Overall, older people are the highest users of medicines. According to the Eurostat data, they are expected to make up nearly a third of Europeans by 2050. Although older people take much more medicines than the rest of the population, the pharmaceutical companies rarely take into account their specific needs when developing, producing and packaging medicines. For instance, some older people may experience challenges such as difficulty opening boxes or bottles, reading instructions, swallowing or breaking tablets and capsules. All these aspects may lead to the fact that patients do not take medicines as intended. Such medication errors ultimately reduce the quality of life.
The reflection paper describes aspects that pharmaceutical companies may consider when designing medicines for older people, such as choosing appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and clear user instructions in the product information.
As for example, when there is evidence that older patients find it tough to break a tablet by hand, medicine developers should find innovative ways to improve the breakability of the tablet or probably consider another route of administration, such as small tablets in a dose dispenser. Similarly, pharmaceutical companies may think about re-designing the containers so that older people can open them easily without any assistance.
The EMA is inviting comments from the public on this reflection paper. Comments are particularly welcome on the accuracy of tablet breaking, the administration of medicines through feeding tubes, and multiple drug dispensing systems (containers that clearly say the name of the day or the moment when a medicine should be taken). Depending on the result of the public consultation, the content of the reflection paper may be changed and further developed into regulatory or scientific guidance.