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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.

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.

OPTIMIZING ASPIRIN DESENSITIZATION WITH A PHARMACY-PREPARED ORAL SUSPENSION

European Statement

Production and Compounding

Author(s)

LYG Lidia Ybañez García, VPG Virginia Puebla García, ERS Estefanía Rosón Sanchez, NSO Natalia Sánchez Ocaña, JCV Javier Corazón Villanueva, MTO María de la Torre Ortiz, TBG Teresa Benitez Gimenez.

Why was it done?

Dual antiplatelet therapy with clopidogrel and ASA is standard for acute coronary syndrome and post-stent patients. ASA hypersensitivity occurs in approximately 1.5–2.6% of coronary patients, requiring rapid desensitization. The previous capsule-based protocol involved up to 10 strengths in batches of 100 capsules, many of which were discarded.
A literature search identified only capsule-based protocols or preparations made from dispersible tablets at the ward. To minimize the risk of errors from bedside manipulation, we developed a pharmacy-prepared oral suspension from the active ingredient, allowing centralized, standardized, and safer compounding.

What was done?

A new ASA desensitization protocol was implemented using an extemporaneous pharmacy-prepared oral suspension. It replaced multiple-strength capsules, which were laborious to produce and generated considerable waste. The suspension allowed faster preparation, simplified administration of incremental doses (standardized in the protocol), and offered a more patient-centered approach. It also eliminated the need for ward-based dilutions from dispersible tablets, enhancing safety through centralized pharmacy preparation.

How was it done?

A bibliographic review (RUESA, PubMed, SEFH, Compounding Today, Trissel’s) and analysis of existing protocols were conducted. No suitable aqueous formulations were available, and oily preparations were discarded due to poor palatability. The suspension was prepared according to national pharmacy compounding and quality guidelines.
Composition: ASA 100 mg, glycerin 3 g, carboxymethylcellulose gel 1.5% (35 mL), and purified water q.s. to 100 mL (1 mg/mL). Stable for 24 hours, packaged in individualized oral syringes

What has been achieved?

Since 2017, thirteen patients (median age 83, eight males) have undergone desensitization using the oral suspension. All tolerated the process, allowing initiation of ASA therapy. Compared with the previous protocol, the new approach is faster to prepare and administer, reduces waste, simplifies the process, and maintains patient safety and treatment effectiveness. Centralized preparation eliminated bedside dilutions and enabled safe, standardized incremental dosing.

What next?

This initiative highlights the role of hospital pharmacists in developing practical solutions to optimize patient care. The approach is easily transferable to other hospitals facing similar challenges with ASA desensitization

SECURING THE COLD CHAIN: PORTUGUESE HOSPITAL PHARMACY RESPONSE TO THE 2025 NATIONAL BLACKOUT

European Statement

Patient Safety and Quality Assurance

Author(s)

Inês Carmo, Ana Parola, Inês Oliveira, Margarida Carvalho, Marta Carvalho, Ana Mirco.

Why was it done?

On April 28, 2025, a nationwide blackout affected Portugal, disrupting the national power grid and severely compromising the cold chain of vaccines in primary health care facilities, along with all forms of mobile communication. Given this event, the response by the Pharmaceutical Department (PD) of a Local Health Unit responsible for delivering vaccines to 38 Primary Health Care Facilities (PHCF) required evaluation due to major clinical, financial, and operational risks.

What was done?

Vaccines exposed to any temperature excursion during storage were identified and placed under quarantine, preferably using an alternative cold storage unit with an independent power source, when available, and distinctly labeled. Through a standardized notification form, each incident was promptly reported within 48 to 72 hours to the cold chain supervisor and PS. During the first week after the blackout, PS reviewed each report to determine the vaccine’s stability and possible return to the supply chain.

How was it done?

Hospital pharmacists collected key data such as temperature variations, time outside safe range, and affected vaccine batches. They consulted reliable sources (databases and Summary of Product Characteristics) and sought information from the supplier laboratory. Upon analyzing all data, PHCF received precise recommendations on suitability for ongoing use.

What has been achieved?

On April 28, 2025, 40 cold chain incidents were notified, affecting 12,442 vaccines units. After thorough analysis, 12,202 units were authorizes for use, reducing clinical and economic impact. Only 240 units were discarded, resulting in a loss of 6,018.50 € out of a total stock valued at 284 544, 60 €. Joint action by Pharmacist and PHCF assured continuity of patient care and vaccine safety, preventing disruptions to the National Vaccination Program.

What next?

The nationwide blackout exposed vulnerabilities in the PHCF cold chain, highlighting the need for more refrigerators, continuous electronic monitoring, backup generators, refrigerated vehicles, and standardized protocols between PS and PHCF.

COST- AVOIDANCE ANALYSIS OF PHARMACEUTICAL INTERVENTIONS IN HOME STORAGE ERRORS OF REFRIGERATED MEDICINES.

European Statement

Patient Safety and Quality Assurance

Author(s)

Martín Santamaria, A. López Fernández, A. Menchén Viso, B. Sanabrias Fernández de Sevilla, R. Folguera Olias, C. Guerrero Feria, I. Herrero Collado, L. De España Zaforteza, P. Pérez García, E. Sánchez Guerrero, A.

Why was it done?

Unnecessary disposal of high-cost injectables is often triggered by home storage errors, placing a burden on the public health system. The aim was to quantify avoidable expenditure through pharmacist review, and to identify opportunities for the education of targeted patients, prompted by these incidents.

What was done?

A pharmacist-led stability verification program for refrigerated medicines stored at home was implemented. When an out-of-fridge incident was reported, stability was assessed by a pharmacist and, when safe, continued use was authorised, avoiding replacement costs.

How was it done?

A retrospective analysis was conducted of incidents recorded in an Excel database from 2021 to 2024. For each case, the following variables were collected: active drug, units affected, units saved, and costs (potential replacement and avoided cost). Stability decisions were based on summaries of product characteristics (SmPCs), manufacturer information, and published temperature-excursion evidence (Stabilis database, Fridge Stability Tool by NHS) interpreted against the reported time/temperature exposure.

What has been achieved?

From 2021 to 2024, 115 incidents were recorded, involving 288 injectable units; 66 were authorized for continued use, avoiding 18.590€ in replacement costs. Savings by year and share of the total were: 6.922€ in 2021 (37,2%), 5.498€ in 2022 (29,6%), 4.012€ in 2023 (21,6%), and 2.159€ in 2024 (11,6%). By year, injectable units saved/affected were: 2021: 28/46, 2022: 19/150, 2023: 6/33, 2024: 13/59. The most frequently implicated drugs were adalimumab (38), etanercept (10), darbepoetin alfa (10), filgrastim (7), and golimumab (4). These drugs were also the most frequently consumed across this period. A substantial proportion of excursions were cleared for safe continued use through a structured pharmacist verification process.

What next?

An infographic will be developed to standardise patient counselling: correct home storage (fridge placement, do-not-freeze warnings, time-out-of-refrigeration windows by product), safe travel with injectables (cool bags/ice packs, temperature monitoring, air/rail travel tips, hotel-fridge checks), and recommended actions after an incident—product quarantine, time/temperature recording, and immediate contact with the hospital pharmacy (email/phone). The infographic will be provided at first dispense and after any excursion, and its impact will be evaluated through subsequent incident and saved units rates.

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.

ENHANCING SAFETY IN CYTOTOXIC DRUG PREPARATION THROUGH SIMULATION-BASED TRAINING

European Statement

Production and Compounding

Author(s)

Bennani I.,Cherif Chefchaouni A.,Alaoui S., Hajjaj S., El Deeb S., Boufaress S., Hafidi Y., El Merrakchi S., Moukafih B., Bandadi F., El Kartouti A.

Why was it done?

A structured training programme was established to improve cytotoxic drug preparation in our hospital pharmacy. The initiative combined updated Standard Operating Procedures (SOPs), simulation sessions using non-hazardous substitutes, and debriefings focused on error prevention and occupational safety.

What was done?

Cytotoxic preparation carries significant risks: dosage errors compromise patient safety, while inadequate protective measures expose staff to hazardous drugs. Audits in our unit revealed inconsistent practices and insufficient adherence to safety protocols. A reproducible, safe method of training was needed to harmonise techniques and reduce risks.

How was it done?

The initiative was implemented through a structured program combining simulation sessions, observation checklists, and debriefing meetings. Teams were trained using standardized SOPs and dummy materials, allowing safe practice of aseptic techniques. Performance indicators were measured before and after simulation training to assess impact on safety and compliance.

What has been achieved?

More than 60 pharmacists and technicians have completed the programme. Error rates in cytotoxic preparations decreased by about 30%, and environmental monitoring showed a 25% reduction in contamination markers. Surveys confirmed improved confidence (92%) and adherence to protective measures (95%). The training is now part of our hospital’s continuous education system.

What next?

The programme will be extended to all new pharmacy staff and residents. Plans include developing e-learning modules and inter-hospital workshops to spread the model nationally and internationally.

FROM COLLABORATION TO AUGMENTATION: INTEGRATING AN ARTIFICIAL INTELLIGENCE (AI)-POWERED DOSING TOOL INTO A PHYSICIAN–PHARMACIST COLLABORATIVE WARFARIN CLINIC (PPCC-AI MODEL) — A QUASI-EXPERIMENTAL STUDY AT TAKUAPA HOSPITAL, THAILAND.

European Statement

Clinical Pharmacy Services

Author(s)

daruni sitthikan

Why was it done?

Warfarin management is complex due to its narrow therapeutic index and wide interpatient variability. Although the physician–pharmacist collaborative clinic (PPCC) model has improved anticoagulation outcomes, genetic variability remains a key challenge, as pharmacogenomic (PGx) testing is rarely available in Thai hospitals. To overcome this, an AI-based dosing tool (WarfaWise web application) was developed to assist clinicians in personalizing warfarin therapy without genetic testing.

What was done?

To evaluate the effectiveness of an AI-assisted dosing tool (WarfaWise web application) integrated into the PPCC model (PPCC–AI Model) for optimizing warfarin therapy at Takuapa Hospital, Thailand.

How was it done?

This quasi-experimental study included patients (≥18 years) who received warfarin for ≥3 months (January 2023–May 2025). The WarfaWise web-based AI dosing application was incorporated into the PPCC workflow to predict individualized weekly warfarin doses based on patient-specific parameters (age, sex, weight, comorbidities, concomitant drugs, adherence, and INR trends). The primary outcome was the percentage of Time in Therapeutic Range (%TTR). Secondary outcomes included dosing accuracy (Mean Absolute Error: MAE) and incidence of bleeding or thromboembolic complications. Statistical significance was set at p<0.05.

What has been achieved?

A total of 230 patients were enrolled. The AI-assisted PPCC demonstrated superior dosing precision (MAE=2.09±1.20 mg/week) and significantly improved mean %TTR (primary outcome) from pre-intervention 65.10±1.09% to post-intervention 71.4±8.6% (p<0.02). The incidence of minor bleeding decreased by 69.5%, and no major bleeding or thromboembolic complications occurred during the study period. Pharmacists also reported enhanced workflow efficiency and a reduction in dosing calculation errors. In conclusion, the study showed that the PPCC-AI model demonstrated superior dosing precision, enhanced INR control, and improved patient safety. This pragmatic digital innovation facilitates the scalable adoption of AI-assisted clinical decision-making tools in resource-limited settings where PGx testing is inaccessible, underscoring the evolving role of pharmacists in precision anticoagulation management.

What next?

To develop a mobile application that is easily accessible and free of charge, and can be used in hospitals at all levels.

DEVELOPMENT OF AN INTERNAL GUIDELINE TO IDENTIFY THE ORIGIN OF LACTOSE EXCIPIENTS AND IMPROVE SAFETY IN PATIENTS WITH COW’S MILK PROTEIN ALLERGY

European Statement

Patient Safety and Quality Assurance

Author(s)

M. Echávarri de Miguel, C. Varela Guisasola, A. Sánchez Alonso, A. Abril Cabero, E. Nieto Martil, A. Merino Pardo, E. Algarra Sánchez, B. Riva de la Hoz, B. Márquez Arce, B. Leal Pino, M. Pozas del Río

Why was it done?

Lactose used as a pharmaceutical excipient is generally obtained from skimmed milk and purified to remove milk proteins. Pharmacopoeias specify that lactose must be free from protein contaminants; hence, it has been considered safe for patients with cow’s milk protein allergy (CMPA). However, in severe allergies, medicines containing natural lactose should be avoided due to the potential risk of protein contamination. Although rare, cases of anaphylaxis from contaminant milk proteins have been reported, particularly with dry-powder inhalers, injectables, and vaccines.
This initiative arose after a suspected allergic reaction in a patient with severe CMPA following administration of an injectable containing lactose as an excipient. Given limited evidence and lack of transparency about lactose origin, an internal guideline was developed to enhance patient safety.

What was done?

An internal hospital guideline was developed and implemented to verify the origin—natural or synthetic—of lactose used as an excipient in medicines. The guideline was created through systematic screening assisted by artificial intelligence, followed by verification with manufacturers.

How was it done?

With ChatGPT support, a Python-based code was created to analyze 3,278 pharmaceutical specialties for the presence of lactose. Manual validation of 360 medicines (95% confidence level, ±5% margin of error) confirmed the method’s reliability. The most dispensed medicines and all intravenous formulations, vaccines, and inhalers were reviewed due to higher risk described in literature. Manufacturers were contacted to determine whether lactose was natural or synthetic. Main challenges included delayed responses and limited data due to confidentiality.

What has been achieved?

Of the 3,278 medicines analyzed, 350 contained lactose or mentioned it in their product information, 1,522 did not, and 1,406 were inactive codes. Lactose origin was investigated for 152 products from 58 manufacturers, with responses in 92 cases (60.5%). Only five (5.4%) contained synthetic lactose. High-risk medicines included one inhaler and eight injectables (two vaccines) with natural lactose. Manual validation showed 100% concordance with automated results.

What next?

Next steps include expanding data to over 350 confirmed medicines, publishing results for open access, and developing an app for healthcare professionals. Integration into prescribing and dispensing systems is planned to generate automatic alerts for patients with severe CMPA.