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QJM. 2016 May; 109(5): 363.
Published online 2016 January 19. doi:  10.1093/qjmed/hcv225
PMCID: PMC4888331

Approval for medicines in older people—time for a more focused approach

A. Cherubini,corresponding author1 M. Petrovic,2 D. O’Neill,3 and on Behalf of the EUGMS Pharmacology Special Interest Group4

The proportion of people aged >65 years in the European Union is expected to rise from 84 million in 2008 to 141 million by 2050.1 Older people are the main consumers of medicines.2 The use of medicines in advanced age is associated with increased risks from age-related changes in pharmacokinetics, pharmacodynamics, multimorbidity and polypharmacy. Polypharmacy is the most consistent predictor of drug-related problems (DRPs) such as drug use without an indication, adverse drug interactions, subtherapeutic dosage, overdosage, non-compliance and adverse drug reactions. DRPs occur frequently in both community-dwelling older people and nursing home residents.

Despite these risks, little data have been generated about the efficacy and safety of medicines in older people. Older people, particularly multimorbid and/or frail patients who consume multiple medicines, are underrepresented in clinical trials,3 so the evidence base for drug licensing and clinical practice is deficient.

To address these complexities, regulatory processes to license a medicine should take into consideration the specific clinical needs of older people. One mechanism is to involve geriatricians in the drug evaluation process. In 2011, the European Medicines Agency convened a Geriatric Expert Group to provide scientific advice on geriatric aspects of drug development and safety monitoring.

This expertise needs to be replicated at a national level. In a 2009 survey of 31 national regulatory agencies across Europe, 90% of respondents had neither committees nor policies for medicine use by older people.4 We undertook follow-up closed-question survey to determine whether the involvement of geriatric expertise has improved since 2009; 16 of 21 responses were collected (84%).

The results show that few national agencies in 2015 have dedicated committees (6%) and policies (13%) to regulate medicines for older people. However, compared with 2009, nearly twice as many agencies (50% at present) involve geriatricians in their medical advisory boards and most boards (75%) can seek ad hoc advice from geriatricians. More than one-third (37%) follow a policy on the inclusion of older people in clinical trials: 60% of these policies prohibit exclusion of trial participants on the basis of age, compared with 24% in 2009.

In order to assure appropriate prescribing to older people, the information about medicines gathered during the pre-approval and post-approval trials needs to be assessed for applicability to older patients in everyday practice. In that sense, much can still be done to involve geriatric expertise in medicine evaluation in Europe to make the process more age-attuned.


2. Onder G, Bonassi S, Abbatecola AM, Folino-Gallo P, Lapi F, Marchionni N., et al. High prevalence of poor drug prescribing in older individuals: a nationwide report from the Italian Medicines Agency (AIFA). J Gerontol A Bio Sci Med Sci 2014; 69:430–7. [PubMed]
3. Cherubini A, Oristrell J, Pla X, Ruggiero C, Ferretti R, Diestre G., et al. The persistent exclusion of older patients from ongoing clinical trials regarding heart failure. Arch Intern Med 2011; 171:550–6. [PubMed]
4. Martin R, Cherubini A, O’Neill D. Medical licencing for older people. Eur Geriatr Med 2011; 2:319–21.

Articles from QJM: An International Journal of Medicine are provided here courtesy of Oxford University Press