The landscape of Human Immunodeficiency Virus (HIV) epidemic control is shifting with the United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 benchmarks for epidemic control. Community-based ...Antiretroviral Therapy (CART) models have improved treatment uptake and demonstrated good clinical outcomes. We assessed the feasibility of integrating community pharmacy as a task shift structure for differentiated community ART in Abuja-Nigeria.
Stable patients on first line ART regimens from public health facilities were referred to community pharmacies in different locations within the Federal Capital Territory, Abuja for prescription refills and treatment maintenance. Bio-demographic and clinical data were collected from February 25, 2016 to May 31st, 2017 and descriptive statistics analysis applied. The outcomes of measure were prescription refill and patient retention in care at the community pharmacy.
Almost 10% of stable patients on treatment were successfully devolved from eight health facilities to ten community pharmacies. Median age of the participants was 35 years interquartile range (IQR); 30, 41 with married women in the majority. Prescription refill was 100% and almost all the participants (99.3%) were retained in care after they were devolved to the community pharmacies. Only one participant was lost-to-follow-up as a result of death.
Excellent prescription refill and high retention in care with very low loss-to-follow-up were associated with the community pharmacy model. The use of community pharmacy for community ART is feasible in Nigeria. We recommend the scale up of the model in all the 36 states of Nigeria.
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.
The World Health Organisation (WHO) introduced the twelve early warning indicators for monitoring and evaluating drug Procurement and Supply management (PSM) systems, intended to prevent drug ...stock-outs and overstocking. Nigeria--one of the high Multi Drug Resistant Tuberculosis (MDR-TB) burden countries, scaled-up treatment in 2012 with the concurrent implementation of a PSM system.
We evaluated how well this system functioned using the WHO indicators, including all seven MDR-TB treatment centres in the country that were functional throughout 2013.
The quantity of MDR-TB drugs ordered for 2013 matched the annual forecast and all central orders placed during the year were delivered in full and on time. Drug consumption was 81%-106% of the quantity allocated for routine consumption. Timely submission of complete inventory reports ranged from 86-100%, late submissions being 5-15 days late. Forty to 71% of treatment centres placed a drug order when stock was below the minimum level of three months. The proportion of drug orders received at the treatment centres in full and on time ranged from 29-80%, late orders being 1-19 days late.
The PSM was found to be performing well in terms of forecasting and procurement of MDR-TB drugs, but there were shortcomings in drug distribution, reporting at treatment centre level and in drug order placements. Despite these gaps, there were no stock outs. These findings indicate that where it matters most, namely ensuring that no drug stock outs affect patient management, the PSM system is effective. Addressing the observed shortcomings will help to strengthen the existing PSM system in anticipation of a growing MDR-TB case burden in the country.
Adverse drug reactions are an important causes of death and account for 5–35% of hospital admissions. Operation Save the World from Adverse Drug Reactions is a drug safety surveillance programme ...developed in 2005 by the Institute of Human Virology Nigeria (IHVN) to address the under-reporting of adverse drug reaction in Nigeria, where millions of people use antiretroviral, anti-tuberculosis, and anti-malaria drugs. The drug safety surveillance programme runs in major public hospitals but is managed by the National Pharmacovigilance Center in collaboration with IHVN. The goal is to ensure public and global health, while the primary outcome is the reporting of adverse drug reactions to the Uppsala Monitoring Centre, through the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC). Pharmacovigilance training and the publishing of papers are secondary outcomes.
The drug safety surveillance programme in Nigeria combines six key activities: collaboration between government and the private sector; the training of medical doctors, pharmacists, and nurses; establishment of pharmacovigilance centres in public hospitals; development of platforms for submitting individual case safety reports; the publishing of peer-review articles; and submission of individual case safety reports. To ensure sustainability, we collaborated with the Nigerian Government and research institutions, and trained only government health-care workers, who were randomly selected from a pool of applicants that applied to advertisements in three national newspapers.
Between 2004 and 2016, Nigeria's National Pharmacovigilance Center received 16 500 individual case safety reports out of 80 000 adverse drug reaction reporting forms. The number of health-care workers who were trained in the reporting of adverse drug reactions was fewer than 300 and there was no training model during this time. However, between 2014 and 2018 when Operation Save the World from Adverse Drug Reactions was introduced and implemented, more than 5000 individual case safety reports, with more than 40 000 reactions were submitted. Furthermore, more than 3000 health-care workers have been trained in the reporting of adverse drug reactions, and a Structured Pharmacovigilance and Training Initiative (SPHARTI) model has been developed, with two peer-reviewed articles published. Serious adverse drug reactions, such as bilateral gynaecomastia, violent psychiatric disorders, and Stevens-Johnson syndrome have also been reported.
The drug safety surveillance programme Operation Save the World from Adverse Drug Reactions has increased the reporting of adverse drug reactions in Nigeria and increased the critical mass of qualified health-care workers trained in the reporting of adverse drug reactions. The strength of the programme is in the combination of the six key activities. Challenges remain in establishing causality of the reported reactions and operating the programme at primary health centres.
US PEPFAR.
Obesity is associated with detrimental changes in cardiovascular and metabolic parameters, including blood pressure, dyslipidemia, markers of systemic inflammation, and insulin resistance. In the ...elderly living with the human immunodeficiency virus (EPLHIV), and being treated with antiretroviral medications, the obesity complications escalate and expose the elderly to the risk of noncommunicable diseases. Given that over 3 million EPLHIV in sub-Sahara Africa, we assessed the prevalence of obesity and its associated factors among EPLHIV in a low-resource setting.This was a cross sectional study of EPLHIV aged 50 years and older, being treated with antiretroviral medications from 2004 to 2018. HIV treatment data collected from multiple treatment sites were analyzed. Baseline characteristics of the participants were described, and multivariable relative risk model was applied to assess the associations between obesity (body mass index BMI ≥30 kg/m2) and the prespecified potential risk factors.Of the 134,652 in HIV cohort, 19,566 (14.5%) were EPLHIV: 12,967 (66.3%) were normal weight (18.5 ≤ BMI < 25), 4548 (23.2%) were overweight (25 ≤ BMI < 30), while 2,051 (10.5%) were obese (BMI ≥30). The average age the normal weight (57.1; standard deviation 6.6) and the obese (56.5; standard deviation 5.5) was similar. We observed that being an employed (relative risk RR 1.71; 95% confidence interval CI 1.48-2.00; P < .001), educated (RR 1.93; 95% CI 1.54-2.41; P < .001), and presence of hypertension (RR 1.78; 95% CI 1.44-2.20; P < .001), increased the risk of obesity. Also, being male (RR 0.38; 95% CI 0.33-0.44; P < .001), stages III/IV of the World Health Organization clinical stages of HIV (RR 0.58; 95% CI 0.50-0.68; P < .001), tenofovir-based regimen (RR 0.84; 95% CI 0.73-0.96, P < .001), and low CD4 count (RR 0.56; 95% CI 0.44-0.71; P < .001) were inversely associated with obesity.This study demonstrates that multiple factors are driving obesity prevalence in EPLHIV. The study provides vital information for policy-makers and HIV program implementers in implementing targeted-interventions to address obesity in EPLHIV. Its findings would assist in the implementation of a one-stop-shop model for the management of HIV and other comorbid medical conditions in EPLHIV.
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