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BUILDING A ZERO-ERROR MEDICATION WORKFLOW THROUGH SMART DISPENSING SYSTEMS AND BIG DATA GOVERNANCE

European Statement

Patient Safety and Quality Assurance

Author(s)

Hui-Yu Chen, Kai-Cheng Chang

Why was it done?

Medication safety remains a cornerstone of healthcare quality, yet adverse drug events (ADEs) continue to cause preventable harm in hospitals. Traditional manual dispensing workflows, dependent on human memory and paper-based checks, are prone to errors, particularly in large medical centers with high prescription volumes.

What was done?

We launched the “Smart Dispensing and Data Governance Project,” aiming to transform the pharmacy workflow through digitalization and data-driven quality management.

How was it done?

A two-pronged strategy was adopted: (1) deployment of smart dispensing hardware and (2) establishment of a big data governance platform. The hardware featured personalized login for accountability, closed-loop barcode verification of both medications and prescription bags, LED guidance and voice feedback for real-time alerts, and final barcode validation before dispensing. Advanced automation such as real-time stock sensing, weight-based verification, and image-assisted accuracy checks further minimized human errors. A SAS Visual Analytics–based Business Intelligence dashboard visualized error trends and enabled continuous PDCA (Plan-Do-Check-Act) improvement cycles through near real-time feedback.

What has been achieved?

Implementation led to substantial quality improvements: the dispensing error rate decreased by 78.3% (0.023‰ to 0.0050‰, P < 0.05); data analysis time for error monitoring shortened from 4 hours to 10 minutes (-98.3%, P < 0.05); and pharmacist training time reduced from 10 days to 3 days (−60.0%). All indicators showed statistically significant enhancement in accuracy and efficiency. Integrating smart dispensing systems with big data governance effectively advanced medication safety and operational efficiency. This model established a scalable, data-driven, and high-reliability pharmacy workflow, transforming quality management from reactive correction to proactive prevention and serving as a replicable benchmark for digital hospital transformation.

What next?

We plan to apply AI algorithms to dynamically optimize drug storage locations based on usage and safety risk, and to digitalize all storage displays through an integrated electronic shelf–label system. These enhancements will further strengthen accuracy, reduce human-factor variability, and advance a highly reliable smart dispensing workflow.

IMPLEMENTATION OF A TECHNICAL PLATFORM IN A PHYSICOCHEMICAL CONTROL LABORATORY : OPERATIONAL OUTCOMES AND FUTURE OPTIMIZATION

European Statement

Patient Safety and Quality Assurance

Author(s)

B.Ben Houria, F.ElKara , M.Ben Messaoud, M.Bizid, A.Tabbabi, S.Gmati

Why was it done?

Improving the performance of quality control laboratories is crucial to ensure the quality, safety and regulatory compliance of medicines. Ongoing challenges, including fragmented workflows and limited traceability, highlighted the need for a structured and harmonized operational model. To address this, a technical platform was established within the physicochemical control laboratory of a National Agency for Medicines and Health Products to consolidate resources, streamline work organization and align analytical activities with international standards and best practices.

What was done?

A technical platform was implemented to reorganize analytical activities, restructure laboratory areas by function and strengthen quality assurance practices. The initiative included assessing the existing system, defining functional analytical zones (e.g. spectroscopy, High Performance Liquid Chromatography (HPLC)…), optimizing equipment allocation and appointing an equipment manager to coordinate scheduling, oversee maintenance and ensure operational traceability. Then, a performance evaluation matrix was developed and applied to objectively assess the effectiveness of the newly implemented technical platform and identify areas requiring further improvement.

How was it done?

This descriptive and comparative study combined documentary analysis, on-site observation and review of international guidelines. The methodological approach comprised three steps:
1-Assessment of the existing system : Review of the laboratory’s organization, equipment, analytical processes and human resources to identify factors influencing overall performance.
2-Structuring of the technical platform and performance evaluation: Organization by instrument specialization and the use of structured matrix.
3-Comparison with international standards : Scientific literature and reports from European reference laboratories were reviewed to benchmark the implemented technical platform against international standards.

What has been achieved?

The platform was implemented in July 2025 through a spatial and functional reorganization that improved methodological coherence, reduced unnecessary sample manipulation and increased equipment utilization. The designation of an equipment manager contributed to better planning, coordinated instrument scheduling and enhanced workflow oversight, thereby reinforcing operational continuity. Performance matrix results indicated satisfactory compliance across key domains: infrastructure (100%), human resources (50%), equipment (75%) and quality assurance (50%). These outcomes confirm the solid implementation of the technical platform while highlighting the need to strengthen documentation, staff training and performance monitoring.

What next?

Future developments will focus on digital integration through paperless analytical workflows, automated test scheduling and real-time electronic traceability to enhance data integrity and predictive performance analysis. Gradual introduction of artificial intelligence, while respecting regulatory data confidentiality, offers promising opportunities to predict analytical deviations, optimize equipment use and improve resource management. Ongoing monitoring of Key Performance Indicators (KPIs) and continuous staff development will be essential to maintain and sustain long-term performance improvements.

SOFTWARE FAILURE IN A RADIOPHARMACY: IMPLEMENTATION OF A BUSINESS CONTINUITY PLAN AND DEVELOPMENT OF SUPPORT TOOLS

European Statement

Patient Safety and Quality Assurance

Author(s)

A. BRUYÈRE1, A. DESCHAVANNES1, C. RIOUFOL2, M. PIQUEMAL1.
1GROUPEMENT HOSPITALIER SUD – HOSPICES CIVILS DE LYON, RADIOPHARMACY, LYON, FRANCE.
2GROUPEMENT HOSPITALIER SUD – HOSPICES CIVILS DE LYON, PHARMACY, LYON, FRANCE.

Why was it done?

Following an IT failure in our radiopharmacy and nuclear medicine departments, the professional software system became unavailable for over two hours. This incident led to the establishment of a Business Continuity Plan (BCP) to ensure preparedness for similar future events. The BCP aims to guarantee the resumption and continuity of operations in the event of disruptive situations.

What was done?

This study aims to ensure operational continuity and safety of radiopharmaceutical workflows during IT failures through the development of a BCP and support tools.

How was it done?

A multidisciplinary staff meeting, using a Focus Group approach, was organized to reach a consensus on service organization during degraded operating conditions. The workflows of both radiopharmaceuticals (RPs) and patients were analyzed. A feedback analysis of the initial incident was also conducted to adjust the proposed tools to daily operational constraints.

What has been achieved?

A specific procedure was developed, detailing the overall organization of the department during degraded conditions and defining the tasks of each professional group: patient reception, paper-based prescription, scheduling of injections and imaging sessions, RP preparation, quality control, dispensing, and traceability. Paper versions of all necessary documents were compiled into a “BCP binder,” including pre-filled labels, RP quality control batch records, prescriptions, and dispensing registers. A preparation support chart for RP activities was also included. Additionally, digital tools were designed to support dispensing, such as an Excel spreadsheet allowing automated decay calculations and volume determinations for each dispensation.

What next?

This organizational work, along with the development of both paper-based and digital tools, has strengthened the safety and continuity of the RP circuit during IT outages. However, real-life testing of the BCP is required to confirm its feasibility. Given their reliance on digital systems, professionals may face adaptation challenges in crisis situations, increasing the risk of error. Regular training sessions and simulation exercises are therefore essential to ensure BCP effectiveness. In parallel, a broader BCP is being developed to address other identified risks, including cybersecurity threats, network failures, and equipment or facility malfunctions (e.g., automated system breakdowns or air supply interruptions).

IDEA BOX: INVOLVING HOSPITAL PHARMACY ASSISTANTS IN A QUALITY APPROACH

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European Statement

Patient Safety and Quality Assurance

Author(s)

Adeline HERLIN, Hermine ZIGA, Pauline PAYOT

Why was it done?

The aim is to continuously improve quality and efficiency.

What was done?

In the interests of continuous quality improvement, we have set up a suggestion box in the pharmacy’s unit repackaging sector.

How was it done?

We have set up a suggestion box for technician and pharmacists.
Each person can submit ideas or questions, anonymously or not.
After one month, the box was unpacked. The ideas and queries were analysed and discussed.

What has been achieved?

Eight points were raised.
 One point concerns procedures.
The existing procedures on the intranet network are not well known to users. We have provided an easy-to-access binder.
 Three points relate to packaging methods (list of products according to packaging method, removal of expired packaged products, mismatch of the Eticonform® label with the blister pack).
A decision tree was made (Euraf®: large quantities, multi-dose vials, magistral formula, small blister packs). The printing of the ledgers indicates the packaged products and their expiry dates. The removal of expired products is done according to the ledgers. A precaution must be taken when editing labels Eticonform® “laboratory” labels. Indeed, the size of the blister packs differs from one laboratory to another.
 The fifth point concerns the organization.
Technicians wish a storage area dedicated to repackaged specialties to compensate for stock errors.
After discussion, we did not retain this proposal.
 The other point concerns the lack of equipment.
A stool and a ruler were provided.
 The penultimate point concerns the use of returns from services in multi-dose vials.
We propose the packaging of small units with expiry dates < 3 months with the Euraf® bagging machine.
Otherwise (e.g. Carbimazole), we propose the packaging of sufficient quantities for 7 days in the vials with pre-printed labels with an expiry date of one week.
 The last point concerns the labelling of blisters with desiccant capsule (e.g. Nicorandil).
We offer Eticonform® re-labelling with a statement: USE BY xx/xx/202x (30 days after re-labelling).

What next?

The involvement of the technician team in a proactive approach to risk management is essential. We wanted to harness their practical expertise and energize the team.
The box will be integrated into our current practice.

EXCEPTIONAL HEALTH SITUATIONS: OBSERVATION OF AN IMMERSIVE EXERCISE IN THE HOSPITAL PHARMACY AND FEEDBACK

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European Statement

Patient Safety and Quality Assurance

Author(s)

Delphine BODEN, Laura RODRIGO, Rachel MAHE, Olivier SELLAL, Maxime PARE, François RONDEAU

Why was it done?

The main objective was to test the activation of our Pharmacy-Sterilization-Operational-Unit (PS-OU), established in December 2022, and to work on its interaction with the others OU of the different hospital services. The second aim was to continue the training of pharmaceutical teams on exceptional health situations (EHS).

What was done?

In March 2024, our hospital pharmacy (HP) took part in an inter-departmental exercise based on the scenario of managing a massive influx of polytrauma victims at our hospital. The quick engagement of mobile medical units and sterilization department, dependent on the HP, is indeed a key element in the optimal care of victims, whether in hospital or pre-hospital.

How was it done?

Two interns and one pharmacy technician, with an analysis framework, were in attendance as observers through the exercise. During the PS-OU activation, various points were observed: global crisis management, task assignment and communication between the members, data centralization and communication with the others OU, efficiency and speed of response to problems… A feedback questionnaire was then sent to the 9 main players (PS-OU members, on-call pharmacist…). Intra-HP and inter-departmental feedback were provided immediately, then a posteriori.

What has been achieved?

For 3 hours, our HP had activated its OU to provide the best possible response to this exercise. The observation of this exercise pointed out the rapid activation and efficiency of the PS-OU (by the on-call pharmacist, on the order of the head of department), so a great intern and extern communication. Areas for improvement were raised, such as the optimization of available tools. 89% of players answered the feedback questionnaire. The communication was considered operational and the PS-OU essential by all the respondents. They also feel that this type of exercise is needed (75%) and helps prepare them for EHS (88%).

What next?

Aims of this exercise were achieved. Preparing, hosting and then analyzing this kind of exercise, although seemingly time-consuming, enables us to validate and, where required, consolidate the intended organization for EHS. These results also strengthen our determination to pursue our annual exercise program. Shortly, an exercise with the supply members of our PS-OU will be organized, in order to train the less experienced members as well.

EVALUATION AND DECISION-MAKING RELATED TO QUALITY AND WORKLOAD ASSESSMENT OF PARENTERAL NUTRITION COMPOUNDING

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European Statement

Patient Safety and Quality Assurance

Author(s)

Jorge Esquivel Negrín, Amara Magdalena Pérez, Josephine Peña Hernández, Jenifer González Chávez, Carmen Lidia Díaz Díaz, Silvia González Suárez, Alba Domínguez Hernández, Jaime Muñoz Manrique, Esther González Carrillo, Pilar Díaz Ruiz

Why was it done?

PN is a high-risk preparation that carries a significant risk of iatrogenesis, making it essential for staff responsible for its prescription, validation, and preparation to be well-trained, and for a reliable quality assurance plan to be in place. Monthly quality indicators include errors by pharmacists during transcription to nutrition software, errors by technicians in tray preparation, and nursing errors during PN preparation. Acceptable monthly error thresholds were set at 2 for transcription, 25 for tray preparation, and 6 for sterile PN preparation. Additional activity indicators, such as the number of PN preparations per month, episode duration, and reasons for suspension, were also analyzed.

What was done?

A training program centered on audiovisual resources related to parenteral nutrition (PN) procedures was implemented in a tertiary hospital after a quality assessment within the PN department revealed a decline in certain indicators between 2020 and 2022. A shared folder with video tutorials covering various processes was made available to pharmacy staff, mainly intended for nursing staff and pharmacy technicians, who typically have high turnover rates between departments.

How was it done?

The indicators showed a steady increase in PN preparations, rising from 411±74 per month in 2020 to 475±51 in 2023, with a record of 634 preparations in March 2024. Notably, 18.1% of episodes in 2023 lasted over two weeks, partly due to the underutilization of home PN and a lack of hospital beds despite increased outpatient activity. Errors in tray preparation increased from 2020 to 2022, peaking in 2021. This coincided with high staff turnover and an increased workload. In response, the implementation of video tutorial training for rotating staff was introduced in 2022.

What has been achieved?

This initiative reduced tray preparation errors, which decreased to an average of 12±4.9 between January 2023 and March 2024.

What next?

These measures could be adapted and implemented in other departments within the pharmacy service. Regarding PN, we are now aiming to optimize the workload by promoting home PN, and implementing semi-automated systems such as barcodes and gravimetric control, which are also recommended to improve safety and traceability.

IMPROVING AUTOIMMUNE FEVER DISEASE PATIENTS’ AMBULATORY TREATMENT- WHEN MEDICAL QUALITY MEETS EFFICIENCY

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European Statement

Patient Safety and Quality Assurance

Author(s)

R. Malberger
A. Shinawi
M. Hamed said
C. Hamza

Why was it done?

We developed a unique ambulatory medical and pharmaceutical service providing treatment for children with autoimmune diseases at Carmel hospital.

What was done?

The ambulatory children’s clinic in Carmel hospital provides several medical services for children including those with autoimmune fever diseases, treated with canakinumab (ILARIS), a monoclonal antibody drug .
The ILARIS is given individually at the clinic during morning hours simultaneously with other treatments. The dosage is calculated individually, the remaining drug goes to waste. The treatment is not supplied by a permanent medical team.
Our initiative aims to establish a specific multidisciplinary service for ILARIS patients which will increase the quality, safety and economic efficiency of the treatment.

How was it done?

1. The current medical service was analyzed including all needs and goals, infrastructures and obstacles.
2. The pharmacy presented a multidisciplinary plane addressing all goals and difficulties suggesting a specific time scheduled for ILARIS treatments exclusively, involving a personal rheumatologist, a trained nursing team and a pharmacist dispensing process.
3. Assessment tools including financial formulas and patients’ questionnaire were established before implementation began.

What has been achieved?

1. The patient receives the services of a personal rheumatologist and a familiar trained nursing staff.
2. From the pharmacy perspective the intervention led to a decrease in prescription, preparation and administration errors as well as an impressive economical decrease in the cost of drug waste, saving more than 400,000$ over 13 months.
3. Questionnaires collected show increase in patients and family satisfaction.
4. Patients do not loose school or work days.
5. Community bonds between families of ILARIS patients were formed.

What next?

creating a unique treatment plan for ILARIS patients, collaboration of nursing, pharmacy and medical teams led to a significant improvement in the quality of care, economic efficiency and an increase in the satisfaction of patients. Our initiative achieved its aim in a short time and can be
applied to a verity of medical services in diverse settings in any clinic or hospital worldwide.

IMPROVING MEDICATION SAFETY IN PATIENTS WITH HEPATIC CIRRHOSIS

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European Statement

Patient Safety and Quality Assurance

Author(s)

ANDREA RODRÍGUEZ ESQUÍROZ, AMAYA ECHEVERRÍA GORRITI, Mª CONCEPCIÓN CELAYA LECEA, MARTA MARÍN MARÍN, LOREA SANZ ÁLVAREZ, PATRICIA GARCÍA GONZÁLEZ, JAVIER GORRICHO MENDIVIL, JAVIER GARJÓN PARRA.

Why was it done?

A prescription alert system was developed in our region for the management of drugs in patients with hepatic cirrhosis.

What was done?

A preliminary study made in our region showed that around one in four prescribed medications in cirrhotic patients are contraindicated or overdosed. Besides, it is estimated that around 38% of cirrhotic patients suffer any adverse effect despite approximately 70% of them are preventable.
In addition, safety problems can emerge due to the lack of data regarding drugs management in patients with cirrhosis.
For these reasons, it was essential to develop a tool that helped clinicians during the prescription process and pharmacists while pharmaceutical validation and medication review.

How was it done?

A computer-generated prescription alert system was developed. This system provides security data and dosing recommendations according to Child-Pugh classification of each patient. Besides, the tool suggests safer alternatives when an unsafe drug is prescribed. These recommendations were extracted from the product information and three databases: UpToDate, RxCirrhosis and Geneesmiddelen bij.
According to last laboratory data available from the electronic medical records such as bilirubin, prothrombin time and albumin, this tool estimates the Child-Pugh score, that must be completed with ascites and encephalopathy grade.
At this time, this tool is only available for clinical pharmacists for validation, and it is expected to be implemented for physicians soon.

What has been achieved?

From May to September 2024, a total of 202 drugs were included, 59 (29.2%) were considered contraindicated in some degree of cirrhosis, so it was recommended not to use. Dose adjustment was proposed in 109 (54.0%) drugs, while in 13.9% the tool recommended a safer alternative drug.
In order to complement this issue, information and training sessions were given about safe management of drugs in cirrhotic patients.

What next?

We are working in order to include safety data about more drugs in this alert system.
We hope this tool can help professionals of other regions and countries.

FROM HIGH-RISK TO HIGH-SAFETY: A TRANSITION FROM POTASSIUM AMPOULES TO PRE-DILUTED INFUSIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Douwe H. van der Meer

Why was it done?

Potassium ampoules are concentrated electrolytes categorized as high-risk medications due to the potential for immediate cardiac arrest following accidental injection. Consequently, safety guidelines, such as those established by Qmentum and the Joint Commission International, advocate for the utilization of pre-diluted infusion bags containing potassium and recommend the removal of concentrated ampoules from clinical wards.

What was done?

In our large teaching hospital, we conducted a comprehensive assessment of all clinical indications for potassium ampoule usage. Based on this analysis, we developed a plan to replace ampoules with the right pre-diluted infusion bags. The majority of ampoule applications were identified as follows: treatment of hypokalemia, hyperhydration during cisplatin and high-dose methotrexate therapy, fluid replacement in pancreatitis, and prevention of hypokalemia in diabetic ketoacidosis. To address these indications, we implemented three types of pre-diluted potassium infusion bags: 20 mmol in 1 L normal saline, 40 mmol in 1L normal saline, and 40 mmol in 500 mL of isotonic saline (0.47% sodium chloride).

How was it done?

We established standardized infusion protocols for all indications of potassium supplementation and successfully removed potassium ampoules from all adult wards, including the Intensive Care Unit (ICU) and emergency care settings. Potassium ampoules are now available solely upon request from the pharmacy. Following the introduction of pre-diluted infusion bags, the utilization of ampoules decreased by 95%. Prior to implementation, the hospital utilized 4,000 potassium ampoules per quarter; this number has now reduced to 200 ampoules, with a continuing downward trend.

What has been achieved?

Following the introduction of pre-diluted infusion bags, the utilization of ampoules decreased by 95%. Prior to implementation, the hospital utilized 4,000 potassium ampoules per quarter; this number has now reduced to 200 ampoules, with a continuing downward trend.

What next?

In our neonatal intensive care units and pediatric clinical wards, certain applications of potassium ampoules remain that are not compatible with the use of pre-diluted infusion bags. We are currently investigating potential interventions to facilitate the removal of ampoules in these settings as well.

TRACE AROUND THE BLOCK! VALIDATION OF AUTOMATED INTEGRATION OF IMPLANTABLE MEDICAL DEVICE TRACEABILITY DATA INTO AN ELECTRONIC PATIENT RECORD

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European Statement

Patient Safety and Quality Assurance

Author(s)

L. Scherer(1), L. Lassara(1), A. Choquer(1), D. Delaitre(2), E. Maguer(2), L. Papin(3), O. Chauvel(1), G. Nicolaos(1), C. Dupont(1)
(1) Hospital Pharmacy, Hôpital Fondation A. de Rothschild, Paris, France
(2) Information Systems and Medical Technologies Department, Hôpital Fondation A. de Rothschild, Paris, France
(3) Operative unit, Hôpital Fondation A. de Rothschild, Paris, France
leontine-scherer@hotmail.fr

Why was it done?

French regulations require traceability of Implantable Medical Devices (IMDs) to be recorded on discharge documents and in the Electronic Patient Record (EPR). An audit carried out in 2023 showed that only 69.5% of patients’ EPRs mentioned the type of IMD used. We aimed to validate the data transfer automation from the Pharmaceutical Management Software (PMS) to the EPR via an interface.

What was done?

We developed an HL7 interface between our PMS and our EPR. It automatically uploads to the EPR, a file specifying the traceability data of IMDs entered in the PMS.

How was it done?

A “single day” audit was carried out by a single observer on three independent days (August and September 2024). Surgical program data were extracted via the medical management software (Web100T®, Dedalus): name, administrative file number (AFN), date and type of surgery, surgical specialty. Traceability data provided by the pharmacy were extracted from the PMS (PHARMA®, Computer Engineering): name, AFN, number of IMDs tracked. The presence of a traceability document in the EPR (DxCare®, Dedalus) was objectivized and the traceability delay was collected.

What has been achieved?

Over this period, 259 patients underwent surgery: (ophthalmology (74.5%, n=193), otolaryngology (9.3%, n=24), neurosurgery (9.3%, n=24), neuroradiology (5.4%, n=14), cardiology (1.5%, n=4)). At least one IMD was traced for 56.4% (n=146) of patients, with an average of 1.2±0.6 implants per patient ([1;5]; median=1). In all, traceability was achieved in the PMS for 146 patients (170 implants traced), including 139 patients within 48 hours after implantation (95.2% of patients, 150 implants). For these 146 patients, a traceability document was found in the EPR in 99.3% of cases (n=145). It was associated with the correct AFN for 143 patients. The presence of several traceability documents (2) was found for 2 patients, indicating that traceability had been carried out on 2 occasions (dispensing on different departments: common supply and specialized depot).

What next?

Opening up the interface between the PMS and the EPR automated the traceability data transfer (99.3%). The result is a complete EPR with exhaustive health traceability. These results encourage us to implement the final stage in the data transfer automation between the EPR and the shared digital medical record.