Basics Concept of

Pharmacoepidemiology

Yusi Anggriani
Sekilas tentang Saya
Nama : Dr. Yusi Anggriani, M.Kes, Apt.
Riwayat Pendidikan:
• S3 Social Pharmacy & Administrative, University Sain Malaysia, 2014
• S2 Magister Manajemen & Kebijakan Obat, Fak Kedokteran UGM, 2002
• Apoteker Farmasi UGM, 2000
• S1 Farmasi UGM, 1999

Pengalaman:
• Dosen Fakultas Farmasi Universitas Pancasila (2004- sekarang)
• Komite Nasional Evaluator Obat Baru Badan Pengawasan Obat dan Makanan (
2001-Sekarang)
• Tim Nasional Percepatan Penanggulangan Kemiskinan Sekretariat Wakil Presiden,
Pokja Kesehatan, Bidang Obat (2014-Sekarang)
• Komite Nasional Penilai Obat Jadi BPOM RI (2002- sekarang)
• Komite Nasional Informatorium Obat Nasional Indonesia BPOM (2011-sekarang)
• Tim penyusun Pedoman Farmakoekonomi Kementerian Kesehatan RI (2011)
• Dosen Manajemen penggunaan obat, MM Kebijakan Obat UGM (2003-2004)
• Apoteker pengelola Apotek di Yogya (2000-2004)
• Staff peneliti Pusat Studi dan Kebijakan Obat UGM (2001-2003)
Objectives
• Define pharmacoepidemiology
• Understand the relationship of
pharmacoepidemiology to other disciplines
• Understand types of Pharmacoepidemiology
studies
• Understand the importance and clinical
relevancy of pharmacoepidemiology
Pharmacoepidemiology- What is it?

• Pharmacology is the study of the effect of

drugs
• Epidemiology can be defined as the study of
the distribution and determinants of diseases in
populations
• Clinical Pharmacology is the study of effect
of drugs in humans.
 Part of the task of clinical pharmacology is
to provide a risk benefit assessment for the
effect of drugs in patients.
Pharmacoepidemiology- What is it?
Doing the studies needed to provide:
 an estimate of the probability of beneficial
effects in populations
 the probability of adverse effects in populations
 other parameters relating to drug use

Pharmacoepidemiology then can also be defined

as the application of epidemiological
methods to pharmacological issues
Pharmacoepidemiology- What is it?
• Pharmacoepidemiology may be defined as
the study of the utilization and effects of drugs in
large numbers of people.
• Pharmacoepidemiology borrows from both
pharmacology and epidemiology.
• Pharmacoepidemiology can be called a bridge
science spanning both pharmacology and
epidemiology.
Pharmacoepidemiology in Practice
1. The basics idea of pharmacoepidemiology is: to
measure the source, diffusion, use, and effects
of drugs in a population
2. To determined the frequency and distributions
of drug used outcomes in that population
The focus of the types of
pharmacoepidemiology research:
1. What is being used (an assessment of specific
drugs being used in certain situations)
2. How it is being used (an assessment of patterns
of use, including how much, where, when, by
whom)
3. Why it is being used (an assessment of the
reasons for drug-taking behaviors)
Pharmacoepidemiology in Practice
• The World Health Organization focuses it
pharmacoepidemiological efforts on ensuring :
 The quality, safety. efficacy of drugs
 Drugs used in specific populations
Pharmacoepidemiology in Practice
The organization’s of pharmacoepidemiological
studies are performed to:
1. Describe current patters of drug used in specific
populations.
2. Determined changed in drug used over time
3. Measure the effect of information, education,
promotional activities, media accounts, and prices
of drug use
4. Detect inappropriate drug use and associated
problems
5. Estimate drug needs in terms of disease pattern
6. Plan the selection, supply, and distribution of drugs
Problem Solving with
Pharmacoepidemiology
Medical drug use
 Beneficial effect of drug therapy
 Risk (AEs, side effects) of drug therapy
 Inappropriate prescribing behaviors
 Patient noncompliance
 Irrational self medication practices
 Poor drug use outcomes

Non medical drug use

Source of Data on Drug Use
Institutional record systems and databases
Drug utilization studies
Hospital-based medical audits (in Patiens)
Systemwide databased
Institutionally based reviews (outpatient)
Health insurance groups and third-party payers
Pharmaceutical organization
National databases
Government sponsored studies
Essential drug list and inventory data
Field data
records of drug dispensers, sellers, and distributors
Drug-taking behaviors of individuals and small groups
Experimental data
Clinical trial results
Types of epidemiology studies
Epidemiological studies can be divided into two
main types:
1. Descriptive epidemiology
2. Analytic epidemiology
Descriptive epidemiology

Describes disease and/or exposure and may

consist of calculating rates, e.g., incidence and
prevalence.
 Such descriptive studies do not use control
groups and can only generate hypotheses, not
test them.
 Studies of drug utilization would generally
fall under descriptive studies.
Analytic epidemiology

Observational studies ( such as case-control and

cohort studies)

Experimental studies (such as randomized clinical

trials)

The analytic studies compare an exposed group

with a control group and are usually designed
as hypothesis testing studies.
Rifampicin capsules, single dose 450 mg

Plasma RMP concentration (mcg/ml)

25
A (local
B (local)
20 C (local)
D (multinational)
15 E (multinational)

10

0
0

12

15

18

21

24
5

4.5

7.5

.5

.5

.5
.5

.5
1.

19
10

13

16

22
Time (hours)
Suryawati, 1992
 18/2
2

Compliance with clinical guidelines over

11/25/2015

time by region
 20

Hasil Evaluasi Pola Peresepan AB

Evaluasi Pola Peresepan
Parameter menggunakan Prescribing indicators for Rational Use of Medicines
dari WHO.
NO Tempat Tahun % peresepan
AB
1 Puskesmas Jakarta Barat 2005 59,6

2 Puskesmas Jakarta Selatan 2005 53,1

3 Puskesmas Jakarta Timur 2007 53,9

4 Puskesmas Jakarta Pusat 2008 50,9

5 Puskesmas kota depok 2005 58,4

6 Apotek kota depok 2005 25,2

Perbedaan Harga Apotek Antar Provinsi
• Uji statistik dengan One Way Anova atau Kruskal-Wallis
• Dari 74 item produk yang dianalisis, secara umum tidak terjadi
perbedaan harga signifikan (95% item produk)

• Hanya 4 item (5%) yaitu :

Amoxicillin 500 mg,
Amoxicillin 125 mg/ml
sirker, Domperidon 10 mg
dan Simvastatin 20 mg yang
memiliki beda harga
signifikan.