title: Summary of product characteristics (SmPC)--study on utilization of information presented in SmPC by different groups of physicians.
abstract: Cross-sectional survey study was done, investigating whether information included in SmPC (changing often due to safety reasons) is actually used, properly used or not used at all by cardiologists, GP's (general practitioners), internists and internal diseases physicians. Conducting readability test of Patient Information Leaflet, required by European Commission improved utilization of medical information included in it by European patients. Since there was no such requirement on Summary of Product Characteristics (SmPC), we examined utilization of information presented in Summary of Product Characteristics by physicians. Investigated were six drugs used in antiplatelet therapies, ATC (Anatomical, Therapeutic Chemical classification system) code B01AC. A random sample of 800 physicians took part in the study. They were physicians (300 cardiologists and 300 GP's) chosen from The Polish Chamber of Physicians and Dentists (PCPD) database interviewed using regular mail and 200 physicians interrogated during the XV International Congress of Polish Cardiac Society.Physicians. They were asked to complete a questionnaire consisting of 20 questions (13 concerning active substances, 6 general questions and one open question "Indicate the best way of receiving safety information"). Questions were constructed on the basis on new safety information included in actualized SmPC after submission of Periodic Safety Update Reports (PSURs) for medicinal products concerned. The overall response rate was 16.5% (132 filled in of 800 questionnaires). Of the respondents there were 65 and 67 from group I (cardiologists) and group II (GP's, internists and internal diseases), respectively. Eligible questionnaires (85) were obtained during the Congress (64.4%). Only 47 were received via regular mail (35.6%). Most correct answers were noted for clopidogrel and ASA (acetylsalicylic acid). 72.98% and 72.73%, respectively. The less known substance appeared eptifibatide, only 34.47% of answers were correct. Analyzing both groups (I and II), there were no significant differences regarding percent of correct answers, however, a statistical tendency level has been reached for "drugs for hospital use only" (abciximab, eptifibatide and tirofiban). For the open question, concerning best pipeline for receiving safety information according to respondents, both groups were relatively similar. Most popular were e-mail alerts, web pages/portals and drug compendiums, 44.37 and 24 indications, respectively. Study has limitation of a small sample size. The results are based on small amount of received questionnaires. Due to small sample size, it can be assumed that there are no significant differences between two compared groups (I--cardiologists; II--GP's, internists and internal diseases physicians) with regard to utilization of information from SmPC; however, beside two substances--clopidogrel and ASA, the level of knowledge is below expected. It also should be emphasized that "drugs for hospital use only" pointed out tendency that cardiologists can have better knowledge regarding these substances.
authors.affiliation: Medical University of Lodz, Poland. lukasz.dzioba@gmail.com
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Dzioba
authors.forename: Andrzej
authors.initials: A
authors.lastname: Stańczak
mesh_terms: D003430:Cross-Sectional Studies; D004348:Drug Labeling; D006801:Humans; D010820:Physicians; D011795:Surveys and Questionnaires