MODERNIZING CYTOSTATIC PRODUCTION: A DATA-DRIVEN APPROACH TO DECISION-MAKING FOR SELECTING A COMPOUNDING SYSTEM
European Statement
Production and Compounding
Author(s)
Stefanie Fuchs, Michele Tadiotto
Why was it done?
Compounding cytotoxic therapies in hospital pharmacies is a complex and safety-critical process. As part of a planned modernization of the production site, which handles around 40.000 preparations annually, the project was launched to investigate the impact of integrating an automated compounding technology (ACT).
This project also provided decision-makers with structured, data-driven insights to support the selection of the most appropriate technology for the specific production needs.
What was done?
A comprehensive analysis to identify the most suitable ACT for our chemotherapy production was conducted.
The approach taken was twofold: first, production data was used to run simulations, allowing for the evaluation of how the different ACTs would perform in our environment.
Second, interviews with international ACT users with hands-on experience were conducted to gather valuable, pragmatic insights.
How was it done?
A detailed examination of the production data was conducted, assessing each ACT’s compatibility with our portfolio (approx. 100 chemotherapy substances). Customized MS-Excel calculation sheets were developed and used to cross-reference drug-specific production metrics (for each drug: total annual preparations, average production time, average transferred volume, other critical parameters). Based on this analysis, the drugs best suited for compounding with each ACT candidate were identified.
Simulations were then run to compare theoretical performance both against current manual compounding and among ACT candidates.
Additionally, the information collected during the interviews was used to develop a comprehensive evaluation of process impacts including: maintenance of quality standards, personnel requirements, potential contamination risks, software integration, microbiological and cleaning aspects, and GMP compliance requirements.
What has been achieved?
This dual methodology enabled a robust evaluation of both theoretical and practical aspects of each system.
Critical technical limitations that could hinder system applicability were identified and the potential proportion of the total compounding workload realistically manageable by ACTs was assessed.
Furthermore actionable, data-driven insights were collected and provided to decision makers to guide strategic decisions.
What next?
The findings are tailored for management decision-makers, enabling them to select the ACT best suited to the pharmacy’s needs without requiring in-depth pharmacy expertise.
Additionally, the methodology from this project can serve as a replicable framework for other hospital pharmacies interested in adopting an ACT.
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.
ELECTRONIC PRESCRIPTION INTEGRATION: ACHIEVING 98% COVERAGE AND REDUCING TRANSCRIPTION ERRORS
European Statement
Patient Safety and Quality Assurance
Author(s)
VB Pinto, CSA Souza, NL Mizutani, RP Santos, MA Dias, ACP Sforsin
Why was it done?
The unification of two outpatient prescription platforms into a single, institutional electronic system was carried out. The initiative was led by a multidisciplinary team (pharmacists, physicians, and systems analysts) from a public, tertiary care hospital.
What was done?
Despite the high rate of electronic prescribing (92%), the coexistence of the two systems generated data fragmentation, rework, and exposed patients to unnecessary risks of transcription errors. The central objective was, therefore, to unify the process to universalize the use of electronic prescribing and, consequently, reduce transcription errors, strengthening patient safety and pharmaceutical care.
How was it done?
The intervention took place between July and September 2025. Actions included the technical integration of the systems into a single platform, the development of new standardized prescribing protocols, and training for prescribers. The impact was evaluated by monitoring the electronic prescribing coverage percentages and transcription errors rates at the outpatient level before and after implementation.
What has been achieved?
The integration demonstrated fast and significant results. Electronic prescription coverage increased from 92% to 98% in just one month after unification. In parallel, there was a progressive and sharp reduction in transcription errors: from 8.5% (pre-implementation) in July to 2.7% in September (after integration), representing a 68% decrease in the manual correction rate.
What next?
This initiative demonstrates the importance of technological unification for the advancement of Hospital Pharmacy. The model is highly replicable for other institutions dealing with fragmented electronic prescribing systems. The integration of systems has a direct and measurable impact on patient safety, establishing universal electronic prescribing as an efficient care standard and proof against transcription errors.
IMPLEMENTATION OF CPFARMA® SOFTWARE TO OPTIMIZE THE MANAGEMENT OF MAGISTRAL FORMULATION IN A TERTIARY UNIVERSITY HOSPITAL
Pdf
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.
IMPLEMENTATION OF AN INFORMATIC PLATFORM FOR THE REQUEST/MANAGEMENT OF MEDICINES IN EXCEPTIONAL CIRCUMSTANCES
Pdf
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 medication procurement through integrated database
Pdf
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.
Too good to go – sharing medication near expiry with a digital solution
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Charlotte Sørensen, Karin Aagot Møller Jørgensen, Anne Grethe Nørgaard Kyndi, Charlotte Lund Madsen, Line Scriver Poulsen, Charlotte Hjorth, Gitte Slyngborg Morbjerg, Janni Østergaard Jensen, Mette Juul-Gregersen, Rune Dalsenni Rask
Why was it done?
A sustainability project in 2020 highlighted manual and time-consuming workflows when checking expiry dates in hospital medicine rooms. For example, manual reading, interpretation and notation of expiry dates in paper forms every half year. Therefore, a smartphone application was developed and implemented in a large university hospital in 2022. The application was a huge success and colleagues from other Clinical Pharmacy departments in other hospitals within the same region wanted to be part of the success of the initiative.
What was done?
A smartphone application for managing expiry dates in medicine rooms was applied in one hospital in 2022 and in four other hospitals in 2023. The data-matrix of medicine packages is scanned with a smartphone camera and the application gives a sorted overview of medication near expiry. In the application you can register a medicine package as either used, discarded or released. By releasing medicine packages, the medicine is made available to colleagues in other medicine rooms.
How was it done?
The smartphone application was implemented in Clinical Pharmacy departments in four other hospitals, one by one from February 2023. After implementation the application is used in 373 medicine rooms.
What has been achieved?
Clinical Pharmacy staff are happy with the application. It takes significantly less time to check and scan expiry dates with the digital solution.
From February to September 2023 (five hospitals)
• 47491 packages were scanned
• 5251 packages were released (11%)
• 2664 packages were moved between medicine rooms to avoid medicine wastage (51%; 147000 €). Most activity (78%) was seen at the hospital that had been using the application since 2022. Most packages were moved between medicine rooms at the same hospital; however, in 215 cases (8%), medicines were exchanged between hospitals as well (20.000 €)
• 10918 packages were discarded due to expiry (743168 €; 0.5% of bought medicine).
What next?
The full potential of the digital solution remains to be achieved.
Pharmaconomists have to release medicine in the application a few months earlier than they do now. To go shopping in the application before ordering from the pharmacy, will probably also result in discarding less medicine. Sharing medication across hospitals to a greater extent will also be relevant to consider.
Implementation in a pharmacy service of a big data analysis programme for successful treatment
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
LUCIA SOPENA, ALBERTO FRUTOS, VICENTE GIMENO, OLGA PEREIRA, RAQUEL FRESQUET, ARITZ MERCHAN, REYES GARCIA, PAULA GOMEZ, ALBERTO APESTEGUIA, MARIA ANGELES ALLENDE, TRANSITO SALVADOR
Why was it done?
The growing technological development of pharmacy services involves the coexistence of traditional warehouses with automated medicine dispensing systems controlled by different computer programs. The information is split into different systems and databases giving rise to possible errors due to the greater complexity. This is a threat but also an opportunity for the hospital pharmacist to lead the development, review, and improvement of medicine use processes and the use of health technologies to improve quality of care, patients’ safety and reduce costs. KNIME data analysis covered the need of our Pharmacy Service to blend data from any source in a single file simplifying the process.
What was done?
The Pharmacy Service of a university hospital has implemented Konstanz Information Miner (KNIME) data analysis and develop successful treatment project to optimise the stock management of several medicines.
How was it done?
An initial algorithm was designed by the union of seven files and can be executed at any time to obtain the updated data.
What has been achieved?
This file provides up-to-date information about the stocks, stock-outs, consumptions, orders and purchasing data of all medicines (average price, laboratory, date and number of orders, units to be received).
In addition, KNIME calculated the coverage time in days and months from weekly and monthly consumption, and the current stock in the warehouses, obtaining a global vision of highest turnaround pharmaceuticals drugs.
The program also allows to link and merge data of the list for shortages of medicines, supply disruptions and restocking time, and to improve the storing, delivering and administering of COVID-19 vaccines.
KNIME program has been especially important in our Pharmacy Service to get better care outcomes and more precise medication ordering, which allows significantly higher patient safety.
What next?
KNIME is a tool that could be successfully implemented and appropriately generalised as recommended to all Pharmacy Services that use different data sources and want to have a generalised view of the information. KNIME represents an advance in the stock and purchase management of medicines specialties to work more efficiently, which improve patient care and safety. Digital medication management also contributes to greener pharmacies by preventing unnecessary overstocking and thus excessive disposal arising from expired medications.
TELEMEDICINE AND HOMEDELIVERY: MANAGEMENT OF THERAPEUTIC CONTINUITY IN THE PANDEMIC ERA.
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Marta Del Vecchio, Federica Chinotti , Claudia Lauria Pantano, Elirosa Minniti, Erika Cataldo, Francesco Guidoni, Vito Ladisa
Why was it done?
The Severe Acute Respiratory Syndrome – Coronavirus – 2 (SARS-CoV-2 ) pandemic made it difficult to monitor the patient’s health condition because many of them were locked down at home, unable to attend routine hospital visits.
What was done?
The hospital pharmacist, focusing on therapeutic continuity, closely collaborated with the clinicians in monitoring patient’s condition using telemedicine and homedelivery services.
How was it done?
In the multidisciplinary team, the pharmacist and the clinician defined the criteria to choose the most suitable patients for the homedelivery service. One of the options was to dispense the drug in a neighboring hospital. Because of the sanitary system regionalization, some of those hospitals could have been located even more than 100 km away, resulting in a problem for the most critical patients. In order to help them, home delivery and telemedicine services has been considered. The clinician used to visit patients on digital platforms, making clinical evaluations based on the results of blood tests, diagnostic tests and imaging techniques. According to clinician’s indications, the pharmacist took contact with patients, in first to collect informations about any residual storage of the drugs, adverse reactions, therapeutic compliance and then to proceed with the delivery. Everything has been done in conformity with the General data protection regulation (GDPR).
What has been achieved?
From March to September 2020, the homedlivery service count 501 speditions all over the Nation, 480 patients has been contacted to recive therapy and 250 of them has been intensively monitored by calling to manage their follow up. Everything has been done in order to protect critical patients from pandemic, safeguarding the therapeutic continuity,in compliance with pharmacovigilance, risk managment and cost saving for the national health system, considering that the suspension of therapies could be considered an additional and not quantifiable cost, but certainly important.
What next?
The hospital pharmacist must collaborate ever more with the clinician even in the post-pandemic phase, remotely managing not only the most weak patients, but extending the telemedicine and homedelivery services to an increasing number of patients, in order to safeguard their health .
DEVELOPMENT OF AN IT TOOL TO ESTIMATE THE THERAPEUTIC NEEDS OFHOSPITALISED PATIENTS WITH COVID19 INFECTION BASED ON SIR EPIDEMIOLOGICALMODEL
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Daniele Leonardi Vinci, Adriano Meccio , Alessio Provenzani, Piera Polidori
Why was it done?
The COVID 19 pandemic unprecedently challenged National Health Services to assure adequate patient care, despite a constantly escalating drugs demand. This complex situation requires appropriate planning to avoid misleading estimations, which would have consequences on patients and overall resources available.
What was done?
We created a tool to perform a timely estimation of the drug needs to treat the COVID-patients based on epidemiological forecasting.
How was it done?
The tool’s epidemiological forecasting was based on a compartmental model in which the population is divided into three compartments (Susceptible-Infectious-Removed, SIR), and transmission parameters are specified to define the rate at which persons move between stages. The appropriate data entry was guaranteed by the creation of a form in which users can enter information regarding: The population considered, the R0 calculation, the number of already known infected cases, the application of Non-Pharmaceutical Interventions and the number of hospital beds. The drugs need for the forecasted patients was calculated according to a list of critical care drugs compiled consulting previous published scientific works, national and international guidelines. The list includes 51 drugs belonging to different therapeutic group, such as: antiarrhythmics, antibiotics, antipyretics, antivirals, heparins, IV-fluids, local anesthetics, neuromuscular blockade agents, sedative agents and vasopressors. For each drug it was estimated the percentage average ICU uptake for therapeutic group and active principle.
What has been achieved?
A tool consisting of an excel template, that, based on the information inserted, automatically calculate the number of patients classified by the intensity of care (hospitalized not-ICU, Hospitalized ICU, ventilated, intubated or with shock) and creates a table that includes, for each drug to be used, the following information: therapeutic group, active principle, dosage considered, pharmaceutical form, total dosage for patients considered and total quantity of unit doses for patients considered. The tool is also made adaptable to different clinical situations, through the possibility of editing the assumptions adopted regarding the epidemiological and therapeutical parameters or the inclusion of new items in the drugs list.
What next?
Our tool represents an opportunity for the immediate and efficient estimation of the drugs necessary to assist the COVID19 patients during emergency scenarios. It will be periodically updated as new evidences will be available.