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.
Technical Highlight: Strengthening Bangladesh’s National Pharmacovigilance System: Lessons Learned and Opportunities
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:
- Bangladesh National Drug Formulary 2015 Launched
- Real-Time Stock Reporting: Safeguarding the Lives of Women and Children
- Health Information System Mapping Analysis Conducted
- MOHFW Gears Up to Take Over SCMP
- DGDA Partners with KOICA to Bolster Staff Capacity
- Electronic Logistics Management Information System Developed for DGHS
- Reducing Newborn and Child Death through Public-Private Partnership
- Innovative Approach Helps Peripheral TB Patients Get Quality Medicines
- Development of the 4th HPNSDP is Underway
- International Training Enhances MOHFW’s Official’s Procurement Capacity
- SOP Developed to Strengthen DGDA’s Post-Marketing Surveillance Capacity
- SIAPS Extends Support to Bangladesh Country Coordination Mechanism
- Harmonization of Inventory Tools Improves DGHS’ Inventory Management
- Ensuring Medicine Safety through Improved Pharmacovigilance
- e-TB Manager Improves Recording and REporting for TB Control
- SMC’s Logistics Management Improves with SIAPS Assistance
- Abstracts and Poster Presentations Showcasing SIAPS Bangladesh at International Forums in 2015
Safety of Medicinal Products in the Philippines: Assessment of the Pharmacovigilance System and its Performance
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.
Implementing Active Pharmacovigilance and Cohort Event Monitoring for Multidrug-Resistant Tuberculosis Regimens in the Philippines
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.
Georgia: Establishing a drug safety management and monitoring system for bedaquiline and other drugs
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 […]
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Project dates: September 2012 – December 2016
The Department of Health-Pharmaceutical Division (DOH-PD) and National TB Program (NTP) in the Philippines adopted the web‐based application Pharmacovigilance Monitoring […]