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.
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.
TB patients on second-line treatment experience a significant number of adverse effects. Some TB medicines result in adverse effects that, if not continuously monitored, can become serious and/or permanent and may hinder patient adherence to treatment. A number of other risk factors can also impact the safety of patients taking TB medicines, including drug interactions […]
SIAPS, in partnership with the FDA, NTP, and LCP-NCPR, conducted a readiness assessment to determine the current information technology (IT) infrastructure, human resources, processes, and data management and quality control mechanisms available and to identify gaps in the current PV recording and reporting of patients in the seven Programmatic Management of Drug-Resistant TB (PMDT) treatment facilities implementing the 9MTR for multidrug-resistant (MDR)-TB study. The results of this assessment will provide inputs for developing the PViMS implementation plan.
An online system for monitoring and reporting cases of adverse drug reactions and lack of efficacy of medicines comprehensively addresses the need for improved access to quality, safe, and effective medicines. “The evaluation and analysis of PAIS system in Ukraine has brought out gaps and identified recommendations on operational PAIS system optimization and enhancing its […]
The SIAPS team has helped the Ethiopian Food, Medicine, and Health Care Administration and Control Authority (FMHACA) and many health facilities in the country incorporate product quality reporting into its national adverse drug event (ADE) reporting system. This has proven to be an efficient and cost-effective measure to detect products with problems in quality and […]
SIAPS mobilized stakeholders from the Swaziland National AIDS Program (SNAP) and the National Tuberculosis Control Program (NTCP) to introduce and implement the Sentinel Site-based Active Surveillance System for Antiretroviral and Anti-TB (SSASSA) treatment programs. SIAPS partnered with the Pharmacovigilance Unit of the MOH to create the protocol and tools for the electronic SSASSA system, and developed a patient recruitment system at HIV and TB sites.
By publishing this newsletter, The Directorate General of Drug Administration (DGDA) will be able to communicate information on the safety of medicines and other health products to health care professionals, consumers, and the public on a regular basis. In the event of an emergency, when serious risks arise, that information will become crucial to ensuring the availability of safe, effective, and quality medicines.
To learn more about SIAPS program activities worldwide, please read our annual report for program year 6.
Project dates: January 2012 – September 2017
SIAPS is presenting its webinar “What Gets Defined, Gets Measured: Definitions and a Framework for Measuring Pharmaceutical Systems Strengthening” on […]