Title 5. CASE REPORTS.pdf ✅

PHARMD GURU Page 1 INTRODUCTION:  Case report is an example of observational descriptive study in Pharmaco- epidemiology.  It is a non experimental method, and is one of the simplest methods in Pharmaco- epidemiology.  Quite often, experts consider it as one of the weakest form of evidence for causation.  Case reports are simply reports of events observed in single patients. A case report describes a single patient who was exposed to a drug and experiences a particular, usually adverse outcome.  Case reports are useful for raising hypothesis about drug effects, which should be tested with more rigorous study designs.  However, in a case report, one cannot know, if the patient reported is either “typically of those with the exposure” or “typically of those with the disease”.  In a case report one cannot usually determine whether the adverse outcome was due to the drug exposure or would have would have happened anyway.  Case reports are hypothesis generating reports. A case report is not ordinarily used to make a report (or) statement on causation of an event.  But it gives a signal that can make others, alert to the possibility of casual association.  The strength of a case report rests on its ability to produce signals. But case reports are very weak in causation. It is to be noted that Pharmaco-epidemiology evolved with the publication of case reports in USA in 1960s, mostly by hospital pharmacists & clinical pharmacist. CASE STUDY - CASE REPORTS EXAMPLE:  Dr. William McBride of Sydney, Australia, who published the first report indicating that thalidomide, might be a human-teratogen, as a letter in the Lancet on 16th of December 1961.  The signal generated letter helped to confirm that thalidomide could produce fetal abnormalities. It was in fact responsible for the origin of teratology as a discipline. CASE REPORTS