Presented at the 2012 AAPM Annual Meeting « Back

Evaluating Patient Understanding of Written Information Provided with Prescription Medications

Sidney H. Schnoll, MD PhD, sschnoll@pinneyassociates.com¹, Karen K. Gerlach, PhD², Mark A. Sembower, MS3, Saul Shiffman, PhD2, (1) Pinney Associates, Bethesda, Maryland, (2) Pinney Associates, Pittsburgh, Pennsylvania, (3) Consultant, Pittsburgh, Pennsylvania

Background: In the United States, antidepressants are required to be dispensed with a Medication Guide and a Patient Package Insert. Many pharmacies also include Consumer Medication Information for antidepressants. Objectives: To assess the ability of people with a high school education or less to comprehend the information provided with an anti-depressant medication well enough to respond appropriately to scenarios depicting issues described in the written information. Setting: Fifty-two participants (33 males, 19 females) were from one large city and had a high school education or less. Exposures or Interventions: Participants given blinded (to drug name) copies of the actual Medication Guide, Package Insert and Consumer Medication Information included with an antidepressant and were allowed up to 45 minutes to read the materials. Main Outcome Measures: Participants were questioned to determine their understanding of the safety and use information in the materials. Fictional scenarios involving symptoms included in the materials were presented, and participants were asked what action should be taken in the situation. Statistical Analysis: Proportion with correct responses. Results: Less than 20% of participants identified the symptoms of a potentially life-threatening condition that can occur with this medication (covered in Patient Package Insert and Consumer Medication Information). Only 61.5% recalled the risk of suicide with the medication (only risk addressed in the Medication Guide). Conclusions: Written materials dispensed with prescriptions are not conveying safe use information. This research shows that it is not difficult to evaluate the information and, from that knowledge basis, to improve the materials.

Funding: None