‫بسم هللا الرحمن الرحيم‬

Relationship between epidemiology

and medication safety
Ali Qasim Saad
 History
Drug safety dates back to the 1950s, when in“ •
response to reports of chloramphenicol-
associated aplastic anemia, the American
Medical Association established an adverse
drug reaction (ADR) reporting system and the
Food and Drug Administration began requiring
pharmaceutical manufacturers to report
.”ADRs
http://jama.ama-assn.org/cgi/content/short/289/9/1154
 Medication safety
• “The safety profile of any medicine reflects an
evolving body of knowledge, extending from
preclinical studies of a potential medicine to
its first use in humans and then through the
postapproval life cycle of the medicine”.
http://media.pfizer.com/files/health/medicine_safety/2-5_How_is_Epidemiology_Used.pdf
 Medication safety
• Study of adverse drug reaction or medical error of administrating
a drug in patient population.
• One area of medication safety evaluation is the study of
medication error in a large population (puplic)  epidemiology
of medication error.
• One unique area of pharmaco-epidemiology is
pharmacovigillance (post marketing surveillance) which mainly
concerns about medication safety profile.
• Epidemiology or pharmaco-epidemiology is not used to study
cause and effect but rather “statistical association, at the
population level, between putative risk factors or causes and
outcomes of interest”.
• Pharmaco-epidemiology help identifying drug
hazard in real-world population so excluding
the weakness of RCTs.
• Also pharmaco-epidemiology can identify
medical errors and patient incompliance and
its correlation with adverse drug events.
 Pharmaco-epidemiology
• Epidemiology has many function in the pharmaceutical company, of
the most important is evaluation of medication safety.
• There are cases where epidemiological approach is more practical
than other types of studies :
1. Estimation of incidence of rare events in a large population.
2. Studying events that developed through a long time or latent to the
administration of a drug. (in countries like in the US and Europe, it is
unacceptable to the study the effect of anti-hypertensive drug against
placebo using RCTS for a long term )
3. “Studying cross-generational effects of a drug”. For example , studying
“possible associations between medicines and birth defects”.
4. RCTs usually don’t include children and elderly people who are the most
consumers of some drugs with other drugs they are taking for the co-
morbidity.
• Pharmaco-epidemiologic research approach
include :
- case- control studies
- cross sectional studied
- community survey
- randomized trail
- before and after
http://intqhc.oxfordjournals.org/content/17/1/1.full
 Refrences
• Mitchell H. Gail, Jacques Bénichou, encyclopedia
of epidemiological methods,Willy,England,2000.
• David Classen, Medication Safety : Moving from
illusion to reality, JAMA, Vol. 289 ,No. 9, March
2003.
• How Is Epidemiology Used in Risk Management
Planning and Safety Assessment?, pifzer, augest
2008. available in
(ww.pfizer.com/medicinesafety)
• Thomas V. Perneger, Investigating safety
incidents: more epidemiology please,
internation journal of quality in health care,
International Society for Quality in Health Care
and Oxford University Press, vol. 17, issue 1 ,
2005.
• http://www.pharmacoepi.org/about/index.cf
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