Medicines for older people

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The European Medicines Agency (EMA) plays an important role in ensuring that the needs of older people are taken into account in the development, approval and use of medicines in the European Union. This includes developing guidelines on how to address the specific requirements of older patients in medicine development programmes and improving the provision of information for those patients.

Older people are the fastest growing population group in Europe and are the main users of medicines

EMA has been undertaking various initiatives to ensure that the development, evaluation and safety monitoring of medicines take into account the unique considerations associated with older patients.

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Geriatric medicines strategy  

EMA published its geriatric medicines strategy in 2011 which sets out the Agency’s vision for better addressing the needs of older people in the development and evaluation of medicines, by building on its existing activities:

The strategy aims to:

  • ensure that the medicines used by older people are of high quality and are studied appropriately in the older population, throughout the medicinal product lifecycle;
  • improve the availability of information for older people on the use of medicines.

EMA has also set up a Geriatric Expert Group to advise the Agency and its Committee for Medicinal Products for Human Use (CHMP) on issues related to the elderly and to provide scientific advice to medicine developers.

Support for medicine development 

EMA develops scientific guidelines to help medicine developers address the specific requirements of older people in their medicine development programmes, including in the design and conduct of clinical trials:

In addition, EMA encourages medicine developers to address questions on developing medicines for use in the older population as part of scientific advice or in business-pipeline meetings.

EMA also aims to ensure that all of its scientific guidelines relevant for older patient populations take account of the needs of those patients. In 2013, the Agency published an analysis of the number of scientific guidelines that it reviewed and provided comments on to reflect the geriatric population between 2011 and 2013:

In 2006, EMA published a report on the extent to which CHMP guidelines and clinical trials supporting marketing authorisations address the needs of older people. This found adequate compliance with international requirements and made recommendations on how to improve the implementation of existing guidelines and update guidelines on the design and conduct of clinical trials:

Improving product information 

With the aim of improving product information and enabling informed prescription, EMA's CHMP has revised its assessment templates and guidance to assessors to improve clarity of geriatrics-specific issues. This should help:

  • increase focus on the relevance of data to geriatric populations during assessment;
  • ensure that the summary of product characteristics, the package leaflet and the European pubic assessment report reflect geriatric aspects appropriately and clearly.

The CHMP first updated the assessment template with clearer information on the number of elderly people involved in a medicine's clinical-trial programme and side effects in older patients in 2011.

It ran a pilot on a dedicated geriatric section in the Day 80 and Day 210 assessment templates with ten new medicines between May 2016 and March 2018. The CHMP will decide on inclusion of updates in the standard templates following an assessment of the pilot.

EMA has also prepared training on how to reflect information targeted at older patients in the summary of products characteristics:

In 2013, EMA published an analysis on how appropriately product information reflected data on the geriatric population in marketing authorisation applications submitted between 2011 and 2013:

Pharmacovigilance 

When evaluating marketing authorisation applications, EMA's CHMP considers if specific activities concerning aspects such as co-morbidities and the monitoring of specific side effects associated with older patients should be included in the risk management plan or as post-authorisation measures.

EMA is also developing a specific module of the guideline on good pharmacovigilance practices (GVP) which will address the specific needs of the geriatric population. EMA expects to publish this module in the second quarter of 2018.

Stakeholder meetings 

EMA engages with regulatory authorities, pharmaceutical companies and organisations representing the interests of elderly people in Europe and beyond, such as AGE Platform Europe and the European Union Geriatric Medicine Society (EUGMS).

EMA organises workshops which address the needs of older populations in medicine development and use:

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Related content

Leaflet: Improving medicines for older people

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