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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.

SAFETY AT THE RIGHT DOSE: THE PHARMACIST’S INTERVENTION IN THE PREVENTION AND TREATMENT OF IFOSFAMIDE-INDUCED ENCEPHALOPATHY

European Statement

Clinical Pharmacy Services

Author(s)

Vera Pires, Maria João Teixeira, Rui Marques

Why was it done?

Ifosfamide-induced encephalopathy (IIE) is a serious and often underdiagnosed adverse effect of ifosfamide, with variable incidence and no standardized approach to prevention or treatment. The project aimed to improve patient safety and clinical outcomes by developing a standardized, evidence-based institutional protocol to guide prophylaxis and management of IIE.

What was done?

An institutional protocol for the prevention and treatment of IIE was developed and implemented, defining clear recommendations for methylene blue and thiamine use, standardizing dosing regimens, and providing practical instructions for clinical teams.

How was it done?

A comprehensive literature review was carried out, current local practices were analyzed, and a multidisciplinary team collaborated to design the protocol. The final version was reviewed and approved by the Pharmacy and Therapeutics Committee (PTC) before implementation.

What has been achieved?

The protocol reduced variability in prescribing practices, increased medication safety, and enhanced the pharmacist’s involvement in monitoring and managing adverse events. It established consistent dosing, preparation, and administration procedures for both adult and pediatric patients, improving overall care quality and coordination.

What next?

The next step is to evaluate the clinical and organizational impact of the protocol from both patient and institutional perspectives, with a focus on outcomes such as incidence reduction, safety indicators, and staff adherence.

MEDICATION ERROR IN A CLINICAL TRIAL: ROOT CAUSE ANALYSIS AND IMPROVEMENT ACTIONS

European Statement

Patient Safety and Quality Assurance

Author(s)

Cristina Garcia Fernandez, Estela Alamino Arrebola, Bárbara Lopez Bautís, Carmen Gallego Fernandez, Begoña Tortajada Goitia.

Why was it done?

Patient safety in clinical trials relies on the correct management of both investigational and auxiliary/comparator medications. While investigational products are usually managed through automated systems (e.g., IWRS) ensuring traceability and standardization, auxiliary medications often lack similar oversight from sponsors. A preventable medication error in an oncology clinical trial—caused by the preparation of an incorrect drug concentration due to the absence of automated supply and harmonization—highlighted the need to analyze system gaps and implement corrective actions to strengthen patient safety and medication traceability.

What was done?

A Root Cause Analysis (RCA) was conducted following the detection of a medication error involving the preparation of hospital stock (20 mg/mL) instead of the clinical trial formulation (10 mg/mL). The objective was to identify systemic weaknesses and design a Corrective and Preventive Action (CAPA) plan aimed at preventing recurrence and improving management of auxiliary medication in clinical trials.

How was it done?

The RCA was performed in July 2025 using the “5 Whys” methodology, supported by:
-Document review, staff interviews, and chronological reconstruction of the event.
-Analysis of human, technical, communicative, and organizational factors.
-Classification of the incident (NCC MERP category D — no patient harm).
Corrective measures implemented included:
– Creation of a pre-trial pharmacy checklist to ensure drug availability and concentration verification.
– Mandatory pharmaceutical validation after any protocol amendment.
– Formal requests to sponsors to standardize drug concentrations across sites.
– Improved communication channels between sponsors, pharmacy, and clinical teams

What has been achieved?

-Identification of the main root cause: lack of automation in auxiliary drug supply requiring manual requests.
-Prevention of similar future events through harmonized pharmacy processes.
-Reinforcement of patient safety culture and traceability of clinical trial medications.
-Strengthened collaboration among hospital pharmacy, clinical teams, and sponsors.
-No patient harm resulted from the event, confirming the importance of early detection and system review.

What next?

-Extend IWRS automation and standardization practices to include auxiliary medications in all clinical trials.
-Share the initiative with other hospital pharmacies and sponsors to promote harmonization at institutional and multicenter levels.
-Continue monitoring the implemented CAPA and evaluate its impact on error prevention.
-Foster continuous improvement in pharmacy oversight and communication workflows for clinical research.

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.

IMPLEMENTATION OF ALERT MODEL/SYSTEM IN AN E-PRESCRIBING PROGRAM TO IMPROVE DRUG ALLERGY CAPTURE AND CLINICAL DECISION SUPPORT

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European Statement

Patient Safety and Quality Assurance

Author(s)

Muñoz Cid, CL; Sierra Torres, MI; Sánchez Martín, A; Martín Roldán, A; González Sánchez, B

Why was it done?

A procedure was designed for the registration of drug allergies of patients admitted to the hospital in the electronic prescription program by reviewing the digital medical record.

What was done?

Several issues lead to the need of this development:
-Lack of integration of allergy information from computerized history and electronic prescribing.
-To facilitate the appropriate triggering of alerts, correct allergy terminology, coded properly, and captured in a standard location
-Variability in the recording of this information at the different levels of healthcare (primary care and hospitalized).
-Difficulty in accessing information on drug allergies when prescribing and validating medical treatments.
-To improve Patient safety, there is a high risk of serious adverse events if the patient receives a drug to which he/she is allergic.

How was it done?

-Review of allergy documentation (free text), including a more detailed specification and characterization of the patient´s allergies to coded properly (allergy to medicines or therapeutic groups, contraindications, intolerances).
-Validation and configuration of the alert system stratifying risk by means of different colors of according to the information from the clinical history.
-Development of an algorithm to evaluate how to register each allergy depending on every different situation.
-Elaboration of a procedure to alert management and incorporation into the electronic prescription program.
-Dissemination of the procedure and awareness-raising of the need for proper recording.

What has been achieved?

-Preventing medication errors related to drug allergies and ensuring patient safety.
– Improving access to all allergy information for all healthcare professionals involved in the prescription and validation of medication.
– To have a standardized methodology for recording and coding allergies.
– Integrating medical record information into the electronic prescription system.
– Setting-up an effective alert system to avoid allergy errors in the e-prescribing system.

What next?

We have achieved the implementation in the Pharmacy Service of our hospital, but it has already been taken to the safety committee in order to extend this practice to all the services of our hospital and we are working on the formation of a working group within the Patient Safety Commission. We are considering extending this procedure to primary care in order to address this problem from all healthcare areas.

DERMATOLOGICAL CARE IN PATIENTS UNDERGOING TREATMENT WITH CETUXIMAB

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European Statement

Patient Safety and Quality Assurance

Author(s)

Elena Blanco Saiz

Why was it done?

It is estimated that over 80% of patients receiving treatment with cetuximab experience acneiform eruptions and/or skin dryness and flaking. Approximately 15% of these cutaneous reactions are severe, including cases of skin necrosis.
These skin lesions may predispose patients to secondary infections, potentially leading to complications such as cellulitis, erysipelas, staphylococcal scalded skin syndrome, necrotizing fasciitis, or sepsis, which can result in death.

What was done?

A kit consisting of an alcohol-free moisturizing cream, an alcohol-free gel, and a sunscreen with a sun protection factor of 100 was provided to patients undergoing treatment with cetuximab for daily skin care.

How was it done?

When the oncology department prescribes cetuximab, the patient is informed that a kit will soon be dispensed.
The pharmacy service reviews daily the patients who will initiate treatment with cetuximab in the day treatment center. If there is a patient starting treatment, nursing staff notify us when they arrive at the center, and the pharmacy dispenses a kit while explaining its contents.
We periodically call the patient to check whether they are continuing to use it correctly, if they have noticed any changes in their skin, what changes they have observed, and whether they have needed to take antibiotics and/or topical corticosteroids.

What has been achieved?

• To date, the kit has been dispensed to 21 patients undergoing treatment with cetuximab.
• It empowers patients by actively involving them in their care.
• It prioritizes the overall well-being of the patient, as it may prevent the onset of dermatological side effects and the use of topical corticosteroids and oral antibiotics.
• The process facilitates the pharmacist’s engagement with the patient in the day treatment center and throughout the treatment, allowing for addressing concerns, answering questions, and providing information about adverse effects.
• It promotes the creation of a multidisciplinary team by involving collaboration between oncology, nursing, and pharmacy.

What next?

We present a practical approach that enhances patient safety during the oncology process.
This practice can be adopted by any center.
It is necessary to continue collecting data to obtain reliable results regarding its impact on improving patient safety.

Implementation of a multidisciplinary circuit for the management of haematologic patients under treatment with bispecific antibodies

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European Statement

Patient Safety and Quality Assurance

Author(s)

Carla Noguera-Jurado, Alba Manzaneque, Gloria Molas, Genis Castells, Sandra Jara, Bernat Tenas, Jordi Nicolas

Why was it done?

Bispecific antibodies (BA) have the ability to specifically bind two different antigens, thereby presenting specificity for two different cells. Among the toxicities associated with these drugs are cytokine release syndrome (CRS) and immunoeffector cell-associated neurotoxicity syndrome (ICANS), the management of which requires multidisciplinary action. The purpose of this circuit is to ensure adequate management of these toxicities to guarantee patient safety.

What was done?

Creation of an action plan for haematological patients treated with bispecific antibodies for the detection and proper management of their toxicities.

How was it done?

A multidisciplinary team formed by Pharmacy, Haematology, Nursing, Intensive Care Medicine and Neurology was created and the healthcare professionals involved were specifically instructed. Moreover, an action circuit was implemented for the detection and management of these toxicities, and a specific protocol was created for the preparation and dispensing of tocilizumab. The protocol contemplated: centralisation of the preparation in the pharmacy department (within the pharmacy hours) or preparation in the hospitalisation ward by trained professionals using a kit previously prepared by the pharmacist (containing drug, serum and closed system dispositive for the preparation and administration of tocilizumab outside pharmacy hours).

What has been achieved?

From July 2022 to August 2023, a total of five patients have been treated with BA in our institution (elranatamab (4/5), and teclistamab (1/5)), including clinical trials and compassionate use, for Multiple Myeloma.
Three patients presented grade 1 CRS in the first cycle of treatment, which was resolved with symptomatic therapy, with no need for tocilizumab administration in any case. In addition, one also presented grade 1 ICANS, which only required monitoring without treatment.
The availability of the toxicity management circuit, in addition to staff training, allowed toxicities to be detected and resolved early and, if tocilizumab had been needed, the circuit would have ensured its immediate availability.

What next?

The implementation of a multidisciplinary care circuit led by pharmacy and haematology guarantees the adequate management of toxicities associated with the treatment, ensuring the best quality of care for the patients and their safety.

Implementation of a new work circuit in monography consultation of immune-mediated diseases of the pharmacy service

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European Statement

Patient Safety and Quality Assurance

Author(s)

ALBA MARIA MARTINEZ SOTO, MARIA ONTENIENTE CANDELA, CARLES INIESTA NAVALON, PATRICIA ORTIZ FERNANDEZ, PILAR FERNANDEZ-VILLACAÑAS FERNANDEZ, ANABEL HERREROS HERNANDEZ, GEMMA MARTINEZ SOTO, CARMEN CABALLERO REQUEJO, MAYTE GIL CANDEL, ELENA URBIETA SANZ

Why was it done?

– Guide the pharmacist in the development of an individualised follow-up strategy for patient evaluating the frequency with which appointments should be established in the consultation of Pharmaceutical Care.
– Use the information from the specific questionnaires to detect possible failures therapeutic.
– Use the results obtained in the PROs to direct the recommendations pharmacotherapeutic to perform, which will be assessed in a multidisciplinary committee of immune-mediated diseases.
– Promote higher quality pharmaceutical care.

What was done?

Implementation of a circuit to improve pharmaceutical care and follow-up pharmacotherapeutic, incorporating the stratification of
patients according to the “Model of Stratification and Pharmaceutical Care for Diseases Immune-mediated Inflammatory Diseases” (MAPEX) and the use of Patient Reported Outcomes (PROs).

How was it done?

1. Selection of patients to include.
2. Design a database in Access for the collection of stratification data and PROs.
3. Selection of specific and generic PROs.
4. Stratification of active patients according to the MAPEX methodology at the beginning of the implantation and in patients who start during the follow-up period will be stratified at the baseline visit.
5. Establish a strategy for carrying out questionnaires (PROs) in consultation.

What has been achieved?

An Access database has been created that incorporates the blocks established by the MAPEX model with each of its variables broken down, allowing us to obtain the patient global score.
3 pathology-specific PROs have been selected (RAPID3 in rheumatoid arthritis, PSAID12 in Psoriatic Arthritis and BASDAI in Ankylosing Spondylitis) and a generic one, EuroQol-5D-5L.
The follow-up strategy based on the stratification was selected as the one proposed by the MAPEX model.
To carry out the PROs, those patients with arthropathies that are were under treatment with biological drugs.
It was decided to pass a specific PRO according to his pathology and the generic having a baseline intake, another at 16 weeks and another a year.

What next?

Design a study to measure the results in terms of quality of care obtained with this new circuit.

Implementation of a screening circuit and prevention of infections in cancer patients treated with immune checkpoint inhibitors

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European Statement

Clinical Pharmacy Services

Author(s)

Alba Manzaneque, Carla Jurado , Cristina Alonso , Mireia Cairó, Glòria Molas, Fernando Salazar , Lucía Boix, Roser Font, Laura López, Jordi Nicolás, Marc Campayo, Esther Calbo

Why was it done?

Although an intrinsic risk of infection has not been associated with ICI, there are different studies and case-series in the literature in which an increased risk of infection is observed, mainly associated with the use of immunosuppressive drugs (like corticoids) for immune-mediated toxicities. The objective of implementing this circuit in our centre is to reduce all preventable infections, by carrying out an initial infection screening that allows detection of those patients susceptible to vaccination measures, prophylaxis, or specific recommendations.

What was done?

Implementation of an infection screening circuit in cancer patients treated with immune checkpoint inhibitor drugs (ICI).

How was it done?

To carry it out, a multidisciplinary work team was created (pharmacy/oncology/infections department) that designed the ICI template and the clinical circuits. At this point, we believed it was necessary to centralise requests, results, and follow-ups in the oncology pharmacy team (OPT) in order to ensure that all patients were included.
Before the patient initiates treatment with ICIs, the OPT makes the request for a pre-established ICI analysis and the oncology nurse (ON) extracts it. Within 7-10 days, the infection department checks the results and makes the necessary recommendations (vaccination/prophylaxis/specific recommendations).
The OPT is then responsible for both vaccination and initiation of prophylaxis.

What has been achieved?

A total of 30 patients (January to September 2022) have been included in the circuit, 25/30 being men and with a mean age of 67.8 (± 8.8) years.
In 25/30 the treatment was with palliative intent, and 21/30 had lung neoplasia.
The ICIs prescribed were: pembrolizumab (15/30) and nivolumab/atezolizumab/durvalumab (5/30 in each case).
Screening results are available for 26/30 patients. Some type of recommendation was made in 25/26 patients, being: 20/26 hepatitis B vaccination, 5/26 start prophylaxis (2/5 hepatitis B and 3/5 tuberculosis), 6/26 hygienic-dietary measures (aimed at toxoplasmosis).
Additionally, all previously unvaccinated patients (23/26) have been vaccinated against pneumococcus.

What next?

A comparative analysis of infection with a historical cohort is planned when larger sample size is available, to demonstrate that these types of measures reduce the occurrence of infections. Centralising this type of initiative from the OPT is key to our integration into clinical teams, by avoiding important adverse reactions and taking care of our patients.

Assessing the Application of Essential Medication Errors Prevention Strategies in Healthcare Institutes: STOP Medication Error Project

European Statement

Patient Safety and Quality Assurance

Author(s)

Monira Alwhaibi

Why was it done?

This study is the first project of the STOP ME projects which aims to develop a tool that can assess the application of the essential strategies that can stop or minimize MEs in healthcare institutes in Saudi Arabia. Consequently, stakeholders in the healthcare system can identify current gaps that need feature improvement to enhance patient safety

What was done?

Medication Errors (ME) are defined as unintentional drug-induced harm that led to morbidity and mortality. The STOP (ME) project is a comprehensive series of research studies that aim to explore MEs in Saudi Arabia and how to stop such harmful events.

How was it done?

Extensive search of the literature review for the essential strategies to stop or minimize MEs was carried by the research team to develop a draft of the aimed tool. The survey tool was sent in round 1 to the Delphi experts’ panel for review. Based on received recommendations, the tool was updated and sent for round 2 review and consensus. The developed tool was then piloted to test the practicability of the tool before running the survey on large sample size (second project). The study was approved by the King Saud University Medical Centre IRB ethics committee [20/0153/IRB].

What has been achieved?

After using the Delphi technique two major changes happened to the survey. 1) Section A was removed (high alert medications). 2) A new section was added (ISMP publications) with some minor changes. Launching a pilot survey on thirty healthcare practitioners (physicians n=11, pharmacists n=10, nurses n=9) resulted in further minor changes by adding two new columns. The final tool was a survey consists of six sections including Demographics, Prescription, Dispensing, Administration, Monitoring and Quality, and Targeted Medication Safety Best Practices for Hospitals. All combined 86 questions with the determined time to answer the survey is in the range of 25-30 minutes. Overall feedback of the pilot survey was good.

What next?

This initiative “STOP ME” will have a significant impact in the field of medication safety research and will build awareness among institutes in Saudi Arabia that are lacking important strategies that prevent MEs