Key Premarket Considerations for Improving Medication Safety
Event Type
Oral Presentations
TimeFriday, April 161:10pm - 1:30pm EDT
LocationPatient Safety Research and Initiatives
DescriptionMedication error reports submitted by healthcare practitioners and patients to the Institute for Safe Medication Practices (ISMP) national error reporting programs continuously demonstrate the increased need for identifying and preventing safety risks before drug products reach the market and have the potential to cause patient harm. In many cases, harmful or potentially harmful medication errors involving the use of drug products could have been avoided had human factors principles been proactively applied and an assessment of potential risks been conducted. While healthcare practitioners can implement risk-reduction strategies to reduce the risk of error once a product has been on the market, or a drug manufacturer can make some retrospective, postmarket improvements, any potential risks with drug products should be identified and mitigated before they can result in harmful patient outcomes. The design, packaging, and labeling of a drug product should take into consideration the end users and how they will interact with the drug product in all potential areas of use, and should also incorporate high-leverage strategies to mitigate any safety risks, making it difficult for users to incorrectly use the product or induce harm.

During this presentation, the importance of considering human factors during the design and labeling process for drug products within the premarket setting will be illustrated through actual error examples that have been reported to ISMP. Scenarios will include reports involving use-related issues with drug-device combination products and confusing or error-prone medication packaging and/or labeling. Discussion of how these preventable medication errors could have been eliminated prior to introduction of the associated drug products to the market will also be addressed, as well as key considerations for how human factors practitioners can assist drug manufacturers in identifying and minimizing medication safety hazards.