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

A comparative assessment of the awareness of danger signs and practice of birth preparedness and complication readiness among pregnant women attending rural and urban general hospitals in Lagos State

Background: Nigeria still experiences a high burden of unsafe motherhood. The knowledge of obstetric danger signs and the effective application of the principles of birth preparedness and complication readiness (BPACR) have the potential to significantly reduce the high maternal and perinatal morbidity and mortality rates. However, rural-urban differences may exist in the knowledge and practice of  BPACR among women, and these may limit its potential benefit. We set out to assess and compare the knowledge of obstetric danger signs and practice of BPACR among pregnant women attending Rural (Agbowa) and Urban (Gbagada) Hospitals in Lagos State. Materials and Methods: In this cross-sectional comparative study, pregnant women attending antenatal clinics in each health facility were recruited into the study using a systematic sampling method. A structured interviewer administered questionnaire adapted from the safe motherhood John Hopkins Program for International Education in Gynecology and Obstetrics prototype questionnaire was used for data collection. Data were analyzed using SPSS version 17.0. Results: Awareness of obstetric danger signs during pregnancy was good among rural and urban study participants accounting for 62.4% and 68.4%, respectively. The most commonly identified danger sign in pregnancy, labor, and after delivery was bleeding from the genital tract. The awareness of danger signs during labor and after delivery identified by the women was low in both settings, though relatively higher in the urban area. The level of BPACR was low in both groups of women but was higher among women attending the urban center (31.6%) compared with the rural center (13.2%) P-value < 0.001. Conclusion and Recommendations: Activities aimed at improving birth preparedness practices particularly among rural women should be considered