PHARMACOEPIDEMIOLOGI

Sendi Lia Yunita

Program Studi Farmasi
Universitas Muhammadiyah Malang
October 2020
 Pharmacoepidemiology ?

ф Pharmaco => Medicine / Drug

ф Epidemiology => The Distribution & Determination Study of
Diseases in Population
ф Pharmacoepidemiolpgy => The Study of the Usage & Effects
of Medications in population
ф 1st=> British Medical Journal editorial by Lawson in 1984
ф introduced unknown ADR lately
epidemiology

 Epi=> tentang/ pada

 Demos=> penduduk
 Logos=> ilmu
 Study of frequency (amount) & distribution (man, place, time)
of health problems in population & factors that influenced
 Morbidity, mortality, birth rate, prevalence, incidance etc
 Are tools & method
 definition

✓ Study of pharmaceutical products usage & effects in population

/large number of peoples (Strom)
✓ The Application of Epidemiologic Knowledge, Methods, Reasoning
to the Study of Effects (Beneficial & Adverse) then drugs usage in
Human Populations. (Porta & Hartzema)
✓ The Study of Drugs as Determinants of Health & Disease in general
Unselected population (Spitzer)
✓ It’s an applied field bridging clinical pharmacology & epidemiology
✓ collection of several disciplines (mahyar etminan)
 ADR

❖ Singapore’s hospital >12% (Walther, 2017)

❖ In India, 35.33% caused by AB (S Sre et al, 2017)
❖ In Nigeria, 2% from total cost of medication used to treat ADR
(P.E Akhideno et al, 2018)
❖ In Sub Saharan countries, 62.8% at least 1 ADR happened &
almost one third were serious (L Hagos et al, 2019)
❖ 3-10% happened in European hospitalized Px (J.C Bouvy et al,
2015)
❖ 10.7% pregnant women occured in Brazil (Lima et al, 2019)
❖ 18.8% caused by AB for systemic use in Malaysia (SF Abu et al,
2018)
 THE RELATIONSHIP of
PHARMACOEPIDEMIOLOGY & OTHER
DISCIPLINES

Clinical Pharmacology
– PE is the Implementation of Epidemiological Methods,
Knowledge & Logical Justifications in the Field of
Clinical Pharmacology by Focusing upon Studies on the
Drug Effects & Drug Use by Large Numbers of People.
– CP => a Scientific Discipline that investigates the
Efficiency & Drugs Safety also Seeking answers of
Clinical Questions.
– CP focuses on individuals or Px groups in a clinical
environment
 THE RELATIONSHIP Cont..

Epidemiology
– epidemiology defined as study of the distribution &
causes of health-related events in certain societies &
the use of gathered knowledge to control health
problems
– Since it investigates the interactions observed in
many people,
– conducting pharmacoepidemiological studies with a
focus on society & establishing relationships between
health cases & drug exposures
Conts..

✓ PE takes its focus of knowledge from CP

& the research methods from
epidemiology
✓ it applies the methods of epidemiology in
the field of CP
 Potential contributions of pharmacoepidemiology

A. Information that Supplements info available from Pre-

marketing Studies=>better Quantitation of the incidence
on Known Adverse & Beneficial Effects
1) Higher Precision
2) In Patients Not Studied Prior to Marketing, i.e., Elderly,
Children, Pregnant
3) As Modified by Other Drugs & Illnesses
4) Relative to other Drugs used for same Indication
 CON..

B. New Types of Information not available From

Premarketing Studies
1. Discovery of Previously Undetected Adverse & Beneficial
Effects
A. Uncommon Effects
B. Delayed Effects
2. Patterns of Drug Utilization
3. The Effects of Drug Overdoses
4. The Economic Implications of Drug Use
C. General Contributions of PE
1. Reassurances about Drug Safety
2. Fulfillment of Ethical & Legal Obligations
 Clinical Pharmacology

Pharmacoepidemiology

Epidemiology
 Pharmacoepidemiology-collection of several disciplines

Epidemiology
Biostatistics Medicine

Pharmacoepidemiology

Computer programming Administrative data

Pharmacology
 Drug evaluation never ends

preclinical
clinical (I-III)
Discovery &
screening
phase 4
Pre-clinical
development Fase I/IIa
Fase IIb/III
10,000 15-30 10-15 5 1

registration
& launch
Proof of Concept

first administration to man

discovery

approx. 10-12 years

 The Application

• In drugs after being

1 marketed

• Changes the
2 pharmaceutical law

• Main focus on the study

3 of drug usage & adverse
effects
 Adverse Drud Reactions

Since 1970 Classified as

▪ Pharmacodynamic (i.e.
– Type A Reactions
Bronchospasm From Beta-
– Type B Reactions
blocker)
Nowdays as:
❖ Type A Reactions, A-enggaged With ▪ Toxic (i.e. deafness from
Pharmacological Response
aminoglycoside overdose)
▪ Generally are:
• Dose-related
• Predictable from Drug Pharmacology
• Common
• Normally Reversible
• May Be Manageable with Dose
Adjustment
 Cont...

❖ Type B Reactions,
generally: Type B-nonpharmacological
 Unrelated Dose Response (often: Allergic)
 Unpredictable
▪ Medicine Induced Diseases (i.e. AB
 Uncommon associated colitis)
 May be ▪ Allergic Reaction (i.e. penicillin-
Serious/Irreversible anaphylaxis shock)
 Indicate, Drug to ▪ Idiosyncratic Reaction (i.e.
be Stopped chloramphenicol-aplastic anemia)
 Con...
❖ Type C-continuous/long
term/Chronic, time related
▪ Osteophorosis, Supresi ginjal
=> Oral Steroids
❖ type D-Delayed, lag time
▪ Teratogenic Effects with
Anticonvulsant Or Lisinopril
▪ Dyskinesia with Neuroleptics
❖ Type E-ending od usage
(witdrawl)
▪ Withdrawal Syndrome
with Benzodiazepines
❖ type F-failure of
efficacy, no response
▪ Resistance to Antibiotics