Basics Concept of

Pharmacoepidemiology
Yusi Anggriani

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.

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.

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 organizations 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

Rifampicin capsules, single dose 450 mg

Plasma RMP concentration (mcg/ml)

Suryawati, 1992

Time (hours)

16
/22

Compliance with clinical guidelines over

time by region
7/12/16

Ketersediaan OGB di PBF 16 Provinsi

18

Hasil Evaluasi Pola Peresepan AB

Evaluasi Pola Peresepan
Parameter menggunakan Prescribing indicators for Rational Use of
Medicines dari WHO.
NO

Tempat

Tahun

% peresepan
AB

Puskesmas Jakarta Barat

2005

59,6

Puskesmas Jakarta Selatan

2005

53,1

Puskesmas Jakarta Timur

2007

53,9

Puskesmas Jakarta Pusat

2008

50,9

Puskesmas kota depok

2005

58,4

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.

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

 Ibu Putu:
Farmasi Klinis
gammatasunggara@yahoo.com
ariyantikusumadewi@yahoo.com
yusi1777@yahoo.com