New FDA Guidance on "Safety by Design"

On April 11, 2016, the FDA released a new guidance on "Safety Considerations for Product Design to Minimize Medication Errors".

The recommendations in this guidance apply broadly to the development stage of drug and biologic products. The guidance provides a set of principles for using a systems approach to minimize medication errors relating to drug product design and container closure design to enhance patient safety. The recommendations are intended to provide best practices on how to improve the drug product and container closure design. The guidance also contains examples of product designs that have resulted in postmarketing medication errors. Many medication errors can be avoided at the design stage by drawing on lessons learned from past medication errors and by conducting proactive risk assessments before marketing.

The guidance is the first in a series of three planned guidances to minimize or eliminate hazards contributing to medication errors at the product design stage. The second guidance focuses on minimizing risks associated with the design of drug product container labels and carton labeling, and the third focuses on minimizing risks when developing and selecting proposed proprietary names.

Safety by Design: FDA expects manufacturers to perform proactive risk assessments 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. A proactive risk assessment should start with an evaluation of why and how problems have occurred with similar products and should be conducted before finalizing the physical design features of a drug product. Additionally, the guideline provides examples of known problems and medication errors due to design of the drug product and container closure systems.

The selection of the container closure system, for example, should be based not only on stability and manufacturing considerations, but also on the ability of the design to protect against improper use:

  • Drug products should not be packaged in a container/closure system that implies or affords a route of administration other than the route intended;
  • Container closures should not look confusingly similar to those of other products within the same product line or a different product line;
  • Products that require further dilution prior to administration should not be packaged in containers that could afford direct administration;
  • Small-volume and large-volume injectable products whose labeling advises against admixing with other drugs should be packaged in a container with a single port;
  • Commercial containers should not provide an amount of drug that is incongruent with recommended doses;
  • The amount of residual drug in a system after use should be minimized to the lowest possible level;
  • If container closures serve as the container labels, they should not have illegible lettering or make information such as product name and strength difficult to read;
  • Thoughtful use of unit-of-use container closures (e.g., blister packaging, calendar-packaging, sachets, and pouches) that can be dispensed intact to patients may help to reduce medication errors;
  • Requirements for special packaging to confer child resistance should be considered to minimize accidental ingestions.

To avoid safety issues and costly redesigns when a product is already on the market, it is important to consider the end user(s) in their environments of use early in the development and design of a drug product. FDA recommends the use of proactive risk assessments (e.g. by using FMEA) early and throughout the development and design of a drug product. Identification of clinically relevant characteristics of the drug product during development will highlight potential areas for risk assessment. Risk assessments also are valuable for identifying potential medication errors that may result from postmarketing changes or additions to an already marketed drug product throughout its lifecycle.

For more details please see the complete FDA guidance "Safety Considerations for Product Design to Minimize Medication Errors".

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