A Brief History of Consumer Medication Information


Nothing beats a well-written consumer medication information leaflet; our patients’ health literacy depends upon it!

Every day, we hand out pharmacy leaflets to patients to help them better understand their medication treatment. Like everything else, consumer medication information (CMI) has a history.

Since 1968, the FDA has been working on providing CMI to patients. This is based on the FDA’s belief that individuals are able to make better decisions about their health care and better use of the prescription medications available to them when they’re well informed about the medications they take. Here’s a chronology:

  • 1968: FDA required that patient package inserts be written for certain drugs.
  • 1970s: FDA began evaluating the “usefulness” of these patient education documents.
  • 1979-1980: FDA proposed and finalized regulations that manufacturers were required to write CMI.
  • 1982: FDA revoked these regulations in favor of private-sector production of CMI.
  • 1982-1995: Periodic review showed increased distribution but questionable usefulness of CMI.
  • 1996: FDA approved a law stating that by the year 2000, 75% of patients receiving new medications would receive useful CMI, and that by 2006 that number would increase to 95%.
  • 1996: FDA approved law also defined an Action Plan, which specified criteria to determine whether a particular piece of CMI should be considered “useful.” The Action Plan was made up of the following 6 criteria:

1. Scientifically accurate

2. Unbiased in content and tone

3. Sufficiently specific and comprehensive

4. Presented in an understandable and legible format that’s readily comprehensible to consumers

5. Timely and up-to-date

6. Useful, that is, enables the consumer to use the medicine properly and appropriately, receive the maximum benefit, and avoid harm

  • 1998: FDA contracted with the NABP to see how the CMI progress was going.
  • 2002: Results of the study were announced: on average, 89% of patients in the study received some form of written medication information. However, the average usefulness of the information was only about 50%.
  • 2003: FDA advisory committee met in order to encourage the private-sector to meet the goals for 2006 of having 95% of new medications dispensed with useful CMI. The committee came up with 8 points of criteria to determine if a specific CMI should be considered useful:

1. Drug names, indications for use, and how to monitor for improvement

2. Contraindications and what to do if they apply

3. Specific directions about how to use and store the medicine, and overdose information

4. Specific precautions and warnings about the medicine

5. Symptoms of serious or frequent possible adverse reactions and what to do

6. Certain general information, including encouraging patients to communicate with health care professionals, and disclaimer statements

7. Information that’s scientifically accurate, unbiased in tone and content, and up-to-date

8. Information in an understandable and legible format that’s readily comprehensible to consumers

  • 2006: FDA guidance document developed to recommend how CMI should be written. 2008: FDA commissioned a study to be done to see if the CMI goals for 2006 had been met.
  • “We identified various shortcomings in the provision of written medication information to consumers, including lack of 30 critical pieces of information about the management of medications, significant redundancy of information resulting in excessively long leaflets, poor formatting, and inadequate legibility and reading level.”
  • A random sample of 420 pharmacies across the nation were selected. As stated, the CMI was drastically different from pharmacy to pharmacy. The final result showed, on average, CMI was between 58% and 61% useful based on the 8 criterion defined by the 2003 FDA advisory committee.

Here we are in 2016, still handing out CMI leaflets to patients. Over time, new and novel methods of providing CMI to patients may help increase the usefulness as well as the accessibility to patients. For now, remember, CMI doesn’t replace the importance of face-to-face counseling with a patient’s own pharmacist.

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