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DEVELOPMENT OF PATIENT EDUCATION MATERIALS ON WARFARIN AND DIRECT ORAL ANTICOAGULANTS: A NATIONAL PATIENT SAFETY AND QUALITY IMPROVEMENT COLLABORATIVE

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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

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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 specialised knowledge of the EHR medication module, aiming to assure quality, optimise workflows, strengthen interdisciplinary coordination, and support safer and more efficient clinical use.

What was done?

CPS IT Team standardised workflows, enhanced coordination of medication order tasks, and created a forum to effectively utilise professional knowledge and networks across areas.

How was it done?

To address diverse Clinical Pharmacy challenges, CPS IT Team became the bridge between internal organisation (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 optimisation and standardised workflows. Acting as a coordinating unit, it optimises 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 optimised workflows. CPS IT Team efforts have helped prevent medication-related adverse events, improve workflows, and optimise 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.

DEVELOPMENT OF A NATIONAL ORAL ONCOLOGY MEDICINES DATABASE: ADVANCING TREATMENT OUTCOMES THROUGH DATA INTEGRATION

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European Statement

Patient Safety and Quality Assurance

Author(s)

Z. Ćetković, I. Popović

Why was it done?

Due to the specific mechanism of action of oral oncology medicines, these patients require advanced clinical pharmacy services facilitated by information technology to deliver better person-centred healthcare. The purpose of this database is to gather all important information on oral oncology medicines and make them easily accessible, to educate patients and improve their treatment outcomes.

What was done?

A hospital pharmacy team created a national database of oral oncology medicines, which was further integrated into a mobile application compatible with both iOS and Android device. This database included 79 medicines grouped by therapeutic indications, along with indications and dosage, information on administration and storage, interactions with other medicines and food, as well as precautions for the use in special populations.

How was it done?

The initiative was first developed during our national Symposium of hospital pharmacists, and within six months, it resulted in a national database of oral oncology medicines, supported by our Ministry of Health. After selecting a list of medicines, the next step involved creating a database in Excel. All information was straightforward and easy to comprehend for the general population. The final version of the database was thoroughly evaluated, and all issues were carefully addressed. In collaboration with the IT sector, the database was incorporated into the mobile application, available for all patients and healthcare professionals.

What has been achieved?

· Oral oncology medicines database provides evidence-based information on oral oncology medicines and offers medical support to patients taking these medicines at home, thus improving adherence and patient safety. · This database improves patient knowledge. · Situations with different scenarios are available to help manage interactions and various adverse reactions. · Instructions for the use of oral oncology medicines in special populations are available with just one click. · Continuous update by the hospital pharmacists is required to ensure data accuracy and optimal use.

What next?

Our next mission is to promote this database to a broader population of patients through the development of specialised pharmaceutical services and further expand into interactive communication between patients and healthcare professionals. We intend to regularly update it, as new medicines and information become available.

ASSESSMENT OF THE COMPLIANCE OF READY-TO-USE NEONATAL PARENTERAL NUTRITION ADMIXTURES PRESCRIPTIONS WITH THE FRENCH NATIONAL HEALTH AUTHORITY RECOMMENDATIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

S. CHIKHI, A. DIALLO, X. DEVIOT

Why was it done?

Ready-to-use neonatal parenteral nutrition admixtures (RTUs) are indicated for preterm infants when enteral or oral nutrition is either impossible or insufficient. To meet patients\’ specific nutritional needs, some RTUs must be supplemented with vitamins, trace elements or electrolytes. Considering the microbiological contamination risk associated with supplementation procedures, the French National Health Authority (HAS) stated that supplemented RTUs are safer when prepared by the pharmacy, in controlled atmosphere areas, rather than in healthcare services. It also recommended no more than three supplementations.

What was done?

To centralise RTUs supplementation within our parenteral nutrition unit, we carried out a retrospective analysis of prescriptions from 2023 and 2024 to evaluate their compliance with HAS recommendations.

How was it done?

Prescriptions were extracted from the prescription support software (Logipren). For each prescription, the number of supplements was noted, and the quantities added were evaluated against the maximum limits indicated in the Summary of Product Characteristics (SMPC).

What has been achieved?

A total of 1,073 prescriptions for 5 different RTUs were recorded. 91% (979) of prescriptions contained less than 3 additives. 9% (94) of prescriptions contained more than 3 supplements. 97% (91) of these prescriptions were for Numeta.
Regarding the compliance of added quantities, 7 prescriptions had a sodium level exceeding the authorized limit and 91 prescriptions involved supplementation with small volumes of zinc, despite the insufficient information on the feasibility of adding it.

What next?

To reduce the risk of infection and preparation errors, according to HAS recommendations, supplementation of RTUs with fewer than 3 additives, previously done in the neonatal care unit, is now performed in the pharmacy. Meanwhile, we suggested that physicians prioritize the prescription of individualized parenteral nutrition over supplemented Numeta when more than 3 supplements are required.

FAILURE MODE AND EFFECTS ANALYSIS OF A TERTIARY LEVEL HOSPITAL ANTIDOTE STORAGE

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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.

FROM HIGH-RISK TO HIGH-SAFETY: A TRANSITION FROM POTASSIUM AMPOULES TO PRE-DILUTED INFUSIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Douwe H. van der Meer

Why was it done?

Potassium ampoules are concentrated electrolytes categorized as high-risk medications due to the potential for immediate cardiac arrest following accidental injection. Consequently, safety guidelines, such as those established by Qmentum and the Joint Commission International, advocate for the utilization of pre-diluted infusion bags containing potassium and recommend the removal of concentrated ampoules from clinical wards.

What was done?

In our large teaching hospital, we conducted a comprehensive assessment of all clinical indications for potassium ampoule usage. Based on this analysis, we developed a plan to replace ampoules with the right pre-diluted infusion bags. The majority of ampoule applications were identified as follows: treatment of hypokalemia, hyperhydration during cisplatin and high-dose methotrexate therapy, fluid replacement in pancreatitis, and prevention of hypokalemia in diabetic ketoacidosis. To address these indications, we implemented three types of pre-diluted potassium infusion bags: 20 mmol in 1 L normal saline, 40 mmol in 1L normal saline, and 40 mmol in 500 mL of isotonic saline (0.47% sodium chloride).

How was it done?

We established standardized infusion protocols for all indications of potassium supplementation and successfully removed potassium ampoules from all adult wards, including the Intensive Care Unit (ICU) and emergency care settings. Potassium ampoules are now available solely upon request from the pharmacy. Following the introduction of pre-diluted infusion bags, the utilization of ampoules decreased by 95%. Prior to implementation, the hospital utilized 4,000 potassium ampoules per quarter; this number has now reduced to 200 ampoules, with a continuing downward trend.

What has been achieved?

Following the introduction of pre-diluted infusion bags, the utilization of ampoules decreased by 95%. Prior to implementation, the hospital utilized 4,000 potassium ampoules per quarter; this number has now reduced to 200 ampoules, with a continuing downward trend.

What next?

In our neonatal intensive care units and pediatric clinical wards, certain applications of potassium ampoules remain that are not compatible with the use of pre-diluted infusion bags. We are currently investigating potential interventions to facilitate the removal of ampoules in these settings as well.

TO IMPROVE TIMELY MEDICINES PROVISION AND ENSURE SAFE PRESCRIBING AS WELL AS SUPPORT EARLY DISCHARGE PLANNING TO IMPROVE FLOW INSIDE AND OUTSIDE AN NHS TRUST

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European Statement

Clinical Pharmacy Services

Author(s)

Christina Anastasiadou – Lead Pharmacist Acute & Emergency Medicine
Karen Dicks – Chief Pharmacy Technician Medicines Management
Radhika Patel – Pharmacy Technician MMS

Why was it done?

Until October 2023, the A&E department in Croydon University Hospital in London lacked a full-time pharmacy service, unlike other London trusts. This has contributed to suboptimal medicine management and a delay in the identification of prescribing errors. This has resulted in longer stays, missed medication doses, and a rise in patient safety incidences. At a hospital level this reduces flow and increases cost due to medication wastage. Ultimately, the aim is to improve the flow of patients within the hospital via timely medicines provision, early clinical pharmacy intervention and early discharge planning.

What was done?

We have obtained funding from the Better Care Fund for a period of 2 years. This funding is aimed at assisting local systems in effectively achieving the integration of health and social care in a manner that promotes person-centred care, sustainability, and improved outcomes for individuals and caregivers. Therefore, we introduced a full-time pharmacy service including one pharmacist and two medicines management technicians (MMTs)—one full-time and one part-time. This initiative was implemented as a 2-year trial period, using key performance indicators (KPIs) to evaluate its effectiveness.

How was it done?

Data has been collected against the below KPIS:
1) Number of drug histories completed on admission, before patient is allocated a ward (by MMT or pharmacist) per calendar month.
2) Number of medicines reconciliations completed (by pharmacist) per calendar month.
3) Number of clinical interventions completed by all members of the pharmacy team.
4) Savings secondary to the use of patient’s own drugs (PODs) brought from home for administration to reduce medicines wastage.
5) Savings due to the return of medicines to inpatient pharmacy for re-use from other patients when appropriate.
6) Time between request of medicines from pharmacy dispensary and medicine being dispensed, checked and released to A&E.
7) Review of stock lists in all areas in A&E.
8) Reduction in omitted doses.
9) Discharge medicines supply and screening from A&E to streamline discharge.
10) Number of patients counselled on their medicines and provided with patient-friendly information on them.
11) Number of referrals to community teams i.e allocated chemist via Discharge Medicines Service, Integrated Care Network (ICN) pharmacists or specialty teams (i.e anticoagulation clinic for newly initiated anticoagulant) to provide continuation of care.
12) Liaising with specialty teams within the hospital to expedite review and treatment in a time efficient and cost-effective way.

What has been achieved?

The current pharmacy team is fully integrated into the A&E service and has contributed significantly towards advancing patient experience, via early pharmacy engagement with patients. During the first 10 months of the project, we have data to show:
1) A 540% increase in drug histories and medicines reconciliation on admission.
2) A 19.525% increase in clinical interventions and early detection of medication errors.
3) We have completed 5 teaching sessions so far, in order to tackle common prescribing and medicines management inaccuracies and embedding solutions into nurses and doctors training.
4) We have contributed towards the reduction in omitted doses by 6%.

Positive contribution towards tackling medicines wastage has been shown too. Our team contributed towards saving £13.110 from April to September 2024 by using PODs for administration in hospital and £10.483 by returning dispensed medications to the inpatient pharmacy for recycling and use for other patients for the same time period.

In addition, the team has completed 66 referrals to the community pharmacy team for follow up on newly started medicines, stopped medicines, adherence concerns and polypharmacy. This is in order to provide continuous care and establish follow-up after discharge from hospital.

All in all, improved safe patients flow in and out of hospital.

What next?

Work towards a business case for a permanent pharmacy service in A&E, to continue further developing the above. Utilise all the skills our MMTs hold, in order to continue working on patient safety, improved flow and cost improvement plans. Introduce a pharmacist-prescriber who will be able to tackle arising problems as soon as possible and provide high quality care in liaison with doctors, nurses and advanced care practitioners.

AN APPROACH TO SHIFT FIRST-LINE OPIOID FOR ACUTE PAIN MANAGEMENT IN ORTHOPAEDIC SURGERY TOWARDS MORPHINE

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European Statement

Patient Safety and Quality Assurance

Author(s)

RBH, Rie Bager Hansen (presenting author), rie.bager.hansen@regionh.dk
ALK, Annabel Lee Krarup
The Capital Region Pharmacy, Hvidovre, Denmark and Department of Orthopaedic Surgery, Amager og Hvidovre Hospital, Copenhagen

Why was it done?

Patients undergoing acute orthopaedic surgery experience significant pain. The choice of pain-relieving treatment is based on national guidelines and regulatory actions. Considering the U.S. Opioid Crisis and the risk of opioid addiction, it was in 2022 politically decided by the Capital Region of Denmark to focus on consumption patterns of opioids within the region’s hospitals. Morphine is considered an opioid with a lower risk of misuse and was recommended as the first-line opioid. At the start of 2022, the Department of Orthopaedic Surgery at Hvidovre Hospital accounted for approximately 30% of the total oral opioid consumption with oxycodone being the preferred opioid. Thus, a strategy was initiated to shift opioid use towards morphine.

What was done?

The Department of Orthopaedic Surgery initiated a strategy to shift opioid use in hospitalised patients towards morphine. The strategy included including education, revision of guidelines and technical modifications to promote appropriate prescribing practices.

How was it done?

Opioid consumption was continuously monitored and evaluated. At the same time, administration of the antidote naloxone was recorded. The initiative included 1) education about the risk of opioid misuse, 2) e-mail follow-up to clinicians reinforcing that morphine was the first-line opioid, 3) revision of pre-filled electronic prescription packages used at the ward and operating room, 4) publication and implementation of a regional guideline specifically aimed at acute pain management in the orthopaedic surgery setting, and 5) ongoing support from pharmacists to facilitate appropriate selection of opioids.

What has been achieved?

Opioid consumption effectively shifted towards morphine, with the proportion of patients receiving oral morphine increasing from about 40% to approximately 80% of patients administered oral opioids. Moreover, the shift has remained stable for the past 10 months following the last intervention and there has been no trend toward increased usage of naloxone.

What next?

Future efforts will aim to identify reasons behind patients being prescribed non-morphine opioids and to investigate the specific circumstances under which naloxone is administered. This will enable further refinement of opioid prescribing practices and enhance patient safety.

RISK ASSESSMENT OF STERILE PREPARATIONS PERFORMED IN THE HOSPITAL PHARMACY SERVICE

RISK ASSESSMENT OF STERILE PREPARATIONS PERFORMED IN THE HOSPITAL PHARMACY SERVICE

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European Statement

Patient Safety and Quality Assurance

Author(s)

A. HERREROS FERNÁNDEZ, P. FERNÁNDEZ-VILLACAÑAS FERNÁNDEZ, R. AÑEZ CASTAÑO, P. ORTIZ FERNÁNDEZ, M.A. MEROÑO SAURA, I. GARCÍA MASEGOSA, R. GUZMÁN LAIZ, P. SELVI SABATER, C. CABALLERO REQUEJO, L. RENTERO REDONDO, E. URBIETA SANZ.

Why was it done?

The preparation of sterile magistral formulas involves significant risks due to complex processes, material handling, and sterility requirements. A systematic risk assessment was essential to identify vulnerabilities, classify risk levels, and implement preventive measures to improve safety and compliance with regulatory standards.

What was done?

Sterile magistral formulas are personalized medications prepared in hospital pharmacy services to meet individual patient needs. In 2023, a risk matrix was implemented to systematically evaluate the risks associated with their preparation. This initiative aimed to enhance patient safety and ensure compliance with the “Guide to Good Practices for the Preparation of Medications in Hospital Pharmacy Services” (GGP).

How was it done?

Sterile magistral formulas prepared in the pharmacotechnics area of a hospital during 2023 were identified from a Microsoft Access® database. A Microsoft Excel® database was specifically designed to apply the GGP-based risk matrix, categorizing formulas into low, medium, or high risk. Each formula was evaluated across six key criteria: preparation process, route of administration, drug safety profile, number of units prepared, preparation vulnerabilities, and distribution process. Risk levels were assigned using a combination of letters (A-D) based on the matrix. Challenges included standardizing data collection and ensuring multidisciplinary collaboration to refine the matrix and ensure its applicability.

What has been achieved?

A total of 80 sterile magistral formulas were assessed. Of these, 38.75% were classified as medium risk, 36.25% as high risk, and 25% as low risk. Among medium-risk formulas, 67.7% included a “C” in the matrix, while 96.6% of high-risk formulas contained at least one “D.” The most frequent risk combinations were “BBAAAA” (11.25%) and “BBBAAA” (10%). The preparation process and administration route were the primary contributors to overall risk. Medium- and high-risk formulas, primarily intravenous mixtures of antibiotics and biological drugs, required preparation in a cleanroom environment, as recommended by the GGP.

What next?

This initiative demonstrated the value of a risk matrix in identifying and managing risks in the preparation of sterile magistral formulas. It represents a best practice model with significant potential for adaptation in other healthcare settings, enhancing patient safety and standardizing risk management in hospital pharmacy operations.

Sustainable practice in parenteral medication administration: gloves at your disposal?

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European Statement

Patient Safety and Quality Assurance

Author(s)

Carine Schuurmans

Why was it done?

• The use of gloves in medication administration can vary depending on several factors, including the specific healthcare hygienic policies, local guidelines, and the type of medication being administered. There is no uniform practice across all of Europe.
• According to the Dutch guideline on administration of parenteral medication disposable gloves are traditionally used during parenteral medication administration.
• Most parenteral medications do not pose a significant hazardous risk and the administration of ready to use preparations does not pose a significant infection risk.

What was done?

• Re-evaluation of the Dutch guideline on administration of parenteral medication from a sustainability point of view.
• Reducing unnecessary glove usage in medication administration.

How was it done?

• Re-evaluating the need for disposable gloves from both an infection prevention and medication hazard point of view.
• Discussion with experts and users.
• Implementation of findings both in the inpatient and outpatient departments.

What has been achieved?

• Overall growing attention to correct glove usage.
• Reduction of use of disposable gloves during parenteral medication administration and other medical procedures
• CO2-, land occupation and water reduction by respectively 6000 CO2 eq, 600m2, 300m3 and 3500 €/month

What next?

• Revision of the Dutch guidelines on administration of parenteral medication