Pharmacoepidemiology

What I learn from the 1st. Asian International Society for Pharmacoepidemiology Conference, Shanghai

Su-su Liao

Department of Epidemiology

Peking Union Medical College

A desire to take medicine is, perhaps, the great feature which distinguish man from other animals.

Sir William Osler, 1891

Pharmacoepidemiology is the study of the use of and the effect of drugs in large number of people. Pharmacoepidemiology applies the methods of Epidemiology to the content area of Clinical Pharmacology.

• Brian L. Storm, the Editor of “Pharmacoepidemiology”, 4th. Edition, 2005

Pre-Marketing:

--- Pre-clinical Phase

--- Clinical trials Phase I-III

Post-Marketing: not always required by regulatory agency

--- Rare adverse effect

--- AEs in patients different from the study subjects

--- Long-term effects

--- Effectiveness of the drug for the original indications

--- Other beneficial effects of the drugs

Pre-De-Marketing

Information to Supplement the Info. available

from Pre-marketing

After marketing, nonexperimental epidemiologic studies can be preformed to evaluate the effects of drugs administered as part of ongoing medical care.

New Types of Information NOT available from

Premarketing Studies

Delayed drug effect, e.g. unusual clear cell adenocarcinoma of the vagina and cervix, occurred two decades later in women exposed in utero to diethylsitlbestrol.

Patterns of physician prescribing and patient drug utilization

Since recent decades, cost implication of drug use has been drawing more attention.

Data Sources for Pharmacoepidemiology

Spontaneous case reports of adverse reactions to regulatory agency – 欣弗事件

Aggregate population-based data sources Computerized collection of data from

organized medical care programs Data collected for pharmacoepi. on an

ongoing basis Existing data collected as part of other ad hoc

studies Data collected de novo

What else I See from the Conference

国内参加者主要来自：药学背景（药物不良反应监测中心，医院药剂科）

国外参加者：大学、制药公司、……