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

Cost of three models of care for drug-resistant tuberculosis patients in Nigeria

Background: Nigeria accounts for a significant proportion of the global drug-resistant tuberculosis (DR-TB) burden, a large proportion of which goes untreated. Different models for managing DR-TB treatment with varying levels of hospitalization are in use across Nigeria, however costing evidence is required to guide the scale up of DR-TB care. We aimed to estimate and compare the costs of different DR-TB treatment and care models in Nigeria. Methods: We estimated the costs associated with three models of DR-TB treatment and care: Model (A) patients are hospitalized throughout the 8-month intensive phase, Model (B) patients are partially hospitalized during the intensive phase and Model (C) is entirely ambulatory. Costs of treatment, in-patient and outpatient care and diagnostic and monitoring tests were collected using a standardized data collection sheet from six sites through an ingredient's approach and cost models were based on the Nigerian National Tuberculosis, Leprosy and Buruli Ulcer Guideline - Sixth Edition (2014) and Guideline for programmatic and clinical management of drug-resistant tuberculosis in Nigeria (2015). Results: Assuming adherence to the Nigerian DR-TB guidelines, the per patient cost of Model A was 18,528 USD, Model B 15,159 USD and Model C 9425 USD. Major drivers of cost included hospitalization (Models A and B) and costs of out-patient consultations and supervision (Model C). Conclusion: Utilizing a decentralized ambulatory model, is a more economically viable approach for the expansion of DR-TB care in Nigeria, given that patient beds for DR-TB treatment and care are limited and costs of hospitalized treatment are considerably more expensive than ambulatory models. Scale-up of less expensive ambulatory care models should be carefully considered in particular, when treatment efficacy is demonstrated to be similar across the different models to allow for patients not requiring hospitalization to be cared for in the least expensive way