Irujo Marta, Beitia Guadalupe, Bes-Rastrollo Maira, Figueiras Adolfo, Hernández-Díaz Sonia, Lasheras Berta
Department of Pharmacy Practice, University of Navarra, Pamplona, Spain.
Drug Saf. 2007;30(11):1073-82. doi: 10.2165/00002018-200730110-00006.
The spontaneous reporting system is the most efficient warning system of adverse drug reactions (ADRs). Pharmacists can play an important role in the detection and reporting of ADRs. The factors that affect under-reporting among these professionals are unknown in Spain.
To identify the factors that influence community pharmacists' ADR under-reporting in Navarra, a Northern Spanish region.
A case-control study was conducted on a population of 802 community pharmacists working in Navarra. Cases were pharmacists who had reported at least two ADRs to the region's drug surveillance unit between 2003 and 2005 and who agreed to participate in the study (18/20; 90%). A random sample of 60 controls was selected from the 762 pharmacists who had not reported any ADR during the same period of time.
Factors positively associated with ADR reporting were age, years of work experience as a pharmacist, participation in educational activities related to the detection and resolution of drug-related problems, the habit of detecting ADRs as part of pharmacists' duties, having the basic knowledge needed to report ADRs, and disagreement with the common belief among healthcare professionals that 'to report an ADR it is necessary to be sure that the reaction is related to the use of a particular drug'. The most frequently mentioned reasons for not reporting ADRs were the ADR is not serious, the ADR is already known, uncertainty concerning the causal relationship between the ADR and the drug, forgetting to report the ADR and a lack of time.
Pharmacists' knowledge, beliefs, behaviour and motivation play an important role in ADR reporting. Under-reporting might be improved through activities focused on modifying such factors.
自发报告系统是最有效的药物不良反应（ADR）预警系统。药剂师在ADR的发现和报告中可发挥重要作用。在西班牙，这些专业人员中影响漏报的因素尚不清楚。
确定影响西班牙北部纳瓦拉地区社区药剂师ADR漏报的因素。
对在纳瓦拉工作的802名社区药剂师进行了一项病例对照研究。病例为2003年至2005年间向该地区药物监测部门报告至少两例ADR且同意参与研究的药剂师（18/20；90%）。从同期未报告任何ADR的762名药剂师中随机抽取60名作为对照。
与ADR报告呈正相关的因素有年龄、药剂师工作年限、参与与药物相关问题的发现和解决有关的教育活动、将发现ADR作为药剂师职责一部分的习惯、具备报告ADR所需的基本知识，以及不同意医疗保健专业人员中“要报告ADR必须确定反应与特定药物的使用有关”这一普遍看法。未报告ADR最常提及的原因是ADR不严重、ADR已为人所知、ADR与药物之间因果关系不确定、忘记报告ADR以及缺乏时间。
药剂师的知识、信念、行为和动机在ADR报告中起着重要作用。可通过专注于改变这些因素的活动来改善漏报情况。
