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

Background Adverse 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. Methods A 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. Results Fifty-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. Conclusion Participants 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

Trends in Adverse Event Reporting Before and After the Introduction of the Medsafety App in Nigeria

This is the accepted manuscript version of the work that will be published in its final form as Elemuwa, U. G., Bitrus, F., Oreagba, I. A., Osakwe, A. I., et al. Trends in Adverse Event Reporting Before and After the Introduction of the Medsafety App in Nigeria. Journal of Pharmaceutical Medicine. https://doi.org/10.1007/s40290-023-00494-8. Deposited by shareyourpaper.org and openaccessbutton.org. We've taken reasonable steps to ensure this content doesn't violate copyright. However, if you think it does, you can request a takedown by emailing [email protected]

Number and severity of adverse events among MDR-TB patients in Nigeria, 2012–2013 (N = 482).

<p>Number and severity of adverse events among MDR-TB patients in Nigeria, 2012–2013 (N = 482).</p

Categorizing of adverse events based on signs and symptoms.

<p>Categorizing of adverse events based on signs and symptoms.</p

Baseline characteristics of MDR-TB patients admitted to in-patient care, Nigeria, 2012–2013 (N = 482).

<p>Baseline characteristics of MDR-TB patients admitted to in-patient care, Nigeria, 2012–2013 (N = 482).</p

Grouping of adverse events of second—line anti-tuberculosis drugs.

<p>Grouping of adverse events of second—line anti-tuberculosis drugs.</p

Duration of ADRs among MDR-TB patients admitted to in-patient care, Nigeria, 2012–2013.

<p>Duration of ADRs among MDR-TB patients admitted to in-patient care, Nigeria, 2012–2013.</p

Association between AEs, sex, age and body weight among MDR-TB patients admitted to in-patient care, Nigeria, 2012–2013.

<p>* <i>Adjusted Odds Ratio and p-value (Wald’s test) based on multivariate logistic regression using a stepwise backward elimination approach</i>.</p><p><i>Note</i>: <i>Treatment centers</i>: <i>DL HMH = Dr</i>. <i>Lawrence Henshaw Memorial Hospital</i>, <i>Calabar; GCH = General Chest Hospital</i>, <i>Ibadan; IDH = Infectious Disease Hospital</i>, <i>Kano; JUTH = Jos University Teaching Hospital</i>, <i>Jos; MHY = Mainland Hospital</i>, <i>Yaba; NTBLCT = National Tuberculosis and Leprosy Training Center; UCH = University College Hospital</i>, <i>Ibadan; UPTH = University of Port Harcourt Teaching Hospital; UUTH = University of Uyo Teaching Hospital</i>, <i>Uyo</i>.</p><p>Association between AEs, sex, age and body weight among MDR-TB patients admitted to in-patient care, Nigeria, 2012–2013.</p

Pharmacovigilance Form (Yellow Form).

<p>Pharmacovigilance Form (Yellow Form).</p