Abstract
BACKGROUND AND OBJECTIVES: Additional risk minimization measures (aRMMs), such as direct healthcare professional communication (DHPC) and risk management plan (RMP) educational materials, are required for certain medicinal products to mitigate the risks associated with their use. This research aimed to assess healthcare professionals' (HCPs) awareness and experiences of DHPC and RMP educational materials, identify the safety information most valued by HCPs, and determine ways to improve the processes and content of DHPCs and RMP educational materials. METHODS: An open, anonymous online questionnaire was created and made available to HCPs through their respective professional associations. The Chi-squared test for independence was the primary statistical analysis method used. Content analysis of the open-ended answers was conducted by two independent coders. RESULTS: A sample size of 185 HCPs (32 physicians, 50 nurses, 26 MSc pharmacists, and 77 BSc pharmacists) was achieved. HCPs showed limited familiarity with aRMMs, with 45% unsure whether they had received DHPCs, 41% uncertain whether they had used RMP educational materials, and 42% unaware where to check whether a product had RMP educational material. Overall, MSc pharmacists demonstrated the highest awareness of RMP educational materials and DHPCs. In addition, 54% of HCPs felt they received insufficient safety information, and 57% desired further training in pharmacovigilance (PhV). CONCLUSIONS: This research reinforces and complements our previous findings on the need to enhance PhV awareness and expertise among HCPs, particularly in areas such as adverse drug reaction (ADR) reporting, additional monitoring, DHPCs, and RMP educational material. Future DHPCs and RMP educational materials should be made more distinguishable to effectively capture HCPs' attention.