TY - JOUR
T1 - Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population
AU - van Riet-Nales, Diana A.
AU - van den Bemt, Bart
AU - van Bodegom, David
AU - Cerreta, Francesca
AU - Dooley, Brian
AU - Eggenschwyler, Doris
AU - Hirschlérova, Blanka
AU - Jansen, Paul A.F.
AU - Karapinar-Çarkit, Fatma
AU - Moran, Abigail
AU - Span, Jan
AU - Stegemann, Sven
AU - Sundberg, Katarina
N1 - Publisher Copyright:
© 2022 British Pharmacological Society
PY - 2022/4
Y1 - 2022/4
N2 - 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.
AB - 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.
KW - drug delivery
KW - drug regulation
KW - drug safety
KW - health policy
KW - public health
UR - http://www.scopus.com/inward/record.url?scp=85124623399&partnerID=8YFLogxK
U2 - 10.1111/bcp.15207
DO - 10.1111/bcp.15207
M3 - Article
AN - SCOPUS:85124623399
SN - 0306-5251
VL - 88
SP - 1500
EP - 1514
JO - British Journal of Clinical Pharmacology
JF - British Journal of Clinical Pharmacology
IS - 4
ER -