MANAGEMENT AND TRACEABILITY OF IMPLANTABLE MEDICAL DEVICES: THE BREAST IMPLANT CONSIGNMENT STOCK
European Statement
Selection, Procurement and Distribution
Author(s)
M Rivano, N Tatti, V Mureddu, G Bertolino, M Atzeni, R Deidda, A Cadeddu
Why was it done?
Breast implants are invasive medical devices classified as Class III — the highest risk category. The European Medical Device Regulation (EU MDR 2017/745), fully applicable since 26 May 2021, requires implantable devices to be tracked using a Unique Device Identification (UDI) code, serial number, batch number, and expiration date.
In addition, a National Breast Implant Registry was established in Italy in 2023 (DM 207/2022), which must be completed after each implantation. The Registry’s objectives are to ensure clinical follow-up for individuals who have undergone implantation, enabled timely patient traceability when needed, and support epidemiological surveillance. This initiative aimed to ensure compliance with both European and national requirements while improving device availability and minimizing waste.
What was done?
The hospital pharmacy implemented a new management system for breast implants used in plastic surgery, based on a consignment stock model and computerized traceability of each device.
How was it done?
To comply with regulatory requirements and optimize surgeons’ workflow, the hospital pharmacy in collaboration with plastic surgery department, set up a consignment stock for breast implants. Devices are recorded upon arrival at the pharmacy and stored within the surgical department. A predefined selection of implants of various sizes is made available in the operating room, allowing surgeons to choose the most suitable option for each procedure.
After implantation, the surgeon completes the implant form and registers the device in the National Registry, while the pharmacy issues the corresponding billing order.
What has been achieved?
The consignment stock ensures the availability of different sizes according to patient needs and provides cost savings, as devices are billed only after implantation, thereby reducing product expiry.
Computerized registration guarantees accurate tracking of serial numbers and UDIs in compliance with MDR regulations and the National Breast Implant Registry.
In 2024, a total of 106 breast implants were made and registered, with a stock expiry rate of 0%. Currently, 47 devices, including sizers and implants, are available in the consignment stock.
What next?
This management model has already been extended to other class III devices, such as aortic endoprostheses used in vascular surgery, and is increasingly being applied in interventional cardiology. Future implementation is planned for cochlear implants and pacemakers.
COST-EFFECTIVENESS OF PERSONALIZED THERAPY IN A RARE CANCER CASE AT END-OF-LIFE: A REAL-WORLD EXPERIENCE
European Statement
Clinical Pharmacy Services
Author(s)
Rossella Centola, Elisabetta D’Amico, Stefano Morabito, Maria Alfieri, Maria Giovanna Elberti, Lucilla Grisi, Giorgio Lilla, Amelia Filippelli, Francesco Sabbatino
Why was it done?
Precision Medicine (PM) in oncology remains a highly debated topic within Italian healthcare institutions. Currently, Next-Generation Sequencing (NGS) tests are not included in the Essential Levels of Care (LEA), and reimbursement policies vary across regions. Moreover, most targeted therapies based on mutational profiling are prescribed off-label.
What was done?
This study aimed to conduct a cost-effectiveness analysis of a personalized cancer therapy administered in an end-of-life setting.
How was it done?
Clinical and prescription data were collected for a targeted treatment with olaparib. Data were presented as a case report, and median progression-free survival (PFS) and overall survival (OS) were calculated in months. A cost-effectiveness analysis was performed comparing standard care with NGS-driven therapy, using company management software to estimate healthcare expenditure. The Incremental Cost-Effectiveness Ratio (ICER) was calculated and compared against a willingness-to-pay (WTP) threshold of €60,000, considering the rarity of the tumor.
What has been achieved?
The case involved a 56-year-old male diagnosed with cholangiocarcinoma in 2017. After multiple treatments, an NGS test revealed a BAP1 gene mutation associated with a BRCA-like phenotype. Off-label treatment with olaparib 300 mg BID began in June 2019. The personalized therapy resulted in a PFS of 21 months compared to approximately 2 months with best supportive care (standard treatment), and an OS of 48 months versus 29 months, respectively. The cost-effectiveness analysis, conducted from the Italian National Health Service perspective, considered direct healthcare costs including disease management, drug administration, and management of serious adverse events. Personalized therapy showed a survival gain of 2.5 life-years (LY) compared to 1 LY with standard care. The resulting ICER was approximately €45,000 per LY gained—well below the €60,000 WTP threshold.
What next?
This case illustrates that applying PM in end-of-life care for a rare cancer can yield significant survival and economic benefits. These findings highlight the need for greater integration of PM into clinical trials, structured data-sharing networks, and the establishment of solid evidence-based and pharmacoeconomic frameworks.
REVOLUTION IN MEDICATION RECONCILIATION: DEVELOPMENT AND IMPLEMENTATION OF A DIGITAL TOOL TO PRIORITIZE PATIENTS IN RECONCILIATION.
European Statement
Clinical Pharmacy Services
Author(s)
Mireia Coll-Vinent Ollé, Alba Martin Val, Lidia Estrada, Adrián Vilariño Seijas, Ana Cia Hidalgo, Marlene Álvarez Martins, Clara Rodríguez González, Júlia Galí Fortuny, Raquel Gil Bardají.
Why was it done?
Care transitions are a major source of medication errors; therefore, therapeutic reconciliation plays an essential role in patient safety and treatment continuity. However, increasing workload and limited staff make it unfeasible to conduct thorough reconciliation for all patients systematically. The aim of this initiative was to develop a tool that enables prioritization of patients in therapeutic reconciliation and high-risk medication-related problems (MRPs) detection
What was done?
A digital tool was developed and implemented to prioritize patients for therapeutic reconciliation at hospital admission and discharge. This approach allows hospital pharmacists to focus on patients with the greatest need for reconciliation, optimizing available resources and improving care continuity. The tool integrates structured clinical data from multiple sources: hospital and primary care records, electronic prescriptions, laboratory results, and nursing documentation.
How was it done?
A multidisciplinary team composed of clinical pharmacists and data engineers was established to design and implement the tool. Intelligent algorithms were developed to detect predefined alerts related to pathological history, inappropiate medication, anticholinergic burden, MRPs, drug–diagnosis and drug–parameter interactions, and drugs increasing fall risk. The tool was first validated through a pilot project, after which the algorithms were redefined based on preliminary results. Obstacles such as data integration from different systems, synchronization, and resource constraints were addressed by close collaboration with IT teams, and practical application of the tool.
What has been achieved?
The tool successfully reduced the time required for reconciliation by automatically prioritizing high-risk patients. It facilitated early detection of MRPs, leading to timely interventions and preventing potential adverse drug events. It also strengthened communication between hospitals, primary care, community pharmacies, and social-health centers, and supported health-care continuity.
What next?
This initiative represents a scalable model of good practice. It can be expanded to other hospitals and care settings where provided clinical data are structured and IT integration is feasible. Its adoption in broader healthcare contexts could optimize therapeutic reconciliation processes, reduce errors, and enhance patient safety across systems.
DEPLOYMENT OF FLASH TRAINING SESSIONS ON HIGH-RISK MEDICATIONS IN CARE UNITS AS PART OF MEDICATION SAFETY
European Statement
Clinical Pharmacy Services
Author(s)
Cartaillac-Julien C.(1), Danjean S.(1), Demazière V.(1)
Why was it done?
As part of the 2026 HAS certification, the “Medication Safety” group launched short training sessions for nurses on high-risk medications. Designed by a pharmacy resident and validated by a nurse, these sessions were implemented despite limited resources and 12-hour shifts.
What was done?
To strengthen medication safety by maintaining a consistent level of knowledge among nurses through regular, unit-based sessions.
How was it done?
These 20-minute “flash” trainings, integrated into continuing education, are conducted by a pharmacy resident directly within care units to optimize staff time. An anonymous 12-question MCQ is completed before and after each session to measure impact. The interactive slideshow format promotes discussion, and participants receive a pocket summary of key points. Satisfaction questionnaires assess the program’s quality in line with QUALIOPI standards. The first module focused on anticoagulants, high-risk drugs frequently involved in “Never Events.” Developed from official and nursing references and reviewed by a frontline nurse, it covers indications, side effects, contraindications, interactions, interprofessional communication, and patient counseling.
What has been achieved?
Seventeen sessions were delivered across eight departments, involving 45 nurses. Small-group formats required several sessions per unit. Knowledge improved, with mean scores rising from 14.2/20 to 16.3/20 (+14.8%). The least-known topics were bleeding signs, indications, and management of missed doses.
Nurses valued the practical content and on-site format, which saved time. Opinions on duration were mixed—some found 20 minutes too short, others saw it as the only feasible format. Unit managers praised the pharmacy team’s adaptability. Participants requested new topics such as antibiotics, antidotes, insulins, potassium, and adverse drug effects, as well as stronger physician involvement.
What next?
These successful short trainings foster collaboration between nurses and pharmacists, standardize practices, and improve medication safety. The initiative will continue with additional modules and expanded participation from other professionals, contributing to a shared culture of safe medication use.
RISK-DRIVEN TRANSFORMATION: INTEGRATED RISK MATRIX WITH PDCA AND KPIS IMPROVES MEDICATION SAFETY AND OPERATIONAL PERFORMANCE
European Statement
Patient Safety and Quality Assurance
Author(s)
Vanusa Barbosa Pinto, Andréa Cássia Pereira Sforsin, Cleuber Esteves Chaves, Carolina Broco Manin, Priscila Faria França, Amanda Magalhaes Vilas Boas Cambiais, Carolina Ferreira Dos Santos, Lidiane Baltieri Gomes, Priscilla Alves Rocha, Maria Cleusa Martins
Why was it done?
The Pharmacy Division of a large tertiary hospital implemented structured risk governance, anchored by a risk matrix integrated into strategic planning and monitored by Key Performance Indicators (KPIs). The primary goal was to reduce risks across the entire medication use process—from selection to administration—using the matrix to guide continuous improvement cycles (PDCA) and ensure proactive, predictive risk management.
What was done?
Tertiary hospitals with complex medication processes often face a high incidence of adverse events and waste due to fragmented risk management. The aim was to proactively mitigate risks classified as high and extreme, not only enhancing medication safety but also improving efficiency and operational response time. The initiative also sought to strengthen the internal safety culture by encouraging increased near-miss reporting.
How was it done?
The project involved an end-to-end mapping of pharmaceutical care in 2024, with risk scoring (probability x consequence). Critical KPIs were defined: service level, prescription evaluation rate, adverse event reports for compounded products, and near-miss reports. Results were reviewed in multi-professional committees to guide PDCA improvement cycles. One specific action plan involved implementing Personal Digital Assistants (PDAs) in medication distribution to enhance traceability.
What has been achieved?
Between 2024 and 2025, the absolute number of risks classified as extreme decreased, and five risks reduced their criticality. The intervention demonstrated objective gains: service level increased from 77.82% to 84.40%; adverse event reports for compounded products decreased from 11 to 6; and the average monthly near-miss reports increased from 34 to 44, strengthening the safety culture. Notably, the PDA implementation contributed to the medication traceability rate increasing from 12.5% to 50.2%.
What next?
This governance model, focused on risk mitigation through PDCA cycles and critical KPIs, proved to be a practical and effective strategy for achieving sustainable gains in medication safety and efficiency. The practice is highly transferable and scalable, reinforcing the strategic role of the hospital pharmacy in integrating planning, quality, and technological innovation, and serving as a benchmark for other high-complexity institutions.
STRUCTURED INNOVATION GOVERNANCE: AN INTERPROFESSIONAL COMMITTEE IN HOSPITAL PHARMACY
European Statement
Introductory Statements and Governance
Author(s)
Vanusa Barbosa Pinto, Cleuber Esteves Chaves, Andréa Cássia Pereira Sforsin, , Priscila Faria França, Mayara Araújo Dias, Erik Magnus Lindh, Caroline Sandoli de Almeida Souza, Maria Cleusa Martins, Maristela Barros De Sousa, Rafael Alves de Souza,
Why was it done?
We implemented a structured, interprofessional Innovation Committee within the hospital pharmacy to systematically manage the entire innovation pipeline. The team, comprising pharmacists, nutritionists, physicians, and Information Technology (IT) specialists, established a formal process to guide high-potential projects from initial ideation to final submission for competitive funding. This governance model was successfully applied in 2025 at the pharmacy of a public teaching hospital.
What was done?
Innovation often lacks strategic coordination in hospital pharmacy, limiting the translation of valuable ideas into robust projects. Our objective was to overcome this unstructured environment by creating a governance framework. The committee began its work by specifically focusing on identifying deep clinical “pain points,” such as fragmentation in antimicrobial management, difficulty in customizing medication dosages, and low adherence to training programs for Generation Z staff.
How was it done?
Projects were prioritized based on a methodology that weighed clinical impact, economic feasibility, and technical executability. The team utilized agile management tools, including the value-versus-effort matrix and the problem-solution canvas, complemented by sprint rituals to ensure progress and alignment. The committee successfully generated and developed three large, scalable proposals, validating the model’s capacity to identify and mature high-impact ideas. These proposals were submitted to a competitive institutional innovation grant (In.Cube-InovaHC).
What has been achieved?
The structured process resulted in a robust innovation pipeline with three high-potential proposals: PrintPharma (3D-printed personalized medications), FarmáciaLab (a gamified platform for team training), and Sentinela-ATB (an antimicrobial stewardship hub). The PrintPharma project, which aimed to develop an in-hospital 3D printing solution for personalized medicines, was ranked 8th among 134 highly competitive proposals in a major institutional innovation grant (In.Cube-InovaHC). This ranking validated the quality and maturity of the committee’s output.
What next?
This structured, pharmacy-managed innovation pipeline is a feasible and high-impact strategy that significantly strengthens the institution’s capacity to drive change. It should be considered a best practice example because the governance model and its agile tools are fully replicable and adaptable by any other hospital pharmacy, establishing the pharmacist as a protagonist in healthcare 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.
FIRST INDIVIDUALISED BACTERIOPHAGE INTRAVENOUS TREATMENT OF A PATIENT IN THE CZECH REPUBLIC
European Statement
Production and Compounding
Author(s)
Michal Kočí, Kateřina Grygarová
Why was it done?
Individualised bacteriophage therapy has not previously been used in the Czech Republic. A polymorbid patient was treated for over two years for recurrent spondylodiscitis caused by methicillin-resistant Staphylococcus aureus (MRSA). Despite various antibiotic regimens, the infection could not be controlled, leading to repeated hospitalisations. Based on international experience, the medical-head of the infectious diseases department asked the hospital pharmacy to procure a bacteriophage medicine active against the patient\’s specific pathogen.
What was done?
The objective was to analyse the legislative pathway and subsequently secure approval for, prepare, and administer individualised phage therapy as a salvage treatment for a patient with a chronic, antibiotic-resistant infection.
How was it done?
In collaboration with the infectious disease clinic and a domestic phage manufacturer, the optimal regulatory route was identified and an approval for using the active pharmaceutical ingredient containing bacteriophage for final drug preparation was requested from the Ministry of Health and the State Institute for Drug Control. The hospital pharmacy coordinated the entire submission process, overcoming regulatory and production challenges. Following approval, the pharmacy secured the delivery and developed a new Standard Operating Procedure (SOP) for the aseptic preparation of the phage lysate for intravenous administration.
What has been achieved?
After successfully obtaining all approvals, the pharmacy prepared and dispensed 35 intravenous infusions. Following the therapy, the patient has remained symptom-free for nine months and significant clinical improvement was observed. The infection is currently considered effectively treated, and no further infection-related hospitalisations have been necessary. This outcome demonstrates the successful implementation of a complex therapeutic strategy, from regulatory navigation to clinical application.
What next?
This pioneering initiative demonstrates that individualised bacteriophage therapy might be, in some cases, a feasible and safe option for patients with untreatable, multi-resistant infections. It highlights the crucial role of the hospital pharmacist in this process. Significantly, this first-in-country application sparked a nationwide expert debate and directly contributed to the establishment of a Ministry of Health working group on bacteriophages. This established pathway could be transferable to other Czech hospitals, and possibly even to other European countries.
POST-CONSTRUCTION CLEANROOM COMMISSIONING AND OPERATIONAL IMPACT: A COMPLIANCE-DRIVEN APPROACH TO USP STANDARDS
European Statement
Production and Compounding
Author(s)
Natalie Kuchik PharmD, MS, BCSCP and Jacalyn Rogers PharmD, MS, BCPS, CPEL, FASHP and Victoria Lubarsky RPh, MBA., BCACP
Why was it done?
Due to evolving and increasingly stringent USP requirements, multiple cleanroom construction and renovation projects were necessary to ensure continued compliance. These upgrades were critical to maintaining sterile compounding capabilities, keeping pharmacy operations uninterrupted, and safeguarding patient care.
What was done?
Each cleanroom underwent a structured post-construction commissioning process, including environmental certification, workflow validation, staff re-training, and installation of continuous monitoring systems. Pharmacy operations were strategically coordinated to minimize disruption during each phase.
How was it done?
Third-party experts conducted ISO-class environmental testing and microbial sampling. Pharmacy teams performed workflow simulations to assess layout and aseptic technique. Updated SOPs were implemented, and staff received targeted training. Real-time monitoring tools were installed to track pressure, temperature, and particle counts.
What has been achieved?
All renovated cleanrooms achieved full USP compliance prior to go-live. Pharmacy operations remained efficient, with no delays in patient care. Staff confidence improved, and workflow efficiency increased by 25%. No adverse events or regulatory citations were reported.
What next?
We plan to develop a standardized cleanroom commissioning protocol for future projects and share it across our hospital network. Ongoing monitoring, periodic revalidation, and continuous staff education will support sustained compliance and operational excellence.
BRIDGING GENERATIONS TO STRENGTHEN HOSPITAL PHARMACY DEPARTMENTS
European Statement
Education and Research
Author(s)
Edurne Fernandez de Gamarra-Martinez; Begoña Tortajada-Goitia; Monike de Miguel-Cascon; María Alfonsín-Lara; Hilario Martínez-Barros; Carles Quiñones-Ribas; Covadonga Pérez Menéndez-Conde; Eva Negro-Vega
Why was it done?
A generation is defined as a group of people who, having been born around the same time and received similar education and cultural and social influences, adopt a similar attitude. According to the Spanish Society of Hospital Pharmacy (SEFH) membership database, four generations currently coexist in Spanish Hospital Pharmacy Departments (HPD): Baby Boomers (8%), Generation X (32%), Millennials (52%), and Generation Z (8%). This generational diversity can result in different professional approaches, shaped by varied worldviews and experiences.
To explore this topic, we first conducted a survey to assess intergenerational relationships among hospital pharmacists and their impact on learning and professional development. Within this context, the SEFH published a report and launched the SEFHFUTURE project to address generational coexistence in the workplace.
The project was presented during the 2024 SEFH National Congress. The first initiative was the ‘Intergenerational Dialogues’ conference: a pilot session designed to raise awareness among hospital pharmacists about the value of generational diversity in the professional environment.
What was done?
We organized a meeting titled Intergenerational Dialogues. Four groups of ten hospital pharmacists—each representing one of the current working generations—came together to share their perspectives in an open, respectful, and collaborative setting.
How was it done?
We applied the listening circle methodology, forming one circle per generation, and carried out a collective debrief to share the identified aspects. We structured the dialogue around four strategic themes: Knowledge Transfer, Professional Expectations, Workplace Well-being and People Management.
What has been achieved?
Despite generational differences, participants from all groups expressed shared concerns around both professional and personal matters, emphasizing well-being and workplace climate as key areas for development within HPD. Setting aside stereotypes, the experience provided by a generation can be complemented by the innovation contributed by others.
The session identified intergenerational differences that must be managed to prevent generational gaps and transform the challenge into opportunities.
What next?
This initiative lays the groundwork for developing targeted strategies to address current and future challenges of generational diversity within HPD. Moving forward, we aim to design and implement actions that promote synergy among professionals, support both personal and career development, and enhance collaboration, coexistence, and performance across all generations of hospital pharmacists.