A survey of geriatric expertise in medicines evaluation at national regulatory agencies in Europe: There is still room for improvement!

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• 作者：K. Perehudoff^a ; M. Petrovic^b ; D. O&rsquo ; Neill^c ; A. Cherubini^d ; ^{a.cherubini@inrca.it" class="auth_mail" title="E-mail the corresponding author} ; On behalf of the EUGMS Pharmacology Special Interest Group¹
• 关键词：National regulatory agency ; Geriatrics ; Drug ; Geriatrician ; Europe
• 刊名：European Geriatric Medicine
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：7
• 期：5
• 页码：430-433
• 全文大小：270 K

文摘

We investigated geriatric medicine input in national regulatory medicine licensing agencies across Europe, focusing on changes occurred since a previous survey published in 2011. A questionnaire was mailed to 22 national regulatory agencies in 2014. Four reminders followed: 16/22 (73%) answered. Currently only one agency (6%), i.e. the Swedish Medicines Authority, has a specific committee to evaluate medicines for older people, while previously, 2/21 agencies (10%) had a specific committee to assess medicines used by older people. The Swedish and Dutch regulatory agencies (13%) have binding policy on how to assess medicines for older people. On the other hand, nine national agencies (56%) follow external policies for the evaluation of geriatric medicines. Six agencies (38%) follow a policy concerning the inclusion of older people in clinical trials. Eight agencies (50%) have at least one geriatrician on their medical advisory boards, although this position is permanent at only three of them. Twelve agencies (75%) have access to ad-hoc geriatric advice. Compared to the previous survey, 6/21 agencies (28%) had a geriatrician on their medical advisory boards and 10/21 (48%) agencies provided for ad-hoc input of geriatricians into advisory board discussions. Finally, three regulatory authorities (19%), involve geriatricians in research on drug prescription in older people. This survey demonstrates that, despite some improvement from the previous investigation, there is still a need for promoting a greater involvement of geriatric expertise in medicines evaluation across Europe.