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
5
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
5
8%
7%, 18%
National policy
6
15%
14%, 24%
Economic strategies
7
15%
14%, 31%
Provider education
25
18%
11%, 24%
Consumer education
3
26%
13%, 27%
Provider+consumer education
12
18%
8%, 21%
Provider supervision
25
22%
16%, 40%
Provider group process
8
37%
21%, 59%
Essential drug program
5
28%
26%, 50%
Community case mgt
5
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
3
5
7
9
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
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
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 Dynamic—regular 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