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.
OPTIMIZED LABELING OF PREFILLED CATECHOLAMINE SYRINGES PREPARED FULLY AUTOMATED IN HOSPITAL PHARMACY
European Statement
Patient Safety and Quality Assurance
Author(s)
David Ackermann
Dr. Judith Thiesen
Prof. Dr. Irene Krämer
Why was it done?
Recently we started batchwise preparation of 10 mL prefilled syringes (PFS) containing different active substances and concentrations using APOTECAsyringe. The syringes are automatically filled, capped, and labeled. However, layout and formatting of the inline printed labels (only black printing) needed improvement to avoid look-alike errors. Moreover, readability of PFS labels is compromised, since labels are wrapped around the syringes. Good labeling is absolutely necessary when norepinephrine (NE) 10 µg/ml, norepinephrine (NE) 100 µg/ml, and epinephrine (E) 100 µg/ml PFS are delivered in a set of three to be used in emergency cases. Erroneous identification of the PFS can have serious consequences for patients.
What was done?
Based on the national guideline and the international standard (ISO 26825) we decided to go for color-coded labeling and Tall Man lettering to maximize the difference between the two similar drug names. For E and NE the recommended label color is pink, on E labels the drug name is printed in pink on black background. Measures to enhance the readability of the labels were limited by the predefined size of the label and a scarce label assistant in the software.
How was it done?
Drug names and concentrations were printed in bold letters on the best visible part of the PFS label. The Tall Man lettering chosen was NORepinephrin and EPINEPHrin. To ease the identification of the two different NE concentrations, for NE 10 µg/mL a darker pink label was chosen and for NE 100 µg/mL the concentration was underscored. On E labels, the recommended black background was printed as bar beyond the drug name.
What has been achieved?
An optimized printing image of inline printed labels for pharmacy prepared NE and E PFS was successfully developed. The optimized labeling enhances readability of the PFS labels and contributes to reduced error rates in emergency cases.
What next?
Three months after implementation of the optimized PFS labels a survey among users is planned to evaluate the need for further optimization.
FROM LEARNING TO PRACTICE: THE ROLE OF THE HOSPITAL PHARMACY RESIDENT IN PRIMARY CARE
European Statement
Education and Research
Author(s)
Ciuciu David, CD; Campabadal Prats, C; Salom Garrigues, C; Romero Denia, M; Suñer Barriga, H; Pascual Carbonell, D; Bejarano Romero, F; Canadell Vilarrasa, L.
Why was it done?
The integration of Hospital Pharmacy Residents (HPr) into primary care (PC) services represents an essential step toward strengthening the continuity of care between hospital and community health centers. Through this collaboration, safe, efficient, and evidence-based pharmacotherapy is promoted, while keeping the patient at the center of the healthcare system. By involving HPr in multidisciplinary teams, the program aims to enhance medication management, optimize therapeutic outcomes, and reduce the incidence of adverse drug events.
What was done?
To describe the role of the HPr in PC services and demonstrate the importance of their contribution to well-keeping relationships between primary and specialized care.
How was it done?
The involvement of the HPr in PC services was classified into clinical, educational, and management activities. To develop their activities, a HPr rotation was scheduled and carried out within a Healthcare Management area, responsible for overseeing 20 PC centers and 20 nursing homes (NH). Within this area, the PC pharmacy team consists of eight pharmacists who perform medication reviews across.
Rotation steps:
Training: HPr receives instruction on PC protocols, quality indicators, and digital tools, including prescription management and indicators recording systems.
Clinical review: HPr evaluates prescriptions, modify treatments based on clinical evidence, and apply a person-centered approach, focusing on complex chronic and institutionalized patient’s guidelines.
Multidisciplinary collaboration: Take an active part in meetings with general practitioners (GP), nurses, and PC pharmacists to discuss patient cases and optimize pharmacotherapy.
Health education: Provide training to nurses and GP residents on rational drug use, adverse reactions, and sustainability.
Evaluation: Oversee the impact of pharmaceutical interventions and suggest continuous improvement measures.
What has been achieved?
A total of 416 interventions were recorded, distributed as follows:
56.7%: Drug discontinuation due to non-adherence, not indication or therapeutic simplification.
23.1%: Therapeutic switches for efficiency.
7.7%: Changes to another molecule.
6.7%: Regimen deintensification.
4.8%: Regimen intensification.
Additionally, 46 interventions were conducted in NH:
52.2%: Drug discontinuation due to overcontrol or lack of indication.
23.9%: Regimen deintensification due to overcontrol.
17.4%: Therapeutic switches for efficiency.
6.5%: Drug initiation due to lack of control.
What next?
The participation of HPr in PC resulted in a significant increase in pharmaceutical interventions, which contribute to safer, more effective and efficient pharmacotherapy and promotes superior coordination between healthcare levels. Also contributed to the education of family and community medicine residents, enhancing their skills in managing complex chronic patients. This experience demonstrates the value of integrating pharmacy residents into primary care and may be replicated in other hospital pharmacy services with similar organizational structures.
TRANSFORMING MEDICATION RECONCILIATION: PHARMACY-ASSISTED PROCESSES IN LARGE ACADEMIC MEDICAL CENTER
European Statement
Patient Safety and Quality Assurance
Author(s)
Victoria Lubarsky, Jacalyn Rogers, Nataly Kuchik
Why was it done?
Accurate home medication history and admission reconciliation are critical during care transitions to prevent harm. In my hospital, the medication history team reviews over 85% of daily admissions, yet providers often face challenges with timely reconciliation. To address this, the pharmacy team proposed a dual-approach initiative: provider education to support reconciliation within 24 hours of admission, and a pharmacy-assisted process enabling pharmacists to reconcile select medications or collaborate with providers to finalize reconciliation.
What was done?
This initiative aimed to meet the hospital’s quality goal of achieving 90% completion of accurate admission medication reconciliations within 24 hours. A retrospective observational study was conducted over nine months in 2024. Data collected was quantitative, focusing on medication reconciliation completion rates, pharmacist interventions, and provider engagement. Descriptive statistics analyzed trends and measured improvements in reconciliation rates.
How was it done?
A dual-strategy approach was implemented: provider education and pharmacy-assisted workflow. A standardized flow sheet and enhanced EMR patient lists improved provider visibility. A new procedure and dashboard enabled pharmacists to identify incomplete medication reconciliations within 24 hours and intervene by reconciling select medication classes (e.g., OTCs, supplements, duplicates, long-acting meds), communicating via secure chat to resolve discrepancies, and documenting post-reconciliation additions in pharmacy notes. Prior to admission, home medication lists were reviewed by pharmacy technicians using the MARQUIS framework to support reconciliation accuracy.
What has been achieved?
A quantitative analysis using descriptive statistics was conducted to evaluate changes in medication reconciliation completion rates before and after implementing the initiative. • Overall reconciliation completion rates increased by 30 percentage points, from 52% to 82% over nine months • The pharmacy team’s consistent contribution accounted for 15% of the total improvement • Provider education accounted for an additional 15%, with 13% from pharmacy’s provider outreach and 2% from education initiatives and process awareness.
What next?
This initiative demonstrates the effectiveness of provider education and pharmacy-assisted processes in improving timely and accurate medication reconciliation outcomes and patient safety during care transitions. Future directions include expanding pharmacy-assisted hours and replicating the model across additional hospital sites to broaden impact and strategize best practices.
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.
DEVELOPMENT OF DEDICATED INFORMATION BROCHURES TO IMPROVE THE MANAGEMENT AND SAFETY OF PAEDIATRIC GALENIC MEDICINAL PREPARATIONS
European Statement
Patient Safety and Quality Assurance
Author(s)
S. GAMBA1, M. FRANCHINA1, M. GIACONIA1, C. INTRA1, M. CASTIGNONE1, E. PANETTA1, G. D’ARENA1, C. PERASSO1, P. BARABINO1, G. SPIGA2.
1IRCCS GASLINI, HOSPITAL PHARMACY, GENOVA, ITALY.
2IRCCS GASLINI, CLINICAL GOVERNANCE, GENOVA, ITALY
Why was it done?
Paediatric galenic preparations are essential for neonates, patients with rare diseases, and those requiring highly individualised treatments or unable to swallow solid dosage forms, for whom no commercial alternatives exist. Despite widespread use, there is a significant need for accessible, user-friendly guidance to support correct home administration. Lack of clear instructions increases the risk of dosing errors—particularly during dose conversion or with multi-dose containers—a safety concern highlighted by regulatory bodies such as the Italian Medicines Agency (AIFA). To address this, the initiative aims to improve the safety and effectiveness of home administration through a personalised educational brochure for patients, caregivers, and healthcare professionals.
What was done?
A personalised brochure was created to guide patients and caregivers in the safe home administration of paediatric galenic medicines. It covers therapeutic indications, composition, storage, dosage and conversion, posology, management of missed doses, potential interactions and side effects, and instructions for medicine collection from the hospital pharmacy. A satisfaction questionnaire is distributed at dispensing to gather feedback for iterative improvements.
How was it done?
The brochure was developed collaboratively by pharmacists and prescribing physicians to ensure accuracy and consistency, so that all patients receive standardised information. Written in plain language and supported by icons, it is easy to understand. A QR code linking to a digital version allows continuous access via smartphone. Feedback from the questionnaire informs ongoing refinements.
What has been achieved?
This initiative reflects the evolving role of hospital pharmacies toward a clinical, patient-centred, and collaborative model. The brochure serves as both an informative resource and a practical tool for patient empowerment, improved communication, and enhanced care quality. In paediatrics—where treatments require heightened attention—this tool bridges the information gap, supporting patients and caregivers and increasing medication safety.
What next?
Ongoing feedback will be used to refine the brochure and digital resources. The initiative will expand to additional paediatric units and be adapted for other patient groups requiring complex or individualised therapies. Collaboration between healthcare professionals and families will continue to ensure accuracy, usability, and patient-centred design. Long-term monitoring will assess the impact on medication safety, adherence, and clinical outcomes, with potential wider application across other therapeutic areas and hospital settings.
FAILURE MODE AND EFFECTS ANALYSIS OF A TERTIARY LEVEL HOSPITAL ANTIDOTE STORAGE
European Statement
Patient Safety and Quality Assurance
Author(s)
Sánchez Suárez MM¹, Montero Lázaro M², Martín Roldán A², Maganto Garrido S², Sánchez Sánchez MT²
Affiliations
¹Pharmacy Department, Hospital Comarcal de Baza, Granada, Spain
²Pharmacy Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
Why was it done?
Antidote availability is critical for the management of poisoning and overdose cases. Although hospital protocols for antidote use exist, they are often inconsistent or incomplete, and there is no universal consensus on the essential antidotes that hospitals should stock. This initiative aimed to assess and optimise the antidote inventory in a tertiary hospital to ensure adequate supply and management.
What was done?
A comprehensive review of all antidotes stored in the hospital pharmacy was conducted, focusing on quantity, expiry date, and compliance with national and international recommendations. A failure mode and effects analysis (MFEA) was developed to identify potential risks and propose corrective measures.
How was it done?
A prospective cross-sectional study was performed. The antidote stock was compared with reference lists from other hospitals and published guidelines to evaluate discrepancies in composition and quantities. Data accuracy in the electronic stock records was assessed, and errors in inventory management were categorised. Improvement actions included updating the antidote list, correcting electronic records, defining minimum and maximum stock levels, and implementing a poisoning management protocol. One year after these measures, the stock was re-evaluated.
What has been achieved?
The initial audit identified 48 antidotes (3 compounded formulations); 10% were out of stock, 16% below the required minimum, and 2% expired. Digital record review revealed 64% with data inconsistencies, including missing quantity limits, mismatched real and computerised stock, and incorrect expiry or batch details. After implementing corrective actions, no expired antidotes were found, only two compounded formulations were missing, and all others met minimum stock requirements.
What next?
Continuous monitoring of antidote stocks and regular data validation are necessary to maintain readiness for toxicological emergencies. Extending this model to other hospitals could support the establishment of unified national standards.
IMPLEMENTING FAILURE MODE AND EFFECTS ANALYSIS TO IMPROVE ISOLATOR HANDLING PRACTICES IN CHEMOTHERAPY PREPARATION: A TRANSFERABLE MODEL FOR HOSPITAL PHARMACIES
European Statement
Patient Safety and Quality Assurance
Author(s)
S. EL DEEB, I. BENNANI, A. CHERIF CHEFCHAOUNI, S. ALAOUI, S. HAJJAJ, S. BOUFARESS, S. EL MARRAKCHI, B. MOUKAFIH, F.Z. BANDADI, Y. HAFIDI, A. EL KARTOUTI.
Why was it done?
In the oncology pharmacy, isolators are vital for aseptic compounding and operator protection. However, daily handling steps can still introduce contamination risks and affect patient safety. We recognized the need to systematically analyse and minimize these risks, especially in a resource-constrained setting, to ensure safer and more standardized chemotherapy preparation practices.
What was done?
We applied Failure Mode and Effects Analysis (FMEA) to identify and reduce risks in isolator handling during chemotherapy preparation. The objective was to evaluate each step of the process, implement corrective measures to lower risk priority numbers (RPNs), and develop a practical model that could be shared with other hospital pharmacies.
How was it done?
An observational checklist was used to evaluate six key isolator handling steps: glove installation, surface cleaning, material transfer, logbook entry, waste removal, and glove removal. During 100 routine preparations, failures were recorded to calculate occurrence scores. Severity and detection were assessed by an interdisciplinary team, and risk priority numbers (RPNs) were obtained by multiplying severity, occurrence, and detection scores.
What has been achieved?
The analysis identified surface cleaning, material transfer, and glove installation as the most critical steps, with RPNs of 240, 210, and 144 respectively. These represented the main contamination and safety risks. After implementing targeted corrective actions, including improved procedures and staff awareness, we projected significant reductions in RPNs to below 80, confirming the effectiveness of the intervention.
What next?
We will continue to apply and monitor the corrective measures through updated SOPs, dedicated monitoring tools, and continuous staff training to ensure sustained improvement. This initiative offers a transferable model that other oncology pharmacies can adopt to harmonize practices and strengthen patient and operator safety in chemotherapy preparation.
MEDICATION ERROR IN A CLINICAL TRIAL: ROOT CAUSE ANALYSIS AND IMPROVEMENT ACTIONS
European Statement
Patient Safety and Quality Assurance
Author(s)
Cristina Garcia Fernandez, Estela Alamino Arrebola, Bárbara Lopez Bautís, Carmen Gallego Fernandez, Begoña Tortajada Goitia.
Why was it done?
Patient safety in clinical trials relies on the correct management of both investigational and auxiliary/comparator medications. While investigational products are usually managed through automated systems (e.g., IWRS) ensuring traceability and standardization, auxiliary medications often lack similar oversight from sponsors. A preventable medication error in an oncology clinical trial—caused by the preparation of an incorrect drug concentration due to the absence of automated supply and harmonization—highlighted the need to analyze system gaps and implement corrective actions to strengthen patient safety and medication traceability.
What was done?
A Root Cause Analysis (RCA) was conducted following the detection of a medication error involving the preparation of hospital stock (20 mg/mL) instead of the clinical trial formulation (10 mg/mL). The objective was to identify systemic weaknesses and design a Corrective and Preventive Action (CAPA) plan aimed at preventing recurrence and improving management of auxiliary medication in clinical trials.
How was it done?
The RCA was performed in July 2025 using the “5 Whys” methodology, supported by:
-Document review, staff interviews, and chronological reconstruction of the event.
-Analysis of human, technical, communicative, and organizational factors.
-Classification of the incident (NCC MERP category D — no patient harm).
Corrective measures implemented included:
– Creation of a pre-trial pharmacy checklist to ensure drug availability and concentration verification.
– Mandatory pharmaceutical validation after any protocol amendment.
– Formal requests to sponsors to standardize drug concentrations across sites.
– Improved communication channels between sponsors, pharmacy, and clinical teams
What has been achieved?
-Identification of the main root cause: lack of automation in auxiliary drug supply requiring manual requests.
-Prevention of similar future events through harmonized pharmacy processes.
-Reinforcement of patient safety culture and traceability of clinical trial medications.
-Strengthened collaboration among hospital pharmacy, clinical teams, and sponsors.
-No patient harm resulted from the event, confirming the importance of early detection and system review.
What next?
-Extend IWRS automation and standardization practices to include auxiliary medications in all clinical trials.
-Share the initiative with other hospital pharmacies and sponsors to promote harmonization at institutional and multicenter levels.
-Continue monitoring the implemented CAPA and evaluate its impact on error prevention.
-Foster continuous improvement in pharmacy oversight and communication workflows for clinical research.
OPTIMIZING STERILE AND IMPLANTABLE MEDICAL DEVICE CIRCUITS: CONTRIBUTION OF THE INTERDIAG DMS® TOOL
European Statement
Patient Safety and Quality Assurance
Author(s)
Khalil MEDDINE, Yasmine EL YOUSSOUFI, Madiha ALAMI CHENTOUFI, Houda ATTJIOUI, Driss TANANI, Abdelhafid BENOMAR
Why was it done?
To identify performance gaps and critical points within the sterile and implantable medical device circuits, with the aim of guiding targeted improvements and ensuring safer, more reliable management of these devices.
What was done?
A multidisciplinary self-assessment of the sterile and implantable medical device circuits was carried out using the Interdiag DMS® evaluation tool.
How was it done?
The evaluation was conducted using the Interdiag Excel file, which includes dedicated modules for sterile and implantable medical devices. The analysis focused on the tool’s implementation, the objectives of the self-assessment, the resulting action plans, and feedback obtained throughout the process.
What has been achieved?
The assessment highlighted strong performance in information systems and traceability for implantable devices, but weaknesses were identified in their documentation management. For sterile medical devices, major deficiencies were observed in quality management, transport, and return/disposal processes (10–20% compliance), while pharmacy premises and demand management showed moderate performance (50–60% compliance). These findings allowed for the implementation of targeted corrective actions.
What next?
The findings will guide ongoing targeted improvements, enhance coordination among healthcare stakeholders, and foster a sustainable culture of quality and safety in medical device circuits.