ABSTRACT
BACKGROUND: The number and severity of nonconformities generated during an audit of a medicine testing laboratory indicates its level of quality compliance. Quality standards are established and maintained to ensure the reliability of laboratory test reports. The National Medicines Regulatory Authority (NMRA) Quality Control laboratories assess the quality of medicines used by the populace as part of their regulatory function. Although countries desire to have reliable medicine testing facilities, accrediting a national laboratory to international standards poses financial and technical challenges for many low-income countries. Sharing the benefits of laboratory accreditation could help more countries within sub-Saharan Africa overcome existing challenges to achieve accreditation and robust quality systems. This study investigated the impact of ISO/IEC 17025 accreditation on the performance of an NMRA Quality Control laboratory to provide evidence of improved quality compliance within a low-resource setting. METHODS: Pre- and post- accreditation audits of nonconformities for management and technical requirements of the ISO/IEC17025:2005 standards were evaluated from a Quality Control laboratory in the National Agency for Food and Drug Administration and Control (NAFDAC), located in Nigeria, West Africa. The following research questions were addressed: "does accreditation impact the adherence to quality standards?" and "does accreditation decrease the severity of nonconformities in Quality Control laboratory audits?" RESULTS: Statistical analysis of the pre- to post- accreditation audits from the years 2013 through 2017 revealed a significant decrease in the total number of nonconformities (χ2 = 74, p-value = 9.99e-05, r = 0.67). Further examination of audits from the years 2013 through 2018 audits also revealed a reduction in the number of nonconformities (χ2 = 53, p-value = 9.99e-05, r = 0.62). A reduction in the number of major observations and a decrease in the severity of nonconformities was also observed. CONCLUSIONS: A higher level of quality compliance was exhibited for the laboratory during the post-accreditation years. Overall, ISO/IEC 17025 accreditation of the NMRA Quality Control laboratory resulted in improved reliability of test reports and enhancement of the laboratory quality system.
Subject(s)
Accreditation , Laboratories , Africa South of the Sahara , Africa, Western , Humans , Nigeria , Reproducibility of ResultsABSTRACT
BACKGROUND: Despite proven benefits of isoniazid preventive therapy (IPT) for people living with HIV (PLHIV), its implementation remains limited in low-resource settings. There are also programmatic concerns of the completion rate of IPT particularly when full integration with other HIV services has not been achieved. AIM: The aim of this study was to determine the completion rate of IPT and predictive factors among PLHIV attending six government hospitals in Kebbi state, Northern Nigeria. METHODS: This was a retrospective cohort study of program data spanning a 5-year period (December 2010-June 2016). Data were collected between January 2017 and June 2017. RESULTS: A total of 1,134 IPT patients were enrolled of whom 740 (65.3%) were female. The mean age was 40.3 ± 3.7 years. Four hundred and fifty-four (40%) of those who initiated IPT completed the 6-month course. Of the 680 (60%) IPT noncompleters, 117 (17.2%) were lost to follow-up by month 1, 305 (44.9%) by month 2, 156 (22.9%) by month 3, 48 (7.1%) by month 4, and 54 (7.9%) by month 5. Being initiated on IPT by a pharmacist (adjusted odds ratio [aOR]: 23.7, 95% confidence interval [CI]: 16.5-33.9) and receiving ≤2 tuberculosis screening evaluation during IPT period (aOR: 0.58, 95% CI: 0.43-0.78) were associated with a higher and lower risk of completing IPT, respectively, whereas age, sex, and anti-retroviral therapy (ART) status were not significantly associated. CONCLUSION: IPT completion rate among PLHIV is relatively low, highlighting the need to strengthen IPT rollout in public health facilities in Nigeria. Pharmacy-led IPT adherence education and regular clinical evaluation may improve IPT completion rates, along with synchronizing and prepackaging IPT and ART resupplies for PLHIV.
ABSTRACT
BACKGROUND: The high level of maternal mortality and morbidity as a result of complications due to childbirth is unacceptable. The impact of quality medicines in the management of these complications cannot be overemphasized. Most of those medicines are sensitive to environmental conditions and must be handled properly. In this study, the quality of oxytocin injection, misoprostol tablets, magnesium sulfate, and calcium gluconate injections was assessed across the six geopolitical zones of Nigeria. METHOD: Simple, stratified random sampling of health facilities in each of the political zones of Nigeria. Analysis for identification and content of active pharmaceutical ingredient was performed using high-performance liquid chromatography procedures of 159 samples of oxytocin injection and 166 samples of misoprostol tablets. Titrimetric methods were used to analyze 164 samples of magnesium sulfate and 148 samples of calcium gluconate injection. Other tests included sterility, pH measurement, and fill volume. RESULTS: Samples of these commodities were procured mainly from wholesale and retail pharmacies, where these were readily available, while the federal medical centers reported low availability. Approximately, 74.2% of oxytocin injection samples failed the assay test, with the northeast and southeast zones registering the highest failure rates. Misoprostol tablets recorded a percentage failure of 33.7%. Magnesium sulfate and Calcium gluconate injection samples recorded a failure rate of 6.8% and 2.4%, respectively. CONCLUSION: The prevalence of particularly of oxytocin and misoprostol commodities was of substandard quality. Strengthening the supply chain of these important medicines is paramount to ensuring their effectiveness in reducing maternal deaths in Nigeria.
