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IMPROVING INVESTIGATIONAL DRUG MANAGEMENT: AN INNOVATIVE PROCESS

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European Statement

Clinical Pharmacy Services

Author(s)

Francesca Vecchione, Melania Rivano, Patrizia Tadini

Why was it done?

The new process was developed in order to face the significant increase of ID management assigned to the Pharmacy, along with the logistic problems due to the several areas of storage, dispensing and administration. Additionally, it allowed to assure the effective use of ID reducing the risk of failure and improving the patient safety.

What was done?

The Good Clinical Practice guidelines establish that the principal investigator (PI) can delegate the investigational drug management to a pharmacist. In our university teaching hospital with a large amount of clinical trials (CT), pharmacy service proposed an optimisation of ID (investigational drug) management through the elaboration of a form to request the ID. Along with this, we assigned each protocol to a specific type of management and we created an intranet site from where healthcare professionals can download the form.

How was it done?

The pharmacy service created for each CT a specific form organized into 5 sections. Section A, B and C were filled up with protocol information (name, centre code, PI) patient data (initials, patient code) and the treatment schedule. Section C, completed by data manager, showed the quantity of drug to be dispensed and the expected day of administration. Section D was completed with batch and expiry date. The form had to be signed by the pharmacist at the moment of the dispensation and signed back by the committed person who took it. Section E reminded the type of management assigned to the protocol. Five different types of management had been identified, based on the characteristics of storage, the activities required by the protocol (IWRS, unblinded pharmacist, drug preparation) and the dispensing method.

What has been achieved?

Data from January to June 2017 attested 60 ongoing protocols, 722 dispensations for patient, 237 drugs prepared by pharmacists and 986 in Chemotherapy preparation unit. The development of the new procedure ensured the ID tracking, the overcoming of logistical difficulties and an increase of the safety.

What next?

We are going to keep on improving the pharmacist role in CT by ensuring ID are handled, stored and correctly managed. The objective is to enhance the collaboration of clinical research professionals in the management of CT.

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