Medicines for older people
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.
EMA's geriatric medicines strategy 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 published the strategy in 2011.
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.
Scientific guidelines are available 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:
- Physical frailty: instruments for baseline characterisation of older populations in clinical trials
- Pharmaceutical development of medicines for use in the older population
- ICH E7 Studies in support of special populations: geriatrics
- ICH E7 Studies in support of special populations: geriatrics - questions and answers
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:
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 public 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:
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 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:
- EMA - Payer community meeting (19/9/2017)
- EMA/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products (4/12/2014 - 5/12/2014)
- Seventh stakeholders' forum on the implementation of the new pharmacovigilance legislation (27/9/2013)
- European Union regulatory workshop on medication errors(28/2/2013 - 1/3/2013)
- EMA workshop on medicines for older people (22-23/3/2012)
- Brain diseases in the elderly (16-17/5/2008)
- Second EMA workshop on neurodegenerative diseases: Focus on dementia (11/2/2008)
- European Medicines Agency workshop on slowing the progression of neurodegenerative diseases(2/10/2006)
- Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population
- Roadmap to 2030 for Drug Evaluation in Older Adults
- Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
- Medication use among older people in Europe: Implications for regulatory assessment and co-prescription of new medicines
- New harmonized considerations on the evaluation instruments for baseline characterisation of frailty in the European Union
- Medicines for older people. Assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products
- Product information and older people: how to assist informed prescription and safe therapeutic use?
- Adherence measurement systems and technology for medications in older patient populations
- Drug policy for an aging population — The European Medicines Agency's geriatric medicines strategy
- Promoting access to innovation for frail old persons. IAGG (International Association of Gerontology and Geriatrics), WHO (World Health Organization) and SFGG (Société Française de Gériatrie et de Gérontologie) Workshop
- Regulatory activities to address the needs of older patients
- Baseline frailty evaluation in drug development
- Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects
- Regulatory considerations on the enrollment of older adults in oncology clinical trials