Evaluating Consumer Understanding of Two Patient Instructions for Use Inserts Provided by Manufacturers


In addition to the approved package inserts, manufacturers of certain prescription drug products provide approved patient instructions for use inserts to increase patients’ understanding of their medication, aid in its use, and improve compliance. However, the extent to which consumers understand and use the information provided in these inserts is not known. The purpose of this study was to assess these patient instructions for use in inserts supplied in addition to the normal package inserts from the manufacturer.

Ohio consumers between the ages of 18 and 70 were randomly selected for inclusion. Two diverse patient instructions for use from the same product class, Flonase and Nasonex, were evaluated in the study. Sixty-three consumers completed and returned the self-administered questionnaire, which contained 47 questions and used a Likert-type scale with 1 = strongly disagree to 6 = strongly agree. After data analysis was completed, it was found the inserts were not too complex, and were viewed as educational and a reliable source of drug information. Also, consumers felt very confident that they could use the products correctly. In conclusion, these inserts appear to be well understoud, informative, educational, and a useful source of drug information.

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Correspondence to Dr. Donald L. Sullivan RPh, PhD.

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Rollins, B.L., Sullivan, D.L. Evaluating Consumer Understanding of Two Patient Instructions for Use Inserts Provided by Manufacturers. Ther Innov Regul Sci 39, 43–51 (2005). https://doi.org/10.1177/009286150503900106

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Key Words

  • Consumer
  • Understanding
  • Instruction
  • Inserts