[Clinical trials and outpatient dispensation: the pharmaceutical counseling place]. / Dispensation ambulatoire du médicament pour essai clinique: place du conseil pharmaceutique.

ABSTRACT

Drug dispensations in clinical trials essentially concern outpatients (90%), and several mistakes and bad uses have been noted. The aim of this work is to set up a pharmaceutical counselling for outpatients in clinical trials. The bibliographic research on this subject did not learn us about similar experiences, but several references helped us to select the support of information personal meeting between patient and pharmacist to introduce a written leaflet. Pharmaceutical information mentioned in the leaflet has to be validated and has to respect the clinical trials regulations. In the same way, information does not interfere with the inclusion-exclusion criteria or with the physician's observations. Then, information has been deliberately limited to the practical aspects of medications. Anonymous questionnaires have been delivered to the thirty first patients concerned to value their satisfaction with our services. The need of a clear and practical pharmaceutical counselling in clinical trials has been clearly established. Such a pharmaceutical counselling in clinical trials is one component of the overall drug-use process and potentially increases drug compliance. This pharmaceutical counselling on drug management has been well accepted by patients and has been supported by physicians and clinical trial sponsors.