Skip to main content
main-content

Tipp

Weitere Artikel dieser Ausgabe durch Wischen aufrufen

30.04.2019 | Original Contribution

Medicinal products for geriatric patients in Germany

Current status of regulatory requirements and clinical reality

Zeitschrift:
Zeitschrift für Gerontologie und Geriatrie
Autoren:
Gabriele Gempel-Drey, Michael Drey

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.

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Sie möchten Zugang zu diesem Inhalt erhalten? Dann informieren Sie sich jetzt über unsere Produkte:

Zeitschrift für Gerontologie und Geriatrie

Print-Titel

• Themenbezogene Hefte behandeln Fragen der Gerontologie, der Biologie und Grundlagenforschung des Alterns und der geriatrischen Forschung

• Erweitert mit Beiträgen zu Therapie, Psychologie und Soziologie sowie der praktischen Altenpflege.  

• Hot topics von Experten knapp, aussagekräftig und provokativ kommentiert

Literatur
Über diesen Artikel