Inside this issue:
- Pharmacovigilance in Swaziland
- Update on 2016-2017 Spontaneous Reporting Systems
- Medicine Safety Alerts
- How to Report an ADE
Inside this issue:
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.
In 2012, the US Agency for International Development-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, implemented by Management Sciences for Health, started working with the DGDA and conducted a comprehensive assessment of the DGDA’s regulatory systems and capacity. As part of the recommendations made in the assessment, SIAPS provided technical support to the DGDA to revive the national PV program and establish an Adverse Drug Reaction Monitoring (ADRM) cell. This cell, which is responsible for collecting adverse event reports from health care facilities, hospitals, and pharmaceutical companies, maintains and analyzes adverse event databases, including data entry and quality assurance, and shares adverse event information with WHO’s International Drug Monitoring Center (WHO-UMC) at Uppsala.
The SIAPS May 2016 Storify includes web content on SIAPS technical leadership in pharmacovigilance across multiple online platforms. Check out the selection of website features, tweets, and other posts below. [View the story “SIAPS Focus on Pharmacovigilance: May 2016” on Storify]
Inside this issue:
The Food and Drug Administration (FDA) Philippines, with support from the US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program conducted an assessment of the Philippines’ pharmacovigilance (PV) system and its components. They are (1) governance, policy, law, and regulation; (2) systems, structures, and stakeholder coordination; (3) signal generation and data management; (4) risk assessment and evaluation; and (5) risk management and communication, using the Indicator-based Pharmacovigilance Assessment Tool.
The Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is a five- year cooperative agreement funded by the United States Agency for International Development (USAID) and implemented by Management Sciences for Health (MSH). The goal of SIAPS is to improve the availability of quality pharmaceutical products and effective pharmaceutical services through strengthening pharmaceutical systems.
In the Philippines, SIAPS supports the Philippines Department of Health (DOH) initiatives to reduce the TB disease burden through a systems approach to strengthening pharmaceutical management and services. SIAPS works with the National TB Program (NTP), National TB Reference Laboratory (NTRL), Food and Drug Administration (FDA), and other partners to build their capacity in pharmaceutical management.
As part of this support, USAID Philippines requested the technical assistance and services of SIAPS to conduct a pharmacovigilance (PV) workshop and provide technical assistance to the NTP and the FDA to strengthen their PV system.
In April 2015, USAID and Janssen Therapeutics officially launched the bedaquiline donation initiative, under which Janssen committed to providing free bedaquiline to 30,000 patients with multidrug-resistant tuberculosis (MDR-TB) over a four-year period. Bedaquiline is the first anti-TB medicine to be approved by the U.S. Food and Drug Administration in more than 40 years, and is […]
This week, at the 46th Union World Conference on Lung Health, the USAID-funded SIAPS Program is launching a new tool to improve pharmacovigilance in low- and middle-income countries. Although all medicines undergo rigorous clinical testing prior to being made publicly available, continuing to monitor the safety and effectiveness of medicines in real world settings, also referred to […]
To learn more about SIAPS program activities worldwide, please read our annual report for program year 6.
Project dates: January 2012 – September 2017
A presentation by Mohan P. Joshi, Principal Technical Advisor and Lead for Pharmaceutical Services, SIAPS, at USAID in Arlington, VA […]