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DEVELOPMENT OF A CENTRALIZED CLINICAL TRIALS UNIT: THE STRATEGIC IMPORTANCE FOR HOSPITAL PHARMACY

European Statement

Clinical Pharmacy Services

Author(s)

Mafalda Cavalheiro 1
Joana Simões 1
Carolina Marques 1
Patrícia Batalha Silva 1
Miriam Capoulas 1
Cláudia Santos 1
1 – Pharmacy Department, Hospital da Luz Lisboa, Portugal

Why was it done?

Due to the connection with the clinical area and innovation, trials in our pharmacy services were previously assigned to each pharmacist specialized in the corresponding therapeutic area. In the beginning of 2024, the increasing number of clinical trials, coordination and investigational drug management challenges emerged and proved that the previous model was inefficient. Our aim is to develop a centralized unit that is the key to coordinate pharmaceutical activity and improve patient care in clinical trials. In addition to dispensing process, pharmacists become responsible for ensuring therapeutic reconciliation, patient education and treatment adherence, improving medication safety.

What was done?

During a time of continued growth in clinical trials number, it was defined as a pharmacy services’ goal the creation of a centralized clinical trial unit. Additionally, the need to structure a pharmaceutical consultation has arisen.

How was it done?

The process unfolded in three phases: team structuring, logistical reorganization and consolidation of the pharmaceutical care process. A lead pharmacist was appointed as coordinator, supported by a backup and three pharmacists in oncology and three in non-oncology. The major limitation was the establishment of the pharmaceutical team and their training for the several ongoing trials. The unit was reorganized into a larger area, including workstations, medication storage and a meeting room. The pharmaceutical consultation was structured into an initial evaluation and follow-ups. During the first consultation, the pharmacist conducts patient assessments, medication education, toxicity management information and drug/herbal interactions checking. Follow-up consultations focused on medication dispensing, compliance, adverse effects and patient concerns.

What has been achieved?

The centralized unit currently manages 66 clinical trials (37 oncologic; 29 non-oncologic). Seven oncologic trials regularly include pharmaceutical consultations, representing an average of 10 appointments per month. Given the benefits of pharmaceutical intervention, particularly in terms of increased adherence, reports of drug safety and compliance, the importance of this centralization is clear.

What next?

Due to logistical challenges, pharmaceutical consultations have only been implemented for oncologic oral medications. With the robustness of the centralized unit, the next goal is to expand pharmaceutical consultations to oral non-oncologic trials, following the successful model used for oncologic trials.

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