Participation of the pharmaceutical services of the hospitals of the University of Coimbra in the kidney transplantation unit’s clinical trials

Abstract

HE RECEPTION and distribution of drugs do not always pass through the Pharmaceutical Services (PS) in Portuguese Hospitals (PH). We may give the example of drugs ceded as clinical samples to support marketing activities, drugs for compassion use, and drugs for clinical trials. Clinical investigation in hospitals demands the constitution of multidisciplinary teams to allow the development and effective implementation of clinical trials. 1 The centralization of all aspects related to the drug in clinical trial is advantageous regarding safer and more reliable results, 2 greater adherence to therapeutics, and reduction of dropouts, as well as monitoring costs for all its intervenients: the institution, the clinical trial’s subject, the investigator, the research center, the promoting entity, the official entities, and the trial’s monitor. The hospital’s PS are in our opinion the hospital’s services where all the conditions should be gathered to centralize the whole process related to the control of drugs in clinical trials. There are almost 80 clinical trials (CT) performed in the University of Coimbra (HUC) every year. The PS have been part of the Ethics Committee since 1997. For the first time, by the end of that year a clinical trial promoter asked for the direct intervention of the PS in a CT. Aiming to centralize the whole process, a section for CT was created in the PS, dealing with CT’s drugs and creating conditions for the pharmacist to play a greater and more effective role within the team involved in the investigation of new drugs. Today, there is a pharmacist in charge of the coordination of all the trials, and whenever it’s necessary all colleagues responsible for the services where the trial is being done are also in charge. The aim of this paper is to present the protocols and results of the CT section of the PS of HUC in clinical trials carried out by the Kidney Transplant Unit (KTU) of the same hospital. MATERIALS AND METHODS The following is the methodology for the approval of CT in the HUC: the promoter asks the Administration Council (AC) of the hospital for permission to perform the trial. The AC asks the Ethics Committee (EC) for an opinion. If the EC gives a positive answer, the AC negotiates with the promoter and the counterpart for the hospital and may or may not authorize the CT. The PS participate in two phases of the CT: in the EC and in the trial’s execution. The CT only begins after the authorization of the AC, with the following stages: 1. Meeting for the protocol’s presentation with collaboration of the trial’s promoter, main investigator, nurse, and pharmacist. The goal of this meeting is to present the protocol to all the trial’s intervenors and study the necessary conditions to perform it. 2. Development of an individual internal procedure protocol for each study. These protocols are based in the trial’s protocol, but adapted to fit our hospital’s realities. The main goal is granting safe reception, storage, distribution, preparation, administration, and devolution of the drug in CT, allowing the gathering of all the necessary data to fulfill the CFRs of the trial’s protocols, with respect to drugs.