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

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 ph...

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Published in:	PloS one Vol. 13; no. 8; p. e0200810
Main Authors:	Avong, Yohanna Kambai, Jatau, Bolajoko, Gurumnaan, Ritmwa, Danat, Nanfwang, Okuma, James, Usman, Istifanus, Mordi, Dennis, Ukpabi, Blessing, Kayode, Gbenga Ayodele, Dutt, Saswata, El-Tayeb, Osman, Afolabi, Bamgboye, Ambrose, Isah, Agbaji, Oche, Osakwe, Adeline, Ibrahim, Ali, Ogar, Comfort, Nosiri, Helga, Avong, Eunice B, Adekanmbi, Victor, Uthman, Olalekan, Abimiku, Alash'le, Oni, Yetunde O, Mensah, Charles Olalekan, Dakum, Patrick, Mberu, Kamau Edward, Ogundahunsi, Olumide A T
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 22-08-2018 Public Library of Science (PLoS)
Subjects:	Acquired immune deficiency syndrome Acquired Immunodeficiency Syndrome - classification Acquired Immunodeficiency Syndrome - epidemiology Adult Adverse Drug Reaction Reporting Systems Adverse drug reactions AIDS Care and treatment Cohort analysis Cohort Studies Drug-Related Side Effects and Adverse Reactions - classification Education - methods Female Health care Health care facilities Health education Health Personnel - education HIV Human immunodeficiency virus Humans Malaria Malaria - classification Malaria - epidemiology Male Management Medical personnel Medicine and Health Sciences Middle Aged Mortality Nigeria Occupational health Operations research People and Places Pharmacology Pharmacovigilance Prospective Studies Public health Public Health - education Public Health - methods Public Health Practice - economics Risk factors Side effects Training Tropical diseases Tuberculosis Tuberculosis - classification Tuberculosis - epidemiology Vector-borne diseases Viruses Wellness programs Workers World Health Organization Nigeria Benin United Kingdom > UK Switzerland Africa
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Summary:	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. 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. 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. 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.
Bibliography:	Competing Interests: The authors including those affiliated with commercial organization declare that they have no competing interest. The affiliation with Wise Health Services Limited does not alter our adherence to PLOS ONE policies on sharing data and materials (as detailed online in our guide for authors, http://journals.plos.org/plosone/s/competing-interests).
ISSN:	1932-6203 1932-6203
DOI:	10.1371/journal.pone.0200810