Clinical Pharmacology Information in Summaries of Product Characteristics and Package Inserts B Arguello 1 and F Fernandez-Llimos 2,3 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. In the European Union, there are two different sources of drug information: package inserts and summaries of product characteristics (SPCs). The first is addressed to patients, and the second to health-care professionals. These different targets should be accompanied by different standards in language and comprehensiveness. Although physicians and pharmacists should sufficiently inform their patients, the package inserts provide written information that can be referred by the patient. 1 Patients must be made aware of the importance of complying with treatment and should be informed about the possible risks and how to react in case they occur. 2 In this regard, the written material enclosed with every medicine provides highly accessible and what should be complete and accurate information for future consultation. In the European Union, a patient package insert is mandatory for every medicine, and the information it contains must be in accordance with the SPC. The European Union regulates both the information and the structure of patient package inserts, which must be approved by a competent Health Authority. 3 As package inserts are intended for patients, extensive scientific information is not required, but the information included must be legible and written in concise and easy-to-understand terms. 4 In 2002, a report from the G10 Medicines Group to the European Commission recommended the improvement of such information for patients. 5 European package inserts have been criticized not only because the information is frequently inconsistent and incomprehensible, 6–8 but also because they often lack information that is essential for the patient. 9 The SPC is the information source addressed to health- care professionals, 10 and the information that it must contain is clearly defined by European Union regulations. A proposal describing the SPC must be included in the application dossier accompanying a medicine under consideration for approval by the European Union Medicines Agencies. 11 Moreover, SPCs must be regularly updated and the modifications must also be approved by regulatory agencies. Nonetheless, European SPCs have been criticized for their incomplete and confusing information. 12–14 Our hypothesis was that clinical pharmacology informa- tion in European SPCs is more complete than the one in European patient package inserts, but is similar to US package inserts in the Physicians’ Desk Reference (PDR). The objective of this study was to assess clinical pharmacology information found in SPCs of European drugs and to compare it with information in their package inserts. RESULTS From the initial list of 150 drugs, 42 were excluded: 26 drugs were considered duplicates because they differed slightly with respect to dose or pharmaceutical form (but not in their ARTICLES nature publishing group Received 11 December 2006; accepted 19 February 2007; published online 4 April 2007. doi:10.1038/sj.clpt.6100198 1 Farmacia Arguello, Pharmaceutical Care Research Group, University of Granada, Leon, Spain; 2 Department of Social Pharmacy, University of Lisbon, Portugal, Spain; 3 Pharmaceutical Care Research Group, University of Granada, Spain. Correspondence: F Fernandez-Llimos (f-llimos@cipf-es.org) 566 VOLUME 82 NUMBER 5 | NOVEMBER 2007 | www.nature.com/cpt