EMA acts its age: drug development push for older populations

In a reflection paper​ published August 1, the European Medicines Agency (EMA) said it is inviting public comment on how medicine developers can better address the needs of older populations.

“Depending on the outcome of the public consultation, the content of the reflection paper might be furthered into regulatory or scientific guidance,”​ said the Agency.

A growing need​

According to EU statistics provider Eurostat​, the older population in the EU is expected to grow from approximately 84 million in 2008 to around 141 million by 2050.

Annie-Sophie Patent from AGE Platform Europe – a non-profit organisation representing the needs of older people – told us there is disparity between life expectancy and wellness.

“We know that life expectancy is increasing, but healthy life expectancy is not increasing in parallel.”​

“Therefore, we can expect to face disability, or chronic illness, and a need to take several medications, for an increasing number of years,” ​she said. 

Similarly, the EMA said the development of tailored medicines is timely.

“It is essential that the needs of older (and especially frail) people are duly considered in the pharmaceutical development of medicines that may be used in the older population,” ​said the Agency.

Packaging, dosing, swallowability ​

Despite this increased need for tailored medication, the EMA said medicines are rarely developed or packaged with older populations’ specific needs in mind, which it says puts older people at risk.

“Some older people can’t face challenges such as difficulty opening boxes or bottles, reading instructions, or 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.”  ​ 

Peter Passmore from the British Geriatrics Society also said the administration of drugs for older populations is an issue.

“Any difficulty with medication administration can mean that management of patients’ conditions can be less than optimal,” ​Passmore told us.

“Thus, the tailored development of medication, with a preference for oral and liquid preparations of the use of topical medication, is important,” ​he added.

The EMA welcomes comments on routes of administration, dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information.