PhD ceremony Ms. S. Piening: Communicating Risk Effectively

PhD ceremony: Ms. S. Piening, 12.45 uur, Academiegebouw, Broerstraat 5, Groningen

Dissertation: Communicating Risk Effectively

Promotor(s): prof. S.M. Haaijer-Ruskamp, prof. P.A. de Graeff

Faculty: Medical Sciences

This thesis focuses on risks of side effects of drugs. Once a drug is allowed on the market serious safety problems may arise, possibly leading to hospitalization, disability, or even death of patients. Paper based warning letters, so-called Direct Healthcare Professional Communications (DHPCs) are sent to inform healthcare professionals of these side effects. However DHPCs have not always been successful. Following a third of DHPCs we observed a significant decrease in the long-term use of the drugs. DHPCs proved to be specifically effective in case of well-structured information, and very serious side effects. Healthcare professionals preferred to receive safety information via e-mail and from an independent source. An additional e-mail that was sent by the Dutch Medicines Evaluation Board appeared to enhance the effect of the written DHPC. Healthcare professionals were more aware of the side effect and took more action in response to the issue. Risk communication of side effects should be improved by addressing several factors. Communication methods should be improved, for example, by communicating through new channels such as e-mail, and by an independent source. Healthcare professionals and professional associations should be involved in the DHPC drafting process. Also, it should be determined at which point a DHPC may be considered sufficiently effective. Evaluation of safety warnings is useful only when thresholds are set and additional measures will be demanded if these thresholds are not reached. Currently, the DHPC has a clear added value, but future developments will need to be monitored.