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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.

90% reduction of medication waste by reusing returned medication from medical wards

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European Statement

Selection, Procurement and Distribution

Author(s)

Douwe van der Meer, Peder Nygard

Why was it done?

In our hospital 30% of the daily distributed medication for individual patients was not administered. Reasons for not administering were for example lack of need because of patients clinical performance, discontinuation of prescriptions or early discharge. Because of safety concerns, like mix-ups, our standard procedure was to discard all returned medication. This resulted in a waste of about 220.000 pills annually.

What was done?

We reduced medicine waste by 90% by reusing returned medication from our medical wards. With this result we made an important step for our hospital to meet the national sustainability goals in the Dutch ‘Healthcare Green Deal (3.0)’.

How was it done?

Reusing returned medication brings multiple safety concerns. By performing a prospective risk analysis we identified three major risks: mix-ups, expired medication and accepting non-qualitative packages (like slightly opened blisters or incomplete labels). With these risks identified we redefined our distribution process on four key elements: 1) Every medication has a barcode on unit level and if not, is labelled by our team through duplicating the ‘Falsified Medicine Directive’-barcodes to small 2D barcode labels which includes expiration date. 2) All returned medication is checked by a pharmacy employee on major quality aspects. 3) Returned medication is placed in a separate ‘return-box’ in front of the original stock inside the distribution cabinet. 4) Expiration dates are checked more frequently and are checked upon distribution and administration through barcode scanning.

What has been achieved?

The new distribution process was implemented in all of our eight distribution cabinets and resulted in saving 90% of the returned medication; witch amount to 200.000 pills and 70.000 euro savings annually. On average we work with 6 employees daily, who need 15 minutes extra per person per day to process returned medication.

What next?

Our goal is to save all returned medication that meets our quality standards. 5% of the returns that are not reused are medicines not included in the assortments of the specific distribution cabinet, so extra logistic and administrative steps are needed to place them back in the pharmacy stock. We are exploring new ways to make this next step in reducing medication waste further.

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