Development of a tool to assess the completeness of drug information sources for health care professionals: A Delphi study.

The aim of this study was to create a standard set of essential drug information items as a tool to assess the completeness of any type of drug information source, regardless of its length, using a Delphi consensus panel of European health care professionals. A compilation of drug-related information items was performed by searching several resources for health care professionals and a final list of 162 items was obtained. Fifty-seven experts in drug information from 23 different European countries were invited to participate in a three-round Delphi technique to obtain consensus on items considered essential and non-essential content of information. Consensus for the first, second, and third rounds was defined as ≥90%, ≥80%, and ≥75% agreement, respectively. Of the 57 experts invited, 32 completed the first round, 27 the second, and 29 the third. Consensus was achieved for 28.3% of the items in the first round, 49.3% in the second, and 58.3% in the third. The final cumulative consensus was 67.7% (n = 126) for items considered essential and 16.1% (n = 30) for items considered non-essential. The final tool obtained to assess the completeness of drug information sources was composed by 126 essential items grouped into 11 sections. This tool allows for the comparison of different information sources for the same medicine and the information content for different medicines in the same source.

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation.

AIMS: To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODS: SmPCs 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. RESULTS: Of 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. CONCLUSIONS: Important information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs.

Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment.

PURPOSE: Information about dosing adjustments in patients with chronic kidney disease is important to avoid toxicity for several medicines. The aim of our study was to assess the clinical relevance of the instructions for dose adjustment in patients with renal impairment provided in the Summaries of Product Characteristics (SmPCs) approved by the European Medicines Agency (EMA). METHODS: SmPCs available on the EMA website on April 2011 were retrieved, and information on the elimination route and instructions for use in renal impairment was analysed independently by two of the authors. SmPCs were classified as containing 'explicit' or 'poor' information based on whether they presented (or not) instructions for use of the medicine in renal impairment. Information was considered 'relevant' if SmPCs provided clear instructions for dose adjustment. RESULTS: Of the 356 SmPCs analysed, 13.8 and 37.4 % were classified as providing poor information and explicit but not relevant information, respectively. Only 48.8 % SmPCs provided both explicit and relevant information on medicine use in renal impairment. No difference was found in the average time since last update among SmPCs classified as containing explicit or poor information, as well as those classified as containing relevant or not relevant information. Also, no association was found between the clinical relevance of the information and whether or not the medication was an orphan drug, and 80 % SmPCs did not provide information on the use of the medicine in patients undergoing haemodialysis. CONCLUSIONS: 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.

A Comparison of Patient-Centered Care in Pharmacy Curricula in the United States and Europe.

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.

Worldwide analysis of factors associated with medicines compendia publishing.

BACKGROUND: Medicines compendia, also called formularies, are the most commonly used drug information source among health care professionals. OBJECTIVE: The aim was to identify the countries publishing medicines compendia and the socio-demographic factors associated to this fact. Additionally, we sought to determine the use of foreign compendia in countries lacking their own. SETTING: Global web-based survey. METHOD: Healthcare practitioners and researchers from 193 countries worldwide were invited to complete a web-based survey. The questionnaire investigated the existence of a national compendium, or the use of foreign compendia in the absence of one. Demographic and socioeconomic variables were used to predict compendia publishing through a multivariate analysis. MAIN OUTCOME MEASURE: Existence of national medicines compendia and foreign compendia used. RESULTS: Professionals from 132 countries completed the survey (response rate at a country level 68.4%, comprising 90.9% global population). Eighty-four countries (63.6%) reported publishing a medicines compendium. In the multivariate analysis, only two covariates had significant association with compendia publishing. Being a member of the Organisation for the Economic Cooperation and Development was the only variable positively associated with compendia publishing (OR = 37.5; 95% CI = 2.3:599.8). In contrast, the countries that listed French as an official language were less likely to publish a compendium (OR = 0.07; 95% CI = 0.007:0.585). Countries without national compendia reported using the British National Formulary most commonly, followed by the Dictionnaire Vidal. CONCLUSION: Publication of medicines compendia is associated with socio-economic development. Countries lacking a national compendium, use foreign compendia from higher-income countries. Creating an international medicines compendium under the leadership of the World Health Organisation, rather than merely a 'model', would reduce the risks of using information sources not-adapted to the necessities of developing countries.