Mathias Møllebæk awarded PhD degree

Risks that emerge after a drug is approved for the market constitute a significant public health problem. In the EurMathiaopean Union and elsewhere such risks are sought minimized with Direct to Healthcare Professional Communications (DHPC), typically in the form of a letter sent from the manufacturer to prescribers. However, evaluations show that DHPCs have limited impact on prescribing behavior, and the factors that influence prescribers’ lack of adoption of DHPCs remain underexamined.

This thesis advances a formative approach to the evaluation of DHPCs which enables an exploration of the factors that influence prescribers’ adoption of DHPCs. The methodology is developed on the basis of a systematic literature review of empirical studies of drug safety communication and a scoping review of relevant theorical literature. On this basis a combination of a semi-structured interview method and a think-aloud reading method was employed with a sample of 17 Danish general practitioners (GPs) within a single-case research design that revolved around emergent risks in new oral anticoagulants.

The studies found that the sample of GPs has an active information behavior related to patient consultations and a passive information behavior related to clinical guidelines and newsletter subscriptions. When presented with a case-DHPC, the GPs stated that it lacked clinical relevance; that the risk of commercial bias of the information deterred them from reading it; that they considered the DHPCs isolated from routinely used clinical information sources; and for some GPs, that DHPCs were primarily distributed with the intention of relocating responsibility from the manufacturer onto prescribers.

The thesis concludes that the limited adoption is associated with organizational and governance-related aspects rather than with the risk information conveyed in DHPCs. Therefore, focus of improvement should be to integrate the information conveyed in DHPCs in prescribers’ preferred sources and to establish closer partnerships with stakeholders who are closer to prescribers’ everyday work.

Read the full thesis

The thesis is based on two published original research articles and a submitted manuscript:

1. The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies
   Møllebæk M, Kaae S, De Bruin ML, Callréus T, Jossan S, Hallgreen CE.
   Research in Social and Administrative Pharmacy. 2019 May;15(5):475-482.
   https://doi.org/10.1016/j.sapharm.2018.06.015
2. Why do general practitioners disregard direct to healthcare professional communication? A user-oriented evaluation to improve drug safety communication
   Mollebaek M, Kaae S
   Basic Clinical Pharmacology Toxicology. 2020
   https://doi.org/10.1111/bcpt.13516
3. Are Drug Safety Advisories Compatible with Physicians’ Information Behavior? Semi-Structured Interviews with GPs about Safety Information for Direct Oral Anticoagulants.
   Therapeutic Advances in Drug Safety. 2020 aug 4. Pending review.

The Assessment Committee was composed of Professor Anna Birna Almarsdóttir (Chairperson), Dr Doris Irene Stenver and Professor Frederic Bouder.

The supervisors were Associate Professor Susanne Kaae (Department of Pharmacy), Professor Lisa Storm Villadsen (Department of Communication), Assistant Professor Christine Hallgreen (CORS), Chief Medical Officer Thorbjörn Callreus (Danish Medicines Agency), Vice president Sukhwinder Singh Jossan (Ferring Pharmaceuticals Denmark), Professor Marie Louise De Bruin (CORS).