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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).

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Quality and Safety of HIV/AIDS Medicines in Namibia October 2015-September 2016

In the last five years, SIAPS has provided technical assistance to the Namibia Medicines Regulatory Council (NMRC) to strengthen its capacity for registration and quality testing by training technical staff in medicines dossier evaluation, developing guidelines for conducting the routine PMS of quality of medicines, and collecting medicine samples at selected ART and TB treatment sites for laboratory testing. SIAPS mentored and provided guidance and technical support to NMRC staff and other personnel in conducting efficient dossier reviews for the registration of ARVs, anti-TB, and other essential medicines. Consequently, intensive dossier review sessions were organized and fully funded by NMRC after effective and successful transition of the activity to NMRC for sustainability. SIAPS provided technical assistance to the NMRC to develop guidelines and collect medicine samples from seven priority regions (Kavango East and West, Khomas, Ohangwena, Omusati, Oshana, Oshikoto, and Zambezi) and one urban hotspot (Grootfontein [Otjozondjupa]).

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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.

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Post-Qualification Monitoring and Evaluation of Pharmacist Assistants Trained at the National Health Training Centre in Namibia

Namibia has a decentralized public health system with 14 administrative regions. It is challenged by a dual burden of HIV and AIDS and tuberculosis (TB) as well as by the persistent shortage of pharmaceutical personnel. Well-trained pharmacist assistants (PA) are central to ensuring that the correct medicines are available in sufficient quantities as well as for counseling patients on the proper use of medicines and monitoring patients’ adherence to antiretroviral therapy (ART) and other treatments. The National Health Training Centre (NHTC) has conducted this first formal workplace assessment of PAs who have graduated from the institution since 2007 in response to support from the US Agency for International Development (USAID) for a series of systematic interventions to strengthen the capacity and quality of PA training. Broadly, the USAID-funded SIAPS program supported the NHTC to conduct a tracer study to inform strategies for improving the PA training program and its reaccreditation by the Namibia Qualifications Authority (NQA). Specifically, the study assessed: the proportion of NHTC PA graduates who are working in a PA role; the PAs’ satisfaction with the training they received at the NHTC; employers’/supervisors’ satisfaction with the PAs’ services; and strengths and weaknesses of the PA training program. Stakeholders’ recommendations for improving the PA training program were also obtained.

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National Pharmacists’ Forum 2014 Technical Report: Dissemination of Pharmaceutical Services Information

SIAPS and its predecessor projects—Strengthening Pharmaceutical Systems (SPS) and Rational Pharmaceutical Management (RPM) Plus—have worked extensively to introduce and support tools that capture dispensing and supply chain data from public health facilities. SIAPS supports the Ministry of Health and Social Services (MoHSS) to conduct periodic analyses of antiretroviral therapy (ART) data by using available data sources, specifically the Electronic Dispensing Tool (EDT) and national database. In order for such data to inform programmatic decisions, it needs to be actively disseminated to program managers. The Division of Pharmaceutical Services (Div: PhSs), with technical assistance from SIAPS and the Supply Chain Management System (SCMS), compiles a quarterly ART Logistics Management Information System (LMIS) feedback report, a quarterly Pharmaceutical Management Information System (PMIS) feedback report, and an annual supportive supervision visit (SSV) feedback report. Hard and soft copies of the ART LMIS and PMIS reports are disseminated quarterly to all regions of Namibia, and SSVs reports are disseminated annually.

To improve dissemination and stimulate discussions of results, SIAPS supported Div: PhSs to conduct the National Pharmacists’ Forum 2014. Findings from PMIS feedback reports and recommendations made by SSVs were discussed with participants of the forum, which took place from September 29 to October 3, 2014, in Otjiwarongo, Namibia. Participants included pharmacists and stakeholders from 13 of Namibia’s 14 regions. The forum also provided opportunities to disseminate, discuss, and analyze other pharmaceutical services information in reports, such as the standard treatment guidelines (STGs) post-assessment report, and to introduce new medicines added to the Namibia Essential Medicines List (Nemlist).

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Strengthening the Capacity of the Namibia Medicines Regulatory Council in the Regulation of Antiretroviral Medicines and Other Essential Pharmaceuticals

This consultancy and assessment is the follow up to the original 2009 SPS report, which described the structure and function of the NMRC, identified challenges in its operations, and provided recommendations for improvements in the NMRC’s processes. In this consultancy, several substantive recommendations are made to enhance the effectiveness and efficiency of the NMRC, particularly in the registration of ARV/AM/ATB medications and to accelerate the processing of medicines on the Namibian EML.

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Improving the Professional Registration Process of Pharmacy Personnel through Streamlining the Assessment Framework, Methods, and Tools in Namibia

Namibia faces a shortage of pharmaceutical personnel. The increased burden that HIV and AIDS has placed on national health systems in general has made this burden even more severe. USAID-funded SIAPS conducted a preliminary assessment to evaluate the screening system and processes in use for pharmaceutical practitioners concerning legal recognition to practice in Namibia. This was also conducted to advise the Pharmacy Council of Namibia (PCN) on improvements that can be made to the screening process for the pharmacy practitioner competency assessment and registration/licensure process. The goal is to make more pharmacists, technicians, and pharmacists’ assistants (PAs) available to provide appropriate pharmaceutical care services in general and make antiretroviral therapy (ART) in particular more accessible to patients, especially in rural settings.

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