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IMPLEMENTATION OF INTRAVENOUS WORKFLOW TECHNOLOGY FOR PEDIATRIC CHEMOTHERAPY: ENHANCING SAFETY, COMPLIANCE, AND OPERATIONAL EFFICIENCY

European Statement

Patient Safety and Quality Assurance

Author(s)

Natalie Kuchik PharmD, MS, BCSCP and Jacalyn Rogers PharmD, MS, BCPS, CPEL, FASHP

Why was it done?

Pediatric chemotherapy compounding requires exceptional precision and strict adherence to USP and standards due to the high-risk nature of the medications and vulnerable patient population. Traditional manual compounding workflows are prone to human error and operational inefficiencies, especially in busy hospital settings. To address these challenges, IV workflow technology was implemented to enhance patient safety, improve compliance, and streamline pharmacy operations.

What was done?

An IV workflow technology system was introduced in a pediatric hospital pharmacy to support chemotherapy compounding. The system included barcode scanning for drug and diluent verification, image capture of each preparation step, and remote pharmacist verification. This allowed pharmacists to review compounding steps in real time without being physically present in the cleanroom, improving both safety and workflow efficiency.

How was it done?

The implementation was carried out prospectively, with pharmacists transitioning to remote in-line verification using the IV workflow platform. The system flagged incorrect drug or diluent scans and captured images of each preparation step for pharmacist review. This setup enabled pharmacists to detect and intervene in real time when errors occurred, such as incorrect labeling or volume discrepancies. Data were collected on scan alerts, image-based interventions, and workflow metrics, including preparation throughput and pharmacist time allocation.

What has been achieved?

The technology successfully identified all instances of incorrect drug and diluent selections before finalization, significantly reducing the risk of medication errors. Image review further enhanced error detection, particularly for labeling and preparation accuracy. Removing pharmacists from the cleanroom improved workflow flexibility and reduced interruptions, resulting in a 25% increase in preparation throughput. Compliance with USP and standards improved due to automated documentation and verification processes.

What next?

Future steps include expanding the use of IV workflow technology to other high-risk compounding areas and evaluating its impact on broader pharmacy operations. Additional enhancements may include integrating the system with electronic health records and exploring further automation to support scalability. Continued monitoring of safety, compliance, and efficiency metrics will guide optimization and inform best practices for pediatric and adult oncology settings.

OPTIMIZED LABELING OF PREFILLED CATECHOLAMINE SYRINGES PREPARED FULLY AUTOMATED IN HOSPITAL PHARMACY

European Statement

Patient Safety and Quality Assurance

Author(s)

David Ackermann
Dr. Judith Thiesen
Prof. Dr. Irene Krämer

Why was it done?

Recently we started batchwise preparation of 10 mL prefilled syringes (PFS) containing different active substances and concentrations using APOTECAsyringe. The syringes are automatically filled, capped, and labeled. However, layout and formatting of the inline printed labels (only black printing) needed improvement to avoid look-alike errors. Moreover, readability of PFS labels is compromised, since labels are wrapped around the syringes. Good labeling is absolutely necessary when norepinephrine (NE) 10 µg/ml, norepinephrine (NE) 100 µg/ml, and epinephrine (E) 100 µg/ml PFS are delivered in a set of three to be used in emergency cases. Erroneous identification of the PFS can have serious consequences for patients.

What was done?

Based on the national guideline and the international standard (ISO 26825) we decided to go for color-coded labeling and Tall Man lettering to maximize the difference between the two similar drug names. For E and NE the recommended label color is pink, on E labels the drug name is printed in pink on black background. Measures to enhance the readability of the labels were limited by the predefined size of the label and a scarce label assistant in the software.

How was it done?

Drug names and concentrations were printed in bold letters on the best visible part of the PFS label. The Tall Man lettering chosen was NORepinephrin and EPINEPHrin. To ease the identification of the two different NE concentrations, for NE 10 µg/mL a darker pink label was chosen and for NE 100 µg/mL the concentration was underscored. On E labels, the recommended black background was printed as bar beyond the drug name.

What has been achieved?

An optimized printing image of inline printed labels for pharmacy prepared NE and E PFS was successfully developed. The optimized labeling enhances readability of the PFS labels and contributes to reduced error rates in emergency cases.

What next?

Three months after implementation of the optimized PFS labels a survey among users is planned to evaluate the need for further optimization.

TRANSFORMING MEDICATION RECONCILIATION: PHARMACY-ASSISTED PROCESSES IN LARGE ACADEMIC MEDICAL CENTER

European Statement

Patient Safety and Quality Assurance

Author(s)

Victoria Lubarsky, Jacalyn Rogers, Nataly Kuchik

Why was it done?

Accurate home medication history and admission reconciliation are critical during care transitions to prevent harm. In my hospital, the medication history team reviews over 85% of daily admissions, yet providers often face challenges with timely reconciliation. To address this, the pharmacy team proposed a dual-approach initiative: provider education to support reconciliation within 24 hours of admission, and a pharmacy-assisted process enabling pharmacists to reconcile select medications or collaborate with providers to finalize reconciliation.

What was done?

This initiative aimed to meet the hospital’s quality goal of achieving 90% completion of accurate admission medication reconciliations within 24 hours. A retrospective observational study was conducted over nine months in 2024. Data collected was quantitative, focusing on medication reconciliation completion rates, pharmacist interventions, and provider engagement. Descriptive statistics analyzed trends and measured improvements in reconciliation rates.

How was it done?

A dual-strategy approach was implemented: provider education and pharmacy-assisted workflow. A standardized flow sheet and enhanced EMR patient lists improved provider visibility. A new procedure and dashboard enabled pharmacists to identify incomplete medication reconciliations within 24 hours and intervene by reconciling select medication classes (e.g., OTCs, supplements, duplicates, long-acting meds), communicating via secure chat to resolve discrepancies, and documenting post-reconciliation additions in pharmacy notes. Prior to admission, home medication lists were reviewed by pharmacy technicians using the MARQUIS framework to support reconciliation accuracy.

What has been achieved?

A quantitative analysis using descriptive statistics was conducted to evaluate changes in medication reconciliation completion rates before and after implementing the initiative. • Overall reconciliation completion rates increased by 30 percentage points, from 52% to 82% over nine months • The pharmacy team’s consistent contribution accounted for 15% of the total improvement • Provider education accounted for an additional 15%, with 13% from pharmacy’s provider outreach and 2% from education initiatives and process awareness.

What next?

This initiative demonstrates the effectiveness of provider education and pharmacy-assisted processes in improving timely and accurate medication reconciliation outcomes and patient safety during care transitions. Future directions include expanding pharmacy-assisted hours and replicating the model across additional hospital sites to broaden impact and strategize best practices.

IMPROVING THE SAFETY, USE AND WASTE OF CONTROLLED MEDICATIONS IN SAN IGNACIO UNIVERSITY HOSPITAL

European Statement

Patient Safety and Quality Assurance

Author(s)

Pinzon Garcia, Viviana Andrea
Fajardo Escolar, Angelica Paola

Why was it done?

Since implementing the Opioid Stewardship Programme in 2018, we have improved the management of morphine and hydromorphone in our hospital. This has not only reduced medication waste, but also created a hospital culture that recognises the importance of standard single-dose in ensuring medication safety. Based on this, we extended the programme to include other controlled medicines, after identifying the need to limit the use of vials and ampoules of fentanyl, remifentanil and ketamine considering the available commercial presentations and the probability of using these products on multiple patients without maintaining their sterility.

What was done?

We extended the coverage and monitoring of the unit-dose system to include other controlled medications apart from morphine and hydromorphone, through interdisciplinary collaboration between the Anaesthesia and Pharmacy Departments, with the aim of reducing waste and the risk of misuse at San Ignacio University Hospital, a high-level hospital in Bogotá, Colombia.

How was it done?

As part of the annual Pharmacy and Therapeutic Committee operative plan, the pharmacy and anaesthesia departments evaluated the risks in the medication order cycle of opioids and other controlled medications, defining strategies using an improvement cycle model. We assessed the feasibility of preparing unit doses of these medications, as well as the storage, preservation conditions and logistics of medication inventory. We deployed the strategy through staff training, mainly in operating rooms, intensive care and resuscitation, and established a follow-up of consumption and adherence, records of remnant disposal, cases of naloxone use and events reported to the pharmacovigilance programme.

What has been achieved?

The average proportion of standard single-dose prescriptions in 2025 was 74% for hydromorphone, 77% for morphine, 84% for fentanyl and 50% for remifentanil. Through our compounding center, we prepared 143,854 doses of these medications in 2024 and 78,421 from January to August 2025. The inventory write-off percentage due to expiration was 1.06% in 2024 and 0.38% in the first eight months of 2025. The percentage of hospitalised patients who received naloxone was 0.20 in the first semester of 2024 and 0.17 in the first semester of 2025.

What next?

Conducting interdisciplinary rounds in services to identify on-site adherence to implemented practices and supportting Human Talent, maintaining the improvement cycle process.

MEDICATION SAFETY AT CARE HOMES. A PENDING ISSUE.

European Statement

Patient Safety and Quality Assurance

Author(s)

M.A. Iriarte; A. Gascón

Why was it done?

In care homes, it is essential to ensure safety at all stages of the medication process in order to prevent medication errors and contribute to the quality of care.

What was done?

Identify improvement actions in a care home to make the process of using medication safer.

How was it done?

A SWOT analysis of the medicine usage process is carried out to identify proposals for improvement to be implemented

What has been achieved?

The SWOT analysis showed us the following:
– We identified the following weaknesses: the organisational model could be improved, technologies are not adapted to the social and healthcare environment, staff burnout, lack of leadership in the implementation of processes related to the use of medication, and lack of standardised criteria.
– As strengths, we identified the creation of a multidisciplinary team with a high capacity for teamwork, management support, and opportunities to use technology and adapt it to the process.
– As threats, we identified an unfavourable economic situation for the allocation of resources, continuous staff changes and an excessive workload.
– Finally, the opportunities we have are a favourable regulatory and organisational framework, policies to enhance the quality of care, the incorporation of clinical pharmacists into the teams and a positive perception of the team by other workers.
Analysis of the results has helped us identify areas for improvement and establish priority objectives to increase the safe use of medicines at our centre.

These actions have led to improved organisation and motivation among staff at this centre, which serves as a model for implementation at other centres.

What next?

Following this analysis, the following improvement proposals were decided upon:
– Select a person to lead the entire process of medicine use.
– Optimise the organisation of resources and staff.
– Promote and adapt the use of available health technologies.
– Foster a culture of medicine safety.
– Train and motivate staff to standardise criteria.
– Update work procedures with the agreed improvements and implement actions to ensure they are known and executed.

EVIDENCE-BASED STANDARDISATION OF RECOMMENDATIONS AND PATIENT INFORMATION FOR HANDLING EXCRETA AFTER CHEMOTHERAPY

European Statement

Patient Safety and Quality Assurance

Author(s)

S. ADEVA ANTONA, E. ZHAN ZHOU, J.J. MARTINEZ SIMON, S. RISCO MARTÍNEZ, O. GUERRA GOMEZ, S. LOPEZ LOPEZ.

Why was it done?

A multidisciplinary initiative between Hospital Pharmacy and Onco-haematology nursing team was carried out to review and standardise recommendations provided to patients and caregivers regarding precautions with urine and faeces wastes after oral/intravenous chemotherapy.
A pharmacokinetic-based model was developed to determine the length of time during which such precautions should be maintained and all patient information leaflets were subsequently updated. Additionally, a general recommendations leaflet was created to be delivered to the patient at treatment initiation.

What was done?

Antineoplastic drug residues have been detected inside patients’ homes, especially on toilet and bathroom surfaces¹. Due to the scarce literature available, the information provided to patients on excreta handling precautions after chemotherapy varied considerably, leading to unsafe handling of excreta, with the risk of exposure to cohabitants and caregivers.
The project aimed to review the literature, establish evidence-based precaution periods grounded in pharmacokinetic principles, and standardise patient information across the hospital to improve safety and ensure consistency.

How was it done?

A structured literature review was performed to collect data on drug half-lives, renal and biliary excretion rates, metabolite activity, and their excretion and half-lives. Based on these data, a model was designed to estimate the period during which excreta might contain significant cytotoxic substances, defined as 4 to 5 half-lives(90% excreted). A 48-hour precaution period was set as standard, extended up to 7 days for drugs with longer half-lives or active metabolites, as no evidence supported longer periods.
140 drugs were reviewed, including 73 oral agents. Recommendations were established for the management of urine in 29 drugs and for faeces in 36.

What has been achieved?

Patient information leaflets were updated to include a section on excreta handling precautions, specifying the duration and safety measures. A general leaflet was also introduced at treatment initiation. This standardisation improved the consistency of information provided by healthcare professionals and enhanced safety for patient and caregiver.

What next?

This initiative provides a pragmatic, evidence-based framework adaptable to other hospitals to harmonise recommendations and improve safety. Future steps include formal auditing of adherence and exploring publication to support broader implementation. The methodology could be extended to other hazardous drugs and newly introduced anticancer agents into clinical use.

UDI-BASED END-TO-END TRACEABILITY: A SMART APPROACH TO MEDICAL DEVICE MANAGEMENT

European Statement

Patient Safety and Quality Assurance

Author(s)

Andrea Piovanelli, Ivan Schimmenti, Enrico Almici, Paola Crosasso, Fabio Genestrone, Elena Toniato

Why was it done?

Medical devices’ traceability is a critical issue in hospital settings due to the high cost of devices and the need to associate item-patient-procedure. Standardized identification systems become fundamental to manage clinical risk, while addressing inefficiencies in inventory management, and minimizing waste from poorly monitored expiration dates. RFID-based solutions have been tested to implement identification and traceability with the promise of automating procedures and facilitating personnel activities, nonetheless their complexity and cost have limited their adoption so far. EU Regulation 2017/745 (MDR) introduced the requirement of native UDI (Unique Device Identifier) codes present on each medical device. As such, it is now possible to implement simple and cost-effective solutions for identification and traceability that do not require specific hardware or tedious relabeling procedures compared to RFID, and exploit 2D data carriers natively present on MDs.

What was done?

To implement a digital, end-to-end traceability system for medical devices using native UDI (Unique Device Identifier) codes, in compliance with EU Regulation 2017/745 (MDR). The objective is to improve patient safety, optimize inventory management, reduce operational costs, and ensure regulatory compliance without the need for relabelling and dedicated personnel.

How was it done?

The proposed solution leverages optical identification technologies and hands-free systems to automate device tracking from hospital entry to patient association. Smart cabinets manage inventory and access control, while smart baskets automatically link devices to patients. An AI-powered platform analyses data across all phases to support stock optimization, automatic reordering, structured reporting, and performance evaluation.

What has been achieved?

The system enables real-time inventory visibility, eliminates manual errors, improves device utilization. Avoiding costly, time-consuming and risky relabeling of MDs with RFID tags lowers implementation costs, minimizing environmental impact. Clinically, it enhances patient safety enabling rapid response to recalls and adverse events. Operationally, it streamlines logistics, reduces staff workload, and improves planning through AI-driven insights.

What next?

The adoption of an end-to-end UDI-based traceability system represents a significant advancement in medical device management. It delivers tangible benefits in terms of economic efficiency, clinical safety, organizational performance, and environmental sustainability. This innovative approach aligns with the digital transformation of healthcare and offers a scalable model for hospitals seeking to modernize their logistics and compliance processes

DEVELOPMENT OF DEDICATED INFORMATION BROCHURES TO IMPROVE THE MANAGEMENT AND SAFETY OF PAEDIATRIC GALENIC MEDICINAL PREPARATIONS

European Statement

Patient Safety and Quality Assurance

Author(s)

S. GAMBA1, M. FRANCHINA1, M. GIACONIA1, C. INTRA1, M. CASTIGNONE1, E. PANETTA1, G. D’ARENA1, C. PERASSO1, P. BARABINO1, G. SPIGA2.
1IRCCS GASLINI, HOSPITAL PHARMACY, GENOVA, ITALY.
2IRCCS GASLINI, CLINICAL GOVERNANCE, GENOVA, ITALY

Why was it done?

Paediatric galenic preparations are essential for neonates, patients with rare diseases, and those requiring highly individualised treatments or unable to swallow solid dosage forms, for whom no commercial alternatives exist. Despite widespread use, there is a significant need for accessible, user-friendly guidance to support correct home administration. Lack of clear instructions increases the risk of dosing errors—particularly during dose conversion or with multi-dose containers—a safety concern highlighted by regulatory bodies such as the Italian Medicines Agency (AIFA). To address this, the initiative aims to improve the safety and effectiveness of home administration through a personalised educational brochure for patients, caregivers, and healthcare professionals.

What was done?

A personalised brochure was created to guide patients and caregivers in the safe home administration of paediatric galenic medicines. It covers therapeutic indications, composition, storage, dosage and conversion, posology, management of missed doses, potential interactions and side effects, and instructions for medicine collection from the hospital pharmacy. A satisfaction questionnaire is distributed at dispensing to gather feedback for iterative improvements.

How was it done?

The brochure was developed collaboratively by pharmacists and prescribing physicians to ensure accuracy and consistency, so that all patients receive standardised information. Written in plain language and supported by icons, it is easy to understand. A QR code linking to a digital version allows continuous access via smartphone. Feedback from the questionnaire informs ongoing refinements.

What has been achieved?

This initiative reflects the evolving role of hospital pharmacies toward a clinical, patient-centred, and collaborative model. The brochure serves as both an informative resource and a practical tool for patient empowerment, improved communication, and enhanced care quality. In paediatrics—where treatments require heightened attention—this tool bridges the information gap, supporting patients and caregivers and increasing medication safety.

What next?

Ongoing feedback will be used to refine the brochure and digital resources. The initiative will expand to additional paediatric units and be adapted for other patient groups requiring complex or individualised therapies. Collaboration between healthcare professionals and families will continue to ensure accuracy, usability, and patient-centred design. Long-term monitoring will assess the impact on medication safety, adherence, and clinical outcomes, with potential wider application across other therapeutic areas and hospital settings.

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

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.

IMPLEMENTING FAILURE MODE AND EFFECTS ANALYSIS TO IMPROVE ISOLATOR HANDLING PRACTICES IN CHEMOTHERAPY PREPARATION: A TRANSFERABLE MODEL FOR HOSPITAL PHARMACIES

European Statement

Patient Safety and Quality Assurance

Author(s)

S. EL DEEB, I. BENNANI, A. CHERIF CHEFCHAOUNI, S. ALAOUI, S. HAJJAJ, S. BOUFARESS, S. EL MARRAKCHI, B. MOUKAFIH, F.Z. BANDADI, Y. HAFIDI, A. EL KARTOUTI.

Why was it done?

In the oncology pharmacy, isolators are vital for aseptic compounding and operator protection. However, daily handling steps can still introduce contamination risks and affect patient safety. We recognized the need to systematically analyse and minimize these risks, especially in a resource-constrained setting, to ensure safer and more standardized chemotherapy preparation practices.

What was done?

We applied Failure Mode and Effects Analysis (FMEA) to identify and reduce risks in isolator handling during chemotherapy preparation. The objective was to evaluate each step of the process, implement corrective measures to lower risk priority numbers (RPNs), and develop a practical model that could be shared with other hospital pharmacies.

How was it done?

An observational checklist was used to evaluate six key isolator handling steps: glove installation, surface cleaning, material transfer, logbook entry, waste removal, and glove removal. During 100 routine preparations, failures were recorded to calculate occurrence scores. Severity and detection were assessed by an interdisciplinary team, and risk priority numbers (RPNs) were obtained by multiplying severity, occurrence, and detection scores.

What has been achieved?

The analysis identified surface cleaning, material transfer, and glove installation as the most critical steps, with RPNs of 240, 210, and 144 respectively. These represented the main contamination and safety risks. After implementing targeted corrective actions, including improved procedures and staff awareness, we projected significant reductions in RPNs to below 80, confirming the effectiveness of the intervention.

What next?

We will continue to apply and monitor the corrective measures through updated SOPs, dedicated monitoring tools, and continuous staff training to ensure sustained improvement. This initiative offers a transferable model that other oncology pharmacies can adopt to harmonize practices and strengthen patient and operator safety in chemotherapy preparation.