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GLYOXYLIC ACID POISONING AFTER USE OF HAIR TREATMENT PRODUCTS: CLINICAL AND PHARMACEUTICAL APPROACH

European Statement

Clinical Pharmacy Services

Author(s)

Pons Maria, A; Fernández Huertas, L; Samblas Ruiz, M; Hernandez Silveira, L; Barceló Sansó, F; Juez Santamaria, C; Luque Mesa, JA

Why was it done?

This case describes a 23-year-old patient admitted with acute kidney injury (AKIN III) of unknown origin. Due to poor clinical progression, along with symptoms of scalp itching and redness, and the presence of calcium oxalate crystals in urine, glyoxylic acid poisoning was suspected. Glyoxylic acid is a component found in certain hair straightening products. The potential use of fomepizole as an antidote was considered, prompting a pharmaceutical intervention.

What was done?

A literature review was conducted on the use of fomepizole in poisonings caused by glyoxylic acid and ethylene glycol, considering that glyoxylic acid is an intermediate metabolite in the toxic pathway of ethylene glycol.

How was it done?

The mechanism of action of fomepizole was analyzed as a competitive inhibitor of the enzyme alcohol dehydrogenase, assessing its ability to block the conversion of glyoxylic acid into toxic metabolites such as oxalic acid, which is responsible for renal damage. To evaluate the feasibility of using the antidote, the National Institute of Toxicology was consulted. After reviewing the case, and given that more than 72 hours had passed since exposure to the toxin, its administration was ruled out. Supportive treatment already initiated was continued, including fluid therapy, bicarbonate, thiamine, and pyridoxine. The patient showed progressive improvement in renal function without requiring dialysis.

What has been achieved?

The multidisciplinary approach enabled the identification of the toxic etiology and helped prevent major complications. The case highlighted the key role of the hospital pharmacist in the evaluation of antidotes.

What next?

Similar poisoning scenarios—both uncommon and typical—will be reviewed to establish well-defined clinical pathways that allow for rapid and coordinated action in case antidotes such as fomepizole need to be used. This review will help improve the preparedness of both pharmacy and clinical teams for toxicological situations not currently covered by existing protocols.

DETERMINATION OF THE PH OF SELECTED ANTI-INFECTIVES FOR SAFE INTRAVENOUS ADMINISTRATION

European Statement

Clinical Pharmacy Services

Author(s)

L. Čermanová, V. Slezáková, J. Babiaková, D. Fábiánová, S. Porubcová

Why was it done?

Phlebitis is one of the most common complications of infusion therapy. Intravenous drugs with extreme pH values (9) may chemically irritate or damage the venous endothelium, triggering an inflammatory response. Understanding the pH of intravenous anti-infectives is essential for clinical decision-making to prevent infusion-related complications.

What was done?

The aim of this work was to determine the pH values of selected intravenous anti-infectives administered at the National Institute of Cardiovascular Diseases, Bratislava (NÚSCH, a. s.) due to their potential to cause endothelial damage.

How was it done?

A literature review was performed to collect available data on the pH of reconstituted and diluted anti-infectives used at NÚSCH, a. s. Sources included Summaries of Product Characteristics, ASHP Injectable Drug Information®, pharmaceutical recommendations of Hôpitaux Universitaires de Genève, and relevant scientific publications.
The criteria used to select anti-infectives for pH analysis were a complete lack or insufficient information on the drug’s pH, reported pH values approaching the extreme thresholds of 5 or 9, and excessively wide pH ranges exceeding these limits.
Subsequently, the pH of 21 selected drugs was measured at 37 commonly administered concentrations (including ready-to-use formulations) using a glass-electrode pH meter (XS pH 7 Vio portable pH meter; electrode CHS ChemFlex). The diluents used were 0.9% sodium chloride solution, 5% glucose solution, and water for injection.

What has been achieved?

A table summarising selected anti-infectives at commonly administered concentrations, along with their mean pH values (± standard deviation) was compiled. Dilution volumes used in clinical settings with either 0.9% sodium chloride or 5% glucose solution for extremely acidic or alkaline medications did not appear to significantly modify pH in a way that would affect vascular access choice.
The pH values enable the identification of anti-infectives with a higher potential risk of phlebitis and support the selection of the most appropriate vascular access device.

What next?

The results will be applied in developing institutional recommendations for the dilution and administration of anti-infectives, supporting safer infusion practices and the prevention of chemically induced phlebitis across NÚSCH, a. s. wards. They will also inform staff training and may contribute to the reduction of medication errors.

ELECTRONIC PRESCRIPTION INTEGRATION: ACHIEVING 98% COVERAGE AND REDUCING TRANSCRIPTION ERRORS

European Statement

Patient Safety and Quality Assurance

Author(s)

VB Pinto, CSA Souza, NL Mizutani, RP Santos, MA Dias, ACP Sforsin

Why was it done?

The unification of two outpatient prescription platforms into a single, institutional electronic system was carried out. The initiative was led by a multidisciplinary team (pharmacists, physicians, and systems analysts) from a public, tertiary care hospital.

What was done?

Despite the high rate of electronic prescribing (92%), the coexistence of the two systems generated data fragmentation, rework, and exposed patients to unnecessary risks of transcription errors. The central objective was, therefore, to unify the process to universalize the use of electronic prescribing and, consequently, reduce transcription errors, strengthening patient safety and pharmaceutical care.

How was it done?

The intervention took place between July and September 2025. Actions included the technical integration of the systems into a single platform, the development of new standardized prescribing protocols, and training for prescribers. The impact was evaluated by monitoring the electronic prescribing coverage percentages and transcription errors rates at the outpatient level before and after implementation.

What has been achieved?

The integration demonstrated fast and significant results. Electronic prescription coverage increased from 92% to 98% in just one month after unification. In parallel, there was a progressive and sharp reduction in transcription errors: from 8.5% (pre-implementation) in July to 2.7% in September (after integration), representing a 68% decrease in the manual correction rate.

What next?

This initiative demonstrates the importance of technological unification for the advancement of Hospital Pharmacy. The model is highly replicable for other institutions dealing with fragmented electronic prescribing systems. The integration of systems has a direct and measurable impact on patient safety, establishing universal electronic prescribing as an efficient care standard and proof against transcription errors.

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.

FROM LEARNING TO PRACTICE: THE ROLE OF THE HOSPITAL PHARMACY RESIDENT IN PRIMARY CARE

European Statement

Education and Research

Author(s)

Ciuciu David, CD; Campabadal Prats, C; Salom Garrigues, C; Romero Denia, M; Suñer Barriga, H; Pascual Carbonell, D; Bejarano Romero, F; Canadell Vilarrasa, L.

Why was it done?

The integration of Hospital Pharmacy Residents (HPr) into primary care (PC) services represents an essential step toward strengthening the continuity of care between hospital and community health centers. Through this collaboration, safe, efficient, and evidence-based pharmacotherapy is promoted, while keeping the patient at the center of the healthcare system. By involving HPr in multidisciplinary teams, the program aims to enhance medication management, optimize therapeutic outcomes, and reduce the incidence of adverse drug events.

What was done?

To describe the role of the HPr in PC services and demonstrate the importance of their contribution to well-keeping relationships between primary and specialized care.

How was it done?

The involvement of the HPr in PC services was classified into clinical, educational, and management activities. To develop their activities, a HPr rotation was scheduled and carried out within a Healthcare Management area, responsible for overseeing 20 PC centers and 20 nursing homes (NH). Within this area, the PC pharmacy team consists of eight pharmacists who perform medication reviews across.
Rotation steps:
Training: HPr receives instruction on PC protocols, quality indicators, and digital tools, including prescription management and indicators recording systems.
Clinical review: HPr evaluates prescriptions, modify treatments based on clinical evidence, and apply a person-centered approach, focusing on complex chronic and institutionalized patient’s guidelines.
Multidisciplinary collaboration: Take an active part in meetings with general practitioners (GP), nurses, and PC pharmacists to discuss patient cases and optimize pharmacotherapy.
Health education: Provide training to nurses and GP residents on rational drug use, adverse reactions, and sustainability.
Evaluation: Oversee the impact of pharmaceutical interventions and suggest continuous improvement measures.

What has been achieved?

A total of 416 interventions were recorded, distributed as follows:
56.7%: Drug discontinuation due to non-adherence, not indication or therapeutic simplification.
23.1%: Therapeutic switches for efficiency.
7.7%: Changes to another molecule.
6.7%: Regimen deintensification.
4.8%: Regimen intensification.
Additionally, 46 interventions were conducted in NH:
52.2%: Drug discontinuation due to overcontrol or lack of indication.
23.9%: Regimen deintensification due to overcontrol.
17.4%: Therapeutic switches for efficiency.
6.5%: Drug initiation due to lack of control.

What next?

The participation of HPr in PC resulted in a significant increase in pharmaceutical interventions, which contribute to safer, more effective and efficient pharmacotherapy and promotes superior coordination between healthcare levels. Also contributed to the education of family and community medicine residents, enhancing their skills in managing complex chronic patients. This experience demonstrates the value of integrating pharmacy residents into primary care and may be replicated in other hospital pharmacy services with similar organizational structures.

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.

POST-CONSTRUCTION CLEANROOM COMMISSIONING AND OPERATIONAL IMPACT: A COMPLIANCE-DRIVEN APPROACH TO USP STANDARDS

European Statement

Production and Compounding

Author(s)

Natalie Kuchik PharmD, MS, BCSCP and Jacalyn Rogers PharmD, MS, BCPS, CPEL, FASHP and Victoria Lubarsky RPh, MBA., BCACP

Why was it done?

Due to evolving and increasingly stringent USP requirements, multiple cleanroom construction and renovation projects were necessary to ensure continued compliance. These upgrades were critical to maintaining sterile compounding capabilities, keeping pharmacy operations uninterrupted, and safeguarding patient care.

What was done?

Each cleanroom underwent a structured post-construction commissioning process, including environmental certification, workflow validation, staff re-training, and installation of continuous monitoring systems. Pharmacy operations were strategically coordinated to minimize disruption during each phase.

How was it done?

Third-party experts conducted ISO-class environmental testing and microbial sampling. Pharmacy teams performed workflow simulations to assess layout and aseptic technique. Updated SOPs were implemented, and staff received targeted training. Real-time monitoring tools were installed to track pressure, temperature, and particle counts.

What has been achieved?

All renovated cleanrooms achieved full USP compliance prior to go-live. Pharmacy operations remained efficient, with no delays in patient care. Staff confidence improved, and workflow efficiency increased by 25%. No adverse events or regulatory citations were reported.

What next?

We plan to develop a standardized cleanroom commissioning protocol for future projects and share it across our hospital network. Ongoing monitoring, periodic revalidation, and continuous staff education will support sustained compliance and operational excellence.

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.

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.