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Pengantar:

Pengobatan Rasional
Rustamaji

Sleman, 10 April 2012


Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM
2012

Tujuan
Difinisi Pengobatan Rasional dan mengidentifikasi
besarnya masalah yang ditimbulkan

Memahami mengapa terjadi pengobatan yang


tidak rasional
Mendiskusikan strategi intervensi unutk
memperbaiki masalah
Mendiskusikan pedoman pengobatan

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Definisi
The rational use of drugs requires that patients
receive medications appropriate to their clinical
needs, in doses that meet their own individual
requirements for an adequate period of time, and
at the lowest cost to them and their community.
WHO conference of experts Nairobi 1985

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Ciri pengobatan rasional


Tepat dalam pemilihan obat
Obat digunakan sesuai indikasi
Obat memenuhi kriteria kemanfaatan klinkk, keamanan,
kecocokan dengan kondisi pasien, dan biaya
Tepat dosis, cara pemberian, dan lama terapi
Tidak ada kontraindikasi pada pasien
Pemberian obat yang tepat (termasuk informasi yang cukup agar
pasien dapat mengikuti program pengobatan dengan benar)

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Ketepatan dalam diagnosis

Pakistan
Bangladesh
Burkino Faso
Senegal
Angola
Tanzania
0

10

20

30

40

50

% observed consultations where the diagnostic process was adequate


Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

60

5-55% pasien di PHC menerima injeksi90% tidak perlu secara medis


Quick et al, 1997, Managing Drug Supply
Ghana
Cameroon
Nigeria
Sudan
Tanzania
Zimbabwe

Yemen
Indonesia
Nepal

15

juta injeksi/tahun secara global


50% tidak menggunakan jarum steril
2.3-4.7 juta infeksi hepatitis B/C dan
sekitar 160,000 infeksi HIV/tahun

Ecuador
Guatemala
El Salvador
Jamaica
Eastern Caribean

0%

10%

20%

30%

40%

% pasien di PHC yang mendapatkan injeksi


Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

50%

60%

Pola pemakaian antibiotika di 26


negara Eropa tahun 2002
35

DDD per 1000 inh. per day

30

25

20

15

10

0
FR GR LU PT IT

BE SK HR PL IS

IE ES FI BG CZ SI SE HU NO UK DK DE LV AT EE NL

Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.


Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

% Ketaan terhadap Pedoman Pengobatan


60
50
40
30
20
10
0
1982-1994

1995-2000

2001-2006

Sub-Saharan Africa (n=29-48)

Lat. America & Carrib (n=5-13)

Middle East & C. Asia (n=4-8)

East Asia & Pacific (n=7-11)

South Asia (n=6-12)


Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pola Pengobatan Diare Akut oleh Dokter,


Perawat, dan paramedis
80
70
60
50
40
30
20
10
0
% antibiotika

% antidiare

Public (n=54-90)

% larutan rehabilitasi oral

Private-for-profit (n=5-10)

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pola Pengobatan ISPA Berdasarkan Tenaga


80
70
60
50
40
30
20
10
0
% Antibiotika pada ISPA
viral
Dokterr (n=26-62)

% pneumonia yang
mendapatkan antibiotika

Perawat/paramedis (n=12-86)

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

% ISAP yang diobati


dengan sirup obat batuk
Staf Farmasif (n=9-17)

Penggunaan antimikroba dan


Pengaruhnya terhadap resistensi
WHO country data 2000-3

Malaria
choroquine resistance pada 81/92 negara
Tuberculosis
0-17 % multi-drug resistance primer
HIV/AIDS
0-25 % resistance primer (minimal 1 antiretroviral)
Gonorrhoea
5-98 % penisillin resistance terhadap N. gonorrhoeae
Pneumonia and bacterial meningitis
0-70 % penicillin resistance terhadap S. pneumoniae
Diarrhoea: shigellosis
10-90% ampisillin resistance, 5-95% cotrimoxazole resistance
Hospital infections
0-70% S. Aureus resistance terhadap seluruh penisillin &
cephalosporins

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Community surveillance Resistensi dan


Penggunaan antimikroba
Antimicrobial resistance
E.Coli patogen pada wanita hamil di India
Cotrim 46-65%; Ampi 52-85%; Cipro 32-59%; Cefalex 16-50%
S.Pneumoniae & H.influenzae sputum di afrika Selatan
Cotrim > 50% (both organisms); Ampi >70% (H.influenzae)

Penggunaan antibiotika
Sekitar 50% pasien di India dan <25% di AfrikaSelatan menerima
antibiotika
Penggunaan fluoroquinolones unutk common cold di India terutama di
sektor private

Motivasi provider dan konsumen


Permintaan pasien menganggap lebih cepat menyembuhkan
Tidak ada CME & takut kehilangan klien
Promosi obat yang tidak terkontrol dan alasan finasial
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Adverse drug events


White et al, Pharmacoeconomics, 1999,
15(5):445-458

Penyebab ke- 4-6 kematian di USA


Biaya yang dikeluarkan sekitar 30 ribu -130 juta US$
in the USA

4-6% kasus yang memerlukan perawatan di rumah


sakit di USA & Australia
Sering ditemukan, penyebab kasus yang
memerlukan biaya perawatan : pendarahan, cardiac
arrhythmia, gangguan jiwa, diare, demam, hipotensi,
itching, mual, rash, gangguan ginjal
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Upaya mengatasi masalah


1. EXAMINE
Measure Existing
Practices
(Descriptive
Quantitative Studies)
4. FOLLOW UP
Measure Changes
in Outcomes
(Quantitative and Qualitative
Evaluation)

improve
diagnosis

improve
intervention
3. TREAT
Design and Implement
Interventions
(Collect Data to
Measure Outcomes)

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

2. DIAGNOSE
Identify Specific
Problems and Causes
(In-depth Quantitative
and Qualitative Studies)

Banyak Faktor Yang Mempengaruhi


Penggunaan Obat
Information

Scientific
Information

Influence
of Drug
Industry

Habits
Social &
Cultural
Factors

Treatment
Choices

Workload &
Staffing

Workplace

Intrinsic

Prior
Knowledge

Infrastructure

Relationships
With Peers

Societal
Economic &
Legal Factors

Authority &
Supervision

Workgroup

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Strategi untuk memperbaiki


Educational:
Inform or persuade
Health providers
Consumers

Managerial:
Guide clinical practice
Information systems/STGs
Drug supply / lab capacity

Use of
Medicines
Economic:
Offer incentives
Institutions
Providers and patients

Regulatory:
Restrict choices
Market or practice controls
Enforcement

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Educational Strategies
Goal: to inform or persuade
Training for Providers

Undergraduate education
Continuing in-service medical education (seminars, workshops)
Face-to-face persuasive outreach e.g. academic detailing
Clinical supervision or consultation

Printed Materials
Clinical literature and newsletters
Formularies or therapeutics manuals
Persuasive print materials

Media-Based Approaches
Posters
Audio tapes, plays
Radio, television
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Impact of Patient-Provider Discussion Groups


on Injection Use in Indonesian PHC Facilities
Source: Hadiyono et al, SSM, 1996, 42:1185
% Prescribing Injections
80

60
Pre
Post

40

20

0
Intervention

Control

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Training for prescribers


The Guide to Good Prescribing

WHO has produced a Guide for Good


Prescribing - a problem-based method
Developed by Groningen University in
collaboration with 15 WHO offices and
professionals from 30 countries
Field tested in 7 sites
Suitable for medical students, post grads,
and nurses

widely translated and available on the WHO


medicines website
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Managerial strategies
Goal: to structure or guide decisions
Changes in selection, procurement, distribution to
ensure availability of essential drugs
Essential Drug Lists, morbidity-based quantification, kit systems

Strategies aimed at prescribers


targeted face-to-face supervision with audit, peer group
monitoring, structured order forms, evidence-based standard
treatment guidelines

Dispensing strategies
course of treatment packaging, labelling, generic substitution

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

RCT in Uganda of the effects of STGs, training and


supervision on % of Px conforming to guidelines
Source: Kafuko et al, UNICEF, 1996.

Randomised
group

No. health
PrePostfacilities intervention intervention

Change

Control group

42

24.8%

29.9%

+5.1%

Dissemination of
guidelines

42

24.8%

32.3%

+7.5%

Guidelines + onsite training

29

24.0%

52.0%

+28.0%

14

21.4%

55.2%

+33.8%

Guidelines + onsite training + 4


supervisory visits

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Economic strategies:
Goal: to offer incentives to providers an consumers

Avoid perverse financial incentives


prescribers salaries from drug sales
insurance policies that reimburse non-essential
drugs or incorrect doses
flat prescription fees that encourage
polypharmacy by charging the same amount
irrespective of number of drug items or quantity
of each item

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pre-post with control study of an economic


intervention (user fees) on prescribing quality in Nepal
Holloway, Gautam & Reeves, HPP, 2001

Fees (complete
drug courses)

control fee / Px 1-band item fee 2-band item fee


n=12
n=10
n=11

Av. no. items


per prescription

2.9 2.9
(+/- 0)

2.9 2.0
(-0.9)

2.8 2.2
(-0.6)

% prescriptions
conforming to
STGs

23.5 26.3
(+2.7%)

31.5 45.0
(+13.5%)

31.2 47.7
(+16.5%)

Av.cost (NRs)
per prescription

24.3 33.0
(+8.7)

27.7 28.0
(+0.3)

25.6 24.0
(-1.6)

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

PHC prescribing with and without Bamako


initiative in Nigeria
Source: Scuzochukwu et al, HPP, 2002

15.3

no.EDL drugs avail

35.4

21

% pres EDL drugs

93

25.6

% Px with antibiotics

64.7
38

% Px with injections

72.8

2.1
5.3

no.drug items/Px
0

20

21 Bamako PHCs

40

60

12 non-Bamako PHCs

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

80

100

Regulatory strategies
Goal: to restrict or limit decisions
Drug registration
Banning unsafe drugs - but beware unexpected results
substitution of a second inappropriate drug after banning a first
inappropriate or unsafe drug

Regulating the use of different drugs to different


levels of the health sector e.g.
licensing prescribers and drug outlets
scheduling drugs into prescription-only & over-the-counter

Regulating pharmaceutical promotional activities

Only work if the regulations are enforced


Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Intervention impact: largest % change in any


medicines use outcome measured in each study
Database on medicines use 2009

Intervention type

No. studies Median impact

25,75th centiles

Printed materials

8%

7%, 18%

National policy

15%

14%, 24%

Economic strategies

15%

14%, 31%

Provider education

25

18%

11%, 24%

Consumer education

26%

13%, 27%

Provider+consumer education

12

18%

8%, 21%

Provider supervision

25

22%

16%, 40%

Provider group process

37%

21%, 59%

Essential drug program

28%

26%, 50%

Community case mgt

28%

28%, 37%

Providr+consumr ed & supervis 7

40%

18%, 54%

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Proportion of visits
with injection

Impact of multiple interventions on injection


use in Indonesia
Interactive group discussion (IGC group only)

100%

Seminar (both groups)


80%

District-wide monitoring
(both groups)

60%
40%
20%
0%
1

11

13 15

17 19

21 23

25

Months
Comparison group

Interactive group discussion

Source: Long-term impact of small group interventions, Santoso et al., 1996


Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

What national policies do countries have to promote rational use?


Source: MOH Pharmaceutical policy surveys 2003 and 2007
Drug use audit in last 2 years
National strategy to contain AMR
Antibiotic OTC non-availability
Public education on antibiotic use
DTCs in >half general hospitals
Drug Info Centre for prescribers
Obligatory CME for doctors
UG doctors trained on EML/STGs
STGs updated in last 2 years
EML updated in last 2 years

2007 (n>85)

0
2003 (n>90)

20
40
60
80
% countries implementing policies

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

100

Percent change in antibiotic consumption,


out-patient care in 25 European countries 1997-2003
Data from ESAC
25
20

Increase

Percent change

15
10
5
0
-5

Decrease

-10
-15

For Iceland, total data (including hospitals) are used

U
Fr K
an
ce

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la
n
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ro
at
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re
ec
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rtu
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e
l
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xe ar
m k
bo
ur
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un g
ga
ry
It
Sl aly
ov
ak
ia
Is
ra
N el
or
w
Sw ay
ed
e
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s
Sl tria
ov
en
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to
n
Fi ia
nl
an
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d
e
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et
he ain
rla
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er
m
a
Be ny
lg
iu
m
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ze Ic
ch ela
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ep
ub
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-20

Slide courtesy of Otto Cars, STRAMA, Sweden

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Percent change in antibiotic consumption,


out-patient care in 25 European countries 1997-2003
Data from ESAC
25
20

Co-ordination programs

and national campaigns

Percent change

15
10
5
0
-5
-10
-15

For Iceland, total data (including hospitals) are used

U
Fr K
an
ce

Po
la
n
C d
ro
at
G ia
re
ec
Ire e
la
Po nd
rtu
D ga
e
l
Lu nm
xe ar
m k
bo
ur
H
un g
ga
ry
It
Sl aly
ov
ak
ia
Is
ra
N el
or
w
Sw ay
ed
e
Au n
s
Sl tria
ov
en
Es ia
to
n
Fi ia
nl
an
Th
d
e
Sp
N
et
he ain
rla
G nds
er
m
a
Be ny
lg
iu
m
C
ze Ic
ch ela
R nd
ep
ub
lic

-20

Slide courtesy of Otto Cars, STRAMA, Sweden

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Why does irrational use continue?

Very few countries regularly monitor drug


use and implement effective nation-wide
interventions - because
they have insufficient funds or personnel?
they lack of awareness about the funds wasted
through irrational use?
there is insufficient knowledge of concerning the costeffectiveness of interventions?

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

What are we spending to promote rational


use of medicines ?
Global sales of medicines 2002-3 (IMS):

US$ 867 billion

Drug promotion costs in USA 2002-3:

US$ >30 billion

Global WHO expenditure in 2002-3:

US$ 2.3 billion

Essential Medicines expenditure

2% (of 2.3 billion)

Essential Medicines expenditure on


promoting rational use of medicines

10% (of 2%)

WHO expenditure on promoting


rational use of medicines

0.2% (of 2.3 billion)

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

2nd International Conference for Improving


Use of Medicines, Chiang Mai, Thailand, 2004
472 participants from 70 countries

http://www.icium.org

Recommendations for countries to:


Implement national medicines programmes to
improve medicines use
Scale up successful interventions
Implement interventions to address community
medicines use

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Health systems with no national programs:


No coordinated action
No monitoring of use of medicines
Situational analysis

Modify
action plans

WHO facilitating
multi-stakeholder
action in countries

Implement & evaluate


national action plans using
govt & local donor funds

Health systems with national programs:


Coordinated action
Regular monitoring of use of medicine
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Develop
national plans
of action

Global monitoring and identifying effective


strategies to promote rational use of medicines
WHO/EMP databases on drug use and policy
quantitative data on medicines use and interventions to
improve medicines use from 1990 to present day
data from MOHs on pharmaceutical policies every 4 years
1999, 2003, 2007

ICIUM3 in 2011
3rd international conference on improving the use of
medicines (ICIUM3)

Surveillance of antimicrobial use & resistance


method for community-based surveillance in poor settings
interventional approach for improving use in private sector
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pembekalan MTP (STG) kepada staf Puskesmas


mengurangi penggunaan antibiotika
Yudatiningsih, ICIUM, 2004
100
80

MTP

60

Feedback
Month 14

Feedback
Month 30

Feedback
Month 45

40
20
0
Agust-99 Nop99 Feb-00

Mei00 Agust-00 Des00

Mrt01

Jun01. Sep01. Des01.

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Apr02.

Jul02.

Oct02.

Jan03.

Apr03. Aug03.

Standard Pengobatan
Tujuan pembahasan :
Menilai manfaat dan kerugian penerapan
standard pengobatan
Pemahaman tahap pengembangan standard
pengobatan
Menyiapkan pembuatan standard
pengobatan

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pengantar
1.
2.
3.
4.
5.

Therapeutic Anarchy
Keuntungan penerapan pedoman pengobatan
Dampak pedoman pengobatan
Pengembangan pedoman pengobatan
Penerapan pedoman pengobatan

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pedoman Pengobatan

Tatacara diagnosis

Pilihan intervensi (non


obat dan obat)

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pedoman pengobatan harus mencakup


tatacara diagnosis yang esensial

Health Problem =
symptom - headache
diagnosis - malaria
health service antenatal care

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Pedoman Pengobatan dan Proses Terapi


Signs and
Symptoms

Diagnosis
(Health Problems)

Rx
Drug
Supply

Treatment
(Responses)
Adherence
(Compliance)

Rx
Rx

Rx
Clinical Outcome
Rx = focus of standard treatments
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Advantages of Standard Treatments


Patients
Consistency among prescribers
Most effective treatments prescribed
Improved drug supply

Providers

Provides expert consensus


Provider can concentrate on diagnosis
Quality of care standard
Basis for monitoring and supervision

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Advantages of Standard Treatments

Supply Management Staff


Performance standard for drug supply
Allows pre-packs of common items
Drug demand more predictable

Health Policy Makers


Funds used more efficiently
Assess and compare quality of care
Therapeutic integration of special
programs

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Key Features
1.
2.
3.
4.
5.
6.
7.

Simplicity
Credibility
Same standards for all levels
Drug supply based on standards
Introduced in pre-service training
Dynamicregular updates
Durable pocket manuals

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Developing Standard Treatment Guidelines

1. Target priority conditions


2. Base on local disease factors
3. Coordinate with special programs
4. Use fewest drugs necessary
5. Choose cost-effective treatments
6. Use essential drug list drugs only
7. Involve respected clinicians
8. Consider patient perspective

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Approaches to Standard Treatment


Guidelines
Individual
Selective
Comprehensive

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Implementing Standard Treatments

1. Printed reference
2. Official launch
3. Initial training
4. Reinforcement
training
5. Monitoring
6. Supervision
Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

Conclusion
Standard treatment guidelines can have
considerable impact if they are
developed and used in a sensible
fashion
They can also be an expensive waste of
effort
With standard treatment guidelines, the
process of production and use is more
important than the product

Pusat Studi Farmakologi Klinik dan Kebijakan Obat UGM 2012

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