Kiguba Ronald, Karamagi Charles, Waako Paul, Ndagije Helen B, Bird Sheila M
Department of Pharmacology and Therapeutics, Makerere University College of Health Sciences, Kampala, Uganda.
Clinical Epidemiology Unit, Makerere University College of Health Sciences, Kampala, Uganda.
PLoS One. 2015 Apr 23;10(4):e0123974. doi: 10.1371/journal.pone.0123974. eCollection 2015.
Lack 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.
During 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.
Ninety 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.
Surveyed 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.
缺乏足够的细节会影响对报告的疑似药物不良反应（ADR）的分析。我们调查了乌干达医疗保健专业人员（HCP）对其上个月最近一次疑似ADR的描述有多全面，并确定了提供全面ADR描述的HCP的特征。我们还识别了具有药物安全警示潜力的罕见、严重和意外的疑似ADR描述。
在2012/13年期间，这项调查在有目的地选择的乌干达医疗机构（公立/私立）中进行，包括国家转诊医院和代表所有地区的六家区域转诊医院。方便地选择了地区医院、二级至四级卫生中心以及区域转诊医院集水区内的私立医疗机构。与药物处方、转录、配药和给药相关的医疗保健专业人员被联系并被邀请自行填写一份关于ADR报告的问卷。发放的问卷中有三分之二（1345/2000）被收回。
上个月怀疑有ADR的HCP中有90%（241/268）提供了关于五个更高层次描述符的信息，如下所示：身体部位（206）、药物类别（203）、给药途径（127）、患者年龄（133）和ADR严重程度（128）。至少五分之二（46%，124/268）的HCP实现了全面性（明确提供至少四个更高层次的描述符）。私立医疗机构、中部以外地区以及不参与医学生教学的HCP提供的描述更有可能是全面的。总体而言，描述了106例严重和51例罕见的上个月疑似ADR。最常见的严重和罕见ADR是史蒂文斯-约翰逊综合征（SJS）；主要与口服奈韦拉平或复方新诺明有关，但也描述了双氯芬酸镇痛后咯血和奎宁注射后麻痹。
接受调查的上个月至少怀疑有一例ADR的乌干达HCP能够提供全面的ADR描述：实际上，比全国每年收到的描述还要多。经过适当分析并给予当地反馈，HCP的自愿ADR报告可能是识别乌干达罕见和严重疑似ADR的重要警示工具。
