有关苄星青霉素紧缺的调查报告

苄星青霉素（BPG）是唯一医治和防范梅毒母婴传播的药品 梅毒在生殖道感染中是与众不同的，由于它依然能够根据单使用量头孢类(无抗药性风险性纪录)医治，因此目地配置了高效苄星青霉素G (BPG)。世卫组织可能，每一年有93万多名孕妇怀孕将会身患活跃性梅毒(怀孕期内可传播)，每一年造成约35万欠佳孕妇分娩結果(包含器管畸型和巨大儿)。悲哀的是，新生婴儿致死和死产占这种欠佳出世結果的一半左右。BPG是防范梅毒母婴传播的唯一强烈推荐医治方式 。一剂成本低的BPG告一段落成年人的梅毒感染，沒有直接证据说明存有抗药性风险性。殊不知，以协助明确2014-2016年期内该难题的经营规模，并叙述导致紧缺的要素。 有关此项科学研究 此项科学研究是由国际卫生组织生殖保健和科研部人们生殖系统科学研究、发展趋势和科学研究培圳非常计划方案和尼克松环境卫生获得号召(CHAI)开展的。它融合了数据采集方式 ，从全世界范围之内的低、中、高收益国家搜集统计数据。 科学研究結果 紧缺水平在涉及到的114个国家中，95个有可点评的材料。你在95个国家中，39个国家(41%)汇报了BPG紧缺，56个国家(59%)汇报沒有BPG紧缺。在95个国家中，有10个国家表达应用了包含头孢曲松、阿莫西林和红霉素以内的替代疗法。你在10个国家中，3个汇报彻底应用了取代抗菌素，7个汇报除开汇报BPG紧缺外还应用了取代抗菌素。殊不知，这种取代方式 要不不可以根据胚胎避免母婴传播梅毒，要不在医治母婴梅毒层面比不上BPG合理。 2014-2016年汇报头孢类G紧缺的国家 有关供求平衡和要求的难题 做为一种特许权药品，BPG现阶段的市场价极低。CHAI可能，120万国际单位(IU)使用量均值市场价为0.11美金，中低收入者国家(LMICs)为240万国际单位(IU)使用量均值市场价为0.2美金。一些国家还对BPG的市场价格设定了限制，这也使价钱维持在较适度性。殊不知，做为一种可打针药品，BPG务必在无菌检测标准下生产制造，这必须在技术专业生产制造基础设施建设上开展很多的投资理财。这类经济发展影响力限定了商业服务制造商进到乃至再次进到BPG销售市场的激情。除此之外，也有对生产制造品质的忧虑。现阶段BPG的化学原料药制造商均未得到世卫组织等全世界监管部门的销售市场受权，在其中2家过去两年亲身经历了产品质量问题，造成供货终断。 尽管制造商的确有工作能力考虑全世界对BPG的要求，但一些制造商实行的最少采购单总数将会会产生挑戰，非常是对较小的国家，这种国家对BPG的要求通常不足高，不能满足这一最少规定。 尽管供货难题危害到BPG的易用性，但例如小看要求(主要是因为设备级別的商品应用统计数据)、购置周期时间不灵便、欠缺资产和BPG商品申请注册有现等难题也会对易用性造成危害，并造成全世界供货紧缺。 下一个流程 做为清除母婴传播梅毒全球计划的一部分，世卫组织的手册提议，95%接纳临产前健康保健的孕妇怀孕应开展梅毒检测，95%诊断的孕妇怀孕应接纳医治。只能保证BPG的出示，这种总体目标才可以保持，近期的进度才有将会坚持下去。 以便协助减轻生产制造层面的难题，必须采用流程在制造商中间融洽产品品质和标准规范。全部关键利益相关者接纳的相互商品标准将控制成本，并容许在一切单一经销商终止生产制造的状况下开展商品取代。因而，2016年，世卫组织申请办理将BPG列入“审批”药品，并邀约制造商申请办理世卫组织审批资质，以确保药品的品质。 在要求层面，必须将提升国家一级物流系统基础设施建设以改进国家BPG预测分析和购置做为卫生系统的优先选择事宜。必须提升对BPG的了解，包含应用BPG可医治的普遍状况，及其尽快掌握能够采用什么流程来降低断货或紧缺。 梅毒的检验和医治必须变成公共卫生服务的优先选择事宜。BPG是己知的唯一一种可以越过胚胎并避免梅毒母婴传播的抗菌素，这促使卫生保健工作人员对世卫组织强烈推荐的梅毒治疗方式 开展培圳，非常是对孕妇怀孕开展培圳越来越尤为重要。对卫生保健服务提供者的培圳还必须处理相关BPG是一种品质差、药品不良反应风险性高的药品的很多误会。附：全文Shortages of benzathine penicillin. How big is the problem? And why it mattersThe only drug to treat and to prevent mother-to-child transmission of syphilis 27 December 2017: Syphilis is unique among sexually transmitted diseases in that it remains curable with a single dose of penicillin (with no documented risk of resistance), formulated for this purpose as long-acting Benzathine Penicillin G (BPG). WHO estimates that every year, 930 000 pregnant women have probable active syphilis (transmissible during pregnancy) which results in approximately 350 000 adverse birth outcomes (including organ deformities and prematurity) annually. Tragically, neonatal death and stillbirth account for more than half of those adverse birth outcomes.BPG is the only recommended treatment to prevent mother-to-child transmission of syphilis. A single dose of low-cost BPG ends syphilis infectivity in adults with no documented risk of antibiotic resistance. In 2015, however, anecdotal reports began to reach WHO, indicating country-level shortages of BPG. In response to these reports, 114 countries and territories were approached to help determine the scale of the problem during the time period 2014-2016 and to describe factors contributing to the shortages.About the studyThe study was carried out by HRP the Special Programme of Research, Development and Research Training in Human Reproduction in WHO’s Department of Reproductive Health and Research and the Clinton Health Access Initiative (CHAI). It used a combination of data collection methods to collect data globally from a range of low-, middle- and high-income countries.indingsCountries with reported shortages of benzathine penicillin G 2014–2016 · Enlarge map Extent of the shortagesOf the 114 countries approached, 95 had evaluable information. Of these 95 countries, 39 (41%) reported a BPG shortage, and 56 (59%) reported no BPG shortage. Ten of the 95 countries indicated the use of alternative treatments including ceftriaxone, amoxicillin, and erythromycin. Of these 10 countries 3 reported exclusive use of antibiotic alternatives and 7 reported the use of alternatives in addition to reporting BPG shortages. These alternatives, however, either do not cross the placenta to prevent mother-to-child transmission of syphilis or are much less effective than BPG for treating maternal syphilis.Countries with reported shortages of benzathine penicillin G 2014–2016Issues around supply and demandAs an off-patent medication, BPG is currently sold at a very low price. CHAI estimated that it is sold on average at a cost of US$0.11 for a 1.2 million international unit (IU) dose and US$0.20 for 2.4 million IU dose in low-and middle-income countries (LMICs). Some countries additionally set a cap on the price at which BPG can be sold which also keeps the price low. However, as an injectable drug, BPG must be manufactured under sterile conditions which require significant financial investment in specialised manufacturing infrastructure. This economic position limits the enthusiasm for commercial manufacturers to enter or even continue in the BPG market. In addition, there are also concerns about the quality of manufacturing. None of the 3 current API manufacturers of BPG has market authorization from a global regulatory authority, such as WHO, and 2 have experienced quality issues in the past few years which have disrupted supply.While manu