Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: A prospective cohort study

Abstract

BackgroundAdverse Drug Reactions (ADRs) are a major clinical and public health problem world-wide. The prompt reporting of suspected ADRs to regulatory authorities to activate drug safety surveillance and regulation appears to be the most pragmatic measure for addressing the problem. This paper evaluated a pharmacovigilance (PV) training model that was designed to improve the reporting of ADRs in public health programs treating the Human Immunodeficiency Virus (HIV), Tuberculosis (TB) and Malaria.MethodsA Structured Pharmacovigilance and Training Initiative (SPHAR-TI) model based on the World Health Organization accredited Structured Operational Research and Training Initiative (SOR-IT) model was designed and implemented over a period of 12 months. A prospective cohort design was deployed to evaluate the outcomes of the model. The primary outcomes were knowledge gained and Individual Case Safety Reports (ICSR) (completed adverse drug reactions monitoring forms) submitted, while the secondary outcomes were facility based Pharmacovigilance Committees activated and health facility healthcare workers trained by the participants.ResultsFifty-five (98%) participants were trained and followed up for 12 months. More than three quarter of the participants have never received training on pharmacovigilance prior to the course. Yet, a significant gain in knowledge was observed after the participants completed a comprehensive training for six days. In only seven months, 3000 ICSRs (with 100% completeness) were submitted, 2,937 facility based healthcare workers trained and 46 Pharmacovigilance Committees activated by the participants. Overall, a 273% increase in ICSRs submission to the National Agency for Food and Drug Administration and Control (NAFDAC) was observed.ConclusionParticipants gained knowledge, which tended to increase the reporting of ADRs. The SPHAR-TI model could be an option for strengthening the continuous reporting of ADRs in public health programs in resource limited settings.

Pharmacovigilance: Present Scenario and Future Goals

“…Fast revealing of ADRs to medicate administrative bodies is a critical medication safety check yet under-detailing is a noteworthy test even in created nations with satisfactory human and material assets to stand up to the issue. 9 Variables that may add to underreporting among HCPs incorporate learning, carelessness, absence of time and drive. Absence of institutionalized revealing procedures and holes in human services data frameworks additionally causes underreporting.…”

Assessing the Quality of Reporting to China's National TB Surveillance Systems

“…Many national disease surveillance systems may provide an incomplete picture due to under-reporting diseases of public health importance [2][3][4][5][6].…”

Optimizing spontaneous adverse drug reaction reporting in public healthcare setting in Namibia

“…In addition, this integration of new essential medicines into standard treatment guidelines not only demands improved pharmacovigilance but also raises the need for training and awareness of healthcare workers concerning ADRs and ADR reporting. Dealing with ADRs requires a multi‐professional approach by healthcare workers—including medical practitioners, pharmacists and nurses—both in public and in private healthcare settings to safeguard population health …”

“…Dealing with ADRs requires a multi-professional approach by healthcare workers-including medical practitioners, pharmacists and nurses-both in public and in private healthcare settings to safeguard population health. 8 Namibia, a country in southern Africa with a population of about 2.5 million people, has a high burden of infectious diseases such as HIV, tuberculosis and malaria as well as a growing burden of non-communicable diseases. The HIV prevalence in Namibia was estimated at 12.6% in 2017 among adults aged 15-64; 9 the burden of the disease has reduced dramatically in the last two decades largely as a result of effective roll-out of efficacious ARVs and other essential medicines.…”