Article Text

Download PDFPDF
Pharmaceutical care in the screening process of phase I oncohaematological clinical trials
  1. Rosa Rodríguez-Mauriz1,
  2. Monica González-Laguna1,
  3. Maria Perayre-Badia1,
  4. Toni Lozano-Andreu1,
  5. Maria Emilia Miquel-Zurita1,
  6. Salomé Cañizares-Paz1,
  7. Lorena Santulario-Verdú2,
  8. Marina Millan-Coll1,
  9. Sandra Fontanals1,3,
  10. Ana Clopés-Estela1,3
    1. 1Pharmacy Department, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona, Spain
    2. 2Pharmacy Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain
    3. 3Instituto de Investigación Biomédica de Bellvitge, Barcelona, Spain
    1. Correspondence to Dr Rosa Rodríguez-Mauriz; rosarmauriz{at}gmail.com

    Abstract

    Objective To determine the pharmaceutical interventions in patients eligible for phase I cancer clinical trials, focusing specifically on exclusion criteria related to medication or relevant interactions.

    Method Descriptive, observational study conducted at a comprehensive cancer centre. Patients undergoing screening for phase I clinical trials (March 2019–December 2022) were included. The pharmacist reviewed concomitant medication and provided a recommendation.

    Results The concomitant medication of 512 patients eligible to participate in 84 phase I clinical trials was analysed. In 230 (44.9%) patients, the clinical trial treatment included oral medication. The median number of concomitant medications was 5 (IQR 3–8) per patient.

    A total of 280 pharmaceutical interventions were performed in 140 (27.3%) patients: 240 (85.7%) were due to interactions in 124 (24.2%) patients, and 40 (14.3%) were due to exclusion criteria in 34 (6.6%) patients. Interactions and exclusion criteria were detected in 18 (3.5%) patients. The main groups of drugs involved were 68 (24.3%) antacids and antiulcer drugs, 28 (10.0%) antidepressants and 26 (9.3%) opioids. Acceptance analysis of the recommendation was applicable in 215 cases; in 208 (96.7%), the pharmaceutical intervention was accepted.

    Differences were identified for exclusion criteria (7 vs 27) and interactions (37 vs 87) between parenteral and oral clinical trial medication (p<0.001).

    Conclusion The pharmacist’s review of concomitant medication during the screening period in phase I clinical trials enables the detection of prohibited medication or relevant interactions, potentially avoiding screening failures and increasing the efficacy and safety of treatments.

    • ONCOLOGY
    • Clinical Trial
    • DRUG INCOMPATIBILITY
    • Drug Substitution
    • HEMATOLOGY
    • PHARMACY SERVICE, HOSPITAL

    Data availability statement

    Data are available upon reasonable request.

    Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.