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.
DIGITAL COUNSELLING
European Statement
Clinical Pharmacy Services
Author(s)
Sam Coombes
Michael Jackson
Why was it done?
The project aimed to strengthen clinical pharmacy services by introducing a digital counselling model for commonly prescribed medicines. It focused on improving the quality and accessibility of medicines information, particularly for patients discharged outside pharmacy hours who might otherwise miss vital counselling. Embedding digital resources into routine practice promoted equity, consistency, and inclusivity.
What was done?
Structured counselling scripts were created for prednisolone, glyceryl trinitrate (GTN) spray, and metered dose inhalers (MDIs). These were reviewed, approved, and recorded using an AI voice generator, enabling rapid updates. Accessibility features were built in to support patients with sensory impairments. Finalised videos were hosted on YouTube and accessed via QR codes, while a telephone audio service was provided for patients without smartphones. Codes and numbers were placed directly on medicine boxes.
How was it done?
Quality improvement methodology guided the design. AI voice technology allowed quick production of professional-standard audio and easy updates when clinical guidance changed. Using QR codes and phone lines ensured patients with varying digital literacy could access information. Accessibility was prioritised to support inclusivity.
What has been achieved?
Analytics showed strong engagement: the GTN spray video gained 7,000 views, 40 likes, and 59% viewer retention halfway through. Prednisolone had 2,600 views and 8 positive interactions, while MDI reached 29 views during pilot testing. A fluoroquinolone video was launched in late 2025, with outcomes pending. A staff survey confirmed no undue administrative burden.
What next?
Digital counselling via video or audio is feasible, scalable, and well received by patients. It addresses barriers such as limited staffing, out-of-hours discharges, and health literacy. Unlike written leaflets, often above the UK reading age, multimedia resources provide clearer, more engaging support and may improve adherence. AI technology ensures efficiency, cost-effectiveness, and currency of content. This model is replicable and has strong potential for wider NHS adoption, supporting equitable and consistent medicines counselling.
IMPLEMENTATION OF A NORDIC NETWORK FOR 3D-PRINTING OF PERSONALIZED MEDICINES IN HOSPITAL PHARMACIES
European Statement
Production and Compounding
Author(s)
Maria Rautamo, M.R., Senior Pharmacist, PhD (Pharm), HUS Pharmacy, HUS Helsinki University Hospital and University of Helsinki, Helsinki, Finland, maria.rautamo@hus.fi
Mattias Paulsson, M.P., PhD, Deputy chief pharmacist, associate professor, Uppsala University Hospital, Uppsala, Sweden, mattias.paulsson@akademiska.se
Marija Tubic-Grozdanis M.T-G., Head of Clinical Trial Supply, PhD (Pharm), Pharmacy Department, University Hospital Center of Johannes Gutenberg-University, Mainz, Germany, marija.tubic-grozdanis@unimedizin-mainz.de
Randi Hamre Svendsen, R.H.S., M.Sc (Pharm), Hospital Pharmacies Enterprise, South-Eastern Norway, Oslo, Norway, Randi.Maria.Hamre.Svendsen@sahf.no
Rikke Stick Højmark, R.SH., M.Sc, The Pharmacy of the capital region of Denmark, Herlev, Denmark, rikke.stick.hoejmark@regionh.dk
Trine Schnor, T.S., M.Sc (Pharm), The Pharmacy of the capital region of Denmark, Herlev, Denmark, trine.schnor@regionh.dk
Why was it done?
During the last two years, pharmacies worldwide have started to introduce printing technologies, such as semi-solid extrusion, into pharmacy production to provide personalized doses in dosage forms that are easy to administer to children and workflows that are more ergonomic and safer for production personnel and nurses in healthcare units. However, the implementation of new technology and equipment has also revealed challenges regarding patient safety and qualification (e.g. stability, homogeneity, identification). The need for peer support in addressing and overcoming various barriers and obstacles, which everyone must resolve, has influenced the establishment of the network.
What was done?
In 2024, the members of the production group in the Nordic Pharmaceuticals Forum (NLF) established a collaborative network for the implementation of 3D-printing of medicines in hospital pharmacies. The focus of the collaboration is on production issues related to equipment, production processes and quality, as well as on clinical implementation.
How was it done?
Colleagues in the Nordic countries that could be interested in and benefit from potential collaboration around 3D-printing of medicines were identified and invited to a kick-off meeting held in November 2024. Criteria for joining the network include expertise in 3D-printing of medicines or involvement in planning or executing the implementation of 3D-printing into pharmacy production. During the 29th EAHP Congress in March 2025 colleagues from other European countries expressed their interest in joining the network. Since August 2025, the network has received valuable reinforcement and expertise from new members across Europe.
What has been achieved?
The network has expanded to include participants from 6 different countries who meet online 3-4 times a year. The topics discussed are the status of implementation and projects in the participating organizations, experiences and challenges, requirements from regulatory agencies and news from publications, congresses and webinars. The value gained for the individual members is the knowledge sharing and peer support among colleagues in an activity that is still very new and lacks specific regulations and guidelines.
What next?
The future goal is to expand our collaboration into scientific research by identifying relevant topics where our combined strengths can provide important new knowledge and insights for the entire European hospital pharmacy sector and, especially for future patients.
IMPLEMENTING AN ASEPTIC PROCESS SIMULATION FOR OPERATOR (RE)QUALIFICATION IN A HOSPITAL COMPOUNDING UNIT
European Statement
Production and Compounding
Author(s)
Sadaoui Talwit, Guicheron Gaëlle, Llari Tahina, Jolicart Maude , Bloch Vanessa, Delage Clément, Gasmi Linda, Belaid Imene
Why was it done?
Compounding sterile injectables carries a contamination risk, and sterility of extemporaneously compounded preparations cannot be verified afterwards. In line with national Good Compounding Practices (BPP 2023), we sought to formalise APS to assess and (when needed) rehabilitate operators’ aseptic technique while strengthening patient safety and quality assurance.
What was done?
We implemented an aseptic process simulation (APS; media fill) as a standardised pathway for initial qualification and requalification of operators involved in sterile injectable compounding. The APS challenges the process in worst-case conditions and provides documented evidence of aseptic competence.
How was it done?
We conducted a literature and practice review, including BPP 2023 guidance and NHS recommendations (“Universal Operator Broth Transfer Validation”), canvassed three French hospital pharmacies for return of experience, and selected commercial kits. We drafted a local SOP and protocol defining a worst-case scenario: simulated failure of the microbiological safety cabinet (work on a clean bench in a controlled area), without an assistant, and under real-life constraints. Each session was supervised by an evaluator; glove prints were taken on Count-Tact plates at the end of the run. All filled units were incubated for 14 days (7 days at 20–25 °C, then 7 days at 30–35 °C) with daily visual checks recorded in an electronic log, and final turbidity reading.
What has been achieved?
Four APS runs have been completed to date (pharmacist, pharmacy intern, and technicians), all compliant with no microbial growth detected. One technician remains to be tested due to scheduling constraints. The process now underpins our documented pathway for operator assessment and provides a basis for microbiological trending.
What next?
APS will be rolled out to all staff with annual requalification, and ad-hoc re-testing whenever there are changes to the process, critical equipment (e.g., MSC/BSC), or the classified cleanroom (e.g., grade change, layout/HVAC modifications), or when practice drift is observed. We will add structured behavioural/technical checklists to each run and track KPIs (pass rate, contamination rate, time-to-certification, observation deviations). Microbiological results (glove prints, environmental plates) will be trended with action thresholds, and APS will be complemented by routine observation-based assessments to ensure safe sterile compounding.
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.
ENHANCING THE RHEUMATOLOGY HOMECARE PRESCRIPTION PROCESS USING THE LEEDS IMPROVEMENT METHODOLOGY
European Statement
Clinical Pharmacy Services
Author(s)
P.Chu, W.Short, L.Bailey, S.Williams, D.Moss and LA Bissell
Why was it done?
This improvement initiative addressed national recommendations following the United Kingdom Parliamentary Inquiry in 2023 into homecare services calling for improved processes and systems. Homecare represents over half of the medicines spend for Leeds Teaching Hospitals (LTH). Rheumatology serves the largest clinical cohort with over 3,500 patients receiving homecare medicines. This project aimed to address service gaps in safety, communication and efficiency to ensure delivery of high-quality, patient-centred care.
What was done?
Using the Kaizen-based Leeds Improvement Methodology (LIM) modelled through an intensive, week-long event, this project aimed to optimise the homecare process within Rheumatology. Objectives included improving workflow efficiency for prescription batching, query tracking and enhancing the patient-staff communication model, thereby increasing overall patient and staff satisfaction. Multiple process changes were implemented to improve overall efficiencies.
How was it done?
Triumvirate team buy in was crucial for the success and facilitation of this event because it required one week of multidisciplinary team (MDT) engagement from representatives in all stages of the process flow. Iterative Plan-Do-Study-Act (PDSA) cycles were used to test improvements. Value Stream Mapping supported the visualisation of workflow and identified non-value-adding activities. Quantitative data and emotional touchpoint surveys informed changes throughout this event and acted as ongoing metrics to monitor impact.
What has been achieved?
• A single, co-located MDT homecare hub was established, facilitating a streamlined, one-piece flow and minimised delays.
• An electronic text messaging system alerted patients to required blood tests to facilitate safe prescribing, this replaced postal notifications and supported the sustainability agenda.
• Prescription lead time decreased by 71% from 24 days to 7 days.
• Volume of work in progress reduced by 30%.
• Staff satisfaction relating to process efficiency rose from 24% to 65%.
• Staff satisfaction relating to morale rose from 0% to 60%.
• Incident reports and formal patient complaints were 0 by day 90.
What next?
The LIM framework and MDT approach resulted in significant enhancements in operational efficiency, communication and improved patient experience. The measured outcomes aligned with national recommendations for increased transparency and accountability. The project established a scalable and sustainable model by empowering staff to effect change. The next step is to review practice in other therapy areas to translate these improvements Trust wide.
FROM PAPER TO PLATFORM: STRENGTHENING ADVERSE DRUG REACTION REPORTING IN TUBERCULOSIS CARE VIA A PHARMACIST-LED DIGITAL SYSTEM IN AN OVERCROWDED HOSPITAL SETTING
European Statement
Clinical Pharmacy Services
Author(s)
Netchanok Kanjana, Ratnaton Khangkhasuwan, Thumwadee Thongkamchum, Pitchaporn Tepsuone, Nawiga Plong-on, Siriwan Wongvarodom, Rungnapa Songsiriphan
Why was it done?
Assessment of adverse drug reactions (ADRs) in tuberculosis (TB) patients is complex due to the concurrent administration of multiple anti-TB agents and the 9–12 day process often required for rechallenge. At our tertiary referral center, frequent transitions of TB patients between inpatient wards and the outpatient clinic, exacerbated by persistent overcrowding and a bed occupancy rate of 138%, resulted in paper-based ADR documentation being vulnerable to loss or fragmentation. This compromised patient safety and increased the risk of repeated hypersensitivity reactions.
What was done?
A digital platform was developed and implemented to systematically document and monitor ADRs in TB patients, aiming to enhance patient safety, prevent recurrent hypersensitivity events, and significantly improve the continuity, completeness, and quality of ADR reporting across all care transitions.
How was it done?
Key data elements were identified through structured pharmacist interviews and literature review. An AppSheet-based application was designed to enable real-time documentation and centralized monitoring of ADR data. The system was deployed across relevant inpatient wards and the outpatient TB clinic during the 3-month pilot period (March 1 to May 31, 2025). Pharmacists were trained to record ADR reports directly into the application, ensuring seamless information access.
What has been achieved?
Complete ADR reporting increased substantially: 56 ADR entries for 21 TB patients were documented during the pilot. This includes 8 complete ADR assessments (e.g., 3 Augmented, 5 Bizarre), compared to only 3 and 4 complete reports recorded on paper in 2023 and 2024, respectively. Crucially, no recurrent hypersensitivity reactions were observed during the intervention period. The application significantly improved continuity of care and facilitated timely, comprehensive ADR reporting.
What next?
Future plans focus on strengthening data security and system stability by migrating the application to the hospital’s internal server and integrating login with the national health provider authentication system. Expansion will involve scaling the system to include ADR monitoring across network hospitals, ensuring complete information transfer when patients are referred back to their primary facilities.
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.
IMPROVING OCCUPATIONAL HEALTH AND PATIENT SAFETY THROUGH AN AUTOMATED MULTIDOSE DISPENSING SYSTEM
European Statement
Clinical Pharmacy Services
Author(s)
P. Frandsen
M. Nissen
C. Olesen
Why was it done?
Medicines dispensed by an automatic multidose dispensing system (ADS) was introduced on an orthopaedic surgery ward to improve the occupational health of pharmacy technicians. The hope was to release time for medication reconciliation, allowing pharmacy technicians to use their professional skills in supporting the orthopaedic surgeons and enhancing patient safety.
What was done?
In the orthopaedic surgery ward, pharmacy technicians manually dispensed medication to inpatients and upon discharge. Prior to dispensing, they compared prescriptions in the hospital electronic patient journal to prescriptions patients receive at home. In case of discrepancies, the orthopaedic surgeon was contacted to make any necessary changes.
Due to pharmacy technicians’ occupational health being affected by long hours dispensing medicines, medicines dispensed by an ADS was introduced. Per agreement with the chief surgeon, pharmacy technicians took on expanded responsibilities, including authority to independently adjust certain prescriptions.
How was it done?
Pharmacy technicians were asked to register time used dispensing medicines and time used reviewing prescriptions before the workflow changes and again after six months.
Semi-structured interviews were conducted with the six pharmacy technicians involved before the workflow changes and again after six months.
What has been achieved?
Total pharmacy technician time spent dispensing medicines per day was reduced from 326 minutes (range: 175–546) to 203 minutes (range: 105–358).
Time spent on prescription review per day increased from 44 minutes (range: 18–77) to 93 minutes (range: 30–170).
Before introducing the ADS, several pharmacy technicians reported physical strain in their hands and mental fatigue after long hours of dispensing.
After the introduction of the ADS, there was a marked improvement in occupational health. Pharmacy technicians, who had experienced strain in their hands noticed improvement, and half of them also reported reduced mental fatigue.
Collaboration with surgeons was mentioned by pharmacy technicians as problematic before the new workflows but significantly improved, with pharmacy technicians feeling their expertise was appreciated by surgeons and ward staff.
What next?
Across Denmark, pharmacy technicians spend hours dispensing medicines in hospital wards. Implementing an ADS could relieve pharmacy technicians, improve occupational health and allow pharmacy technicians to focus on other tasks such as medication reconciliation, which would enhance patient safety.