The European Medicines Agency (EMA) is issuing new guidance focusing on the potential for newly-formulated or altered medicinal products to harm patients through substitution, mix-ups and errors.
In a 4 June position paper, EMA notes products frequently come onto the market with changes made to a referenced drug. These changes can include variations to the formulation, presentation, route of administration, strength or composition and indications of a medicinal product. While these products contain the same active pharmaceutical ingredient (API) at the original drug, the variations in the products represent the potential for patient harm if prescribed or used incorrectly.
EMA said it was issuing the position paper in the hopes of providing guidance to sponsors on how to weigh the risks and benefits of reformulated and altered products and how to address the potential medication errors resulting from those changes.
There are a number of benefits to changing medications, explains EMA in the guidance. These benefits include higher-quality products, improved product stability, safer products, products which are more user-friendly, and products with additional economic benefits (multi-use instead of single use preparations capable of reducing waste, for example).
However, these benefits can be outweighed by a number of potential harms which are unique to each medication. Risks can include incorrect dosing, the range of a product's therapeutic index being too narrow for easy substitution, the populations likely to be using the product being particularly susceptible to harm (e.g. pregnant or immune-compromised patients), self-administering a product without the instructions for use, and a product being too difficult to administer.
These risks are not insurmountable, but do require a well-thought-out risk minimization and monitoring strategy or strategies to assist patients and healthcare providers to prevent medication errors. EMA recommends companies utilize user testing, institute clear labeling and package leaflets, train pharmacists and healthcare professionals regarding changes, and monitor any medication errors or adverse reactions for trends resulting from the medication changes.
"It will be important that the applicant is able to justify [a modified drug] application by demonstrating a prevailing benefit to counterbalance the potential product-associated increased risk of medication error," writes EMA.
EMA - Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures