TY - JOUR
T1 - A survey of geriatric expertise in medicines evaluation at national regulatory agencies in Europe
T2 - There is still room for improvement!
AU - Perehudoff, K.
AU - Petrovic, M.
AU - O'Neill, D.
AU - Cherubini, A.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
KW - Drug
KW - Europe
KW - Geriatrician
KW - Geriatrics
KW - National regulatory agency
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U2 - 10.1016/j.eurger.2016.07.003
DO - 10.1016/j.eurger.2016.07.003
M3 - Article
AN - SCOPUS:84992179505
VL - 7
SP - 430
EP - 433
JO - European Geriatric Medicine
JF - European Geriatric Medicine
SN - 1878-7649
IS - 5
ER -