Product Design and Safety Considerations
To assist with this assessment, the guidance provides examples of known problems and medication errors caused by the design of drug products. The examples include various types of products, including solid oral products, transdermal systems, and intravenous products, among others. The guidance similarly provides factors to consider during the development of the container closure design, which includes the immediate unit, bottle, vial, ampule, tube or other receptacle containing the product as well as the cap, stopper or seal. The guidance cautions that particularly problematic container closure systems include those that are: (1) incongruent with the intended dosage and administration of the product; or (2) atypical for similar products marketed with a different type of container closure. Because of the problems inherent in such designs, the guidance recommends that such designs be redesigned because they cannot be remedied with additional labeling statements or healthcare provider or patient education. Finally, the guidance recommends that the proactive risk assessment be conducted from the earliest stages of product design (and throughout the development and design of the product) to help manufacturers anticipate and mitigate against medication errors and should include failure mode and effects analyses as well as simulated use testing.
This guidance could impact pending and future private litigation involving medication errors. Although FDA guidance does not create or confer any rights and does not operate to bind FDA or the public, it can be used by plaintiffs and their experts to support theories of defect. Further, it may be a basis for healthcare providers named in a lawsuit to file a third party complaint against product manufacturers.
One can argue that FDA, through the guidance, is establishing a potential roadmap for plaintiffs’ lawyers. While FDA must weigh product design issues against the need to ensure access to new medicines, and against the overall safety and efficacy of the product, we would expect the product liability bar to read guidance documents such as this as establishing a regulatory standard against which a product must be measured. This may lead to increased claims against product manufacturers for cases involving medication errors when such claims have traditionally been asserted primarily against health care providers. It is important, however, to read the guidance as recommending, and only recommending, a process for creating an inventory of risks and for considering methods to reduce those risks within the context of the FDA approval process. As the agency states in the guidance, “FDA expects manufacturers to consider the use of these analytical methods when developing drug products to build safety into drug product throughout its lifecycle and to identify those safety characteristics of the product that they consider to be critical.” The guidance, however, does not and cannot require any specific measures.
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