be recorded in separate result
forms. If two or more tests are simultaneously being requested from the same TB
laboratory, only a single request form shall be required. The upper half of the form
shall be accomplished by the health worker from the requesting facility. The bottom
half of the form shall be for the results of DSSM and/or Xpert MTB/RIF and will be
accomplished by the TB laboratory staff. The filled-out result form shall be kept in
the patient’s chart. A duplicate copy may be given to the patient.
Form 2c. NTP TB Culture Result Form

The NTP TB Culture Result Form shall be used by TB Culture laboratories and
shall be accomplished by TB Culture Medical Technologists. The form contains the
patient demographics and the culture result. The filled-out result form shall be kept
in the patient’s chart. A duplicate copy may be given to the patient. The result shall
be recorded in the NTP Laboratory Register (TB Culture and DST) (See Annex A
List of Forms on page 148).
Form 2d. NTP Drug Susceptibility Testing Result Form

The NTP Drug Susceptibility Testing Result Form shall be used by DST
laboratories and shall be accomplished by Medical Technologists performing DST.
The form contains the patient demographics and the DST result. The filled-out
result form shall be kept in the patient’s chart. The result shall be recorded in the
NTP Laboratory Register (TB Culture and DST) (See Annex A List of Forms on
page 149).

Form 2e. NTP Line Probe Assay Result Form

The NTP LPA Result Form shall be used by LPA centers and shall be
accomplished by Medical Technologists performing LPA test. The form contains
the patient demographics and the LPA result. The filled-out result form shall be
kept in the patient’s chart. The result shall be recorded in the NTP Laboratory
Register (TB Culture and DST) (See Annex A List of Forms on page 150).
Form 3a. NTP Laboratory Register (Microscopy and Xpert MTB/RIF)
The NTP Laboratory Register (Microscopy and Xpert MTB/RIF) shall be used by
TB Microscopy Laboratories and Xpert Sites and shall be accomplished by the
Medical Technologist or Xpert Technician. The form contains patient demographic,
TB classification, reason for examination, examination result, and laboratory staff
who performed the test. The form shall be kept at the laboratory and shall be the
source for Xpert test reports.

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 Form 3b. NTP Laboratory Register (TB Culture and DST)

The NTP Laboratory Register (TB Culture and DST) shall be used by Culture
Laboratories, DST Laboratories, and LPA Laboratories and shall be accomplished
by the Medical Technologist. The form contains patient demographic,
classification, reason for examination, examination result, and laboratory staff who
performed the test. The form shall be kept at the laboratory and shall be the source
for culture, DST, and LPA reports (See Annex A List of Forms on page 152).
Form 4b. DR-TB Treatment Card
The DR-TB Treatment Card shall be used for all DR-TB patients that were initiated
on treatment. The 4-page booklet type form shall include patient demographics,
TB treatment history, TB classification, HIV status, treatment regimen, record of
daily drug intake, weight, laboratory, and x-ray monitoring, contact tracing
activities, and post-treatment follow-up. This shall be accomplished by the health
care provider upon initiation of DR-TB treatment and is maintained in the patient’s
chart. It shall be updated daily for DOT and at least monthly for laboratory results
and other pertinent patient updates. The form shall serve as source for recording
in the DR-TB Register.
Form 5b. DR-TB Patient's Booklet

The DR-TB Patient’s Booklet is an individualized form that shall serve as the
patient’s treatment diary. The booklet shall be given to the patient and shall to be
brought every day during intake of medications. This form shall consist of the
patient identifiers, record of daily drug intake, and reminders for patient such as
laboratory follow-ups due among others. This form shall be accomplished by the
treatment partner upon conclusion of supervised treatment.
Form 6b. DR-TB Register

The DR-TB Register is a registry of all detected DR-TB cases initiated on

treatment. The form shall contain patient demographics, contact information,
source of patient, TB classification, HIV status, treatment regimen, diagnostic
examination requested and results, laboratory monitoring, outcome and post-
treatment follow-up. The form shall be accomplished by the health care provider
once DR-TB treatment is initiated. This form shall be updated during patient
monitoring, assignment of outcome and post-treatment follow-up. This form shall
be kept at the PMDT treatment facilities. The form shall serve as source for all DR-
TB treatment reports.
Form 7. NTP Referral Form

The NTP Referral form shall serve as official communication form between/among
treatment facilities regarding patient transfers. The form shall be accomplished by
the health care provider in the following situations but not limited to referring a
patient for screening or evaluation of presumptive DR-TB, registration, and
continuation of treatment (transfer-out or decentralization). The upper part of the
form shall be filled out by the referring facility indicating reason for transfer and
supporting details while the bottom part shall filled out by the receiving facility to
acknowledge receipt of referral and provide feedback. The bottom part, once

97
accomplished, shall be cut and sent back to referring facility either through the
patient, relative or significant others, snail mail, or coordinators. If there is foreseen
delay in the transmittal of the form, feedback on the referral shall be done through
phone call, SMS, fax or e-mail. All referral shall be accompanied by copies of
supporting documents, such as but not limited to previous or current treatment card
or ID card, results of DSSM, X-ray or other diagnostic tests and certification of
diagnosis from previous physician (e.g., for EP-TB).
B. Patient Management Forms

The following forms shall be used to help in patient management. The form may
be adjusted, modified or integrated with other existing forms according to local
implementation needs.
1. DR-TB Screening Form – shall be accomplished for DR-TB patients for
initiation of treatment; this form contains a more detailed clinical information of the
DR-TB patient (See Annex B List of Patient Management Forms on page 165-166).
2. DR-TB Case Presentation Form – shall be accomplished to recommend
change in regimen, clinical management and assignment of outcome of difficult
cases (See Annex B List of Patient Management Forms on page 167-168).
3. TB Medical Advisory Committee Masterlist – shall be accomplished every
after the meeting. (See Annex B List of Patient Management Forms on page 169).
4. Patient's Progress Report Form –shall be accomplished to record significant
patient events such as AEs, treatment interruption and other clinical or psycho-
socio-economic problems and actions taken.
C. Administrative Forms

The following forms shall be used to track transport of specimens, drugs, and
supplies. The form may be adjusted, modified or integrated with other existing
forms according to local implementation needs.
1. TB Laboratory Specimen Receiving Form – Is a line list of specimens
being sent to the laboratory to signify receipt; shall be accomplished in
triplicate by the DOTS facility sending specimens to the laboratory.
2. TB Laboratory Result Releasing Form – Is a line list of laboratory results
being sent to the DOTS/PMDT treatment facility to signify receipt; shall be
accomplished in triplicate by the laboratory sending results to the
DOTS/PMDT treatment facility.
3. Quarterly Laboratory Report Attachment Form – Is a document used by
the laboratory staff in tracking the number of sent-out cases to other
laboratories. This form is being attached to quarterly reports. It includes the
date referred, laboratory number, and result or status, if available (See
Annex C List of Administrative Forms on page 173).
4. Solid TB Culture Workbook – Is a document used by the Medical
Technologist inside the laboratory for their weekly reading of solid culture
isolates in monitoring contamination and quantifying growth colonies. This
is also used as a record of identifying colonies whether Mtb or Non-

98
 tuberculous Mycobacteria (NTM). (See Annex C List of Administrative
Forms on page 174).
5. Laboratory Solid TB DST Workbook – Is a document used by the Medical
Technologist inside the laboratory for their weekly monitoring of isolates for
susceptibility and/or resistance to TB drugs. This is also used in monitoring
contamination and quantifying growth colonies. (See Annex C List of
Administrative Forms on page 175).
6. Liquid TB Culture and DST Workbook – Is a document used by the
Medical technologist inside the laboratory for their weekly monitoring of
isolates for susceptibility and/or resistance to TB drugs. This is also used in
monitoring contamination and quantifying growth colonies. This is also used
as a record of identifying colonies whether Mtb or Non-tuberculous
Mycobacteria (NTM). (See Annex C List of Administrative Forms on page
176).
7. Stock Cards – Shall be accomplished for all TB commodities; shall be
accomplished upon receipt of delivery, dispensing, and updated at least
monthly. (See Annex C List of Administrative Forms on page 176).
8. Temperature and Humidity Monitoring Log – Shall be accomplished
ideally twice daily to monitor temperature and humidity in drug and key
supplies storage. (See Annex C List of Administrative Forms on page 177).
9. Drugs and Supplies Receiving Form – Is a line list of drugs and supplies
being sent to another officer of facility to signify receipt; shall be
accomplished in triplicate by the sending office or facility. (See Annex C List
of Administrative Forms on page 178).
10. Expired/Damaged Drug Disposal Report Form – shall be accomplished
to report expired drugs or damaged drugs. (See Annex C List of
Administrative Forms on page 179).

D. Reporting Forms

Report 1a. Quarterly Report on TB Microscopy and Xpert MTB/RIF Laboratory

Examination

The Quarterly Report on TB Microscopy and Xpert MTB/RIF Laboratory Examination

shall be accomplished by the Medical Technologist or Xpert Technician and shall be
submitted to the PHO/CHO. The data source of this report shall be the Form 3a. NTP
Laboratory Register (Microscopy and Xpert MTB/RIF). The report contains number of
cases examined, number of cases per result and number of cartridges used. The
cohort to be reported are specimens received from previous quarter (See Annex D List
of Reports on page 182).

Cohort of Specimens to be Reporting Period Date of Submission

Reported
st
1 Quarter of current year
1st Quarter of current year Apr 2016
(e.g. Jan-Mar 2016)
nd
2 Quarter of current year
2nd Quarter of current year Jul 2016
(e.g. Apr-Jun 2016)
rd
3 Quarter of current year
3rd Quarter of current year Oct 2016
(e.g. Jul-Sep 2016)

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 4th Quarter of current year
4th Quarter of current year Jan 2017
(e.g. Oct-Dec 2016)

Report 1b. Quarterly Report on TB Culture and Performance Indicator

The Quarterly Report on TB Culture and Performance Indicator shall be accomplished

by the Medical Technologist performing TB Culture and shall be submitted to the RO.
The data source of this report shall be the Form 3b. NTP Laboratory Register (TB
Culture and DST) and TB Culture Workbook. The report contains number of cases
examined and number of cases per result including performance indicator (i.e.
Recovery rate, workload, and contamination rate). The culture result of specimens
received shall be reported after 3-5 months of receipt as follows: (See Annex D List of
Reports on page 183-184)

Cohort of Specimens to be Reporting Period Date of Submission

Reported
th
4 Quarter of previous year
1st Quarter of current year Apr 2016
(e.g. Oct-Dec 2015)
st
1 Quarter of current year
2nd Quarter of current year Jul 2016
(e.g. Jan-Mar 2016)
nd
2 Quarter of current year
3rd Quarter of current year Oct 2016
(e.g. Apr-Jun 2016)
rd
3 Quarter of current year
4th Quarter of current year Jan 2017
(e.g. Jul-Sep 2016)

Report 1c. Quarterly Report on 1st Line Solid and Liquid DST

The Quarterly Report on 1st Line Solid and Liquid DST shall be accomplished by the
Medical Technologist performing 1st Line Solid and Liquid DST and shall be submitted
to the RO. The data source of this report shall be the Form 3b. NTP Laboratory
Register (TB Culture and DST). The report contains number of cases examined and
number of cases per result, disaggregated by sex and age. The DST result of
specimens received shall be reported after 6-8 months of receipt as follows: (See
Annex D List of Reports on page 185-186)

Cohort of Specimens to be Reporting Period Date of Submission

Reported
3rd Quarter of previous year
1st Quarter of current year Apr 2016
(e.g. Jul-Sep 2015)
4th Quarter of previous year
2nd Quarter of current year Jul 2016
(e.g. Oct-Dec 2015)
1st Quarter of current year
3rd Quarter of current year Oct 2016
(e.g. Jan-Mar 2016)
2nd Quarter of current year
4th Quarter of current year Jan 2017
(e.g. Apr-Jun 2016)

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Report 1d. Quarterly Report on 2nd Line DST

The Quarterly Report on 2nd Line DST shall be accomplished by the Medical
Technologist performing 2nd Line DST and shall be submitted to the RO. The data
source of this report shall be the Form 3b. NTP Laboratory Register (TB Culture and
DST). The report contains number of cases examined and number of cases per result.
The DST result of specimens received shall be reported after 9-11 months of receipt
as follows: (See Annex D List of Reports on page 187-188)

Cohort of Specimens to be Reporting Period Date of Submission

Reported
2nd Quarter of previous year
1st Quarter of current year Apr 2016
(e.g. Apr-Jun 2015)
3rd Quarter of current year
2nd Quarter of current year Jul 2016
(e.g. Jul-Sept 2015)
4th Quarter of current year
3rd Quarter of current year Oct 2016
(e.g. Oct-Dec 2015)
1st Quarter of current year
4th Quarter of current year Jan 2017
(e.g. Jan-Mar 2016)

Report 1e. Quarterly Report on Line Probe Assay – 1st Line for TB

The Quarterly Report on Line Probe Assay – 1st Line for TB shall be accomplished by
the Medical Technologist performing LPA and shall be submitted to the RO. The data
source of this report shall be the Form 3b. NTP Laboratory Register (TB Culture and
DST). The report contains number of cases examined and number of cases per result.
The cohort to be reported are specimens received from previous quarter. (See Annex
D List of Reports on page 189).

Cohort of Specimens to be Reporting Period Date of Submission

Reported
st
1 Quarter of current year
1st Quarter of current year Apr 2016
(e.g. Jan-Mar 2016)
nd
2 Quarter of current year
2nd Quarter of current year Jul 2016
(e.g. Apr-Jun 2016)
rd
3 Quarter of current year
3rd Quarter of current year Oct 2016
(e.g. Jul-Sep 2016)
th
4 Quarter of current year
4th Quarter of current year Jan 2017
(e.g. Oct-Dec 2016)

Report 1f. Quarterly Report on Line Probe Assay – 2nd Line for TB

The quarterly Report on Line Probe Assay – 2nd Line for TB shall be accomplished by
the Medical Technologist performing LPA and shall be submitted to the RO. The data
source of this report shall be the Form 3b. NTP Laboratory Register (TB Culture and
DST). The report contains the number of cases examined and number of cases per

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result. The cohort to be reported are specimens received from previous quarter (See
Annex D List of Reports on page 190)

Cohort of Specimens to be Reporting Period Date of Submission

Reported
st
1 Quarter of current year
1st Quarter of current year Apr 2016
(e.g. Jan-Mar 2016)
nd
2 Quarter of current year
2nd Quarter of current year Jul 2016
(e.g. Apr-Jun 2016)
rd
3 Quarter of current year
3rd Quarter of current year Oct 2016
(e.g. Jul-Sep 2016)
th
4 Quarter of current year
4th Quarter of current year Jan 2017
(e.g. Oct-Dec 2016)

Report 3b. Quarterly Report on All DR-TB Cases

The Quarterly Report on DR-TB cases shall be accomplished by the health care
provider in the PMDT treatment facility. Data source for this report shall be Form 1.
Presumptive TB Masterlist or Referral Logbook, and Form 6b. DR-TB Register. This
report shall be submitted to the PHOs/CHOs. The report contains number of
presumptive DR-TB identified and tested, number of DR-TB detected and initiated
treatment, disaggregated by bacteriologic status at start of treatment, age and sex,
number of DR-TB with HIV, and contact tracing. Screened and registered patients
shall be reported after 3-5 months as follows: (See Annex D List of Reports on page
191-192)

Reporting Period Date of Submission Cohort of Specimens to be

Reported
1st quarter of current year Apr 2016 rd
4 quarter of previous year
(Jan-Mar 2016) (e.g. Oct-Dec 2015)
nd
2 quarter of current year Jul 2016 th
1 quarter of current year
(Apr-Jun 2016) (e.g. Jan-Mar 2016)
rd
3 quarter of current year Oct 2016 nd
2 quarter of current year
(Jul-Sep 2016) (eg, Apr-Jun 2016)
th
4 quarter of current year Jan 2017 rd
3 quarter of current year
(Oct-Dec 2016) (e.g. Jul-Sep 2016)

Report 4b. Quarterly Report on Drugs and Supplies Inventory and Requirement
for SLDs and Supplies

The Quarterly Report on Drugs and Supplies Inventory and Requirement for SLDs and
Supplies shall be accomplished by the health care provider in the PMDT treatment
facility. Data source for this report shall be Form 4b. DR-TB Treatment Card and stock
cards. This report shall be submitted to the NTPMO DSM team. The report shall
contain the projected and previous consumption, inventory of stocks on hand and
computation needed for 1 quarter + 3 months buffer of stocks. This shall be reported
every 10th day of every month. Requisition will be derived from reports submitted every

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10th day of the 2nd month of every quarter (See Annex D List of Reports on page 193-
194).

Report 4c. IDOTS/Treatment Site Requisition Form

The iDOTS/Treatment Site Requisition Form shall be accomplished by the health care
provider of the iDOTS facility or treatment site. Data source for this report shall be the
Form 4b. DR-TB Treatment Card and stock cards. This report shall be submitted to
the PMDT satellite/treatment center. The report contains name of patients, anti-TB
drugs and units per day, stocks on hand, and computation needed for 1 quarter + 1
month buffer of stocks. This shall be reported every 10th day of the last month of every
quarter (See Annex D List of Reports on page 195).

Report 5b. Quarterly Report on Treatment Interim Outcome of DR-TB Cases

The Quarterly Report on Interim Treatment Outcome of DR-TB cases shall be

accomplished by the health care provider in the PMDT treatment facility. Data source
for this report shall be Form 6b. DR-TB Register. The report shall contain number of
patients started on treatment and their status at 6th month of treatment, disaggregated
by bacteriologic status. The interim treatment outcomes of registered DR-TB patients
shall be reported after 9-11 months of registration as follows: (See Annex D List of
Reports on page 196)

Reporting Period Date of Submission Cohort of patients to be

1st quarter of current year
(Jan-Mar 2016)
2nd quarter of current year
(Apr-Jun 2016)
3rd quarter of current year
(Jul-Sep 2016)
4th quarter of current year
(Oct-Dec 2016)
reported
Apr 2016 2nd quarter of previous year
(e.g. Apr-Jun 2015)
Jul 2016 3nd quarter of previous year
(e.g. Jul-Sep 2015)
Oct 2016 4rd quarter of previous year
(e.g. Oct-Dec 2015)
Jan 2017 1th quarter of previous year
(e.g. Jan-Mar 2016)

Report 5c. Annual Report on the Treatment Outcome and Post-Treatment

Follow-up of DR-TB Cases

The Annual Report on the Treatment Outcome and Post-Treatment Follow-up of DR-
TB Cases shall be accomplished by the health care provider in the PMDT treatment
facility at the end of the calendar year. Data source for this report shall be Form 6b.
DR-TB Register. The report shall contain number of patients started on treatment and
their outcome as of 12th (for SSTR), and 24th or 36th month (for CTR) and post-
treatment follow-ups done (See Annex D List of Reports on page 197-198).

Two reports shall be submitted every January to cover the outcomes and post-
treatment follow-up of different cohorts. An example of annual reporting for treatment
outcome of DR-TB is below:

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 Reporting Date Report 5c to be Submitted
January 2017 1. STR patients registered in 2015 (12th month)
and CTR patients registered in 2014 (24th
month)
2. Patients registered in 2013 (36th month) and
Post-Treatment Follow-up of patients
registered in 2014 (SSTR) and 2012 (CTR)

FDA Suspected Adverse Reactions Form

The FDA Suspected Adverse Reactions Form (See Annex D List of Reports on page
200) shall be accomplished by the health care provider in the PMDT treatment facility
for all serious adverse events and adverse events of special interests while the
Pharmacovigilance Monitoring System (PVimS) is not yet in place. Data source for this
report shall be the Patient Progress Report Form, Form 4b. DR-TB treatment card,
and laboratory and/or diagnostic forms. This report shall be submitted to the NTP and
NTP to submit to Philippine FDA. The report shall contain the patient’s particulars,
details of the adverse event, management of the adverse event, and reporter’s
particulars. This will be submitted within 15 calendar days from detection of the event
or receipt of information. In case of death and/or life-threatening situation, notification
should be made to NTP immediately within 48 hours of detection by fastest means
possible. (Refer to Chapter 9. Pharmacovigilance on page 118).

I. Implementing ITIS

Training on ITIS shall be integrated in PMDT trainings. A staff trained in PMDT shall
also be trained in ITIS. A facility with at least one trained staff shall implement ITIS.

1. Assign at least one staff as the ITIS encoder. Assign the head of the facility or
physician as the ITIS validator whose role is to ensure accuracy and
consistency of records and encoded data in ITIS. If the head of the facility
and/or physician is/are (both) not available to validate ITIS data, another health
care provider may be delegated this task.
2. Encode key information in ITIS once paper forms are accomplished. Key
information include information required to be reported.
 The android version of ITIS may be used during patient screening to
minimize double reporting.
 For facilities implementing the ITIS Laboratory Module, Laboratory Request
Forms shall be encoded from requesting facility prior to sending of specimen
to the laboratory.
 Screening forms, treatment cards, laboratory results and update on patient
charts shall be encoded at least once a week.
3. Encoded data shall be validated by the designated validator before the case for
PMDT treatment facilities or test for laboratories is counted in the report.
Invalidated cases shall not be counted in reports.

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 4. All PMDT reports shall be coursed through ITIS. Once the report has been
validated at the facility level, the health care provider shall click on the “submit
report” button.
5. Validated reports shall be printed and filed in the facility.
6. Patient records encoded shall not be editable after 6 months of assignment of
outcome. Reports submitted shall not be editable after 6 months of submission.
7. PHO/CHO, RO and NTP shall validate reports in ITIS through any of the
following:
a. within ITIS: such as compare number of cases reported versus number of
encoded cases,
b. comparing ITIS-generated report with other reports: such as Report 3b in
ITIS versus DSM report
c. comparing ITIS-generated report with data source: such as Report 3b and
its list of patients versus DR-TB Register
8. Once validated by CHO/PHO and RO, report shall be submitted to the next
higher level.
9. ITIS shall also be used for patient referrals, reporting of AEs through PVIMS,
transmittal of Xpert results through GX Alert, updating of personnel and facility
contact information, updating of stock inventory, and creation of graphical
representations of accomplishments.

II. Conducting Data Quality Check

A. Offsite DQC

1. The CHO/PHO in coordination with the RO shall conduct at least bi-annual

DQC of all TB data, including both DS, DR and DSSM and Xpert data.
2. The DQC shall consist of checking of completeness and accuracy of paper
records, and consistency among records and with ITIS.
3. Any discrepancy shall be corrected immediately.
4. Previous and current performance shall be compared with targets.
5. Verified and corrected reports shall be submitted not later than one week from
the end of the DQC activity to next higher level immediately.

B. Onsite DQC

1. During quarterly monitoring, the register shall be compared with other sources
of information such as the treatment card, patient booklet and patient progress
report form.

2. Patient interview shall also be done to validate patient’s experience.

Summary of Procedures
A. Recording and Reporting

B. Implementing ITIS

C. Conducting data quality check

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 CHAPTER 8

LOGISTICS MANAGEMENT
I. Introduction

Managing Supply Chain

Supply Chain Management is a systems-based process consisting of product

selection, quantification and procurement, logistics and inventory management and
rational use. The cycle is guided by the national policy and legal framework that
defines the goals for the management of drugs and diagnostic supplies and supports
the continuous availability of these NTP Products and their appropriate use. It is
supported by management systems that include planning, financial management,
logistics information management system, organization and infrastructure, human
resources, training, monitoring and evaluation, and quality monitoring of the NTP
Products and the logistics process.

To go through each step, Product Selection involves the identification of medicines

and commodities that are required and essential, and that are made available for the
health program. Quantification is the process of estimating the quantity and cost of the
products required to ensure an uninterrupted supply. Procurement is the process of
acquiring NTP Products either through purchase or donation via international,
regional, or local sources of supply. Logistics and Inventory Management is the
process by which the NTP Products procured are received, assessed, and stored until
they are distributed to the next level from the central warehouse to the regional and
provincial warehouses, down to the diagnostic and treatment facilities providing
PMDT.

Managing Logistics

Logistics Management is one of the key elements of health system strengthening

ensuring uninterrupted anti-TB treatment, medical and laboratory supplies to all
service delivery points. Proper logistics management guarantees available quality
drugs and health services, and ensures patients are promptly diagnosed and
adequately treated, which ultimately contributes to the attainment of the program
goals.

In understanding logistics management, it is important to see the whole supply chain

management, which is described in the figure below.

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Figure No. 10 - Management component and responsible units for managing NTP
Products²⁶
Component Responsible Unit
Product selection NTP
Quantification and Quantification: NTP
Procurement Procurement: DOH
and partners, RO,
PHO
Logistics Allocation: NTP, RO,
Management PHO/CHO, TC/STC
Distribution: LMD,
RO, PHO/CHO,
TC/STC
Storage & inventory:
LMD, RO
warehouses,
TB laboratory and
PMDT treatment
facilities
Rational Use TB laboratory and
PMDT treatment
facilities

This section is intended to impart guidance on the proper logistics management of

drugs, medical and laboratory supplies for program coordinators, service delivery staff
and focal persons who are directly involved in handling logistics management at PMDT
treatment facilities.

Managing Logistics at PMDT treatment facilities

Management of the supply chain, specifically logistics management at PMDT

treatment facilities, will ensure the continuous supply of NTP products. These sites
provide diagnostic and treatment services for the management of MDR-TB in the
country. PMDT Service delivery points includes the central and regional warehouses
managing NTP products, TCs/STCs, iDOTS Centers as well as laboratory facilities
including culture sites and Xpert sites.

II. Objective

To ensure continuous supply of quality anti-TB drugs, medical and laboratory supplies
and program forms in all diagnostic and treatment facilities providing PMDT services.

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III. Definition of Terms

1. NTP Products – includes all anti-TB drugs, medical and laboratory supplies and
program forms used for and provided by NTP. A listing of all these products is included
in the annex.
2. Quality monitoring – the continuous monitoring of the quality of the NTP Products
and the logistics process for suitability, effectiveness, and efficiency.

3. Rational use of NTP Products – the appropriate, safe, and effective use of NTP
Products based on program guidelines.

4. Recall of drugs – an action enforced by a manufacturing firm as mandated by FDA

to remove a drug product from the market

IV. Policies
A. Selection and procurement procedures of drugs, medical and laboratory
supplies shall be in accordance to national and international standards and
guidelines such as WHO Guidelines, NTP Manual of Procedures. RA 9184 or
the Procurement Law and Philippine National Formulary.
B. Uninterrupted supply of quality assured anti-TB drugs, ancillary medicines,
medical and laboratory supplies and program forms in all PMDT treatment
facilities and laboratories within the NTP laboratory network shall be ensured
by NTP through correct forecast from reports submitted by facilities.
C. PMDT drugs and supplies shall be distributed following the existing DOH
logistics management system. Redistribution of drugs and supplies shall be
done among diagnostic and treatment facilities providing PMDT services to
mitigate shortage and prevent expiration of stocks.
D. Drugs and supplies shall be stored under appropriate conditions in the
warehouses and in all diagnostic and treatment facilities providing PMDT
services and accounted for through proper recording and reporting.
E. Quarterly requisition of supplies shall be submitted by diagnostic and treatment
facilities providing PMDT services to NTP through proper channels. Emergency
requests shall be acted upon immediately by NTP including response in
disaster/conflict affected areas.
F. Management of expired and damaged drugs and supplies shall follow the joint
DENR-DOH AO no. 02 s.2005 “Policies and Guidelines on effective and proper
handling, collection, transport, treatment, storage and disposal of health care
wastes”.

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V. Procedures

A. Selecting anti-TB drugs, medical and laboratory supplies

DOH-NTP central office shall have the primary responsibility of performing selection
of anti-TB drugs and medical and laboratory supplies. Selection of these NTP Products
shall be based on local and international guidelines such as standard treatment
guidelines, registration to the Food and Drug Administration (FDA) and inclusion to the
Philippine National Formulary (PNF).

B. Quantifying and Forecasting of Centrally Procured Drugs

DOH-NTP central office, together with other partner stakeholders, shall have the
primary responsibility of performing the forecasting and quantification of NTP
Products. Forecasting and quantification will be performed using the appropriate data
from reports and records submitted to the program as well as using available tools
such as QuanTB.

In performing quantification and forecasting of NTP products for PMDT, critical and
prerequisite information to be prepared and reviewed includes the following:
 Period and scope of the forecast and quantification
 Treatment regimen considered, including quantities of drug needed per
regimen
 Number of on-going patients
 Target Number of patients to enroll
 Actual consumption or percentage utilization of medicine based on quality
reports or consumption data
 Current stocks-on-hand with expiry dates
 Pending stocks on delivery or order with expiry dates
 Target buffer stocks
 Target minimum and maximum inventory
 Lead Time or the amount of time it takes for the site to receive a drug from
the time of planning
 Storage capacity of warehouse
 Consumption Trends such as changes in Standard Treatment Guidelines
(STGs) and occurrence of Adverse Drug Reactions (ADRs)
 Programmatic Decisions and Trends such as expansion plan, policy
changes and strategies as disseminated by NTP
 Approved budget

C. Procuring of NTP products

NTP shall have the primary responsibility of facilitating the procurement of NTP
products following government procurement law. NTP products to be procured by the
local government units, following NTP specifications and standards, shall also be in
accordance with government procurement policies.

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D. Distributing and Delivery of NTP products

The Philippines is composed of diverse geographical areas and is prone to various

natural disasters which makes the distribution of pharmaceutical products a critical
function. The distribution system is dynamic and is expected to change in the coming
years due to DOH strategies and policies intended to continually improve and
strengthen the complex structure of distribution.

Distribution is dynamic and is expected to change in the coming years due to evolving
DOH strategies and policies. The following provides two (2) possible scenarios for the
distribution and delivery of NTP Products to be decided upon by DOH-NTP Central:

Figure No. 11 - Engagement of Regional Warehouses

DOH-NTP

Regional
Warehouse

iDOTS Laboratory TC/STC

DOH-NTP Central shall:

1. Prepare allocation list to be delivered to regional warehouse except for
Regions composed of different separate islands, wherein cross docking to
provinces may take place.
2. Ensure and Monitor the distribution of NTP Products to Regional
Warehouse
3. Inform Regional NTP Team and Regional Supply Officer the incoming
delivery

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At the level of the Regional Warehouses, the:
1. Regional Supply Officer shall receive NTP Products and ensure
appropriateness and promptness of delivery (refer to section on Receipt
and inspection upon delivery)
2. Regional Supply Officer shall inform Regional NTP Team of delivery
made
3. Regional NTP Team shall prepare allocation list to be delivered to TC,
STC, laboratory and iDOTS facilities
4. Regional NTP Team shall ensure and Monitor the distribution of stocks to
TC, STC, laboratory and iDOTS facilities
5. Regional Supply Officer shall facilitate the distribution of stocks to TC,
STC, laboratory and iDOTS facilities
6. Regional NTP Team and Regional Supply Officer shall inform the treatment
facility regarding incoming delivery
7. Regional Supply Officer shall report receipt of delivery to DOH-NTP Central
Office.
8. Regional NTP Team and Regional Supply Officer shall coordinate and
inform PHO/CHO regarding delivery of NTP Products.

TC/STC/Laboratory/iDOTS shall:
1. Receive NTP Products from Regional Warehouse
2. Submit quarterly request to regional office

Figure No. 12 – Delivery direct to the Treatment Facilities

DOH-NTP

TC/STC Laboratory

iDOTS

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 DOH-NTP shall:
1. Prepare allocation list to be delivered to TC, STC, laboratory facilities
2. Ensure and Monitor the distribution of stocks to TC, STC, laboratory
facilities
3. Facilitate the distribution of stocks to TC, STC, laboratory facilities
4. Inform the treatment facility regarding incoming delivery or changes in
the delivery request

TC/STC/Laboratory shall:
1. Receive NTP Products from Central
2. Send receipts of delivery to Central
3. Submit quarterly DSM report
4. Provide stocks to iDOTS facilities
5. Coordinate and inform PHO/CHO regarding delivery of NTP Products.

For Allocation/Delivery of PMDT TC/STC to lower levels:

1. Review and validate the requisition form of iDOTS facilities

2. Provide feedback for any adjustments and clarifications
3. Based on validated and consolidated reports, prepare an allocation
list for distribution to all iDOTS facilities.
4. Review if stocks are available and sufficient to allocate all requisitions
 If insufficient, arrange for requisition and replenishment from
the higher level.
5. Prepare delivery documents
6. Prepare for packaging and labeling according to allocation list
7. Update inventory records: stock cards and/or electronic system
8. Determine if the goods are to be picked-up by recipients or delivered
 If the goods are to be picked-up, inform the recipients of the
following:
i. Schedule when goods are available for pick-up
ii. Description and quantity of items
 If the goods are to be delivered, arrange for vehicle and driver.
Inform the recipient of the delivery schedule and time/date of
arrival
9. Upon handing over of drugs and supplies, secure signature of
recipient on the delivery documents

E. Receiving and Inspecting the NTP products

Receipt and inspection of the delivery of NTP Products shall be the responsibility of
the treatment facilities with the following process:

1. Receive the NTP Products from delivery staff

a. Ensure that the delivered stocks are placed separately while ongoing
inspection to avoid mix up with the other stocks
b. Review the delivery receipt documents whether consistent with the
requisition form
c. Count the delivered NTP Products and check for accuracy:
 Name of the item, strength and dosage form

112
  Quantity in specific unit of measure (in tablets, boxes or
cartons, etc.)
 Expiry date and batch number (accept items that you can only
consume before expiration)

2. Check the condition of NTP Products according to priority:

a. Products needing refrigeration
 Ensure cold chain during transport. These items should be
checked first for immediate storage
b. Signs of damage by checking the conditions of the cartons and
packaging
c. Quality of items delivered

3. Document any discrepancy or damage:

a. Record discrepancies explicitly in the delivery receipt
b. Take pictures of damaged goods for documentation
c. Report and notify supervisor or coordinator
d. Plan necessary actions on issues encountered

4. Sign the delivery receipt as a proof of acceptance:

a. Ensure delivery staff also affixed signature in the form
b. Keep and file the forms properly

5. Drug donations shall be received following the standard recommended

receiving process with emphasis on the following:
a. Accept only donated drugs of uncompromised quality
b. Do not accept expired drug or products very near their expiry and
which will not be consumed prior to the indicated expiry date. Ensure
that the drugs are of acceptable expiration dates which will be used
based on the consumption rate.
c. Accept only donated drugs with complete documentation,
manufacturer and supplier details which can assure product quality
d. Ensure that the donated products follows in-country requirements
such as having been registered/exempted with FDA, with GMP
Certification, with import clearances and is included in the Philippine
National Formulary (PNF)
e. Check if the product packaging is approved or acceptable with FDA
(i.e. labels should be in English)
f. Ensure that there is enough storage space available before
accepting the products. It is recommended to store and separate
received donated products in a different area inside the store room.
g. Document and maintain a list of donated products, with their
quantities, expiration dates and source details, received and carried
in the facility
h. File all donated drugs receiving forms
i. Coordinate with PHO/CHO regarding drug donations handled

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F. Storing of NTP products

Storage of NTP Products shall be the responsibility of the treatment facilities with the
following process:

1. Assign an appropriate area for storage of received NTP Products.

 Assign fast moving items to the most accessible area

2. Transfer NTP Products to assigned storage area and organize stocks

 Ensure all are handled properly during transfer
 Arrange similar items together by type or by classification
 Separate drugs from other supplies or chemicals

3. Arrange stocks with expiration dates according to first expiry, first out (FEFO)
and other NTP Products without expiration dates according to first in, first out
(FIFO).

4. Monitor expiry dates of drugs and assess with the utilization rate of the drugs
to ensure minimal expiration. Clearly label the outside of the boxes to reflect
the month and day of the expiry date (mmm/dd/yy).

5. Monitor temperature regularly of refrigerator and storage room. Ensure

appropriate temperature condition as per recommendations by manufacturers

6. Schedule regular cleaning and maintenance of the storage area.

7. Ensure security of drugs and other NTP Products in the storage area by
limiting the access to authorized personnel.

G. Conducting Inventory Control

Inventory control of NTP Products shall be the responsibility of the treatment facilities
with the following process:

1. Inventory control functions shall be performed every time there is movement

of stocks.

2. Fill out a stock card for every commodity

 Use a separate stock card for different dosage form, strength, unit size
or expiration date
 Update stock card when receiving NTP Products and when issuing or
dispensing NTP Products
 Place stock card in a location which is near the product and is easily
retrieved

3. Ensure quantities recorded tallies with the actual stock on hand

 Conduct physical count regularly and compare with the stock card
 Record and investigate discrepancies in quantities
 File stock cards for future reference

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 4. Update electronic system inventory such as National Online Stock Inventory
Recording System (NOSIRS), if applicable

H. Dispensing and Administering anti-TB drugs

Dispensing and administering NTP Products shall be the responsibility of the treatment
facilities with the following process:

1. Prepare drugs based on the patient’s daily treatment regimen.

2. Count correct quantity of drugs to be dispensed. Review and ensure

correct dosing based on the patient’s weight.

3. Keep drugs and other NTP Products clean, safe, and organized:
 Ensure that drugs dispensed to patients are not expired. Always check
the expiry date.
 Keep drugs properly labeled and covered to avoid contact with direct
sunlight and dust.
 Maintain drugs requiring cold chain in the refrigerator or in a cooler with
frozen ice packs.
 Do not remove tablets from blisters until they are to be taken.

4. In preparing and administering injections, take note of the following:

 Always use a new syringe and needle for each patient.
 Ensure aseptic technique in preparation and administration.
 Discard used syringe and needles in a safe container.

5. Explain the proper way of taking drugs to the patient. Encourage the
patient’s adherence to treatment and provide counseling.

6. Observe the patient while taking all the drugs.

7. Update the patient’s treatment card and ID card after the patient’s intake.

I. Redistributing of NTP Products

Redistribution NTP Products shall be the responsibility of the treatment facilities with
the following process:

1. Review stock on hand and facility consumption regularly based on reports

submitted
2. Identify near expiry, excess, and critical stocks at the facility
3. Determine quantity of excess and needed drugs
4. Coordinate with higher level regarding the status and seek concurrence for
redistribution of stocks. Central level may initiate redistribution of stocks.
5. Coordinate with other health facilities that can consume or provide stocks and
schedule transfer of stocks
6. Accomplish receiving forms and update stock cards
7. Sign receiving forms and ask the receiving facility to sign upon receipt and send
back one copy

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 8. File receiving copies
9. Coordinate and inform PHO/CHO regarding NTP products redistributed

J. Donating excess near expiry drugs to public and private health institutions

1. Review stock on hand and facility consumption regularly based on reports

submitted
2. Identify near expiry, excess, and critical stocks at the facility
3. Determine quantity of excess and needed drugs
4. Coordinate with higher level regarding the status and seek concurrence for
donation of stocks to other institutions if redistribution with other health facilities
cannot be done
5. Coordinate with public or private institutions on the availability of excess near
expiring stocks and inquire if they need it for their use
6. Ask the institution to submit formal request letter addressed to NTP manager
with requester’s name, drug, quantity, how it will be used, and name of the
patient who will use if possible
7. Sign receiving forms and ask the receiving facility to sign upon receipt and send
back one copy
8. File receiving copies

K. Disposing of damaged and/or expired drugs and medical and laboratory

supplies

Disposal shall be the responsibility of the treatment facilities with the following process:

1. Carefully identify the expired and damaged drugs and laboratory supplies.
2. Separate the storage of expired or damaged medicines from the good stock
and label the containers properly.
3. Reflect the quantities expired or damaged on their corresponding stock cards.
4. Record the expired/damaged medicines in the DSM report to be submitted to
NTP
5. Take pictures of the damaged or expired NTP Products for documentation.
6. Coordinate with the sanitary engineer or sanitary officer of the mother unit of
the health facility for their proper disposal. Refer to DOH Health Care Waste
Management Manual as references.
7. Participate in, take pictures of, and document the disposal process.
8. Coordinate and inform PHO/CHO regarding NTP products disposed
9. File all documentation. Submit incident report explaining what cause the
expiration of the drugs. Accomplish and submit Expired/Damaged Drug
Disposal Report Form to NTPMO.

L. Requesting of NTP products

Preparing the requisition is the responsibility of the treatment facilities with the
following process:

1. Requisition shall be submitted quarterly specifically at the 10th day of the 2nd
month of every quarter.
2. Identify the facility’s need based on medicine utilization of patients.

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 3. Update stock on hand inventory by conducting physical count and verification
with the stock card.
4. Fill up and submit Report 4b. DSM Report and Requisition Form. Consider the
quarterly need, buffer and stock on hand in accomplishing the report
 TC and STC submit PMDT DSM report to NTP DSM coordinator, copying
the RO coordinator.
 TS and iDOTS submit Report 4b. Requisition Form to TC/STC, copying the
PHO/CHO coordinator.
5. In cases that projections shows that possible stock outs are unavoidable, call the
DSM unit and prepare the emergency request as soon as possible.

M. Recalling of anti-TB drugs

Performing recall is the responsibility of the treatment facilities with the following
process:

1. NTP shall secure a copy of the recall order issued by FDA

2. NTP shall issue a department memorandum for all TB laboratories and PMDT
treatment facilities to comply to the recall
3. Check availability of the recalled lot in the facility’s stock.
4. Separate and secure the recalled lot from the good stocks.
5. Label the container properly to note that the stock is recalled or for recall.
6. Accomplish releasing form, which includes the drug information regarding the
products to be recalled and quantities, and affix signature.
7. Establish proper communication with the receiving facility
8. Coordinate and inform PHO/CHO regarding NTP products recalled
9. File all documentation.

Service
Summary of Procedures
Level
A. Selecting anti-TB drugs, medical and laboratory supplies
B. Quantifying and Forecasting of Centrally Procured Drugs Central
C. Procuring of NTP products
D. Distributing and Delivery of NTP products
E. Receiving and Inspecting the NTP products
F. Storing of NTP products
G. Conducting Inventory Control
H. Dispensing and Administering anti-TB drugs
I. Redistributing of NTP Products RO/PHO/
J. Donating excess near expiry drugs to public and private health CHO/Facility
institutions
K. Disposing of damaged and/or expired drugs and medical and
laboratory supplies
L. Requesting of NTP products
M. Recalling of anti-TB drugs

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 CHAPTER 9

PHARMACOVIGILANCE
Active Drug-Safety Monitoring and Management

I. Introduction

Pharmacovigilance (PV) is defined by WHO as “the science and activities relating to

the detection, assessment, understanding and prevention of adverse effects and other
drug-related problems”. It is part of the overall public health surveillance activities.

As per Administrative Order 2011-0009 “National Policy and Program on

Pharmacovigilance”, all DOH offices managing the provision of pharmaceutical
products for their programs shall ensure the submission of adverse reports arising
from drugs used in their public health programs, emergency health services and
others”. Second line anti-TB drugs are known to cause significant adverse events,
which introduce additional cost to medical care. It is therefore imperative to monitor
adverse events and patient safety to reduce loss to follow up, encourage treatment
adherence, and improve case outcomes.

In the WHO guideline released last November 2015, the adaptation of an essential
requirements for active Drug-Safety Monitoring and Management (aDSM) for DR-TB
patients on treatment is being recommended. The appropriate and timely
management of all AEs and ADRs is an integral component of aDSM and patient care.
Refer to Chapter 3. Case Holding (Management of Common Adverse Drug Reactions
to FLDs and SLDs) for the details on the management of ADRs.

The FDA is implementing passive drug safety surveillance system in the country for
most drugs. In PMDT, aDSM will be implemented with the objectives of reducing risks
from drug-related harms in patients on second line anti-TB treatment for drug-resistant
TB and generating standardized aDSM data to inform future policy updates on the use
of such drugs. This is in line with the overall objective of pharmacovigilance.

The following are three essential PV activities:

a. DR-TB patients should undergo active and systematic clinical and laboratory
assessment during treatment to detect drug toxicity and AEs. Refer to Chapter
3. Case Holding Table No. 10 - Schedule of Clinical and Laboratory Baseline
and Follow-up Examinations for DR-TB Patients during the Intensive Phase and
Continuation Phase of Treatment.

b. All AEs detected should be managed in a timely fashion in order to deliver the
best possible patient care.

c. Standardized data should be systematically collected and reported for any

serious adverse event (SAE) detected and for adverse events of special

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 interest. These will eventually be used to characterize the types of SAEs,
assess the safety of the treatment and to inform future policy.

In this guideline, all AEs should be managed clinically but only SAEs and AEs of
special interest will be reported to NTPMO and FDA.

II. Objective

To improve patient care and safety in relation to the use of anti-TB drugs.

III. Definition of Terms

Active TB Drug-Safety Monitoring and Management (aDSM) – Refers to the active

and systematic clinical and laboratory assessment of DR-TB patients while on
treatment. The objectives of aDSM are to reduce risks from drug-related harms in
patients on second-line treatment for drug-resistant TB and to generate standardized
aDSM data to inform future policy updates on the use of such medicines.

Adverse Drug Reaction – A response to a drug which is noxious and unintended and
which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of
disease or for modification of physiological function.

Adverse Events (AE) – Any untoward medical occurrence that may present during
treatment with a pharmaceutical product but which not necessarily have a causal
relationship with this treatment

Serious AE – Any untoward medical occurrence that at any dose:

 Results in death
 Is life threatening
Life threatening refers to an event in which the patient was at risk of
death at the time of the event; it does not refer to an event that
hypothetically might have caused death if it were more severe
 Requires inpatient hospitalization or results in prolongation of existing
hospitalization
 Results in persistent disability/incapacity
 Is a congenital anomaly/birth defect

AE of special interest - Is an adverse event documented to have occurred

during clinical trials and for which the monitoring programme is specifically
sensitized to report regardless of its seriousness, severity or causal relationship
to the TB treatment.

 Prolonged QT interval (using Fridericia Formula)

 Hepatitis (defined as increases in alanine aminotransferase (ALT) or
aspartate aminotransferase (AST) ≥5x the upper limit of normal (ULN),
or increases in ALT or AST ≥3x ULN with clinical manifestations, or
increases in ALT or AST ≥3x ULN with concomitant increase in bilirubin
≥1.5 x ULN)

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  Ototoxicity (hearing impairment, hearing loss)

Causality Assessment – Is the evaluation of the likelihood that a drug was the
causative agent of an observed adverse reaction.

IV. Policies

1. All SAEs and AEs of special interest shall be promptly reported to NTPMO and
FDA by the PMDT treatment facility. This will require coordination between
PMDT treatment facilities to avoid duplication of reporting.

2. Causality assessment shall be conducted by FDA and feedback to reporters

shall be provided.

3. Recommendations of FDA regarding causality analysis shall be acted upon by

NTP and PMDT treatment facilities.

V. Procedures

The procedures below follow the standard and systematic clinical and laboratory
assessment of patients during treatment. Once AEs are identified, these should be
managed clinically according to guidelines.

A. Reporting of Serious Adverse Events

1. Accomplish the prescribed reporting form network or system for all SAEs and
AES of special interests. (If PviMS is not accessible, accomplish the
spontaneous reporting form of FDA. This shall be later entered into PViMS).

2. Conduct initial analysis of the adverse event.

3. Classify the adverse event according to seriousness.

4. Submit the report (electronic or paper format) to NTPMO and FDA within 15
calendar days from detection of the event or receipt of information. In case of
death and/or life-threatening situation, notification should be made to NTPMO
and FDA immediately within 48 hours of detection by fastest means possible.
Telephone, text message facsimile or electronic mail can be employed as a
means of notification.

5. For the PMDT treatment facilities participating in the introduction of new SLDs
or new treatment regimen shall comply with prescribed timelines in its protocol
in reporting.

B. Conducting Causality Assessment

Causality assessment shall be conducted by the FDA in coordination with the

National Drug Advisory Committee, as needed. FDA may conduct interview/follow-
up of PMDT facility staff and/or patient/significant others to get additional

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 information or data as necessary. Safety signals that may generate from the series
of case reports shall be promptly coordinated by FDA to NTP.

C. Deciding, Providing feedback and Making appropriate action

1. PMDT treatment facility level shall conduct appropriate actions to address the
SAEs and AEs of special interest.

2. NTPMO/RO shall promptly coordinate with the reporting facilities to monitor the
patient’s progress.

3. Provision of feedback to reporting facility and NTP shall be done by FDA within
90 calendar days. The FDA shall execute necessary and appropriate regulatory
actions. NTP shall prepare a department memorandum to disseminate FDA
regulatory actions to the regions. Regions shall inform all PMDT treatment facilities
regarding the FDA regulatory actions. NTP shall monitor and ensure compliance
of all facilities.

Summary of Procedures
A. Reporting of Serious Adverse Events
B. Conducting Causality Assessment
C. Deciding, Providing feedback and Making
appropriate action

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 CHAPTER 10

HEALTH PROMOTION

I. Introduction

Health Promotion is a process of enabling people to increase control over the

determinants of health and thereby improve their health. It uses communication and
other related strategies to inform and influence the way individuals and communities
think, feel, behave, and make informed decisions about their health.²⁹
It has 5 action areas: 1) building healthy public policy 2) creating supportive
environment 3) strengthening community action 4) developing personal skills and, 5)
re-orienting health services.
Building health public policy means putting health on the agenda of policy
makers and influencers in all sectors and at all levels. Creating supportive environment
refers to linking people and their environment that is the basis for a socio-ecological
approach to health. Furthermore, it generates living and working conditions that are
safe, stimulating, satisfying and enjoyable.
Strengthening community action refers to the empowerment of the communities
that means leading to their ownership and control of their own endeavors and
destinies. It helps communities set priorities, make decisions, plan strategies and
implement them to achieve better health.
Developing personal skills refers to personal and social development by
providing information, education for health, and enhancing life skills.
Re-orienting health services refers to shared responsibility among individuals,
community groups, health professionals, health service institution and government.
These guidelines shall focus on four (4) major strategies of health promotion
namely a) patient-centered and integrated health services, b) triggering community-
level response, c) integrated marketing communication, and d) advocacy to increase
demand for PMDT services and leverage for continued government support (at all
levels) to sustain implementation of PMDT.
These shall be used to identify and address TB control challenges in the
following critical areas of PMDT: a) obtaining support from policy and decision makers
and other influential people at the national and local levels; b) ensuring proper
identification and referral of presumptive DR-TB and their initiation until completion of
treatment; c) combat stigma and discrimination among patients, their relatives, people
surrounding them, and even among health care providers; and d) community action
so that presumptive TB would be motivated to seek early consultation, diagnosis, and
for confirmed DR-TB patients to initiate and complete treatment. Community actions
are also utilized to provide social support to patients and their families, including
reducing stigma.
This section aims to guide the PMDT implementers, and program managers in
the implementation of the abovementioned strategies and conduct of concrete steps
and procedures on how to do health promotion activities among presumptive DR-TB
individuals, DR-TB patients, their families and other influencers, and among the public.

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II. Objectives

Health promotion aims to:

1. Facilitate health-seeking behaviors of individuals towards early consultation, and
improved adherence of clients to the diagnostic and treatment protocol;

2. Improve the interpersonal communication/counseling skills of DR-TB health service

providers;

3. Increase participation of LGUs, support groups, communities and social sectors in

the prevention and elimination of DR-TB.

III. Definition of Terms

Advocacy³º – Activities designed to place TB control high on the political and

development agenda, foster political will, increase financial and other resources on a
sustainable basis, and hold authorities accountable to ensure that pledges are fulfilled
and results achieved.

Integrated marketing communication³¹ – Is a concept and practice that employs a

variety of communications disciplines – for example, printed information materials
(more commonly referred to as Information, Education and Communication or IEC
materials), interpersonal communications, and public relations through events – and
combines these disciplines to provide clarity, consistency, and maximum impact
through the seamless integration of messages. IMC should improve the NTP’s ability
to reach the right people (key affected populations) with right messages at the right
time and in the right place.

Social Mobilization³² – The process of bringing together multi-sectoral allies to raise

awareness of and demand for the particular program, to assist in the delivery of
resources and services, and to strengthen community participation for sustainability
and self-reliance.

Interpersonal Communication and Counselling (IPC/C) – Face-to-face, verbal and

non-verbal exchange of information or feelings between two or more people. In the TB
program, this refers to structured though often informal communication process
between the health provider and the patient for the latter to complete treatment for DR-
TB.

Community Mobilization – The process of building the capacity of individuals,

groups, or organizations designed to plan, implement, and evaluate specific set of
activities on a participatory and sustained manner to achieve a certain set of goals,
through their own initiative or through stimulation by others.

Community-based Organizations (CBOs) – A group of individuals made up of and

generally operated by the community residents themselves organized with a common
objective of achieving a set of goals. In most cases, CBOs are assisted by other groups
such as government agencies, non-government organizations (NGOs), and faith-
based organizations.

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Barangay Health Worker (BHW) – An individual who voluntarily renders primary
health care services in a community after having been accredited to function as such
by the local health board in accordance with the guidelines promulgated by DOH.

Policy and Decision Makers – persons or groups of persons with the authority to
craft and approve policies and budgets that may affect TB control in various settings
and situations, such as local chief executives (LCEs – provincial governors, municipal
and city mayors and their respective councils / Sanggunian), and heads or
managements of hospitals and healthcare facilities.

IV. Policies

1. Health Promotion activities related to PMDT shall be conducted at all levels of the
health care system.

2. Key affected populations shall be involved in all key PMDT activities.

3. Mechanism for ensuring patient support shall be in place at all levels of

implementation in coordination with LGUs, non-government organizations (NGOs)
and communities.

4. Appropriate information, education and communication (IEC) materials shall be

made available in all PMDT treatment facilities and other health settings.

5. Targeted TB education campaigns shall be conducted among high risk groups and
vulnerable populations in coordination with other government agencies, CBOs, NGOs
and other civil society organizations.

V. Procedures

Preparing a Health Promotion Plan

1. Develop TB Strategic Plan at the Regional and Provincial/City level.

2. Identify the needs and gaps in the plan that can be met by health promotion
strategies.
3. Prepare the Health Promotion Plan using the following suggested format. (Please
see below).
4. Mobilize political commitment and budgetary support from the Local Chief
Executive/Councils.
5. Implement the Health Promotion plan.
6. Monitor and evaluate the effectiveness of the Health Promotion plan in addressing
the implementation gaps.

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 Table No. 20 - Health Promotion Plan of Activities (with Sample Entries for Information)

Activity (Date / Venue) / Target Person(s) Responsible Tools Needed Budget Expected Outcome /
Audience / Key Message Result
Advocacy
 Courtesy call and orientation  NTP program  PMDT briefing / PhP5,000  Ordinance
session on PMDT (date) for coordinator / MHO and info kit supporting PMDT
newly-elected municipal cured patient from the  Color-coded map passed by
officials municipality of PMDT Sangguniang Bayan
 Key message: Craft and pass a prevalence in the (municipal council)
municipal ordinance supporting municipality  Budget allocated by
PMDT with corresponding  Template of such LGU for TB program
budget ordinance for (including PMDT)
easy reference
by concerned
municipal
officials
 Advocacy meeting (date) with  NTP program  PMDT briefing / PhP5,000  Ordinance on No
city government to pass No coordinator / MHO info kit Prescription, No
Prescription, No Dispensing  Template of such Dispensing policy
ordinance for pharmacies to ordinance for passed by
prevent self-medication easy reference Sangguniang Bayan
 Key message: Self-medication by concerned (municipal council)
can give rise to drug-resistant municipal
TB officials
 Meeting/ advocate with officials  PMDT Treatment facility  Photos or short  Patient-centered
to request for adequate space staff in coordination videos where facility improvement
for DR-TB patients to receive with RO/PHO/CHO in the facility
their medications and when the patients
they experience severe ADRs are getting
such as vomiting their
treatment;

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 Table No. 20 - Health Promotion Plan of Activities (with Sample Entries for Information)

Activity (Date / Venue) / Target Person(s) Responsible Tools Needed Budget Expected Outcome /
Audience / Key Message Result
 Key message: Treatment patients
facility needs to adopt a more experiencing
patient-centered approach to ADRs
treatment because patients
who experience such are more
likely to complete their
treatment
Communication
 Radio guesting on municipal /  NTP program  PMDT briefing / No cost (free  Number of people
city local radio station on (title coordinator / MHO and info kit time slot for who heard the
of program, radio station, cured patient from the PHO) broadcast
particular date and time slot) municipality  Number of phone in
 Key messages: DR TB is and SMS questions /
infectious and deadly. DR TB feedback during the
is curable. Treatment and program
medicines for DR TB is FREE  Number of TB
in government facilities (TCs / presumptives who
STCs) consulted with
health facility on
 Key message: If you have the
hearing the interview
following signs and
/ broadcast
symptoms, seek consultation
at the nearest health center /
RHU.
 Opinion piece or editorial on  PMDT program  PMDT briefing / No cost  Number of readers
DR-TB / PMDT submitted and coordinator working with info kit reached by the
published in a popular tabloid supportive journalist / tabloid
on (particular date) columnist

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 Table No. 20 - Health Promotion Plan of Activities (with Sample Entries for Information)

Activity (Date / Venue) / Target Person(s) Responsible Tools Needed Budget Expected Outcome /
Audience / Key Message Result
 Key messages: DR TB is  Number of letters to
infectious and deadly. DR TB is the editor generated
curable. Treatment and by the opinion piece
medicines for DR TB is FREE  Number of TB
in government facilities (TCs / presumptives who
STCs) consulted with
health facility on
 Key message: If you have the
reading the opinion
following signs and symptoms,
piece
seek consultation at the nearest
health center / RHU.
Social / Community Mobilization
 Special event advocating  NTP program  IEC materials on PhP15,000  Number of people
PMDT (i.e., World TB Day in coordinator / MHO + DR TB (posters, (merienda of who attended the
March or Lung Month in cured patient from the tarpaulins, audio pax, event
August) municipality public service transportation,  Media coverage of
 Key messages: DR TB is  Partner organizations, announcements) the event (news
production of
infectious and deadly. DR TB is other government stories, live radio
agencies and institutions IEC materials) coverage, FB
curable. Treatment and
medicines for DR TB is FREE in the community postings, tweets)
in government facilities (TCs /  Number of TB
STCs) presumptives who
consulted with
health facility after
attending the event
or reading / hearing
news and social
media coverage of
the event

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 Table No. 20 - Health Promotion Plan of Activities (with Sample Entries for Information)

Activity (Date / Venue) / Target Person(s) Responsible Tools Needed Budget Expected Outcome /
Audience / Key Message Result
 Number of
additional
organizations and
institutions signing
up to support PMDT
 Partnership / networking  PMDT implementers,  PMDT briefing / PhP5,000  Number of
meeting to organize a TB NTP team working LGU info kit organizational /
Council or multisectoral supporters institutional
stakeholder alliance in the representatives who
municipality attended the
 Key messages: DR TB is meeting
infectious and deadly. DR TB is  Multisectoral
curable. Treatment and formation / alliance
medicines for DR TB is FREE formed as a result of
in government facilities (TCs / the activity
STCs)
 Key message: The fight
against DRTB is everybody’s
fight. Everyone has a unique
contribution.
 Organization of patient support  PMDT treatment facility  IEC materials/  P15,000  Organized and
groups in TC/ STC’s staff in coordination with kits functional KAP
Target audience: all on-going RO/PHO/CHO groups
patients, patients completed  Policy supporting
treatment and family members the sustainability of
KAP groups
Key message: KAP’s serve as  Involvement of
TB advocates and provide KAPs group in

128
 Table No. 20 - Health Promotion Plan of Activities (with Sample Entries for Information)

Activity (Date / Venue) / Target Person(s) Responsible Tools Needed Budget Expected Outcome /
Audience / Key Message Result
mutual psychosocial support to program
patients and family members management at all
who experience the same levels
situation
 P50, 000
 Capacity building of KAPs for
advocacy, peer education Training kits
and livelihood programs
Target audience: members of
KAPs

Key message: KAP’s serve as

TB advocates and provide
mutual psychosocial support to
patients and family members
who experience the same
situation

 Conduct Mother’s class to  PMDT treatment facility  IEC materials/  P5,000  Mothers are
discuss Cough to Cure to MDR staff in coordination kits mobilized as change
pathway with RO/PHO/CHO agents for
 Key message: DR-TB is and BHWs (to encouraging people
infectious and deadly. DR-TB is gather the to consult;
curable. Treatment and mothers) supporting patients
medicines for DR-TB is free in to complete their
government facilities (PMDT treatment; and
Treatment facilities e.g. TC, addressing stigma.
STC, iDOTS, Treatment Sites)

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 Table No. 20 - Health Promotion Plan of Activities (with Sample Entries for Information)

Activity (Date / Venue) / Target Person(s) Responsible Tools Needed Budget Expected Outcome /
Audience / Key Message Result
 The fight against DR-TB is
everybody’s fight. Everyone
has a unique contribution. We
should encourage/support each
other.
 Presumptive DR-TB to go to
RHU for initial diagnosis/referral
 TB patients to complete their
treatment

 If you have the following

signs and symptoms,
seek consultation at the
nearest health center/
RHU.

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PMDT treatment facility staff shall conduct Health Promotion activities taking into
consideration the characteristics of their target audiences, the key messages they want
to deliver to these audiences and the particular support for PMDT that each target
audience can provide.³³ (see following tables)

Table No. 21 - Matching Health promotion strategies and implementation with TB

Program objectives
TB Program Health Promotion strategies Range of Activities, Channels,
Objectives Tools and Materials
Ensure political Educate national policy makers Orientation and briefing
support and and political leaders about the meetings with LCEs and
commitment for governance, health and policymakers
PMDT and a economic benefits of PMDT. Lobbying with Sangguniang
supportive policy Aim to have TB (including DR- Bayan (provincial, city and
environment for TB) declared an LGU health municipal councils)
TB control priority. Special events (World TB Day,
Educate local and community Lung Months) – pledging of
level authorities to encourage support by LGU officials and
them to contribute to TB control other policy makers / decision
efforts through laws, policies makers
and budgets Use of patient support groups
Tools and Materials: fact sheets,
presentations on DR-TB and
PMDT, PMDT maps
Improving case Raise public awareness about Conduct research or focus group
detection / DR-TB discussions and key informant
referrals Reduce stigma against DR-TB interviews to determine key
presumptives and patients and messages and approaches for
correct TB myths and different population and publics
misconceptions by involving Use of mass media and social
current and former TB patients media
as champions / advocates Interpersonal communication
Encourage initial interrupters to and counseling training for
begin treatment in DOTS health care providers
centers, TCs / STCs Community mobilization
Help health care providers, activities (special events)
communities, CBOs / NGOs / Tools and Materials: letters to the
FBOs, and individuals identify editor, press releases, print
DR TB cases materials for community
Encourage DR-TB meetings and events, public
presumptives to seek early service announcements (audio
care in DOTS centers or video), informational flyers
Target vulnerable populations Use of patient support groups
(i.e., jail population, urban
poor, homeless)

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Table No. 21 - Matching Health promotion strategies and implementation with TB
Program objectives
TB Program Health Promotion strategies Range of Activities, Channels,
Objectives Tools and Materials
Increasing Connect individuals under Interpersonal communication
treatment success treatment with patient and and counseling training for
/ decreasing other support groups (to give health care providers
default concrete experience about Use of mass media and social
possibility of cure and life media
beyond DR-TB) IEC materials distribution in
Encourage interrupters to health facilities
resume treatment in DOTS Peer education at community
centers, TCs / STCs level and patient support group
Provide materials and training meetings and activities
to counselors Tools and materials: training
Support patients to complete modules, fact sheets, flyers, flip
treatment by engaging former charts, job aids, videos,
patients as treatment partners presentation slides
Encourage family members Use of patient support groups
and other significant others to
support patients to complete
treatment

Table 22 - Matching Health Promotion activities and key messages with specific
target audiences
Desired Behavior Key Message(s) Recommended Action /
Personnel who will implement
Target Audience: Local chief executives (governors, mayors) + policy makers +
managers
Pass national and local Undiagnosed and For TC / STC staff: Use statistics
legislation (i.e., untreated DR-TB is a to advocate support for PMDT
ordinances) supporting threat to the health of among LCEs – i.e, show how
PMDT in their localities the community many persons an untreated DR-
Allocate budgets for Supporting the fight TB presumptive can infect in the
PMDT to augment funds against DR-TB is good course of the year; show in which
from the national governance municipalities / barangays DR-TB
government / PMDT LGUs can support the cases or presumptive are
program fight against DR-TB by concentrated
passing laws and For national PMDT managers:
allotting budgets for Engage LCE champions to
PMDT advocate with their fellow LCEs
(via the League of Municipalities
of the Philippines, League of
Cities and the League of
Provinces) for support to PMDT

132
 For PMDT managers, TC / STC
staff: Provide PMDT / DR-TB
briefing materials / information kit
to the Office of the Governor /
Mayor and the Provincial
Information Office with
instructions on how to use the
materials
Target Audience: Private health providers (stand-alone, schools, workplace /
company) and Public health providers (Rural Health Units, Health Centers)
Do not discriminate There are Xpert facilities For TC / STC staff: Set orientation
against presumptive TB for DR-TB diagnosis for / advocacy visits on DR-TB and
individuals free PMDT with individual
Identify and Refer DRTB treatment is free practitioners or medical societies
presumptive DR-TB Become part of the TB Provide a directory of TCs / STCs
individuals to TC / STC referral network / RHUs / HCs where they can
Anti-stigma messages: refer DRTB presumptives
dispel myths and PMDT staff: Set orientation on DR
misconceptions about TB and PMDT implementing
TB guidelines
Use key messages PMDT staff: Set orientation on
contained in the patients’ rights on TB care
Patients’ Charter for TB
Care³⁴ (see Annex M on
page 231-233)

Target Audience: Community Residents

Seek early care DR-TB is infectious and For HC / TC / STC staff / BHWs:
Approach the barangay deadly Conduct community health
health worker assigned DR -TB is curable education on TB / DR-TB
to community and Treatment and symptoms, transmission and
inquire where services medicines for DR-TB is treatment
for TB are available FREE in government Conduct active case finding;
Encourage members of facilities (TCs / STCs) counsel TB presumptive to seek
the household to be If you love your family care wherever and whenever they
checked up for TB as and are concerned for are spotted / identified
well their welfare, seek early Screen household contacts of
care at the nearest presumptive DRTB individuals
health center / TC / STC Provide IEC materials to the
Encourage your fellow community on DR-TB
household members to
be checked up as well
Target Audience: Significant others / household members and contacts of DR TB
individuals (family members, co-workers, friends)
All contacts of DR-TB If you care for your loved For HC / TC / STC staff / BHWs:
patients must be one in the family, your

133
screened at the nearest friend or co-worker, Conduct one-on-one / small
HC, TC, STC encourage him / her to group discussion on TB / DR-TB
be checked up for TB at in neighborhood
the nearest health Provide IEC materials to the
facility. influencer on DR-TB
Target Audience: Community-based organizations (CBO), NGOs, faith-based
organizations (FBO)
Get involved in TB / DR- DR-TB is everybody’s For HC / TC / STC staff
TB control efforts business Conduct health education on TB /
Refer presumptive DR- Anyone can become DR-TB with the CBO / FBO / NGO
TB individuals among sick with DR-TB; it Screen presumptive DR-TB
own ranks to the nearest spares no one individuals and close contacts
BHW, HC, TC / STC (regardless of age, sex / from their ranks
Formally link up with gender, social class, Provide a directory of TCs / STCs
HCs, TCs and STCs to religion) / RHUs / HCs where they can
identify and refer You can help fight DR- refer DR-TB presumptive
TB by encouraging and Establish referral, recording and
referring people with reporting mechanisms between
symptoms to seek early the CBOs / NGOs / FBOs and the
care at the nearest HC, TC / STC / HC (i.e., referral slips
TC / STC and logbooks to complement
records in the health facilities)

Summary of Procedure
A. Preparing a Health Promotion Plan

134
 CHAPTER 11

MONITORING, SUPERVISION AND EVALUATION

I. Introduction

Monitoring, Supervision and Evaluation (MSE) is a collective set of activities that informs
the manager whether program activities are being implemented as planned to attain the
set objectives. In all these activities, accurate and timely data and information are very
important. Indicators from the NTP are used for the analysis of performance using
routinely collected data.

II. Objectives
Regular and systematic MSE of the Programmatic Management of Drug-Resistant TB
(PMDT) implementation is critical due to the following reasons:
 To ensure adherence of program implementers to NTP PMDT policies and
implementing guidelines.
 To determine the progress of program implementation, identify gaps and provide
basis for decision making to improve implementation.
 To determine that the program targets on PMDT are reached and maintained.
 To disseminate MSE data to program managers, LCEs and stakeholders to serve
as guide in program planning and decision making.

III. Definition of Terms

Monitoring – Regular, systematic and purposeful observation of program performance
to determine whether activities are implemented as planned and according to schedule.
It also involves giving feedback to implementers, program managers, donors and
beneficiaries of the program.

Supervision – The process of overseeing the performance and progress of a person or

group. It aims to increase efficiency of health care providers by developing their
knowledge and skills, improving work attitude, and increasing their motivation.

Evaluation – The careful collection and analysis of information about program, or some
of its aspects, with particular focus on its effectiveness and impact over time.

IV. Policies
1. PMDT monitoring, supervision and evaluation (MSE) activities shall be integrated
within the general MSE framework of NTP.

2. PMDT MSE activities shall be part of the annual work plans with defined budgetary
support at all levels of implementation.

135
3. Monitoring and supervisory visits shall be done quarterly at all levels of
implementation using the standard monitoring tool. More frequent visits to priority
areas shall be done based on program performance, stage of PMDT
implementation and technical needs of staff.

4. The NTP shall be the technical assistance provider (TAP) to DOH-RO. The RO
NTP coordinators shall serve as technical assistance providers for the PHO/CHO
NTP coordinators. The provincial or city NTP coordinators shall serve as technical
supervisors for all PMDT facilities within their area including iDOTS/ComCare and
Xpert sites.

5. Supervision of PMDT staff shall follow the existing organizational structure of the
DOTS facility. The PMDT staff shall report to the same LGU or hospital department
head where the DOTS staff reports to.

6. Oral and/or written feedback shall be provided during monitoring and supervisory
visits.

7. Accomplishments based on key program indicators shall be regularly analyzed and

discussed used by all organizational levels including the PMDT treatment facility
physician and his/her team to identify and address problems in program
implementation.

8. The central and regional offices shall publish PMDT annual reports, integrated in
the NTP annual report, and disseminated to stakeholders. Request for other data
shall be coursed through a formal letter to NTP stating the intended use of the
data.

9. Program implementation shall be evaluated regularly. Internal assessments shall

be integrated with the regular schedules of Program Implementation Review (PIR)
at all levels of implementation, while external evaluations shall be conducted by
the regional Green Light Committee/WHO annually.

V. Procedures
A. Monitoring and Supervision

1. Develop an annual MSE plan for TB control including PMDT at all levels of
implementation that includes the areas and facilities to be visited,
timeframe, and resource requirements. Lower levels shall develop an
annual MSE plan in coordination with the next higher level.

2. Inform the facilities and health care providers beforehand of the planned
monitoring to ensure that the data and the key personnel will be available
at that time.

136
3. Monitor and supervise the PMDT treatment facility through the following
methods:
 Review records and reports which can be done at the office or during
monitoring visits. Verify that the information in the records and
reports are complete, accurate and consistent by comparing the
source documents and the reports.
 Directly observe how certain PMDT tasks are performed by the staff.
Routine tasks that can be observed include sputum collection,
screening of presumptive DR-TB, heath education and counselling,
initiation of treatment, drug storage and inventory, waste disposal
practices and infection control practices.
 Interview the health care provider and patients to determine their
level of knowledge about TB and MDR-TB and the program policies
and guidelines.
 Joint monitoring visits which includes partners and/or coordinators
from other areas shall also be done.

4. Utilize the NTP prescribed monitoring form and supervisory checklist (See
Annex C List of Administrative Forms on page 180-181) for all facilities
providing PMDT services.

5. Practice supportive supervision by being tactful, diplomatic and facilitative.

6. Provide oral and/or initial written feedback to the facility and personnel
monitored and supervised. Discuss the findings with the concerned staff
and agree on appropriate and feasible actions.

7. Prepare official report of the monitoring and supervision conducted within

the timeframe prescribed by the organization. Give a copy of the report to
the PMDT treatment facility or personnel visited and to the next higher level.

Note: The PMDT staff shall be supervised by the immediate supervisor based on
the organizational structure of the DOTS facility (e.g., hospital PMDT staff must be
monitored by OPD head who supervises the DOTS staff as well). PMDT treatment
facility staff shall file MSE reports for reference and compliance.

B. Conducting Evaluation

1. Review and analyze all NTP Quarterly reports on PMDT by the facility
supervisor prior to submission to management office of the parent institution
and concerned higher level of NTP network:

137
 Report Reviewer Submitted to

3b, 5b, 5c PMDT Physician Parent Institution and

CHO/PHO

1a Laboratory Supervisor/ Parent Institution and

DOTS Physician CHO/PHO

1b, 1c, 1d, 1e, Laboratory Supervisor Parent Institution and RO

1f

2. Collect, consolidate, and analyze quarterly reports by the PHO/CHO, RO

and NTPMO. At all levels, identified problems and recommended actions
shall be given as feedback within 3 months of submission of report.

3. Integrate PMDT implementation review into the PIR of NTP or infectious

disease control program at the provincial/city/regional/national level.
Collect the necessary data prior to the actual PIR and analyze and interpret
the TB data collected. Include into the operational plan activities to address
identified problems or issues.

4. Analyze the core program indicators.

C. Measuring Program Indicators

The program indicators measure the progress of implementation towards the set
goals and objectives. They will be determined at least quarterly at all levels. The
table below summarizes the main PMDT indicators, the definition and calculation,
target, and the data sources based on the MOP.

Table No. 23 – Program Indicators

Indicator Definition and Calculation Target Data Source
Treatment Proportion of MDR/RR-TB cases 90% by Report 3b. Quarterly
Coverage of registered out of the estimated 2022 Report on DR-TB
MDR/RR-TB MDR/RR-TB cases among notified Cases
TB cases

Numerator = No. of registered

bacteriologically-confirmed
MDR/RR-TB cases

Denominator = estimated
MDR/RR-TB cases among the
new and retreatment TB cases

138
 Treatment Percentage of MDR/RR-TB that 85% Report 5c. Annual
Success Rate are successfully treated Report on the
of MDR/RR-TB Treatment Outcome
Numerator = No. of notified of DR-TB Cases
bacteriologically confirmed
MDR/RR-TB cured and completed
treatment

Denominator = No. of notified

bacteriologically confirmed
MDR/RR-TB registered during a
specified period
TB-HIV Percentage of registered DR-TB 100% Report 3b. Quarterly
cases that underwent HIV Report on DR-TB
counseling and testing Cases

Numerator = Number of registered

DR-TB cases provided with HIV
counseling and testing 15 years
old
and above

Denominator = Total number of

registered DR-TB cases 15 years
old and above

Below is the list of other indicators that the PMDT implementers should also review and
analyze since these will guide in identifying barriers to PMDT services and in formulating
solutions:

Table No. 23 – Program Indicators

Indicator Definition and Target Data Source
Calculation
Proportion of Numerator: 100% of DR-TB identified at Presumptive
presumptive Presumptive DR-TB the Rural Health Unit or TB Masterlist
DR-TB identified who were Health Center tested for or Referral
identified who tested for rapid rapid diagnostic test with Logbook
were tested for diagnostic test available result.
rapid diagnostic Denominator: To ensure TESTING OF
test Presumptive DR-TB ALL IDENTIFIED
(disaggregated identified presumptive DRTB patients
by history of To identify both facilitative
treatment— and hindering factors in
New or successfully referring
Retreatment) presumptive DRTB patients

139
Turn-around Average duration (in Maximum of 3 working days Presumptive
time of Xpert days) from specimen To identify both facilitative TB Masterlist
MTB/RIF collection to receipt of and hindering factors or Referral
results results attaining the desired TAT Logbook

Programmatic Average duration (in Maximum of 2 weeks Presumptive

TAT days) from specimen To identify both facilitative TB Masterlist
collection to initiation of and hindering factors or Referral
treatment attaining the desired TAT Logbook

Proportion of Numerator: 100% of those detected Presumptive

detected DR-TB No. of DR-TB patients must be treated TB Masterlist
patients who who were registered To identify both facilitative or Referral
were enrolled to Denominator: and hindering factors in Logbook
DR-TB No. of those detected in ensuring early initiation of / TB Register
treatment one quarter (this is a treatment
cohort)
Proportion of Numerator: ≥ 90% of those detected DR-TB
RR-TB patients No. of RR-TB patients must be treated under Register
enrolled under enrolled under SSTR SSTR
SSTR Denominator:
Total number of RR-TB
patients detected
Proportion of Numerator: 0% DR-TB
enrolled DR-TB No. of enrolled DR-TB Treatment
patients who patients with more than Card
are in crisis 3 missed doses any
time during treatment
Denominator:
Total number of
enrolled DR-TB patients
Percent of Percentage of
80% Report 5b.
bacteriologically bacteriologically Quarterly
confirmed confirmed MDRTB Report on
MDRTB cases cases with negative Treatment
with negative culture after 6 months of Interim
culture after 6 treatment Outcome of
months of DR-TB
treatment Numerator: No. Cases
(INTERIM bacteriologically
OUTCOME) confirmed MDRTB
cases with negative
culture after 6 months of
treatment

140
 Denominator: Total no.
of bacteriologically
MDR-TB cases
Percent of Percentage of 10% Report 5b.
bacteriologically bacteriologically Quarterly
confirmed confirmed MDR-TB Report on
MDR-TB cases cases who are LTFU at Treatment
who are LTFU 6th month of treatment Interim
at 6th month of Outcome of
treatment Numerator: No. DR-TB
bacteriologically Cases
confirmed MDRTB
cases who are LTFU at
6th month of treatment

Denominator: Total no.

of bacteriologically
MDR-TB cases
Proportion of Numerator: Number of No target, compare FDA form /
cases with SAE cases with at least one quarterly trend ongoing
among total SAE patients (DR-
registered DR- Denominator: Number TB Register)
TB cases of cases ongoing
treatment in a specified
period

Summary of Procedures

A. Monitoring and Supervision

B. Conducting Evaluation
C. Measuring Program Indicators

141
 References
1.

2. Department of Health. Philippine Health Statistics. 2013

3. Department of Health – Infectious Disease Office – National TB Control Program and

the RITM – National Tuberculosis Reference Laboratory. Second National Drug-
Resistance Survey on Tuberculosis in the Philippines, Technical Report. 2014 pp 15-16

4. World Health Organization. Global Tuberculosis Report 2016. Geneva, Switzerland:

WHO 2016. pp 153

5. Department of Health. Administrative Order No. 2016-0040: Revised Policies and 6.

Guidelines on the Implementation of Programmatic Management of Drug-Resistant
Tuberculosis (PMDT). Manila: DOH, 2016

7. Department of Health. Joint Program Review: Programmatic Management of Drug-

resistant Tuberculosis in the Philippines. 2016

8. Tupasi et. al. Factors Associated with Loss to Follow-up during Treatment for Multidrug-
Resistant Tuberculosis, the Philippines. Emerg Infect Dis. 2012-2014
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Infectious Tuberculosis in low and middle-income Countries. Geneva, Switzerland: WHO,
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9. World Health Organization. Definition and Reporting Framework of Tuberculosis – 2-

13 Update. Geneva, Switzerland: WHO, 2013

10. Department of Health. Department Memorandum 2016-0034: Classification of

Tuberculosis (TB) disease based on Bacteriological Status of Drug-Resistant Cases.
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11. World Health Organization. Guidance for National Tuberculosis Program on the
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5th Edition. Manila: DOH, 204 pp 22, 26-27

13. Department of Health. Administrative Order 2009-2003: Technical Guidelines for

Implementing DOTS Strategy in jails and Prison. Manila: DOH, 2009

14. WHO treatment guidelines for drug-resistant tuberculosis 2016 update. WHO.

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15. Determine whether there are special conditions... = Partners in Health. The PIH Guide
to the Medical Management of Multidrug-resistant Tuberculosis 2nd edition. PIH, 2013
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16. Tupasi et. al. Factors Associated with Loss to Follow-up during Treatment for
Multidrug-Resistant Tuberculosis, the Philippines. Emerg Infect Dis. 2012-2014

17. Severity of Adverse Events = US Department of Health and Human Services. National
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18. Task Force on Tuberculosis, Philippine Practice Guidelines 4Group in Infectious

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19. Community-Based Therapy for Multidrug-resistant Tuberculosis in LIma, Peru Carole

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21. USAID/TB Care II (2011) Community-Based Care for Drug-resistant Tuberculosis: A

guide for Implementers

22. Planning and implementing palliative care services: a Guide for Program Managers,
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23. Companion Handbook to the WHO guidelines for the programmatic management of
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24. N. Sarita Shah, Courtney M. Yuen, Moonseong Heo, Arielle W. Tolman, Mercedes C.
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391

25. The PIH Guide to the Medical Management of Multidrug-resistant Tuberculosis 2nd
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26. Management Sciences for Health. 2012. MDS-3: Managing Access to Medicines and
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27. WHO/HTM/TB/2015.28 Active tuberculosis drug-safety monitoring and management

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28. WHO/HTM/TB/2014.11 Companion Handbook to the WHO Guidelines for the
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29. http://www.who.int/healthpromotion/conferences/previous/ottawa/en/

30. The Health Promotion Handbook. A Guide to Doing Advocacy, Communication, and
Social Mobilization for the TB Control Program in the Community

31. Marketing Management / Philip Kotler, Kevin Keller. 12th ed. 2006. Chapter 17.
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32. The Health Promotion Handbook. A Guide to Doing Advocacy, Communication, and
Social Mobilization for the TB Control Program in the Community

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Control: A Handbook for Country Programmes. WHO / Stop TB Partnership. 2007

34. The right to: CARE, DIGNITY, INFORMATION, CHOICE, CONFIDENCE, JUSTICE,
ORGANIZATION and SECURITY. Patients’ responsibilities: Share information; Follow
treatment; Contribute to community health; and, Show solidarity.
http://www.who.int/tb/publications/2006/istc_charter.pdf

35. Management of Drug-Resistant Tuberculosis training for health facility staff in the
Philippines Module B p.5, Tropical Disease Foundation (TDF) and Department of Health,
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Lemaine, et al, 2012,

37. Philippines PMDT review mission report, 24-28 November 2014, p 12

38. Joint Program Review Philippines 2013, pp 69-67

39. Supporting TB clinicians managing difficult cases: the ERS/WHO Consilium

Francesco Blasi*, Masoud Dara#, Marieke J. van der Werf" and Giovanni Battista Migliori,
Eur Respir J 2013; 41: pp 491–494

144
 Annexes
Annex A List of Forms
Form 1. Presumptive TB Masterlist or Referral Logbook

145
146
Form 2a. NTP Laboratory Request and Result Form

147
Form 2b. NTP Laboratory Result Form for HIV Testing

Form 2c. NTP TB Culture Result Form

148
Form 2d. NTP Drug Susceptibility Testing and Result Form

149
Form 2e. NTP Line Probe Assay Result Form

150
Form 3a. Laboratory Register (Microscopy and Xpert MTB/RIF)

151
Form 3b. NTP Laboratory Register (TB Culture and DST)

152
Form 4. TB Treatment/IPT Card

153
Form 4b. Drug-resistant TB Treatment Card

154
155
156
157
158
159
Form 5b. Drug-resistant TB Patient’s Booklet

160
161
Form 6b. Drug-resistant TB Register

162
163
Form 7. NTP Referral Form

164
 Annex B List of Patient Management Forms

DR-TB Screening Form

165
166
DR-TB Case Presentation Form

167
168
TB Medical Advisory Committee Masterlist

169
Patient Progress Report Form

170
 Annex C List of Administrative Forms

TB Laboratory Specimen Receiving Form

171
TB Laboratory Results Releasing Form
TB Laboratory Result Releasing Form

From: _______________ TML To: _________________ Collection Unit

_______________ Xpert Laboratory _________________ TML

_______________ Culture Laboratory _________________ Xpert Laboratory

_______________ DST Laboratory _________________ Culture Laboratory

_______________ LPA Laboratory _________________ DST Laboratory

Date Date
Laboratory Test
No. Name Received Released Remarks
No. Requested
(mm/dd/yy) (mm/dd/yy)

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Endorsed by:_______________________________________ Date:________________

Received by:_______________________________________ Date:________________

172
Quarterly Laboratory Report Attachment Form

173
Solid TB Culture Workbook

Liquid TB Culture and DST Workbook

174
Laboratory Solid TB DST Workbook

175
Stock Cards

176
Temperature and Humidity Monitoring Log

177
Drugs and Supplies Receiving Form

178
Expired/Damaged Drug Disposal Report Form

179
NTP Standard Monitoring Tool

180
181
 Annex D List of Reports

Report 1a. Quarterly Report on TB Microscopy and Xpert MTB/RIF Laboratory Examination

182
Report 1b.Quarterly Report on TB Culture and Performance Indicator

183
184
Report 1c. Quarterly Report on 1st Line Solid and Liquid DST

Report 1c. Quarterly Report on 1st Line Solid and Liquid TB DST
(Source of Data – TB Culture and DST Laboratory Register)

Laboratory Quarter/
Name: Year:

Date
Region:
Submitted:

Prepared by: Name: Signature: Designation:

Approved by: Name: Signature: Designation:

1st Line SOLID / LIQUID TB DRUG SUSCEPTIBILITY TEST

Method: Solid TB DST Liquid TB DST

Registration Group TOTAL

Case Other Re-

New Relapse
treatment
No. %
(Items 1 to 6, 10 to 11 are required fields)

1. Total TB cases examined for first line DST (HRES).

(Count cases with result only. Do not include cases referred (sent-out) to other DST centers for
first-line DST testing. Referred cases shall be included in the workload of receiving facility that
processed the specimens)

2. Total TB cases resistant to Rifampicin (R) but not H.

(monoR, polyRS, polyRE, polyRES)
3. Total TB cases resistant to Isoniazid (H) but not R.
(monoH, polyHS, polyHE, polyHES)
4. Total TB cases resistant to both Isoniazid and Rifampicin
(MDR-TB). (polyHR, polyHRE, polyHRS, polyHRES)
5. Total TB cases susceptible to all first-line anti TB drugs.
6. Total TB cases with other drug resistance.
(monoE, monoS, polyES)
Fill-out if applicable:

7. Total TB cases with non-viable isolates.

185
 8. Total number of MDR-TB cases that are NOT RR in Xpert
MTB/RIF (i.e. Rif Susceptible, not tested at all in Xpert
MTB/RIF)
9. Among TB cases recorded in DST register, number of TB
cases referred (sent-out) to other DST center for first line
DST.
(Attach summary of names & specify laboratory facility)

10. Among TB cases referred, number of MDR.

(Attach summary of results & specify laboratory facility)

Note: Count cases based on “date of released”. Avoid double reporting of a specific case. Use the LRF to determine GX result
for DST.
*Mono resistant TB- resistance to one first-line anti-TB drug only.
**Polydrug resistant TB - resistance to more than one first-line anti-TB drug (other than both Isoniazid and Rifampicin).

Sex Age

Case Female Male Unknown Total 0-14 ≥15 Unknown Total

11. Total MDR cases. (# 4 above)

12. Total TB cases susceptible
and with any drug-resistance
except MDR. (#2, #3, #5, #6
above)

TOTAL

Remarks:
_______________________________________________________________________

186
Report 1d. Quarterly Report on 2nd Line DST

Report 1d. Quarterly Report on 2nd Line Solid TB DST

(Source of Data – TB Culture and DST Laboratory Register)

Laboratory Quarter/
Name: Year:

Date
Region:
Submitted:

Prepared by: Name: Signature: Designation:

Approved by: Name: Signature: Designation:

2nd LINE SOLID TB DRUG SUSCEPTIBILITY TEST

Registration Group TOTAL

Case Other
Re-
(Items 1 to 5 are required fields) New Relapse No. %
treatme
nt

1. Total MDR-TB cases examined for second line

DST.

(Count cases with result only. Do not include MDR-TB cases referred to
other 2nd Line DST laboratory. Referred cases shall be included in the
workload of receiving facility that processed the isolates)

2. Total MDR-TB cases resistance to

Fluoroquinolones*.
(monoLfx)
3. Total MDR-TB cases resistance to any second-line
injectable (2LI)**
(monoKm, monoAmk, monoCm, polyKmAmk, polyKmCm, polyAmkCm,
polyKmAmkCm)

4. Total XDR-TB*** cases detected.

(polyLfxKm, polyLfxAmk, polyLfxCm, polyLfxKmAmk, polyLfxKmCm and
polyLfxAmkCm)

187
 5. Total MDR-TB cases susceptible to all second-line
anti-TB drugs.
Fill-out if applicable:

6. Among MDR-TB cases examined, number with

non-viable isolates.
7. Among the MDR-TB cases recorded in TB Culture
and DST laboratory register, number of cases
referred (sent-out) to other DST center for
second line DST.
(Attach summary of names & specify laboratory facility)

8. Among the MDR-TB cases referred, number of

XDR-TB cases detected.
(Attach summary of results & specify laboratory facility)

Note: Count number of cases based on “date of released”. Avoid double reporting of a specific case.

* Fluoroquinolones include Levofloxacin

** Second-line injectable include Kanamycin, Amikacin, and Capreomycin
***XDR-TB - resistant to any fluoroquinolones and atleast one of the three second-line injectables in addition to multi-drug
resistance.

Remarks:
_________________________________________________________________________
i.e., number of cases with unknown registration group

188
Report 1e. Quarterly Report on Line Probe Assay – 1st Line for TB

189
Report 1f. Quarterly Report on Line Probe Assay – 2nd Line for TB

190
Report 3b. Quarterly Report on All DR-TB Cases

191
192
Report 4b. Quarterly Report on Drug and Supply Inventory for SLDs and Supplies

193
194
Report 4. iDOTS/Treatment Site Requisition Form

195
Report 5b. Quarterly Report on Treatment Interim Outcome of DR-TB Cases

196
Report 5c. Annual Report on the Treatment Outcome and Post-Treatment Follow-up of
DR-TB Cases

197
198
FDA Suspected Adverse Reaction Form

199
 Annex E Paunawa Form

National TB Control Program (NTP)

Programmatic Management of Drug-resistant Tuberculosis (PMDT)

Commitment to Undergo Diagnosis and Treatment for Drug-resistant TB

(PAUNAWA)

I understand and agree to the following:

1 I shall answer honestly all questions given to me by the health worker and I shall provide
records relevant to the queries.
2 I shall submit a sputum sample for Xpert MTB/RIF test. The test determines if my sputum
has TB bacteria, and if the TB bacteria is resistant to Rifampicin, one of the most effective first-
line anti-TB medicines.
3 I shall promptly report to the health facility with a family member or significant other if the
result for the above is positive.
4 I shall commit myself to start treatment. An Xpert MTB/RIF result showing resistance to
Rifampicin shall be used as the basis for initiation of treatment. I understand that empiric treatment
may also be started if found necessary by the Treatment Facility physician.
5 I understand that if I cannot start treatment immediately my condition may become worse
and may even lead to death. TB disease shall remain active, may cause further destruction of my
lungs, and may spread to the people around me especially to my immediate family.
6 Once initiated on treatment for DR-TB, I shall adhere and complete the prescribed number
months of treatment (either at least 9 months or 20 months) with second-line anti-TB medicines
under direct supervision. Treatment interruption will lead to worsening of my condition and
development of further drug- resistance, making my disease more difficult to treat.
7 To prevent the spread of my disease, I shall:
- cover my mouth and nose with handkerchief while coughing and sneezing
- dispose my sputum properly based on the instruction provided by the health care provider (e.g.,
spitting on a tissue paper and disposing it to a trash bin disinfected with Sodium hypochlorite, e.g.
Chlorox, or spitting directly to the toilet bowl
- keep my room well-ventilated by opening windows and letting the sunrays in.
8 All the tests for diagnosis and medications for the whole duration of treatment of DR-TB
patients shall be provided by the PMDT program free of charge.

_______________________ ______________________ _____________________

Name & Signature of Patient Name and Signature of Relative Name and Signature of Health Care Provider

_____________ _________________ _______________

Date Date Date

Treatment Facility:_______________________________________________
Address:_______________________________________________________
Contact Number:_________________________________________________

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 Annex F DR-TB Treatment Information Form

National TB Program (NTP)

Programmatic Management of Drug-resistant Tuberculosis (PMDT)

DR-TB TREATMENT INFORMATION FORM

We request you to go through and to understand the following information before starting
the DR-TB treatment.

Purpose of the treatment:

Based on the results of your screening (medical check-up and sputum test), it was found
out that you suffer from a form of tuberculosis that is not responsive to the first line anti-
TB drugs such as Isoniazid, Rifampicin, Pyrazimide and Ethambutol. It is called drug-
resistant TB. It is important for you to undergo appropriate treatment for greater possibility
of cure and to prevent the spread of disease to your family and community.

Your Health Care Provider will:

 Check your history of TB treatment, clinical condition, and severity of the disease
to assess the appropriate treatment regimen.
 Provide either the Standard Short Treatment Regimen (SSTR) or the
Conventional Treatment Regimen (CTR).
 Provide medications daily in a place that is most accessible and acceptable to
you. You can arrange with the health care provider where you want to take your
medications daily. However, your treatment partner will be oriented on how to
provide supervised treatment. The doctor or nurse will administer the injection
during the intensive phase (4-8 months) and your treatment partner will observe
you swallowing pills for the entire duration of your treatment (9-24 months).
 Monitor your body’s response to treatment and conduct regular examinations:
o Monthly medical check-up with the doctor, or whenever needed.
o Sputum examination at the start of treatment, monthly while you are on
treatment, and every 6 months for 2 years once you have successfully
completed your treatment.
o Blood test at the start of treatment and monthly during the intensive phase
of treatment or any time during treatment as per recommendation by your
attending physician. For this, small quantity of blood will be drawn.
o Chest x-ray at the start of treatment, and at the end of the intensive phase
of treatment.
o There might be a need to check your heart’s electrical activity (ECG) at the
start of treatment and monthly while on treatment if you will be receiving
anti-TB drug/s that can potentially affect the heart.

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 o Hearing test at the start of treatment and monthly while you are receiving
an injectable anti-TB drug.
o Eye tests at the start of treatment and monthly if you will be receiving anti-
TB drug/s that can potentially affect the eyes.
o All examinations will be free of cost to you.

How long you will be in the treatment:

If you will receive the standard short treatment regimen, it will lasts for 9 months, but may
be extended up to 12 months depending on your body’s response to treatment. If you will
receive the conventional treatment regimen, duration of treatment is 20-24 months.

Guide and reminders in taking anti-TB medications:

1. Take the medications daily, seven (7) days a week, at the right time with the right
dose under the supervision of a health care provider or a treatment partner.
2. Do NOT stop taking the drugs unless there is an advice from the DOTS physician.
3. Inform the DOTS physician if you are taking other drugs prescribed by other
physician or as self-medication.
4. STOP or avoid smoking, drinking alcohol and use of prohibited drugs while on
treatment.
5. Take a light meal before intake of anti-TB drug. However, if you are taking
fluoroquinolone (Levofloxacin, Moxifloxacin), avoid dairy products (milk, cheese,
etc) and multivitamins since they can interfere with the absorption of the anti-TB
drug making them less effective. You may take these two (2) hours before or four
(4) hours after intake of anti-TB drugs.
6. If you are taking PASER, mix it with acidic juice (orange, pineapple, calamansi).
Do NOT mix it with buko juice, grape juice, softdrink, iced tea or plain water.

Risks of taking anti-TB drugs

The following may be the anti-TB drugs that you will take and may cause side effects
which usually are, but not limited to:
(Note: The preparation of the anti-TB drugs may change.)

Name of Anti-TB Drug Drug Potential Side Effects

Preparation

ISONIAZID 300 mg/tablet abdominal discomfort/pain, burning

sensation in the hands and feet,
yellowish discoloration of the sclera
(white portion of the eye) and skin,
convulsion, depression, psychosis

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RIFAMPICIN 300 abdominal discomfort/pain, orange/red
mg/capsule colored urine, flu-like symptoms,
yellowish discoloration of the sclera
(white portion of the eye) and skin

PYRAZINAMIDE 500 mg/tablet abdominal discomfort/pain, joint pain,

discoloration of the sclera (white portion
of the eye) and skin

ETHAMBUTOL 400 mg/tablet blurring of vision

MOXIFLOXACIN abdominal discomfort/pain, burning

sensation in the hands and feet,
LEVOFLOXACIN 400 mg/tablet depression, psychosis, convulsion, heart
(Fluoroquinolone) 500 mg/tablet problem

250 mg/tablet

KANAMYCIN 1 gm/vial electrolyte imbalance, kidney problem,

hearing loss, burning sensation in the
CAPREOMYCIN hands and feet,
(Injectable Agents)

PROTHIONAMIDE 250 mg/tablet nausea and vomiting, abdominal

discomfort/pain, yellowish discoloration
of the sclera (white portion of the eye)
and skin, headache, thyroid problem

CYCLOSERINE 250 burning sensation in the hands and feet,

mg/capsule depression, psychosis, headache,
convulsion

CLOFAZIMINE 50 mg/capsule abdominal discomfort/pain, heart

problem
100
mg/capsule

LINEZOLID 600 mg/tablet nausea and vomiting, abdominal

discomfort/pain, burning sensation in the
hands and feet, blurring of vision, anemia

BEDAQUILINE 100 mg/tablet nausea and vomiting, abdominal

discomfort/pain, yellowish discoloration

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 of the sclera (white portion of the eye)
and skin, headache, heart problem

DELAMANID 50 mg/tablet heart problem

PASER 4 gm/sachet nausea and vomiting, abdominal

discomfort/pain, diarrhea, yellowish
discoloration of the sclera (white portion
of the eye) and skin, thyroid problem

IMIPENEM/CILASTATIN 1 gm/vial nausea and vomiting

The doctor and nurses will do their best to relieve you of any side effect according to the
standards of care.

Benefit of taking anti-TB drugs:

 Great possibility of getting cured
 Prevent the spread of disease in the family and in the community
 Improve the quality of life

Infection Control:
You need take necessary precautions to prevent the spread of TB disease at your home
and in your community:
 Cover your mouth and nose with a clean cloth (i.e. handkerchief) when coughing
or sneezing. If possible, wear a facemask or ordinary face mask at all times until
your physician tells you that you are no longer infectious.
 Keep the house or the room well-ventilated by opening windows or using electric
fan to control the direction of the wind and let the sun rays in.
 Refrain from sleeping with other household members in an enclosed space, if
possible.
 Perform sputum collection in an open space, well ventilated area, away from
other household members.
 Dispose your sputum properly into a disinfected trash bin with Sodium
hypochloride, e.g. Chlorox.

To ensure the health of your family and close contacts, their sputum will also be tested
for TB. Other tests such as Chest X-ray, Tuberculin Skin Testing may also be done, if
necessary.

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Persons to contact:
If you have questions about your treatment, you may contact:
 Name of DOTS facility:
______________________________________________
 Name of DOTS facility staff
o Physician:
___________________________________________________________
o Nurse:
___________________________________________________________
 Address of the DOTS facility:
________________________________________________________________
________________________________________________________________
________________________________________________________________
 Contact number of the DOTS facility:
________________________________________________________________

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 Annex G Procedures on Collection and Transport of Specimen

Source: National TB Control Program Manual of Procedures, 5th Edition, Manila: DOH,
204 Pages 23-24

Collection and Transport of Sputum Specimen

1. Motivate the presumptive DR - TB to undergo Xpert MTB/RIF test and explain the
importance of the procedure. The only contraindication to collecting sputum is massive
hemoptysis which is expectoration of large volumes of blood (200-600 ml in 24 hours)
from the respiratory tract. Blood streaked sputum can still be examined.
Specimen such as blood, urine, stool or sputum containing food particles shall not be
accepted for Xpert MTB/Rif testing.

2. Prepare the sputum cup or 50 ml conical tube and Form 2a: NTP Laboratory
Request and Result Form. Label the body of the sputum cup/conical tube, indicating
patient’s complete name and indicating specimen for Xpert.

3. Demonstrate how to produce quality sputum. Mucus from the nose and throat, and
saliva from the mouth are NOT good specimens. Advise the patient to:

3.1. Clean mouth by thoroughly rinsing with water. Food particles or other solid
particulates may inhibit the test for Xpert MTB/RIF.
3.2. Breathe deeply, hold breath for a second or two, and then exhale slowly. Repeat
the entire sequence two (2) more times.
3.3. Cough strongly after inhaling deeply for the third time and try to bring up sputum
from deep within the lungs.
3.4. Expectorate the sputum in the sputum cup or conical tube.
3.5. Collect at least one (1) ml of sputum sample.
3.6. Examine the specimen to see that it is not just saliva. Repeat the process if
necessary.
Sputum induction for individuals unable to expectorate should be done only in facilities
where the staff is trained, supplies and equipment are available, and infection control
measures are in place.

4. Observe proper precautions against infection during the demonstration. Stay

behind the patient. Collect specimen in a well-ventilated designated sputum collection
area, or outside the DOTS facility.

5. Check quantity (must be at least 1-5 ml.) and quality of sputum. Wipe off the
external surface of the sputum cup or conical tube if needed and wash your hand
thoroughly with soap and water.

6. Seal the sputum specimen container, pack it securely, and transport it to an Xpert
MTB/RIF site together with the completely filled out Form 2a: NTP Laboratory Request
and Result Form.

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7. Results of Xpert MTB/RIF test can be released within 3 working days. Inform
patient when to follow-up regarding the results.
8. If no prior DSSM examination was done for the presumptive DR – TB (e.g.
household contacts of registered DR – TB cases identified as presumptive DR – TB during
contact investigation), collect additional two (2) sputum specimens for DSSM.

A. Presumptive DR – TB less than 15 years old.

1. Diagnostic procedures for presumptive DR – TB who are less than 15 years old
are the same as the diagnostic procedures for presumptive TB of the same age category.

2. If the child can expectorate, collect one (1) sputum specimen for Xpert MTB/RIF
test. However, if coughing out of sputum is difficult, gastric aspirate may be collected. In
cases gastric aspirate fails and if appropriate with facilities and expertise, bronchoscopy
is an option. (Companion Handbook WHO page 70)

3. If the child cannot expectorate, TST can be done according to the standard set of
procedures. A positive TST is an area of induration of the skin with diameter of 10 mm
or more.

4. If the TST result is negative, chest x – ray can be requested.

B. Presumptive extra-pulmonary DR – TB

Extra-pulmonary TB can also be confirmed bacteriologically using Xpert MTB/RIF test for
body fluids such as cerebrospinal fluid (CSF) and gastric aspirate. Tissues/biopsy
specimens (e.g., lymph node tissue aspirate) processed in accordance with national
policies can also be used. Pleural fluid shall not be used for Xpert MTB/RIF test.

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 Annex H TB Medical Advisory Committee Guidelines

TB Medical Advisory Committee (TB MAC)

I. Introduction:

In early 2000, access to service of drug-resistant tuberculosis (DR-TB) was

centralized in the National Capital Region and management of each patients is
discussed among 2-3 physicians and nurses who are giving direct patient care.
When programmatic management of DR-TB services expanded in additional sites
in Metro Manila in 2005, the Philippines created a specialized team called
Consilium. The Consilium is a multi-disciplinary case management committee
composed of program staff, physicians, nurses and other relevant health care
workers with expertise on DR-TB management. This committee meets regularly to
confirm the diagnosis, determine treatment regimens, assess response to
treatment, and determine final outcome through a consensus using standards
based on the WHO Guidelines for Programmatic Management of Drug-resistant
TB.³⁵ With further expansion to different regions in the country and with the
increase in the number of cases being presented, it was recommended by the
Regional Green Light Committee (rGLC) in 2012 to decentralize the Consilium in
each regions³⁶. In response to the recommendation, new physicians were
mentored and became Consilium Officers. Each PMDT treatment facility was
grouped according to geography (3 main island groups and NCR (National)) and
two Consilium Officers were assigned for each main group. The subgroup was
called Regional Consilium. Initially, the meetings were face to face, but due to
geographical and logistic challenges, cases and recommendations were sent via
email and no real time discussion of cases were done. The increase in the number
of cases sent via email became a burden to the Consilium Officers, thus, there
were referrals that were not properly reviewed and answered. Hence, it was
recommended by the rGLC in 2014 that the National Consilium should regularly
supervise Regional Consilium, and ensure that Consilium Officers of Regional
Consilium are well trained in clinical management of drug-resistant TB 37,38.

On March 23, 2016, the NTP issued Department Memorandum 2016-0133

“Integration of the Programmatic Management of Drug-resistant Tuberculosis
(PMDT) Services into the Basic Directly Observe Treatment Short course (DOTS)
Services in All Health Facilities”. Through iDOTS, the health facilities shall
diagnose, register and treat DR-TB patients within their catchment area. On
January 1, 2017, the NTP adopted the programmatic implementation of Standard
Short Treatment Regimen (SSTR) for rifampicin-resistant/multi drug-resistant TB
(RR/MDR-TB). With this, there is a need to revisit the composition, function and
roles of the Consilium. It is also decided by the NTP to rename the group and be
called TB Medical Advisory Committee (TB MAC).

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II. Objective:

TB MAC will provide technically sound and evidence-based recommendations to

clinicians and health care providers who are managing patients with DR-TB and patients
with difficult-to-treat DR-TB to achieve correct diagnosis and management, to prevent
development of further drug resistance and further complications due to TB disease.

III. Committee Composition:

A. NATIONAL TB MAC (N-TB MAC)

The National TB MAC shall be composed of 7 core members represented by

physicians and nurses from PMDT treatment facilities, member from any
subspecialty group and any of the members of the NTP core team of the DOH
Central Office. The clinicians shall focus on the holistic medical management of
patient while the member coming from the NTP Central Office will specifically focus
on the public health aspect of patient’s management (i.e. availability of treatment
partners in the community, treatment interruptions due to access to treatment).
The N-TB MAC shall meet at least once a month. Special meeting maybe called
by the chair.

The following positions shall be occupied by designated member of the committee

and they will be responsible in creating the final recommendations for the regional
cases presented.

Table 24. Position, Qualifications and Responsibilities of Each Member of the

National TB Medical Advisory Committee
Position Qualifications Responsibilities
Chair  Trained in NTP-MOP  Convenes and chairs
He/She will be appointed and PMDT (Basic and the meetings
by the DOH-NTP Central Clinical Management  Finalizes and
Office. Training) approves the
 Physician with at least recommendation
2 years-experience in agreed by the group
managing DRTB  Ensures that National
according to NTP TB MAC meeting is
Protocol regularly conducted
with proper quorum

Co-Chair  Trained in NTP-MOP  Performs the duty of

He/She will be designated and PMDT (Basic and the Chair in his/her
by the Chair. Clinical Management absence.
Training)
 Physician with 2 years-
experience in

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 managing DRTB
according to NTP
Protocol

Members:  Trained in NTP-MOP  Assists in providing

 PMDT treatment and PMDT evidences and sound
facility physician recommendations in
 PMDT treatment managing the cases
facility nurse presented
 Representative from
any medical
subspecialty
 Representative from
NTP-Central Office
Secretariat  Preferably a PMDT  Informs all members
He/She will be designated treatment facility nurse about the schedule of
by the Chair.  Trained in NTP-MOP TB MAC meeting
and PMDT  Coordinates with N-TB
MAC Chair on cases to
be presented
 Organizes and
schedules meeting
 Files all documents

The Committee may invite other participants from PMDT treatment facilities and
other specialists and stakeholders to attend the meeting as observers or resource
person/s.

B. REGIONAL TB MAC (R-TB MAC)

The R-TB MAC shall be composed of 7 core members represented by physicians

and nurses from PMDT treatment facilities, member from any subspecialty group
and any of the members of the NTP core team of the DOH Regional Offices. The
clinicians will focus on the holistic medical management of patient while the
member coming from the DOH-RO shall specifically focus on the public health
aspect of patient’s management. The R-TB MAC shall meet at least twice a
month.

The following positions will be occupied by designated member of the committee

and they shall be responsible in creating the final recommendations for the regional
cases presented.

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Table 25. Position, Qualifications and Responsibilities of Each Member of the
Regional TB Medical Advisory Committee
Position Qualifications Responsibilities
Chair  Trained in NTP-MOP  Convenes and chairs
He/She will be appointed and PMDT (Basic and the meetings
by the DOH-NTP Central Clinical Management  Finalizes and
Office. Training) approves the
 Physician with at least recommendation
2 years-experience in agreed by the group
managing DRTB  Ensures that Regional
according to NTP TB MAC meeting is
Protocol regularly conducted
with proper quorum

Co-Chair  Trained in NTP-MOP  Performs the duty of

He/She will be and PMDT (Basic and the Chair in his/her
designated by the Clinical Management absence.
Chair. Training)
 Physician with 2 years-
experience in
managing DRTB
according to NTP
Protocol

Members:  Trained in NTP-MOP  Assists in providing

 PMDT treatment and PMDT evidences and sound
facility physician recommendations in
 PMDT treatment managing the cases
facility nurse presented
 Representative from
any medical
subspecialty
 Representative from
NTP-Regional Office
Secretariat  Preferably a PMDT  Informs all members
He/She will be treatment facility nurse about the schedule of
designated by the  Trained in NTP-MOP TB MAC meeting
Chair. and PMDT  Coordinates with
Regional-TB MAC
Chair and N-TB MAC
Secretariat on cases to
be presented
 Organizes and
schedules meeting
 Files all documents

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 The Committee may invite other participants from PMDT treatment facilities and
other specialists and stakeholders to attend the meeting as observers or resource
person/s.

The Chair and other members of the TB MAC will have 3 years tenure and can be
renewed as necessary.

IV. Functions:

1. National TB MAC shall:

a. Formulate technically sound and evidence-based recommendations to manage
difficult cases coming from the Regional TB MAC
b. Monitor the outcome of the recommendations
c. Review and develop a compendium of difficult cases and their
recommendations
d. Solicit technical support/advice from other local and international experts
e. Recommend policies and procedures to NTP arising from the discussions
f. Document N-TB MAC Meetings
g. Assists in the capability building of the members of the R-TB MAC

2. Regional TB MAC shall:

a. Formulate technically sound and evidence-based recommendations to manage
difficult cases that cannot be addressed by the PMDT treatment facilities
(S/TCs and iDOTS facilities) within the region
b. Monitor the outcome of the recommendations
c. Refer unresolved clinical cases to the National TB MAC
d. Schedule a remote meeting with the referring PMDT treatment facility
e. Review and develop a compendium of difficult cases and their
recommendations and submit them to N-TB MAC
f. Recommend policies and procedures to NTP arising from the discussions
g. Document R-TB MAC Meetings

V. Cases to be presented/discussed:
1. Clinically-Diagnosed DR-TB
2. Cases with special conditions such as but not limited to:
a. Pregnant
b. Renal Failure
c. Liver Diseases
d. Psychiatric and Neurologic Diseases
3. Mono and Poly-resistant cases
4. Cases with DSSM positive at the end of 4th month of SSTR
5. Cases with serious adverse events (SAEs) and uncontrolled ADRs

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 6. Other difficult clinical cases that are not covered by PMDT Implementing
Guidelines

V. Requirements for the conduct of meeting:

1. Computers with video camera
2. Fast and reliable internet connection (at least 3mbps)
3. Email accounts (preferably g-mail), skype account
4. Forms:
a. DR-TB Case Presentation Form (previously known as Consiliumex)
b. TB MAC Masterlist
5. Patient’s clinical records – Screening forms, Progress report forms, laboratory
results (Blood chemistry, sputum examination results), Chest Xray and other
pertinent records

VI. Procedures:

A. For R-TB MAC:

1. The PMDT treatment facility physician shall prepare difficult cases that are not
covered/discussed in the PMDT Implementing Guidelines. An electronic copy
of DR-TB Case Presentation Form shall be filled out and uploaded in an
electronic platform (i.e. google docs, dropbox) designated for each PMDT
treatment facility. This can be viewed by all the members of the R-TB MAC
and the representatives from the PMDT treatment facilities in the region. Only
the referring PMDT treatment facility physician or his/her representative and R-
TB MAC Chair and Secretariat can edit the electronic form.

2. The PMDT treatment facility physician or his/her representative shall send a

real time email to the R-TB MAC Secretariat about the number of cases
uploaded.

3. The R-TB MAC Secretariat shall inform all its members on the cases uploaded
for their initial review and shall determine the case that needs further
recommendations from the R-TB MAC. For cases that were uploaded but do
not warrant R-TB MAC discussions (i.e. cases that can be answered using the
PMDT IG), the PMDT treatment facility physician or his/her representative shall
be given guidance to refer back to the PMDT Implementing Guidelines and
policies.

4. The R-TB MAC Secretariat shall record the cases for presentation in the
electronic copy of the Regional TB MAC Masterlist for later update.

5. The R-TB MAC Chair, together with all its members, shall schedule a remote
meeting with the PMDT treatment facility with cases for review.

213
 Representatives from other PMDT treatment facilities without cases to be
presented may also be invited.

6. The R-TB MAC Secretariat shall set up the skype call or any related platform
on the day of the meeting.

7. Using the DR-TB Case Presentation Form as reference, the PMDT treatment
facility physician or his/her representative shall present the case to the
committee. All clinical records of the patients shall be available during the
meeting to serve as reference for the answers to queries of the committee.

8. In consultation with all the members of the committee and inputs from the
observers, the Chair shall finalize the recommendation and the Secretariat shall
update the electronic copy of the DR-TB Case Presentation Form. The
Secretariat shall also update the TB MAC Masterlist.

9. The Chair shall ensure that all cases presented by the PMDT treatment
facilities are discussed during the meeting. He/She shall remind the PMDT
treatment facility physician or his/her representative to update the TB MAC
Masterlist whether the problem was resolved or not after the recommended
management is instituted. These cases shall be reviewed next meeting. For
cases that are not yet resolved, further discussion shall be done during the
subsequent meeting and the cases shall be re-entered in the TB MAC
Masterlist.

10. For cases that warrant further discussions, these shall be referred to N-TB MAC
for final recommendations.

B. For N-TB MAC:

1. The R-TB MAC Chair shall prepare difficult cases that were not resolved during
the R-TB MAC meeting. An electronic copy of the filled out DR-TB Case
Presentation Form shall be uploaded in an electronic platform (i.e. google docs,
dropbox) designated for each region. This can be viewed by all the members
of the N-TB MAC, and R-TB MAC Chair and Secretariat. Only the R-TB MAC
and N-TB MAC Chairs, and R-TB MAC and N-TB MAC Secretariats can edit
the electronic form.

2. The R-TB MAC Secretariat shall send a real time email to the N-TB MAC
Secretariat about the number of cases uploaded.

3. The N-TB MAC Secretariat shall inform all its members on the cases uploaded
for their initial review and shall determine the case that needs further
recommendations from the N-TB MAC. For cases that were uploaded but do

214
 not warrant N-TB MAC discussions (i.e. cases that can be answered using the
PMDT IG), the R-TB MAC Chair shall be given guidance to refer back to the
PMDT Implementing Guidelines and policies.

4. The N-TB MAC Secretariat shall record the cases for presentation in the
electronic copy of the National TB MAC Masterlist for later update.

5. The N-TB MAC Chair shall schedule a remote meeting together with all its
members and chair(s) of R-TB MAC.

6. The N-TB MAC Secretariat shall set up the skype call or any related platform
on the day of the meeting.

7. Using the DR-TB Case Presentation Form as reference, the R-TB MAC Chair
(or alternate) shall present the case to the committee. All clinical records of the
patients shall be available during the meeting to serve as reference for the
answers to queries of the committee.

8. In consultation with all the members of the committee and inputs from the
observers, the Chair shall finalize the recommendation and the Secretariat shall
update the electronic copy of the DR-TB Case Presentation Form. The
Secretariat shall also update the National TB MAC Masterlist.

9. The Chair shall ensure that all the cases presented by the R-TB MAC are
discussed during the meeting. He/She shall remind the R-TB MAC Chair to
update the N-TB MAC Masterlist whether the problem was resolved or not after
the recommended management is instituted. These cases shall be reviewed
next meeting. For cases that are not yet resolved, further discussion shall be
done during the subsequent meeting and the cases shall be re-entered in the
N-TB MAC Masterlist.

10. For cases that warrant further discussions, these shall be referred to other local
and international experts on DR-TB Management.

VII. Monitoring, Supervision and Evaluation

Both Regional and National TB MAC will be monitored by the DOH-NTP and Partners.
The following shall be considered during monitoring:
a. Number of meetings done per quarter
b. Number of cases presented per quarter disaggregated by reasons of referral
c. Number of cases resolved per quarter (Final outcome of the cases discussed
per quarter)
d. Clinical practices on the ground in terms of prevention, diagnosis and treatment

215
 e. Challenges and difficulties in implementation in terms of human resources,
capacity building, compliance to WHO recommendations and country policies
f. Compendium of difficult cases and their recommendations

Group’s performance shall be evaluated. The methodology and schedule shall be

determined by the NTP.

VIII. Logistical and Funding Support:

The conduct of the TB MAC meeting shall be primarily supported by the DOH-ROs
and this shall include provisions of venue, internet connection, and other
peripherals. Other development partners may also give other support.

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 Annex I WHO recommended Weight-based dosing for Adults under the
Conventional Treatment Regimen

Annex J Assessment Checklist for Healthcare Facilities and other Congregate

Settings
Annex K Patients Charter for TB Care

217
Weight – Based Dosing for Children
(Source: Companion Handbook to WHO guidelines on PMDT, revised edition, pp. 332-
337)

The dosing tables for children have been adapted from the following:
1. Management of multi drug-resistant tuberculosis in children: A field guide. Sentinel
Project on Pediatric Drug-Resistant Tuberculosis/TB CARE II; 2012.
2. Tuberculosis: Practical guide for clinicians, nurses, laboratory technicians and medical
auxiliaries. Medecins Sans Frontieres and Partners In Health; 2013.
3. PIH guide to the medical management of multi drug-resistant tuberculosis, 2nd
Edition. Partners In Health and USAID TB CARE II; 2014.

General considerations
 Anti-TB drugs should be dosed according to weight and adjusted regularly as weight
increases during treatment.
 When a liquid formulation is available, it should be used for patients less than 15 kg.
 Most second-line TB drugs do not have paediatric liquid or tablet formulations, so it
may be necessary to split the pills in order to approximate the correct dose. To split
tablets into 0.75, it is suggested to split the tablet in half and then split a half tablet in
half. Discard the smaller quarter tablet and give the child a half tablet plus the
remaining quarter tablet.
 Doses of most anti-TB drugs have not been established for children below 5 kg, but
often the potential benefit outweighs the risks. In such cases, the child should be
dosed as close to the middle of the mg/kg range as possible.

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Annex J Department Memorandum No. 2016-0228: Expanded List of
PMDT Ancillary Drugs

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 Annex K Community-based PMDT Care Commitment Form

DEPARTMENT OF HEALTH
National TB Control Program

Community Based PMDT Care Initiative

COMMITMENT FORM

Ako,_______________________________________,isang______________________________
__________ ng _______________________________________________________________ ay
nag-dedesisyon na maging isang Community Treatment Partner para sa mga pasyenteng may
MDR-TB sa aking komunidad sa ilalim ng proyekto ng ComPCare. Ninais kong maging community
treatment partner dahil
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

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Annex K Assessment Checklist for Healthcare Facilities and other Congregate
Settings

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Annex L Patients Charter for Tuberculosis Care

Patients’ Rights

You have the right to:

Care

 The right to free and equitable access to tuberculosis care, from diagnosis
through treatment completion, regardless of resources, race, gender, age,
language, legal status, religious beliefs, sexual orientation, culture or having
another illness
 The right to receive medical advice and treatment which fully meets the new
International Standards of Tuberculosis Care, centering on patient needs,
including those with multi drug-resistant (MDR-TB) or tuberculosis- human
immunodeficiency virus (HIV) co-infections and preventable treatment for young
children and others considered to be at high risk
 The right to benefit from proactive health sector community outreach, education
and prevention campaigns as part of comprehensive care programs.
Dignity

 The right to be treated with respect and dignity, including the delivery of services
without stigma, prejudice or discrimination by health providers and authorities
 The right to quality healthcare in a dignified environment, with moral support from
family, friends, and the community
Information

 The right to information about what healthcare services are available for TB and
what responsibilities, engagements, and direct or indirect costs are involved
 The right to receive a timely, concise, and clear description of the medical
condition, with diagnosis, prognosis (an opinion as to the likely future course of
the illness), and the treatment proposed, with communication of common risk and
appropriate alternatives
 The right to know the names and dosages of any medication or intervention to
be prescribed, its normal actions and potential side-effects, and its possible
impact on other conditions or treatments
 The right to access medical information which relates to the patient’s condition
and treatment and to a copy of the medical record if requested by the patient or
a person authorized by the patient
 The right to meet, share experiences with peers and other patients and to
voluntary counseling at any time from diagnosis through treatment completion
Choice

 The right to a second medical opinion, with access to previous medical records

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  The right to accept or refuse surgical interventions if chemotherapy is possible
and to be informed of the likely medical and statutory consequences within the
context of a communicable disease
 The right to choose whether or not to take part in research programs without
compromising care

Confidence

 The right to have personal privacy, dignity, religious beliefs, and culture
respected
 The right to have information relating to the medical condition kept confidential
and released to other authorities contingent upon the patient’s consent
Justice

 The right to make a complaint through channels provided for this purpose by the
heath authority and to have any complaint dealt with promptly and fairly
 The right to appeal to a higher authority if the above is not respected and to be
informed in writing of the outcome
Organization

 The right to join, or to establish, organizations of people with or affected by TB

and to seek support for the development of these clubs and community-based
associations through the health providers, authorities and civil society
 The right to participate as ‘stakeholders’ in the development, implementation,
monitoring and evaluation of TB policies and programs with local, national, and
international health authorities
Security

 The right to job security after diagnosis or appropriate rehabilitation upon

completion of treatment
 The right to nutritional security or food supplements if needed to meet treatment
requirements
Patients’ Responsibilities

You have the responsibility to

Share Information

 The responsibility to provide the healthcare giver as much information as

possible about present health, past illnesses, any allergies, and any other
relevant details
 The responsibility to provide information to the heath provider about contacts
with immediate family, friends, and others who may be vulnerable to TB or may
have been infected by contact

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Follow treatment

 The responsibility to follow the prescribed and agreed treatment plan and to
conscientiously comply with the instruction given to protect the patient’s health,
and that of others
 The responsibility to inform the health provider of any difficulties or problems
with following treatment if any part of the treatment is not clearly understood
Contribute to Community Health

 The responsibility to contribute to community well-being by encouraging others

to seek medical advice if they exhibit the symptoms of TB
 The responsibility to show consideration for the rights of other patients and
health care providers, understanding that this is the dignified basis and respectful
foundation of the TB community
Show Solidarity

 The moral responsibility of showing solidarity with other patients, marching

together towards cure
 The moral responsibility to share information and knowledge gained during
treatment and to pass this expertise to others in the community, making
empowerment contagious
 The moral responsibility to join in efforts to make the community tuberculosis
free

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