Factors affecting pharmacovigilance reporting among healthcare professionals at Butabika National Referral Mental Hospital. A multi methods study
Abstract
BACKGROUND Pharmacovigilance is the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any other possible drug related
problems. Low reporting of medication related problems has been documented in African
countries with one of the reasons for this being weak healthcare and pharmacovigilance systems.
Drug related problems frequently occur among psychiatric patients due to common prescribing
errors and complex treatment schedules. The reporting rate of Butabika National referral hospital
is low with only 3 adverse reactions reported in 2020 and 35 reported in 2022.
OBJECTIVE The study’s main objective was to examine the factors affecting
pharmacovigilance reporting and its extent among health care professionals at Butabika National
Referral Hospital.
METHODS It was a cross-sectional study employing quantitative and qualitative data
collection. The study was conducted among 145 randomly selected healthcare professionals, one
key informant and four focus group discussions purposively selected at Butabika National
Referral Hospital located in Butabika Nakawa Division. Descriptive characteristics were
presented using frequencies and percentages in tables and graphs. Qualitative data was analysed
in Atlas-ti version 22.2.5 thematically by generating themes and subthemes.
RESULTS Adverse drug reactions were the most reported drug related issues by 72% of the
healthcare professionals whereas, counterfeit drugs and medication errors were the least reported
by 13% and 17% respectively. Improper guidelines, poor funding mechanisms, untimely
feedback, poorly structured reporting tools, insufficient training and human resource affected
pharmacovigilance reporting at the hospital.
CONCLUSION Over the past year, the majority of healthcare professionals identified and
reported adverse drug reactions as the primary focus of pharmacovigilance efforts at the hospital,
however, reporting of other medication related problems was low due to lack of properly
structured guidelines, tools and insufficient training. Limited funding for conduction and
coordination of pharmacovigilance activities, untimely feedback from the National
Pharmacovigilance Centre, fear of punitive action, limited human resource limited reporting of
medication related problems.