Rare, Serious, and Comprehensively Described Suspected Adverse Drug Reactions Reported by Surveyed Healthcare Professionals in Uganda

BackgroundLack of adequate detail compromises analysis of reported suspected adverse drug reactions (ADRs). We investigated how comprehensively Ugandan healthcare professionals (HCPs) described their most recent previous-month suspected ADR, and determined the characteristics of HCPs who provided comprehensive ADR descriptions. We also identified rare, serious, and unanticipated suspected ADR descriptions with medication safety-alerting potential.MethodsDuring 2012/13, this survey was conducted in purposively selected Ugandan health facilities (public/private) including the national referral and six regional referral hospitals representative of all regions. District hospitals, health centres II to IV, and private health facilities in the catchment areas of the regional referral hospitals were conveniently selected. Healthcare professionals involved in prescribing, transcribing, dispensing, and administration of medications were approached and invited to self-complete a questionnaire on ADR reporting. Two-thirds of issued questionnaires (1,345/2,000) were returned.ResultsNinety per cent (241/268) of HCPs who suspected ADRs in the previous month provided information on five higher-level descriptors as follows: body site (206), drug class (203), route of administration (127), patient age (133), and ADR severity (128). Comprehensiveness (explicit provision of at least four higher-level descriptors) was achieved by at least two-fifths (46%, 124/268) of HCPs. Received descriptions were more likely to be comprehensive from HCPs in private health facilities, regions other than central, and those not involved in teaching medical students. Overall, 106 serious and 51 rare previous-month suspected ADRs were described. The commonest serious and rare ADR was Stevens-Johnson syndrome (SJS); mostly associated with oral nevirapine or cotrimoxazole, but haemoptysis after diclofenac analgesia and paralysis after quinine injection were also described.ConclusionSurveyed Ugandan HCPs who had suspected at least one ADR in the previous month competently provided comprehensive ADR descriptions: more, indeed, than are received per annum nationally. Properly analyzed, and with local feed-back, voluntary ADR reports by HCPs could be an essential alerting tool for identifying rare and serious suspected ADRs in Uganda.研究背景：现有报告的疑似药品不良反应（Adverse Drug Reaction, ADR）因细节不足而制约分析质量。本研究旨在调查乌干达医护人员（Healthcare Professionals, HCPs）对其上月发生的最新疑似药品不良反应的描述详尽程度，并明确能提供详尽不良反应描述的医护人员特征；同时识别具备药物安全预警潜力的罕见、严重及非预期疑似药品不良反应报告。 研究方法：2012至2013年间，本研究于目的抽样选取的乌干达各级公立/私立医疗机构开展，涵盖国家转诊医院及代表全国各区域的6家区域转诊医院；同时便利抽样选取上述区域转诊医院服务覆盖范围内的地区医院、II至IV级卫生所及私立医疗机构。研究对象为参与药物处方、转录、调配与给药工作的医护人员，邀请其自行填写关于药品不良反应报告的调查问卷。本次研究共发放问卷2000份，回收1345份，回收率达三分之二。 研究结果：上月曾疑似出现药品不良反应的医护人员中，90%（241/268）提供了5项核心描述要素的信息，分别为：受累身体部位（206例）、药物类别（203例）、给药途径（127例）、患者年龄（133例）及不良反应严重程度（128例）。至少五分之二（46%，124/268）的医护人员实现了详尽描述（即明确提供至少4项核心描述要素）。分析显示，私立医疗机构医护人员、非中部区域医护人员及未参与医学生教学工作的医护人员所提交的报告更易具备详尽性。本次研究共收录106例严重及51例罕见的上月疑似药品不良反应报告。其中最常见的严重及罕见不良反应为史蒂文斯-约翰逊综合征（Stevens-Johnson Syndrome, SJS），多与口服奈韦拉平或复方新诺明相关；此外还记录到双氯芬酸镇痛治疗后出现咯血、奎宁注射后引发瘫痪的案例。 研究结论：本研究纳入的上月曾疑似至少1例药品不良反应的乌干达医护人员，能够较为规范地提供详尽的不良反应描述，其报告详尽程度甚至高于乌干达全国年度平均收到的报告质量。经合理分析并结合本地反馈后，医护人员自愿提交的药品不良反应报告可成为乌干达识别罕见、严重疑似药品不良反应的重要预警工具。