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

• 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
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0200810

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.