Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population
British Journal of Clinical Pharmacology, vol. 88, pp. 1500–1514
Abstract
Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease-related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice.
Authors 11
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Diana A. van Riet‐Nales corresponding
Affiliation as printed
Department of Chemical Pharmaceutical Assessments Medicines Evaluation Board (MEB) Utrecht Netherlands
Department of Chemical Pharmaceutical Assessments, Medicines Evaluation Board (MEB), Utrecht, Netherlands
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Bart J. F. van den Bemt corresponding
Radboud University Nijmegen · Radboud University Medical Center · Sint Maartenskliniek · Sint Maartenskliniek
Affiliation as printed
Department of Pharmacy Radboud University Medical Center Nijmegen Netherlands
Department of Pharmacy Sint Maartenskliniek Ubbergen Netherlands
Department of Pharmacy, Radboud University Medical Center, Nijmegen, Netherlands
Department of Pharmacy, Sint Maartenskliniek, Ubbergen, Netherlands
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David van Bodegom Aachen Department Public Health and Primary Care Leiden University Medical Centre Leiden Netherlands Department Public Health and Primary Care Public Health and Primary Care
Leiden University · Leiden University Medical Center · Leyden Academy on Vitality and Ageing
Affiliation as printed
Department Public Health and Primary Care Leiden University Medical Centre Leiden Netherlands
Public Health and Primary Care Leyden Academy on Vitality and Ageing Leiden Netherlands
Department Public Health and Primary Care, Leiden University Medical Centre, Leiden, Netherlands
Public Health and Primary Care, Leyden Academy on Vitality and Ageing, Leiden, Netherlands
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Affiliation as printed
Scientific Evidence Generation Department, Human Medicines Division European Medicines Agency Amsterdam Netherlands
Scientific Evidence Generation Department, Human Medicines Division, European Medicines Agency, Amsterdam, Netherlands
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Affiliation as printed
Quality Department Swissmedic Basel Switzerland
Quality Department, Swissmedic, Basel, Switzerland
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State Institute for Drug Control
Affiliation as printed
Department of Pharmaceutical Assessment of Chemical and Herbal Products State Institute for Drug Control (SUKL) Prague Czech Republic
Department of Pharmaceutical Assessment of Chemical and Herbal Products, State Institute for Drug Control (SUKL), Prague, Czech Republic
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University Medical Center Utrecht · Medicines Evaluation Board
Affiliation as printed
Department of Chemical Pharmaceutical Assessments Medicines Evaluation Board (MEB) Utrecht Netherlands
Expertise Centre Pharmacotherapy in Old Persons (EPHOR) Utrecht Netherlands
Geriatric Department University Medical Center Utrecht Netherlands
Department of Chemical Pharmaceutical Assessments, Medicines Evaluation Board (MEB), Utrecht, Netherlands
Expertise Centre Pharmacotherapy in Old Persons (EPHOR), Utrecht, Netherlands
Geriatric Department, University Medical Center, Utrecht, Netherlands
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Affiliation as printed
Department of Clinical Pharmacy OLVG Hospital Amsterdam Netherlands
Department of Clinical Pharmacy, OLVG Hospital, Amsterdam, Netherlands
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Medicines and Healthcare products Regulatory Agency
Affiliation as printed
Medicines and Healthcare Products Regulatory Agency London UK
Medicines and Healthcare Products Regulatory Agency, London, UK
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Affiliation as printed
Department of Chemical Pharmaceutical Assessments Medicines Evaluation Board (MEB) Utrecht Netherlands
Department of Chemical Pharmaceutical Assessments, Medicines Evaluation Board (MEB), Utrecht, Netherlands
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Affiliation as printed
Institute of Process and Particle Engineering Graz University of Technology Graz Austria
Institute of Process and Particle Engineering, Graz University of Technology, Graz, Austria
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