Arnela Boskovic1, Mathias Møllebæk2, Susanne Kaae3. 1. Department of Pharmacy, University of Copenhagen, Copenhagen Centre for Regulatory Science, Universitetsparken 2, 2100, Copenhagen, Denmark. cors@sund.ku.dk. 2. Department of Pharmacy, University of Copenhagen, Copenhagen Centre for Regulatory Science, Universitetsparken 2, 2100, Copenhagen, Denmark. 3. Department of Pharmacy, University of Copenhagen, Social and Clinical Pharmacy, Copenhagen, Denmark.
Abstract
BACKGROUND: Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA. METHODS: European MAHs ([Formula: see text]) and EMA representatives ([Formula: see text]) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation. RESULTS: The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA's internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal Obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice. CONCLUSION: DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.
BACKGROUND: Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA. METHODS: European MAHs ([Formula: see text]) and EMA representatives ([Formula: see text]) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation. RESULTS: The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA's internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal Obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice. CONCLUSION:DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.
Entities:
Keywords:
direct healthcare professional communication; pharmaceutical industry; regulatory authority; risk minimization; safety communication