Masterstudiengang "Drug Regulatory Affairs"


Medicinal products for geriatric patients in Germany - Current status of regulatory requirements and clinical reality ***

Gabriele Gempel-Drey (Abschlußjahr: 2017)

Language: English
Due to the significant increase in life expectancy over the past century, the proportion of people aged 65 years or over will increase significantly in the coming decades. Therefore access to safe and effective medicines for these patients is of high importance and needs to be considered in the development and testing of geriatric medicinal products.
As ageing changes human organ and body functions, older people are different from young or middle-aged adults in many ways. In addition, the elderly are more susceptible to diseases and have a higher risk for multiple medication use and polypharmacy with increasing age.
Regulatory agencies started to ask for inclusion of geriatric patients in clinical trials since the late 1980s. In 1993, the International Conference on Harmonisation (ICH) published the efficacy guideline E7 "Studies in Support of Special Populations: Geriatrics". In 2006, the European Medicines Agency introduced regulatory guidelines for medicinal products for geriatric patients and adopted in 2011 the "EMA Geriatric Medicines Strategy" to ensure that geriatric medicines are of high quality and appropriately tested in the elderly, as well as to improve the availability of information on geriatric medicines (informed prescription). In 2015, the "Points to Consider on Frailty" was introduced to encourage recruitment of frail patients into clinical trials.
The objective of this master thesis is to evaluate the prescriber information in the SmPC (of medicinal products mainly prescribed to patients older than 65 years) with respect to a safe and effective use in older patients
In summary, 33 medicinal products fairly exclusively prescribed to patients older than 65 years, determined from the "Arzneimittelverschreibungsreport 2016" were evaluated for information necessary for an appropriate prescription to older people. The overall result of the survey is that the information included SmPCs is incomplete, with a positive availability of 33%.
More than 82% medicines mention older patients in their SmPC and 62% inform about the drug dosage and if necessary dose adjustments for the elderly. But information about pharmacokinetic data or clinical trials with older patients of different age groups seem to depend partly on the age of the drugs marketing authorization.
However, sufficient data in the SmPC for a safe and effective prescription to geriatric patients needs to be available for the prescribers because in clinical practice, the dilemma of treating elderly patients with multiple chronic conditions without recommendations in the SmPC results in approaches such as the German PRISCUS- and FORTA (Fit for the Aged) list. Both lists have been established by physicians by experience and are not based on clinical trial data of the pharmaceutical companies.
To improve this situation, the competent authorities for marketing authorizations of medicinal products need to clarify their requirements (e.g., Points to Consider on Frailty) and provide further guidances to ensure a better development and testing of drugs in older patients. Furthermore, a mandatory Geriatric Investigation Plan (GIP) similar to the Paediatric Investigation Plan (PIP) would be an appropriate measure to ensure safe and effective medicines for the elderly.
Pages: 56, Annexes: pages: 28