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Securing the management of experimental product in investigator services in case of non-nominative dispensing: a risk based approach

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European Statement

Patient Safety and Quality Assurance

Author(s)

Mélanie Hinterlang, Mona Assefi, Pauline Glasman, Delphine Brugier, Meriem Charfi, Fanny Charbonnier-Beaupel, Marie Antignac, Carole Metz

Why was it done?

Clinical trials in critical care sometimes demand swift inclusion and administration, often occurring at any hour of the day or night. To enhance patient care, the experimental drug may be provided in a non-nominative manner directly from the pharmacy unit to the care unit for storage before any inclusion as a stock. This dispensing pathway is considered less secure than the conventional named dispensing but can be necessary. The objective of this risk analysis for this dispensing process was to identify the risks, determine the number of them with unacceptable criticality, and propose actions to reduce criticality of these risks.

What was done?

A risk analysis of non nominative dispensation of experimental drugs process was conducted to streamline, secure, optimize, and standardize this dispensing process.

How was it done?

Following a preliminary investigation, three pilot services were chosen: surgical intensive care, post-interventional recovery room (SSPI), and cardiology. The Failure Mode, Effects, and Criticality Analysis (FMECA) method was applied to the non-nominal dispensing circuit of experimental drugs from reception at the pharmacy unit to the administration of the drug to patient. Investigators, clinical research associates, nurse, and pharmacists participated.

What has been achieved?

Following the FMECA, 281 risks were identified. The majority were either acceptable (123 or 44%, 110 or 39%, 147 or 52%) or tolerable (139 or 49%, 148 or 53%, and 130 or 46%) for the intensive care, SSPI, and cardiology services, respectively. Unacceptable risks numbered 19 (7%), 23 (8%), and 4 (1%) for intensive care, SSPI, and cardiology services, respectively. The process identified as most critical for all three services was communication. After risk prioritization, a plan comprising 17 actions was implemented.

What next?

This risk analysis demonstrated that control over the non-nominal dispensing circuit is achievable. Once the actions are in place, a reduction in criticality is anticipated due to a decrease in the frequency. Theoretically unacceptable risks are now at 0%. In the long term, this project has the potential to participate to improve the care of patients enrolled in emergency clinical trials and boost research in the concerned units.

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