The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
Assessment of the safety of advanced therapy medicinal products (ATMP) process: a tutorial video creation module
European Statement
Patient Safety and Quality Assurance
Author(s)
Chloé JADOUL, Audrey DURAND, Rémy TORDJEMAN, Isabelle MADELAINE, Romain de JORNA
Why was it done?
With the development of advanced therapy medicinal products (ATMPs), a specific pharmaceutical process is necessary to secure the handling of genetically modified organisms. Gene therapy includes Chimeric Antigen Receptor T (CAR-T) cell therapy as well as clinical trials with oncolytic viruses and nucleic acids. Limited experience on these new activities and high staff turnover based on resident pharmacist explain the need of additional training material to supplement written procedures. Multimedia support seems to be the most appropriate didactic tool.
What was done?
The objective of this work is to create pedagogical tools as short video clips. The final aim is to standardise hands-on training in order to improve ATMPs circuit safety.
How was it done?
All steps of each activity were listed and filmed in order to create a video database. Clinical trial mock preparations were performed to create the clinical trial tutorials whereas CAR-T cell activities were filmed in real conditions.
Clipchamp (Microsoft) video editing software is used to create tutorial videos. Repetitive parts were edited once and reused for other videos. They are part of the database videos.
As a validation, all staff members’ approbation was required.
What has been achieved?
Activities include, to this day, five gene therapy clinical trials and the CAR-T cell activities: reception, shipment to the pharmaceutical hub, thawing and distribution.
We filmed 55 step clips and edited six repetitive parts. Finally, eight tutorial videos were created: three for clinical trials and four for different CAR-T cell activities.
To make the training more meaningful, we made dynamic videos that last no more than 5 minutes. The average time of a tutorial was 2 minutes 17 seconds.
What next?
The tutorial videos bank is created to be dynamic and can be easily adjusted. Videos of repetitive parts will be reused for new clinical trials implementation. These video tutorials allow new resident, student or technicians to be trained faster and in a more innovative way. They also allow permanent teams to benefit from a quick refresh. In order to assess the efficiency of this new process, next operators will have to read the procedure, watch the videos and will be evaluated in practice.
Development of method for mobile aseptic preparation of advanced therapy medical products
European Statement
Production and Compounding
Why was it done?
The pharmacy received a request for reconstitution of an ATMP Luxturna. The pharmacy or hospital did not have a suitable aseptic facility that could perform the reconstitution in a way that allowed the ATMP to be administered to patients before the expiry after reconstitution (max. 4 hours).
What was done?
Development of a single use isolator for advanced therapy medical products (ATMP) or gene therapy drug preparation was undertaken. The single use isolator had to be mobile to enable pharmacy staff to preform reconstitution directly on ward or in OP-theatre. It had to comply with Health and Safety regulations and at the same time make it possible for pharmacy staff to use aseptic technique to be able to reconstitute ATMP.
How was it done?
A review of isolator technology was performed, and a suitable solution identified. The set-up was further developed in a team with representatives from pharmacy, the eye department at Rigshospitalet-Glostrup. A manufacturer of the equipment was selected, and development performed. The set-up for ATMP preparation was presented to The Danish Health and Safety (DHS) department responsible for handling this type of treatment. The approval was granted after a standard 90-day period. Pharmacy staff were trained in working with the set-up and a dry run made in the eye theatre with the full surgical team.
What has been achieved?
10 patients (19 eyes) have been treated, 4 male and 6 female patients with age span 12-39 years. After having performed the procedure twice there was enough routine to treat 2 patients per theatre day hence reducing the cost of preparation and increasing efficiency of the team.
The pharmacy and surgical team have established a great working relationship and now consider the set-up as routine.
In spring 2021 the set-up was approved by (DHS) for reconstitution of Zolgensma. On July 1 a pediatric patient was treated with Zolgensma using the method.
What next?
Plan to develop the method further and make it available for coming preparations of ATMPs and share knowledge of the method with other hospital pharmacy organizations.
THE EXPERIENCES OF A UNIVERSITY HOSPITAL MEDICATION PREPARATION UNIT IN COVID-19 PANDEMIC
European Statement
Clinical Pharmacy Services
Author(s)
Sinem Şeker Şimşek
Why was it done?
In terms of medication and patient safety, to establish a safe non-cytotoxic medication preparation process, to ensure continuity of well-educated and motivated pharmacy staff are the key elements of pharmacy-based medication preparation units. This work aimed to share our experiences about how to be challenged with the risk in the drug preparation process during the pandemic as a university hospital pharmacy centered non-cytotoxic medication preparation unit.
What was done?
We have taken general precautions recommend by the World Health Organization. However, the protocol we have used to prepare Lopinavir/Ritonavir, Preparation of Hydroxychloroquine sulfate, Favipiravir and Hydroxychloroquine sulfate with Simple Syrup, Preparation of intravenous drugs (Tocilizumab)
How was it done?
The preparation of solid oral dosages, which should be administered to intubated Covid-19 patients through a nasogastric tube, was prepared by the ready to administration team of our pharmacy.
There is no evidence-based data on the bioavailability of these enteric-coated tablets after being crushed and administered to these vulnerable patients. The biggest challenge was lack of the reliable medication information sources. Before starting the Covid-19 medications preparation process, possible risks that could arise if crushed administration of these drugs were evaluated with a multidisciplinary team.
What has been achieved?
We suspended the Lopinavir/Ritonavir with dextrose during the preparation phase. We preferred the lavage syringe for intravenous administration risk elimination through ensuring patient and drug safety by preventing the risk of intravenous administration of the diluted suspended drug we have prepared. However, when we used a 3-way infusion manifold the strain during pushing and easy disconnection of the joints thus the risk of dose loss were the disadvantages.
What next?
The two pillars of dealing with the COVID-19 epidemic, which has affected the whole globally, are the proper preparation of the necessary medicines for treatment and the treatment itself. Drugs were prepared in line with the search for “a practical solution immediately” and the directives of the Ministry of Health and successfully administered to the patients. Our study is noteworthy as it shows that drugs can be prepared not only by the default ways but also by the different methods