Professional Documents
Culture Documents
UNIVERSITY
BY
MAY 2014
1
DECLARATION
I,Kamakune Carolynn Murungi, hereby affirm that this dissertation is original and has not been
submitted to any other institution for any other academic award. Appropriate references have
been cited where works from other authors have been used.
SIGNATURE.............................................
DATE.......................................................
This dissertation has been submitted with approval of the following supervisors:
ASSOCIATE PROFESSOR JOAN KALYANGO (B Pharm, MscComm Pharm, MscClinEpid
and Bios)
.............................................................
PROFESSOR RICHARD ODOI ADOME (B Pharm, MscPharmcol, PHD)
................................................................
DEDICATION
This study is dedicated to all the people and organisations whose work is committed to ensuring
that medicines are available, safe, and efficacious and used rationally by those that need them.
ACKNOWLEDGEMENTS
First and foremost, I would like to thank the almighty God for giving me the grace, wisdom,
persistence and resilience for preparing and completing this work.
My supervisors: Professor Richard Odoi and Associate Professor Kalyango Joan: thank you so
much for letting me share your profound knowledge and wisdom and for always being available
whenever I needed you. God bless you.
My classmates and professional colleagues provided me with the zeal and external drive to keep
pushing on until the end. For this I am forever grateful.
And finally my family, my daughters Melinda and Nicole- thankyou for just being you and my
husband for being understanding, caring and supportive during this tumultuous time of my life- I
could not have asked for better.
This study has been completed with the generous support of SURE Uganda: the financial
assistance rendered covered the cost of travel to the districts, accommodation and data collection.
I am highly indebted to Birna Trap and Dorthe Konradsen of SURE Uganda for giving
constructive criticism right from concept development to the write up of the final report.
TABLE OF CONTENTS
DECLARATION..............................................................................................................................i
DEDICATION.................................................................................................................................ii
ACKNOWLEDGEMENTS...........................................................................................................iii
LIST OF TABLES..........................................................................................................................vi
LIST OF APPENDICES................................................................................................................vii
ABBREVIATIONS AND ACRONYMS.....................................................................................viii
OPERATIONAL DEFINITIONS:..................................................................................................ix
ABSTRACT...................................................................................................................................xi
CHAPTER ONE:.............................................................................................................................1
1.0 Introduction........................................................................................................................1
1.1 Background........................................................................................................................3
1.1.1 The Health System Structure...........................................................................................3
1.1.2 Health work force of Uganda..........................................................................................3
1.1.3 Regulatory Framework....................................................................................................4
1.2 Problem Statement.............................................................................................................5
1.3 Justification........................................................................................................................6
1.4 Study Objectives.................................................................................................................7
CHAPTER TWO: LITERATURE REVIEW..................................................................................8
2.0 Introduction........................................................................................................................8
2.1Results from literature search..............................................................................................8
CHAPTER THREE: METHODS..................................................................................................13
3.0 Study Design....................................................................................................................13
3.1 Study Setting....................................................................................................................13
3.2 Study Population..............................................................................................................13
3.3 Sample Size and Selection...............................................................................................14
3.4 Study Variables.................................................................................................................15
3.5 Data Collection and Entry................................................................................................16
3.6 Study Tools.......................................................................................................................17
3.7 Data Management and Analysis.......................................................................................17
3.8 Quality Control.................................................................................................................17
4
LIST OF TABLES
LIST OF APPENDICES
FBO
G.P.P
HSSP
MOH
Ministry of Health
NDA
NDP
PHP
PNFP
SURE
OPERATIONAL DEFINITIONS:
Dispensing refers to the interpretation, evaluation, and implementation of a prescription drug
order including the preparation and delivery of a drug or device to a patient, or patients agent, in
a suitable container appropriately labelled for subsequent administration to, or use by, a patient
(College of respiratory therapists of Ontario, 2006).
In this study a facility was classified as a dispensing facility if it provides medicines for sale to
its patients in addition to all the facilities it offers to its patients.
Good pharmacy practice is the practice of pharmacy that responds to the needs of the people
who use the pharmacists services to provide optimal, evidence-based care. (FIP/WHO, 2011)
Medicine: In this study the words medicine and drug were used interchangeably to mean a
chemical substance used in the treatment, diagnosis or prevention of disease or used otherwise to
enhance physical or mental wellbeing.
Medicines management encompasses the entire way that medicines are selected, procured,
delivered, prescribed, administered and reviewed to optimise the contribution that medicines
make to producing informed and desired outcomes of patient care.
Medical clinic: in this study was defined as: a private health facility that is dedicated to the care
and treatment of outpatients including those offering specialist services. It included all those
facilities that offer services that are the equivalent to those provided by a public health centre
level II.
Prescriber: in this study a prescriber was a health professional authorised to prescribe medicines
by the medical and dental practitioners act 1998, including a medical practitioner, veterinary
doctor and dental surgeon.
Private health facilities: these are places that provide health care: either primary or secondary
care or both: and which are not owned by government: but are owned by individuals/ individual
organisations and that operate for profit.
Profession: the definition was adapted from Cruess et al, 2010 who defined it as an occupation
whose core element is work based upon the mastery of a complex body of knowledge and skills.
9
10
ABSTRACT
AIM: To assess the level of adherence of private medical clinics in Uganda to the standards of
good pharmacy practice in regard to dispensing, storage and stock management of medicines.
METHODS: A cross sectional survey of private medical clinics in three districts of Uganda was
done. It involved observation of dispensing practices, storage practices and stock management
practices in 60 randomly selected private medical clinics. The person responsible for dispensing
of medicine in each clinic was interviewed using a semi structured questionnaire. In addition, ten
patients were asked a few questions regarding their medicine as they left the clinic. The data was
entered using Epi data software and analysed using SPSS version 21.
KEY FINDINGS: Dispensing in more than 60% of all the clinics was done by inadequately
qualified staff (nursing assistants), with very short dispensing time (half a minute),
poor
medicine labeling (less than 10% of all the medicine packs examined had been labeled with
patient name, date, strength and quantity).
The aspects of medicines storage that warrant the most attention were: the absence of a
functional system for cold storage in majority of the clinics surveyed (76.7%), absence of a
designated area for storage of expired medicines and non adherence to First Expiry First Out
method of medicine storage in more than half of all the clinics surveyed.
Stock management had the worst scores among all the three areas assessed: none of the clinics
surveyed had a manual stock management system (stock card) while only three clinics had a
computerized stock management system.
CONCLUSIONS: This study has shown that adherence to good pharmacy practice in respect to
medicines dispensing, storage and stock management is suboptimal in most of the private
medical clinics surveyed.
11
CHAPTER ONE:
1.0 Introduction
Private Health practitioners play an important role in the delivery of health services and account
for about 46% of the total number of health facilities in Uganda. They have a large urban and
peri-urban presence and provide a wide range of services, mainly in primary and secondary care.
Few provide tertiary services. Curative services are widely offered while preventive services are
more limited, with the exception of family planning, offered by 75% of PHP facilities (Andrea et
al, 2005).
Curative services in health care have two very important of components: prescribing and
dispensing of medications. Prescribing involves the selection of a particular therapy (which may
or may not involve the use of medicines) based on a diagnosis reached after careful consideration
of
the
patients
history,
physical
examination
and
where
necessary
supporting
activities in Uganda, with dispensers performing the role of prescribers, and prescribers equally
performing the dual role of prescribing and dispensing.
Perhaps because of the noted shortage of pharmacists in Uganda, anecdotal evidence suggests
that in spite of the existing regulations, other health care professionals such as: doctors, nurses,
and clinical officers dispense and prescribe medicines at the same time. The combination of
prescribing and dispensing functions in one professional usually leads to overprescribing, as
there is a financial incentive to sell more or more expensive drugs. These two functions should
be separated as much as possible, except in rural areas where there is insufficient market for
separate pharmacies. Such a measure usually meets with strong opposition by dispensing doctors
(who may earn a considerable part of their income by selling drugs) and by pharmacists (who
may earn a considerable part of their income by selling drugs without prescription). (WHO,
2001)
Previous studies have revealed that doctors dispense medicines for many reasons such as:
insufficient pharmacy coverage, increased drug accessibility and availability, and for economic
reasons (Trap et al, 2003). Dispensing by prescribers may improve patient access to medications,
promote greater use of lower-cost generic medications and therapeutic substitutions due to the
prescribers enhanced awareness of medication costs, and ultimately improved patient adherence
with medication regimen (Cohen, 2012). On the other hand, dispensing by physicians may pose
medication safety concerns, particularly lead to lax procedures for medication labeling, recordkeeping, storage, and supervision of the dispenser.
1.1 Background
1.1.1 The Health System Structure
The National Health System in Uganda constitutes of all institutions, structures and actors whose
actions have the primary purpose of achieving and sustaining good health. It is made up of the
public and the private sectors (MOH, 2012a).
The public sector is comprised of Government health facilities under the Ministry of Health,
health services of the Ministries of Defense, Internal Affairs (Police and Prisons) and Ministry of
Local Government. The public health care delivery system is comprised of seven levels. There
are four Health centre categories ( levels I to IV) that are categorized on the basis of population
served and range of services provided. Heath Center I typically serves a population of 1000
inhabitants or less and provides basic preventive and health education services while Health
Center IV covers a population of about 100,000 and offers preventive, cure, rehabilitation and
emergency surgeries. The next three levels consist of general hospitals, regional referral hospitals
and national referral hospitals (Markle et al, 2007).
The private health delivery system consists of Private Health Providers (PHPs), Private Not for
Profit (PNFPs) providers and the Traditional and Complimentary Medicine Practitioners
(TCMPs).
1.1.2 Health work force of Uganda
One of the key building blocks of the health system is the health workforce . A strong health
workforce is one that works in ways that are responsive, fair, and efficient to achieve the best
health outcomes possible, given available resources and circumstances (WHO, 2007).
Uganda is one of the fifty seven countries with a critical shortage in human resources for Health
(WHO,2006). The human resource policy (MOH, 2006) demonstrates that medical doctors,
3
practitioners from retailing of medicines without a valid license. However, up to date no such
license is issued permitting medical practitioners to dispense medicines as part of the
professional services that they offer to their patients. In some other African countries like South
Africa and Zimbabwe, prescribers that dispense medicines are given additional training and also
issued with a license to operate (WHO, 1997). This laxity in enforcing the law in Uganda may
lead to lax procedures for dispensing and stock management in these facilities and hence put
patients lives at risk. Inappropriate or incorrect dispensing can undo many of the benefits of the
health care system as all of the resources required to bring a drug to the patient will be wasted if
dispensing does not ensure that the correct drug is given to the right patient in an effective
dosage and amount, with clear instruction, and in packaging that maintains the integrity of the
drug (MSH, 1997)
Previous studies have focused on dispensing practices in pharmacies and drug shops (Abula et
al. 2006, Maija et al. 2007) however there is still limited documented information on dispensing
practices in medical clinics. This study aims to attempt to close the gaps in knowledge by
assessing the level of adherence of medical clinics to the standards of good pharmacy practice in
Uganda.
1.3 Justification
The WHO estimates that more than half of all medicines are prescribed, dispensed or sold
inappropriately, and that half of all patients fail to take them correctly (WHO, 1998). Several
strategies have been undertaken to curb this irrational medicines use in Uganda however most
have focused on drug shops and pharmacies.
One of the goals of the Uganda national drug policy is to ensure that dispensing practices at all
levels in both the public and private sectors comply with recommended standards of good
practice (MOH, 2002) and therefore it is crucial that pharmacy practices in private medical
clinics are assessed because they offer an important portal for access of medicines especially in
rural communities where the majorities (85%) of Ugandans live.
Findings from this study will provide information to policy makers for further planning and
designing of appropriate intervention strategies to ensure that medicines are handled
appropriately by duly qualified health professionals and ultimately improve medicines use and
medicines use outcomes in Uganda.
1.4 Study Objectives
The general objective of this study was:
To assess the adherence of medical clinics in Uganda to the standards of good pharmacy practice
related to dispensing, storage and stock management of medicines
Specifically, this study set out to:
Assess the level of adherence of private medical clinics to the standards of good
pharmacy practice related to dispensing, storage and stock management of medicine.
Document the reasons for dispensing of medicines by dispensers in private health care
facilities.
studies reviewed had any relevance to good pharmacy practice in private medical facilities and
this provides further justification for this study.
Private health facilities usually have poor adherence to the standards of GPP: In Sri Lanka,
compliance to seven subsystems of good pharmacy practice was studied in 38 private pharmacies
using observation checklists. It was found that: storage of drugs, maintenance of cold chain,
dispensing and documentation were comprehensively substandard in both the rural and urban
districts (Wijesinghe and Senevirante, 2006).
Significant differences have been observed in the compliance to specific aspects of GPP in public
and private pharmacies. A cross sectional study which involved 105 drug sellers in both public
and private pharmacies in Lao PDR found that public pharmacies had lower mean scores for
availability of medicines and essential materials, and a higher percentage of antibiotics
dispensed, however, overall both public and private pharmacies performed sub optimally in
relation to various aspects of good pharmacy practice and rational drug use (Syhakang et al,
2001).
A small number of studies have used a limited number of indicators to assess specific topics
around pharmacy practice (Gokecus et al, 2012, Boonstra et al, 2003, Syhakang et al, 2001) these
will be discussed in detail under the relevant sub themes:
Medicines dispensing
Dispensing refers to the process of preparing and supplying medicine to a given person on the
basis of a prescription. It involves the correct interpretation of the prescription, and accurate
preparation and labeling of medicine for use by the patient (MSH, 2011).
The dispensing process is often assumed to be simple and routine yet it represents the final
interface between the patient and health care system. It provides a one last window of
opportunity within which proper medicine use can be encouraged and reinforced.
Public and private health facilities usually show significant differences in their dispensing
practices: several studies have shown that dispensing practices are worse in public facilities as
compared to private health facilities. A cross sectional study carried out in 30 public health
facilities in Pakistan demonstrated that dispensing time was only 38 seconds(Hafeez et al, 2004)
9
while in rural public health facilities in Bangladesh it was 23 seconds. The corresponding
dispensing time in private pharmacies in Northern turkey was 149 seconds (Gokeckus, 2012).
The dispensing behavior is influenced by many factors, i.e. training and knowledge, professional
compensation, communication skills, dispenser-prescriber relationships, social status of a
dispenser in the healthcare system, public versus private sector, promotional/ marketing
techniques and availability of supply.
Boonstraet al, 2003 found that the quality of dispensing as evidenced by patient knowledge was
optimal in less than 50% of the cases in clinics and health posts in Botswana. This study
concluded that the qualification of the dispenser was the strongest predictor of patient knowledge
about medicines dispensed and that it was only trained dispensers achieved a satisfactory
dispensing quality.
Medicines stock management/ stock control
The ultimate goal of a stock management/ inventory management system is to ensure that the
right drugs are kept in the right quantities and are available at the right time (MSH, 2011)
therefore; availability of the right quantity and quality of drugs is one of the main indicators of a
well managed inventory system.
Availability of medicines is usually higher in the private sector compared to the public sector: In
Sudan, Elamin et al, 2010 carried out a cross sectional survey that demonstrated that availability
of medicines was higher in private pharmacies (93.0%) compared to public pharmacies (80.6%).
In Uganda, the private sector was found to have a higher availability of essential drugs and a
lower stock out duration for those drugs as compared to the public sector (MOH, 2008).
Several factors have been found to affect availability of drugs in health facilities: In Malawi
medicine availability at community health facilities was directly dependent on availability of
medicines at resupply points while in Rwanda and Ethiopia it was affected by availability of
appropriate transportation and supply chain knowledge among the community health workers
and their supervisors (Chandani et al, 2012).
Stock records are the core records in a good inventory management system: they are the primary
source of information for calculating reorder levels and they also provide a system of
10
accountability for medicines (MSH, 2011). Several studies have shown that there is a very low
availability of stock records in most developing countries: In Ethiopia and Rwanda, only 4% of
the facilities surveyed had stock records (Chandani et al, 2012) while in Sudan stock records
were found only at the central medicine stores, no stock records were found in either public or
private pharmacies (Elamin et al, 2010).
In Uganda, the public and private not for profit health facilities show a more favorable outcome
compared to the private for profit: the pharmaceutical sector assessment demonstrated that Public
and mission health facilities had stock records in about three quarters of the facilities surveyed
(MOH, 2009).
Medicines storage
Proper storage practices for medicines and other health supplies are vital for ensuring that their
quality is maintained until expiration (MSH, 2011).
Studies on availability and adequacy of storage facilities in private health care settings in
developing countries were quite few; therefore this section will review studies that evaluated
storage practices mostly in public health care settings.
A cross sectional study of 60 public health facilities in two districts of Uganda showed that
adequacy of storage conditions was poor in the health facilities surveyed: majority of the
facilities did not have cold storage facilities, there was evidence of pests in the storage areas and
they did not store their medicines systematically (HEPS, 2012).
In developing countries, storage facilities are usually more appropriate and adequate in the
public sector as compared to the private sector: A level II pharmaceutical sector assessment done
in Ghana using WHO indicators demonstrated that storage conditions were adequate in 80% of
all the public facilities surveyed , the corresponding figure for private drug outlets (pharmacies)
was 60% (Kojo, 2009).
Implications of inappropriate medicine storage practices
Medicines save lives and prevent disease only if they are safe, efficacious and of good quality.
11
Poor storage conditions and practices generally enhance chemical degradation and may alter the
biopharmaceutical properties of most drugs thus rendering them ineffective (Kayumba et al,1995
and Ballereau et al, 1997). Okeke and Lamikanra, 1995 demonstrated this using a cross sectional
study that evaluated the quality of tetracycline capsules in Nigeria.
12
Private medical clinics which had been duly licensed for operation in the districts of
13
14
Ten patient exit interviews were conducted to assess patient knowledge of the medicines and also
to assess whether the packaging and labelling of medicines was done appropriately. Only 10
patients were included per facility so that the study can be feasible within the time available for
carrying out research for a postgraduate degree. Where less than ten patients were seen at the
clinic then the principal investigator had to go back the next day and interview more patients.
The sampling strategy employed was a multi stage process with districts being purposively
selected at the first stage and health facilities randomly sampled at the second stage.
3.4 Study Variables
The indicators used herein are adopted from Trap 2010s a new indicator based tool for
assessing and reporting on Good pharmacy practice. These indicators assess five specific
components on Good Pharmacy Practice including system, storage, service, dispensing and
finally use. However this study limited itself to the indicators related to storage management,
stock management and dispensing.
The dispensing indicators included: average dispensing time, percentage of patients with
appropriate knowledge about dispensed drugs (including dose, frequency and side effects
of their medicines), percentage of appropriately packaged drugs ( where appropriately
packaged means that medicines are in a clean sealed container/envelope), percentage of
facilities with appropriate dispensing equipment available (tablet tray and spatula for
tablets and measuring cylinder for liquids) and percentage of dispensed drugs that are
adequately labeled (where adequately labeled means that medicines are in a sealed
container/envelope with name, dose per time and number of times a day well indicated)
The storage indicators included: Percentage of facilities with acceptable clean stores
(acceptable defined as clean storage areas without the accumulation of waste and
vermin.), Percentage of facilities with an appropriate system for storage of medicines
(appropriate defined as medicines stored on shelves in alphabetical manner, in therapeutic
categories or on a basis of first in first out), Percentage of facilities with acceptable
storage conditions (acceptable defined as clean and dry and maintained within acceptable
temperature limits. Where special storage conditions are required on the label (e.g.
temperature, relative humidity), these should be provided), Percentage of facilities with
15
acceptable storage practices (acceptable encompasses storage of products off the floor,
away from direct atmospheric conditions).
The stock management indicators included: Percentage of facilities with stock card
available for a basket of medicines, percentage availability for a basket of tracer drugs
and Percentage of facilities with stock cards accurate for a basket of medicines (accurate
defined as stock card balance equals physical count.
Also considered as a core indicator in this study is the percentage of the surveyed
facilities where dispensing of medicines is done. This information was collected to
determine the prevalence of dispensing of medicines in the clinics.
patient presented to the dispensing window, paused during packing of the medicines and started
when the dispenser is explaining to the patient how to take the medicine. The average dispensing
time was then computed for each facility. The data was entered using Epi data software version
3.1.
3.6 Study Tools
The data collection tool used for this study was a semi structured questionnaire that included
multiple response questions, open ended questions and also observation checklists to evaluate
storage and stock management indicators.
The questionnaire was interviewer administered to ensure complete and accurate data collection.
At the health facility: the questionnaire was administered to the dispensing health worker. The
questionnaire was pre tested on five private medical facilities.
3.7 Data Management and Analysis
All the data was checked for completeness, sorted and entered into the computer using
appropriate software packages. The raw data was securely stored to maintain confidentiality.
Data analysis was done using the Statistical package for social sciences (SPSS) software
version 21 for windows. Under univariate analysis :categorical variables like Education, sex,
professional qualifications, appropriate dispensing equipment, appropriate storage conditions,
appropriate packaging materials and ownership were summarized using frequency distributions,
proportions and graphs. Numerical variables like age of the dispenser, opening hours of the
facility, average dispensing time were summarized using means and standard deviations.
3.8 Quality Control
Quality assurance of the data collected was achieved by training of the principal investigator, pre
testing of data collection tools and lastly double entry of data. The principal investigator carried
out the data collection by herself to ensure uniformity of the data.
3.9 Ethical Considerations
Approval to do the research was sought from the Institutional Review Board of the school of
Health Sciences.
17
Informed consent was obtained from all the participants before they were recruited into the
study.
The names of private health care facilities and the study participants were kept anonymous and
any other personal information obtained was kept confidential.
18
Value
Dental
18 (30%)
10 (16.7%)
Paediatrics
12 (20%)
Maternity
Laboratory
Opening hours, n (%)
9 (15%)
50 (83.3%)
0 - 8hours
1(1.7%)
9 16hours
41 (68.3%)
17 24hours
Years of operation, median (min, max)
Patient load per day, median (min, max)
Distance to nearest pharmacy in metres, median (min, max)
18 (30%)
5 (1, 27)
15 (4, 20)
200 (10, 2000)
Variable, measure
Professional designation of clinic owners, n (%)
Value
19
Medical doctor
28 (46.7%)
Clinical officer
16 (26.7%)
Nurse
7 (11.7%)
Midwife
4 (6.7%)
Others
5 (8.3%)
6 (1, 16)
12 (20%)
15 (25%)
Graduate doctor/nurse
25 (41.7%)
Postgraduate training
Presence of dispensing guidelines, n (%)
8 (13.3%)
3 (5%)
Table 1 above presents a summary of the characteristics of the sixty medical clinics surveyed.
The vast majorities had a laboratory, were open for more than 9 hours but less than 16 hours, and
had been operating for about 5 years. Almost half of the clinics were owned by medical doctors
and these were the most frequent prescribers found. However, only 5% of the clinics had
dispensing guidelines.
20
Values
25 (19, 63)
3 (1, 37)
Male
19 (31.7)
Female
41 (68.3)
Qualification, n (%)
Certificate in health related course
49 (81.7)
7 (11.7)
Graduate doctor/nurse
3 (5.0)
Paramedical qualification
Position of responsibility, n (%)*
1 (1.7)
Prescriber
20 (33.0)
Administrator/manager
6 (10.0)
Owner
4 (6.7)
Others
Knowledge of appropriate labeling information, n (%)*
4 (6.7)
Dosing Frequency
52 (86.7)
Drug name
51 (85.0)
Duration of therapy
9 (15.0)
Strength of drug
7 (11.7)
Patient name
4 (6.7)
Others
* Multiple responses possible
13 (21.7)
Majority of the dispensers interviewed were female, had a working experience of about 3years
and were 25 years of age. Table 2 above presents a summary of the background characteristics of
the dispensers interviewed and it shows that more than three quarters of them had certificate
level training.
21
4.3 Adherence of private medical clinics in Uganda to the standards of good pharmacy
practice
An assessment of good pharmacy practice in the private medical clinics involved assessing three
aspects: dispensing, storage and stock management in the medical clinics. The indicators used
therein attempt to measure three elements of good pharmacy practice which include: supply and
use of medicines, self care and influencing prescribing and dispensing.
4.3.1 Dispensing Indicators of the Surveyed Clinics
Table 3: Dispensing indicators of the clinics surveyed
Indicator
Appropriate packaging material available
Spatula/spoon available
Tablet counting tray available
Tablets not counted by bare hands
Dispensing equipment cleaned before use
Chairs/Bench in waiting area
Privacy during dispensing
Hand washing facilities available
Drinking water available
Clean cups available for use
Dispensing log available and in use
n (%)
58 (96.7)
42 (70.0)
33(55.0)
35 (58.3)
17 (28.3)
55 (93.3)
31 (51.7)
41 (68.3)
32 (53.3)
31 (51.7)
32 (53.3)
Table 3 above presents a summary of the dispensing indicators in the surveyed clinics. Almost
all the clinics had appropriate packaging materials (96.7%) for the dispensed medicines and
chairs or benches (93.3%) at the waiting area. Although majority of the clinics had dispensing
equipment available (70% had a spatula/spoon), only about a quarter of them (28.3%) reported
that they clean their dispensing equipment before use.
Findings from the observations of the dispensing process in the private medical clinics
Table 4: Mean dispensing time (seconds) by district
District
Kampala
Lira
Mbarara
Overall
Mean
42.3
15.3
20.3
30.5
Standard deviation
21.0
10.3
15.2
21.3
22
From table 4 above: the measured overall mean dispensing time for the surveyed clinics was 30.5
seconds (SD 21.3). Kampala district had the highest mean dispensing time of 42.29 seconds
while Lira had the shortest mean dispensing time.
Patient knowledge of dispensed medicines
Table 5: Patient knowledge on medicines that they had received:
Aspect
Dose/how much to take
Frequency/when to take
Duration/how long to take
Patient knows why hes taking the medicine
Knowledge of all medicine administration instructions
n (%)
520 (92.0)
456 (76.0)
229 (38.1)
263 (43.8)
105 (17.5)
Table 5 above shows that majority of the patients effectively recalled the dose and frequency of
the medicines that they had received. Only17.5% of all the patients had adequate knowledge of
all the medicine administration instructions given.
Medicine Labeling
Table 6: Patients whose medicines were appropriately labeled
Aspect
Dose
Medicine name
Strength
Quantity
Date
Patient name
Number (n)
456
454
57
34
0
0
Percentage (%)
76.0
75.7
9.5
5.7
0
0
23
Table 6 above shows that majority of patients (76%) received medicine packs that were labeled
with name and dose; however, none received medicine packs labeled with the date and patient
name.
4.3.2 Storage Indicators of the Surveyed Clinics
Table 7: Storage indicators for the surveyed clinics
Aspect
Number (n)
Medicines stored only on shelves
57
Medicines stored in a systematic manner (either 46
Percentage (%)
95.0
76.7
45
3
7
25
57
57
75.0
5.0
11.7
41.7
95.0
95.0
14
23.3
seen
Functioning system for cold storage
* FEFO means First to Expire First Out
Table 7 presents an assessment of the storage practices of the medicines in the medical clinics in
relation to nine indicators. Most of the surveyed clinics (70% or more) had acceptable storage
conditions for five out of the nine indicators which included medicines stored only on shelves, in
a systematic manner, and protected from direct sunlight.
It was hard to determine whether FEFO was adhered to in most clinics as most clinics kept low
stock quantities, however, only 41.7% of the assessed clinics showed adherence to storing drugs
in such a way that those that had shorter expiry periods would be dispensed first. No expired
drugs were found on the shelves in any of the medical clinics surveyed.
4.3.3 Stock Management Indicators
This component of good pharmacy practice was assessed using 4 indicators: percentage of
facilities that had a stock card available and correctly filled, percentage of facilities that had a
computerized stock management system, percentage of facilities that had the computerized stock
management system capturing key information and percentage availability of a list of tracer
medicines.
24
Percentage(%)
0
5.0
management system
Computerized
1.7
system 1
Table 8 shows that only 5% of the clinics had a computerized stock management system while
none of the clinics kept stock cards as a stock control tool.
Table 9: Availability of tracer medicines in medical clinics on the day of the survey
Medicine
Artemether and lumefantrine
Number of clinics
47
Percentage
78.3
20/120mg
Sulphadoxine and
40
66.7
Trimethoprim
Oral rehydration salts
Zinc sulphate tablets
Amoxicillin, 250mg
Cotrimoxazole, 480mg
Albendazole 200mg
Benzyl penicillin
43
37
56
54
42
38
71.7
61.7
93.3
90
70
63.3
Table 9 presents the percentage availability of the tracer medicines in the clinics: the most
commonly available medicines were Amoxicillin 250 mg and Cotrimoxazole 480mg tablets: all
the medicines assessed were available in more than 60% of the clinics.
4.4 Prevalence of medicines dispensing in private medical clinics in Uganda
25
For this study: a clinic was categorized as a dispensing facility if it dispenses medicines to
patients regardless of the quantities involved in addition to all the services that it provides to the
patients.
All the surveyed clinics reported that they dispensed medicines to their patients and therefore the
prevalence of medicines dispensing was found to be 100%.
4.5 Reasons for medicines dispensing in the private medical clinics
The reasons why private medical clinics held stock/dispensed medicines to their patients were
quite varied but belonged to one or more of the following themes:
dont have the medicines that were prescribed without first consulting us. So the patient fails to
respond to the treatment and they come back and tell you that doctor the medicine you asked
me to take did not work and when you inquire further you find that they were given something
totally different from what you prescribed.
Medicines are an essential component of medical care
Some responses were in agreement with the opinion that medicines constitute a very important
component of medical care. In fact for most of the dispensers interviewed: medical care came
down to dispensing/administering of medications to the patients. Responses to this effect
included: we give our patients medicine because it is part of treatment and how else can we
treat our patients without giving them medicine?
Financial incentives
Some respondents implied that they dispensed medicines to their patients because of the
financial rewards associated with it.
Two of the respondents interviewed said that they dispensed medicines to their patients because
they had to stave off competition from other dispensing clinics. A registered nurse who was a
clinic owner/prescriber and dispenser in Mbarara district put it like this: I keep medicines that I
dispense to my patients because if I dont have them then they will go and get them from other
clinics. If I want to compete favorably with other clinics then I definitely have to dispense
medicines to my patients.
Other reasons for dispensing of medicines in private medical clinics included: because they have
been prescribed by the prescriber, for emergency situations and because that is the business
policy. Interesting to note is the fact that none of the respondents said they dispensed medicines
because there was no nearby pharmacy or drug shop.
27
28
pharmacy practices in the private medical clinics and not to explore the factors responsible for
them; these could be taken on by a follow on study.
29
This study has shown that corrective action is urgently required in the areas of: cadre of staff that
should be allowed to participate in medicines management in private medical clinics, dispensing
practices, storage practices and stock management practices in the private medical clinics.
Nursing assistants were most frequently found to be in charge of storage (61.7%) and dispensing
of medicines in private medical clinics (60%). This is in agreement with the findings from a
cross sectional study on 360 private health care facilities in Uganda that also found that nursing
assistants were employed in 60% of all the private health care facilities surveyed (Mandelli et al,
2005). Given the fact that this cadre of staff has been phased out in public health facilities
(Ministry of Public Service, 2012) and that the level of training they receive does not equip them
with the prerequisite knowledge and skills to effectively manage medicines, this poses a great
risk to the patients that receive medicines and medication related advice from them. This view
was also demonstrated by a study carried out in Botswana that revealed that only qualified and
well trained dispensing staff provided adequate patient medication information which was
reflected as adequate patient medication knowledge (Boonstra et al, 2003).
The prevalence of dispensing in private medical clinics was found to be 100%, therefore,
prescribers in private medical clinics sold medicines in their own clinics in all the clinics that
were surveyed: this mirrors results from a retrospective study carried out on data from a national
health survey which found that private providers sold medicines in their own clinics in about
95% of the cases (Nguyen, 2011) in Vietnam. This finding demonstrates a probable laxity in the
enforcement of regulations in Uganda given the fact that the regulations (Uganda Medical and
Dental practitioners act, 1996) ban private providers from retailing of medicines in their own
practices. In 33% of the cases the dispenser and prescriber was the same person denoting a lack
of separation of functions which might result into conflict of interest including selling drugs with
a profit incentive.
Reasons for dispensing of medicines by private medical clinics
Most respondents said they dispensed medicines in their own clinics to provide a comprehensive
service to their patients and to be able to compete favorably with other clinics. This implies quite
a number of things: that the health workers in these clinics are ignorant about the regulations,
that they know the regulations wont be enforced but then again the desire to compete
30
favorably may mean that there is a profit motive behind the need to dispense medicines/ keep
medicines as stock items. Trap et al, 2002 found that private health providers who were licensed
to dispense medicines to their patients prescribed a higher average number of drugs per patient
encounter and were more likely to have patient encounters with injections as compared to their
counterparts that were not allowed to dispense medicines. This principal-agent problem in
private health care has been further confirmed by Nguyen, 2011 who demonstrated that private
providers prescribed more drugs and injections unnecessarily in order to increase their revenue.
The need to ensure that patients get the right medication came out as a strong case for medicines
dispensing in private medical clinics. This could facilitate patient compliance and improve
rational use of medicines however I did not find any studies that have demonstrated improved
patient compliance due to medicines being dispensed in private health clinics.
Dispensing practices in private medical clinics
Good dispensing practices ensure that an effective form of the correct medicine is delivered to
the right patient in the correct dosage and quantity, with clear instructions, and in a package that
maintains the potency of the medicine (MSH, 2011).
An analysis of the dispensing indicators of the private medical clinics revealed that dispensing
time was extremely short, just about half a minute, almost half of the clinics did not have
dispensing equipment, even fewer clinics cleaned the equipment before use, patients had
inadequate knowledge about the medicines that they received and medicine labeling was
extremely poor.
Provision of adequate medication counseling takes time, and therefore the measured average
dispensing time of 30 seconds is considered inadequate for provision of medicine information.
The dispensing time was highest in Kampala (42.29s) possibly because the patients received
more drugs per prescription compared to those in Lira and Mbarara. A study in public health
facilities in Pakistan (Hafeez et al, 2004) showed that the average dispensing time was about 38
seconds while that in UK is 15 minutes. This short dispensing time in the three districts surveyed
maybe the reason why patient knowledge about medicines supplied is also poor.
31
Almost half of all the private clinics surveyed did not have dispensing equipment, and slightly
more than a quarter cleaned the dispensing equipment before use. The risk of cross
contamination of medicines therefore is very high. This would be fatal in cases where a patient
receives medicine that was contaminated with another medicine to which he is sensitive.
Less than half of all the patients interviewed effectively recalled the reason (43.8%) for taking
their medicines and the length of the duration (38.1%) for which to take their medicines. These
findings agree with the findings from Botswana where duration of treatment was recalled by less
than half of all the patients interviewed (44%). Adequate patient knowledge of medicines
supplied is one of the important prerequisites for patient compliance. Therefore correct use of
medicines maybe compromised by inadequate patient knowledge. Boonstra et al, 2003 showed
that one of the strongest factors associated with patient knowledge was qualification of dispenser
and prescriber, however, this study did prove that as it was purely a descriptive study.
Storage practices of private medical clinics
This study has demonstrated that storage practices of most medical clinics were considered
appropriate in as far as: storage space, storage on shelves and protection from atmospheric
conditions was concerned. Of grave concern though, was the: lack of a system for recording
expired drugs, lack of a designated area to store expired drugs and lack of a cold chain system in
most of the clinics. These findings may partly be due to the fact that the stock quantities kept are
very low in majority of the clinics and therefore expiry of drugs is not a salient issue in these
private medical clinics but they might also denote ignorance by the dispensers about the need to
track and record expiries of medicines. Katabaazi et al, 2010 found that one of the main
contributing factors to expired drugs in health facilities is the lack of a stock control system and
lack of knowledge about basic expiry prevention tools. Therefore there is a high chance that
expired drugs will be dispensed to the patients.
Stock management practices
This study showed that stock management practices in private medical clinics were extremely
poor. None of the clinics used a stock card as a stock control tool while only 3% had a
computerized system of stock management. Trap et al, 2010 found that only 6% of private sector
facilities had either a computerized or manual stock management system in Uganda. These
32
findings mirror the situation in Sudan where there was neither a manual nor a computerized
stock management system in both the public and private sector (Elamin et al, 2010).
Stock records are the primary source of information for reordering formulae and they can also
be used to make performance reports(managing drug supply,2011), absence of stock records
therefore might lead to inaccurate quantification of medicines with the result that there will be
either too much stock (that results into expiries) or too little stock (that will not provide an
adequate service level to the clients, however, availability of medicines was generally found to
be good: all the drugs on the tracer list were found to be available in 60% or more of the clinics
sampled.
5.3 Limitations
The main limitation of this study was the risk of observer effect/hawthorne effect. The
respondents could have demonstrated a more favorable outcome because they knew that they
were being observed. This was overcome by assuring the study participants that the research was
for academic purposes only and that it was not for law enforcement. This ensured that their
behavior remained as close to normal as was practically possible.
Six of the clinics on the list of level II clinics had upgraded to health centre IV status by the time
that the study was carried out. This was overcome by replacing them with other facilities that
were randomly selected.
The districts of Lira and Mbarara did not have a well structured list of private health clinics. The
principal investigator had to create one by getting lists from the different professional councils
and thereafter create a simple random sample.
There were very few patients for exit interviews at some clinics. Where less than 10 patients
were seen the principal investigator had to go back to the facility the next day to make the
number up to ten.
33
therefore requires urgent corrective action to ensure that the maximum benefits are achieved
from the medicines used in the private for profit sector.
6.2 Recommendations
Standards should be set on the minimum cadre of health workers that are allowed to
provide pharmaceutical services in private medical clinics.
The pharmaceutical services expected to be provided by private medical clinics need to
be clearly defined by the relevant stakeholders.
There is need to develop and implement a system for carrying out GPP inspections in
private medical clinics for the purpose of licensure of facilities that can provide a
satisfactory pharmaceutical service by the National Drug Authority. The licensing system
needs to put in place a procedure for delicensing those private medical clinics that
dont meet certain standards.
All health workers/dispensers in private medical clinics need to receive basic training
appropriate to the level of pharmaceutical service that they are expected to provide.
Specific issues that should be addressed include: basic pharmacology and appropriate
medicines use.
Regular and frequent supportive supervision should be provided to dispensers in private
medical clinics to uphold the standards of practice.
The government needs to allocate resources for training of more pharmacists and
pharmacy technicians in order to mitigate the shortage of adequately qualified staff both
the private and public sectors.
National guidelines for GPP for the different health care settings should be developed and
implemented by the relevant stakeholders.
Further research is needed to assess the effectiveness of regulatory action as well as to
define the most appropriate order of implementing the interventions.
For these recommendations to work there are key success factors that need to be considered:
Political will: the government of Uganda needs to be convinced of the need and value
of a quality pharmaceutical service in contributing to the overall health of the
population in order for it to allocate more funds to the training of pharmacists and
pharmacy technicians.
The public should be educated and empowered about the quality of pharmaceutical
services they should demand from all healthcare facilities.
35
36
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American
Journal
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and
medicine,retrieved
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2012
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Birna T, Ebba H H, and Hans V Horgezeil (2002), Prescription habits of dispensing and non
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Birna T, Hansen EH, Trap R, Kahsay A, Simoyi T, Oteba MO, Remedios V, Everard M (2010),
A new indicator based tool for assessing and reporting on good pharmacy practice,
Southern Med Review 3(2), 4-11.
Bonnie S, Wilkie P, Raftery J, Anderson S, Freeling P(1992),Prescribing at the hospital-general
practice interface. II: Impact of hospital outpatient dispensing policies in England on general
practitioners and hospital consultants, British Medical Journal; 304: 31 -34
Boonstra E, Lindbaek M, Ngome E, Tshukudu K, Fugelli P(2003), Labeling and patient
knowledge as quality indicators in primary care in Botswana, Quality Safety Health care
Journal; 12: 168 175.
College of Respiratory therapists of Ontario (2006), Dispensing medications, Professional
practice guidelines.
37
Daniel Kojo (2009), WHO pharmaceutical situation assessment - level II Health facilities survey
in Ghana. Ministry of Health Ghana
Dejan Z, Tibenderana K J, Nankabirwa J, Ssekitooleko J, Njogu J N, Rwakimari J Bet al (2004),
Malaria case-management under artemether-lumefantrine treatment policy in Uganda, Malaria
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Donald Macarthur, 2007, European pharmaceutical distribution: Key players, challenges and
future
strategies.
Informa
UK
ltd,
retrieved
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at:
www.scripintelligence.com/multimedia/archive/.../BS1353_124a.pdf
Elamin E I, Izham M, IbrahimM ,Mirghani A E Y ( 2010),Availability of Essential Medicines in
Sudan, Sudanese Journal of Public Health, 5, 32 - 37.
Hafeez A, Kiani A G, Din S U and Muhammad W(2004), Prescription and dispensing practices
in public sector health facilities in Pakistan: Survey report, JPMA, 54, 187 -189.
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Peterson G M, Wu M S H and Bergin J G(1999), Pharmacists attitudes towards dispensing
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health care in rural areas of Uganda,BMC international Health and human rights.
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40
APPENDICES
Appendix 1: Patient Consent Form
Title of the study: Assessment of the level of adherence of medical clinics in Uganda to the
standards of good pharmacy practice
Purpose of the study: the study is intended to assess the level of adherence of medical clinics in
Uganda to the standards of good pharmacy practice specifically related to dispensing, storage
and stock management.
I am requesting you take part in this study.
Study procedure: You will be asked some questions regarding identity, duration and dosage of
the medicine you are taking.
Confidentiality: the information collected will only be used for research purposes. The forms
will only have a number and will be stored securely with the principal investigator. Your name
will not appear anywhere on the questionnaires or even in the final report.
Benefits: There are no immediate benefits to you but important recommendations from this
study will be communicated to the Ministry of Health and all the other relevant stakeholders and
will be used to generate and implement policies which will contribute to rational use of drugs in
Uganda.
Risks: There are no major risks to you as you are only going to be asked to answer a few
questions.
Your rights: you are free to decline to participate in this study, or withdraw from it anytime and
this will not affect how you will be managed as a patient at this medical facility.
Statement of consent:
I have fully understood the purpose and nature of this study and hereby voluntarily choose to
participate as signed below:
..............................................................
41
Name of client
.............................................................
Signature/ thumbprint
...........................................................
Name of investigator
............................................................
Signature
42
omu
nkoresa ehikire yemibazi omu Uganda, ahabwokwenda kuhikiiriza enkoresa yemibazi enungi.
Ekigyenderwa
kyokucondooza:
Okucondooza
oku,
kugyendereire
kushwijuma
oku
amarwariro garikukuratira enkoresa ehikire yemibazi omu Uganda, namunonga omu kugigaba,
okugibiika gye, hamwe nokugireeberera kurungi ahi ebiikire.
Ninkushaba ngu oikirize kwetaba omu kucondooza oku.
Entwaza
yokucondooza:
Noija
kubuuzibwa
ebibuuzo
ebikwatiraine
na
byona
ebirikukukwataho, obwire obu omazire orikukoresa omubazi hamwe nekipimo kyagwo eki
orikumira.
Okukuuma enaama: Ebi oraagarukyemu nibiija kwejunisibwa omu kucondooza kwonka.
Foomu egi neija kuba eriho enamba yonka, kandi omuntu orikucondooza neija kugibiika gye.
Eiziina ryawe tiririkwija kugira ahi ryahandiikwa hoona, nangwa naha ripoota eyahamuheru
tiririkwija kuteibwaho.
Ebirungi ebiraarugyemu: Tihariho birungi bingi ebyahonaaho ebi oraatungye kuruga omu
kucondooza
oku,
okwihaho
ebishemereire
kukorwa
ebikuru
ebiragambweho
nibiija
44
45
.............................................................................................................
Nying akwan
.............................................................................................................
Dwallo cing/Capa Atwon Cingi
.............................................................................................................
Nying apeny peny
.............................................................................................................
Cinge Odwalo
46
47
I have fully understood the purpose and nature of this study and hereby voluntarily choose to
participate as signed below:
..............................................................
Name
.............................................................
Signature/ thumbprint
...........................................................
Name of investigator
............................................................
Signature
48
Week
days
We
Week
ends
0 to 8hrs
9 to 16
hrs
17 to
24hrs
.
.
12. Do you a dispensary A. YES
within this medical clinic?
B. NO
A. Medical doctor......................................
B. Clinical officer.......................................
C. Nurse...................................................
D. Midwife................................................
E. Pharmacy technician.............................
F. Pharmacist...........................................
G. Others ( specify)..................................
.
.
.
14.Type of ownership
SINGL
E
PARTN
ERSHI
P
15.
List
the
number
of
health
care
Medical doctor.....................................
50
Clinical officer.......................................
Nurse...................................................
Midwife...............................................
Pharmacy technician............................
Pharmacist.........................................
Laboratory
technician..
Others ( specify)..................................
..................................
people
prescribe medicines
in
this
medical
E. others specify..........................................
professional
designations in
..
question 15 above,
orders
person responsible
for performing the
following functions
related to medicines
management?
B. clinic administrator
C. Dispenser..
D. prescriber..
E. other ( specify).
19. Age
20. Gender
Male
MALE
Female
FEMAL
E
21. Nationality
22. Qualification
Do
you
dispense Yes
YES
52
No
NO
25. Why do you dispense A.
Because
they
have
been
prescribed
by
the
convenience,
expectations)?
26.
Do
you
have
guidelines
for
good
YES
NO
to see them
27.
What
information
be
included on a medicine
B. Drug name..
D. Dosing frequency.
E. duration of therapy
F. others (specify)
Average
in
seconds
29. Packaging Material
Observe and verify the packaging material available and in use (Yes=1/No=0)
1/0
a) Are appropriate dispensing envelopes available?
b) Are appropriate clean containers i.e. bottles made specifically for
the purpose of dispensing liquids and bottles that are not reused
available?
30. Dispensing equipment
Verify that the dispensary has the following equipment in the dispensing area (Yes=1/No=0)
Equipment
a) A spatula or spoon
b) Tablet counting tray or similar
c) Tablets not counted by bare hands
d) Graduated measuring cylinder
e) Are the equipment for counting/measuring cleaned before use?
1/0
54
Interview 10 patients and ask to see the medicines they have received and if possible their
prescription. Select one of the medicines to check patient knowledge of the following areas:
(Yes=1/ No=0)
Dose/
Patie
How
nt no. much
to take
is
getting
the
treatment
to take
1
2
3
4
5
6
7
8
9
10
33. Labelling of dispensed medicines
Interview 10 patients and ask to see the medicines they have received. Select one and check for
labelling (Y=1/ N=0)
Medicine no.
Medicine
Strength
Quantity
Date
Dose
Patient name
name*
1
2
3
4
5
6
7
8
9
10
PART C: STORAGE MANAGEMENT
Yes=1 No=0
55
in
cupboards
and
not
in
56
57
2
Sulphadoxime/pyrimetha
mine
3
ORS
4
Zinc sulphate
5
Amoxicillin, 250 mg
6
Cotrimoxazole, 480mg
Albendazole, 200mg
Benzyl
58
- 20/120 mg
Is the card filled correct with name, strength, dosage
Artemether/Lumefantrine
injection
penicillin
Check for 3 months
1
Unit pack
Name of medicine