EMA invites comments on reflection paper by 31 January 2018

The European Medicines Agency (EMA) is inviting comments from the public on a reflection paper on how medicine developers can better address the needs of older people who take medicines.

In general, older people are the highest users of medicines. According to Eurostat, they are expected to make up almost a third of all Europeans by 2050, and they take more medicines than the rest of the population. Yet, medicines are rarely developed or packaged to take into account their specific needs. For example, some older people can face challenges such as difficulty opening boxes or bottles, reading instructions, swallowing or breaking tablets and capsules, which can result in medicines not being taken as intended, medication errors and ultimately a reduced quality of life.

The reflection paper describes aspects that medicines developers may consider when designing medicines for older people, such as selecting appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information.

For example, when there is evidence that older people find it difficult to break a tablet by hand, companies may find ways to improve the breakability of the tablet or consider alternative administration approaches, such as small tablets in a dose dispenser. Similarly, companies may consider re-designing the containers so that older patients can open them easily without any assistance.

Comments are particularly invited on the accuracy of tablet breaking, the administration of medicines through feeding tubes, and on multiple compliance aids and multiple drug dispensing systems (containers that clearly state the name of the day or the moment when a medicine needs to be administrated).

Depending on the outcome of the public consultation, the content of the reflection paper might be further developed into regulatory or scientific guidance.