Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria.

INTRODUCTION: Spontaneous reporting of adverse events (AEs) is a mainstay of pharmacovigilance, and an ongoing challenge is how to ensure that more high-quality reports are collected for comprehensive information provision. The Med Safety App, a smartphone-based application, was launched in Nigeria in November 2020 to provide an electronic platform for users to seamlessly report AEs. There has been a paucity of evidence on the use of this application or other mobile applications for reporting adverse drug reactions/AEs following immunization in the Nigerian environment. OBJECTIVE: The aim of this study was to evaluate the trends in adverse event reporting before and after the introduction of the Med Safety App in Nigeria. METHODS: This was a retrospective, observational study using data from the VigiFlow database to compare adverse event reporting in Nigeria before and after the deployment of the Med Safety App. The baseline period was 1st April 2019 to 30th October 2020 and the comparison period was 1st November 2020 to 31st May 2022. We used Vigilance Hub, the back-end system for the Med Safety App, to extract data on App downloads and de-identified user statistics. Data were summarized using descriptive statistics, frequencies and proportions. Quality was assessed by assigning a completeness score to each individual case safety report. The Kruskal-Wallis test was used to test for differences in medians between groups. RESULTS: Following deployment of the App, the Nigerian National Pharmacovigilance Centre recorded an increase in the total number of adverse event reports received in VigiFlow, from 2051 in the baseline period to 18,995 following deployment of the App, with 81.7% of those reported via the Med Safety App. There was a reduction in the proportion of paper-based reporting from 98.4 to 15.7% post-deployment, and direct reporting by consumers increased from 2.7 to 17.6%. Of the 15,526 reports submitted via the App, 15,111 (97.3%) had a completeness score above 70% and 6993 (45%) had a completeness score of 100%. The median completeness score of adverse event reports on the Med Safety App was 6 out of 7. On bivariate analysis using the Kruskal-Wallis test, there was an association between means of reporting and completeness score, and this association was significant, with a p value of 0.0001, which may reflect the validation rules that are applied within the App. CONCLUSION: Deployment of the Med Safety App increased both the number and quality of adverse event reports; however, more awareness and capacity building are needed to strengthen and sustain reporting on the tool by all categories of healthcare professionals and consumers/patients.

Prevalence, predictors and pregnancy outcomes of unprescribed and herbal medicine use in Ibadan, Nigeria.

BACKGROUND: Unprescribed and herbal medicines use among pregnant women is a public health concern in low and middle-income countries because of the potential teratogenic effects, insufficient safety and weak drug regulatory systems. Unprescribed and herbal medicines are common among pregnant women in Nigeria, and only a few researchers have documented the prevalence and the risk factors. However, evidence on the associated pregnancy outcomes is still lacking. We assessed the prevalence, predictors and pregnancy outcomes of unprescribed and herbal medicines use among pregnant women in Ibadan, Nigeria. METHODS: This study was a component of the Ibadan Pregnancy Cohort Study, a prospective cohort study, among pregnant women in Ibadan, Nigeria, who were enrolled at ≤ 20 weeks gestation at their first antenatal visit and followed up till delivery. In all, 571 women participated in the maternal drug use assessment during the third trimester using a pretested interviewer-administered questionnaire. The primary outcomes were unprescribed and herbal medicines use and pregnancy outcomes, secondary outcomes, were abstracted from medical records. The predictors assessed included sociodemographic, obstetric, antenatal care utilization, and lifestyle characteristics. Bi-variate logistic and Poisson regression analyses were used to evaluate the predictors and relative risk for the pregnancy outcomes of unprescribed and herbal medicines at 5% significance. RESULTS: The prevalence of unprescribed and herbal medicine use was 31.9% and 21.7%, respectively. On bivariate analysis, the significant predictors of unprescribed medicine (which were protective) were tertiary education, increasing income, adequate antenatal care (≥ 4 visits), and at least two doses of sulfadoxine-pyrimethamine. However, high parity and having an antenatal admission increased the risk. However, after adjusting for confounders, the significant factors associated with unprescribed medicines were; tertiary education (AOR) = 0.23; 95% CI: (0.06 - 0.95); p-value: 0.043] and obtaining at least two doses of sulfadoxine-pyrimethamine [AOR = 0.33; 95% CI: (0.29 - 3.60); p-value: 0.048]. For herbal medicines, the predictors were similar to unprescribed drugs. However, after adjusting for confounders, none was significant for herbal medicines. Unprescribed and herbal medicines were not significantly associated with pregnancy outcomes. CONCLUSIONS: Unprescribed and herbal medicines use were common among pregnant women in Ibadan, Nigeria, particularly among women with low economic status and those with poor utilization of antenatal care services. These significant predictors can be targeted for public health intervention. Specifically, health education that discourages the use of unprescribed and herbal medications to pregnant women during antenatal care.

Do private health providers adhere to National Tuberculosis Guideline while assigning treatment outcome? Findings from a lower middle-income country.

Background: Treatment success rate is an important indicator to measure the performance of the National Tuberculosis Program (NTP). There are concerns about the quality of outcome data from private facilities engaged by NTP. Adherence of private providers of tuberculosis care to NTP guideline while assigning treatment outcomes to patients is rarely investigated. We aimed to determine whether Lagos private for-profit (PFP) and private not-for-profit (PNFP) facilities adhere to domestic TB guideline while assigning treatment outcome and the availability of periodic sputum acid-fast bacilli (AFB) results. Method: A retrospective review of facility treatment register and treatment cards of TB patients managed between January and December 2016 across 10 private directly observed treatment short-course (DOTS) facilities involved in the public-private mix (PPM) in Lagos, Nigeria. The study took place between January and June 2019. Results: Of the 1,566 patients, majority (60.7%) were male, >30 years (50.2%), HIV-negative (88.4%), and attended PNFP (78.5%). The reported treatment success rate (TSR) was 84.2% while the actual TSR was 53.8%. In total, 91.1, 77.6, and 70.3% of patients had sputum acid-fast bacilli (AFB) at 2/3, month 5, and month 6, respectively, while 68.6% had all the three sputum AFB in the register. Healthcare workers (HCWs) were adherent in assigning treatment outcome for 65.6% of TB patients while 34.4% of patients were assigned incorrect treatment outcomes. Most variations between reported and actual treatment outcomes were found with cured (17%) and completed (13.4%). Successful and unsuccessful outcomes were overreported by 30.4% and 4.1%, respectively. DOTS providers in private facilities with available TB guideline (OR 8.33, CI 3.56-19.49, p < 0.0001) and PNFP facility (OR 4.42, CI 1.91-10.3, p = 0.001) were more likely to adhere to National TB Guideline while assigning TB treatment outcome. Conclusion: Frontline TB providers in Lagos private hospitals struggled with assigning correct treatment outcome for TB patients based on NTBLCP guideline. Increased access to all the periodic follow-up AFB tests for TB patients on treatment and availability of National TB Guideline for referencing could potentially improve the adherence of private TB service providers while assigning TB treatment outcomes.

How Do Private Providers Unaffiliated With the Nigeria National TB Program Diagnose and Treat Drug-Susceptible TB Patients? A Cross-Sectional Study.

INTRODUCTION: TB diagnosis and treatment practices among private providers not affiliated with the Nigeria National TB Program (NTP) have implications for TB control efforts. Studies evaluating these practices among non-NTP providers are scarce. We aimed to investigate TB diagnosis and treatment practices among non-NTP private providers in urban Lagos State, Nigeria. METHODS: We conducted a cross-sectional study among doctors and nurses operating private facilities not formally affiliated with the NTP for TB case notification. Between May 2018 and January 2019, we implemented a survey using a pretested questionnaire among 152 doctors and nurses attending TB sensitization seminars in Lagos, Nigeria. We used descriptive statistics to summarize the sociodemographic information and proportion of non-NTP providers with different self-reported TB diagnostic, prescription, and monitoring practices. RESULTS: Private non-NTP doctors and nurses self-reported diagnosing TB using 8 different types of tests. Acid-fast bacilli was the most common (39.8%) means of diagnosing TB. Private non-NTP providers also self-reported prescribing 23 different TB regimens, including streptomycin, to treat TB. Only 32.4% of providers self-reported using the correct combinations of anti-TB drugs to treat TB. Additionally, 58.3% of providers prescribed the standard 6-month treatment duration for pulmonary TB patients, and the remaining 41.7% either undertreated or overtreated TB. CONCLUSION: A large proportion of private doctors and nurses not formally affiliated with the NTP in Nigeria were not following the NTP guidelines in the diagnosis and treatment of TB. Overtreatment and undertreatment were common. Engagement of these practitioners by the NTP in the form of supervision, on-the-job mentorship, and other strategies can mitigate the negative effects of their current practices on TB case notification and the spread of drug-resistant strains in Nigeria.