October 2009
Hangzhou
8
A public health perspective

Not only providing scientific evidence

Not only publishing a peer-reviewed article Support medical product development Support regulatory decisions Support reimbursement decisions Prevent / control public health disaster
October 2009
Hangzhou
7
Strom

Pharmacoepidemiology, 4th edition (Wiley 2005) “Pharmacoepidemiology is the study of the use of and the effects of drugs in large numbers of people.”
October 2009
Hangzhou
20
Drug utilization
October 2009
Hangzhou
21Leabharlann Change in the use of hormone replacement therapy after
results of the Women‟s Health Initiative were published




Different types of data and methods to study drugs Clinical trials Spontaneous reports Observational studies / Epidemiology Specific application of epidemiology methods to the evaluation of medical products Cohort study and case control study Bias and confounding Statistics and quantitative reasoning Epidemiology and drug regulation Signal detection Risk management Case studies from literature -- aprotinin as an example Case discussion
4

The driving force for early development of pharmacoepidemiology

SAFETY !!
Clioquinol and subacute myelo-optic neuropathy in Japan Practolol and oculomucocutaneous syndrome in U.K. Diethylstilbestrol and vaginal cancer
Drugs, vaccines, and medical devices
Hangzhou 3

Covers all medical products

October 2009
/pharma coepidemiology.php
October 2009
Hangzhou


International Society for Pharmacoepidemiology (ISPE) and International Society for Pharmacovigilance (ISoP) PE = PVG ? -- No PE ≥ PVG ? -- No PE ≤ PVG ? -- No Some overlap between PE and PVG

October 2009
Hangzhou
6
Hartzema, Tilson, and Chan
“Pharmacoepidemiology can be defined as the application of epidemiologic knowledge, methods, and reasoning to the study of the effects (beneficial and adverse) and uses of drugs in human populations. It aims to describe, explain, control, and predict the effects and uses of pharmacologic treatments in a defined time, space, and population. Its core lies at the intersection of two subspecialties: clinical pharmacology and clinical epidemiology.”

Menopause 2008; 15: 487-493
October 2009
Hangzhou
22
An ongoing study that will provide actionable data
October 2009
Hangzhou
23
From ad hoc studies to safety surveillance
October 2009
Hangzhou
11
Pharmacoepidemiology vs. Pharmacovigilance

WHO definition for Pharmacovigilance (PVG)
“the science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug related problems”

Neurology 2007; 68: 146-149
October 2009
Hangzhou
19
A cohort study based on a large automated data source

New England Journal of Medicine 2008; 358: 771 - 783

New England Journal of Medicine 2009; 361: 645-647
October 2009
Hangzhou
24
First break
Questions ?
October 2009
Hangzhou
25
Different methods in medical product research

Academia Government Industry
October 2009
Hangzhou
10
/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/u cm071696.pdf
Real-life Studies of Pharmaceutical Agents
陳建煒, MD, ScD, FISPE
Harvard School of Public Health i3 Drug Safety October 17-18, 2009
October 2009
Hangzhou
1
Pharmacoepidemiology, drug safety assessment, and risk management
October 2009
Hangzhou
16
A case-control study to evaluate an epidemic of vaginal cancer (n=8)

New England Journal of Medicine 1971; 284: 878-881
October 2009
Hangzhou 12
October 2009
http://www.emea.europa.eu/pd fs/human/euleg/9626805en.pdf
October 2009
Hangzhou
13
http://ec.europa.eu/enterprise/pharmaceut icals/eudralex/vol-9/pdf/vol9a_092008.pdf
October 2009
Hangzhou
14
/LOB/media/M EDIA1195.pdf
October 2009
Hangzhou
15
https:///res ources/ispe_guidelines_2008.pdf

Some classical cases


Recent cases of drug withdrawal in the U.S.

terfinadine & astemizole troglitazone phenylpropranolamine rofecoxib valdecoxib lumiracoxib aprotinin …
Hangzhou 2
October 2009