BACKGROUND The direct to healthcare professional communication letter (DHPC) is the main regulatory instrument to inform prescribers of emergent, post-approval risks, yet it has limited impact on prescribing. Recent research efforts to understand this has not examined the contextual factors which may be involved.
OBJECTIVE We examined 1) the everyday clinical context in which Danish general practitioners (GPs) receive and use information about emergent risks, and 2) how GPs respond to and assess a specific letter about an emergent risk; a 2014 DHPC regarding new oral anti-coagulants. The end-goal of this project is to provide recommendations for improving the DHPC.
METHODS We conducted semi-structured interviews including read-aloud protocols of the case-DHPC with 17 Danish GPs in Copenhagen and Zealand regions recruited primarily through chain-referrals. We sought specifically to reduce social desirability bias in the interviews. Verbatim transcripts were analyzed separately for major thematic patterns using nVivo 12 for Mac.
RESULTS We found that Danish GPs use multiple, interrelated sources of risk information for a range of purposes related to prescribing medicines. The paramount use criteria for risk information was clinical, patient-related usefulness. Among the sources used, the DHPC played a marginal role, if any. In the case-specific protocol analyses, however, we found that most GPs recognized the DHPC as a type of recurrent risk information. Yet, we also found that GPs perceived the letter’s recommendations for risk mitigation to be of low clinical relevance, and that the medicine manufacturers role as the sender and signatory of the letter had a deterring effect on GPs’ uptake.
CONCLUSIONS The limited impact of DHPCs among Danish GPs can be explained by its low penetration compared to other sources and by the GPs’ perception that DHPCs are of low clinical relevance and that commercials interests may bias the information. As a regulatory instrument to minimize emergent post-approval risks in general practice in Denmark, the DHPC should be revised.