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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.

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.

Pdf

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.

Author(s)

Boglárka Lengyel
Nadine Haubenwalllner
Ingrid Sattlecker

Why was it done?

The global shortage of nursing staff increases the risk for medication errors due to higher workload and stress. The intravenous (I.V.)-service, launched in March 2020, alleviates nurses’ workload and minimizes application errors by standardizing concentrations and providing pharmaceutical training. Producing all infusions with producing pumps in the hospital pharmacy’s clean rooms improves microbiological quality and dosing accuracy. Standardized concentrations with defined stability and proper documentation practices ensure consistent quality.

What was done?

We implemented the production of patient-specific I.V.-infusions and total parenteral nutrition (TPN) for neonatal intensive care units (NICU) to meet the specialized needs of neonates and enhance individualized care. Additionally, pharmacy staff assembles patient infusion sets daily, focusing on Y-Site compatibility and catheter types tailored to each patient.

How was it done?

After discussing demand with physicians and nurses, data on NICU medications and dosages were systematically collected. Standard infusion concentrations were harmonized, considering fluid intake and physical-chemical stability. Protocols for automated compounding of continuous infusions and TPN were established, alongside standard operating procedures for additional volumetric preparation. I.V. compatibility of the drugs was researched, and compatibility tables were created.

What has been achieved?

The project successfully implemented individualized compounding of infusions and TPN with established standards in the hospital pharmacy’s clean rooms. Complete traceability and continuous monitoring during production ensure high product quality. The initiative enhanced interprofessional collaboration, strengthening confidence among physicians, nurses, and pharmacists and significantly reduced nurses’ workload for preparing medications, TPN, and assembling patient sets. The service currently supports five wards, producing an average of 98 infusions and TPN daily. The assembly of patient sets is provided for 44 care beds across NICU and Intermediate Care (IMC) wards, averaging 25 sets daily.

What next?

The service aims to maximize automated production by implementing new compounding pump plans, increasing output to supply more wards. Plans also include expanding the service to the Pediatric Intensive Care Unit (PICU), where both intermittent infusions and patient set assembly will be offered in addition to the existing continuous infusion supply.

Author(s)

H. RIBES-ARTERO, MJ RUIZ-CALDES, E. MONTEAGUDO-SANTOLAYA, J. GARCIA-PELLICER, J.L. POVEDA-ANDRES

Why was it done?

We have implemented a quality management system (QMS) in the Pharmacy Advanced Therapies Unit for the management of advanced therapy medicinal products (acquisition, receipt, storage and dispensation) in accordance with ISO 9001:2015 standards.

What was done?

In the healthcare field, improving the quality of care is a fundamental objective. This involves a continuous and self-critical process of evaluation to identify problems and opportunities for improvement in care. The Spanish National Health System’s Quality Plan includes strategies such as external and periodic evaluation of the quality and safety of healthcare centres and services through audits, with the aim of achieving clinical excellence and improving patient safety and care. The rise of advanced therapies led to a change in the processes of acquisition, storage, and dispensing of medications, as these are cryopreserved therapies that require specific facilities. In our hospital, the Pharmacy Service was designated to carry out these processes.

How was it done?

The project was developed over 12 months in three phases: phase 1 (analysis of the current situation, establishment of a pharmacist working group and training of pharmacists), phase 2 (design documentation, and implementation of the QMS and certification), and phase 3 (analysis of the indicators after the implementation of the QMS, continuous evaluation of them and application of corrective measures).

What has been achieved?

To develop the QMS, we had to create 1 management manual, 8 work protocols, 25 records, 2 work instructions and 2 annexed documents. Once created, we obtained the ISO 9001:2015 certification for our QMS through an external auditing company. As quality indicators (after the certification) we have obtained favourable outcomes in 2 external audits from the pharmaceutical industry and recorded a total of 4 minor non-conformities. Regarding activity indicators, we have dispensed 18 therapies and 4 new work protocols have been created.

What next?

The pharmacist must be the healthcare professional responsible for managing advanced therapies, and implementing, certifying and recertifying a QMS in accordance with ISO 9001:2015 standards is a guarantee of the quality of our healthcare work at the hospital, recognized by other healthcare professionals, patients and the pharmaceutical industry.

Author(s)

MC. SÁNCHEZ ARGAIZ, A. TRUJILLANO RUIZ (presenting author) , M. GALLEGO GALISTEO, A. VILLA RUBIO, E. CAMPOS DÁVILA

Why was it done?

Weekly consultations are held for the administration of intravitreal injections, serving around 50 patients per week. To optimize preparation and ensure efficient use of vials, we implemented a system to repackage pre-filled syringes, taking advantage of the drugs’ physico-chemical stability for up to 28 days. This centralized process, handled by the hospital pharmacy, follows Good Manufacturing Practices (GMP) for sterile medicines, ensuring quality and efficiency.

What was done?

We established a production process to repackage intravitreal anti-vascular endothelial growth factor (anti-VEGF) drugs, specifically bevacizumab, ranibizumab, and aflibercept, for use in ophthalmic treatments such as age-related macular degeneration (AMD), retinal vein occlusion (RVO), and diabetic macular edema (DME).

How was it done?

The preparation process for intravitreal injections was reviewed to improve batch traceability. A literature review was conducted on the physicochemical and microbiological stability of bevacizumab, ranibizumab, and aflibercept. Based on the GMP risk matrix, intravitreal injections were classified as high-risk. Batch preparation protocols were developed for these three drugs, and microbiological control measures were put in place to ensure aseptic handling and product quality. All processes were validated according to regulatory standards, including environmental, instrumental, and maintenance controls.

What has been achieved?

By standardizing batch protocols for bevacizumab, ranibizumab, and aflibercept, we have significantly reduced the weekly workload and optimized the use of anti-VEGF vials. We strictly follow national guidelines for validating aseptic techniques in intravitreal preparation and have thoroughly trained our technical staff.

What next?

This practice is recommended for broader implementation in hospital settings, as it provides significant cost savings while maintaining high-quality and safe treatments for patients. Looking forward, we aim to expand this approach to include emerging therapies such as faricimab, ensuring that our repackaging protocols can adapt to new treatments as they become available, maintaining both efficiency and patient safety in line with evolving clinical practices.

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.

Author(s)

Maibritt Skov Olsen, Bernd Utech

Why was it done?

Pharmacy technicians at the Medical Ward of Bornholm Hospital adjusted medication orders to align with the hospital’s medication assortment. Operating under delegated prescribing authority; they prescribed, paused, and discontinued specific medications within a framework agreement and documented changes in the Electronic Medication Module “Sundhedsplatform” system.

What was done?

Patients often bring medications outside of the hospital’s assortment. Adjustment of these medications is time-consuming and can lead to documentation challenges. Delegating this responsibility to pharmacy technicians aimed to enhance patient safety by ensuring scan-ready medications and freeing up physicians’ time for other tasks.

How was it done?

A medication adjustment list was created by the pharmacy and department physician, outlining which drugs the technicians could adjust or discontinue. Pharmacy technicians were trained, and annual audits were conducted by the department physician. In a period of 13 days, a time study was made to track interventions; consultations with physicians, and time spent adjusting medications in the Sundhedsplatform.Nurses and physicians were asked about their experience of the pharmacy technician’s work.

What has been achieved?

During the test period, 97 patients were dispensed medication, and interventions was made for 39 (40%) of those patients. Technicians performed 60 interventions, of which 11 were physician-consulted. They spent 220 minutes on adjustments and notes, saving physicians 160 minutes. Feedback from nurses and physicians was positive, with improvements in medication scanning and reduced interruptions for physicians.

What next?

The task will be expanded to include all patients in the medical and surgical wards. An extension of the pharmacy technicians’ prescribing authority is also planned.

Author(s)

V. LE BIGOT, A. BROS, F. NATIVEL, T. ADNET, D. CABELGUENNE, F. LINDENBERG, S. GENAY, P. BESNIER, S. RODIER

Why was it done?

Creation of a training tool for infusion set-ups in a digital 360° virtual reality, utilizing a fun format based on learning from errors. It is specifically designed for novice professionals, with a focus on pharmaceuticals teams.

What was done?

Errors in infusion set-ups are common and can have serious consequences on patient care. Adhering to best practices in infusion is essential to mitigate these risks. Therefore, comprehensive training for both healthcare staff on proper techniques and procedures, is crucial to ensure safe and effective infusion management. Choosing a digital navigating environment allows a remote or a mobile use and enhances interactivity between the trainer and learners when used for in-person training.

How was it done?

A multicenter working-group of 9 pharmacists with expertise in infusion and healthcare simulation was formed, divided into three subgroups: two for content creation and one for reviewing. Firstly, the priority issues were selected, drawn on the guidelines issued by learned societies. An illustrated presentation of the most frequently encountered infusion errors was developed using an online Learning Management System platform, integrating the teaching content into a 360° virtual reality environment.

What has been achieved?

A virtual patient pathway was designed in 3 different environments: an operating room, a post-operative recovery room and a ward. Within the virtual spheres, 12 “points of interest” (POIs) were defined as a clickable elements, focusing on predefined key themes. Each POI was illustrated with photos or videos and included errors that required learners to answer up to three multiple choice questions (MCQs). In total, there were 25 MCQs. Additionally, each POI featured an explanatory debriefing slide that was presented afterwards.

What next?

This training tool will be tested under real-life conditions at a national pharmacy congress. It will be approved by a panel of experts/learned societies, then evaluated by trainers/learners, so that it can find its place in the training programs of all healthcare professionals involved with infusion set-up.

Author(s)

ESTEBAN ALONSO, M TERESA; RODRIGUEZ FERNANDEZ, ZULEMA; ALAMO GONZALEZ, OLGA; GUTIERREZ FERNANDEZ, ISABEL; SANCHEZ LUQUE, LAURA; MARTINEZ TOMAS, PAULA; BENITO JUEZ, PILAR; ESPINOSA GOMEZ, M PAZ; GUEMES GARCIA, MAGDALENA.

Why was it done?

This initiative was arose from the need to improve the quality of pharmaceutical care (PC) and stock management to ensure adequate coverage for patients. Without appointments, it was challenging to align consultations with individual patient needs and to prepare medications for the time until the next visit, as patients arrived irregularly. Additionally, multiple patients on the same treatment would often visit on the same day, increasing the risk of stock shortages. This unpredictability led to inefficiencies in both patient care and stock management. The goal was to ensure a smoother patient flow, enhance PC quality, and improve stock control through scheduled visits.

What was done?

An initiative was developed to introduce a scheduled appointment system for Oncology and Hematology patients who need to collect medication from the hospital pharmacy. Previously, patients arrived without appointments, causing unpredictable patient flow and difficulties managing stock. The new system schedules patients around one hour after their medical consultations, with special arrangements for those on long-term stable treatments.

How was it done?

The main challenge was integrating the new appointment system into existing workflows in Oncology and Hematology. Close coordination between pharmacy staff, clinicians, and administrative personnel was essential. Patients were scheduled to pick up their medication around an hour after their consultations. Long-term patients, who need consultations every six months or more, were scheduled during less busy times, such as early mornings. This improved workload management in the pharmacy, ensuring more efficient and higher quality patient care. Effective communication with patients was key to overcoming early hesitation.

What has been achieved?

The system has resulted in a more predictable patient flow, leading to better PC quality through improved preparation and more efficient medication use, reducing shortages and surpluses. Patients now receive more personalized care, as workload is more balanced.

What next?

This initiative serves as an example of good practice, transferable to other hospital pharmacies and healthcare settings facing similar challenges. The next step is to verify patient satisfaction through surveys