Who was affected by the shortage of penicillin for syphilis in Rio de Janeiro, 2013-2017?

OBJECTIVE: To analyze the shortage of benzathine penicillin G (BPG), characterizing its temporal evolution and spatial distribution in the city of Rio de Janeiro from 2013 to 2017. METHODS: This ecological study used gestational and congenital syphilis notifications, BPG distribution records, and sociodemographic data from the population of Rio de Janeiro. To quantify the shortage, a BPG supply indicator was estimated per quarter for each neighborhood between 2013 and 2017. Thematic maps were created to identify areas and periods with greater BPG shortage, described according to sociodemographic factors, health services network, and epidemiological features in the incidence of syphilis. RESULTS: BPG shortage in Rio de Janeiro from 2013 to 2017 was not homogeneous in space nor in time. The temporal evolution and spatial distribution of BPG scarcity shows that the shortage affected the inhabitants of the municipality in different ways. Shortage was lower in 2013 and 2016 and more severe in 2014, 2015, and 2017, particularly in neighborhoods within the programmatic areas PA3 and PA5, poorer and with higher prevalence rates of gestational and congenital syphilis. CONCLUSIONS: Analyzing BPG shortage and its temporal evolution and spatial distribution in Rio de Janeiro allowed us to realize that the inhabitants are affected in different ways. Understanding this process contributes to the planning of actions to face shortage crises, minimizing possible impacts on the management of syphilis and reducing inequality in access to treatment.

Who was affected by the shortage of penicillin for syphilis in Rio de Janeiro, 2013-2017? / A quem afetou o desabastecimento de penicilina para sífilis no Rio de Janeiro, 2013-2017?

ABSTRACT OBJECTIVE To analyze the shortage of benzathine penicillin G (BPG), characterizing its temporal evolution and spatial distribution in the city of Rio de Janeiro from 2013 to 2017. METHODS This ecological study used gestational and congenital syphilis notifications, BPG distribution records, and sociodemographic data from the population of Rio de Janeiro. To quantify the shortage, a BPG supply indicator was estimated per quarter for each neighborhood between 2013 and 2017. Thematic maps were created to identify areas and periods with greater BPG shortage, described according to sociodemographic factors, health services network, and epidemiological features in the incidence of syphilis. RESULTS BPG shortage in Rio de Janeiro from 2013 to 2017 was not homogeneous in space nor in time. The temporal evolution and spatial distribution of BPG scarcity shows that the shortage affected the inhabitants of the municipality in different ways. Shortage was lower in 2013 and 2016 and more severe in 2014, 2015, and 2017, particularly in neighborhoods within the programmatic areas PA3 and PA5, poorer and with higher prevalence rates of gestational and congenital syphilis. CONCLUSIONS Analyzing BPG shortage and its temporal evolution and spatial distribution in Rio de Janeiro allowed us to realize that the inhabitants are affected in different ways. Understanding this process contributes to the planning of actions to face shortage crises, minimizing possible impacts on the management of syphilis and reducing inequality in access to treatment.

RESUMO OBJETIVO Analisar o desabastecimento da penicilina benzatina (PB), caracterizando sua evolução temporal e distribuição espacial no município do Rio de Janeiro de 2013 a 2017. MÉTODOS Trata-se de estudo ecológico misto realizado com notificações de sífilis gestacional e congênita, registros de distribuição de PB e de dados sociodemográficos da população dos bairros do município do Rio de Janeiro. Para mensurar o desabastecimento foi calculado por trimestre um indicador de abastecimento de PB para cada bairro, entre 2013 e 2017. Mapas temáticos foram produzidos para identificar áreas e períodos com maior desabastecimento de PB, o qual foi descrito segundo condições sociodemográficas, rede de serviços de saúde e aspectos epidemiológicos da incidência de sífilis por bairro. RESULTADOS O desabastecimento de PB no município do Rio de Janeiro, no período de 2013 a 2017, não foi homogêneo no espaço ou no tempo. A evolução temporal e a distribuição espacial da escassez de PB revelam que o desabastecimento afetou de formas distintas os habitantes do município, sendo menor em 2013 e 2016 e mais intenso em 2014, 2015 e 2017, principalmente nos bairros das áreas programáticas AP3 e AP5, mais pobres e com maiores taxas de sífilis gestacional e congênita. CONCLUSÕES Analisar o desabastecimento de PB e sua evolução temporal e distribuição espacial no município do Rio de Janeiro permitiu reconhecer que os habitantes do município são afetados de diferentes modos. Compreender esse processo ajuda a planejar ações para enfrentar crises de desabastecimento, minimizando possíveis impactos no controle da sífilis, além de reduzir a desigualdade no acesso ao tratamento.

Availability of benzathine penicillin G for syphilis treatment in Shandong Province, Eastern China.

BACKGROUND: The shortage of benzathine penicillin G (BPG) worldwide presents a major challenge in the treatment of syphilis. Its availability for syphilis treatment has not been adequately evaluated in China. METHODS: Two surveys were conducted among hospitals providing sexually transmitted infection clinical services in Shandong Province in 2012 and 2018. Data on the basic information and BPG availability of the surveyed hospitals and related factors were collected and analyzed using SPSS 17.0. RESULTS: A total of 433 and 515 hospitals were surveyed in 2012 and 2018, respectively. A significant difference in BPG availability was observed among different levels and types of hospitals both in 2012 (X2 = 9.747, p = 0.008; X2 = 37.167, p = 0.000) and 2018 (X2 = 11.775, p = 0.003; X2 = 28.331, p = 0.000). The BPG availability among surveyed hospitals increased from 45.0% in 2012 to 56.4% in 2018 (X2 = 11.131, p = 0.001). The BPG availability was higher in 2018 than in 2012 among county-level hospitals (52.0% vs. 40.8%, X2 = 7.783, p = 0.005), general western medicine hospitals (62.1% vs. 50.0%, X2 = 6.742, p = 0.009), maternal and child health hospitals (57.1% vs. 26.9%, X2 = 13.906, p = 0.000), and public hospitals (56.8% vs. 45.0%, X2 = 11.361, p = 0.001). However, the county-level availability of BPG (at least one hospital has BPG in a county-level unit) has not improved between 2012 and 2018 (65.93% vs. 70.34%; X2 = 0.563, p = 0.453). The absences of clinical needs, restriction of clinical antibacterial drugs, and lack of qualifications for providing syphilis treatment were the major reasons for the low BPG availability of hospitals. CONCLUSIONS: BPG availability for syphilis treatment in Shandong Province remains low and presents disparities among different levels and types of hospitals, although it has been improved in recent years. The low availability of BPG for syphilis treatment in China is related to its clinical use by doctors rather than the market supply. Health care reforms should further improve the availability and accessibility of health services.

A crise do desabastecimento da penicilina benzatina e o impacto na sífilis congênita: um estudo ecológico no município do Rio de Janeiro / The crisis of the shortage of benzathine penicillin supply and its impact on congenital syphilis: an ecological study in the city of Rio de Janeiro

O objeto de estudo é a crise do desabastecimento da penicilina benzatina (PB) e o impacto na sífilis congênita (SC) por um estudo ecológico no Município do Rio de Janeiro. Os objetivos são (i) descrever a evolução temporal do desabastecimento da PB, da incidência de (SC) e do aumento significativo da sua incidência no município no período de 2013-2017; (ii) estudar a relação entre o desabastecimento da PB e o aumento significativo da incidência de SC. Trata-se de um estudo ecológico do tipo misto (múltiplos grupos e temporal) baseado em dados secundários de notificação de SC e sífilis gestacional (SG), de dispensação de PB e dados demográficos das populações residentes nos bairros do município do Rio de Janeiro. As unidades de estudo foram bairro (geográfica) e trimestre (temporal) dos anos estudados. A população de estudo foi constituída por todos os casos de SC notificados pelo Sistema de Informação de Agravos de Notificação (SINAN) do município do Rio de Janeiro, por local de residência (bairro) no município do Rio de Janeiro. O período de estudo considerou a necessidade de contemplar o expressivo desabastecimento de PB nas unidades de saúde. Sabe-se que em 2014, o desabastecimento se iniciou devido a problemas de ordem regulatório-sanitária, uma crise impedindo a plena atividade produtora de penicilina no mercado brasileiro. Somente em 2016 havia indícios que a situação havia sido regularizada. A exposição do estudo foi o nível de abastecimento de PB nas unidades básicas de saúde calculada pela razão entre o número de doses dispensadas e o número de doses necessárias de acordo com dados de notificação de sífilis gestacional do SINAN. O principal desfecho foi o aumento significativo da incidência de SC, mas também foi considerada a taxa de incidência da população de cada bairro. O modelo teórico contemplou a dimensão sociodemográfica (estrutura etária, sexo, mulheres chefes de família, escolaridade), a dimensão econômica (pobreza, desemprego, gini de renda), dimensão geográfica (aglomeração, homicídio) e assistência pré-natal (número de consultas, parceiros tratados e exames realizados). Para a análise de dados foi usado o modelo de regressão binomial negativo inflado de zero para variável desfecho incremento significativo da incidência de SC (> 200% em relação ao trimestre anterior) e o nível abastecimento de PB para unidades de saúde de cada bairro-trimestre/ano de 2013-2017. As variáveis consideradas no ajuste foram aquelas dimensões citadas. Os resultados indicam que (a) o desabastecimento de PB no período estudado teve distribuição heterogênea no espaço e tempo; (b) incremento da incidência de SC também distribuído heterogeneamente no tempo e espaço e (c) relação entre o desabastecimento de PB e incremento de incidência de SC, considerando a influencia dos fatores descritos no modelo teórico. Concluiu-se que o abastecimento influenciou no aumento da incidência dessa doença no Rio de Janeiro nos anos de estudo

The object of study is the crisis of the shortage of benzathine penicillin (BP) supply and the impact on congenital syphilis by an ecological study in the city of Rio de Janeiro. The goals are to (i) describe the temporal evolution of benzathine penicillin supply shortage, the incidence of congenital syphilis (CS) and the significant increase in its incidence in the municipality in the 2013-2017 period; (ii) to study the relation between the shortage of benzathine penicillin and the significant increase in the incidence of CS. This is a mixed-type (multiple groups and temporal) ecological study based on secondary data on CS and gestational syphilis (GS), benzathine penicillin dispensation, and demographic data of populations living in the neighborhoods of Rio de Janeiro. The units of study were neighborhood (geographical) and quarter (temporal) of the studied years. The study population consisted of all cases of SC reported by the Notification Aggravation Information System (SINAN) of the city of Rio de Janeiro, by place of residence (neighborhood) in the city of Rio de Janeiro. The study period considered the need to contemplate the expressive shortage of BP in the health units. It is known that in 2014, the shortage began due to regulatory-sanitary problems, a crisis that prevented the full production of penicillin in the Brazilian market. Only in 2016 were there indications that the situation had been regularized. The study's exposure was the level of BP supply in the basic health units calculated by the ratio between the number of doses dispensed and the number of doses required according to SINAN's gestational syphilis notification data. The main outcome was a significant increase in the incidence of CS, but the incidence rate of each neighborhood population was also considered. The theoretical model included the socio-demographic dimension (age structure, sex, female heads of household, schooling), economic dimension (poverty, unemployment, income gini index), geographic dimension (agglomeration, homicide) and prenatal care (amount of appointments, partners treated and examinations performed). For the data analysis it was used the negative binomial regression model inflated from zero to variable outcome significant increase of the incidence of SC (over 200% comparing the previous quarter) and the BP supply level per health units of each neighborhood-quarter each year between 2013-2017. The variables considered in the adjustment were those dimensions mentioned. The results indicate that (a) the shortage of BP in the studied period had heterogeneous distribution in space and time; (b) increase in the incidence of CS was also distributed heterogeneously in time and space, and (c) a relation between BP shortages and increased CS incidence, considering the influence of the factors described in the theoretical model. The conclusion was that the supply influenced the increase of the incidence of this disease in Rio de Janeiro in the years of study

[Supply disruptions and drug shortages: the example of benzathine benzylpenicillin]. / Tensions d'approvisionnement et ruptures de stock des médicaments : l'exemple de la benzathine benzylpénicilline.

Supply disruptions and drug shortages : the example of benzathine benzylpenicillin. Despite collective mobilisation, drug shortages have increased in recent years, creating a strong impact on public health. Anti-infective drugs, mainly injectable antibiotics, are particularly affected by these shortages. Although the causes of these ruptures are multiple, they are mainly related to the effects of globalisation and industrial strategies of rationalisation of production costs. The shortage of benzathine benzylpenicillin illustrates the action of the French Medicines Agency (ANSM), and the various actors to guarantee access to care and limit the consequences for the patient. Beyond measures taken at national level by the regulatory authorities in connection with the pharmaceutical companies, it is necessary to set up a concerted action at European level to fight effectively against drug shortages.

Tensions d'approvisionnement et ruptures de stock des médicaments : l'exemple de la benzathine benzylpénicilline. Malgré une mobilisation collective, les ruptures de stock des médicaments se sont multipliées ces dernières années, créant un fort retentissement en matière de santé publique. Les médicaments anti-infectieux, principalement les antibiotiques injectables, sont particulièrement impactés par ces pénuries. Bien que les causes de ces ruptures soient multiples, elles sont principalement liées aux effets de la mondialisation et des stratégies industrielles de rationalisation des coûts de production. La rupture de la benzathine benzylpénicilline illustre l'action de l'Agence nationale de sécurité du médicament et des produits de santé et des différents acteurs pour garantir l'accès aux soins et limiter les conséquences pour le patient. Au-delà des mesures prises au plan national par les autorités sanitaires en lien avec les laboratoires pharmaceutiques, il est nécessaire de mettre en place une action concertée au niveau européen pour lutter efficacement contre les pénuries de médicaments.

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.

The WHF Roadmap for Reducing CV Morbidity and Mortality Through Prevention and Control of RHD.

Rheumatic heart disease (RHD) is a preventable non-communicable condition that disproportionately affects the world's poorest and most vulnerable. The World Heart Federation Roadmap for improved RHD control is a resource designed to help a variety of stakeholders raise the profile of RHD nationally and globally, and provide a framework to guide and support the strengthening of national, regional and global RHD control efforts. The Roadmap identifies the barriers that limit access to and uptake of proven interventions for the prevention and control of RHD. It also highlights a variety of established and promising solutions that may be used to overcome these barriers. As a general guide, the Roadmap is meant to serve as the foundation for the development of tailored plans of action to improve RHD control in specific contexts.

Rheumatic Heart Disease in the Twenty-First Century.

Rheumatic heart disease (RHD) is a chronic valvular disease resulting after severe or repetitive episodes of acute rheumatic fever (ARF), an autoimmune response to group A Streptococcus infection. RHD has been almost eliminated with improved social and health infrastructure in affluent countries while it remains a neglected disease with major cause of morbidity and mortality in many low- and middle-income countries, and resource-limited regions of high-income countries. Despite our evolving understanding of the pathogenesis of RHD, there have not been any significant advances to prevent or halt progression of disease in recent history. Long-term penicillin-based treatment and surgery remain the backbone of a RHD control program in the absence of an effective vaccine. The advent of echocardiographic screening algorithms has improved the accuracy of diagnosing RHD and has shed light on the enormous burden of disease. Encouragingly, this has led to a rekindled commitment from researchers in the most affected countries to advocate and take bold actions to end this disease of social inequality.

Health policy: Reducing rheumatic heart disease in Africa -- time for action.

Rheumatic heart disease (RHD) key opinion leaders, health ministers, clinicians, and industry representatives gathered in Ethiopia in February 2015. The question: how to eradicate RHD in Africa. The response: the Addis Ababa communiqué, a practical document outlining seven major barriers to RHD control in Africa and seven strategies to address them.

Seven key actions to eradicate rheumatic heart disease in Africa: the Addis Ababa communiqué.

Acute rheumatic fever (ARF) and rheumatic heart disease (RHD) remain major causes of heart failure, stroke and death among African women and children, despite being preventable and imminently treatable. From 21 to 22 February 2015, the Social Cluster of the Africa Union Commission (AUC) hosted a consultation with RHD experts convened by the Pan-African Society of Cardiology (PASCAR) in Addis Ababa, Ethiopia, to develop a 'roadmap' of key actions that need to be taken by governments to eliminate ARF and eradicate RHD in Africa. Seven priority areas for action were adopted: (1) create prospective disease registers at sentinel sites in affected countries to measure disease burden and track progress towards the reduction of mortality by 25% by the year 2025, (2) ensure an adequate supply of high-quality benzathine penicillin for the primary and secondary prevention of ARF/RHD, (3) improve access to reproductive health services for women with RHD and other non-communicable diseases (NCD), (4) decentralise technical expertise and technology for diagnosing and managing ARF and RHD (including ultrasound of the heart), (5) establish national and regional centres of excellence for essential cardiac surgery for the treatment of affected patients and training of cardiovascular practitioners of the future, (6) initiate national multi-sectoral RHD programmes within NCD control programmes of affected countries, and (7) foster international partnerships with multinational organisations for resource mobilisation, monitoring and evaluation of the programme to end RHD in Africa. This Addis Ababa communiqué has since been endorsed by African Union heads of state, and plans are underway to implement the roadmap in order to end ARF and RHD in Africa in our lifetime.