Transcript Pharmacoepidemiology: What I learn from the 1st. Asian

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
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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
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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
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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
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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）
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国外参加者：大学、制药公司、……