Medicinal products for geriatric patients in Germany : Current status of regulatory requirements and clinical reality.

ABSTRACT

BACKGROUND: Geriatric patients are the main users of medicinal products, although this patient group is most commonly excluded from clinical trials. Several guidelines from the International Conference on Harmonisation (ICH) and the European Medicines Agency (EMA) have tried to ensure the development and the safe use of medicines for geriatric patients. OBJECTIVE: This article aims to evaluate geriatric information provided by the summary of product characteristics (SmPC) to prescribers using relevant medicinal products in Germany for patients older than 65 years. MATERIAL AND METHODS: Based on the annually published drug prescription report (Arzneiverordnungsreport), medication which was prescribed mainly (above 80%) or at a high defined daily dose (DDD [doses per day] > 400) to patients older than 65 years in 2016 was reviewed regarding relevant geriatric information. RESULTS: The average compliance for the investigated drugs regarding geriatric information according to EMA guidelines is 27%. At least older patients are mentioned in the SmPC most frequently (68%). Information about doses or dose adjustments for patients with certain stages of frailty was not provided by the pharmaceutical companies. CONCLUSION: Current information in the SmPC for a safe and effective use of medicines for older patients is insufficient and does not conform to EMA guidelines. Compared to drug authorization in pediatrics where the industry is obliged to submit a special pediatric investigation plan (PIP) to cover the needs of this certain patient group, a mandatory geriatric investigation plan (GIP) similar to the PIP would be an appropriate measure to provide safe and effective medicines for older patients.