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.
Keep Maternal, Newborn, and Child Health Medicines Safe: Introducing MNCH commodities into a pharmacovigilance system
SIAPS final report showcases achievements across 46 countries. Interventions are described by intermediate results and health areas and demonstrate how SIAPS successfully worked with a range of stakeholders, including Ministries of Health, to bolster pharmaceutical systems and address country-specific needs.
In an effort to improve the health status of the Beninese population, a priority activity included in the 2015 convention between the US Government, represented by USAID, and the Benin Government, represented by the Ministry of Health (MOH), was to conduct a comprehensive assessment of the public health supply chain, focused on essential medicines that are associated with the package of low-cost, high-impact interventions. SIAPS undertook this assessment in close collaboration with and under the leadership of the MOH, represented by the National Health Products Supply Chain. This report presents information on the capability, maturity, and operational performance of Benin’s health supply system, along with a strategic plan of interventions to address identified weaknesses that will allow reliable supply and use of medicines in the health system.
A comprehensive assessment of DPM’s medicine regulatory system was conducted September to October 2017 by SIAPS funded by USAID. The WHO Global Benchmarking Tool was used for data collection. The scope of the assessment was focused on the five regulatory functions: national regulatory systems, medicines registration and marketing authorization (MA), pharmacovigilance (PV), market surveillance and control, and clinical trial oversight (CTO).
The objective of the National Guideline on the Pharmacovigilance System in Bangladesh is to guide health care providers (HCPs) and other key actors in the health and pharmaceutical sectors on the operations of the PV system. This document gives an overview of what PV is, how to detect and classify ADRs, and the structural organization of the system in Bangladesh. It also describes the reporting system to the NPC and expected outcomes. The document aims to help expand the roles and responsibilities of stakeholders in the country’s PV system to identify, analyze, and minimize the risks associated with pharmaceutical products. It also promotes better and broader use of PV data for patient safety.
SIAPS conducted a training on pharmacovigilance (PV) to increase the capacity of the National Tuberculosis Program, the Lung Center of the Philippines, Pharmaceutical Division, and Food and Drug Administration. Strengthening the capacity of staff in these organizations and other stakeholders in this area of PV reinforces current safe scale-up efforts and introduction of these lifesaving regimens. Furthermore, providing training for staff in data management, causality assessment, and signal detection enhances expansion of safety monitoring to other medicines used within the health system in the Philippines.
Inside this issue:
- Pharmacovigilance in Swaziland
- Update on 2016-2017 Spontaneous Reporting Systems
- Medicine Safety Alerts
- How to Report an ADE
Analysis of Passive Surveillance Data Collected by the Swaziland Pharmacovigilance Unit, October 2016-March 2017
With support from SIAPS, the Swaziland National Pharmacovigilance Unit (NPVU) has been monitoring the safety of medicines used in the county by collecting and collating reports of adverse drug reactions (ADR) and other medicine-related problems through its spontaneous reporting system established under the country’s Ministry of Health in 2009. In addition, SIAPS has been supporting active surveillance for ARV and TB medicines. ADRs and other medicine-related problems are reported to the NPVU by health care providers using a paper ADR reporting form. Completed forms are sent to the NPVU or collected from health care facilities on a quarterly basis for data entry and analysis. SIAPS supports the collection of the forms and has seconded a data clerk to the NPVU to enter the data from the forms into Microsoft Excel. SIAPS support was further sought to analyze PV data and build the capacity of the PV team to undertake routine analysis of those data. The main objective of the work was to analyze PV data generated from the spontaneous reporting system in Swaziland to inform clinical practice (rational medicine use) and improve patient outcomes.
As a pharmacist, Md. Jahidul Hasan has worked in several hospitals, but it was not until he joined Square Hospital Limited (SHL) that he learned about pharmacovigilance (PV). SHL is a 400-bed tertiary care private hospital in Dhaka, Bangladesh, that serves an average of 1,200 out-patients each day. The Directorate General of Drug Administration (DGDA), with technical assistance from SIAPS, officially launched Bangladesh’s national PV program in 2013. The DGDA first introduced the PV program at 20 private and public hospitals, including SHL, and 13 pharmaceutical companies. Since then, the DGDA and SIAPS have organized trainings for the PV focal persons in these hospitals and pharmaceutical companies to build their skills and knowledge on PV and increase adverse drug event (ADE) reporting.
SIAPS supported the Swaziland Ministry of Health (MOH) in mobilizing key stakeholders from the Swaziland National AIDS Program and the National Tuberculosis Control Program to introduce and implement an active surveillance system for patients on ARVs and anti-TB treatment. SIAPS provided technical assistance to MOH’s National Pharmacovigilance Unit (NPVU) to develop the protocol and tools to implement the system, as well as to develop a system for recruiting patients at the HIV and TB sites.
SIAPS worked with global and in-country partners to improve access to and use of life-saving medicines for women and children, […]
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- Keep Maternal, Newborn, and Child Health Medicines Safe: Introducing MNCH commodities into a pharmacovigilance system
As countries aim to achieve the Sustainable Development Goals, there is an emphasis on increasing the availability of medicines. However, […]