ArticlePloS one2018
Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: A prospective cohort study.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Improving adverse drug event reporting by healthcare professionals.The Cochrane database of systematic reviews · 2024Pooled it
- Awareness, knowledge, attitude, and practice of adverse drug reaction reporting among health workers in primary health centres participating in seasonal malaria chemoprevention campaign in Nigeria in 2022: a cross-sectional survey.BMC health services research · 2024Article
- Identifying strategies to improve adverse drug reporting through key informant interviews among community pharmacists in a developing country.Scientific reports · 2024Article
- Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria.Pharmaceutical medicine · 2024Observational
- PHARMACOVIGILANCE IN SERBIA: A TEN-YEAR PHARMACOEPIDEMIOLOGIC ANALYSIS.Acta clinica Croatica · 2023Article
- Awareness, Actions, and Predictors of Actions on Adverse Drug Reaction Reporting among Patients Attending a Referral Hospital in Southern Highland Tanzania.Advances in pharmacological and pharmaceutical sciences · 2023Article
- Drug Safety Monitoring in Health Programs of Cameroon.Journal of pharmacovigilance · 2022Article
- Influence of Information Sources on Women's Behavioural Practice towards Breast Cancer in Lagos, Nigeria.Healthcare (Basel, Switzerland) · 2022Article
- Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience.BMC medical informatics and decision making · 2022Article
- Knowledge, Attitude, and Barriers Toward ADRs Reporting Among Health-Care Professionals at Tertiary Care Health Settings in Peshawar, Pakistan: A Web Based Study.Hospital pharmacy · 2021Article
- Assessing the Quality of Reporting to China's National TB Surveillance Systems.International journal of environmental research and public health · 2021Article
- Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences.European respiratory review : an official journal of the European Respiratory Society · 2019Review
- Article
- Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates.Journal of drug assessment · 2019Article
Corrections and comments
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Authors and funding
27 authors at 9 institutions in 3 countries.
Funding
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.
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Registered trials
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