Clinical pharmacology information in summaries of product characteristics and package inserts

• Type: Article in International Scientific Journal
• Date: 2007

Authors

Arguello, B (Author) Other; Fernandez Llimos, F (Author) Other

Journal

Title: CLINICAL PHARMACOLOGY & THERAPEUTICS

Vol. 82

Pages: 566-571

ISSN: 0009-9236

Publisher: Wiley-Blackwell

Indexing

ISI Web of Knowledge - 17 Citations

Scopus - 17 Citations

Other information

Authenticus ID: P-004-6ED

DOI: 10.1038/sj.clpt.6100198

Abstract (EN): The aim of the study was to assess the clinical pharmacology information provided in the summaries of product characteristics (SPCs) of European drugs compared with their package inserts. A list of the 150 most prescribed drugs at the local Health Service was assessed. To analyze clinical pharmacology information contained in package inserts and SPCs, Spyker's systematized scoring approach was used (scoring from 0 to 2). Ninety-one SPCs (84.3%) and 108 package inserts were obtained. The mean score for core information provided in the package inserts was 7.94 (confidence interval (CI) 95%: 7.34-8.53), whereas for the SPCs it was 17.62 (CI 95%: 16.48 - 18.75; 35.2% of the maximum). One core information item and two extra credit items were not contained in any of the SPCs. In the European Union the clinical pharmacology information found in SPCs is clearly insufficient. An improved access to and regular review of the SPCs might substantially improve the access and quality of clinical pharmacology and other prescribing information.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 6