Shortages of benzathine penicillin for prevention of mother-to-child transmission of syphilis: An evaluation from multi-country surveys and stakeholder interviews.

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.

Association of vaccine stockout with immunisation coverage in low-income and middle-income countries: a retrospective cohort study.

OBJECTIVES: This study investigated the association between vaccine stockout and immunisation coverage, and infant/under 5 mortality rates. DESIGN: A retrospective cohort study. SETTING: Low-income and middle-income countries. PARTICIPANTS: A cohort of 131 low-income and middle-income countries from 2004 to 2019. PRIMARY OUTCOME MEASURES: Main outcomes included immunisation coverages of (1) diphtheria-tetanus-pertussis containing vaccine (DTP), (2) measles containing vaccine (MCV), (3) BCG and (4) oral polio vaccine (OPV). We also included infant and under 5 mortality rates as secondary outcomes. RESULTS: The countries that experienced national-level stockouts of DTP and MCV had 3.7 and 4 percentage points lower coverage rates of DTP3 and MCV1, respectively, compared with the countries without the stockout events (p<0.01). Moreover, the statistically significant differences in the immunisation coverage rates across the countries with and without the stockout events are 2.4 percentage points and 2.6 percentage points for BCG and OPV, respectively (p<0.01). CONCLUSION: Our findings show that the incidence of vaccine stockout events is associated with the decreased immunisation coverages for children in low-income and middle-income countries. However, we did not observe a statistically significant association between the increasing frequency of vaccine stockout and infant and under 5 mortality rates.