Antiretroviral therapy in community pharmacies - Implementation and outcomes of a differentiated drug delivery model in Nigeria.

INTRODUCTION: The World Health Organization recommended differentiated models of care portends opportunities to decongest hospitals providing antiretroviral therapy (ART) and improve retention, especially in developing countries. A community pharmacy-based ART refill model was implemented where stable clients were devolved to community pharmacies for routine refills at a service fee, to promote private sector participation and sustainability of ART services. The aim of this study was to assess the feasibility, acceptability and outcomes of this model in Nigeria. METHODS: A population-based retrospective analysis of the community pharmacy ART refill program of the United States Agency for International Development-funded 'Strengthening Integrated Delivery of HIV/AIDS Services' project in Lagos, Rivers, Cross River and Akwa Ibom States from October 2016 to February 2018 was conducted. Standard descriptive statistical methods were used for baseline demographic and clinical characteristics of study participants. Outcomes were assessed using the Chi-square test and a multivariate logistic regressions model. Statistical significance was defined at α-level of 0.05. Analyses were performed using SPSS for Windows version 23 (IBM Corp, Armonk, USA). RESULTS: A total of 10015 participants representing 14.4% of ART clients in 50 hospitals opted for this model and were devolved to 244 community pharmacies. All clients consented and paid a service fee of N1000 (about $3) per refill visit. Median follow-up duration was 6 months. Prescription refill rate was 95% (95% CI 94.2-95.3). Retention rate was 98% while viral suppression was 99.12%. Refill rates were significantly affected by ART duration, regimen, age and location (P < 0.001, 0.004, 0.034 and < 0.001 respectively). CONCLUSIONS: This community pharmacy ART refill model of differentiated care is feasible and acceptable by clients and providers and demonstrated excellent clinical outcomes of retention and viral suppression. The ability and willingness of some clients to contribute financially to their HIV care was also demonstrated.

Methodology for processing mastectomy and cryopreservation of breast cancer tissue in a resource- poor setting: A pilot study.

BACKGROUND: There is scarcity of breast cancer tissues derived from women of African origin available for patient - derived xenograft and organoid models. OBJECTIVE: We aim to create a versatile protocol for processing mastectomy and cryopreservation of breast cancer tissue. METHODOLOGY: An immediate collection of breast cancer tissue from mastectomy was bathed in 4 °C HBSS and immediately transferred to 4 °C RPMI1640 containing HEPES, 10% FBS, Streptomycin and Penicillin. Tissues were processed over ice yielding nine samples of cold ischemic time (20-45 min) stored at 3 min interval. Cut samples were transferred into cryovials containing 4 °C cryoprotectant agent (90% FBS +10% Me2SO) before snap -freezing in liquid Nitrogen vapour and final short-term storage in -80 °C Freezer. The histomorphology, tissue and molecular viability were assessed. RESULTS: The cold ischemic times had no detrimental effect to the nine samples despite being processed in a resource poor setting, hence providing a reproducible and reliable protocol.

Evaluation of Vocal Cord Function Before Thyroidectomy: Experience from a Developing Country.

Vocal cord palsy (VCP) is a major complication of thyroidectomy. Some patients have preexisting VCP prompting the need for routine or selective preoperative evaluation of the vocal cords. The study aims at ascertaining the prevalence of preoperative VCP and making appropriate recommendations. This is a retrospective study of all adult patients who had thyroidectomy at the University of Nigeria Teaching Hospital. Case notes of patients who had thyroidectomy at the hospital from July 2010 to June 2015 were retrieved. Variables studied included biodata, duration of goiter, preoperative hoarseness, outcome of indirect laryngoscopy (IDL), histology of specimen, duration of follow-up, and incidence of postoperative hoarseness. Descriptive statistical analysis was done using SPSS version 20. Of the 91 patients aged 21-70 years (mean 42.08 years, SD 15.40), females outnumbered males with a M:F ratio of 1:10.4. Five patients had preoperative hoarseness, but only three had VCP. IDL was done for 25 (27.4%) patients out of which 22 (88.0%) had normal studies while the remaining three (all from the five with hoarseness) had VCP. Histology of the specimens showed malignancy in 10 (11%), benign in 55 (60.4%), and no report in 26 (28.6%). Five of the malignant histology patients showed normal findings on IDL, three had VCP and two had no preoperative IDL. There was no case of asymptomatic VCP. Vocal cord evaluation is recommended for patients with voice symptoms and those with malignant goiter.

Patient satisfaction with services at a tertiary hospital in south-east Nigeria.

BACKGROUND: Patients' views of the services they receive in a healthcare service help identify critical areas that may need improvement. This survey set out to determine patients' satisfaction with quality of general services and specifically with staff attitude and the hospital environment, while on admission at a teaching hospital in Enugu, south-east Nigeria. METHODS: This was a descriptive cross-sectional study using a structured self-administered questionnaire on 170 patients (54% females and 46% males, aged between 20 and 65 years), post admission, selected by multistage sampling. RESULTS: Less than half (47.3%) of the patients were satisfied with care received on admission. More than half of them (51.8%) were satisfied with the cleanliness of the hospital environment and how power supply was maintained in the hospital (62.4%). Doctors (90%), nurses (64.1%) and records staff (60.6%) were considered courteous and professional. Most patients were satisfied with the level of privacy given to them in their course of hospital stay (67.6%) and with the cost of laboratory investigations (51.8%). CONCLUSION: Despite more than half of the surveyed patients being satisfied with some specific aspects of services given while on admission, those satisfied with the overall experience were less than half. Therefore, periodic patient satisfaction surveys should be institutionalized in this facility to provide feedback for continuous quality improvement.

Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria.

AIM: This study evaluated the suspected adverse drug reactions (ADR) reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV) positive patients receiving antiretroviral therapy (ART) in Nigeria. MATERIALS AND METHODS: This descriptive study analyzed individual case safety reports (ICSRs) in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval. RESULTS: From 1237 ICSRs collated, only 1119 (90.5%) were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1-35.5) years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD) of 1.5 (± 0.8) ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0%) peripheral neuropathy, (11.4%) skin rash, (10.1%) pruritus and (6.5%) dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05) unlike gender. Anaemia was associated with Zidovudine (AZT)/ Lamivudine (3TC) /Nevirapine (NEV) regimen [Odds ratio, OR = 6.4 (3.0-13.8); P < 0.0001], and peripheral neuropathy with Stavudine (d4T)/3TC/NEV regimen [OR = 8.7 (5.8-30.0), P < 0.0001] and Tenofovir (TDF)/Emtricitabine (FTC)/Efavirenz (EFV) regimen [OR = 2.1 (1.0-4.1), P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3-6.6), P = 0.0056] and 45-59years [OR = 1.9 (1.3-2.7), P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9-349.6), P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS) [OR = 50.2 (0.9-562.1), P = 0.0040] respectively. CONCLUSION: ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to zidovudine-based regimens. Peripheral neuropathy was also found to be associated with tenofovir-based regimen. This may require further studies and evaluation.

Outcomes and Rates of CD4 cells decline among HIV-positive patients in Pre-Antiretroviral Therapy Care

Background: The CD4 cells count is a marker of HIV disease progression and a criterion for initiation of antiretroviral therapy (ART). Objectives: This study evaluated the outcomes and CD4 cells decline rates among HIV-positive patientsenrolled into pre-ART care in Nigeria. Methods: In a five-year retrospective cohort assessment; 1;098 patients were randomly selected from 1766 HIV positive patients who were ineligible to start ART and enrolled into pre-ART care during 1st March to 31st December 2007 in two health facilities. Routine clinical and immunologic data were extracted from patients'hospital records starting from pre-ART care enrolment and ending April 30; 2012. Paired sample t-test and Chi-square were used for inferential statistics; and P0.05 indicated statistical significance. Results: The patients' mean age was 33.1 (95 CI; 32.6-33.6) years old; and 65.1 were females. Patients' follow-up in pre-ART care was 512.6 person-years. During the 5-year observation period; there was a3 significant decline in CD4 cells count (cells/mm ) at months 3; 6; 12; 18; 30 and 42 (P0.05). The mean CD4 cells3 count decline rate was 2.5 (95CI; 2.1-2.9) cells/mm per annum. Pre-ART outcomes included 56.1 started ART; 39.7 loss to follow up; 2.6 transferred-out; 0.9 active in pre-ART care and 0.5 were dead at the endof observation period. The outcomes were associated with baseline WHO clinical stage and CD4 cells count (P0.05). Conclusion: Majority of patients started ART. There was a significant decline in CD4 cells count of pre-ARTpatients; and the decline rate was very low compared to previous reports

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria.

BACKGROUND: Data on adverse drug reactions (ADRs) related to antiretroviral (ARV) use in public health practice are few indicating the need for ART safety surveillance in clinical care. OBJECTIVES: To evaluate the incidence, type and risk factors associated with adverse drug reactions (ADRs) among patients on antiretroviral drugs (ARV). METHODS: Patients initiated on ARVs between May 2006 and May 2009 were evaluated in a retrospective cohort analysis in three health facilities in Nigeria. Regimens prescribed include nucleoside backbone of zidovudine (AZT)/lamivudine (3TC), stavudine (d4T)/3TC, or tenofovir (TDF)/3TC in combination with either nevirapine (NVP) or efavirenz (EFV). Generalized Estimating Equation (GEE) model was used to identify risk factors associated with occurrence of ADR. RESULTS: 2650 patients were followed-up for 2456 person-years and reported 114 ADRs (incidence rate = 4.6/100 person-years).There were more females 1706(64%) and 73(64%) of the ADRs were reported by women. Overall, 61(54%) of ADRs were reported by patients on AZT with 54(47%) of these occurring in patients on AZT/NVP. The commonest ADRs reported were pain 25(30%) and skinrash 10(18%). Most ADRs were grade 1(39%) with only 1% being life threatening (grade 4). Adjusted GEE analysis showed that ADR was less likely to occur in patients on longer duration of ART compared to the first six months on treatment; 6-12 months AOR 0.38(95% CI:0.16-0.91) and 12-24 months AOR 0.34(95% CI:0.16-0.73) respectively. Compared to patients on TDF, ADR was less likely to occur in patients on d4T and AZT AOR 0.18(95% CI 0.05-0.64) and AOR 0.24(95% CI:0.7-0.9) respectively. Age, gender and CD4 count were not significantly associated with ADRs. CONCLUSION: ADRs are more likely to occur within the first six months on treatment. Close monitoring within this period is required to prevent occurrence of severe ADR and improve ART adherence. Further research on the tolerability of tenofovir in this environment is recommended.