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NATIONAL FOCUS LIST FOR MEDICINE CHANGES: ENHANCING SAFETY AND EFFICIENCY IN TENDER TRANSITIONS

European Statement

Selection, Procurement and Distribution

Author(s)

Susanne Weng Rømer, Hospital Pharmacy North Denmark Region, Aalborg, Denmark
Alissa Maria Kloppenburg, Hospital Pharmacy Funen, OUH, Svendborg, Denmark
Tania Truelshøj, Hospital Pharmacy Central Denmark Region, Aarhus, Denmark
Benene Rguez, Capital Region Pharmacy, Copenhagen, Denmark
Sine Thagaard Wermuth, Region Zealand Hospital Pharmacy, Roskilde, Denmark
Karen Suhr Lausten, Amgros I/S, Copenhagen, Denmark
Katrine Fridthjof Hougaard, Amgros I/S, Copenhagen, Denmark
Mikala Vasehus Holck, Amgros I/S, Copenhagen, Denmark
Thomas Loof Hedegård, Amgros I/S, Copenhagen, Denmark

Why was it done?

Amgros conducts national tenders for medicines on behalf of Hospital Pharmacies in Denmark. The tenders often result in medicine changes. Previously, each of the eight Danish Hospital Pharmacies assessed every change individually. A national study showed this was time-consuming, duplicative, and produced variable quality. A more coordinated process was needed. The project aimed to centralize the workflows to ensure systematic identification of relevant differences while using fewer resources and supporting safe medicine changes. The Focus List was implemented in August 2025.

What was done?

A national decision support tool – the Focus List for Medicine Changes – was developed to make medicine changes following tenders easier, safer, and more efficient for Danish Hospital Pharmacies. By comparing Summaries of Product Characteristics (SPCs), the Focus List provides a structured overview of clinically relevant differences requiring attention during consumption estimation and clinical implementation.
By centralizing and standardizing assessments, the Focus List improves efficiency by reducing duplication of work, saving resources, and ensuring consistent quality. Ultimately, it supports patient safety by ensuring that potential clinical consequences are identified and addressed proactively.

How was it done?

A working group with representatives from Hospital Pharmacies and Amgros collected experiences and mapped existing workflows. Key parameters for comparison, such as storage conditions, therapeutic indications, and unwanted excipients, were identified. These formed the basis of the Focus List, which systematically presents relevant differences between outgoing and incoming tendered medicines. The Focus List was tested and validated by Hospital Pharmacy staff across all regions, supported by templates and guidance documents to ensure consistent use.

What has been achieved?

The Focus List was well received. Hospital pharmacies reported expected time savings, improved support for estimation processes, and higher quality consistency in identifying clinically relevant changes. The Focus List, including 273 medicine switches, was implemented and replaced the decentralized approach with a more streamlined national workflow.

What next?

A formal evaluation will follow once more experience has been gathered. Future work aims to automate SPC comparisons using AI and expand the Focus List to cover all tender-related changes. This initiative could be replicated in other settings through cross-functional collaboration.

RATEC PLATFORM: A REGIONAL DIGITAL SYSTEM FOR THE REQUEST PURCHASE AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES AND AND IN VITRO DIAGNOSTICS

European Statement

Introductory Statements and Governance

Author(s)

E. Santarossa, F.F. Faccioli, L. Dal Cin, M.C. Libralato, M. Saia, A. Cavazzana
Governo Clinico, Azienda Zero, Padova, Italy
elisabetta.santarossa@gmail.com

Why was it done?

In Italy, regions frequently fail to comply with the spending cap for medical devices (MDs) and in vitro diagnostics (IVDs). Guided by the principles of Regulation (EU) 2021/2282, the RATEC platform employs HTA to facilitate timely access to innovation, promote efficient resource allocation through uniform HTA criteria, and foster collaboration among healthcare organizations (HCOs) to avoid duplicative assessments.

What was done?

The RATEC platform digitizes the regional process for the request and health technology assessment (HTA) of new MDs and IVDs. It was developed within the framework of the NET 2018-12368077 ministerial program, funded by the Ministry of Health and the Veneto Region.

How was it done?

The process starts with the healthcare professional completing a specific form (Non-Urgent MDs/IVDs, Urgent MDs/IVDs, Biomedical Equipment,). After validation by the head of the department, the request is evaluated by the Multidisciplinary Hospital Unit for MDs/IVDs assessment (called UVA-DM). RATEC provides to UVA-DM an HTA methodology with a clearly defined PICO (Population, Intervention, Comparator, Outcome) and includes a Multi-Criteria Decision Analysis (MCDA). The model graphically displays the evaluation outcome (Y: Value, X: Risk) and suggests a decision orientation: innovative technologies for central reporting, technologies to be approved or technologies to be rejected. Technologies defined as innovative are forwarded to the central phase for HTA reports, which will be available to all regional HCOs.

What has been achieved?

By October 2025, 1054 MDs/IVDs purchase requests had been submitted to RATEC, with 695 evaluated by UVA-DM and 13 reaching the central phase for the HTA report. The approved requests are estimated to have an economic impact of € 4,181,740, excluding biomedical equipment. From 2025 onwards, all regional public HCOs must use RATEC for evaluation of MDs/IVDs.

What next?

The RATEC platform is not only a tool for regional governance but a scalable digital infrastructure that fosters transparency, equity, and value-based decision-making in healthcare. Its continuous enhancement aims to expand the model beyond regional borders, positioning RATEC as a best practice for integrating HTA into procurement processes and ensuring rapid, sustainable access to innovation.

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.

IMPLEMENTATION OF A CRITICALITY TOOL FOR MEDICAL DEVICES IN A UNIVERSITY HOSPITAL

European Statement

Selection, Procurement and Distribution

Author(s)

C.ALINOVI, J.ZAMPA, D.PECANI
Toulouse University Hospital, FRANCE, Toulouse

Why was it done?

To set up tools to better manage medical device (MD) supply shortages, given the significant increase in the number of shortages in recent years.

What was done?

To better manage MD supply shortages in hospitals, a score has been developed to classify devices by their criticality during supply disruptions. This score considers various factors, such as : number of hospital departments using the product, average daily consumption rate, single-use vs. reusable nature of the product or Availability of alternatives.

How was it done?

A set of criteria and their interrelations were tested to establish a criticality score that categorizes MD into three levels : ‘supercritical’, ‘critical’, and ‘non-critical’. These categories reflect the potential impact on patient care in the event of a shortage. Thresholds, such as the daily consumption rate, were particularly important in defining this score.

What has been achieved?

To validate the scoring method, 33 combinations of criteria and 1,257 threshold variations were tested on a sample of 66 products. These products had previously been rated by expert pharmacists for criticality. Sensitivity and specificity calculations were used to compare the test results with expert evaluations. After testing, three combinations achieved the desired accuracy, and one of these was selected.
The final scoring method was applied to 764 MD in stock at the hospital, identifying 44 as ‘supercritical’. The security storage thresholds were increased for these 44 MD so that they would be less affected in the event of a shortage, and are MD targeted during order delays, so that they can be relaunched as a priority.

What next?

A similar scoring system will be developed for MD managed in non-stock mode to classify the most critical items in the event of a supply shortage.

IMPLEMENTATION OF AN INFORMATIC PLATFORM FOR THE REQUEST/MANAGEMENT OF MEDICINES IN EXCEPTIONAL CIRCUMSTANCES

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European Statement

Selection, Procurement and Distribution

Author(s)

Gutiérrez Palomo, S; Guillén Martínez, O; Miralles Andreu, G; Jiménez Pulido, IP; Soriano Irigaray, L; Murcia López, AC.

Why was it done?

Pharmacy Service(PS)initiates the evaluation, management and procurement of medicines in exceptional circumstances(MEC), a complex process in terms of each treatment requeriment, the regulatory agencies/professionals involved and the phases/timescales of the evaluation process, which can be improved by the implementation of technology.

What was done?

The objective is to describe the implementation of a specific informatic platform(IP)for the use of MEC in a PS.
The IP was implemented in September 2023 to centralize the request MEC process by the optimization of their monitoring and evaluation and to promote specific management knowledge for each treatment.

How was it done?

1. The responsible physician contacts the PS to initiate a treatment considered as MEC, submitting an individualised prescription per patient.

2. The PS determines the specific treatment procedure and the authorizations needed to make the request to the responsible agency.

3. The PS introduces the request into the IP and attaches the corresponding individualised treatment document.

4. With the agreement and signature of the PS head, the request is sent to the Hospital Director for evaluation and conformity, recording the date of processing in the IP.

5. After having the hospital approvals, PS sends the request to the corresponding agency, attaching the document in the IP.

6. Once the request has been assessed by the apropriate health agency, the resolution document is attached in the IP, recording the resolution date and updating its status.

7. The IP is connected to the electronic medical record program , generating an automatic report with the request resolution in the patient’s medical record.

What has been achieved?

Since September 2023, 217 MEC requests have been received. As for their resolution, 190(88%) were authorised, 14(6%)pending resolution, 9(4%) refused and 4(2%)cancelled. By medical services, the most requests were distributed as follows: 69(32%) oncology, 27(12%) haematology, 18(8%) neurology, 16(7%) anaesthesiology, 14 (6%) cardiology. The drugs with the most requests were: glycopyrronium(16), atezolizumab(9), cysplatine(8), pembrolizumab(7), bevacizumab(6), mavacamten(6), nadolol(6), labetalol(6).

What next?

A simple, user-friendly and highly useful platform that can be implemented in any PS with a pharmacist specialised in the management of MEC and included in multidisciplinary teams.

OPTIMISING CUSTOM PACKS: A STEP TOWARDS A SUSTAINABLE HOSPITAL?

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European Statement

Selection, Procurement and Distribution

Author(s)

A. KANDEL (1), L. CABRIT (1), C. HUMARAUT (1), A. MASSRI (2), C. TAILHADES (1), S. ARRAKI ZAVA (1), V. GRENOUILLEAU (1)
(1) Pharmacy Department, Medical Devices Unit, Pau Hospital Center, France
(2) Intensive care unit, Pau Hospital Center, France

Why was it done?

Medical devices (MDs) and drugs account for 55% of the carbon footprint of a hospital’s French healthcare system, making this sector a key focus for the ecological transition. The MD sector alone is responsible for 32% of our hospital’s CO2 emissions, underlining the need to rethink our practices in order to reduce our environmental impact.

What was done?

Elimination of waste produced unnecessarily by optimising customised packs (CP) containing the MD required for treatment.

How was it done?

After a multidisciplinary team (pharmacists, intensive care units, anaesthetists, nurses) was put together, packs containing unused medical devices (UMD) were identified in 2 pilot departments: anaesthesia and intensive care. The packs were weighed with and without the UMD. The savings in terms of waste weight and carbon footprint were calculated according to the type of waste: general waste or biohazardous waste. In conjunction with the medical teams and suppliers, the re-evaluation of the MD required and the withdrawal of UMDs led to the updating of CP in the pilot departments.

What has been achieved?

The packs identified include: the suture pack (SP), the central venous line pack (CVL) and the epidural pack (EP). Over one year, the weight of waste avoided was: 64 kg for the SP, 87 kg for the CVL pack, 55 kg for the EP. After modifying these packs, annual CO2 emissions were reduced by 55% for the SP, 14% for the CVL pack and 8% for the EP, with a total annual saving of €5,423. The annual weight of waste was reduced by 206 kg, a saving of 92 kg of CO2: the equivalent of 86 Paris-London train journeys.

What next?

The re-evaluation of CP can generate a significant ecological impact. This initiative is intended to be rolled out on an institutional scale, with the active collaboration of the sustainable development department, and as part of future calls for tender. These adjustments save time for care staff, significantly reduce the carbon footprint, and contribute to the ecological transition. It is essential to strike a balance between economic and environmental imperatives, given the financial constraints facing public hospitals.

PharmaSwap: a pioneering healthcare initiative reducing medication waste and promoting sustainability

European Statement

Selection, Procurement and Distribution

Author(s)

Piter Oosterhof, Jelmer Hein Faber, Lieke van Kerkhoven, Rob Haenen

Why was it done?

PharmaSwap is a response to the significant issue of medication waste in the healthcare sector. The problem of medication waste was well-documented, with scientific research indicating that annually, a minimum of €100 million worth of prescribed medications was being discarded in the Netherlands. These medications were being wasted when they reached their expiration dates, resulting in both financial losses and environmental pollution. PharmaSwap was introduced to tackle the problem of medication waste by creating an online platform that enables pharmacists and pharmaceutical wholesalers to list and sell medications with approaching expiration dates at discounted rates. Our initiative sought to improve the situation by not only reducing the financial losses associated with medication waste but also by addressing the environmental concerns linked to the disposal of medications. By promoting the reuse of medications and encouraging a shift toward sustainability in the pharmaceutical sector, PharmaSwap aimed to make a positive impact on healthcare and the environment.

What was done?

The initiative that has been developed and implemented is https://www.PharmaSwap.com. PharmaSwap is an online marketplace established in 2018 by pharmacists Piter Oosterhof and Jelmer Faber. This platform facilitates the exchange and sale of medications among (hospital) pharmacies and pharmaceutical wholesalers that are nearing their expiration dates at discounted rates.

How was it done?

The introduction of PharmaSwap faced several obstacles:

1) Regulatory barriers: initially, regulations didn’t allow medication redistribution. We collaborated with regulatory bodies to find a legal solution.
2) Legal adjustments: we worked with authorities to amend regulations, creating a legal framework for PharmaSwap.
3) Building trust: gaining trust from pharmacists and wholesalers required transparent communication and showcasing benefits.
4) Technical development: developing the platform required the right tech partners and resources.
5) Awareness and adoption: we conducted awareness campaigns and partnered with (inter)national associations to promote PharmaSwap.

Through these efforts, we successfully overcame obstacles and implemented PharmaSwap, reducing medication waste and promoting sustainability.

What has been achieved?

1) Medication waste reduction: PharmaSwap has significantly reduced medication waste, preventing the disposal of medications, while pioneering a unique and innovative approach.
2) Environmental impact: PharmaSwap has saved 9,719 packaging units, leading to a substantial reduction in environmental pollution from medication disposal.
3) Cost Savings: healthcare systems have saved €1,165,115 by recovering the value of otherwise discarded medications.
4) Network growth: PharmaSwap connects 836 out of 2,000 Dutch pharmacies and collaborates with 8 pharmaceutical wholesalers, including one partner compliant with Good Distribution Practice (GDP).

These outcomes highlight PharmaSwap’s impactful contributions to waste reduction, cost savings, and sustainability in healthcare, supported by its expanding network of participants.

What next?

PharmaSwap’s success in reducing medication waste, saving costs, and promoting sustainability makes it a compelling example of good practice in healthcare. Its transferability to other healthcare settings involves replication, regulatory adaptation, education, partnerships, technology integration, data management, and a commitment to continuous improvement. Moreover, we are currently in advanced meetings with several other European countries, exploring the potential for international expansion and collaboration to further extend the positive impact of PharmaSwap.

An algorithm for the process of selecting pharmaceutical companies in a pharmacy department

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European Statement

Clinical Pharmacy Services

Author(s)

Moisés Couñago-Fernández, Marisol Samartín-Ucha, Ana María Regueira-Arcay, Sonia González-Costas, María Alfonsín-Lara, Paula Prado-Montes, Iván Agra-Blanco, Elena Cerdeira-Regueira, Noemí Martínez-López de Castro

Why was it done?

When a new pharmaceutical product should be introduced in a hospital, a multitude of factors must be considered in order to choose a specific brand. A lack of uniformity in the criteria for the selection of new medicines has been detected. To avoid selection errors or arbitrary decisions, a selection structured algorithm was developed using quality tools according to management quality system ISO 9001-2015.

What was done?

To ensure that the process of selecting from several pharmaceutical companies fulfil the requirements of quality and lower cost, a decision-making process for these purchases was designed, through a structured method for the evaluation of new pharmaceutical products based on standardised evaluation criteria.

How was it done?

A multidisciplinary group was created focused on making decisions about criteria. All stakeholders were represented (management pharmacist, quality experts, management assistant and pharmacy director). Also, a survey was given to different specialist pharmacists to complete the criteria. Second, criteria were categorised according to their importance or potential impact in pharmacy practice or patient.

What has been achieved?

The algorithm took into account aspects related to: a)pharmaceutical company and b)aspects related to the pharmaceutical product. Each of these aspects is valued as a percentage.

a)Pharmaceutical company: 40% of the score was based on not having a repeated history of stock-outs, 45% on the evaluation of the provider according to an internal file based on incidences registered, and 15% if the provider was already a known supplier.

b)Pharmaceutical product: 50% was based on the cost of the medicine, 15% unit dose presentation (if applicable), 10% expiry conditions of the medicine, 5% allergens, 5% if it was presented in a pre-filled pen (if applicable), 5% if it could be stored at room temperature, 5% if the drug is supplied in diluted vials (in the case of parenteral medicines) and 5% if it had all the possible indications in the technical data sheet.

This methodology has been used successfully in recent months with the pharmaceutical supplier changes of abiraterone and sugammadex.

What next?

This tool will be used for all changes of medicine brands and new drugs purchased in the hospital, enabling uniformity in the purchasing process for all new drugs.

Optimising medication procurement through integrated database

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European Statement

Selection, Procurement and Distribution

Author(s)

Irene Ruiz-Jarabo Gómez, Marcos Gómez Bermejo, Rocío Vázquez Sánchez, Antonio Illescas Bermudez, Elena Martín Suarez, Teresa Molina García

Why was it done?

Digitization was considered essential in reducing costs related to inventory management and improving responsiveness in critical situations, such as supply shortages. Traditional manual inventory checks and order verifications were time-consuming and error-prone, prompting the need for a digital transformation.

What was done?

In our quest for enhanced medication procurement efficiency within our Hospital Pharmacy Service, we have developed an integrated database.

How was it done?

We have developed a database by consolidating data from two primary sources: our automated medication storage system, Smart Ulises®, and the Economic Management software, Farmatools®. This database encompassed information related to medications falling below predefined minimum stock levels, historical acquisition records, pending medication orders, and warehouse capacities for each medication. Additionally, it seamlessly integrated data obtained from the Spanish Agency of Medicines and Medical Devices (AEMPS) regarding medication shortages.
This database enabled several essential functionalities:
It generates reports suggesting orders for medications below the minimum stock levels, recommending quantities based on historical acquisitions and available storage space.
By considering the suppliers for medications at minimum stock levels, it also identifies medications in alert status (1/3 above the minimum stock) for these suppliers.
Cross-referencing with AEMPS’ medication supply problem database swiftly detects critical medications during shortages
It permits agile identification of pending medication orders.
It identifies locations with incomplete medication inventories and propose medication grouping within our automated medication storage system.

What has been achieved?

The outcomes of our project were transformative:
  We streamlined medication procurement significantly and maximized each medication supply request while promoting sustainability by reducing laboratory-specific medication orders.
  We optimized storage space within our automated medication storage system, aligning medication orders precisely with storage capacities for each medication, leading to more efficient space utilization and reduced storage costs.
  Early detection of medication shortages enabled proactive preparation of alternative solutions to effectively mitigate shortages.
  Simplification of tracking pending medication orders enhanced operational efficiency in claim processing or supplier changes.

What next?

Our next phase focuses on continuous system improvement. This involves incorporating additional data sources to refine medication supply predictions and exploring the potential for complete automation of the medication ordering process. We will also enhance performance measurement to evaluate the effectiveness of our improvements.

Making a green and lean choice: evaluating the environmental and economic impacts of reprocessable and single-use medical devices in hospital settings

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European Statement

Selection, Procurement and Distribution

Author(s)

Samantha HUYNH, Olivia MAZZASCHI, Valérie TALON, Emilie MOREAU

Why was it done?

Healthcare systems face a growing need to balance patient care with environmental responsibility. This approach was initiated at the request of surgeons and was proposed during institutional committees addressing environmental issues.

What was done?

Our aim was to perform a comprehensive analysis of the potential benefits and challenges associated with the substitution of single-use medical devices (SUDs) with reprocessable medical devices (RMDs) within a hospital setting.

How was it done?

We evaluated environmental, economic and organizational impact of this transition by comparing the carbon footprints and costs associated with the substitution of SUDs (suture and antiseptic trays) with RMDs as well as their acceptance by healthcare professionals.
Environmental impact was evaluated by considering manufacturing origin, transportation, and material composition, calculating carbon equivalence based on weight. The energy and water consumption during the sterilization process of RMDs was also included in the carbon footprint quantification.
Economic considerations included SUDs purchasing and management costs as well as acquisition and sterilization costs for RMDs.
Observational audits (n=30) and user satisfaction surveys (n=7) were conducted to evaluate the acceptance of RMDs.

What has been achieved?

RMDs led to a significant reduction in the carbon footprint for both devices. The carbon equivalence for suture trays was reduced from 7.1 kg eqCO2 for SUDs to 4.0 kg eqCO2 for RMDs; for antiseptic trays, SUDs generated 2.2 kg eqCO2 while RMDs 1.1 kg eqCO2. The potential annual reduction of CO2 emissions is 5.2 tonnes per year.
The economic analysis showed that the initial investment in RMDs could be recovered within a remarkably short timeframe (10 months for antiseptic trays, 5 years for suture trays) making it a viable long-term cost-saving strategy.
User feedback showed a preference for RMDs despite slight inconveniences, with 71% of respondents supporting the reduction of SUDs and 83% perceiving RMDs as of superior quality.

What next?

Our findings underscore the feasibility and benefits of transitioning to RMDs, with a significant reduction in carbon footprint and economic viability. While complete elimination of SUDs presents challenges, a balanced approach prioritizing sustainability without compromising quality of care is possible. We believe that this approach can be replicated in diverse healthcare settings, contributing to a more sustainable future management.