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College of Pharmacy

HelixTalk Episode #70 - Does rosuvastatin REALLY cause 42 adverse drug reactions? Identifying true ADRs to improve your patient counseling

Date posted: November 28, 2017, 6:00 am

In this episode, we discuss the difficulty in identifying adverse drug reactions (ADR) that ACTUALLY occur from a drug therapy, how tertiary drug references (such as Micromedex or LexiComp) may be misleading, and what tips and tricks you can use to recognize the most clinically relevant ADRs for patient counseling.

Key Concepts

  1. Quantifying and showing causality between a drug and an adverse drug reaction is actually very hard to do.  Differences in study patient populations, baseline adverse reaction rates in placebo, and tricks involving trial design make assessing ADRs difficult.
  2. Most clinical trials are not powered to compare the ADR rate between a drug and its comparator, frequently resulting in type II errors (a non-significant P value where a true difference actually does exist).  Interpret these P values with caution!
  3. Tertiary drug references can be misleading regarding the incidence of an ADR.  Clinicians need to be equipped with the incidence rate of the comparator/placebo in order to evaluate whether a drug actually causes an ADR or not.
  4. DailyMed (with the package insert) provides an exceptional resource to evaluate boxed warnings, warnings/precautions, and adverse reactions (with placebo/comparator rates) in order to help clinicians identify the most important and relevant patient counseling points.

References

DailyMed. US National Library of Medicine.  Available at https://dailymed.nlm.nih.gov/dailymed.