IMPLEMENTATION OF INFUSION LINE INTO PATIENT-SPECIFIC DOSES DURING CENTRALIZED COMPOUNDING
European Statement
Patient Safety and Quality Assurance
Author(s)
E. Bredenberg, M. Knuutila-Jerkku, P. Halonen, E.W. Gröndahl
Why was it done?
On the ward, attaching infusion lines to cytotoxic doses is performed alongside busy clinical work, often resulting in delays. Centralized attachment of infusion lines to patient-specific cytotoxic doses in the hospital pharmacy cleanroom streamlines the chemotherapy workflow. It also enhances medication safety by improving the quality of ready-to-administer doses compared to the previous attachment practices on the ward.
What was done?
In Turku, patient-specific cytotoxic doses are prepared for administration in the hospital pharmacy’s centralized compounding unit, located in EU GMP-compliant cleanrooms. This ensures aseptic preparation and emphasizes occupational safety. As part of this project, we included Cytoset Line® infusion sets pre-filled with saline into patient-specific cytotoxic doses during the centralized compounding process in the cleanroom.
How was it done?
To improve medication safety in chemotherapy, we held a multidisciplinary review of the process, consulted other hospitals for their practices and experiences, and assessed the stability of pre-attached infusion lines compared to non-attached doses.
The process of filling Cytoset Line® infusion lines with saline was introduced to pharmacists. The integrity of the closed infusion system was tested by adding caramel colour dye to the infusion bag. The effect of clamp placement was tested by positioning it at different points along the filled line. Caramel colour leakage into the line indicated insufficient sealing.
What has been achieved?
Performing the line attachment in a Grade A cleanroom improves aseptic conditions and reduces the risk of microbiological contamination. Occupational safety is enhanced by minimizing nurses’ exposure to cytotoxic agents. Centralized preparation optimizes the use of personnel resources. Correct placement of the clamp below the infusion port is critical in preventing contamination.
What next?
Expansion of the practice to other hospital units
Assessing the feasibility of attaching infusion lines to doses intended for extended storage
Standardizing processes: adopting uniform infusion lines across all oncology units (requirement for pre-attached infusion lines)
EMPOWERING PEDIATRIC CAREGIVERS IN MEDICATION SAFETY: A CLINICAL PHARMACY INITIATIVE FOR WORLD PATIENT SAFETY DAY 2025
European Statement
Patient Safety and Quality Assurance
Author(s)
Mengato D, Camuffo L, Todino F, Binanti ME, Sartori S, Benini F, Venturini F
Why was it done?
Medication errors in pediatrics often arise from incorrect handling or administration by caregivers. Strengthening their knowledge is essential to improve safety and adherence. The initiative aimed to raise awareness and assess caregivers’ understanding of safe medication use, storage, and the role of compounded (“galenic”) medicines. It also intended to reinforce the visibility of clinical pharmacists as accessible medication experts for families.
What was done?
On 17 September 2025, during the World Health Organization’s World Patient Safety Day themed “Safe care for every newborn and every child”, the clinical pharmacy team of the Azienda Ospedale–Università Padova organized an awareness event within the Pediatric Department. The initiative included a pharmacist-managed information desk, an interactive quiz for parents and caregivers, educational materials on safe medication practices, and gadgets for children to foster engagement. Pharmacists were available throughout the day to answer questions and provide individual counseling on pediatric medicines.
How was it done?
A voluntary anonymous quiz with 10 knowledge-based and 2 awareness questions was administered to parents visiting the department. Participants received a score (1–10) and tailored feedback: scores ≥8 indicated excellent knowledge, 5–7 good knowledge with room for improvement, and <5 the need for closer pharmacist or physician guidance. The event required coordination with pediatric staff and logistical support for educational materials and space allocation.
What has been achieved?
Thirty-two parents completed the quiz: 68.8% achieved ≥8 points (“super-pharma-parents”), 28.1% scored 5–7, and 3.1% scored <5. Knowledge was strong regarding shaking suspensions (100%), completing antibiotic courses (96.9%), and proper disposal of expired drugs (96.9%). Gaps emerged in measuring tools (9.4% incorrect) and preparation environment (6.2% unsuitable). Awareness of galenic medicines was limited (18.7% misdefinition). The initiative was well-received, stimulating high engagement and requests for future educational sessions.
What next?
The experience improved caregiver awareness and strengthened collaboration between families and clinical pharmacists. This initiative, which is embedded with the Clinical Pharmacy Ambulatory, represents a reproducible model to enhance pediatric medication safety. Future steps include integrating similar educational events into routine hospital activities and developing digital tools to extend pharmacist-led counseling to the community.
PROJECT TO IDENTIFY MEDICATIONS ACCORDING TO JOINT COMMISSION STANDARDS
European Statement
Patient Safety and Quality Assurance
Author(s)
Cruz Pardos, S. González Andrés, D. López San Román, MA
Why was it done?
One of the standards established by the Joint Commission (JC) involves the identification of medications that may have risk to patients and/or be a potential source of error during its dispensation or administration. This includes look-alike/sound-alike (LASA) medications, high-risk medications (HRMs) defined by the Institute for Safe Medication Practices (ISMP), concentrated electrolytes, and hazardous drugs (HD) according to NIOSH classification.
What was done?
A tag system was designed using color-coded stickers with specific text to identify each of the medication groups defined above:
• Red stickers with the statement “High risk medication” for HRMs.
• Red stickers with the statement “Dilute before administration” for concentrated electrolytes.
• Yellow stickers with the statement “Reproductive risk” or “Hazardous drug – handle with care” for HD.
• LASA medications: Red stickers were used for those that are also high-alert, while green stickers were applied to non-high-alert LASA drugs.
In addition, for medications requiring repackaging, the repackaging protocol was modified. The changes included:
• Labelling the medication profile with either HIGH-ALERT MEDICATION or HAZARDOUS DRUG.
• Using different photoprotective packaging paper: red for HRMs and yellow for HD
How was it done?
At first, two working protocols were developed:
1. Labelling protocol, detailing the characteristics of each type of sticker used to identify the different medication categories.
2. Repackaging protocol, ensuring proper identification of these medications during the repackaging process.
Secondly, lists of every category were compiled of the hospital’s available medications.
For LASA medications, brand names and images were included to improve differentiation and minimize errors.
What has been achieved?
• Identification of each medication according to their category at every stage of the medication use process: reception, storage, dispensing, and administration.
• Increased awareness among nursing staff regarding the safe and appropriate handling of these medications.
• The impact of these labelling project among all medicaments available in our hospital was: MAR: 18,6% , MP: 6,1% and LASA: 15,24%
What next?
• Develop a procurement protocol aimed at reducing the number of LASA medications.
• Raise awareness within the pharmaceutical industry about the importance of clearly differentiating pharmaceutical products.
• Automate the labelling process as much as possible, to avoid repetitive work.
PHARMACEUTICAL MANAGEMENT IN COLD CHAIN BREAKDOWN IN PRIMARY HEALTH CARE: FINANCIAL IMPACT
European Statement
Patient Safety and Quality Assurance
Author(s)
Maria Teixeira; André Maia; Ana Catré; Inês Margalho; Joana Duque; Marisa Costa; Marta Susana; Miguel Paulo; Tomás Sousa; Vânia Pereira; Teresa Pereira
Why was it done?
Thermolabile drugs require special storage conditions(2°C-8°C).[1] They represent a group with relevant economic value in Pharmaceutical Services(PS), therefore, processes must be guaranteed to maintain the storage temperature throughout the entire circuit.[2] CBR can cause changes in the characteristics of drugs and compromise their stability, efficacy and safety.[1,2] It is the responsibility of the PS to establish procedures and assess whether or not drugs exposed to a temperature excursion can be used.[3]
What was done?
We analyzed the economic impact of Cold Chain Breaks (CRB) occurring in Primary Health Care (PHC) at the Local Health Unit (ULS).
How was it done?
A spreadsheet document was developed for action in cases of CRB for PHC, and a database was created with the responses provided by the laboratories. The document is sent to the PHC unit, to be completed by the nurse in charge, who identifies the cause, duration, temperature reached, and medications in the refrigerator. After analysis by the PS, a report is sent with information on stability studies and respective conclusions per item. The excursion is then valued based on the average price of the item and the available quantity. A database was created with the valuation of all CRBs.
What has been achieved?
Between April 2024 and July 2025, 14 temperature excursions were recorded, of which 7 in 2025. The total number of affected items was 2,327, representing a total value of €55,595.6. Of these, it was possible to avoid the waste of 1,722(74%), corresponding to €40,652, and 605(26%) were eliminated, with a total of €14,943.6. The CRB occurred due to anomalies in the power supply to the equipment 80%(12) and refrigerator breakdown 20%(3). The number of vaccines subject to CRB per month in 2024 was 257 units(U), and in 2025 it was 80U.
What next?
An analysis of the causes of CRBs reveals that they are mostly related to infrastructure, with only 20% related to equipment failures. Therefore, emergency plans for equipment must be developed. It is essential to establish preventive actions collaboratively among all professional groups involved, with an emphasis on sustainability and efficient resource management, to minimize risks and avoid significant losses.
REFRACTOMETRY SUPPORTED VERIFICATION IN THE SAFE DISPOSAL AND DAILY MONITORING OF NARCOTIC AND PSYCHOTROPIC DRUGS IN A HOSPITAL SETTING
European Statement
Patient Safety and Quality Assurance
Author(s)
Aslı Özyıldırım, Ülker Şener, Öznur Gülertürk Er, Işıl Toros, Aslı Kanburoğlu.
Why was it done?
Narcotic and psychotropic medications, while possessing high therapeutic efficacy, are also among the drug classes with the greatest potential for misuse. The World Health Organization (WHO) and the International Narcotics Control Board (INCB) recommend the implementation of systematic monitoring and documentation systems to ensure the safe management of these substances in healthcare institutions (1,2). This study presents the rationale and methodology for the patient-based daily monitoring of narcotic and psychotropic drug use, the disposal procedures and the verification of active pharmaceutical ingredients in disposed medications using a refractometer in our hospital.
What was done?
A refractometer is a device that measures the refractive index of a liquid, which can be used to determine the concentration of dissolved substances within it. In our hospital, we use a handheld refractometer manufactured by Atago. Preliminary tests were conducted to identify the refractive index ranges for each narcotic and psychotropic medication. Based on these results, a reference list of optimal refractive index values was created for routine use.
How was it done?
During the disposal process, the refractive index of the substance is measured and compared to the reference range of the respective medication. This comparison allows for verification of the destroyed substance and the identification of any potential risk for drug diversion. Measurement results are recorded to complete the verification process.
What has been achieved?
Daily reports on narcotic and psychotropic drug usage are generated across the hospital to ensure accurate administration to the correct patient and in the correct dosage. Based on these reports, the disposal of unused drugs into locked destruction bins, the accuracy of destruction labels, and the verification of the active pharmaceutical ingredients using refractometry are all audited. During ward inspections, storage conditions, dual-witness destruction practices, and correct procedural adherence are also reviewed. This comprehensive approach has significantly reduced potential medication administration errors and improved patient safety.
What next?
This system has contributed to the prevention of drug losses and potential misuse, improved the accuracy of medication records and enhanced patient safety. The daily monitoring of narcotic and psychotropic drugs, along with a dual-witness destruction procedure supported by refractometric verification, has proven to be an effective preventive mechanism for ensuring drug safety. This approach offers an ethically and operationally sustainable model for pharmaceutical management.
References:
1. Diversion of Controlled Drugs in Hospitals: A Scoping Review. Journal of Hospital Medicine, 2023.
2. International Narcotics Control Board (INCB). Report on the Availability and Control of Narcotic Drugs, 2024.
A POCKET GUIDE TO MINIMISE USER ERRORS RELATED TO PATIENTS’ MEDICATION LISTS IN THE ELECTRONIC CHARTING SYSTEM MEONA
European Statement
Patient Safety and Quality Assurance
Author(s)
E Biringer1,2, K Skaare-Fatland1, E Tverborgvik3
1Helse Fonna Local Health Trust, Haugesund, Norway, eva.biringer@helse-fonna.no
2Western Norway University of Applied Sciences, Stord, Norway
3Sjukehusapoteka Vest HF, Stord, Norway
Why was it done?
Why was it done?
The aim was to reduce the risk of medication errors arising during the registration and reconciliation of patients’ medication lists in the electronic charting system MEONA (Mesalvo GmbH, Freiburg, Germany) at patient admission. Prior to the intervention, medication errors were frequent, most likely due to limited MEONA proficiency among newly employed staff and a complex procedure for importing information about patients’ current medications from multiple sources, i.e. the electronic patient records, the Summary Care Record («Kjernejournal») and the Prescription Intermediary («Reseptformidleren»). The initiative was made in 2022 in a mental health hospital in Norway.
What was done?
What was done?
A concise pocket guide was developed for use by health personnel responsible for the registration and reconciliation of medication lists at the acute mental health ward.
How was it done?
The process of registration and reconciliation of medication lists was standardised and visually illustrated by simplified step-by-step illustrations of the user-interfaces of MEONA. The illustrations were included in a two-page pocket-sized brochure along with illustrations pertaining to electronic registrations of patient information in the electronic patient administrative- and laboratory systems. The hospital pharmacist advised the development of the brochure. The communications department of the health trust created the illustrations and lay-out of the brochure.
What has been achieved?
A qualitative evaluation was conducted based on feedback from end-users of the brochure, i.e. the physicians regularly performing medication-related operations in MEONA. They all reported a reduction in erroneous registrations and less time spent on hazzles related to medication reconciliation after the pocket guide was implemented. A newly employed junior doctor stated:
“I think the brochure is excellent! I would have had significantly more trouble during my shifts if I hadn’t had this little guide with me.”
What next?
This simple intervention likely contributed to reducing the risk of medication-related errors in the mental health hospital. Hospital pharmacists could develop similar brochures in other hospitals with electronic charting systems subject to user errors. The efficiency of such pocket guides in terms of reducing erroneous registrations and time spent on registrations should be measured prior to and after their introduction.
RISK-DRIVEN TRANSFORMATION: INTEGRATED RISK MATRIX WITH PDCA AND KPIS IMPROVES MEDICATION SAFETY AND OPERATIONAL PERFORMANCE
European Statement
Patient Safety and Quality Assurance
Author(s)
Vanusa Barbosa Pinto, Andréa Cássia Pereira Sforsin, Cleuber Esteves Chaves, Carolina Broco Manin, Priscila Faria França, Amanda Magalhaes Vilas Boas Cambiais, Carolina Ferreira Dos Santos, Lidiane Baltieri Gomes, Priscilla Alves Rocha, Maria Cleusa Martins
Why was it done?
The Pharmacy Division of a large tertiary hospital implemented structured risk governance, anchored by a risk matrix integrated into strategic planning and monitored by Key Performance Indicators (KPIs). The primary goal was to reduce risks across the entire medication use process—from selection to administration—using the matrix to guide continuous improvement cycles (PDCA) and ensure proactive, predictive risk management.
What was done?
Tertiary hospitals with complex medication processes often face a high incidence of adverse events and waste due to fragmented risk management. The aim was to proactively mitigate risks classified as high and extreme, not only enhancing medication safety but also improving efficiency and operational response time. The initiative also sought to strengthen the internal safety culture by encouraging increased near-miss reporting.
How was it done?
The project involved an end-to-end mapping of pharmaceutical care in 2024, with risk scoring (probability x consequence). Critical KPIs were defined: service level, prescription evaluation rate, adverse event reports for compounded products, and near-miss reports. Results were reviewed in multi-professional committees to guide PDCA improvement cycles. One specific action plan involved implementing Personal Digital Assistants (PDAs) in medication distribution to enhance traceability.
What has been achieved?
Between 2024 and 2025, the absolute number of risks classified as extreme decreased, and five risks reduced their criticality. The intervention demonstrated objective gains: service level increased from 77.82% to 84.40%; adverse event reports for compounded products decreased from 11 to 6; and the average monthly near-miss reports increased from 34 to 44, strengthening the safety culture. Notably, the PDA implementation contributed to the medication traceability rate increasing from 12.5% to 50.2%.
What next?
This governance model, focused on risk mitigation through PDCA cycles and critical KPIs, proved to be a practical and effective strategy for achieving sustainable gains in medication safety and efficiency. The practice is highly transferable and scalable, reinforcing the strategic role of the hospital pharmacy in integrating planning, quality, and technological innovation, and serving as a benchmark for other high-complexity institutions.
ASSESSMENT OF THE COMPLIANCE OF READY-TO-USE NEONATAL PARENTERAL NUTRITION ADMIXTURES PRESCRIPTIONS WITH THE FRENCH NATIONAL HEALTH AUTHORITY RECOMMENDATIONS
European Statement
Patient Safety and Quality Assurance
Author(s)
S. CHIKHI, A. DIALLO, X. DEVIOT
Why was it done?
Ready-to-use neonatal parenteral nutrition admixtures (RTUs) are indicated for preterm infants when enteral or oral nutrition is either impossible or insufficient. To meet patients\’ specific nutritional needs, some RTUs must be supplemented with vitamins, trace elements or electrolytes. Considering the microbiological contamination risk associated with supplementation procedures, the French National Health Authority (HAS) stated that supplemented RTUs are safer when prepared by the pharmacy, in controlled atmosphere areas, rather than in healthcare services. It also recommended no more than three supplementations.
What was done?
To centralise RTUs supplementation within our parenteral nutrition unit, we carried out a retrospective analysis of prescriptions from 2023 and 2024 to evaluate their compliance with HAS recommendations.
How was it done?
Prescriptions were extracted from the prescription support software (Logipren). For each prescription, the number of supplements was noted, and the quantities added were evaluated against the maximum limits indicated in the Summary of Product Characteristics (SMPC).
What has been achieved?
A total of 1,073 prescriptions for 5 different RTUs were recorded. 91% (979) of prescriptions contained less than 3 additives. 9% (94) of prescriptions contained more than 3 supplements. 97% (91) of these prescriptions were for Numeta.
Regarding the compliance of added quantities, 7 prescriptions had a sodium level exceeding the authorized limit and 91 prescriptions involved supplementation with small volumes of zinc, despite the insufficient information on the feasibility of adding it.
What next?
To reduce the risk of infection and preparation errors, according to HAS recommendations, supplementation of RTUs with fewer than 3 additives, previously done in the neonatal care unit, is now performed in the pharmacy. Meanwhile, we suggested that physicians prioritize the prescription of individualized parenteral nutrition over supplemented Numeta when more than 3 supplements are required.
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.
CYBER ATTACK! IS YOUR PHARMACY TEAM READY?
European Statement
Patient Safety and Quality Assurance
Author(s)
Sandra Oliver, Chief Clinical Information Officer, Pharmacy and Medicines.
Chris Green, Director of Pharmacy and Medicines Optimisation
Why was it done?
We describe how our hospital experienced a cyber-attack which resulted in the electronic patient record and other systems being taken offline, including our electronic prescribing system.
What was done?
We describe our response to the cyber-attack and the considerations necessary to replace an entire hospital’s electronic prescribing system with paper. We also describe the co-dependencies with other previously electronic departments and systems, and communications with partner organisations.
How was it done?
The conversion from electronic to paper prescribing was led by the pharmacy team. Initially, this was via a printed downtime solution from the electronic prescribing system, which then required transcription to a paper prescribing chart. This generated a number of logistic, practical and safety issues which were managed by the pharmacy team. We then describe how the hospital was converted back to electronic prescribing over the course of one day, and how the pharmacy team was pivotal to that.
What has been achieved?
We were able to successfully take our hospital off electronic prescribing and initiate a paper-based downtime solution that ran over several days, and then return the hospital to electronic prescribing. Recovery efforts involved pairing prescribers with pharmacists across wards, establishing a pharmacy command centre, coordinating medication administration on ePMA, and communicating service updates across the Trust. Third-party services were reinstated, and recovery was prioritised by acuity, with the least acute wards addressed first. During the downtime period, we actively encouraged the pharmacy team to log patient safety concerns, or ideas to improve the downtime process which were reviewed and acted on in real time and as part of the post-recovery review.
What next?
We have learned several valuable lessons from the downtime experience which we have taken forward as part of our revised business continuity plan. This includes a review of specialist prescribing situations for example insulin, how we contact and work with partner organisations, the robustness of our downtime printer setup, and training material for clinical staff who at the time of the cyber-attack, had never used a paper based prescribing system. This case study serves as a valuable resource for healthcare organisations seeking to strengthen their cybersecurity and business continuity strategies.