Recognizing that consumers were not receiving adequate written information about their medications, in 1979 the FDA approved regulation 44 FR 40016, which stated that patients would receive written information with each medication. By 1980, the FDA had finalized this regulation with the intent that manufacturers of medications would develop and distribute FDA-approved patient medication information.
In 1982 this regulation was revoked by the FDA (47 FR 39147) with the assurance that the development of patient medication information would be met by private sector providers. The theory was that independent developers within the health care world would create a more innovative and effective product without regulation.
Over the next 15 years, the FDA continued to monitor the patient medication information development and distribution process. The FDA found that the distribution of written information had slightly increased; however, the content was highly variable and its usefulness was inconsistent.
By 1995 the FDA felt it was time to intervene once again with the intent of increasing distribution and consistency of the written patient medication information. Regulation 60 FR 44182 was adopted, which was enacted into Public Law 104-180 in 1996. The following were defined in this new public law:
- By the year 2000, 75% of people receiving new prescriptions would receive useful written patient information with their prescriptions.
- By 2006, 95% of people receiving new prescriptions would receive useful written patient information with their prescriptions.
- Require manufacturers to prepare and distribute medication guides for a limited number of prescription drug products that posed a serious and significant health concern.
- The proposed rule defined that criteria for usefulness would be developed so that written information may be evaluated with regards to the target goals.
With criteria for usefulness in mind, a steering committee was enlisted, consisting of health care professionals, consumer organizations, voluntary health agencies, pharmaceutical manufacturers, prescription drug wholesalers, drug information database companies, CMI developers, as well as others. From this committee, a report was written titled: Action Plan for the Provision of Useful Prescription Medicine Information.
Over the following 6 years the FDA contracted with the National Association of the Boards of Pharmacy (NABP) to assess the effectiveness of the Action Plan provisions. The results of the NABP assessment determined that, by 2002, distribution of written information to patients had increased to nearly 89% of all new prescriptions; however, the usefulness of this information was highly variable. Less than 50% of the written information met criteria to be considered "useful."
Following the 2002 review of distribution and usefulness, the advisory committee recommended that the FDA once again take a more active role in the Consumer Medication Information process. Sometime in the early 2000’s, the terminology changed from Patient Medication Information to Consumer Medication Information, or CMI.
The FDA was asked to provide some guidance and clarification regarding the interpretation and implementation of the Action Plan. The guidance provided should describe processes needed to evaluate and develop CMI while also ensuring that all CMI is considered useful based on the criteria developed by the Action Plan.
The FDA notes that CMI, which adheres to the original Action Plan, will be considered useful when:
- Information in generalized CMI about the use of or indication for use of the drug is consistent with the most recent version of the manufacturer’s professional labeling or package insert (PI) (see 21 CFR 201.56 and 201.57).
It includes the components suggested in the Action Plan and substantially conforms to the formatting suggestions made in the Action Plan, specifically:
- Scientifically accurate
- Unbiased in content and tone
- Sufficiently specific and comprehensive
- Presented in an understandable and legible format that is readily comprehensible to consumers
- Timely and up-to-date
This guidance document does not maintain a legally enforceable protocol. This should be looked upon as recommendations, suggestions and guidance. If a vendor has an alternative approach to the development of CMI, they are encouraged to contact the appropriate FDA staff to discuss it with them.
1. US Department of Health and Human Services, FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance Document for Useful Written Consumer Medication Informaiton. FDA web site. July 2006. Accessed Aug. 6, 2017 at: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080602.pdf.
Steve Leuck, PharmD
Steve Leuck, PharmD, has been practicing both hospital and community pharmacy for over 30 years. He founded AudibleRx, in 2011, which provides Consumer Medication Information in an easy-to-listen audible format. Increased health literacy means better outcomes.