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 prioritized 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 specialized treatment responsibility.
• Detailed planning of treatment and pre-switch paraclinical examinations was required.
• The majority of 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 minimalize 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.
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.
DEVELOPING A TERRITORIAL NETWORK TO ENHANCE HOME-HOSPITALIZATION CARE IN REMOTE MAUNTAINOUS REGIONS
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
D. PROTZENKO (1) (2), Y. GONZALEZ (2), M. TASHAN (2), J. CARDI (2), A. PLAN (1) (2).
(1) CHICAS, CLINICAL PHARMACY, GAP, FRANCE.
(2) CHICAS, HOME-HOSPITALIZATION, GAP, FRANCE.
Why was it done?
Our service area spans four departments in France, encompassing numerous mountain valleys with weather-dependent access, making deployment challenging. Additionally, some patients are over two hours’ drive from our hospital.
What was done?
We developed a territorial network by integrating hospital and extra-hospital structures into our home-hospitalization logistics circuit. This integration allowed us to strategically place equipment storage points across our region, enhancing the speed of care in emergencies.
How was it done?
We utilized a computerized tool to map areas accessible within 30 minutes by car and identified strategic points (both hospital and extra-hospital) to maximize coverage with minimal investment.
To optimize operations and improve response times, we established equipment storage points with ready-to-use kits. These kits, created through multi-disciplinary meetings to address key emergency scenarios, are designed to address a range of situations, including post-operative treatments, pressure sores, and end-of-life care, which are particularly prevalent in our population. The variability of care settings—such as patients’ homes, short-term rehabilitation facilities, and long-term care facilities— is also considered. This approach ensures that nurses and doctors can access the necessary equipment at all time, regardless of their location or the specific care requirements. We formalized partnerships to ensure the presence of these kits at designated sites, which are now referenced on a map accessible to our team. Quality processes were implemented to maintain kit quality and prevent expiry.
What has been achieved?
Immediate deployment of equipment for home hospitalization is now possible, regardless of patient location or weather conditions.
What next?
We are expanding our network by recruiting additional partners to enhance our local coverage. This strategy will also apply to areas with shared medical and paramedical skills, improving our responsiveness, particularly in end-of-life care situations. We will also forge new partnerships to broaden our capabilities, enabling other hospitals to prepare patient materials or medications, or to be used as parcel delivery service.
PHARMACEUTICAL LOGISTICS: FIRST OUTSOURCING MODEL IN A REGION OF NORTHERN ITALY
European Statement
Selection, Procurement and Distribution
Author(s)
A. Car, E. Fortina, E. Lanzone, C. Rossi
Why was it done?
Pharmaceutical logistics is a complex process aimed at ensuring patient health. Key tasks include procurement, storage of drugs, as well as medical devices (MD), and economic materials (EM) distribution. The first outsourcing model warehouse, called MUS, was established to minimize inventories, reduce logistics costs, optimize management, improve product tracking and traceability, digitize logistics processes, and expedite administrative tasks.
What was done?
In March 2023, the first centralized warehouse project was launched in a region of northern Italy. MUS is managed by Local Health Authorities (LHA) Leader’s Hospital Pharmacists (HP) in collaboration with administrative staff and an external logistics operator.
How was it done?
The MUS was initiated with the entry of LHA Leader (LHA1). In September 2023, LHA2 and LHA3 joined the project, followed by LHA4 in February 2024. The participating LHAs serve 900,000 inhabitants and cover an area of 6,600 km². Medicines management and movement are entrusted to a logistics operator. LHA1 is responsible for the supply phase of medicines, medical devices (MD), economic materials (EM), and for processing departmental requests.
What has been achieved?
To date, MUS is 18 months old, has an area of 8,000m2 and manages 7 hospitals, 1556 delivery centers (DC), 4781 products: 2639 drugs, 1633 MD, 509 EM. On average, there are 5184 requests and 50300 product lines requested, monthly. MUS’s economic value stocks is 11.9million euros, of which 10.8million euros are drugs. Innovations have been introduced: instrumentation suitable for optical reading, acquisition of license plates, AIC verification. Deliveries to DCs are tracked, the installation of AUTOSTORE, an automated storage and recovery system, is still in the experimental phase. Digitalisation and dematerialisation are replacing old paper systems. The databases of pharmaceutical and MD products have been standardized to satisfy the requests of all LHAs participating in MUS, speeding up the purchasing procedures.
What next?
MUS’s growth must be monitored, in terms of quality of performance and spending optimization. The project is being expanded and the entrance to a hospital is needed to become fully operational. HP’s most challenging task is to orchestrate logistical activities, collaborate with logistics operator, ensuring quality, safety and timeliness of the service and keep the patient’s health as the main objective.
CERTIFICATION OF A PHARMACY ADVANCED THERAPIES UNIT ACCORDING TO ISO 9001:2015 STANDARDS
European Statement
Selection, Procurement and Distribution
Author(s)
H. RIBES-ARTERO, MJ RUIZ-CALDES, E. MONTEAGUDO-SANTOLAYA, J. GARCIA-PELLICER, J.L. POVEDA-ANDRES
Why was it done?
We have implemented a quality management system (QMS) in the Pharmacy Advanced Therapies Unit for the management of advanced therapy medicinal products (acquisition, receipt, storage and dispensation) in accordance with ISO 9001:2015 standards.
What was done?
In the healthcare field, improving the quality of care is a fundamental objective. This involves a continuous and self-critical process of evaluation to identify problems and opportunities for improvement in care. The Spanish National Health System’s Quality Plan includes strategies such as external and periodic evaluation of the quality and safety of healthcare centres and services through audits, with the aim of achieving clinical excellence and improving patient safety and care. The rise of advanced therapies led to a change in the processes of acquisition, storage, and dispensing of medications, as these are cryopreserved therapies that require specific facilities. In our hospital, the Pharmacy Service was designated to carry out these processes.
How was it done?
The project was developed over 12 months in three phases: phase 1 (analysis of the current situation, establishment of a pharmacist working group and training of pharmacists), phase 2 (design documentation, and implementation of the QMS and certification), and phase 3 (analysis of the indicators after the implementation of the QMS, continuous evaluation of them and application of corrective measures).
What has been achieved?
To develop the QMS, we had to create 1 management manual, 8 work protocols, 25 records, 2 work instructions and 2 annexed documents. Once created, we obtained the ISO 9001:2015 certification for our QMS through an external auditing company. As quality indicators (after the certification) we have obtained favourable outcomes in 2 external audits from the pharmaceutical industry and recorded a total of 4 minor non-conformities. Regarding activity indicators, we have dispensed 18 therapies and 4 new work protocols have been created.
What next?
The pharmacist must be the healthcare professional responsible for managing advanced therapies, and implementing, certifying and recertifying a QMS in accordance with ISO 9001:2015 standards is a guarantee of the quality of our healthcare work at the hospital, recognized by other healthcare professionals, patients and the pharmaceutical industry.
MANUAL COUNTING IN CONNECTION WITH THE MIXING OF INTRAVENOUS ANTIBIOTICS IS NOW BEING REPLACED BY A SOFTWARE ROBOT
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Michelle Ann Matzen, Linda Jeffery, Mette Juul-Gregersen, Bente Jonassen, Lene Juhl Biltsted
Why was it done?
At the regional hospitals in Horsens and Randers, the pharmacy helps mix selected intravenous (IV) antibiotics for patients admitted to inpatient wards (piperacillin/tazobactam, cefuroxime, and cloxacillin).
The mixing takes place centrally and is then distributed to the relevant wards.
Our electronic prescribing system does not help us to identify which/how many patients require these antibiotics so the number of prescriptions for each ward was manually counted before the mixing process.
To reduce medication waste, the manual counting was done every morning and noon, with an estimated time consumption of about 1 hour per day per location.
The goal was to move away from manual counting and towards an automated solution.
What was done?
The pharmacy assists wards in mixing IV antibiotics. There was a desire to digitize and streamline the workflow through development of a software robot.
How was it done?
The pharmacy assembled a team from two locations and reached out to the region’s robotic process automation (RPA) developers.
The pharmacy set requirements and expectations for the RPA solution with the developers.
Throughout the development, the programming was revised and adjusted several times to obtain the most accurate prescription data.
To verify the robot’s counting, manual counts were conducted multiple times during the process, leading to adjustments in the robot’s programming.
The development of the RPA solution spanned 9 months.
What has been achieved?
The fully developed RPA solution is now used at both locations. A report is emailed twice a day, after which antibiotics are mixed and distributed to the relevant wards.
Benefits:
• Frees up time for other tasks
• Data is more up-to-date regarding changes in patients’ medications
• Medication waste is minimized
What next?
There are plans to create a similar setup for a central mixing unit at Aarhus University Hospital, where the RPA solution can be implemented from the start.
There is potential for the RPA solution to be used at other locations/departments, with different medications. For example, monitoring of inhalation preparations or anticoagulant medications.