registry will be provided in the forthcoming report of the IOM Committee on the Assessment of the U.S. Drug Safety System.
Drug information is communicated to providers and consumers through labeling and packaging, marketing practices, and advertisements. Poorly designed materials and inadequate representation of drug benefits and risks has led to errors across the medication-use continuum, such as inappropriate prescribing, confusion among products affecting dispensing and administration, and compromised ability to monitor a drug’s effects adequately. This section addresses these issues.
Recommendation 4: Enhancing the safety and quality of the medication-use process and reducing errors requires improved methods for labeling drug products and communicating medication information to providers and consumers. For such improvements to occur, materials should be designed according to designated standards to meet the needs of the end user. Industry, the Agency for Healthcare Research and Quality (AHRQ), the FDA, and others as appropriate (e.g., U.S. Pharmacopeia, Institute for Safe Medication Practices) should work together to undertake the following actions to address labeling, packaging, and the distribution of free samples:
The FDA should develop two guidance documents for industry: one for drug naming and another for labeling and packaging. The FDA and industry should collaborate to develop (1) a common drug nomenclature that standardizes abbreviations, acronyms, and terms to the extent possible, and (2) methods of applying failure modes and effects analysis to labeling and packaging.
Additional study of optimum designs for all drug labeling and information sheets to reflect human and cognitive factors should be undertaken. Methods for testing and measuring the effects of these materials on providers and consumers should also be established, including methods for field testing of the materials. The FDA, the National Library of Medicine (NLM), and industry should work with consumer and patient safety organizations to improve the nomenclature used in consumer materials.
The FDA, the pharmaceutical industry, and other stakeholders should collaborate to develop a strategy for expanding unit-of-use packaging for consumers to new therapeutic areas. Studies should be undertaken to evaluate different unit-of-use packaging