DEVELOPMENT OF PATIENT EDUCATION MATERIALS ON WARFARIN AND DIRECT ORAL ANTICOAGULANTS: A NATIONAL PATIENT SAFETY AND QUALITY IMPROVEMENT COLLABORATIVE
European Statement
Patient Safety and Quality Assurance
Author(s)
Purcell A, Crowley M, Silvari V, O Leary C, Ní Áinle F, Bury E, Savage M, O Neill AM, Garvey S.
Purcell A, Crowley M, Silvari V, O Leary C, Ní Áinle F, Bury E, Savage M, O Neill AM, Garvey S.
Why was it done?
Warfarin and Direct Oral Anticoagulants (DOACs) are internationally recognised as high-alert medicines. The Irish National Health Services Executive (HSE) Clinical Programme for Venous Thromboembolism (VTE) identified the need for standardised, national, patient education materials on these high-alert medicines.
What was done?
This national patient safety initiative was actioned through the National Clinical Programme Patient Information Panel. The panel aimed to develop standardised, national, patient education booklets on warfarin and DOACs, that are trustworthy, easy to read, patient-centric, involve end-users, equitable, sustainable, and accessible for patients and clinical staff.
How was it done?
A multidisciplinary patient information panel including clinical experts and a patient partner was recruited. Panel members were diverse in geography, hospitals, discipline, and expertise. The panel included representation from hospital Chief Pharmacists, Consultant Haematologists, Advanced Nurse Practitioners, and a patient partner.
The panel adopted the principles of Quality Improvement, co-design, plain English guidelines, and used expert -panel consensus methodology followed by iterative cycles of national, expert-panel review and feedback. The prototypes were reviewed by the Irish Medication Safety Network, The Irish Haematology Consultants’ Special Interest Group and the National VTE Clinical Advisory Group.
What has been achieved?
The two patient education booklets contain important safety information for patients including risk-stratified information on side-effects with appropriate actions. The Warfarin booklet contains 17 prioritised questions and the DOAC booklet contains 14 prioritised questions. The two booklets were implemented nationally in July 2025 by the Irish HSE and are freely accessible for patients and clinical staff on the HSE website. These are the first national patient education booklets in Ireland on Warfarin and DOACs, co-designed by iterative cycles of expert panel and patient consensus. They are intended to empower patients with safety information , reduce preventable harm, and support clinical staff with provision of standardised information.
What next?
These booklets are intended to undergo research evaluation using a Patient Education Material Assessment Tool (PEMAT) in conjunction with patient evaluation, followed by continuous cycles of improvement. These booklets may also serve as the basis for adoption or adaptation by regional, national and international patient safety and education panels.
THE CLINICAL PHARMACEUTICAL SERVICE IT TEAM: ENHANCING MEDICATION WORKFLOWS AND PATIENT SAFETY IN EPIC
European Statement
Patient Safety and Quality Assurance
Author(s)
Christina Theil Schnor and Saranya Loganathan.
Why was it done?
In 2018, hospitals in Region Zealand (RZ), Denmark, transitioned to the electronic health record (EHR) system, EPIC. Following this, hospital pharmacists faced repeated medication order challenges causing adverse events such as inappropriate medication orders, dispensing and administration errors, and insufficient workflow coordination. These issues resulted in complex, time-consuming workflows impacting quality and patient safety. Additionally, collaboration between corporate IT and clinical staff was challenged by a lack of understanding of practical issues. To address this, pharmacists of RZ established the Clinical Pharmaceutical Service IT Team (CPS IT Team) to build specialized knowledge of the EHR medication module, aiming to assure quality, optimize workflows, strengthen interdisciplinary coordination, and support safer and more efficient clinical use.
What was done?
CPS IT Team standardized workflows, enhanced coordination of medication order tasks, and created a forum to effectively utilize professional knowledge and networks across areas.
How was it done?
To address diverse Clinical Pharmacy challenges, CPS IT Team became the bridge between internal organization (RZ Hospital Pharmacy and corporate IT) and external partners (EPIC and The Capital Region of Denmark (CRD)). For this reason, CPS IT Team was established with one team manager and two units: Internal and External unit. CPS IT Team continuously adapts to evolving Clinical Pharmacy needs.
What has been achieved?
The establishment of CPS IT Team has driven significant internal optimization and standardized workflows. Acting as a coordinating unit, it optimizes medication processes from ordering to dispensing and administration. Dialogue with IT has been strengthened, enabling more efficient, targeted communication across professional groups.
Collaboration with EPIC and CRD has enhanced quality assurance and optimized workflows. CPS IT Team efforts have helped prevent medication-related adverse events, improve workflows, and optimize medication processes. Interdisciplinary collaboration and professional consultation networks between regional clinics, hospital pharmacies, IT, and EPIC have been notably strengthened. These efforts have increased patient safety and fostered a safer, more coherent workflow in EPIC.
What next?
Fusion of RZ and CRD into Region Eastern Denmark will change CPS IT Team’s working conditions, opening new opportunities such as an expanded collegial network and broader range of tasks and needs. Systematic data use will support Hospital Pharmacy’s work, improving efficiency and quality in daily operations.
OPTIMIZATION OF THE CLINICAL TRIAL CLOSURE PROCESS IN A CLINICAL RESEARCH UNIT OF A HOSPITAL PHARMACY DEPARTMENT (PUI) : VEGACE PROJECT
European Statement
Patient Safety and Quality Assurance
Author(s)
Debaisieux C. (1) ; Gilles M-A. (1) ; Fernando S. (1) ; Zeggagh N. (1) ; Ngeussong A. (1) ; Antignac M. (1) ; Metz C. (1) ; Charbonnier Beaupel F. (1)
Why was it done?
The closure process is a critical stage in clinical trials, ensuring the financial sustainability of the clinical research unit and enabling archiving and relocation to free up storage space. The VEGACE project was designed to reorganize and streamline this process.
What was done?
The initiative aimed to optimize trial closure to improve efficiency, safeguard financial viability, and enhance space management. A structured action plan was developed, focusing on visual management, daily planning, and staff training.
How was it done?
A working group composed of a pharmacy resident, a pharmacy student, and a quality management student implemented the plan between June and August 2025. Visual management was redesigned through a dedicated tracking board displaying each trial’s name, if the closure is urgent or not, and cloture’s status (to do, to validate). Daily scheduling ensured that at least one staff member was consistently assigned to closure tasks. Training sessions involved newly recruited staff, expanding the team’s expertise and engagement.
What has been achieved?
Since the launch of VEGACE, the unit has recorded a substantial increase in productivity. From January to May 2025, only 4 studies were closed, compared with 73 between June and August (4 in June, 13 in July, 56 in August). Over the same period, additional costs amounted to €22,953 before VEGACE versus €239,351 afterwards (€22,138 in June, €77,775 in July, €139,438 in August). In parallel, 3,196 linear meters of clinical trial documentation were archived, freeing valuable storage space. Staff engagement also improved, with 10 members trained compared to only 3 before VEGACE.
What next?
This reorganization has reinforced financial sustainability, optimized space management, and promoted broader staff involvement. The next step will be to ensure continuity by monitoring efficiency through systematic use of the tracking board, cost analysis, and ongoing training of new staff members.
OPTIMIZING DRUG THERAPY AND PATIENT SAFETY IN ILEOSTOMY: A BEST PRACTICE MODEL OF A CLINICAL PHARMACY–LED INTERPROFESSIONAL WORKING GROUP
European Statement
Patient Safety and Quality Assurance
Author(s)
S. Hehenberger, I. Lagoja,
Why was it done?
Metabolic complications as well as altered or reduced drug effects are common in patients with a stoma and require close interprofessional collaboration, particularly after an ileostomy. However, pharmacists are rarely involved in the care of stoma patients, and coordination or communication between the various disciplines is often suboptimal.
What was done?
An interprofessional working group was established to identify the most common metabolic complications associated with ileostomy based on current literature and clinical experience. Preventive measures were formulated and integrated into a structured scheme.
Of particular relevance from a clinical-pharmaceutical perspective:
* Ensuring optimal drug efficacy: A medication analysis framework was developed that addresses the specific challenges of drug therapy in ileostomy patients, followed by routine medication reviews for all inpatients with ileostomies.
* Development of a drug therapy algorithm for high-output stoma (HOS).
How was it done?
A recommendation for action was developed, which is now established and implemented as a standard operating procedure (SOP) throughout the hospital. An interdisciplinary STOMA outpatient clinic has been established to optimize medication, adverse drug reaction management, and the care of stoma patients, thereby improving their quality of life.
What has been achieved?
Through a clinical pharmacy approach involving an interdisciplinary advisory board, readmissions due to adverse drug reactions can be significantly reduced, leading to cost savings for the social system while simultaneously enhancing patients’ quality of life. In 70 reviews almost 400 drug problems (DRPs) were identified, of which more than 60% were stoma-related drug problems. All DRPs and pharmaceutical interventions were categorized and documented. Acceptance of the interventions was also recorded.
What next?
The diverse aspects of ileostomy patient care require interprofessional collaboration. The clinical pharmacist plays a central role in the team and contributes significantly to patient and medication safety and also to the quality of life of ileostomy patients. Measurement of drug levels in plasma further improve the data on drug absorption.
FROM INCIDENT TO INITIATIVE: IMPLEMENTING A MULTI-DISCIPLINARY SURVEILLANCE TOOL FOR PEDIATRIC CONTRAST MEDIA EXTRAVASATION
European Statement
Patient Safety and Quality Assurance
Author(s)
Netchanok Kanjana, Radeepas Suebsaard, Thitinun Raknoo, Jantima Yothapitak
Why was it done?
A serious incident in June 2024 involving pediatric Iodinated Contrast Media (ICM) extravasation requiring enhanced therapy exposed a critical deficiency. Extravasation of ICM occurs in 0.1–1.2% of all injections. In pediatric care, Risk factors include technical and patient-related factors (e.g., impaired communication). Despite these known risks, our regional hospital lacked structured surveillance and a standardized risk assessment tool. The project was initiated to develop and implement a standardized monitoring tool to establish preliminary safety data and a robust framework for prevention and safe management.
What was done?
A standardized, multi-disciplinary pediatric extravasation risk assessment tool was developed and implemented. A subsequent prospective cross-sectional study determined the initial feasibility, incidence, and completeness of assessment, aiming to establish a systematic surveillance mechanism at our hospital.
How was it done?
The structured risk assessment tool was co-developed through multi-disciplinary collaboration involving pediatricians, radiologists, pharmacists, technologists, and nurses. The tool formalized monitoring into three distinct phases: (1) Pre-procedure risk assessment (including patient and catheter risks) by ward nurses, (2) Real-time injection monitoring by technologists, and (3) Post-procedure follow-up (including injection site assessment) by ward nurses. Eligible patients were prospectively enrolled over a two-month period (10 July to 10 September 2024). Data collected focused on patient risk assessment, administration details, adherence (completion rates) to the three-part assessment, and extravasation outcomes.
What has been achieved?
Three pediatric patients underwent ICM administration (mean age 12±1.5 years). The study confirmed the feasibility of multi-disciplinary monitoring using the new tool, despite the small pilot sample. Adherence was mixed: one patient (33.3%) received complete assessment, while two patients (66.7%) were assessed only in sections 1 and 3. Crucially, no extravasation events were reported during this initial surveillance period. The pilot successfully established a new monitoring process, providing initial evidence for clinical workflow implementation viability.
What next?
Future work is essential to standardize and improve adherence to the comprehensive three-part assessment through hospital-wide policy enforcement. The cohort will be expanded significantly to generate statistically robust data on true incidence and risk profiles. The ultimate goal is the integration of this extravasation surveillance into the electronic medical record system to ensure real-time documentation, comprehensive quality improvement, and sustained Patient Safety.
REINVENTING PHARMACOTHERAPY IN PROSTATE CANCER THROUGH STRATIFICATION AND PERSONALIZED DEPRESCRIPTION: OPTIM-CP PROYECT
European Statement
Patient Safety and Quality Assurance
Author(s)
Mª Antonia Meroño Saura
Rebeca Añez Castaño
María García Coronel
Francisco Valiente Borrego
Elena Urbieta Sanz
Why was it done?
Prostate cancer patients are often elderly, frail, and chronically medicated. The introduction of new hormonal therapies has increased treatment complexity and the risk of drug-related problems. Despite evidence linking excessive polypharmacy to poor outcomes, structured deprescribing models are rarely applied in oncology. OPTIM-CP was introduced to address this unmet need by integrating validated stratification tools (Risk stratification model (EM) for the pharmaceutical care of oncology patients with solid or hematologic neoplasms (SEFH)) into routine practice to prioritize patients at highest risk and guide pharmacist-led interventions.
What was done?
The OPTIM-CP initiative was developed to improve the safety and quality of pharmacotherapy in patients with prostate cancer. It implemented a structured pharmaceutical care model based on clinical-pharmacological risk stratification and individualized deprescribing.
How was it done?
A multidisciplinary working group of clinical pharmacists reached consensus on the practical adaptation of the EM to prostate cancer patients, ensuring consistency and clinical validity. Eligible patients receiving oral hormonal therapy were identified and stratified during pharmaceutical care consultations in the Hospital Pharmacy Department through. According to their assigned risk level, follow-up intensity was adapted. Medication reconciliation was performed using the regional electronic prescribing system to ensure accuracy and coherence across hospital and primary care records.
What has been achieved?
The initiative achieved full integration into the hospital’s outpatient pharmacy circuit. A total of 111 patients were stratified during pharmaceutical care consultations. The mean age was 78,25 ± 9,6 years, and most were treated for hormone-sensitive metastatic disease. According to the ME, 4.5% were classified as high risk, 38.7% as intermediate, and 56.8% as low risk. Polypharmacy was present in 73% of patients, and 72% used at least one high-risk medication. Treatment-related variables were the main contributors to overall risk.
The implementation of the stratification model improved communication with patients, reduced medication discrepancies, and allowed prioritization of high-risk patients for closer follow-up.
What next?
OPTIM-CP is now being consolidated as a permanent part of routine care. The next phase focuses on the systematic deprescribing of potentially inappropriate medications identified during stratification, using validated decision-support tools (CheckTheMeds®) and shared decision-making with clinicians. Future steps include expanding the model to other oncologic populations.
IMPLEMENTATION OF A PHARMACEUTICAL VALIDATION SUPPORT PROGRAM THROUGH AN ALERT SYSTEM INTEGRATED INTO THE ELECTRONIC HEALTH RECORD
European Statement
Patient Safety and Quality Assurance
Author(s)
Laura Rueda Montes, David Tomás González, Iker Muñoz Delgado, María Fernández-Vázquez Crespo, Jesús Airam Domínguez Cháfer, Rocío Manzano Lorenzo, José Carlos Tallón Martínez, Cristina González Pérez, María Ángeles Campos Fernández, Susana Sánchez Suárez, María Teresa Benítez Giménez
Why was it done?
One of the core responsibilities of hospital pharmacists is the validation of inpatient medication prescriptions. Our goal was to identify medication errors that could compromise patient safety, and to optimize and standardize pharmaceutical recommendations, ensuring consistent validation practices across pharmacists. This initiative serves as a tool for quality assurance and patient safety.
What was done?
Design and implementation of an automated alert system for pharmaceutical validation of prescriptions integrated into the Electronic Medical Record (EMR), which generates real-time pop-up alerts based on a database parameterized with clinical rules. During validation, the pharmacist decides whether the alert is appropriate and if accepted, a notification is added to the medical prescription, as well as a record of this intervention in the EMR.
How was it done?
Key pharmaceutical interventions (PIs) were established to optimize prescription validation, grouped into two categories:
• Drug-dependent interventions: 577 PIs classified into 9 groups: maximum dose, therapeutic duplication, drug interactions, gastroprotection, laxative prophylaxis with opioids, incorrect administration techniques, treatment duration, potentially inappropriate medications in older adults, and sequential therapy.
• Patient-specific interventions based on lab data: 398 PIs classified into 7 groups: renal failure, electrylite (magnesium, potassium, and sodium) levels, neutropenia, thrombocytopenia, and anemia.
With support from the IT department, an algorithm was configured using a total of 975 rules that we established for 386 drugs. When a prescription meets any of these rules, an alert pops up in the EMR, displaying a predefined pharmaceutical recommendation tailored to the patient.
What has been achieved?
Implementation of the alert system in the pharmacist’s EMR profile in order to detect medication errors in patients who meet one or more of the rules set in the created algorithm.
Moreover, a dashboard was created displaying the number of interventions by prescribing department, drug, and type of intervention.
Since its launch in April 2025, a total of 3,547 PIs were made for 2,411 patients within six months.
What next?
Ongoing review of existing alerts based on feedback from the pharmacy team, along with the incorporation of new rules to maximize medication safety for hospitalized patients.
IMPLEMENTATION OF A PHARMACEUTICAL CARE CIRCUIT FOR PATIENTS UNDERGOING ASSISTED REPRODUCTION AND RECEIVING HOSPITAL-DISPENSED PHARMACOLOGICAL TREATMENT
European Statement
Patient Safety and Quality Assurance
Author(s)
Salvador Llana, I; Quirós Ambel, HA; Sánchez Pascual, B; Martínez Simón, JJ; Prieto Callejero, A; Pérez Encinas, M
Why was it done?
•Ensure proper selection of patients eligible for hospital-dispensed pharmacological treatment(HT) according to the established criteria.
•Reinforce information about HT, including administration technique and storage.
•Detect medication errors and adverse effects(AEs).
•Address patient questions and improve safety.
What was done?
-Informational Materials: 21 information sheets were created for the drugs involved in the treatment. These included:
•Contact details for the Pharmacy Service(PS).
•Storage conditions for medications (including special situations).
•Detailed administration instructions for each drug, taking into account the patients’ lack of experience.
•Possible AEs, especially those requiring an emergency visit.
•Mandatory excipient declarations, allergies…
-Care Circuit: a structured communication and consultation circuit was established between the Assisted Reproduction Unit(ART Unit) and the PS.
How was it done?
•The informational sheets were distributed during the PC consultations and also made available on the hospital’s website.
•The ART Unit informed the PS daily about eligible patients, and the PS verified treatment suitability.
•An appointment was scheduled before the start of the treatment cycle.
•An in-person consultation was conducted for the dispensing and explanation of the HT. When needed, follow-up calls were made.
What has been achieved?
•From January 2023-December 2024, 301 patients were seen: 85%(258) received HT for one cycle and the remainder for multiple cycles(2–5).
•A total of 4,521 medications were dispensed, being the most common ganirelix 0.25UI(1,095).
•The average duration of the PC consultation was 30–45 minutes, depending on the number of drugs/devices(1–5), totaling an average of 220 PC hours.
•The usefulness of the circuit and patient satisfaction were evaluated through indirect measures(direct observation and adherence rate). Patients expressed satisfaction, highlighting the quality/clarity of the information. Adherence was 100%, based on dispensing records and leftover medication counts. Subsequent consultations confirmed that patients correctly followed administration and storage instructions; only minor errors in administration/storage were found in 2 patients(1.24%), which were corrected without affecting treatment cycles.
•All information sheets underwent readability screening; those exceeding the normal comprehension threshold were simplified.
What next?
•Informative videos on the administration, handling, storage, and disposal of medications.
•A mobile app that includes a calendar to record administration days, tracks AEs, and provides a direct chat for contact with the PS.
CREATION OF A DATABASE ON THE COMPATIBILITY OF IMMUNOSUPPRESSANTS AND MONOCLONAL ANTIBODIES WITH BLOOD DONATION
European Statement
Patient Safety and Quality Assurance
Author(s)
Salvador Llana, I; Sánchez Pascual, B; Vicente Ayuso, MdC; Martín García, V; Sánchez León, MdR; Adeva Antona, S; Pérez Encinas, M
Why was it done?
Our main objective was to optimize donor screening by analyzing the compatibility of L04-immunosupresants(including monoclonal antibodies(mAbs)) with blood donation(BD), addressing the questions raised by donors. It was attended to reduce unnecessary exclusions, improve transfusion safety, and streamline decision-making for healthcare staff in Donor Units(DU) and Pharmacy Services(PS), while also providing open access to information for both healthcare professionals and donors.
What was done?
From the hospital’s PS, a database was created compiling all L04-immunosupresants in Spain up to 2025. The medications were classified according to their compatibility with BD. A color-coded system was implemented for easy interpretation:
-Green: compatible with donation(CD)
-Yellow: requires individual assessment(IA)
-Orange: donation deferred after a washout period(DD)
-Red: incompatible with donation(ID)
Each medication entry also includes an “observations” section to provide additional details.
How was it done?
A detailed literature review was conducted, covering national and international guidelines, scientific articles, and official websites, complemented by direct consultations with pharmaceutical laboratories. To ensure reliability, the database was reviewed and validated by the Hematology Service(HS) and the Regional Blood Bank.
What has been achieved?
-A guide was created (67 drugs, 54 of which were mAbs). Individual information was not found for the vast majority of mAbs, but data were available for the mAbs group as a whole.
-It was concluded that, during active treatment, mAbs are ID(100%). After treatment discontinuation, patients with chronic conditions that contraindicate BD(active cancer, multiple sclerosis, solid organ transplant, gastrointestinal diseases, and other conditions deemed excludable by medical criteria) remain permanently deferred. If the underlying condition does not contraindicate BD, donation may be allowed one year after completing treatment.
-Regarding the rest of the immunosuppressants, 61.5%(8) were ID, 7.7%(1) IA, and 30.8%(4) DD.
-For medications classified as DD, in cases of discrepancies in the consulted literature, the most restrictive deferral period was selected.
-Exact information can be now provided to donors, making it clear whether they are not currently eligible for BD and, if they may be eligible in the future, giving them the exact deferral period.
What next?
The objective is to continue expanding/updating the database and to make this information available to all DU across the country.
IMPROVING INTRAVENOUS CHEMOTHERAPY ADMINISTRATION SAFETY VIA SMART INFUSION TECHNOLOGY: ONE-YEAR IMPLEMENTATION AT HYGEIA HOSPITAL
European Statement
Patient Safety and Quality Assurance
Author(s)
IOANNIDIS KONSTANTINOS
SCARLATINIS IOANNIS
KORRE OURANIA
BOTSIOU MARIA
NIKOLAOU KATERINA – ANGELIKI
Why was it done?
The integration of clinical pharmacists in oncology settings plays a critical role in ensuring the safe and effective administration of chemotherapeutic agents. At Hygeia Hospital, over the past five years, clinical pharmacists have identified and prevented 1,272 chemotherapy-related medication errors, corresponding to 2.4 errors per 100 chemotherapy days. Despite this substantial contribution, challenges persist in the administration process by nursing staff, particularly regarding infusion parameters. Common errors include incorrect infusion rates and the omission or improper use of required filters and light-sensitive infusion sets, and their prevention remains a persistent challenge.
What was done?
To mitigate these risks, Hygeia Hospital has implemented parameterized electronic infusion pumps as an additional safety mechanism.
How was it done?
These pumps are pre-programmed by clinical pharmacists with non-modifiable infusion time limits for each chemotherapeutic agent, preventing unauthorized alterations by nursing personnel. Furthermore, the pumps provide mandatory prompts regarding the use of filters or/and light sensitive infusion sets, as specified in the Summary of Product Characteristics (SPC) of each drug.
What has been achieved?
Since their introduction one year ago, these infusion pumps have facilitated the identification and correction of previously undetectable administration errors, with an observed rate of 0.15 errors per 100 chemotherapy days. The majority of these involved incorrect selection of infusion duration by nursing staff. These findings underscore the value of pump parameterization in uncovering latent errors and reinforcing adherence to safe administration practices.
What next?
Future steps include expanding the use of parametrized infusion pumps beyond oncology to other high-risk areas, such as intensive care units, where precise and safe administration is equally critical. By reducing reliance on manual intervention and standardizing administration protocols, this approach enhances the overall safety and efficacy of drug delivery across multiple clinical settings.