EMA highlights multiple considerations when developing drugs for older adults

Regulatory NewsRegulatory News | 23 October 2020 |  By 

In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling.

But the sole focus should not be on chronological age since patients of any age may experience similar needs or impairments. “For example, the need for an easy to open package is relevant for rheumatic patients of any age, and dysphagia can occur in conditions such as multiple sclerosis which can affect both younger and older people,” the EMA wrote.

The EMA urged developers to take a “patient-centric approach” whenever possible.

The reflection paper was adopted by the EMA’s Committee on Medicinal Products for Human Use on 15 October 2020 and will take effect on 01 May 2021. The paper, which is intended to communicate the current status of discussions on the development of medicines that may be used in an older population, was first released as a draft in 2017.

The document highlights patient acceptability – the ability and willingness to self-administer medication -- as a key consideration for older patients. The document lists several product characteristics that influence patient acceptability in older patients, including route of administration, dosage form, site of administration, swallowability, palatability, dosing frequency, shelf life and ease of preparation, among others.

Drug sponsors can demonstrate patient acceptability in a variety of ways, such as using data from clinical trials, representative simulated use studies, human factor studies with healthy volunteers or patients, market experiences, and scientific literature. The selection of the method is left to the companies, according to the EMA, but companies will need to justify their approach. “This justification would include consideration of the risk of poor adherence, any alternative administration strategies and medication errors,” the EMA wrote in the reflection paper.

Container closure systems were also highlighted in the paper. The EMA noted that older people may have difficulty opening containers due to lack of strength and difficulties understanding the necessary handling. Drug sponsors need to account for possible “coping strategies” patients may adopt to get around these difficulties, such as changing the dosing frequency to correspond with caregiver visits or asking someone else to open the medication and leaving it open. These actions have the potential to affect the product’s stability and alter the medicine’s safety and effectiveness.

The issue of polypharmacy was also tackled in the reflections document. Since older patients are often on multiple medications, drug sponsors need to take into consideration that drug-drug interactions and complex dosing regimes may mean medication choice and dosing need adjustment in older individuals. All parties, said the agency, need to consider “the added burden of another medicinal product on the complexity of the overall therapy in an older person.”  

“It is important that the added burden of another medicinal product on the complexity of the overall therapy in an older person is carefully considered by all of the relevant stakeholder parties,” EMA wrote in the document. “Understanding of the considerations of other parties and working practices is likely to assist in deciding on measures to ease medication management e.g. by use of medication reviews and error reporting systems in pharmacy.”


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