Tag Archives | A Mengistu

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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Pediatric Antiretroviral Treatment Uptake, Treatment Adherence, Regimen Switches, and Retention in Care in Namibia

In Namibia, a preliminary review of EDT records suggests that children form a small proportion of the patients accessing ART in any given setting, nationally composing 8% of the patients on ART in the MoHSS facilities. Over the years, managing children has been complicated with formulations that have not been friendly for children, complicated regimens, and occasional stock-outs of pediatric ARVs. These challenges may increase the number of children that might receive suboptimal care, including delayed or no interventions in face of poor adherence, ultimately leading to suboptimal response to treatment. This can then increase the risk of HIV drug resistance and leads to short survival of HIV-infected children. Findings from this assessment will provide much needed evidence on trends in pediatric HIV treatment uptake, levels of adherence, and retention among those on treatment. Ultimately, the evidence generated will support MoHSS policy makers and leaders in modifying and strengthening interventions aimed at enhancing treatment uptake, adherence, retention, and viral load suppression among HIV-infected children in Namibia.

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Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia

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.

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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.

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Sentinel Site Active Surveillance of the Safety of First-Line Antiretroviral Medicines in Windhoek Central Hospital and Katutura Intermediate Hospital

In the Republic of Namibia, the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program receives funding from the US Government to provide technical guidance for the development and implementation of innovative strategies and programs to strengthen pharmaceutical systems in support of the HIV/AIDS program. SIAPS is collaborating with USAID/Namibia to ensure the availability of quality pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes for the government of the Republic of Namibia.

The Therapeutics Information and Pharmacovigilance Centre (TIPC) is responsible for the promotion of the rational and safe use of medicines in Namibia. Officially launched in 2008 as part of the Ministry of Health and Social Services (MoHSS), it is the official centre for the provision of unbiased therapeutics information and pharmacovigilance services to health care professionals and the general public. The Centre became the 90th full member of the World Health Organization (WHO) Programme for International Drug Monitoring in 2008.

The SIAPS Program in Namibia supports the implementation of initiatives to improve treatment outcomes through strategies that promote pharmacovigilance at the health facility and community levels. Additionally, in collaboration with UW, SIAPS is providing technical guidance towards the implementation of medication risk management strategies at selected referral hospitals in Namibia. In FY12, SIAPS supported the initiation of prospective active surveillance of the safety of antiretroviral medicines at the Windhoek Central Hospital and the Katutura Intermediate Hospital. In FY13, SIAPS continued to provide technical assistance towards the implementation of prospective active surveillance of ARV medicines so that the collected data is managed accurately, and to ensure that the active surveillance system is a long-term and beneficial investment.

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Strengthening the Nevirapine Safety Signal by Using the Electronic Dispensing Tool in Namibia

The primary objective of this signal strengthening activity was to estimate the frequency of substitution of NVP with a protease inhibitor (PI) during the period 2008 to 2011 and to determine if any increase detected was statistically significant.

The incidence of NVP-related reactions of grade 3 and 4 increased with the implementation of Namibia’s 2010 ART Guidelines. The NVP safety signal of increased reports of grade 3 and 4 reactions was indeed a true signal. It is possible that initiating NVP-containing ART in women with high baseline CD4 counts, that is >250 cells/mm3, was the cause for the increase in the incidence of NVP-related grade 3 and 4 reactions. Therefore, the national HIV programme needs to review the use of NVP.

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Antimicrobial Sensitivity Patterns of Cerebrospinal Fluid (CSF) Isolates in Namibia: Implications for Empirical Antibiotic Treatment of Meningitis

Mengistu A, Gaeseb J, Uaaka G, Ndjavera C, Kambyambya K, Indongo L, et al. Antimicrobial sensitivity patterns of cerebrospinal fluid (CSF) isolates in Namibia: implications for empirical antibiotic treatment of meningitis. Journal of Pharmaceutical Policy and Practice. 2013;6:4.

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