ObjectiveTo assess whether direct to healthcare professional communications (DHPCs) are of sufficient quality to be applicable in clinical practice and study how the quality differs according to safety concerns and type of monitoring.DesignRetrospective cohort study.SettingDHPCs containing monitoring instructions were identified among all DHPC issued in Denmark between 2007 and 2018.InterventionQuality of information of monitoring instructions was assessed according to the Systematic Information for Monitoring (SIM) score. Associations between different characteristics of instructions and the SIM score were compared with analysis of variance and the post hoc test Tukey’s honestly significant difference if significant.ResultsIn total, 297 DHPCs were issued, of which 97 contained 134 monitoring instructions. For 95% of these DHPCs the European Medicines Agency was involved. The average SIM score was 2.6±1.6 (ranging 0–6) and only 47% were considered of sufficient quality (SIM score ≥3). In addition, even fewer (11%) instructions were considered a ‘adequate instruction’ which also reported about facts and risks. Differences between quality of information according to type of monitoring were observed, specifically between clinical monitoring (average SIM score 1.9) and biomarker monitoring (physical average SIM score 2.9, p=0.029 and laboratory average SIM score 3.4, p<0.0001).ConclusionsMonitoring instructions were found not to be of sufficient quality to be applicable in clinical practice according to the SIM score. Our study concludes the need for further research and regulatory steps to ensure improve quality of information in safety communications.

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 (n = 6) and EMA representatives (n = 2) 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.