Dzioba Łukasz, Stańczak Andrzej
Medical University of Lodz, Poland.
Acta Pol Pharm. 2012 Mar-Apr;69(2):341-6.
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.
开展了一项横断面调查研究，调查产品特性摘要（SmPC，常因安全原因而更改）中包含的信息实际上是否被心脏病专家、全科医生、内科医生和内科疾病医生使用、正确使用或根本未被使用。对患者信息单进行可读性测试，这是欧盟委员会的要求，提高了欧洲患者对其中包含的医学信息的利用率。由于对产品特性摘要（SmPC）没有此类要求，我们研究了医生对产品特性摘要中呈现的信息的利用率。研究对象为六种用于抗血小板治疗的药物，解剖学治疗学化学分类系统（ATC）代码为B01AC。随机抽取800名医生参与研究。他们是从波兰医师和牙医协会（PCPD）数据库中选出的医生（300名心脏病专家和300名全科医生），通过普通邮件进行访谈，以及在第十五届波兰心脏病学会国际大会期间接受询问的200名医生。要求医生填写一份包含20个问题的问卷（13个关于活性物质，6个一般问题和一个开放式问题“指出接收安全信息的最佳方式”）。问题是根据相关药品提交定期安全更新报告（PSURs）后，在更新的SmPC中包含的新安全信息构建的。总体回复率为16.5%（800份问卷中有132份填写完整）。在受访者中，第一组（心脏病专家）有65人，第二组（全科医生、内科医生和内科疾病医生）有67人。符合条件的问卷（85份）是在大会期间获得的（64.4%）。通过普通邮件仅收到47份（35.6%）。氯吡格雷和阿司匹林（乙酰水杨酸）的正确答案最多，分别为72.98%和72.73%。较不为人知的物质是依替巴肽，只有34.47%的答案正确。分析两组（第一组和第二组），正确答案的百分比没有显著差异，然而，对于“仅用于医院的药物”（阿昔单抗、依替巴肽和替罗非班）已达到统计趋势水平。对于开放式问题，关于受访者认为接收安全信息的最佳途径，两组相对相似。最受欢迎的是电子邮件提醒、网页/门户网站和药品手册，分别有44.37和24种选择。该研究存在样本量小的局限性。结果基于收到的少量问卷。由于样本量小，可以假设在比较的两组（第一组——心脏病专家；第二组——全科医生、内科医生和内科疾病医生）之间，在利用SmPC中的信息方面没有显著差异；然而，除了氯吡格雷和阿司匹林这两种物质外，知识水平低于预期。还应强调的是，“仅用于医院的药物”表明心脏病专家对这些物质可能有更好的了解。
