1. introduction to pharmacoepidemiology

7/25/2019 1. Introduction to Pharmacoepidemiology

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PHARMACOEPIDEMIOLOGY


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What is

Pharmacoepidemiology?


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Pharmacoepidemiology can be defined as theapplication of epidemiologic knowledge,

methods, and reasoning to the study of the

effects (beneficial and adverse) and uses ofdrugs in human populations.


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W at is t e aim?


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To describe, explain, control, and predict the

effects and uses of pharmacologic treatments

in a defined time, space, and population.

Efficacy, Safety, EconomyEfficacy, Safety, Economy


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Pharmacoepidemiology as a tool to know:

Efficacy

phase has limitations, mostly due to ethical,practical, and economic reasons.

SafetyAdverse Drug Event

Economy

product


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What is Adverse DrugExperience?


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Adverse Drug Experience is defined in US federal regulation21 CFR (Code of Federal Regulations) 314.80 as:

Any adverse event associated with the use of a drug inhumans, whether or not considered drug related, includingthe following:

an adverse event occuring in the course of the use of adrug product in proffesional practice;

an adverse event from drug overdose whether accidentalor intentional;

an adverse event occuring from drug abuse; an adverse event occuring from drug withdrawal;

and an si nificant failure of ex ected harmacolo icalaction


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Drugs Withdrawal

Year Name Trade Name Comment

Gone, but not forgotten

1961 Thalidomide Distavel

Valgis

A sedative drug, also marketed for morning sickness

that produced fetal malformation. At the time,

its safety in pregnancy

Recently reeintroduced to the market as an

immunosu resant and is used to treat le ros .

1971 Diethylstilbe

strol

Stilboestrol Stilboestrol was prescribed for pregnant women up

to 1970s. It induced cervical and vaginal cancer in

the female children of treated mothers as well asgenital malformation in its previous indication to

prevent miscarriage.

Recently reeintroduced to the market rarely to

treat prostate cancer and breast cancer in

postmenopausal woman


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Year Name Trade

Name

Comment

2005 Co-proxamol Distalgesic An analgesic combination of dextropropoxyphene and

osa ges c paracetamo w c as een w t rawn ecause o ts

toxicity in overdose. Some patients found it beneficialto them, despite little evidence for acute analgesia

benefit com ared to aracetamol alone.

2010 Sibutramine Reductil Withdrawn in EU Jan 2010 due to the required post

marketing surveillance SCOUT study showing excess

cardiovascular mortality

2011 Pioglitazone Actos Withdrawn in France June 2011 due to increased risk of

bladder cancer


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2005 natalizumab Tysabri An anti-4,1 integrin monoclonal antibody which

was withdrawn before European approval but

after FDA approval when 3 cases of progressive

multifocal leukoencephalopathy had occurred

amongst 3000 treated in RCT and 5000 treated in

. ,

rules

2009 Efalizumab Raptiva Withdrawn if EU Feb 2009 due to 3 cases of

ro ressive multifocal leukoence halo ath

Basic molecular and cell biology research have now come of age

,

Although different from traditional pharmacologic agents, products based on

biotechnology should be evaluated in the pharmaceutical context rather than the

production techniques that are employed.

Because of their unique production techniques used and their different mode of action,

it is likely that news pharmacoepidemiology methodologies will need to developed.


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List of approved and withdrawn drug

FDA, 2006

Name Duration

Rofecoxib 1999-2004

Fenfluramine 1979-1980

Temafloxacin 1992-1992

-

Alosteron 2000-2000

Supofen 1985-1987

sapr e -Grepafloxacin 1997-1999

Rapacuronium 1999-2001


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The need for Post Marketingurve ance ar ses rom

the limitations of Phase I, II, and IIIclinical trial


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Comparison between Premarketing and Postmarketing Study

Parameter Pre marketing Study Post marketing Study

Alat/tools Uji Klinik Fase 1-3 Uji Farmakoepidemiologi

Orientasi Explanatory/knowledge-

oriented question

Pragmatic/Decision-

oriented question

Informasi yang didapat Efikasi Obat Efektivitas Obat (focusing

on the effectiveness of the

drug under usual clinical

Subjek penelitian Hasil seleksi ketat Tidak terlalu ketat

Kemungkinan lain Dapat dihilangkan, mis. Ada, namun bisa diseleksi

dikonsumsi, pola makan,

usia


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Main Areas of Inquiry Addressed in

ostmar et ng tu es

Area of Inquiry Example

ong- erm e ec s

manifest after long periods of use Use of exogenous estrogen duringmenopause and endometrial cancer

manifest after long latency periods Adenocarcinoma of the vagina due to

diethylstilbestrol

Low-frequency effects

can only be detected in large

populations

Aplastic anemia: phenylbutazone;

Colitis: clindamycin;

Jaundice; halothane

ec veness n cus omary prac cepatients Children, pregnant or elderly women

therapeutic situations with concurrent pathologies and several

simultaneous treatments, flexible dosages,

tolerance, noncompliance, non-response

emergencies, ambulatory care


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Area of Inquiry Example

ea care se ngs emergency, am u a ory care

healthcare professionals according to training, specialty information

sources

cacy n new n cat ons

discovered after marketing Propanolol as an antihypertensive, captopril inrheumatoid arthritis, amantadine in Parkinsons

,

including secondary effects Antihypertensives to prevent cardiovascular

disease, hypoglycemic agents to prevent

Modifiers of efficacy

concurrent drugs A decrease in sodium intake can improve the

disease severity Severe asthmatics do not respond to

metaproterenol without supplementary therapy

oral contraceptives may be increased by cigarette

smoking

1. introduction to pharmacoepidemiology

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