(022) Temporal Trends in Adverse Drug Reactions Reports of Medicines for Treating Human Immunodeficiency Virus and Tuberculosis, and All Diseases: Joinpoint Regression

Publication Number: 1018

Background: Government needs reliable information on the reporting trend of adverse drug reactions (ADR) of medications for controlling epidemics, such as the Human Immunodeficiency Virus (HIV) and Tuberculosis (TB) but evidence is scarce.

Objectives: To assess changes in ADR reports of HIV medicines (WHO ATC code, J05AR) and TB medicines (WHO ATC codes J04AK) and all other medicines for treating other diseases apart from HIV and TB.

Methods: Setting: Study was conducted in Nigeria, which had 940,793 health workers, representing 26% of the 3.6 million health workers in Africa as of December 2021. Validated reports are transmitted to the WHO vigiBase, the global database for individual case safety reports by the National Agency for Food and Drug Administration and Control.


Design: Joinpoint regression, with Poisson distribution.
Data collection and statistical analysis: Validated VigiFlow data from 2004 to 2020 analysed. ADR counts and proportion estimated with 95% confidence interval (CI). The reporting trend, rate of change, the annual percent change (APC) and average annual percent change (AAPC), 95% CI and the p-values, calculated using the National Cancer Institute’s Joinpoint Regression Program (version 45.9.1.0).

Results: From 2004 to 2020, we identified 15,741 ADR reports. Female (n=9,847) and Pharmacist (n = 10,991) reports were predominant. HIV medicines reporting started in 2008 and increased annually by 20.55% [APC = 20.5 (95% CI: -0.8-45.5; Pvalue- 0.050)]. From 2017 to 2020, reporting declined by 30.3% [APC=-30.3(95% CI: -58-18.1; Pvalue-0.160)]. In the past 16 years, reporting slowly increased annually by 8% [AAPC=8.0 (95%CI:-8.3-27.3, Pvalue: 0.354)]. TB medicines reporting started in 2005, with one report but significantly increased at an annual rate of 28.4% [APC=28.4 (95%CI: 15.0-43.4)], without change for 16 years. All medicines, reporting started in September 2004, with only 52 reports and significantly increased to 4,380 reports in 2013, when the first change occurred [APC=90.1 (95% CI: 51.3-138.9; p-value < 0.001)]. From 2013 to 2016, reporting declined annually by 56.22%, but the change was not significant [APC=56.2, (95% CI: -84-26.9, p-value=0.113)]. From 2016 to 2020, a small but significant annual increase of 41.75% observed and the second change occurred in 2016 [APC=41.8 (95% CI: 8.2-85.6; p-value=0.017). In the last 16 years, the overall annual ADR reporting for all medicines significantly increased by 34.1% [AAPC=34.1 (95% CI: 8.3-66.1; p-value=0.007)].

Conclusions: We observed significant annual increases of reports regardless of the medications. TB medicines reporting was more stable compared with HIV and all medicines. Factors influencing the changes need further research.