Research paperA survey of geriatric expertise in medicines evaluation at national regulatory agencies in Europe: There is still room for improvement!
Introduction
Older people are the main users of drugs in Europe which consequently underlines the need for greater attention to the heightened risks associated with the use of medicines [1], [2]. These heightened risks are frequently associated with multiple chronic diseases affecting older people that often result in polypharmacy. Potentially inappropriate prescribing, or the prescription of medicines for which the risks outweigh the benefits, occurs frequently in older people [3], [4], [5]. In spite of the above mentioned risks, relatively little data is generated about the efficacy and safety of medicines in older people. Older people, particularly those aged 75 years and older, are often underrepresented in clinical trials [6], [7], [8]. Those older people who are included in clinical trials seldom represent the complexity of patients with multimorbidity and/or frailty who need multiple medicines at the same time. Consequently, the evidence base for drug licensing and clinical practice in older people is weak. Moreover, it is inappropriate to expose patients to the risks of medicines based on how they work in a demonstrably different (i.e. younger, more robust) patient population. In the European Union (EU), all medicines must be authorised before they can be marketed and made available to patients. There are two main routes for authorising medicines: a centralised route and a national route.
The European Medicines Agency (EMA) is an agency of the European Union (EU) and it is responsible for the authorisation of medicines that are managed through the central authorisation procedure. The centralised procedure is compulsory for: (1) human medicines containing a new active substance to treat human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS); cancer; diabetes; neurodegenerative diseases; auto-immune and other immune dysfunctions; viral diseases; (2) medicines derived from biotechnology processes, such as genetic engineering; (3) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines; (4) orphan medicines (medicines for rare diseases). The centralised procedure is optional for other medicines: (1) containing new active substances for indications other than those stated above; (2) that are a significant therapeutic, scientific or technical innovation; (3) whose authorisation would be in the interest of public or animal health at EU level.
National competent authorities, on the other side, are responsible for the authorisation of many of the medicines available in Europe that are not authorised by the European Commission on the recommendation of the EMA. The majority of medicines currently available in the EU were authorised at national level, either because they were authorised before EMA's creation or they were not in the scope of the centralised procedure. Each EU Member State has its own national authorisation procedures.
At a European level, the European Union Geriatric Medicine Society (EUGMS) has played an important role in raising the awareness on the need of a better evaluation of drugs in older patients [9].
In 2011, Martin et al. published a survey of 31 European regulatory agencies (with a response rate of 21/31, i.e. 68%) to understand if and how geriatric expertise was systematically incorporated in the evaluation of license applications. At that time, 90% percent of the national European agencies had neither committees nor policies for medicines use by older people [10].
The purpose of this study is to understand how the involvement of geriatric expertise has changed among national regulatory agencies in Europe since the baseline survey.
Section snippets
Methods
A follow-up closed-question survey was developed by the authors to investigating geriatric expertise availability in the committees and policies of national regulatory agencies, specifically policies on clinical trials inclusion and exclusion criteria, and the role of geriatricians at the agencies. The presence of geriatric expertise in in-house committees and policies were compared to answers for paediatric expertise, which served as a ‘control’ group. We chose paediatric regulatory measures
Results
Representatives of 16 national regulatory authorities answered (response rate 73%). An overview of responses by agency can be found in Table 1.
Only one out of 16 agencies (6% of respondents), i.e. the Swedish Medicines Authority, has a specific committee to evaluate medicines for use by older people. This committee for older people was established in 2012 and includes geriatricians as members. In the Dutch and Hungarian regulatory agencies (13% of respondents), there are discussions underway to
Discussion
Since the first survey by Martin et al. [10], the present study shows that geriatric expertise is still underrepresented in national regulatory agencies in Europe. Only one agency has a committee for reviewing medicines used by older people; this is down from two agencies reported in the first study. Two agencies have a binding policy for the evaluation of medicines relating to older people and this has remained the same since the initial survey. In spite of few internal policies for geriatric
Conclusion
Few national agencies have dedicated committees (6%) and policies (13%) to regulate medicines for older people, and these measures are still dwarfed by comparable regulatory measures for paediatric medicines. Moreover, the use of geriatric expertise in still inadequate, even in those Agencies that do have access to geriatricians. Without dedicated committees with geriatricians as members and policies for evaluating medicines for older people, their unique clinical needs and the challenges of
Disclosure of interest
The authors declare that they have no competing interest.
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