Drug policy for an aging population--the European Medicines Agency's geriatric medicines strategy.

I almost every country, the proportion of people over 60 years of age is growing faster than any other age group, as a result of longer life expectancy and declining fertility rates. In Europe, the median age is already the highest in the world, and in 2050 there are projected to be 88.5 million Americans 65 years old or older — more than double the 40.3 million in the 2010 census. Although population aging is a mark of the success of public health policies, it also challenges the established way of implementing such policies. In the case of the European Medicines Agency (EMA), it has prompted an analysis of whether the regulatory system is adapted to taking the needs of older people into account in the development, approval, and use of medications. The process started in 2006, when the EMA provided an opinion on the adequacy of guidance on the elderly regarding medicinal products. In 2011, the agency’s Committee for Human Medicinal Products adopted the EMA geriatric medicines strategy,1 marking its commitment to improving our understanding of how best to evaluate the benefit–risk ratio for a medication in older patients. First, the strategy recognizes that older people are the main users of medications — not a minority or special population (a fundamental difference between the geriatric and pediatric populations). Therefore, legislative and regulatory frameworks must be designed to ensure that the use of newly approved medicines in the intended population is supported by relevant data on the benefit–risk balance. The strategy’s second aim is to improve the availability of information to patients and prescribers, to support safer use of medications. Analysis of the data submitted in support of recent applications for marketing authorization shows that the current regulatory environment has ensured reasonable representation of “younger old” patients, but drug-usage patterns reveal a high prevalence of use in “older old” patients (see graph). Patients who are 75 years old or older often present a complex picture involving coexisting conditions and frailty: they are the fastest-growing demographic group but are largely underrepresented in clinical trials given their disproportionately high actual use of drugs. This imbalance will make it increasingly difficult and potentially inappropriate to extrapolate data to these patients.2 Though trials are less likely to set unjustified age limits than they were a few decades ago, this improvement must be considered in the context of a rapidly aging population and the continued widespread use of exclusion criteria based on coexisting conditions. Corrective efforts must be maintained to ensure that a representative population of patients covering the entire age range is studied in the preauthorization phase, in accordance with international guidelines.3 Chronologic age alone is inadequate for characterizing the population enrolled in a clinical trial. Frailty is a predictor of clinical outcomes,4 and the reduction of frailty has benefits for individuals and society. The EMA is exploring the possibility of reaching a consensus on an operational definition of frailty and tools for evaluating it that could be used for clinical research and to guide therapeutic decisions. Medications commonly prescribed to treat other conditions jections for back and joint pain, a procedure that lacks high-quality evidence of efficacy.4,5 These problems cannot be laid entirely at the feet of compounders when clinicians persist in clinical practices despite weak evidence of efficacy.