Pharmacovigilance in medical cannabis therapy among physicians in Poland: pharmacovigilance knowledge, ADR reporting practice and cannabis-related safety reporting.

چکیده اصلی

BACKGROUND: Medical cannabis is increasingly used in routine care, but its pharmacovigilance profile remains difficult to monitor because products, formulations, doses, routes of administration and clinical indications vary substantially. This study assessed pharmacovigilance knowledge, adverse drug reaction (ADR) reporting practice and attitudes toward medical cannabis among physicians in Poland, with particular attention to factors associated with ADR reporting. METHODS: We conducted a cross-sectional analytical survey among 253 clinically active physicians in Poland using an anonymous self-administered questionnaire. The survey covered demographic and professional characteristics, pharmacovigilance knowledge and awareness, general ADR reporting, clinical exposure to medical cannabis and cannabis-related safety perceptions. Crude associations were examined using chi-square tests, Fisher's exact tests for cannabis-specific sparse-data comparisons, Cramer's V, odds ratios (ORs) and 95% confidence intervals, with Benjamini-Hochberg false-discovery-rate adjustment. For the primary outcome of general ADR reporting, a forced-entry multivariable logistic regression included PV-purpose knowledge, any medical specialization, professional experience greater than 10 years, hospital/university workplace, medical cannabis exposure and sex. Cannabis-specific reporting was analyzed separately using exact methods because only 19 events occurred. RESULTS: Most respondents reported clinical exposure to medical cannabis (81.0%), whereas only 13.4% reported adequate formal education in this area. In crude analysis, knowledge of the purpose of pharmacovigilance showed the strongest association with ADR reporting (OR 46.58; 95% CI 21.20-102.32; p < 0.001; q < 0.001). In the adjusted model, PV-purpose knowledge (adjusted OR [aOR] 24.71; 95% CI 9.40-64.96), any medical specialization (aOR 9.97; 95% CI 3.66-27.20) and hospital/university workplace (aOR 5.72; 95% CI 2.10-15.55) retained positive associations with general ADR reporting. Professional experience greater than 10 years, medical cannabis exposure and sex were not statistically significant after adjustment. Cannabis-specific ADR reporting was uncommon. CONCLUSIONS: In this sample, PV-purpose knowledge, medical specialization and hospital/university workplace retained positive associations with general ADR reporting after multivariable adjustment. Crude associations for longer professional experience and medical cannabis exposure were attenuated after adjustment. The combination of frequent medical cannabis exposure and rare cannabis-specific ADR reporting suggests an exposure-reporting gap. The observational findings support practical, therapy-specific pharmacovigilance training but should not be interpreted causally.

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