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https://www.um.edu.mt/library/oar/handle/123456789/136066| Title: | Signals in the use of antiretroviral therapy |
| Authors: | Okafor, Obianuju Elizabeth (2025) |
| Keywords: | Highly active antiretroviral therapy Pharmacovigilance Drugs -- Side effects HIV infections AIDS (Disease) |
| Issue Date: | 2025 |
| Citation: | Okafor, O. E. (2025). Signals in the use of antiretroviral therapy (Master's dissertation). |
| Abstract: | Antiretroviral therapy (ART) has notably improved the prognosis of people living with Human Immunodeficiency virus (HIV), reducing morbidity and mortality rates. Antiretroviral therapy (ART) has completely transformed the treatment of HIV/AIDS, transforming the disease from a fatal diagnosis to a well-managed chronic disease thus, becoming the cornerstone of global HIV treatment thereby offering millions of people living with HIV the opportunity to enjoy longer and more healthy lives. However, despite its remarkable efficacy, ART is not without risks, like all medications, antiretroviral drugs can cause Adverse Drug Reactions (ADRs). Long-term ART use has been associated with emerging drug safety signals, which indicate potential adverse drug reactions (ADRs) requiring further investigation (1). Pharmacovigilance plays a critical role in identifying, assessing, and mitigating these risks to ensure patient safety and optimize treatment outcomes (2). The objective of this study aims to evaluate safety signals linked to ART, assess their clinical implications, and explore strategies to enhance pharmacovigilance frameworks. The design looked at the systematic review and analysis of ART-related safety signals, focusing on key adverse reactions such as neural tube defects, hypersensitivity, nephrotoxicity and bone loss, and neuropsychiatric effects as well as the financial burden on the healthcare system. The study also examined barriers to effective pharmacovigilance, including underreporting, healthcare infrastructure limitations, and regulatory challenges (2). The research setting focused on ART safety surveillance in low and middle income countries, with emphasis on Africa, where pharmacovigilance systems remain underdeveloped (1). The main outcome of the study evaluates the effectiveness of existing key gaps in ADR reporting, and assess the impact of policy reforms and digital reporting interventions in improving drug safety monitoring (2). The result of the analysis revealed that ART-related safety signals, including neural tube defects, hypersensitivity reactions, nephrotoxicity, bone loss, and neuropsychiatric effects, remain a significant concern, particularly in resource limited settings. Also, pharmacovigilance gaps was noted as well in the form of underreporting, inadequate health infrastructure, and regulatory inefficiencies, which hinder the early detection and mitigation of adverse drug reactions (1) (2). In conclusion, strengthening pharmacovigilance frameworks, increasing healthcare provider awareness, and implementing technology-driven ADR monitoring systems are essential to improving ART safety. This research highlights the need for proactive safety surveillance in order to mitigate risks associated with long-term ART use and optimize treatment guidelines (2). |
| Description: | M.Pharm.(Melit.) |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/136066 |
| Appears in Collections: | Dissertations - FacM&S - 2025 Dissertations - FacM&SPha - 2025 |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| 2518MDSPHR512305083922_1.PDF Restricted Access | 28.37 MB | Adobe PDF | View/Open Request a copy |
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