Abstract:

Off label prescribing and compassionate use programs are in place in each European country, under the umbrella of the EU directives. Although principles and milestones underlying to off label prescribing are common everywhere, the application of these principles may differ from setting to setting, based on local rules and procedures. Off label prescribing has different implications besides the mere evaluation of efficacy and safety, ranging from ethical to economical issues. It is important to understand the basic concepts from a clinical and regulatory point of view. Pharmacists play a supporting role for clinicians in evaluating the rationale of off label use, supporting their decisions, and finding the most suitable way to obtain and/or compound the drug. This seminar will address the framework of compassionate use and off label medicine use in the European Union, as well as describe the role of the hospital pharmacist in this matter.

Teaching goals:

• present different aspects (medical, evidence-based, ethical, legal) of compassionate use and off label prescribing
• describe the decision making process that should be adopted in the decision of prescribing an off label medicine
• present possible scenarios on the role of hospital pharmacists in supporting physicians and documenting the rationale of off label prescribing

Learning objectives:

After the presentation the participant should:

• become familiar with the legislation in place in Europe for compassionate use, expanded access programs and
• become familiar with the necessary elements that constitute the base for off label use
• be able to evaluate the appropriateness of an off label prescription