Prescribing Guidelines for Medicinal Drugs and Driving

Chairs: J.J. de Gier and J. Alvarez
Contact the Prescribing Guidelines for Medicinal Drugs and Driving Working Group

 

Goal: To provide guidelines for safe prescribing and dispensing of medicinal drugs to patients who drive, especially in coordination with DRUID. This working group allows ICADTS members to share information and work together in the intervals between conferences.

 

Recent Developments (2013)

 

Since 2006, the European DRUID project continued the work on the categorisation and some European members of the ICADTS WG (Alvarez, De Gier, Mercier-Guyon, Verstraete) dedicated their time and efforts by joining a group of DRUID Workpackge (WP) 4 Partners to complete the work that was once started within ICADTS. The outcome of DRUID in 2011 with 4 extensive Deliverables (see DRUID website: www.druid-project.eu , look for Deliverables Workpackage 4), about the existing categorisation systems, criteria for establishing a categorisation system and a framework for categorising impairing medicines) was well accepted by many organisations in health care and transportation safety. In collaboration with the PharmacoVigilance WorkingParty (PhVWP) of the European Medicines Evaluation Agency (EMA) in London, DRUID WP 4 Partners and EMA experts could agree upon new warning levels for moderately and severely impairing medicines to be proposed for improvement of the Summary of Product Characteristics, the official document on which the Package Information Leaflet for patients is based. Further developments for following up on the proposals is dependent upon collaboration with EU’s Directorate General (DG Sanco) for consumer protection and health care. So far no follow-up activities since the completion of the work within DRUID (October 2011) could be observed and more emphasis on communication with DG Sanco is needed.

 

Finally the scope of the activities should be broadened in order to include experiences of applying DRUID/ICADTS documentation in national programmes for improving prescribing and dispensing practices worldwide.

 

Future work:

Working Group members during their 2013 ICADTS Meeting in Brisbane agreed that, because extensive work was accomplished by DRUID WP 4 Partners that needed to be disseminated in all possible manners, the following activities could be proposed to the ICADTS membership in order to seek for interest and participation of more ICADTS members:

  • Seek funding for continuation of the work that was started within DRUID on further developing and maintaining the categorisation system;
  • Contact ICADTS members (through the ICADTS website and the Reporter) who are willing to join the ICADTS WG and to take the opportunity to identify key figures who have an interest and can influence federal regulators in their country to use the DRUID materials;
  • Update the information on the ICADTS website based on DRUID materials, in particular the medicines list with 3-tier level categories and the prescribing and dispensing guidelines;
  • Seek for dissemination of DRUID materials to improve prevention, education of patients/drivers, and prescribing and dispensing practices by communication to professional organisations of physicians and pharmacists and share “best practices”, to maintain national databases, and involve ICT software developers for decision support systems used by health care professionals in order to implement DRUID/ICADTS information in prescribing and dispensing computer systems;
  • Develop a short document (max 2 pages) to recommend DRUID/ICADTS materials for activities as listed under 2-4 mentioned above;
  • Organize a session in T2016 to report on progress that was observed in activities undertaken under 2-5 mentioned above and evaluate outcomes to define follow-up activities; and
  • Communication among WG members by e-mail communication and social media to provide updates on 2-6.