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IMPLEMENTATION OF INFUSION LINE INTO PATIENT-SPECIFIC DOSES DURING CENTRALISED COMPOUNDING

European Statement

Patient Safety and Quality Assurance

Author(s)

E. Bredenberg, M. Knuutila-Jerkku, P. Halonen, E.W. Gröndahl

Why was it done?

On the ward, attaching infusion lines to cytotoxic doses is performed alongside busy clinical work, often resulting in delays. Centralised attachment of infusion lines to patient-specific cytotoxic doses in the hospital pharmacy cleanroom streamlines the chemotherapy workflow. It also enhances medication safety by improving the quality of ready-to-administer doses compared to the previous attachment practices on the ward.

What was done?

In Turku, patient-specific cytotoxic doses are prepared for administration in the hospital pharmacy’s centralised compounding unit, located in EU GMP-compliant cleanrooms. This ensures aseptic preparation and emphasises occupational safety. As part of this project, we included Cytoset Line® infusion sets pre-filled with saline into patient-specific cytotoxic doses during the centralised compounding process in the cleanroom.

How was it done?

To improve medication safety in chemotherapy, we held a multidisciplinary review of the process, consulted other hospitals for their practices and experiences, and assessed the stability of pre-attached infusion lines compared to non-attached doses.

The process of filling Cytoset Line® infusion lines with saline was introduced to pharmacists. The integrity of the closed infusion system was tested by adding caramel colour dye to the infusion bag. The effect of clamp placement was tested by positioning it at different points along the filled line. Caramel colour leakage into the line indicated insufficient sealing.

What has been achieved?

Performing the line attachment in a Grade A cleanroom improves aseptic conditions and reduces the risk of microbiological contamination. Occupational safety is enhanced by minimising nurses’ exposure to cytotoxic agents. Centralised preparation optimises the use of personnel resources. Correct placement of the clamp below the infusion port is critical in preventing contamination.

What next?

Expansion of the practice to other hospital units

Assessing the feasibility of attaching infusion lines to doses intended for extended storage

Standardising processes: adopting uniform infusion lines across all oncology units (requirement for pre-attached infusion lines)

COORDINATING A NATIONAL MEDICATION SWITCH FOR FABRY DISEASE: LESSONS FROM A COMPLEX IMPLEMENTATION

European Statement

Selection, Procurement and Distribution

Author(s)

Line Jarvig MSc Pharm.
Christine Dinsen-Andersen MSc Pharm.
Aysegül Sekeroglu MSc Pharm.

Why was it done?

The national Health Technology Assessment (HTA) institute in Denmark issued its first recommendation on medicines for the treatment of Fabry disease based on four therapies considered clinically equivalent. Only one therapy was recommended due to cost. This recommendation initiated a national implementation effort, led by pharmaceutical staff, to support a correct and efficient medication switch to the recommended therapy.

What was done?

A pharmacist coordinated the implementation of the medication switch, in collaboration with the hospital with the national responsible for the treatment of Fabry disease, the hospital pharmacies, and the regional drug committee.

How was it done?

Coordination of the implementation strategy was carried out through virtual meetings and email correspondence. The implementation was based on a robust data foundation and was highly prioritised by hospital management. Representatives from the hospital pharmacies in the patient’s home region were included in the information flow to ensure optimal pharmaceutical inventory management at local hospitals. Furthermore, the pharmaceutical supplier was thoroughly informed regarding the timeline and expected drug consumption.

What has been achieved?

This case demonstrates that even complex medication switches can be successfully implemented when there is clear managerial support, detailed coordination, and strong engagement from all involved parties. It also highlights that there is no standard model for implementation, and that adaptation to local conditions is essential.

Drivers identified as contributing to the complexity of the implementation:

  • Patients’ usual treatment was managed at regional hospitals, while the switch was conducted by the hospital with the specialised treatment responsibility.
  • Detailed planning of treatment and pre-switch paraclinical examinations was required.
  • Most patients had to switch treatment, including a change from oral to intravenous therapy.
  • Early planning was necessary to meet supplier requirements for consumption estimates.
  • Estimating drug use was complex due to the planned full switch over an estimated period.
  • High drug prices required close monitoring of drug inventories to minimalise medication waste.

What next?

The switch is being monitored to ensure continued adherence. Experiences gained form this case will be applied to future switches, with planning focused on early identification of complexity drivers and strategies to manage them.

CLOSED-LOOP DIGITAL TRACEABILITY OF DOSE BANDING BAGS

European Statement

Production and Compounding

Author(s)

Paola Cristina Cappelletto, Linda Cappellazzo

Why was it done?

Ensure complete digital tracking in closed-loop of batches and expiry dates of anticancer drugs prepared in dose banding. Software Medical80© must be able to identify quickly the batches of the drug and solvent used to prepare the bag in dose banding and administered later to a specific patient, following a medical prescription.

What was done?

In 2018, the Pharmacy Unit of Bolzano Hospital introduced automated preparation of fixed-dose anticancer drugs (gemcitabine, paclitaxel, rituximab, pembrolizumab) using Apoteca Chemo© [3]. Until now, the batches prepared have been partially tracked by the Bolzano hospital’s internal software (Indaco©). In 2025, new software called Medical80© was purchased. To digitalise the entire process of prescribing cytostatic drugs by the departments, it was developed a complete batch tracking in closed-loop within the Medical80© software including also dose banding preparations. The hospital pharmacist collaborated with the software developers to ensure a safe and complete batch tracking system, in accordance with current regulations [1] and pharmacovigilance requirements [2].

How was it done?

The pharmacist responsible for the galenic area coordinated the activity. Initially, she requested the coding of dose banding preparation within a national database to assign a unique code to each preparation. Specific records for the individual bags prepared in dose banding were then coded, both in the warehouse software and in the prescription and medical record software. The codes automatically assigned by the warehouse programme were then entered into Medical80©.

What has been achieved?

This process has enabled to fully track batches and check stock levels directly from the prescription and validation software. Once the batches have been set up, labels were printed and affixed to the bags, and the technician loaded the preparations into Medical80©, recording the batch and expiry date of the starting drug. This information was also recorded and tracked through barcode. At the time of prescription, the bag set up in advance was associated and tracked until administration to the patient.

What next?

Complete tracking from preparing dose-banded bags to delivery to the patient, ensured safe dispensing of the cytostatic drugs. The future goal is to digitalise the load of batches prepared in dose banding using an optical scanner in Medica80©.

OPTIMIZATION OF PEGASYS® DOSING THROUGH SYRINGES IN THE HOSPITAL PHARMACY: ENSURING SUPPLY DURING A GLOBAL SHORTAGE

European Statement

Selection, Procurement and Distribution

Author(s)

Torres-Pérez, Andrés
Iglesias-Valín, Ana Rut
Mateos-Salvador, María
Fernandez-Gabriel, Elena
Feal-Cortizas, María Begoña
Fernandez-Diz, Clara
Gómez-Costa, Eva
Caeiro-Martinez, Laura
Margusino-Framiñán, Luis

Why was it done?

An individualized dosing procedure for Pegasys® (peginterferon alfa-2a) was implemented, using syringes adjusted to the prescribed dose. The primary aim was to guarantee continuous and safe patient treatment during the global shortage, while also optimizing the use of 90 µg vials.

What was done?

In 2024, a worldwide supply disruption of Pegasys® occurred, creating a risk of treatment interruption for hematology patients. Since many prescriptions were below 90 µg, direct vial use caused significant drug waste and aggravated the shortage. A fractionation system was developed, combining coordinated workflow and a risk-based stability assignment, to ensure continuity of care for all patients with the additional benefit of reducing economic impact. The project started on 21 October 2024 and remains ongoing.

How was it done?

A structured workflow between hematology and the hospital pharmacy was established. After each medical visit, the hematologist contacted the pharmacist responsible for the hematology outpatient clinic, who reviewed the prescription and informed the compounding pharmacists of the preparation schedule and updated doses. Syringes were filled under aseptic conditions, stored at 2–8°C protected from light, and delivered to the hematology pharmacy clinic the day before dispensing.
The 30-day stability was assigned according to the hospital’s risk assessment matrix, supported by published stability data from similar products. The process was internally validated in line with hospital compounding standards.

What has been achieved?

To date, the strategy has allowed treatment of 18 patients, with 332 syringes obtained from 90 µg vials, the majority of which corresponded to 45 µg or lower doses. This approach achieved a 51% reduction in the number of vials used, representing savings of €20,791.
Most importantly, no patient experienced treatment delays or interruptions, ensuring therapeutic continuity and safe handling during the global shortage. No stability issues or administration-related problems were reported.

What next?

The protocol will be maintained in our hospital and could be adapted by other centers facing similar shortages. This experience highlights the key role of hospital pharmacists not only in cost management, but above all in the guarantee of safe and continuous access to essential medicines.

READY FOR TAKE-OFF : CROSS-BORDER DRONE LOGISTICS FOR EMERGENCY AND DISASTER RESILIENCE

European Statement

Selection, Procurement and Distribution

Author(s)

Sarah Veldeman, Katrin Kootz, Thomas de Haas, Emma Palmen, Marnik Stragier, Andreas Follmann

Why was it done?

Emergency and disaster situations put extreme pressure on hospital pharmacy capacities. Rapid and reliable transport of critical medical supplies between institutions can improve resilience of hospital pharmacies across borders. The EDEN-Medical project aims to establish a cross-border drone network connecting hospitals and emergency medical services in Germany, Belgium and the Netherlands.

What was done?

This study aims to identify relevant use cases for urgent drone transport of medical goods and to integrate both hospital and prehospital perspectives into the project process.

How was it done?

Structured interviews (n=24) were conducted with key stakeholders in three countries (Nl, B, DE). Participants included representatives from hospital pharmacy, laboratory, anesthesiology, intensive care, emergency departments, crime response teams, surgical team, pathology and logistics. Interviews were analyzed to develop a catalog of potential use cases , also specifying transport conditions ( temperature, vibration, weight and volume). In addition , a qualitative focus group with prehospital professionals explored opportunities, barriers and requirements for system integration in emergency care.

What has been achieved?

Hospital stakeholders identified 24 potential use cases for drone transport, ranging from medication and blood products to surgical kits and tissue samples. Next cases were directly relevant : defibrillators, blood products and pharmacy emergencies. The prehospital focus group confirmed the relevance of these scenario’s, while emphasizing barriers such as regulatory limitations, telemedical challenges and interoperability.
The EDEN-Medical study highlights the potential of drone logistics.

What next?

Next steps will be deploying logistical capacity with drone partners, exploring legal issues concerning inter-country transport of medical products, blood and medication. The further development of the use cases will lay the groundwork for future pilot operations and integration into both emergency and disaster response systems.

INTEGRATED STRATEGY FOR THE MANAGEMENT OF MEDICINE SHORTAGES: INFORMATION, COORDINATION AND PATIENT SAFETY

European Statement

Selection, Procurement and Distribution

Author(s)

N. El Hilali Masó
B. García Javier
R. Merino Mendez
M. Sancho Riba
A. González Bote
J. Fabregas Cortes
R. Diez Hernandez
F. Sala Piñol

Why was it done?

Medicine shortages are increasingly frequent and represent a critical challenge for hospital pharmacy services. These shortages can impact both the procurement and use of medication, potentially compromising patient safety. The introduction of alternative presentations or therapeutic options may lead to errors, particularly dosing errors or issues related to look-alike/sound-alike medicines.
Furthermore, the growing number of outpatient referred from community pharmacies due to shortages increases the pressure on hospital pharmacies and may delay treatment access for patients.

What was done?

Define a system that unifies and updates information on shortages and ensure accurate and timely communication of therapeutic alternatives and associated risks to healthcare professionals and reduce the risk of medication errors associated with alternative drugs. Likewise, a communication channel has been established to strengthen coordination with community pharmacies for the dispensing of medicines to outpatients.

How was it done?

An internal file was created to monitor active shortages and available alternatives for both inpatients and outpatients. When a substitution posed a risk related to prescribing or administration (e.g. dosage errors or look-alike/sound-alike) informative sheets were developed as a preventive measure to reduce medication errors.

What has been achieved?

Unify and update available information. 55 medicine shortages were actively managed through the implemented system. Three information sheets have been prepared to prevent administration errors (nitroglycerin, amiodarone, cotrimoxazole). Pharmacist staff have rapid access to validated information that allows healthcare professionals to take faster and safer clinical decisions. This has also improved collaboration with community pharmacies to enhance the outpatient access to needed medicines, reducing delays and patient burden.

What next?

Integration with the new hospital IT system will enable automated alerts and direct access to therapeutic alternatives through Pharmacy program.
Plans are in place to expand the network of collaborating community pharmacies, allowing patients to collect medicines locally during shortages, reducing unnecessary hospital visits and improving continuity of care. Monitoring and evaluation processes will be established to track the impact of this strategy on patient safety and healthcare efficiency.

OPTIMIZING HOSPITAL PHARMACY STOCKS WITH CC-MPC (CHANCE-CONSTRAINED MODEL PREDICTIVE CONTROL) APPROACH

European Statement

Selection, Procurement and Distribution

Author(s)

S.Hajjaj,I.Bennani, S.Alaoui, A.cherif Chefchaouni ,S.El Deeb,S. Boufaress, Y.Hafidi, S.ElMerrakchi,F. Bandadi, B.Moukafih,A.El Kartouti

Why was it done?

Hospital pharmacies frequently face drug shortages due to unpredictable demand, long lead times, and budget constraints. Traditional reorder point policies are insufficient for handling stochastic consumption, and shortages can impact patient care. Applying predictive and probabilistic control methods allows for optimized decision-making, reduces unnecessary orders, and ensures higher service levels.

What was done?

A predictive inventory management framework based on CC-MPC is being developed and assessed through simulation to optimize hospital pharmacy stock levels under uncertainty .

How was it done?

The approach combines:
1. Data collection: Weekly consumption data of strategic drugs over a defined period, including average delivery times and historical stockout events.
2. Probabilistic modeling: A normal distribution is used to characterize demand uncertainty, with mean (μ) and standard deviation (σ) based on historical consumption data.
3. CC-MPC model parameterization: includes Safety stock thresholds, probabilistic stockout risk levels, constraints (storage,order, operational and economical) adapted to the hospital’s context.
4. Prospective simulation: generates optimized ordering plans over 6–12 month horizons, using rolling-horizon updates.
5. Practical integration: daily recalculation of optimal orders based on updated consumption data.

What has been achieved?

Based on previous simulation studies, the CC-MPC approach has the potential to reduce the number of orders by 40% and average stock levels by approximately 10%, while preventing stockouts over extended periods. Estimated annual budget savings ranged from 1 000 € to over 27 000 €, highlighting the possible benefits of implementing this predictive framework in hospital pharmacies.

What next?

Once the method tested and data collected,the next step is to transform the method into a software application, which can be integrated into pharmacy operations. This program is designed for practical hospital use. It aims to optimize stock management under real-world conditions.

SMART ACCESS TO TRANSLATED SMPCS: A QR CODE MODEL FROM A MAJOR ITALIAN UNIVERSITY HOSPITAL

European Statement

Selection, Procurement and Distribution

Author(s)

Calzavara E. (author); Battistutta C.; Zanella E.; Venturini F.

Why was it done?

Imported medicines are often used during national shortages or when certain drugs are unavailable in Italy. These products frequently lack documentation in Italian or English, increasing the risk of prescribing errors. To address this gap and enhance patient safety, the system was introduced in early 2024, providing immediate access to translated information at the point of care. Moreover, this system helps split packs with many doses.

What was done?

The Hospital Pharmacy of the University of Padua developed and implemented a system where imported medicines are labelled with a QR code linking to the Summary of Product Characteristics (SmPC) translated into Italian. Translations are generated using automatic tools and reviewed by pharmacists for accuracy. The QR code, placed directly on the packaging, allows healthcare professionals to access the translated SmPC instantly via mobile devices. Since 2024, 128 imports have been made, with labels created for 6 drugs: Catapresan tablets (Germany), Lysine Acetylsalicylate IV and Suxamethonium IV (Portugal), Rifampicin tablets and Neostigmine IV (India), flecainide IV (Japan).

How was it done?

Translations are stored on a secure internal cloud system. Each QR code, affixed by the Pharmacy to the medicine box, links directly to the corresponding SmPC translation. It was challenging to link translations to a QR code, but after several attempts, we succeeded using a specific cloud function. If there are any doubts about the translation’s accuracy, wards are warned to consult the original SmPC or contact the Pharmacy.

What has been achieved?

Requests from wards for SmPC translations have significantly decreased. This is particularly impactful when dealing with medicines labelled in non-Latin scripts (e.g., Chinese, Greek, Japanese), which can delay interpretation and increase the risk of medication errors, especially in urgent situations where rapid access to information is critical. The initiative has proven cost-effective, scalable, and beneficial to both safety and workflow. It offers a replicable model for other hospitals dealing with imported drugs.

What next?

A shared cloud folder is being created, containing both original and translated SmPCs, organized by internal code and drug name. This will allow staff to quickly retrieve documents using a simple search. A satisfaction survey will soon assess the system’s effectiveness from the wards’ perspective.

IMPROVING THE SAFETY, USE AND WASTE OF CONTROLLED MEDICATIONS IN SAN IGNACIO UNIVERSITY HOSPITAL

European Statement

Patient Safety and Quality Assurance

Author(s)

Pinzon Garcia, Viviana Andrea
Fajardo Escolar, Angelica Paola

Why was it done?

Since implementing the Opioid Stewardship Programme in 2018, we have improved the management of morphine and hydromorphone in our hospital. This has not only reduced medication waste, but also created a hospital culture that recognises the importance of standard single-dose in ensuring medication safety. Based on this, we extended the programme to include other controlled medicines, after identifying the need to limit the use of vials and ampoules of fentanyl, remifentanil and ketamine considering the available commercial presentations and the probability of using these products on multiple patients without maintaining their sterility.

What was done?

We extended the coverage and monitoring of the unit-dose system to include other controlled medications apart from morphine and hydromorphone, through interdisciplinary collaboration between the Anaesthesia and Pharmacy Departments, with the aim of reducing waste and the risk of misuse at San Ignacio University Hospital, a high-level hospital in Bogotá, Colombia.

How was it done?

As part of the annual Pharmacy and Therapeutic Committee operative plan, the pharmacy and anaesthesia departments evaluated the risks in the medication order cycle of opioids and other controlled medications, defining strategies using an improvement cycle model. We assessed the feasibility of preparing unit doses of these medications, as well as the storage, preservation conditions and logistics of medication inventory. We deployed the strategy through staff training, mainly in operating rooms, intensive care and resuscitation, and established a follow-up of consumption and adherence, records of remnant disposal, cases of naloxone use and events reported to the pharmacovigilance programme.

What has been achieved?

The average proportion of standard single-dose prescriptions in 2025 was 74% for hydromorphone, 77% for morphine, 84% for fentanyl and 50% for remifentanil. Through our compounding center, we prepared 143,854 doses of these medications in 2024 and 78,421 from January to August 2025. The inventory write-off percentage due to expiration was 1.06% in 2024 and 0.38% in the first eight months of 2025. The percentage of hospitalised patients who received naloxone was 0.20 in the first semester of 2024 and 0.17 in the first semester of 2025.

What next?

Conducting interdisciplinary rounds in services to identify on-site adherence to implemented practices and supportting Human Talent, maintaining the improvement cycle process.

UDI-BASED END-TO-END TRACEABILITY: A SMART APPROACH TO MEDICAL DEVICE MANAGEMENT

European Statement

Patient Safety and Quality Assurance

Author(s)

Andrea Piovanelli, Ivan Schimmenti, Enrico Almici, Paola Crosasso, Fabio Genestrone, Elena Toniato

Why was it done?

Medical devices’ traceability is a critical issue in hospital settings due to the high cost of devices and the need to associate item-patient-procedure. Standardized identification systems become fundamental to manage clinical risk, while addressing inefficiencies in inventory management, and minimizing waste from poorly monitored expiration dates. RFID-based solutions have been tested to implement identification and traceability with the promise of automating procedures and facilitating personnel activities, nonetheless their complexity and cost have limited their adoption so far. EU Regulation 2017/745 (MDR) introduced the requirement of native UDI (Unique Device Identifier) codes present on each medical device. As such, it is now possible to implement simple and cost-effective solutions for identification and traceability that do not require specific hardware or tedious relabeling procedures compared to RFID, and exploit 2D data carriers natively present on MDs.

What was done?

To implement a digital, end-to-end traceability system for medical devices using native UDI (Unique Device Identifier) codes, in compliance with EU Regulation 2017/745 (MDR). The objective is to improve patient safety, optimize inventory management, reduce operational costs, and ensure regulatory compliance without the need for relabelling and dedicated personnel.

How was it done?

The proposed solution leverages optical identification technologies and hands-free systems to automate device tracking from hospital entry to patient association. Smart cabinets manage inventory and access control, while smart baskets automatically link devices to patients. An AI-powered platform analyses data across all phases to support stock optimization, automatic reordering, structured reporting, and performance evaluation.

What has been achieved?

The system enables real-time inventory visibility, eliminates manual errors, improves device utilization. Avoiding costly, time-consuming and risky relabeling of MDs with RFID tags lowers implementation costs, minimizing environmental impact. Clinically, it enhances patient safety enabling rapid response to recalls and adverse events. Operationally, it streamlines logistics, reduces staff workload, and improves planning through AI-driven insights.

What next?

The adoption of an end-to-end UDI-based traceability system represents a significant advancement in medical device management. It delivers tangible benefits in terms of economic efficiency, clinical safety, organizational performance, and environmental sustainability. This innovative approach aligns with the digital transformation of healthcare and offers a scalable model for hospitals seeking to modernize their logistics and compliance processes