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FROM INCIDENT TO INITIATIVE: IMPLEMENTING A MULTI-DISCIPLINARY SURVEILLANCE TOOL FOR PAEDIATRIC 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 paediatric 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 paediatric care, Risk factors include technical and patient-related factors (eg, impaired communication). Despite these known risks, our regional hospital lacked structured surveillance and a standardised risk assessment tool. The project was initiated to develop and implement a standardised monitoring tool to establish preliminary safety data and a robust framework for prevention and safe management.

What was done?

A standardised, multi-disciplinary paediatric 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 paediatricians, radiologists, pharmacists, technologists, and nurses. The tool formalised 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 paediatric 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 standardise 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.

FOUR-YEAR IMPACT OF INCLUDING A PHARMACIST IN A MULTIDISCIPLINARY TEAM ON GUIDELINE-DIRECTED MEDICAL THERAPY FOR HEART FAILURE WITH REDUCED EJECTION FRACTION: EXPERIENCE AT A TERTIARY-CARE HOSPITAL IN THAILAND

European Statement

Clinical Pharmacy Services

Author(s)

Dhorn Amnuayphonwiwat, Pharm.D.
Outpatient Pharmaceutical care unit, Outpatient Pharmacy Division, Department of Pharmacy, Faculty of Medicine Siriraj Hospital, Bangkok Noi, Bangkok 10700, Thailand

Why was it done?

Within this integrated heart failure (HF) clinic, A HF pharmacists collaborate with multidisciplinary HF specialists to optimise guideline-directed medical therapy (GDMT), increase GDMT usage, resolve drug related problems (DRPs), reconcile medications, and educate patients. They also help patients adhere to therapies and thereby improve clinical outcomes.

What was done?

Optimising GDMT in patients with heart failure with reduced ejection fraction (HFrEF) was suboptimal because many factors, such as patients being unable to tolerate side effects or having non-compliance, health care insurance was limited in access to GDMT and there was a lack of a multidisciplinary care team. Our objective was to optimise GDMT, enabling patients to achieve reach the target or maximally tolerated dose and to resolve DRPs, thereby improving therapeutic outcomes.

How was it done?

Pharmacists performed medication reconciliation, reviewed all medications including GDMT, optimised doses, and identified DRPs at each visit. They also provided relevant interventions to physicians. After physician consultation, pharmacists counselled patients on their home medications. All information was recorded in both the pharmacist’s database and the hospital database. We analysed the data annually and continuously improved our interventions.

We created education tools for HF patients such as flipchart, booklets and animations for focusing on empowering patients’ GDMT knowledge and improving self-care monitoring.

What has been achieved?

Data on GDMT dosage optimisation, usage, and DRPs were gathered from all patient visits between January 2020 and September 2023. Among 2907 patient visits over 4 years, the annual GDMT dose rates were 67% for beta-blockers, 93% for RAAS blockade, 41% for sacubitril/valsartan, 100% for MRAs, and 100% for SGLT2i. The proportion of visits achieving more than 50% of the GDMT dose was 68%, 80%, 46%, 100%, and 100%, respectively. At the 1 year follow-up, these 79 patients showed significant improvements in left ventricular ejection fractions, New York Heart Association functional class and signs and symptoms of congestion such as orthopnoea, paroxysmal nocturnal dyspnoea, oedema, and lung crepitation.

What next?

With more improvement in the HF pharmacist’s role, we aim to develop the program for calculating the GDMT dose in the individual level and design supportive tools to enhance patients’ adherence. Moreover, the HF pharmacist collaborates with multidisciplinary team to disseminate this education initiatives to the other hospitals for improving the HF patients’ standard care.

REINVENTING PHARMACOTHERAPY IN PROSTATE CANCER THROUGH STRATIFICATION AND PERSONALISED 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 haematologic neoplasms (SEFH)) into routine practice to prioritise 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 individualised 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 prioritisation 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.

ENHANCING CLINICAL TRIAL EXCELLENCE IN HOSPITAL PHARMACY: IMPLEMENTATION OF THE UPDATED SPANISH GUIDE

European Statement

Clinical Pharmacy Services

Author(s)

C González-Pérez, E Tejedor Tejada, F Capdevila, C Martínez Nieto, A Ferrer Artola, G Lizeaga Cundín, JA Domínguez Cháfer, A Martín Uranga, V Morales, M Serrano Alonso.

Why was it done?

Spain aims to reinforce its position as a leading country in clinical research at the European and global level. Hospital pharmacists are essential to ensuring the safe and efficient management of IMPs, yet their role is often under-recognised or inconsistently defined.

The increasing complexity of clinical trials—driven by digitalisation, decentralisation, and environmental demands—requires updated, standardised guidance to support excellence, regulatory compliance, and equitable access.

What was done?

A multidisciplinary working group, including representatives from the pharmaceutical industry (Farmaindustria), hospital pharmacists from the Spanish Society of Hospital Pharmacy’s (SEFH) Clinical Trials Group, and the General Council of Official Colleges of Pharmacists, revised the 2022 edition of the Excellence Guide for the Conduct of Clinical Trials in Hospital Pharmacy.

The updated guide focuses on:

Clear definitions of pharmacy and sponsor responsibilities across trial phases.

Practical recommendations for investigational medicinal products (IMP) handling, labelling, donations, traceability, and medicine shortages.

Integration of digital tools and electronic documentation systems.

Sustainability practices aligned with European standards.

Strategic recommendations for decentralised trials and remote patient access.

How was it done?

The guide was developed through consensus among stakeholders, combining regulatory expertise, clinical experience, and operational insights. Contributions were based on real-world practices and aligned with current European legislation.

What has been achieved?

The updated Guide to Excellence in Clinical Trials in Hospital Pharmacy was developed and launched in Barcelona on September 30, 2025. The new edition offers a comprehensive framework to support hospital pharmacists throughout all phases of clinical trials, while also serving as a reference for sponsors and Contract Research Organisations (CROs) regarding hospital pharmacy department procedures.

Additionally, it includes annexes with practical infographics covering key areas such as a welcome manual model for sponsors, IMP accountability, site initiation preparation, remote monitoring, hazardous drug disposal, and non-sponsored medication management. These resources aim to facilitate implementation and harmonise practices across institutions.

What next?

The guide will be disseminated through professional networks, social media, specialised journals, and mailing lists targeting hospital pharmacists, CROs, pharmaceutical sponsors, and universities offering specialised training for clinical trial monitors.

A national survey will be launched to assess the reach and impact of the new edition and to identify challenges and improvement areas for future updates.

INTEGRATION OF THE PHARMACEUTICAL TEAM IN THE CAR T-CELL CARE PATHWAY: HEALTHCARE PROFESSIONALS’ FEEDBACK

European Statement

Clinical Pharmacy Services

Author(s)

RAZEYRE Charlotte, QUINTARD Adeline, BAROUX Gaëlle

Why was it done?

Since 2019, the pharmaceutical team (PT) dedicated to advanced therapy medicinal products (ATMPs) in our institution has been integrated into the care pathway of patients treated with CAR T-cells. The PT intervenes upstream of the first medical consultation through an optimised medication reconciliation (OMR), then 48 hours before apheresis to ensure its update and compliance with washout periods. Prior to CAR-T infusion, a pharmaceutical consultation is conducted to update the OMR, explain the different steps of the pathway, and address patients’ questions. All data are recorded in the electronic medical record. Quality support materials are also provided to healthcare teams. In this context, we aimed to assess healthcare professionals’ satisfaction with these interventions to identify opportunities for practice improvement.

What was done?

To collect and analyse feedback from healthcare professionals involved in the CAR-T pathway regarding the activities and tools implemented by the pharmaceutical team.

How was it done?

A questionnaire was designed using Google Forms by the ATMP-PT and disseminated by email to professionals involved in the CAR-T pathway. It covered several domains: respondent’s role, knowledge and use of OMR and checklists, perceived relevance of pharmaceutical consultations, and satisfaction with quality documents.

What has been achieved?

All professionals involved in the pathway were contacted, with at least one response from each professional group except apheresis physicians. Only 42% of respondents reported being aware of and using OMR during their consultations. However, 86% considered pharmaceutical consultations relevant and were satisfied with their contribution to the CAR-T pathway. In addition, 71% were satisfied with the quality documents, while the remaining respondents reported not using them. Regarding potential improvements, one respondent suggested that the PT should be more involved during the patient’s hospitalisation.

What next?

This study highlights the overall positive perception of the PT’s interventions. Nevertheless, the responses reveal limited use of some tools, particularly OMR and checklists, whose impact remains difficult to assess in the absence of feedback from apheresis physicians the main intended users. These findings underscore the need to further raise awareness among healthcare teams about these tools, in order to optimise their integration into the care pathway and strengthen interprofessional coordination.

DEVELOPING THE ROLE OF A BIOLOGICS PHARMACY TECHNICIAN

European Statement

Clinical Pharmacy Services

Author(s)

Megan Stevens

Why was it done?

The National Health Service (NHS) is under pressure due to workforce shortages. Staff numbers cannot match service demand. In our Trust, Specialist Biologic Pharmacists are not being fully utilised.

What was done?

Promoting the role of a Clinical Pharmacy Technician in a specialist service; releasing Specialist Pharmacists to expand their service.

Showing that Clinical Pharmacy Technicians, with relevant training and support, can safely screen biologic prescriptions and manage stock on BDU.

Reducing the number of items being returned from BDU, by allowing the Clinical Pharmacy Technician to be more present in BDU and make proactive interventions to prevent unnecessary dispensing.

How was it done?

The Specialist Biologics Pharmacist developed a list of tasks appropriate for a Clinical Pharmacy Technician.

A procedure was written to outline the screening process and returns process for biologics by a Clinical Pharmacy Technician. They are unable to screen prescriptions with a change of drug, dose or frequency.

Full training was provided, and competencies were used to assess capability.

Any errors in the screening process will be reported and monitored by Pharmacy Governance.

What has been achieved?

From April to June 2024, a total of 938 biologic prescriptions were screened. 750 of these were screened by a Clinical Pharmacy Technician. This equates to a 70% decrease in Pharmacist screening workload- that’s 9 hours per week of pharmacist screening time saved.

Within those three months, 17 items were returned from BDU. In the same three months the previous year, 64 items were returned. This shows a 73% decrease in returns.

There have been no Datix reports for screening errors on prescriptions screened by Clinical Pharmacy Technicians to date.

What next?

This service development shows that employing a Clinical Pharmacy Technician allows Specialist Pharmacists to be utilised more appropriately. It allows them to increase their outpatient activity; starting a pharmacist-led Dermatology Biologics clinic and increasing patient numbers in Pharmacist-led Gastroenterology clinics.

The reduction in returns shows that Clinical Pharmacy Technicians can make proactive interventions and prevent unnecessary items being dispensed. This reduced unnecessary workload for the Dispensary and Aseptic Unit.

No Datix reports being submitted shows that Clinical Pharmacy Technicians are capable of screening biologic prescriptions when fully trained and supported

IMPLEMENTATION OF A CLINICAL PHARMACIST-LED ELECTRONIC MONITORING SYSTEM FOR SURGICAL ANTIBIOTIC PROPHYLAXIS

European Statement

Clinical Pharmacy Services

Why was it done?

Before this initiative, surgical antibiotic prophylaxis (SAP) monitoring was paper based and mainly handled by nursing staff, with little pharmacist or surgeon engagement. Entries were often incomplete or inaccurate, with frequent confusion between prophylactic and therapeutic use. Critical parameters—timing, duration, and patient-specific factors—were inconsistently recorded, and data were rarely analysed, so protocol compliance went unmonitored. Consequently, surgeons paid limited attention to guideline adherence or to the contribution of suboptimal prophylaxis to antimicrobial resistance. These gaps exposed patients to unnecessary antibiotic exposure and avoidable infection risk. The project was therefore launched to create a reliable, accountable monitoring process that would improve data quality and enable systematic feedback and stewardship.

What was done?

A clinical pharmacist-led, electronic monitoring system for SAP was developed. A comprehensive data-capture form (demographics, surgery type and duration, wound class, antibiotic choice, dose, timing, and duration) was designed after benchmarking similar tools and implemented in the hospital information system (HIS). Clinical pharmacists reviewed all SAP entries, verified completeness before discharge, and generated reports shared with the Infection Control Committee and hospital management to support data-driven interventions.

How was it done?

A multidisciplinary team of pharmacists, infection control experts, IT staff, and surgeons collaborated under hospital leadership to design and implement the process. All patients undergoing surgery and receiving SAP were monitored by trained pharmacists in the wards, and data entries were completed before discharge to ensure accuracy. The collected information was analysed by clinical pharmacists, and discrepancies between clinical practice and established protocols were flagged. The Infection Control Team, in collaboration with hospital management, provided feedback to surgeons and developed targeted training programmes where needed. Initial barriers—limited familiarity with digital forms and resistance to workflow changes—were overcome through structured training, ongoing communication, and continuous on-ward support.

What has been achieved?

Documentation completeness and accuracy improved markedly, enabling routine compliance assessment across antibiotic choice, dose, timing, and duration. Analysis identified delays in administration; corrective actions, education, and protocol updates followed. Surgeon awareness of correct timing increased, and the pharmacist’s role in antimicrobial stewardship was strengthened.

What next?

Next steps include embedding the revised SAP protocol across all surgical units, regular audits, and continued pharmacist-led monitoring to sustain improvements. By integrating SAP monitoring data with patient readmission data for surgical site infections, we aim to evaluate whether improved documentation, training, and protocol revision lead to measurable reductions in infection-related readmissions. The model is effective, scalable, and transferable to other hospitals. Integration with AI-assisted decision-support tools within the HIS is being explored to further optimise prophylaxis management.

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.

ADHERE INITIATIVE: ADVANCE DELIVERY FOR HEALTH ENHANCEMENT & REGULAR ENGAGEMENT

European Statement

Clinical Pharmacy Services

Author(s)

Naila Aljahdali, Hala Al-Buti, Basem Elbehiry, Mohammed AlZahrani, Hani AlZahrani, Jalal Alharbi, Raien Algaidi, Ali AlZahrani, Wael AlZahrani

Why was it done?

Medication adherence is a global challenge, with nearly half of patients failing to take prescribed therapies consistently. This issue contributes to avoidable hospitalisations, treatment failures, and increased healthcare costs. At King Fahd Armed Forces Hospital (KFAFH) in Jeddah, medication refills are identified as a critical issue affecting both patient outcomes and pharmacy workload, and as key barriers to optimal care. This project aimed to improve patient medication adherence and satisfaction while also reducing pharmacy staff workload.

What was done?

ADHERE Initiative was implemented as value-added services (VAS) include: home medication delivery services (HMDS) integrated with digital health tools (delivery refill tracking, telepharmacy consultations) and streamlined logistics, patient education, and feedback loops. A multidisciplinary team oversaw implementation. Performance was monitored and evaluated.

How was it done?

This Quality Improvement (QI) project was conducted from November 2023 to June 2025, using the Plan Do-Study-Act (PDSA) methodology. Baseline data were collected on patient adherence, satisfaction, and pharmacy workload. Root cause analysis was performed using a fishbone tool. ADHERE Initiative was introduced as an intervention to address identified barriers.

What has been achieved?

The real-world data shows that Patients’ Medication Adherence improved by 51%, and HMDS uptake grew substantially from a negligible start (1%) to sustained levels around 30–44%, surpassing the target in several months. Waiting times improved to around 7 minutes after interventions, indicating reduced in-person demand. Delivery performance was strong inside Jeddah with rapid same-day/24-hour delivery for most patients, while outside Jeddah deliveries reliably reached patients within 2–3 days. Estimated refill-related counter workload reduced by ~40%, freeing staff for clinical duties.

What next?

ADHERE Initiative significantly improves patient medication adherence, enhance patient satisfaction, and reduces pharmacy workload. It highlights the dual benefit of technology-enabled pharmacy services for both patients and healthcare providers. Also, it represents a scalable model for healthcare institutions to transform patient-centre ed care in Saudi Arabia.