The provision of information about medicines to the driver is described as a collaboration between the marketing authorisation holder, the regulatory authority and the healthcare professional. An EU regulatory framework exists to ensure the provision of up-to-date, relevant information to the patient to promote safe use, where the information exists. Brief details are given of the system, in particular the Summary of Product Characteristics (SPC), the information upon which labelling is based. The SPC contains a section devoted to the effects of the medicine on ability to drive and use machines. The incorporation of this information into labelling is discussed, in particular the possible responses of some patients in terms of failure to use the medicine or altering their behaviour to accommodate it.
Abstract