As countries aim to achieve the Sustainable Development Goals, there is an emphasis on increasing the availability of medicines. However, poor quality products or dispensing methods may decrease treatment effectiveness or even result in patient death. ADEs negatively affect patient care and increase costs to the system. A functioning PV system monitors these events and triggers actions to minimize their impact. While some disease-specific areas, such as tuberculosis, have made PV a regular tenant of their treatment programs, medicines used for maternal, newborn, and child health (MNCH) are often ignored in reporting. This case study highlights steps taken to ensure the safe use of medicines for mothers, newborns, and children through regular adverse drug event (ADE) reporting as part of the national pharmacovigilance (PV) program in Bangladesh.
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Keep Maternal, Newborn, and Child Health Medicines Safe: Introducing MNCH commodities into a pharmacovigilance system
Pneumonia is one of the leading causes of death in children in the developing world, killing about 1.2 million children under five per year. The number of children with pneumonia symptoms who receive medical care is extremely low, and as a result, they are not properly treated with antibiotics. A child receiving antibiotic treatment within the first 24 hours of displaying bacterial pneumonia symptoms can be saved. Many countries are currently attempting to increase access to appropriate treatment through community-based initiatives such as community case management — and appropriately so, because studies show that by increasing the coverage of integrated interventions to 90%, we can, by 2025, reduce the number of global under-five pneumonia deaths by 67%. In response to these high but preventable infant and child mortality rates, the child survival community has declared an unambiguous commitment to rapidly scaling up efforts to increase access to antibiotic treatment for pneumonia.
In May 2017, SIAPS held a Leadership Development Program (LDP) training to build the capacity of the Directorate of Drugs and Medical Supplies (DDMS), district and hospital pharmacists, and SIAPS field staff. It was the first such training in the country. The program aims to train pharmacists on basic principles and practices of good leadership, management, and governance to help them identify challenges like system and budget constraints—and to lead their teams in handling them with maximum efficiency, collaboration, and transparency. Another training goal is to help pharmaceutical managers optimize the SIAPS-supported Continuous Results Monitoring and Support System (CRMS), which has been implemented nationwide. The training created a pool of local LDP facilitators who can extend their knowledge to other DDMS staff and to pharmacists throughout all 13 districts in Sierra Leone.
In 2015, at the request of the Directorate General of Health Services (DGHS), SIAPS undertook a comprehensive mapping exercise of the existing HIS tools in the country to review their scopes and performances and explore opportunities to link the tools to improve efficiency.
The assessment included a deep dive into the DHIS2 platform to assess the system’s capacity, robustness, data security, and interoperability and strongly recommended that the country continue using DHIS2 for data aggregation, analysis, and reporting, with a caution that overload of individual patient data should be avoided. This recommendation triggered a thoughtful consideration to integrate the standalone e-TB Manager with DHIS2 so that patient summary data become available through DHIS2 for indicator reporting and decision making.
In May 2016, SIAPS began helping Sierra Leone institute a Continuous Results Monitoring and Support System (CRMS) to assess baseline challenges in pharmaceutical management and regularly track and support improvement in key areas. The CRMS uses a series of indicators related to medicine consumption and availability, disease case management, storage conditions and practices, inventory control and human resources. SIAPS is using this approach in Sierra Leone to improve pharmaceutical management in all health facilities as part of the post-Ebola recovery effort. The CRMS approach includes forming and training team members, planning logistics, visiting health facilities, collecting and analyzing data, providing real-time support and mentoring, preparing reports, and bringing key stakeholders together to review results and plan future activities.
SIAPS supported the establishment and initial training of a national quantification committee and seven quantification technical working groups in October 2016. The national quantification committee and the technical working groups are coordination mechanisms for effective management of pharmaceuticals in the country. SIAPS also supported the Directorate of Drugs and Medical Supplies (DDMS) and the Free Health Care Initiative (FHCI) technical working group in conducting a multiyear quantification of pharmaceuticals. Data from multiple sources, including the SIAPS-supported Continuous Results Monitoring and Support System, were used to support evidence-based decision making. SIAPS also trained all members of the tuberculosis quantification technical working group on the use of QuanTB, a quantification and early warning tool SIAPS developed to improve quantification and procurement processes for TB medicines.
In Mozambique, SIAPS has been working with the Ministry of Health’s (MOH) pharmaceutical department (PD), which functions as the country’s regulatory authority, to strengthen its capacity at the national level. The PD’s main function is to ensure access to safe, effective, and quality pharmaceuticals through the public and private sectors that contribute to the best possible health outcomes. One of the PD’s priorities has been to develop a monitoring and evaluation (M&E) system to assess department performance; improve transparency and ensure accountability; help guide the planning, coordination, and implementation of regulatory activities; and foster a culture of evidence-based decision making.
In 2014, SIAPS supported the Ministry of Health (MOH), Central Medical Stores (CMS), and Swaziland Health Laboratory Services (SHLS) by conducting a workshop to build capacity and improve performance of staff that works in warehouse operations. The Imperial Health Services warehouse was used as a model to showcase warehousing best practices.
To begin the project, SIAPS helped coordinate regular planning meetings and discussions with the NTP’s Drugs and Supplies Management (DSM) sub-technical working group. SIAPS then facilitated collaboration among the NTP, the PD, WHO, and the GDF.
Technical Highlight: Strengthening Regulatory Systems in Democratic Republic of the Congo to Improve Access to Safe, Effective, and Quality Medicines
Chronic underfunding of the health sector coupled with long-term civil unrest in the Democratic Republic of the Congo (DRC) has contributed to insufficient regulatory capacity to effectively manage the registration and approval of new medicines in the country. In partnership with the USAID-funded SIAPS Program, the country’s Ministry of Health supported a number of broad interventions to strengthen DRC’s pharmaceutical regulatory system. SIAPS provides technical assistance to the three national control programs—malaria, HIV/AIDS, and tuberculosis—to improving access to quality medicines and other commodities and increase the potential for achieving desired health outcomes.
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