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The Top Five Tenets of Exceptional Medication Counseling

July 26, 2016
Posted by: Tina Schlecht, PharmD, MBA

Medication compliance in clinical research is so much more than the instructions on the kit and tracking whether the patient is or is not taking each dose.

According to a report by the Institute of Medicine (IOM), approximately half of all American adults (90 million people) have trouble reading, understanding, and using health information properly. (1) Furthermore, the report indicates that most health-related resources are not understood by the people for whom they are intended. Another study found that nearly one-third of study patients tested were unable to understand the written directions to “take two tablets by mouth twice daily.” (2)

Pharmacists help patients in the clinical research setting and the commercial marketplace to better understand how to properly take medications and obtain the best health outcomes. Engaging with patients in such a way as to first ascertain the patient’s understanding of the instructions, pharmacists are then able to provide course correction or affirm the patient’s understanding. This important exchange gives patients confidence and further empowers them to follow the instructions and be compliant and successful

The top five areas central to medication counseling for proper drug administration include:

  • Amount to dose – how much medication is to be taken at each dose, duration of dosing
  • Timing of dose – number of times per day, time of day, in relation to food, in relation to daily activities (job, school, travel)
  • How to dose – orally, injection site(s), topically, etc. (specific details are important)
  • Medication storage – temperature (refrigeration, left in hot or cold car, how to travel)
  • What to do if a dose is missed – patients are best equipped if they know in advance what to do in the instance of a missed dose

By reinforcing what patients learn at the study site, pharmacists help patients follow protocol directions and avoid errors that would compromise the quality of the data points and the study overall.  This is critically important when clinical trial data is being collected and analyzed for regulatory review and approval.


1. Nielsen-Bohlman, L.N., et al. Health literacy: a prescription to end confusion. National Academies Press, Washington, DC; 2004
2.  Davis, T.C., et al. Literacy and Misunderstanding Prescription Drug Labels. Ann Intern Med. 2006;145:887-894.

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