(045) Impact of European Union label changes to avoid inadvertent use of once-weekly methotrexate: A cross-sectional survey amongst prescribers, pharmacists and patients on awareness, knowledge, and behaviour
Background: Methotrexate (MTX) is prescribed for auto-immune disease in a once-weekly regimen. Inadvertent once-daily instead of once-weekly use may lead to overdose and serious harm. The European Medicines Agency introduced additional risk minimisation measures (RMM) for once-weekly methotrexate in 2019.
Objectives: To determine the effectiveness of RMM for once-weekly methotrexate we evaluated the awareness, knowledge, and self-declared behaviour of prescribing physicians (‘prescribers’), pharmacists, and patients. regarding these measures
Methods: We performed a cross-sectional online survey in France, Greece, Germany, Poland, and Sweden in respondents that had prescribed, dispensed, or used once-weekly MTX in the past 3 months. Respondents were considered successful if they provided 100% desirable responses for awareness and self-declared behaviour, and ≥80% correct responses for knowledge. Per target population, an outcome was considered successful if achieved by ≥80% of respondents. Effectiveness of RMM was defined as ≥80% of respondents being successful on all outcomes. Data was collected through an online questionnaire. For prescribers and pharmacists, the results were weighted based on the size of the target population per country.
Results: Questionnaires were completed by 151 prescribers, 150 pharmacists, and 150 patients; response rates were 2.8%, 13.3%, and 9.6%, respectively. Almost all prescribers demonstrated correct knowledge of risks and dosing regimen of methotrexate, and ~80% noted the day of intake on the prescription. Patients who were aware of the patient card showed high levels of knowledge on its content (70-80% across questions). Success rates were 56% (95% CI 48-64%) for awareness, 42% (95% CI 34%-51%) for knowledge, and 31% (95% CI 23-39%) for behaviour among prescribers; 19% (95% CI 13-26%) for awareness, 7% (95% CI 4-13%) for knowledge, and 50% (95% CI 42-58%) for behaviour among pharmacists; and 29% (95% CI 22-37%) for awareness, and 3% (95% CI 1-7%) for knowledge among patients. Overall success was not attained by any target population. Results were similar across countries.
Conclusions: RMM were evaluated as not effective, nor did any target population achieve success for any outcome. Relative differences across target populations and outcomes suggested an extra focus on pharmacists was needed, specifically their knowledge, as opposed to other target populations and outcomes. Considering low awareness across target populations, redistributing educational material could be considered. Qualitative future studies may help determine why individual RMM were not successful, and how these may be improved.
