EFFECTIVENESS OF ACTIVE ADVERSE DRUG REACTION SURVEILLANCE FOR FIRST-LINE ANTI-TUBERCULOSIS DRUGS AT HAI PHONG LUNG HOSPITAL

Tran Thi Ngan1,, Hoang Anh Vu2, Nguyen Thi Thu Phuong1
1 Faculty of Pharmacy, Hai Phong University of Medicine and Pharmacy, Hai Phong, Vietnam
2 Department of Pharmacy, Hai Phong Lung Hospital, Hai Phong, Vietnam

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Tóm tắt

Background: Adverse drug reactions (ADRs) related to first-line anti-tuberculosis (TB) drugs remain a major challenge, potentially affecting treatment adherence and outcomes. In many settings, ADR surveillance relies mainly on passive reporting, which may lead to under-detection. Objectives: To evaluate the effectiveness of pharmacist-led active ADR surveillance for first-line anti-TB drugs at Hai Phong Lung Hospital. Methods: A longitudinal before–after study compared passive ADR reporting (January 2023–November 2024) with pharmacist-led active surveillance (December 2024–May 2025) among hospitalized TB patients. Outcomes included ADR reporting frequency, ADR report quality, and the proportion of potentially preventable ADRs. Interrupted time series (ITS) analysis was used to assess changes following implementation. Results: During the passive surveillance phase, 130 ADR reports were recorded from 9,459 inpatient medical records, compared with 190 reports from 2,971 inpatient medical records during active surveillance. Implementation of pharmacist-led active surveillance was associated with a significant increase in ADR reporting from 1.40 to 6.32 ADRs per 100 inpatient records. Interrupted time series analysis demonstrated a significant immediate increase in the ADR reporting rate, corresponding to approximately 5.12 additional ADR reports per 100 inpatient records (β = 5.12; p < 0.001). The mean ADR report quality score improved from 0.84 to 0.99, with a significant immediate increase after the intervention (β = 0.14; p < 0.001) and a significant increasing post-intervention trend (p = 0.001). The proportion of potentially preventable ADRs decreased from 14.62% to 10.52%, with a significant decreasing trend during the post-intervention period (β = −3.99; p = 0.002), corresponding to an average reduction of approximately 4 percentage points per month. Conclusions: Pharmacist-led active ADR surveillance significantly improved ADR reporting frequency and quality and reduced potentially preventable ADRs in hospitalized TB patients, supporting its role in enhancing medication safety in TB treatment settings.

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