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IMPLEMENTATION OF A NORDIC NETWORK FOR 3D-PRINTING OF PERSONALIZED MEDICINES IN HOSPITAL PHARMACIES

European Statement

Production and Compounding

Author(s)

Maria Rautamo, M.R., Senior Pharmacist, PhD (Pharm), HUS Pharmacy, HUS Helsinki University Hospital and University of Helsinki, Helsinki, Finland, maria.rautamo@hus.fi
Mattias Paulsson, M.P., PhD, Deputy chief pharmacist, associate professor, Uppsala University Hospital, Uppsala, Sweden, mattias.paulsson@akademiska.se
Marija Tubic-Grozdanis M.T-G., Head of Clinical Trial Supply, PhD (Pharm), Pharmacy Department, University Hospital Center of Johannes Gutenberg-University, Mainz, Germany, marija.tubic-grozdanis@unimedizin-mainz.de
Randi Hamre Svendsen, R.H.S., M.Sc (Pharm), Hospital Pharmacies Enterprise, South-Eastern Norway, Oslo, Norway, Randi.Maria.Hamre.Svendsen@sahf.no
Rikke Stick Højmark, R.SH., M.Sc, The Pharmacy of the capital region of Denmark, Herlev, Denmark, rikke.stick.hoejmark@regionh.dk
Trine Schnor, T.S., M.Sc (Pharm), The Pharmacy of the capital region of Denmark, Herlev, Denmark, trine.schnor@regionh.dk

Why was it done?

During the last two years, pharmacies worldwide have started to introduce printing technologies, such as semi-solid extrusion, into pharmacy production to provide personalized doses in dosage forms that are easy to administer to children and workflows that are more ergonomic and safer for production personnel and nurses in healthcare units. However, the implementation of new technology and equipment has also revealed challenges regarding patient safety and qualification (e.g. stability, homogeneity, identification). The need for peer support in addressing and overcoming various barriers and obstacles, which everyone must resolve, has influenced the establishment of the network.

What was done?

In 2024, the members of the production group in the Nordic Pharmaceuticals Forum (NLF) established a collaborative network for the implementation of 3D-printing of medicines in hospital pharmacies. The focus of the collaboration is on production issues related to equipment, production processes and quality, as well as on clinical implementation.

How was it done?

Colleagues in the Nordic countries that could be interested in and benefit from potential collaboration around 3D-printing of medicines were identified and invited to a kick-off meeting held in November 2024. Criteria for joining the network include expertise in 3D-printing of medicines or involvement in planning or executing the implementation of 3D-printing into pharmacy production. During the 29th EAHP Congress in March 2025 colleagues from other European countries expressed their interest in joining the network. Since August 2025, the network has received valuable reinforcement and expertise from new members across Europe.

What has been achieved?

The network has expanded to include participants from 6 different countries who meet online 3-4 times a year. The topics discussed are the status of implementation and projects in the participating organizations, experiences and challenges, requirements from regulatory agencies and news from publications, congresses and webinars. The value gained for the individual members is the knowledge sharing and peer support among colleagues in an activity that is still very new and lacks specific regulations and guidelines.

What next?

The future goal is to expand our collaboration into scientific research by identifying relevant topics where our combined strengths can provide important new knowledge and insights for the entire European hospital pharmacy sector and, especially for future patients.

IMPLEMENTING AN ASEPTIC PROCESS SIMULATION FOR OPERATOR (RE)QUALIFICATION IN A HOSPITAL COMPOUNDING UNIT

European Statement

Production and Compounding

Author(s)

Sadaoui Talwit, Guicheron Gaëlle, Llari Tahina, Jolicart Maude , Bloch Vanessa, Delage Clément, Gasmi Linda, Belaid Imene

Why was it done?

Compounding sterile injectables carries a contamination risk, and sterility of extemporaneously compounded preparations cannot be verified afterwards. In line with national Good Compounding Practices (BPP 2023), we sought to formalise APS to assess and (when needed) rehabilitate operators’ aseptic technique while strengthening patient safety and quality assurance.

What was done?

We implemented an aseptic process simulation (APS; media fill) as a standardised pathway for initial qualification and requalification of operators involved in sterile injectable compounding. The APS challenges the process in worst-case conditions and provides documented evidence of aseptic competence.

How was it done?

We conducted a literature and practice review, including BPP 2023 guidance and NHS recommendations (“Universal Operator Broth Transfer Validation”), canvassed three French hospital pharmacies for return of experience, and selected commercial kits. We drafted a local SOP and protocol defining a worst-case scenario: simulated failure of the microbiological safety cabinet (work on a clean bench in a controlled area), without an assistant, and under real-life constraints. Each session was supervised by an evaluator; glove prints were taken on Count-Tact plates at the end of the run. All filled units were incubated for 14 days (7 days at 20–25 °C, then 7 days at 30–35 °C) with daily visual checks recorded in an electronic log, and final turbidity reading.

What has been achieved?

Four APS runs have been completed to date (pharmacist, pharmacy intern, and technicians), all compliant with no microbial growth detected. One technician remains to be tested due to scheduling constraints. The process now underpins our documented pathway for operator assessment and provides a basis for microbiological trending.

What next?

APS will be rolled out to all staff with annual requalification, and ad-hoc re-testing whenever there are changes to the process, critical equipment (e.g., MSC/BSC), or the classified cleanroom (e.g., grade change, layout/HVAC modifications), or when practice drift is observed. We will add structured behavioural/technical checklists to each run and track KPIs (pass rate, contamination rate, time-to-certification, observation deviations). Microbiological results (glove prints, environmental plates) will be trended with action thresholds, and APS will be complemented by routine observation-based assessments to ensure safe sterile compounding.

OUTSOURCING STERILIZATION SERVICES: A SUCCESSFUL COLLABORATION BETWEEN TWO FRENCH PUBLIC HOSPITALS

European Statement

Production and Compounding

Author(s)

T. SANKAR, O. LASNE, E. REMY, G. BRETOT
CENTRE HOSPITALIER INTERCOMMUNAL ELBEUF-LOUVIERS-VAL DE REUIL, PHARMACIE – STERILIZATION, SAINT-AUBIN-LÈS-ELBEUF, FRANCE.

Why was it done?

Without outsourcing, HA’s sterilization department would have closed, jeopardizing surgical interventions and patient care. Therefore, the collaboration with HB was chosen as a cost-effective solution because private providers were expensive. The aim of the initiative was to guarantee continuous sterilization services, maintain patient safety, and ensure uninterrupted surgical activity despite the renovation.

What was done?

The sterilization department of Hospital A (HA) must make renovations to comply with standards. During six weeks of renovation work in 2024, a temporary outsourcing initiative was implemented to guarantee the continuity of surgical and care activities. During this time, the sterilization was subcontracted to Hospital B (HB), located 50 km away and operating with similar activity profile.

How was it done?

A formal agreement defined the activity volume, distribution of resources, responsibilities, and invoice procedures. Anticipated challenges included logistics, equipment shortages, management of urgent requests, and maintaining instrument-level traceability. These were addressed through regular communication with hospital management, technical services, and end-users. A site visit and staff meetings prepared the teams. IT department enabled secure remote access to maintain full traceability. In practice, washing in washer-disinfectors and preparation of surgical sets were performed at HA, followed by three daily shuttle transports to HB, where sterilization was carried out by three HA agents working on-site.

What has been achieved?

The initiative ensured:
• Complete maintenance of instrument traceability.
• Processing of 207,310 instruments, either individually or as part of surgical sets, over six weeks.
• An average turnaround time of 24 hours.
• No surgery cancellations, no instrument loss/breakage, and no major logistics incidents, only minor same-day delays of some surgeries.
• A total cost of €71,977 for transport and subcontracting
• High satisfaction: 17/18 service beneficiaries and 12/13 staff judged the experience positively.

What next?

This initiative demonstrates that inter-hospital cooperation, even across different hospital groups, is feasible and safe to manage temporary shutdowns. The initiative maintained high standards of quality while optimizing costs. Its success relied on strong preparation, effective communication, and staff commitment. This model can be transferred to other healthcare settings facing similar situations, offering a sustainable alternative to private outsourcing.

OPTIMIZING ASPIRIN DESENSITIZATION WITH A PHARMACY-PREPARED ORAL SUSPENSION

European Statement

Production and Compounding

Author(s)

LYG Lidia Ybañez García, VPG Virginia Puebla García, ERS Estefanía Rosón Sanchez, NSO Natalia Sánchez Ocaña, JCV Javier Corazón Villanueva, MTO María de la Torre Ortiz, TBG Teresa Benitez Gimenez.

Why was it done?

Dual antiplatelet therapy with clopidogrel and ASA is standard for acute coronary syndrome and post-stent patients. ASA hypersensitivity occurs in approximately 1.5–2.6% of coronary patients, requiring rapid desensitization. The previous capsule-based protocol involved up to 10 strengths in batches of 100 capsules, many of which were discarded.
A literature search identified only capsule-based protocols or preparations made from dispersible tablets at the ward. To minimize the risk of errors from bedside manipulation, we developed a pharmacy-prepared oral suspension from the active ingredient, allowing centralized, standardized, and safer compounding.

What was done?

A new ASA desensitization protocol was implemented using an extemporaneous pharmacy-prepared oral suspension. It replaced multiple-strength capsules, which were laborious to produce and generated considerable waste. The suspension allowed faster preparation, simplified administration of incremental doses (standardized in the protocol), and offered a more patient-centered approach. It also eliminated the need for ward-based dilutions from dispersible tablets, enhancing safety through centralized pharmacy preparation.

How was it done?

A bibliographic review (RUESA, PubMed, SEFH, Compounding Today, Trissel’s) and analysis of existing protocols were conducted. No suitable aqueous formulations were available, and oily preparations were discarded due to poor palatability. The suspension was prepared according to national pharmacy compounding and quality guidelines.
Composition: ASA 100 mg, glycerin 3 g, carboxymethylcellulose gel 1.5% (35 mL), and purified water q.s. to 100 mL (1 mg/mL). Stable for 24 hours, packaged in individualized oral syringes

What has been achieved?

Since 2017, thirteen patients (median age 83, eight males) have undergone desensitization using the oral suspension. All tolerated the process, allowing initiation of ASA therapy. Compared with the previous protocol, the new approach is faster to prepare and administer, reduces waste, simplifies the process, and maintains patient safety and treatment effectiveness. Centralized preparation eliminated bedside dilutions and enabled safe, standardized incremental dosing.

What next?

This initiative highlights the role of hospital pharmacists in developing practical solutions to optimize patient care. The approach is easily transferable to other hospitals facing similar challenges with ASA desensitization

MODERNIZING CYTOSTATIC PRODUCTION: A DATA-DRIVEN APPROACH TO DECISION-MAKING FOR SELECTING A COMPOUNDING SYSTEM

European Statement

Production and Compounding

Author(s)

Stefanie Fuchs, Michele Tadiotto

Why was it done?

Compounding cytotoxic therapies in hospital pharmacies is a complex and safety-critical process. As part of a planned modernization of the production site, which handles around 40.000 preparations annually, the project was launched to investigate the impact of integrating an automated compounding technology (ACT).
This project also provided decision-makers with structured, data-driven insights to support the selection of the most appropriate technology for the specific production needs.

What was done?

A comprehensive analysis to identify the most suitable ACT for our chemotherapy production was conducted.
The approach taken was twofold: first, production data was used to run simulations, allowing for the evaluation of how the different ACTs would perform in our environment.
Second, interviews with international ACT users with hands-on experience were conducted to gather valuable, pragmatic insights.

How was it done?

A detailed examination of the production data was conducted, assessing each ACT’s compatibility with our portfolio (approx. 100 chemotherapy substances). Customized MS-Excel calculation sheets were developed and used to cross-reference drug-specific production metrics (for each drug: total annual preparations, average production time, average transferred volume, other critical parameters). Based on this analysis, the drugs best suited for compounding with each ACT candidate were identified.
Simulations were then run to compare theoretical performance both against current manual compounding and among ACT candidates.
Additionally, the information collected during the interviews was used to develop a comprehensive evaluation of process impacts including: maintenance of quality standards, personnel requirements, potential contamination risks, software integration, microbiological and cleaning aspects, and GMP compliance requirements.

What has been achieved?

This dual methodology enabled a robust evaluation of both theoretical and practical aspects of each system.
Critical technical limitations that could hinder system applicability were identified and the potential proportion of the total compounding workload realistically manageable by ACTs was assessed.
Furthermore actionable, data-driven insights were collected and provided to decision makers to guide strategic decisions.

What next?

The findings are tailored for management decision-makers, enabling them to select the ACT best suited to the pharmacy’s needs without requiring in-depth pharmacy expertise.
Additionally, the methodology from this project can serve as a replicable framework for other hospital pharmacies interested in adopting an ACT.

ADAPTA: ADAPTED ORAL DRUG FORMULATIONS FOR PREANESTHETIC USE IN CHILDREN WITH AUTISM SPECTRUM DISORDER

European Statement

Production and Compounding

Author(s)

Carlota Mestres Gonzalvo
Juan José Lázaro Alcay
Ángela Pieras López
Marta Duero Adrados
Carlos Javier Moreno Pérez

Why was it done?

Children with ASD frequently reject standard oral medications due to sensory sensitivities, which increases distress and drives the use of invasive routes (intramuscular and/or intravenous), undermining safety, family wellbeing, and perioperative efficiency. Current forms are not adapted to ASD needs; the aim is to maximize acceptability and minimize distress through patient-friendly formulations and calming environments, ensuring equitable, high‑quality preanesthesia care.

What was done?

The project is creating and preparing to clinically evaluate novel, palatable oral formulations—such as sensory-friendly gummies—co-designed by hospital pharmacists, anesthesiologists, and university formulation experts using advanced flavor–texture modification. In parallel, dedicated sensorial rooms with direct street-access entry, adjustable lighting and sound, and tactile comfort features are being incorporated to reduce overstimulation during preanesthetic preparation.

How was it done?

The first phase addresses obstacles such as heterogeneity in ASD sensory profiles and stringent pharmaco-technical and safety requirements. The team is overcoming these through stakeholder engagement with families, sensory mapping, iterative prototyping with in‑house stability and sensory testing, and multidisciplinary collaboration for rapid, compliant development. Hospital infrastructure supports integration, regulatory documentation, and implementation of sensorial rooms and staff training.

What has been achieved?

A multidisciplinary team has been established, equipment and consumables planned, and formulation development initiated, alongside design parameters for sensorial rooms and workflow integration. Expected outcomes include improved medication acceptance, reduced preanesthetic distress, fewer invasive interventions, greater perioperative efficiency, and higher staff confidence in ASD care, with internal dissemination and readiness for pilot evaluation.

What next?

The ADAPTA initiative is developing tailored oral drug formulations and implementing sensorial rooms to improve preanesthesia care for children with autism spectrum disorder (ASD), integrating pharmaceutical innovation with patient-centered strategies in a multidisciplinary hospital setting.
ADAPTA represents good practice by uniting pharmaceutical innovation with environmental and behavioral adaptations, offering a scalable, replicable model for inclusive pediatric anesthesia. Next steps include completing prototype validation, pilot clinical and sensory acceptability studies within sensorial rooms, standardizing operating procedures, and preparing for scale‑up across additional services and pediatric populations.

FIRST TOPIC GENE THERAPY FOR PATIENTS WITH BULLOUS EPIDERMOLYSIS: RECONSTITUTION OPTIMISATION

European Statement

Clinical Pharmacy Services

Author(s)

Manon Dumoulin, Pharmacy
Caroline Chirk, Pharmacy
Claire Jouans, Pharmacy,
Sylvain Auvity, Pharmacy
Robert Ratiney, Pharmacy
Lamia Haï, Pharmacy
Scarlett Wise, Pharmacy

Why was it done?

This initiative began in March 2024, when patients started treatment.
The necessity of optimizing reconstitution was apparent quickly, to absorb activity increase.
The goal was to optimize reconstitution steps, in terms of time dedicated (human resources) and syringe quality (volume, bubbles quantity).

What was done?

Reconstitution of this first topic gene therapy (GT) consists of mixing the active substance (AS) with the gel excipient and drawing four syringes per vial, total volume 2ml.
Extractable volume is less than 2.5ml due to gel viscosity, making it complex to extract final syringe.
This topic GT is applied weekly, which makes it a time-consuming activity impacting the pharmacy’s advanced therapy medicinal product department.
As a result, the most efficient ways to manipulate the vials have been identified.

How was it done?

All manipulators trained on factice vials to apprehend gel texture. This dry run phase allowed identification of reconstitution process key steps.
Manipulator pairs were followed for 6 months: data on each step was collected (duration, reconstitution tips).

What has been achieved?

Reconstitution process is cut down to four steps: thawing (a), AS and gel mixing (b), vial resting (c) and syringe drawing (d).
a) Keep the gel vial right side up: avoids gel accumulation on the septum when punctured.
b) Use an air intake device; avoids overpressure in the vial and syringe.
c) Gel vial should rest at least 5 minutes after being mixed with AS. When more than one vial is reconstituted, prioritize mixing step in a series: increases vial resting time.
d) Draw syringes right side up: avoids gel loss on vial sides. When volume is adjusted, inject gel excess in the vial while needle bevel in the air: prevents injecting bubbles in the remaining volume.
Data collection on steps duration showed a learning curve for all manipulator pairs. Reconstitution duration for 3 vials decreased by 10 minutes after 3 reconstitutions. Each pair arrived up to an incompressible duration: 1 hour for 1st vial (bio-cleaning, dressing) and 20 minutes more for each additional vial.

What next?

Training videos are being created to highlight key steps for reconstitution campaigns.
Process and time standardization, allows fluid organization of a complex activity and improves production efficiency.

OPTIMISATION OF AN IN VITRO RED BLOOD CELL LABELLING PROTOCOL WITH TECHNETIUM-99M FOR THE DETECTION OF GASTROINTESTINAL BLEEDING

European Statement

Production and Compounding

Author(s)

Y Fardo, J Verdier, F Al Shoukr, A Maget, E Verrechia, G Rondelot, S Ben Mahmoud

Why was it done?

An optimisation of an in vitro labelling protocol for red blood cells (RBCs) with technetium-99m (Tc-99m) for the detection of gastrointestinal bleeding was carried out. The initiative aimed to improve a reference protocol that did not achieve the expected labelling yields under local working conditions. By systematically testing several modifications to the protocol parameters, the variables influencing labelling efficiency were identified, and adjusted conditions were defined to obtain satisfactory and reproducible yields.

What was done?

The implementation of existing reference protocols regularly resulted in labelling yields below expected values around 50–60% instead of more than 85%, which limited diagnostic reliability. The objective was to identify the key variables that significantly affected yield, with the aim of optimising the protocol parameters to achieve higher and more consistent results suitable for routine hospital practice

How was it done?

The standard in vitro RBC labelling CNHIM procedure was used as the baseline. Forty-one experimental runs were performed, testing variations in pyrophosphate dilution, centrifugation forces, and agitation times. The resulting labelling yields were recorded and analysed by multiple linear regression to quantify the impact of each parameter on the overall efficiency.

What has been achieved?

Statistical analysis indicated that decreasing both pyrophosphate concentration and centrifugation force during the washing step of unbound Tc-99m significantly improved the yield (+37.0% and +17.2%, respectively). The other tested parameters showed no significant effect. The optimised protocol, diluting reconstituted pyrophosphate at 1:400 and applying a centrifugation force of 700 g during separation steps, consistently achieved labelling yields above 95%.

What next?

This initiative demonstrates that a simplified and reproducible labelling protocol can improve efficiency and reliability in the detection of gastrointestinal bleeding, without increasing procedural complexity. These findings could be easily applied in other hospital laboratories using in vitro RBC labelling.

GALENIC DEVELOPMENT AND STABILITY EVALUATION OF AN ORAL SUSPENSION OF CLOBAZAM FOR THE TREATMENT OF LENNOX-GASTAUT SYNDROME

European Statement

Production and Compounding

Author(s)

A. Telma Leal, António Daniel Mendes, Teresa Cunha, Paula Barbeita, Patrocínia Rocha

Why was it done?

Lennox-Gastaut syndrome is a severe, drug-resistant epilepsy with childhood onset, characterised by irregular brain activity, cognitive impairment and behavioural changes. Given its complexity and major impact on quality of life, therapy requires continuous adjustment, possibly involving valproate, clobazam, lamotrigine, rufinamide, topiramate, felbamate or cannabidiol.
No clobazam formulations are commercially available for paediatric use and data on extemporaneous oral formulations are limited. Regarding this, stability evaluation is essential to ensure quality and safety before therapeutic application.

What was done?

Galenic development, preparation and stability evaluation of a Compounded Formulation (CF) with clobazam for paediatric treatment of Lennox-Gastaut syndrome and other refractory epilepsies.

How was it done?

Development began with a literature review on the pharmacological and physicochemical properties of the drug, followed by election of an oral liquid formula.
Two samples were prepared and assessed for physical stability by an internal protocol on days 7, 14, 21, and 28: one (CF1) stored at Room Temperature (RT) <25 °C, the other (CF2) refrigerated (2–8°C).

What has been achieved?

Based on our findings, a clobazam suspension was designed using xanthan gum as a suspending agent, with pH around 5. According to literature-reported shelf lives and usage periods of CF and raw materials, one batch was refrigerated and the other stored at RT. Also, CFs were prepared at 1 mg/mL concentration (suitable for Paediatrics), packaged in 100 mL type III amber glass bottles and the final product should be whitish suspensions, homogeneous after shaking, with pH around 4–6.
Evaluation showed CF1 developed microbiological contamination on day 14, with gas, fermented odour and pH 6–7 by day 21, then 5–6 (day 28). Other features — sedimentation time, dispersibility, homogeneity and crystal growth—remained normal. CF2 kept colour and appearance until day 28. Mold odour occurred at day 21. pH rose from 6–6.5 to 6.5–7 after day 14. Other parameters remained normal.

What next?

Clobazam CF proved to be suitable for paediatric Lennox-Gastaut syndrome or refractory epilepsy use. Stability evaluation demonstrated physical appropriateness for up to 14 days under refrigeration; for longer use is not recommended.

ARE YOU SURE HOW MANUFACTURERS WORK IN THE HOSPITAL PHARMACY CLEANROOM? THE USE OF TWO SIMPLE CHECKLISTS

European Statement

Patient Safety and Quality Assurance

Author(s)

Susana Redondo-Capafons, Laura Soriano, Carmen Roger, Oriol Arroyo, Raquel Mayoral, Ana Morales, Andrés Reyner, Marta Rueda, Rosario Bueno, Mónica Gómez-Valent, Andrés Joaquim Reyner

Why was it done?

In aseptic cleanroom environments, correct donning and doffing of personal protective equipment (PPE) and adherence to hand hygiene protocols are essential to prevent contamination and ensure both patient and operator safety. Despite existing standard operating procedures (SOPs), interindividual variability in compliance often remains undetected, increasing the risk of deviation from aseptic standards. Our pharmacy department identified the need for a practical tool to systematically monitor and improve these critical procedures. With the aim of continuous improvement in clinical practice and service quality, and in the context of incorporating new staff into the cytotoxic preparation area, this initiative was developed.

What was done?

Two structured checklists were designed and implemented to evaluate compliance with SOPs:
1. Donning and doffing of PPE – assessing sequence, technique, and timing.
2. Hand hygiene – assessing product use, duration, and areas of the hands washed.

How was it done?

The checklists were based on international guidelines (WHO, GMP) and local SOPs. Trained observers performed random assessments of pharmacy technicians during routine cleanroom entry and exit. Each step was scored for compliance, and procedure times were recorded.

What has been achieved?

The use of checklists enabled objective, individualized assessment of compliance. The mean compliance score for donning and doffing PPE was 9.4 ± 0.8, while for hand hygiene it was 8.9 ± 1.2. The 100% of pharmacy technicians acquired the minimum score established in the procedure (7/10). The main issues identified were related to the location where PPE was removed (17%), the duration of hand washing (25%), and the volume of alcohol-based hand rub used (42%). These findings guided targeted retraining sessions and continuous quality improvement actions. This approach increased awareness among staff and promoted more consistent aseptic practices in daily operations.

What next?

The checklists have been integrated into routine training and quality monitoring. They are easy to replicate in other hospital pharmacies with cleanroom facilities, requiring minimal resources. The initiative provides a model to strengthen aseptic procedures, reduce contamination risks, and enhance overall compliance with safety standards.