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 hospital-based estimate of major causes of death among under-five children from a health facility in Lagos, Southwest Nigeria: possible indicators of health inequality.

INTRODUCTION: Current evidence on the root-causes of deaths among children younger than 5 years is critical to direct international efforts to improve child survival, focus on health promotion and achieve Millennium Development Goal 4. We report a hospital-based estimate for 2005-2007 of the major causes of death in children in this age-group in south-west Nigeria. METHODS: We used retrospective data from the intensive care unit of a second-tier health facility to extract the presenting complaints, clinical diagnosis, treatment courses, prognosis and outcome among children aged 6-59 months. SPSS-19 was used for data analysis. RESULTS: Of the 301 children (58% males, 42% females) admitted into the ICU within the period of study, 173 (26%) presented with complaints related to the gastrointestinal system, 138 (21%) with respiratory symptoms and 196 (29%) with complaints of fever. Overall, 708 investigations were requested for among which were full blood count (215, 30%) and blood slides for malaria parasite (166, 23%). Infection ranked highest (181, 31%) in clinicians' diagnosis, followed by haematological health problems (109, 19%) and respiratory illnesses (101, 17%). There were negative correlations between outcome of the illness and patient's weight (r=-0.195, p=0.001) and a strong positive correlation between prognosis and outcome of admission (r=0.196, p=0.001). Of the 59 (20%) children that died, presentation of respiratory tract illnesses were significantly higher in females (75%) than in males (39%) (χ²=7.06; p=0.008) and diagnoses related to gastrointestinal pathology were significantly higher in males (18%) than in females (0%) (χ²=4.07; p=0.05). Majority of the deaths (21%) occurred among children aged 1.0 to 1.9 years old and among weight group of 5.1-15.0 kg. CONCLUSION: The major causes of deaths among under-five years old originate from respiratory, gastrointestinal and infectious diseases - diseases that were recognized as major causes of childhood mortality about half a century earlier. Realization of MDG4 - to reduce child mortality by two-thirds - is only possible if the government and donor agencies look beyond the health sector to find hidden causative factors such as education and housing and within the health sector such as vibrant maternal, new-born, and child health interventions.