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Clin Pharmacol Ther. 2007 Nov;82(5):566-71. Epub 2007 Apr 4.

Clinical pharmacology information in summaries of product characteristics and package inserts.

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  • 1Farmacia Arguello, Pharmaceutical Care Research Group, University of Granada, Leon, Spain.


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.

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