4CPS-210 Patients in clinical trials and their treatment: did the prescription support a first-line information tool?

Background According to the Code of Public Health, the pharmacist advises and informs the patient to ensure the right use and high drug adherence. In clinical trials (CT), investigational medicinal products (IMP) are dispensed by the pharmacy department. A copy of the prescription is given to the patients in ambulatory: it is a support to information for the patient available at any time at home. In our hospital, prescriptions for CT are usually provided by the sponsor. Purpose The purpose of this work was to evaluate information about IMP on the prescriptions provided by the sponsors and to propose areas for improvement. Material and methods All the CTs with at least one IMP was taken at home and opened in the pharmacy department of a university hospital on 1 January 2018 were included in this retrospective study. A checklist of eight criteria deemed essential to inform the patient regarding his treatment was created in accordance with the regulations. Results A total of 93 CTs were evaluated, 35% were institutional CTs. Eleven per cent (n=10) of the prescriptions contained none of the listed criteria. For each criterion, the proportion of prescriptions including the information was 83% for dosage, 69% for product’s conditioning, 43% for treatment’s duration, 25% for time of taking, 19% for intake, 5% for storage temperature, 2% for adverse reactions and 0% for drug interactions. Eighty-eight per cent (n=82) of the evaluated CTs were oral IMP and 30% (n=25) were chemotherapies. Conclusion The most frequent information on prescriptions is the dosage and the packaging of the IMP. At the other end, information on what to do in case of adverse events and drug interactions are rare or non-existent. The pharmacist has an important and essential role in dispensing pharmaceutical advice for CT. 1 A collaboration between services and pharmacy is planned in order to establish a standard prescription for CTs with specific information. Improving the quality of prescription information will optimise the safety of IMP taking. Reference and/or acknowledgements Schoenenberger JA, et al. Assessment of the information on investigational oral treatment provided to patients in clinical trials. Euro J Hospl Pharm 2012;(19):230–1. No conflict of interest.