An Overview of an Initial Experience with a Medication Guide


The responsibility for safe administration of medications has expanded to include the patient as well as the physician and the pharmacist. One method to promote this expansion in responsibility is the creation of labeling information specifically for the patient. In December 1998, the Food and Drug Administration (FDA) published a Final Rule on the requirements for “Medication Guides” for prescription drug products. This regulation became effective on June 1, 1999. Janssen Pharmaceutical drug product, Propulsid®, was determined to be appropriate to carry a Medication Guide even before the regulation went into effect. Therefore, Propulsia® was one of the first drug products to undergo the process of creation, approval, and initial dissemination of a Medication Guide. Subsequent to dissemination of the Medication Guide, Janssen conducted market research to determine whether patients were reading and remembering the message contained in the Propulsid® Medication Guide. Results of this research imply that pharmaceutical manufacturers can do everything in their control to ensure that a Medication Guide reaches the patient; however, there is no guarantee that the patient will read it.

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  1. 1.

    21 CFR 310.515 and 21 CFR 310.516.

  2. 2.

    Department of Health and Human Services; Food and Drug Administration. Prescription Drug Product Labeling; Medication Guide Requirements; Final Rule. Federal Register. December 1, 1998;63(230):66377–66400.

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Correspondence to Cynthia P. Chianese.

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Chianese, C.P. An Overview of an Initial Experience with a Medication Guide. Ther Innov Regul Sci 34, 855–859 (2000).

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Key Words

  • Medication guide
  • Final rule
  • Regulation
  • FDA