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Performance of active drug safety monitoring and management for pharmacovigilance strengthening in Ethiopia, experience from a multidrug-resistant tuberculosis management program: a cross-sectional study

Por: Achalu · D. L. · Meshesha · S. G. · Kiltu · A. B. · Wendimu · D. E. · Tegegne · N. A. · Alemu · A. · Tiemersma · E. W. · Cobelens · F. · Teferi · M.
Objective

The study aimed to assess the performance of active drug safety monitoring and management (aDSM) in the context of multidrug-resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) treatment programmes to generate insights that could support potential scale-up efforts to strengthen the pharmacovigilance (PV) system in Ethiopia and beyond.

Design

A cross-sectional study design was employed. The records of patients with MDR/RR-TB enrolled and treated at selected hospitals during April 2018 through February 2023 were reviewed. Data were collected using a structured data extraction form, and Research electronic Data Capture (REDCap) was used for data entry and management. The data were analysed using SPSS version 25, employing descriptive statistics.

Setting

The study was carried out at ten (10) public hospitals in Ethiopia.

Participants

A total of 1377 patients with MDR/RR-TB were included from 10 hospitals.

Results

Out of the 1377 patients, the majority (59.3%) were males, and 39.9% were new to anti-TB treatment. Deviations from the schedule or missed safety monitoring and other investigations were observed. No records were available for monitoring adverse events (AEs) in 94 (6.8%) of the patients during their treatment follow-up. Overall, 455 (33.0%) patients experienced at least one AE during the treatment period. A total of 774 AE records were identified, of which 134 (17.3%) and 225 (29.1%) were serious adverse events (SAEs) and adverse events of special interest (AESI), respectively. Only 135 (17.4%) of all identified AEs were reported to the PV Centre, of which 70 (51.9%) and 48 (35.6%) were AESI and SAE, respectively. However, the trend of AE detection and reporting showed improvement over the surveyed aDSM implementation period.

Conclusion

Despite the implementation of aDSM, AE detection and reporting remained suboptimal in the MDR/RR-TB treatment cohort. Therefore, routine aDSM needs to be strengthened and consistently implemented to improve the national pharmacovigilance system and enhance patient safety monitoring and management.

Treatment adherence, survival outcomes and barriers to care of non-Hodgkin lymphoma in Northwest Ethiopia: a mixed-methods study

Por: Kassaw · A. T. · Teferi · E. T. · Zerihun · T. E. · Mussie · D. A. · Melese · T. B. · Admasu · M. T. · Wallie · B. Y. · Birarra · M. K.
Objective

To evaluate treatment adherence, survival and systemic patient and provider level factors associated with non-Hodgkin’s lymphoma (NHL) management as reported by healthcare providers.

Design

Explanatory sequential mixed-methods study comprising a retrospective hospital-based cohort and a qualitative descriptive study.

Setting

Felege Hiwot Comprehensive Specialized Hospital in Bahir Dar, Ethiopia, and the University of Gondar Comprehensive Specialized Hospital in Gondar, Ethiopia.

Participants

Adults (≥18 years) with histologically confirmed NHL who initiated systemic chemotherapy were eligible. We randomly selected 182 patients with NHL treated and diagnosed between 1 August 2019 and 31 July 2024, for retrospective chart review out of a total of 283 patients during the study period. 14 healthcare professionals with at least 1 year of oncology experience participated in in-depth interviews.

Primary and secondary outcome

The primary outcome was overall survival, defined as the time from histological diagnosis to death from any cause. The secondary outcome was treatment adherence, defined as interruption between cycles or abandonment of prescribed chemotherapy.

Results

At a median follow-up of 18 months, the estimated 3-year overall survival rate was 48.5% (95% CI 37.8% to 58.4%). Lower survival rate was independently associated with B-symptoms (adjusted HR (AHR) 2.7, 95% CI 1.6 to 4.4), high intermediate International Prognostic Index (IPI) (AHR 3.7, 95% CI 1.8 to 6.9) and high IPI (AHR 5.5, 95% CI 2.7 to 11.3). Treatment abandonment and interruption occurred in 22.5% and 20.5% of patients, respectively. Exposure to rituximab was more likely to abandon therapy (²=4.8, p=0.03). Patient residence in rural areas was associated with higher rates oftreatment interruption (² = 6.0, p = 0.01), whereas absence of healthinsurance was associated with treatment abandonment (² = 8.0, p =0.005).

In the qualitative analysis, healthcare providers identified multilevel barriers to NHL care, including low patient awareness and late presentation, frequent misdiagnosis at the primary care level, weak referral systems, financial constraints, inconsistent drug availability and limited diagnostic capacity. These systemic and patient-level challenges are often associated with delayed diagnosis, treatment interruption and suboptimal survival outcomes.

Conclusions

3-year survival among adults with NHL in Northwest Ethiopia was substantially lower than reported in high-income settings. Mortality was higher among patients with B-symptoms and elevated IPI scores. High rates of treatment interruption and abandonment were observed. Patient-level and system-level factors are associated with reduced survival and treatment continuity. Strengthening early diagnosis, risk stratification and financial protection may support improved treatment adherence and survival outcomes.

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