SIAPS helped improve pharmaceutical product quality by building the capacity of the Namibia Medicines Regulatory Council (NMRC) to review medicine registration dossiers; inspect pharmaceutical manufacturing facilities and finished (imported) products at ports of entry and in the marketplace; to chemically test medicines compliance with established standards; and monitor overall compliance with applicable regulatory standards and norms. In addition, SIAPS supported MOHSS in strengthening the management and regulation of medical devices and support equipment in Namibia, and in revising the National Medicines Policy, a crucial of pharmaceutical regulation and governance. SIAPS supported the reconfiguration of the desk-top Pharmadex tool to a web-based application. In general, the six-year support of the SIAPS project to the NMRC contributed to the strengthening of this regulatory agency, which in turn, contributed to improvements in service delivery to the clients. The registration process improved, to decrease the long-standing backlog of dossiers; PMS ensured safety and quality of pharmaceuticals; and implementation of web-based Pharmadex provided a means for clients/applicants to upload applications and follow up the progress of dossier review, which reduced workload for NMRC staff. SIAPS provided continuous TA for the restructuring of the NMRC.
Therapeutics Information and Pharmacovigilance Centre’s Analysis of Spontaneous Adverse Events due to Antiretroviral and Other Medicines
The use of antiretrovirals (ARVs) in combination for treating patients with HIV has greatly ameliorated morbidity and mortality by reducing viral load to undetectable levels and boosting the body’s immunity. However serious adverse reactions causing long- or short-term effects have been associated with ARV treatment. These reactions have caused major concerns internationally, potentially threatening patient adherence to long-term treatment. The duration of treatment of patients infected with HIV; co-morbid conditions, such as tuberculosis (TB) and malaria; and the complications due to HIV infection or AIDS make it difficult to determine the exact cause of the adverse events (AEs) experienced by patients taking ARV medicines. The prevalence of co-morbid conditions differs across socioeconomic groups and geographical regions, which may contribute to differences in ARV toxicity profiles. Hence, it is recommended that national HIV treatment programs establish population-level ARV toxicity profiles for their countries. Therefore, with increased survival of patients and the long-term duration of antiretroviral treatment (ART), it is important for national pharmacovigilance centers to monitor the immediate and long-term effects of these ARVs on the population. A simple, practical, and cost-effective method for evaluating the safety of drugs approved for human use is the spontaneous reporting of AEs to a pharmacovigilance center. This method is helpful for identifying serious and rare medicine-associated AEs. The evaluation of these AEs informs regulatory decisions on improving the safety of medicines in the country and globally. The objective of the Analysis of Namibia Therapeutics Information and Pharmacovigilance Centre’s Data was to identify drug safety concerns associated with the use of antiretroviral medicines in Namibia’s HIV treatment program, by analyzing pharmacovigilance data generated from spontaneous reports of suspected adverse events (AEs).
SIAPS supported the MoHSS to design and implement a web-based electronic information system (dashboard) for both patient and stock status in Namibia. It was designed to improve coordination among facility, district, regional, and national stakeholders involved in HIV commodity management; increase the use of pharmaceutical information for management decision making at all levels of health care; and improve planning for financial resources for pharmaceutical commodities. The dashboard comprises a module for monitoring 22 pharmaceutical services delivery indicators, a module that summarizes the number of people accessing ART services, and an early warning system against stock-outs of antiretrovirals (ARVs) and other essential medicines.
Capacity Building for Healthcare Personnel to Manage Pharmaceutical Services at ART and NIMART Sites, October 2015 to September 2016
SIAPS supported the Ministry of Health and Social Services to enhance capacity of pharmaceutical HR to manage pharmaceutical services in public health facilities in Namibia. The major objectives of the activities were to build HR capacity in pharmaceutical management and service delivery for improved HIV and AIDS treatment outcomes and improve availability and use of pharmaceutical service data for improved quality of ART services. Activities comprised onsite staff mentoring through supportive supervision visits and training sessions adapted to the needs of the target healthcare workers.
Human Resource Capacity Development for ART and Pharmaceutical Services in Namibia, October 2014-September 2015
SIAPS Namibia applied the capacity building approach to support the Ministry of Health and Social Services to enhance the capacity of two local training institutions—UNAM-SoP and the NHTC—to train pharmacists and PAs, respectively. With SIAPS technical assistance for defining a career path for PAs, UNAM-SoP started training pharmacy technicians, a new cadre in Namibia. SIAPS also continued its efforts to enhance the capacity of individuals through pre- and in-service training to ensure that health workers have adequate skills to administer quality pharmaceutical services. The capacity building interventions were done through training workshops and on-the-job technical assistance provided during support supervisory visits (SSVs) and remotely.
Development of Sustainable HIV/TB Active Surveillance System in Swaziland – Protocol and Operational Plan
A pharmacovigilance system, through active surveillance in sentinel sites, is proposed to monitor the safety and tolerability of antiretroviral medicines (ARV) and anti-tuberculosis (TB) medicines at antiretroviral treatment (ART) clinics and TB clinics in Swaziland. The goal of this activity is to develop, implement, and demonstrate the local feasibility of a practical and sustainable pharmacovigilance system that could later be scaled up to monitor the safety of ARV and TB regimens throughout the country.
Consolidating SIAPS’ Five-Year Support to the Ministry of Health and Social Services for Strengthening Pharmacovigilance in Namibia
The goal of SIAPS in Namibia was to improve the quality and safety of pharmaceutical services to achieve sustained HIV epidemic control. Since 2012, SIAPS focused on interventions that increased the availability of quality antiretrovirals (ARVs), other essential medicines, and services to sustain more than 80% ART coverage of patients in need. SIAPS activities also contributed to ensuring patient safety through pharmacovigilance (PV) activities.
Assessment of the World Health Organization’s HIV Drug Resistance Early Warning Indicators in Main and Decentralized Outreach Antiretroviral Therapy Sites in Namibia
Mutenda N, Bukowski A, Nitschke AM, Nakanyala T, Hamunime N, Mekonen T, Tjituka F, Mazibuko G, Mwinga S, Mabirizi D, Sagwa E, Indongo R, Dean N, Jordan MR, Hong SY. Assessment of the World Health Organization’s HIV drug resistance early warning indicators in main and decentralized outreach antiretroviral therapy sites in Namibia. PLOS One. 2016.
Mann M, Mengistu A, Gaeseb J, Sagwa E, Mazibuko G, Baeten JM, Babigumira JB, Garrison LP, Stergachis A. Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia. Pharmacoepidemiology and Drug Safety. 2016, Vol 25, Issue 9; 1052-1060.
Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost-Utility Analysis
Mann M, Mengistu A, Gaeseb J, Sagwa E, Mazibuko G, Babigumira JB, Garrison Jr LP, Stergachis A. Active surveillance versus spontaneous reporting for first-line antiretroviral medicines in Namibia: A cost-utility analysis. Drug Safety. 2016, Vol. 39, Issue 9; 859-872.
- The Use of Pharmaceutical Information for Decision Making in Namibia's National ART Program: Assessment Report
SIAPS conducted this assessment to determine the extent to which pharmaceutical information generated from the Electronic Dispensing Tool (EDT) and […]
The Directorate of Drugs and Medical Supplies (DDMS) plays a key role in providing technical guidance and setting strategic direction […]
- Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program Inventory of Key Technical Resources
The main purpose of this inventory is to serve as a reference to help stakeholders working in the pharmaceutical sector […]