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Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria : a prospective cohort study
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(2018) Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria : a prospective cohort study. PLoS One, 13 (8). e0200810. doi:10.1371/journal.pone.0200810
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Official URL: https://doi.org/10.1371/journal.pone.0200810
Abstract
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.
| Item Type: | Journal Article | |||||||||||||||
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| Subjects: | R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Medicine > Warwick Medical School |
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| SWORD Depositor: | Library Publications Router | |||||||||||||||
| Library of Congress Subject Headings (LCSH): | Drugs -- Side effects, Drug monitoring, Pharmacovigilance, HIV (Viruses), Tuberculosis, Malaria | |||||||||||||||
| Journal or Publication Title: | PLoS One | |||||||||||||||
| Publisher: | Public Library of Science | |||||||||||||||
| ISSN: | 1932-6203 | |||||||||||||||
| Official Date: | 22 August 2018 | |||||||||||||||
| Dates: |
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| Date of first compliant deposit: | 29 August 2018 | |||||||||||||||
| Volume: | 13 | |||||||||||||||
| Number: | 8 | |||||||||||||||
| Article Number: | e0200810 | |||||||||||||||
| DOI: | 10.1371/journal.pone.0200810 | |||||||||||||||
| Status: | Peer Reviewed | |||||||||||||||
| Publication Status: | Published | |||||||||||||||
| Publisher Statement: | ** From PLOS via Jisc Publications Router. ** History: received 21-09-2017; collection 2018; accepted 03-07-2018; epub 22-08-2018. ** Licence for this article: http://creativecommons.org/licenses/by/4.0/ | |||||||||||||||
| Access rights to Published version: | Open Access | |||||||||||||||
| RIOXX Funder/Project Grant: |
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