Integrating a Pharmacovigilance and Response Unit Team for a Better Adverse Drug Reaction Reporting and Management: Insights from a Prospective Cross-Sectional Study.

OBJECTIVES

The multidisciplinary team approach improves adverse drug reaction (ADR) reporting and management. Our study aims to integrate a pharmacovigilance (PV) and Response Team within the general medicine department to improve ADR reporting and management.

MATERIALS AND METHODS

We conducted a prospective cross-sectional study for seven months in four general medicine wards. We proposed a PV and response unit team (PRUT), comprising a nursing student, and a Doctor of Pharmacy (intern). After the team received interventional educational training, we integrated them with the physician and head nurse of each general medicine inpatient ward. We then evaluated the effectiveness of the team in ADR reporting and management using a feedback survey.

RESULTS

In this study, comorbidities (30.69%) and polypharmacy (≥5 drugs) (26.25%) were major predisposing factors. Among drug-related problems in 125 patients, inappropriate drug use (28.80%) and unclear dose timing (21.60%) were predominant. Gastrointestinal disorders were common (44.73%), with dose adjustment being the top management strategy (36.84%). Over 71% supported the PRUT for improving patient safety and reducing medication errors, noting high effectiveness in consultation (85.92%) and in reducing the ADR reporting burden (87.32%). There is a statistically significant association between the level of agreement on the effectiveness of PRUT among healthcare professionals (p<0.01). Most healthcare professionals agreed on PRUT's effectiveness without any reports of low agreement levels.

CONCLUSION

The PRUT effectively reported and managed ADRs. A multidisciplinary approach improves ADR reporting and management.