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Shortages of benzathine penicillin for prevention of mother-to-child transmission of syphilis: An evaluation from multi-country surveys and stakeholder interviews
PLOS Medicine ( IF 15.8 ) Pub Date : 2017-12-27 , DOI: 10.1371/journal.pmed.1002473
Stephen Nurse-Findlay 1 , Melanie M Taylor 1, 2 , Margaret Savage 3 , Maeve B Mello 4 , Sanni Saliyou 5 , Manuel Lavayen 4 , Frederic Seghers 3 , Michael L Campbell 3 , Françoise Birgirimana 5 , Leopold Ouedraogo 5 , Morkor Newman Owiredu 6 , Nancy Kidula 6 , Lee Pyne-Mercier 7
Affiliation  

Background

Benzathine penicillin G (BPG) is the only recommended treatment to prevent mother-to-child transmission of syphilis. Due to recent reports of country-level shortages of BPG, an evaluation was undertaken to quantify countries that have experienced shortages in the past 2 years and to describe factors contributing to these shortages.

Methods and findings

Country-level data about BPG shortages were collected using 3 survey approaches. First, a survey designed by the WHO Department of Reproductive Health and Research was distributed to 41 countries and territories in the Americas and 41 more in Africa. Second, WHO conducted an email survey of 28 US Centers for Disease Control and Prevention country directors. An additional 13 countries were in contact with WHO for related congenital syphilis prevention activities and also reported on BPG shortages. Third, the Clinton Health Access Initiative (CHAI) collected data from 14 countries (where it has active operations) to understand the extent of stock-outs, in-country purchasing, usage behavior, and breadth of available purchasing options to identify stock-outs worldwide. CHAI also conducted in-person interviews in the same 14 countries to understand the extent of stock-outs, in-country purchasing and usage behavior, and available purchasing options. CHAI also completed a desk review of 10 additional high-income countries, which were also included. BPG shortages were attributable to shortfalls in supply, demand, and procurement in the countries assessed. This assessment should not be considered globally representative as countries not surveyed may also have experienced BPG shortages. Country contacts may not have been aware of BPG shortages when surveyed or may have underreported medication substitutions due to desirability bias. Funding for the purchase of BPG by countries was not evaluated. In all, 114 countries and territories were approached to provide information on BPG shortages occurring during 2014–2016. Of unique countries and territories, 95 (83%) responded or had information evaluable from public records. Of these 95 countries and territories, 39 (41%) reported a BPG shortage, and 56 (59%) reported no BPG shortage; 10 (12%) countries with and without BPG shortages reported use of antibiotic alternatives to BPG for treatment of maternal syphilis. Market exits, inflexible production cycles, and minimum order quantities affect BPG supply. On the demand side, inaccurate forecasts and sole sourcing lead to under-procurement. Clinicians may also incorrectly prescribe BPG substitutes due to misperceptions of quality or of the likelihood of adverse outcomes.

Conclusions

Targets for improvement include drug forecasting and procurement, and addressing provider reluctance to use BPG. Opportunities to improve global supply, demand, and use of BPG should be prioritized alongside congenital syphilis elimination efforts.



中文翻译:

用于预防梅毒母婴传播的苄星青霉素短缺:来自多国调查和利益相关者访谈的评估

背景

苄星青霉素 G (BPG) 是唯一推荐的预防梅毒母婴传播的治疗方法。由于最近有报告称国家级 BPG 短缺,因此进行了一项评估,以量化过去 2 年中出现短缺的国家,并描述造成这些短缺的因素。

方法和发现

使用 3 种调查方法收集了有关 BPG 短缺的国家级数据。首先,世卫组织生殖健康和研究部设计的一项调查分发给美洲的 41 个国家和地区,非洲的 41 个国家和地区。其次,世卫组织对美国疾病控制和预防中心的 28 位国家主任进行了电子邮件调查。另有 13 个国家与世卫组织就相关的先天性梅毒预防活动进行了联系,并报告了 BPG 短缺的情况。第三,克林顿健康获取倡议 (CHAI) 收集了来自 14 个国家(其开展活动的国家)的数据,以了解缺货程度、国内采购、使用行为和可用采购选项的广度,以识别缺货全世界。CHAI 还在相同的 14 个国家进行了面对面访谈,以了解缺货程度、国内购买和使用行为以及可用的购买选项。CHAI 还完成了对另外 10 个高收入国家的案头审查,这些国家也包括在内。BPG 短缺是由于评估国家的供应、需求和采购短缺。该评估不应被视为具有全球代表性,因为未接受调查的国家也可能经历过 BPG 短缺。国家联系人在接受调查时可能没有意识到 BPG 短缺,或者由于可取性偏差而少报了药物替代品。未评估各国购买 BPG 的资金。总共接触了 114 个国家和地区,以提供有关 2014-2016 年发生的 BPG 短缺的信息。在独特的国家和地区中,95 个(83%)作出回应或拥有可从公共记录中评估的信息。在这 95 个国家和地区中,39 个(41%)报告 BPG 短缺,56 个(59%)报告没有 BPG 短缺;10 个(12%)存在和不存在 BPG 短缺的国家报告使用抗生素替代 BPG 治疗产妇梅毒。市场退出、不灵活的生产周期和最小订单量影响 BPG 供应。在需求方面,不准确的预测和单一采购导致采购不足。由于对质量或不良结果可能性的误解,临床医生也可能错误地开出 BPG 替代品。56 家(59%)报告称没有 BPG 短缺;10 个(12%)存在和不存在 BPG 短缺的国家报告使用抗生素替代 BPG 治疗产妇梅毒。市场退出、不灵活的生产周期和最小订单量影响 BPG 供应。在需求方面,不准确的预测和单一采购导致采购不足。由于对质量或不良结果可能性的误解,临床医生也可能错误地开出 BPG 替代品。56 家(59%)报告称没有 BPG 短缺;10 个(12%)存在和不存在 BPG 短缺的国家报告使用抗生素替代 BPG 治疗产妇梅毒。市场退出、不灵活的生产周期和最小订单量影响 BPG 供应。在需求方面,不准确的预测和单一采购导致采购不足。由于对质量或不良结果可能性的误解,临床医生也可能错误地开出 BPG 替代品。

结论

改进的目标包括药物预测和采购,以及解决供应商不愿使用 BPG 的问题。改善 BPG 全球供应、需求和使用的机会应与先天性梅毒消除工作一起优先考虑。

更新日期:2017-12-31
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