Skip to content

FIRST INDIVIDUALISED BACTERIOPHAGE INTRAVENOUS TREATMENT OF A PATIENT IN THE CZECH REPUBLIC

European Statement

Production and Compounding

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.

ROBOTIC SYSTEM FOR THE PREPARATION OF NON-HAZARDOUS STERILE INTRAVENOUS MIXTURES IN A PHARMACY SERVICE

European Statement

Production and Compounding

Author(s)

Trapero-Asenjo E, Palacios-Martínez M, Andrés-Picazo M, Cañizares-Martín A, Negro-Vega E, Molina-García T.

Why was it done?

The Pharmacy Service has a centralized mixing unit (CMU) for the preparation of non-hazardous sterile intravenous mixtures, 66,759 units in 2024 (62.8% are standardized mixtures (SM)), an increase of 20% over the last decad.
The available technological solutions were evaluated, selecting a 100% robotized system in a controlled atmosphere (class A environment) with laminar airflow, which performs the entire process of preparation, labeling and waste management, with traceability of users and products. This implies improvements in patient safety, reducing variability in dosing, labeling errors and minimizing microbiological contamination; also preventing repetitive strain injuries among production staff.

What was done?

Incorporation of a robot designed for preparing non-hazardous sterile intravenous mixtures within the CMU.

How was it done?

First, compliance with ISO14644-1 standards and European Union Good Manufacturing Practices was verified. SM were analyzed to identify those susceptible to robotization: repetitive and standardized work, availability in vials and final packaging in bags/syringes. The initial project included 7 antibiotics, 83% of the total SM, one of which was excluded for technical reasons. The cleanroom work instructions and staff roles were reviewed and redefined. Internal control of aseptic conditions was carried out through environmental testing and microbiological stability testing of test batches until after the physicochemical stability period and preparation times were recorded.

What has been achieved?

10 antibiotic preparations were included. Of these, 108 samples were microbiologically analyzed with negative results except for one bag contaminated during inoculation. Based on these results, the shelf life was extended to physicochemical stability according to the literature, allowing for an increase in maximum stock.
This has freed up nursing time, facilitating the logistical management of clean rooms: stock control, staff organization and incident resolution. In addition, this has enabled the standardisation of new preparations as clindamycin, folinate and vedolizumab.

What next?

· To increase the robot’s profitability
– Increase robot operating hours (maximum 20-22 hours/day).
– Batches with more units and use of bulk vials: minimization of robot assistance and preparation time.
· Parameterization of new SM (ustekinumab) and inclusion of high-risk drugs (morphine, norepinephrine).
· Increase in service portfolio, such as the creation of consultation rooms for the administration of drugs dispensed in outpatient consultations.

POST-CONSTRUCTION CLEANROOM COMMISSIONING AND OPERATIONAL IMPACT: A COMPLIANCE-DRIVEN APPROACH TO USP STANDARDS

European Statement

Production and Compounding

Author(s)

Natalie Kuchik PharmD, MS, BCSCP and Jacalyn Rogers PharmD, MS, BCPS, CPEL, FASHP and Victoria Lubarsky RPh, MBA., BCACP

Why was it done?

Due to evolving and increasingly stringent USP requirements, multiple cleanroom construction and renovation projects were necessary to ensure continued compliance. These upgrades were critical to maintaining sterile compounding capabilities, keeping pharmacy operations uninterrupted, and safeguarding patient care.

What was done?

Each cleanroom underwent a structured post-construction commissioning process, including environmental certification, workflow validation, staff re-training, and installation of continuous monitoring systems. Pharmacy operations were strategically coordinated to minimize disruption during each phase.

How was it done?

Third-party experts conducted ISO-class environmental testing and microbial sampling. Pharmacy teams performed workflow simulations to assess layout and aseptic technique. Updated SOPs were implemented, and staff received targeted training. Real-time monitoring tools were installed to track pressure, temperature, and particle counts.

What has been achieved?

All renovated cleanrooms achieved full USP compliance prior to go-live. Pharmacy operations remained efficient, with no delays in patient care. Staff confidence improved, and workflow efficiency increased by 25%. No adverse events or regulatory citations were reported.

What next?

We plan to develop a standardized cleanroom commissioning protocol for future projects and share it across our hospital network. Ongoing monitoring, periodic revalidation, and continuous staff education will support sustained compliance and operational excellence.

ARTIFICIAL INTELLIGENCE CHATBOT FOR SAFE PREPARATION OF CHEMOTHERAPY AND TARGETED MEDICINES

European Statement

Production and Compounding

Author(s)

C.BAORAKSA1, T. WONGWIAN2.
1UDONTHANI HOSPITAL, UDON THANI, THAILAND.
2QUEEN SAVANG VADHANA MEMORIAL HOSPITAL, CHONBURI, THAILAND.

Why was it done?

MedMixBot is an AI-based chatbot developed to assist hospital pharmacists in the safe preparation of chemotherapy and targeted medicines. It provides rapid access to validated information on reconstitution, dilution, stability, and storage through the LINE Official Account platform.

What was done?

MedMixBot is an AI-based chatbot developed to assist hospital pharmacists in the safe preparation of chemotherapy and targeted medicines. It provides rapid access to validated information on reconstitution, dilution, stability, and storage through the LINE Official Account platform.

How was it done?

The chatbot was constructed using Google Sheets as a dynamic database and Google Apps Script for automated data retrieval and user interaction. Pharmacists can type or select a drug name to instantly receive validated preparation instructions, supported by PDF notes and concise video clips. The content was reviewed by three oncology pharmacists using the Item Objective Congruence (IOC) method to ensure validity and accuracy. The prototype was then piloted among five hospital pharmacists who provided usability feedback for refinement.

What has been achieved?

MedMixBot currently includes ten chemotherapy and targeted medicines:Amivantamab, Antithymocyte globulin (ATG) test dose, Azacitidine, Bortezomib, Brentuximab, Cabazitaxel, Decitabine, L-asparaginase test dose, Paclitaxel protein bound, Trastuzumab emtansine, . IOC values exceeded 0.6, indicating acceptable content validity. User evaluation demonstrated high satisfaction, with an average score of 4.4/5. Pharmacists reported faster access to reliable preparation guidelines and decreased reliance on fragmented or outdated resources. The chatbot facilitated consistent practices and supported real-time pharmaceutical decision-making, contributing to improved safety and workflow efficiency.

What next?

Future development will expand the drug database and integrate MedMixBot into hospital electronic systems for seamless data linkage. The chatbot will also serve as a learning and training platform for pharmacy students and practitioners. This innovation represents a scalable digital solution that enhances safety, efficiency, and quality in oncology pharmacy practice.

FIVE YEARS OF A BIG CONTRIBUTION FOR THE SMALLEST AMONG US – THE IMPLEMENTATION OF AN INTRAVENOUS-SERVICE ON NEONATAL INTENSIVE CARE UNITS BY THE HOSPITAL PHARMACY

Pdf

PDF Icon

European Statement

Production and Compounding

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.

3D-PRINT OF ORALLY DISINTEGRATING TABLETS – HOW TO GET STARTED

Pdf

PDF Icon

European Statement

Production and Compounding

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.

VIDEO CONTENT: FEEDBACK ON THE IMPLEMENTATION AND THE MANAGEMENT OF AN AUTOMATED CYTOTOXIC PRODUCTION UNIT

Pdf

PDF Icon

European Statement

Production and Compounding

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.

COST SAVINGS ASSOCIATED WITH EMICIZUMAB REPACKAGING IN PEDIATRIC PATIENTS WITH HEMOPHILIA A

Pdf

PDF Icon

European Statement

Production and Compounding

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.

STOCK PRODUCTION OF INTRAVITREAL SYRINGES OF BEVACIZUMAB RANIBIZUMAB AND AFLIBERCEPT

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

MC. SÁNCHEZ ARGAIZ, A. TRUJILLANO RUIZ (presenting author) , M. GALLEGO GALISTEO, A. VILLA RUBIO, E. CAMPOS DÁVILA

Why was it done?

Weekly consultations are held for the administration of intravitreal injections, serving around 50 patients per week. To optimize preparation and ensure efficient use of vials, we implemented a system to repackage pre-filled syringes, taking advantage of the drugs’ physico-chemical stability for up to 28 days. This centralized process, handled by the hospital pharmacy, follows Good Manufacturing Practices (GMP) for sterile medicines, ensuring quality and efficiency.

What was done?

We established a production process to repackage intravitreal anti-vascular endothelial growth factor (anti-VEGF) drugs, specifically bevacizumab, ranibizumab, and aflibercept, for use in ophthalmic treatments such as age-related macular degeneration (AMD), retinal vein occlusion (RVO), and diabetic macular edema (DME).

How was it done?

The preparation process for intravitreal injections was reviewed to improve batch traceability. A literature review was conducted on the physicochemical and microbiological stability of bevacizumab, ranibizumab, and aflibercept. Based on the GMP risk matrix, intravitreal injections were classified as high-risk. Batch preparation protocols were developed for these three drugs, and microbiological control measures were put in place to ensure aseptic handling and product quality. All processes were validated according to regulatory standards, including environmental, instrumental, and maintenance controls.

What has been achieved?

By standardizing batch protocols for bevacizumab, ranibizumab, and aflibercept, we have significantly reduced the weekly workload and optimized the use of anti-VEGF vials. We strictly follow national guidelines for validating aseptic techniques in intravitreal preparation and have thoroughly trained our technical staff.

What next?

This practice is recommended for broader implementation in hospital settings, as it provides significant cost savings while maintaining high-quality and safe treatments for patients. Looking forward, we aim to expand this approach to include emerging therapies such as faricimab, ensuring that our repackaging protocols can adapt to new treatments as they become available, maintaining both efficiency and patient safety in line with evolving clinical practices.

IMPLEMENTATION OF CPFARMA® SOFTWARE TO OPTIMIZE THE MANAGEMENT OF MAGISTRAL FORMULATION IN A TERTIARY UNIVERSITY HOSPITAL

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Castejón Grao, I; García Zafra, V; RodrÍguez Morote, M; Jiménez Pulido, IP; Andujar Mateos, A; Murcia López, AC.

Why was it done?

The pharmacist is responsible for magistral formulations in hospitals. Paper-based methods can lead to errors so the software was integrated between 07/2022-06/2023 aiming to reduce human errors,optimize preparation times,standardize procedures,improve stock management, formula traceability and enable statistical analysis capabilities of the area.

What was done?

CPFarma® software was implemented to control the programming, preparation, validation, and dispensing of magistral formulas. It facilitated proper management of the processes involved in galenic preparations at a tertiary-level university hospital.

How was it done?

The implementation of CPFarma® software involved the following stages:
1. Creation of user accounts and permissions.
2. Introduction of active pharmaceutical ingredients and raw materials, including batch and expiry details.
3. Inclusion of packaging materials,tools and required clothing for each preparation.
4. Transfer of Standard Operating Procedures(SOPs) in three phases:
4.1. Integration of the original SOP for each formula.
4.2. Revision and validation of SOPs and associated calculations.
4.3. Determination of active and passive SOPs.
5. Association of patient information sheets.
6. Drafting of a programme use protocol.
7. Training personnel on software use.
8. Validation in daily practice situations.

What has been achieved?

Until August 31, 2024, 249 SOPs (averaging 85 monthly) have been incorporated into the database, 74,7%(186) active and 25,3%(63) passive status, standardizing procedures. The system also includes 67 primary packaging materials and 275 components (185 active ingredients,16 base formulations and 74 excipients), improving stock control.
A total of 1279 magistral formulas have been prepared and validated by a pharmacist:54%(693) for usual stock,40%(510) for specific patients and 6%(76) with no record available. Each formula includes a preparation guide that includes detailed records to ensure traceability, such as patient information,prescriber details and preparation order number. There is also a computerized recipe book with histories filterable for statistical analysis.
No human errors have been detected in the preparation since the program’s implementation, and the patient information sheet helps prevent medication errors.

What next?

Efforts are being made to improve the system by adding features like a barcode reader for batch entry and registering personnel that dispense and collect medication. CPFarma® has optimized magistral formulation management, so Pharmacy Services without specialized software could benefit to improve their practices through its implementation.