Module 6 Discussion

Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and the risk of hemorrhagic stroke. New England Journal of Medicine 2000; 343:1826-1832.

In this module, we discuss the case control study design which is routinely used to study factors associated with rare clinical events. As discussed from the Kernan reading, there are many research issues involved in studying whether use of medications are associated with serious adverse events. With respect to prescription medications, clinical trials used in the drug approval process are often short in duration and there is considerable off-label use upon medication approval. For over-the-counter medications, there is no ability to regulate individual use (i.e. thinking that if a little is good then perhaps a lot is better). In this realm, provide a 2-3 sentence response for the biggest challenge you perceive in being able to rigorously monitor and accurately estimate the risk of potential serious adverse events that may be associated with medication use. Select one of the responses below and elaborate in 2-3 sentences. There are no right or wrong answers.  Respond to 2 to 3 other students' posts.

Biggest challenge (select one):

a) Methodological difficulties in conducting rigorous epidemiological studies

b) Reluctance of physicians and health professionals to report suspected serious adverse events

c) Lack of knowledge among patients and consumers to report suspected serious adverse events

d) Inadequate monitoring and enforcement capacity of the Food and Drug Administration

e) Insufficient commitment by the pharmaceutical industry to conduct mandated post-market surveillance

f) Other (describe)