Objective. To compare United States and European Higher Education Area (EHEA) undergraduate pharmacy curricula in terms of patient-centered care courses. Methods. Websites from all pharmacy colleges or schools in the United States and the 41 countries in the EHEA were retrieved from the FIP Official World List of Pharmacy Schools and investigated. A random sample of schools was selected and, based on analyses of course descriptions from syllabi, each course was classified into the following categories: social/behavioral/administrative pharmacy sciences, clinical sciences, experiential, or other/basic sciences. Results. Of 147 schools of pharmacy, 59 were included (23 in US and 36 in the EHEA). Differences existed in the percentages of credits/hours in all of the four subject area categories. Conclusion. Institutions in EHEA countries maintain a greater focus on basic sciences and a lower load of clinical sciences in pharmacy curricula compared to the United States. These differences may not be in accordance with international recommendations to educate future pharmacists focused on patient care.

AIMSTo assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODSSmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. RESULTSOf the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. CONCLUSIONSImportant information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Reliable information regarding the use of many medicines during pregnancy is critical for researchers and healthcare professionals who work in antenatal care, but this information has been found to differ across different sources.• The Summary of Product Characteristics (SmPCs) is the European official medicines information source for professionals and contains a specific section to include information on medicines use during pregnancy and lactation to guide decision making.• Future electronic versions of SmPCs to be included in clinical decision support systems will require intelligible and logical electronic information. WHAT THIS STUDY ADDS• Important information deficits on the use of medicines during pregnancy and lactation were found in European SmPCs, and the time elapsed since a SmPC's marketing authorization was not associated with an increase in information quality.• Post-authorization data on the exposure to medicinal products during pregnancy and lactation should be actively collected and included in official information sources to keep them updated and to assist decision making.

Based on our analysis, current versions of SmPCs are characterised by several information deficits and by containing recommendations that are not relevant to clinical practice in terms of dose adjustment in renal impairment. These shortcomings might limit their usefulness for healthcare professionals and integration into clinical decision-making support systems.

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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