Background There is great diversity in cooperation of pharmacy departments depending on the clinical areas of study and the investigational product (IP). Identifying the most common diseases in which clinical trials (CT) are conducted could allow the pharmacist to improve their clinical skills and provide quality pharmaceutical care (PC).
Purpose To identify the main areas of study of CT managed in the pharmacy department (PD) of a tertiary hospital and to analyse the implication of pharmacists in the management of CT medication.
Material and methods A retrospective descriptive study of the activity of the CT unit was conducted. CT initiated between 1 January 2014 and 15 October 2015 were included. We collected pathologies under investigation, clinical units involved, implication of the pharmacist and PD regarding the management and traceability of CT medication (including receipt, storage, preparation and dispensing). Information was obtained from internal records of the CT unit (Gidec) and from source documents and documentation of each study.
Results 197 CT were initiated (98 in 2014/99 in 2015). The main pathologies studied were solid tumours 47.2% (lung cancer 12.7%, breast cancer 10.7%), haematological malignancies 16.8%, pneumopathies 5.1% (CODP/asthma/cystic fibrosis) and nephropathies 4.1%. Clinical units involved were: oncology 46.7%, haematology 16.8%, uro-nephrology 6.6%, neurology and pneumology 5.6%, internal medicine 5.1%, paediatrics 3.6%, cardiology, gastroenterology and infectious disease units 2.0% and others 4.0%. The total number of CT samples was 541 (median=2/CT, 0–15). The receipt of CT samples was performed through IWRS (Interactive Web Response System) in 59.2%, through email/fax to monitor in 24.5% and with both methods in 14.3%. 55.3% of trials had samples stored at room temperature (15–25°C), 23.9% refrigerated (2–8°C) and 18.2% both types of storage. For 5 CT, medication was supplied by the hospital. Preparing cytostatic drugs blends in the pharmacy was required for 36.5%. 3 CT involved other drug preparations in horizontal laminar flow hood. Non-cytostatic medication was dispensed directly to patients in the PC consultation in most cases. In 30.6%, we dispensed the medication to the investigator group, and 10.2% were dispensations block.
Conclusion Onco-haematological pathology is the more predominant area of research. PDs play a key role in the successful development of new CT and work closely on a wide variety of activities, highlighting the preparation of CT medication and the PC provided to patients included in CT.
No conflict of interest
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