Consumer Medication Information (CMI)
The FDA and CMI
The FDA has a clear mandate to regulate pharmaceutical manufacturers. In 1995, Congress passed Public Law 104-180, giving pharmaceutical manufacturers and pharmacy operators 10 years to demonstrate the ability, absent national regulations and standards for CMI, to deliver useful information with 95% of all new prescriptions dispensed.
FDA Criteria For Good CMI
After PL 104-180 passed, the FDA and healthcare experts worked to develop criteria for good Consumer Medication Information (CMI). FDA-published criteria for “useful written Consumer Medication Information (CMI)” recommend that CMI be:
- Scientifically accurate
- Unbiased in content and tone
- Specific and comprehensive
- Timely and up to date
Two Studies On The Delivery Of Good CMI Through The Pharmaceutical Supply Chain
PL 104-180 required an interim progress report in 2001. The FDA commissioned a study conducted by faculty of the University of Wisconsin School of Pharmacy.
A second study examining the quality of CMI in the U.S. was conducted in 2008 by the University of Florida College of Pharmacy. The National Association of Boards of Pharmacy facilitated both studies.
The same methodology and criteria were used in both studies. The experts evaluated the information gathered for prescriptions for common drugs from many different pharmacies against accepted criteria for good CMI by looking for the following content:
- Drug names and indications for use
- Contraindications and what to do if they apply
- Specific directions about how to use, monitor, and get most benefit
- Specific precautions and how to avoid harm while using the drug
- Symptoms of serious or frequent adverse reactions and what to do
- General information and encouragement to ask questions
- Scientifically accurate and unbiased, up-to-date information
- Formatting, legibility and comprehensibility.
The Conclusions Of The Studies: Failure To Deliver
The results painted a picture of dismal failure in delivering useful CMI.
- 2001: At best, pharmacy-prepared leaflets met only 50% of the criteria developed to judge usefulness and none of the materials collected during the study met all the criteria developed to gauge consumer usefulness.
- 2008: Consumer Medication Information (CMI) distributed by pharmacies continued to fail versus the same criteria as in 2001, and in some areas the quality declined. In 2008 CMI had lower adherence about how to use, monitor and get the most benefit than in 2001; CMI in 2008 was also worse than in 2001 against the criteria for comprehensibility and legibility.
- In 2001 and 2008, both studies highlight the enormous variability in the length, content and quality of information being distributed to patients.
University of Wisconsin School of Pharmacy, 2001 report on state of CMI:
University of Florida Pharmacy School November, 2008 report on state of CMI:
Progress Since 2008
Since the 2008 study by the University of Florida School of Pharmacy, nothing has changed in the U.S. pharmaceutical distribution system for CMI.
Most of the information is created using printers at the retail outlet. The printing systems are limited in their capabilities; as the 2008 study noted, legibility had actually declined from an already low level in 2001 to 2008. The content of the information is completely unregulated - pharmacy practices are regulated by each state’s Board of Pharmacy, not by the FDA. Even pharmacies drawing information from a central database often edit that information to make it fit – with no review of the edited version. A consumer filling the same prescription for the same drug at five different pharmacies will almost certainly receive five different versions of CMI.
The U.S. pharmaceutical market is unique in the developed world. In all other countries in the developed world, CMI approved by each nation's drug regulatory body accompanies every prescription. In the US, it does NOT.
Careful, scientific studies have shown the poor quality of CMI in the U.S. Further, academics from the U.S. (Bonnie Svarstad, who led the 2001 study for the University of Wisconsin in 2001), the U.K. and Australia compared the quality of CMI in the three countries. Leaflets from Australia received a mean overall score of 90% for adherence with the criteria used, from the U.K. 81%, and from the U.S. 68%. These scholars noted that U.S. leaflets achieved adherence of 50% or less for contraindication and precautions, and also scored lower than the overall average for legibility and comprehensibility.
CMI IN SUMMARY
In summary, U.S. patients do not receive reliable, high quality CMI with their prescriptions. Public Law 104-180 gave the private entities in the pharmaceutical supply chain until 2006 to comply with the standards established. However, almost a decade later, the pharmaceutical supply chain currently does not comply because the FDA has not exercised the legal authority given it by Congress.