Author(s)

D. Samitier; G. Domínguez; JM Montes; P. Ruíz; FJ. García; B. Torroba; C. Jiménez; M. Díaz; M. Guembe; A. Herranz; M. Sanjurjo

Why was it done?

A new standard operating procedure (SOP) was implemented, introducing frozen storage (-20 ºC) to enable large-batch preparation of vancomycin–heparin catheter lock solutions.

What was done?

Vancomycin–heparin lock solution is the most frequently prepared antimicrobial catheter lock in our institution. However, short expiration date limited its efficiency: batches of 16 syringes were prepared and stored under refrigeration (2-8 ºC), with a three-day expiry period, resulting in a high proportion of discarded units.
An in-house physicochemical stability study was carried out. It demonstrated that vancomycin–heparin lock solutions remain stable for up to 12 weeks when frozen and 7 days after thawing, a new preparation and storage protocol was established to optimize workflow, ensure availability and improve sustainability.

How was it done?

The new workflow was implemented in March 2025. Lock solutions (vancomycin 2 mg/mL + heparin 100 IU/mL) were prepared aseptically in 100-syringe batches, stored frozen for up to 3 months, and thawed in sets of 10 for daily use, assigning a 7-day expiry under refrigeration. Implementation required recalculating batch volumes, reorganising storage capacity and performing sterility testing.

What has been achieved?

A six-month comparison period (July–December 2024 vs. April–September 2025) showed that the number of locks prepared decreased from 1024 (64 batches) to 700 (7 batches), while administered locks syringes increased from 605 to 659. Discarded units were reduced from 419 (40.9 %) to 61 (8.7 %). Preparation time per batch increased from 22 minutes (16 locks) to 42 minutes (100 locks), but the overall production time decreased by 79.1 %, waste was reduced by 78.6 %, and the proportion of successfully used locks increased by 35 percentage points. The initiative show to reduce workload, improve product availability, and decrease environmental impact of pharmaceutical waste.

What next?

The frozen-storage strategy has been incorporated in routine practice and is being extended to other antimicrobial lock formulations. This initiative demonstrates how evidence-based stability data can be translated into practical and sustainable improvements in hospital pharmacy operations. The model is transferable to other healthcare settings, particularly those facing limited resources or high discard rates of these preparations.

Author(s)

Michal Kočí, Kateřina Grygarová

Why was it done?

Individualised bacteriophage therapy has not previously been used in the Czech Republic. A polymorbid patient was treated for over two years for recurrent spondylodiscitis caused by methicillin-resistant Staphylococcus aureus (MRSA). Despite various antibiotic regimens, the infection could not be controlled, leading to repeated hospitalisations. Based on international experience, the medical-head of the infectious diseases department asked the hospital pharmacy to procure a bacteriophage medicine active against the patient\’s specific pathogen.

What was done?

The objective was to analyse the legislative pathway and subsequently secure approval for, prepare, and administer individualised phage therapy as a salvage treatment for a patient with a chronic, antibiotic-resistant infection.

How was it done?

In collaboration with the infectious disease clinic and a domestic phage manufacturer, the optimal regulatory route was identified and an approval for using the active pharmaceutical ingredient containing bacteriophage for final drug preparation was requested from the Ministry of Health and the State Institute for Drug Control. The hospital pharmacy coordinated the entire submission process, overcoming regulatory and production challenges. Following approval, the pharmacy secured the delivery and developed a new Standard Operating Procedure (SOP) for the aseptic preparation of the phage lysate for intravenous administration.

What has been achieved?

After successfully obtaining all approvals, the pharmacy prepared and dispensed 35 intravenous infusions. Following the therapy, the patient has remained symptom-free for nine months and significant clinical improvement was observed. The infection is currently considered effectively treated, and no further infection-related hospitalisations have been necessary. This outcome demonstrates the successful implementation of a complex therapeutic strategy, from regulatory navigation to clinical application.

What next?

This pioneering initiative demonstrates that individualised bacteriophage therapy might be, in some cases, a feasible and safe option for patients with untreatable, multi-resistant infections. It highlights the crucial role of the hospital pharmacist in this process. Significantly, this first-in-country application sparked a nationwide expert debate and directly contributed to the establishment of a Ministry of Health working group on bacteriophages. This established pathway could be transferable to other Czech hospitals, and possibly even to other European countries.

Author(s)

David Ackermann
Dr. Judith Thiesen
Prof. Dr. Irene Krämer

Why was it done?

Recently we started batchwise preparation of 10 mL prefilled syringes (PFS) containing different active substances and concentrations using APOTECAsyringe. The syringes are automatically filled, capped, and labeled. However, layout and formatting of the inline printed labels (only black printing) needed improvement to avoid look-alike errors. Moreover, readability of PFS labels is compromised, since labels are wrapped around the syringes. Good labeling is absolutely necessary when norepinephrine (NE) 10 µg/ml, norepinephrine (NE) 100 µg/ml, and epinephrine (E) 100 µg/ml PFS are delivered in a set of three to be used in emergency cases. Erroneous identification of the PFS can have serious consequences for patients.

What was done?

Based on the national guideline and the international standard (ISO 26825) we decided to go for color-coded labeling and Tall Man lettering to maximize the difference between the two similar drug names. For E and NE the recommended label color is pink, on E labels the drug name is printed in pink on black background. Measures to enhance the readability of the labels were limited by the predefined size of the label and a scarce label assistant in the software.

How was it done?

Drug names and concentrations were printed in bold letters on the best visible part of the PFS label. The Tall Man lettering chosen was NORepinephrin and EPINEPHrin. To ease the identification of the two different NE concentrations, for NE 10 µg/mL a darker pink label was chosen and for NE 100 µg/mL the concentration was underscored. On E labels, the recommended black background was printed as bar beyond the drug name.

What has been achieved?

An optimized printing image of inline printed labels for pharmacy prepared NE and E PFS was successfully developed. The optimized labeling enhances readability of the PFS labels and contributes to reduced error rates in emergency cases.

What next?

Three months after implementation of the optimized PFS labels a survey among users is planned to evaluate the need for further optimization.

Author(s)

S. EL DEEB, I. BENNANI, A. CHERIF CHEFCHAOUNI, S. ALAOUI, S. HAJJAJ, S. BOUFARESS, S. EL MARRAKCHI, B. MOUKAFIH, F.Z. BANDADI, Y. HAFIDI, A. EL KARTOUTI.

Why was it done?

In the oncology pharmacy, isolators are vital for aseptic compounding and operator protection. However, daily handling steps can still introduce contamination risks and affect patient safety. We recognized the need to systematically analyse and minimize these risks, especially in a resource-constrained setting, to ensure safer and more standardized chemotherapy preparation practices.

What was done?

We applied Failure Mode and Effects Analysis (FMEA) to identify and reduce risks in isolator handling during chemotherapy preparation. The objective was to evaluate each step of the process, implement corrective measures to lower risk priority numbers (RPNs), and develop a practical model that could be shared with other hospital pharmacies.

How was it done?

An observational checklist was used to evaluate six key isolator handling steps: glove installation, surface cleaning, material transfer, logbook entry, waste removal, and glove removal. During 100 routine preparations, failures were recorded to calculate occurrence scores. Severity and detection were assessed by an interdisciplinary team, and risk priority numbers (RPNs) were obtained by multiplying severity, occurrence, and detection scores.

What has been achieved?

The analysis identified surface cleaning, material transfer, and glove installation as the most critical steps, with RPNs of 240, 210, and 144 respectively. These represented the main contamination and safety risks. After implementing targeted corrective actions, including improved procedures and staff awareness, we projected significant reductions in RPNs to below 80, confirming the effectiveness of the intervention.

What next?

We will continue to apply and monitor the corrective measures through updated SOPs, dedicated monitoring tools, and continuous staff training to ensure sustained improvement. This initiative offers a transferable model that other oncology pharmacies can adopt to harmonize practices and strengthen patient and operator safety in chemotherapy preparation.

Pdf

Author(s)

Jorge Esquivel Negrín, Amara Magdalena Pérez, Josephine Peña Hernández, Jenifer González Chávez, Carmen Lidia Díaz Díaz, Silvia González Suárez, Alba Domínguez Hernández, Jaime Muñoz Manrique, Esther González Carrillo, Pilar Díaz Ruiz

Why was it done?

PN is a high-risk preparation that carries a significant risk of iatrogenesis, making it essential for staff responsible for its prescription, validation, and preparation to be well-trained, and for a reliable quality assurance plan to be in place. Monthly quality indicators include errors by pharmacists during transcription to nutrition software, errors by technicians in tray preparation, and nursing errors during PN preparation. Acceptable monthly error thresholds were set at 2 for transcription, 25 for tray preparation, and 6 for sterile PN preparation. Additional activity indicators, such as the number of PN preparations per month, episode duration, and reasons for suspension, were also analyzed.

What was done?

A training program centered on audiovisual resources related to parenteral nutrition (PN) procedures was implemented in a tertiary hospital after a quality assessment within the PN department revealed a decline in certain indicators between 2020 and 2022. A shared folder with video tutorials covering various processes was made available to pharmacy staff, mainly intended for nursing staff and pharmacy technicians, who typically have high turnover rates between departments.

How was it done?

The indicators showed a steady increase in PN preparations, rising from 411±74 per month in 2020 to 475±51 in 2023, with a record of 634 preparations in March 2024. Notably, 18.1% of episodes in 2023 lasted over two weeks, partly due to the underutilization of home PN and a lack of hospital beds despite increased outpatient activity. Errors in tray preparation increased from 2020 to 2022, peaking in 2021. This coincided with high staff turnover and an increased workload. In response, the implementation of video tutorial training for rotating staff was introduced in 2022.

What has been achieved?

This initiative reduced tray preparation errors, which decreased to an average of 12±4.9 between January 2023 and March 2024.

What next?

These measures could be adapted and implemented in other departments within the pharmacy service. Regarding PN, we are now aiming to optimize the workload by promoting home PN, and implementing semi-automated systems such as barcodes and gravimetric control, which are also recommended to improve safety and traceability.

Pdf

Author(s)

Boglárka Lengyel
Nadine Haubenwalllner
Ingrid Sattlecker

Why was it done?

The global shortage of nursing staff increases the risk for medication errors due to higher workload and stress. The intravenous (I.V.)-service, launched in March 2020, alleviates nurses’ workload and minimizes application errors by standardizing concentrations and providing pharmaceutical training. Producing all infusions with producing pumps in the hospital pharmacy’s clean rooms improves microbiological quality and dosing accuracy. Standardized concentrations with defined stability and proper documentation practices ensure consistent quality.

What was done?

We implemented the production of patient-specific I.V.-infusions and total parenteral nutrition (TPN) for neonatal intensive care units (NICU) to meet the specialized needs of neonates and enhance individualized care. Additionally, pharmacy staff assembles patient infusion sets daily, focusing on Y-Site compatibility and catheter types tailored to each patient.

How was it done?

After discussing demand with physicians and nurses, data on NICU medications and dosages were systematically collected. Standard infusion concentrations were harmonized, considering fluid intake and physical-chemical stability. Protocols for automated compounding of continuous infusions and TPN were established, alongside standard operating procedures for additional volumetric preparation. I.V. compatibility of the drugs was researched, and compatibility tables were created.

What has been achieved?

The project successfully implemented individualized compounding of infusions and TPN with established standards in the hospital pharmacy’s clean rooms. Complete traceability and continuous monitoring during production ensure high product quality. The initiative enhanced interprofessional collaboration, strengthening confidence among physicians, nurses, and pharmacists and significantly reduced nurses’ workload for preparing medications, TPN, and assembling patient sets. The service currently supports five wards, producing an average of 98 infusions and TPN daily. The assembly of patient sets is provided for 44 care beds across NICU and Intermediate Care (IMC) wards, averaging 25 sets daily.

What next?

The service aims to maximize automated production by implementing new compounding pump plans, increasing output to supply more wards. Plans also include expanding the service to the Pediatric Intensive Care Unit (PICU), where both intermittent infusions and patient set assembly will be offered in addition to the existing continuous infusion supply.

Pdf

Author(s)

K. Koch, The Pharmacy of the capital region of Denmark, Quality, Herlev, Denmark
R. Højmark, The Pharmacy of the capital region of Denmark, non-sterile production, Herlev, Denmark
L.R. Duckert, The Pharmacy of the capital region of Denmark, non-sterile production, Herlev, Denmark
T. Schnor, The Pharmacy of the capital region of Denmark, production, Herlev, Denmark

Why was it done?

There is an interest in implementing more safe, affordable, and sustainable treatment methods for patients for whom a personalized approach is beneficial. These treatments can be expensive and associated with patient safety and compliance issues. For the pediatric population, many medications are not available in appropriate form or dose and therefore is being manipulated before administration. Extemporaneous oral solutions often have a limited shelf life and bad physical properties or undesirable excipients.
Patients with impaired renal function or need for accurate dose adjustments are also expected to benefit from 3D-printed orally disintegrating tablets (OTDs).

What was done?

The initial steps necessary before implementing 3D-printing for manufacturing personalized ODTs has been identified and completed. The clinical advantages and barriers of the personalized treatment has been discussed interdisciplinary and the new dosage form has been risk evaluated in dialogue with the competent authority. As a result, the best suited technology has been identified.

How was it done?

The European marked has been searched for technologies suitable for extemporaneous personalized production in hospital pharmacies. 3D-printed OTDs was identified as most easily implemented both concerning technology, GMP and patient acceptance.
A dialogue about risks and benefits regarding 3D-ptinted ODTs was initiated with the hospital staff. Risks identified concerned the number of drugs available for 3D-printing, the need for stability testing and resistance from authorities. Benefits like flexibility, just-in-time preparation and patient safety was identified.
A meeting was held with the competent authority, to establish the level of validation, documentation and analysis needed on the final product and starting materials.

What has been achieved?

The necessary steps to get started have been identified and completed. Risks and benefits were assessed, and the decision about implementing 3D-printed ODTs was made. An equipment that is reliable and automated has been sourced.
An API for the initial manufacture was selected, combining clinical relevance and adequate physical properties.
Ink/matrix for the 3D-printer was evaluated and found safe for medicines for children. The matrix is manufactured according to GMP.
A regulatory framework has been agreed upon with the competent authority.

What next?

Validation of the equipment and printing of the first ODTs to be used in the clinic.

Pdf

Author(s)

M. SIEGWART, A. BENDJAMA, D. KAROUBY, T. MARTIN, L. CITTADINI, MG. MARTINS, P. COLIAT

Why was it done?

Two automated preparation robots were implemented at ICANS in a context of increased activity in oncology, the need to maintain quality assurance in the preparation process and to reduce pharmacy technician’s exposure to cytotoxic agents. Preliminary professional training is crucial to understand this new technology, master the equipment and interfaces, and adapt to the new circuit and procedures.

What was done?

This work was the development of an educational virtual tour of an automated production unit, enriched by feedback, accessible to any professional interested in implementing an automated preparation robot.

How was it done?

The project was developed in collaboration with the Grand Est regional oncology network (NEON). Scripts were written based on a plan, detailing texts and scenarios to create short videos, each addressing a different theme with a voice-over narration. A professional team from NEON shot the film and edited according to the scripts. Location scouting and filming were completed over 3 days, with voice-over recording and editing done afterward.

What has been achieved?

Six scripts were produced. The first introduces the centre, while 4 others detail the management of an automated unit, including the organization and operation of storage areas, decontamination SAS, personal SAS, and the cleanroom (functional parameters, particulate class, airflow schema, dressing and hygiene rules, microbiological controls, cleaning, and the composition of the “breakage kit”). The robots are covered in a dedicated script that discusses the context of automation, their operation, the software used, possible interfaces, preparation procedures, and cleaning. The final script reviews the entire circuit, linking each area and stage of production: pharmaceutical validation, automated production management, material and vial preparation, manufacturing, and pharmaceutical release.

What next?

The virtual tour presents the circuit and the role of each involved personnel, highlighting precautions and subtleties compared to a non-automated circuit according to the most recent french guidelines. Although the practices shown may not be applicable to all centres due to differences in production area layouts, structures, staffing, and equipment, these videos aim to clarify the functioning of an automated unit while adhering to the guidelines. This online training can promote the standardization of practices, helping professionals from other centres install production automation systems. It encourages innovation and supports pharmacists during this critical transition.

Pdf

Author(s)

M.S. Nielsen, The Pharmacy of the capital region of Denmark, Clinical Pharmacy Rigshospitalet, Copenhagen, Denmark
S.L. Otnes; The Pharmacy of the capital region of Denmark, Clinical Pharmacy Rigshospitalet, Copenhagen, Denmark
M.H. Clemmensen, The Pharmacy of the capital region of Denmark, Clinical Pharmacy Rigshospitalet, Copenhagen, Denmark
L.R. Duckert, The Pharmacy of the capital region of Denmark, non-sterile production, Herlev, Denmark
T. Schnor, The Pharmacy of the capital region of Denmark, production, Herlev, Denmark

Why was it done?

Paediatric medicine has limited availability of on-label, age-appropriate formulations. Drug-related challenges encompass variability in dosing, use of tube administration, and the necessity for child-friendly approaches, including formulation issues as well as taste and acceptability of medications.

What was done?

A clinical assessment of the applicability of 3D-printed medicines from a paediatric perspective, with the limitations of the chosen technique.
The aim of this project was to identify specific areas where 3D-printed medicines provide viable solutions to the complexities surrounding paediatric drug-related challenges.

How was it done?

To minimize the need for individual medicine manipulation, we identified key challenges by reviewing the manufacturer’s API list and comparing it with nationally available compounded products. This analysis offered historical insight on the shortcomings of commercial products in addressing patient needs. Additionally, consultations were held with nurses and doctors in selected paediatric wards for further input.

What has been achieved?

Three key areas were identified where 3D-printed medicines could benefit paediatric wards:
Dosage: 3D-printed medicines enable patient-specific doses or customizable low doses, assisting dose tapering and minimizing dosing errors. However, for APIs with a wide therapeutic index, the dose should be aligned with commercially available products. Patients or APIs that frequently require dose adjustments are better suited to a mixture formulation.
Logistics: Individual packaging and room temperature storage offer advantages for travel and storage compared to liquid mixtures, which often require cold storage and are produced in larger, less flexible containers. Additionally, existing options like mixtures increases the risk of losing the entire dose supply at once.
Patient related inappropriate drug form: The 3D-printed tablets can be chewed or partially dissolved, facilitating administration for patients with swallowing difficulties. Additionally, it allows for customizable flavors, offering more flexibility than commercial products.
However, the technique does not yet address the need for medication administration via tubes, as it requires heating of the tablets, which can be hazardous when handled by untrained parents. Highlighting that 3D-printing should complement, rather than replace, existing options.

What next?

A prioritized and condensed list of APIs will be conducted based on the identified key areas and assessed by pharmacists, doctors, and nurses.
Appropriate wards will be selected for the pilot implementation of 3D-printed medicines.

Pdf

Author(s)

Saldaña Soria Raquel, Florit Sánchez María, Yunquera Romero Lucía, Fernández Martín Jesús, Gallego Fernández Carmen, Tortajada Goitia Begoña

Why was it done?

The aim of this protocol is to evaluate and quantify the cost saving of the optimisation of the use of emicizumab vials through repackaging into syringe under aseptic conditions.

What was done?

Emicizumab is indicated for routine prophylaxis of bleeding episodes in patients with hemophilia A. This drug has a significant economic impact, so it has been decided to initiate a protocol for the use of emicizumab in which it has been established to group patients and dispense pre-filled syringes of repackaged emicizumab for each patient, dividing the vials according to the patient’s dose in the syringes as a savings strategy.

How was it done?

Two male patients, aged 4 and 5 years, with hemophilia A, have been treated with emicizumab in our hospital from February 2022 to September 2024. A protocol was implemented consisting of dispensing repackaged pre-filled syringes of emicizumab (expiry date 7 days according to the Good Practice Guide for the preparation of medicines) to each patient, grouping the patients receiving treatment with emicizumab on the same day for dispensing and dividing the vial into syringes to adjust it to the recommended dose according to the Technical Data Sheet in a laminar flow cabinet.

What has been achieved?

This treatment would have cost 337.125,95€ from February 2022 to September 2024. However, since patients (grouped on the same day of the week) were dispensed repackaged emicizumab pre-filled syringes and emicizumab repackaging was performed under aseptic conditions, the total cost has been 168.562,98€. Therefore the cost savings would be 168.562,98€ (63.211,12 €/year).
In conclusion, this new way of working can allow us to save 63.211,12€ (43 vials of 30 mg) every year. For this reason, the repackaging could represent a significant economic saving in patients with hemophilia A, while contributing to maintaining the sustainability of the national health system.

What next?

We hope to include all patients from our hospital in the emicizumab optimization protocol to continue contributing to the sustainability of the national health system.