Standardizing Medication Labels Confusing Patients Less: Workshop Summary (2008) / Chapter Skim
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3 Federal Agency Reaction to Prescription Use Instruction Standardization
3 Federal Agency Reaction to Prescription Use Instruction Standardization
Pages 19-24
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From page 19... ...
The presumption is that there is a correlation between understanding and adherence. What is less clear is what should be placed on drug labels to remedy the problems, despite some good best practices from the health literacy research literature as well as specific testing of different labeling approaches.
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From page 20... ...
And AHRQ is developing a health literacy assessment of patients' experiences, including a question about how easy it was to understand the medication instructions given by the physician. ePrescribing is defined as "the transmission, using electronic media, of prescription or prescription-related information, between a prescriber, dispenser, PBM, or health plan, either directly or through an intermediary, including an ePrescribing network.
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From page 21... ...
and with information obtained from public meetings, the FDA Center for Drug Evaluation and Research is putting together a strategic risk communication plan that will include an examination of all the tools currently used by FDA for communicating drug information. Furthermore, even though consumer medication information sheets are not regulated by the FDA, Congress
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From page 22... ...
The committee will not be addressing specific drug issues or specific device issues but rather will focus on broader issues, such as health literacy and how to appropriately communicate both the risks and benefits of the products FDA regulates from foods through biologics, drugs, and medical devices. The FDA agrees that standardization is a good idea and that implementation should be evidence based.
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From page 23... ...
Discussion An audience member asked if, without considering whether it is the correct thing to do, it would it be possible to write federal legislation or regulations that would mandate standardized drug labeling. Brach stated that the Medicare Prescription Drug, Improvement and Modernization Act of 2003 actually mandates the adoption of standards for inter operability for ePrescribing so that from the prescriber to the pharmacist, there will be a standard.
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From page 24... ...
Brach suggested that the implementation issues are beyond the purview of one federal agency and, instead, require the cooperation of all those involved. From the AHRQ perspective, Brach stated, one needs to determine how drug label standardization would be integrated into the overall strategies of improving other pieces of the system, such as patient counseling, since merely standardizing drug labeling would not fix the problems of medication safety and adherence.
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