Ndiaye Jean-Louis A, Diallo Ibrahima, NDiaye Youssoupha, Kouevidjin Ekoue, Aw Ibrahima, Tairou Fassiatou, Ndoye Tidiane, Halleux Christine M, Manga Isaac, Dieme Mbaye Niang, Ndiop Medoune, Faye Babacar, Olliaro Piero, Merle Corinne S, Gaye Oumar, Milligan Paul
1Department of Parasitology, Cheikh Anta Diop University, Thies University, Dakar, Senegal.
National Malaria Control Programme, Ministry of Health and Social Affairs, Dakar, Senegal.
Pharmaceut Med. 2018;32(3):189-200. doi: 10.1007/s40290-018-0232-z. Epub 2018 Jun 1.
Seasonal malaria chemoprevention (SMC) using sulfadoxine-pyrimethamine plus amodiaquine has been introduced in 12 African countries. Additional strategies for safety monitoring are needed to supplement national systems of spontaneous reporting that are known to under represent the incidence of adverse reactions.
This study aimed to determine if adverse event (AE) reporting could be improved using a smartphone application provided to village health workers, or by active follow-up using a symptom card provided to caregivers.
Two strategies to improve reporting of AEs during SMC campaigns were evaluated, in comparison with the national system of spontaneous reporting, in 11 health post areas in Senegal. In each health post, an average of approximately 4000 children under 10 years of age received SMC treatment each month for 3 months during the 2015 malaria transmission season-a total of 134,000 treatments. In three health posts (serving approximately 14,000 children), caregivers were encouraged to report any adverse reactions to the nurse at the health post or to a community health worker (CHW) in their village, who had been trained to use a smartphone application to report the event (enhanced spontaneous reporting). In two health posts (approximately 10,000 children), active follow-up of children at home was organized after each SMC campaign to ask about AEs that caregivers had been asked to record on a symptom card (active surveillance). Six health posts (approximately 23,000 children) followed the national system of spontaneous reporting using the national reporting (yellow) form. Each AE report was assessed by a panel to determine likely association with SMC drugs.
The incidence of reported AEs was 2.4, 30.6, and 21.6 per 1000 children treated per month, using the national system, enhanced spontaneous reporting, and active surveillance, respectively. The most commonly reported symptoms were vomiting, fever, and abdominal pain. The incidence of vomiting, known to be caused by amodiaquine, was similar using both innovative methods (10/1000 in the first month, decreasing to 2.5/1000 in the third month). Despite increased surveillance, no serious adverse drug reactions were detected.
Training CHWs in each village and health facility staff to report AEs using a mobile phone application led to much higher reporting rates than through the national system. This approach is feasible and acceptable, and could be further improved by strengthening laboratory investigation and the collection of control data immediately prior to SMC campaigns.
使用磺胺多辛-乙胺嘧啶加阿莫地喹进行季节性疟疾化学预防（SMC）已在12个非洲国家推行。需要额外的安全监测策略来补充国家自发报告系统，因为已知该系统无法充分反映不良反应的发生率。
本研究旨在确定使用提供给乡村卫生工作者的智能手机应用程序，或通过使用提供给照料者的症状卡进行主动随访，是否可以改善不良事件（AE）报告。
在塞内加尔的11个卫生站地区，将两种改善SMC活动期间AE报告的策略与国家自发报告系统进行比较评估。在每个卫生站，2015年疟疾传播季节期间，平均每月约4000名10岁以下儿童接受3个月的SMC治疗，共进行了134,000次治疗。在三个卫生站（服务约14,000名儿童），鼓励照料者向卫生站护士或村里经过培训可使用智能手机应用程序报告事件的社区卫生工作者（CHW）报告任何不良反应（强化自发报告）。在两个卫生站（约10,000名儿童），每次SMC活动后组织对家中儿童进行主动随访，询问照料者已被要求在症状卡上记录 的AE（主动监测）。六个卫生站（约23,000名儿童）使用国家报告（黄色）表格遵循国家自发报告系统。每个AE报告由一个小组进行评估，以确定与SMC药物的可能关联。
使用国家系统、强化自发报告和主动监测时，每月每1000名接受治疗儿童报告的AE发生率分别为2.4、30.6和21.6。最常报告的症状是呕吐、发热和腹痛。两种创新方法报告已知由阿莫地喹引起的呕吐发生率相似（第一个月为10/1000，第三个月降至2.5/1000）。尽管加强了监测，但未检测到严重的药物不良反应。
培训每个村庄和卫生机构工作人员使用手机应用程序报告AE，导致报告率比通过国家系统高得多。这种方法可行且可接受，通过加强实验室调查以及在SMC活动前立即收集对照数据可进一步改进。
