CERTIFICATION OF A PHARMACY ADVANCED THERAPIES UNIT ACCORDING TO ISO 9001:2015 STANDARDS
European Statement
Selection, Procurement and Distribution
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.
STOCK PRODUCTION OF INTRAVITREAL SYRINGES OF BEVACIZUMAB RANIBIZUMAB AND AFLIBERCEPT
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European Statement
Production and Compounding
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.
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.
PHARMACY TECHNICIANS’ DELEGATED ROLE IN MEDICATION ADJUSTMENT FOR HOSPITALIZED PATIENTS: IMPLEMENTATION OF THERAPEUTIC SUBSTITUTIONS AND DISCONTINUATIONS IN THE ELECTRONIC MEDICATION MODULE
Pdf
European Statement
Clinical Pharmacy Services
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.
DESIGNING A 360° IMMERSIVE VIRTUAL REALITY TOOL FOR TRAINING IN INFUSION SET-UP
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European Statement
Education and Research
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.
TRANSFORMING PHARMACY WORKFLOWS: APPOINTMENT-BASED CARE FOR ONCOLOGY AND HAEMATOLOGY PATIENTS
Pdf
European Statement
Patient Safety and Quality Assurance
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
IMPLEMENTATION OF A CRITICALITY TOOL FOR MEDICAL DEVICES IN A UNIVERSITY HOSPITAL
European Statement
Selection, Procurement and Distribution
Author(s)
C.ALINOVI, J.ZAMPA, D.PECANI
Toulouse University Hospital, FRANCE, Toulouse
Why was it done?
To set up tools to better manage medical device (MD) supply shortages, given the significant increase in the number of shortages in recent years.
What was done?
To better manage MD supply shortages in hospitals, a score has been developed to classify devices by their criticality during supply disruptions. This score considers various factors, such as : number of hospital departments using the product, average daily consumption rate, single-use vs. reusable nature of the product or Availability of alternatives.
How was it done?
A set of criteria and their interrelations were tested to establish a criticality score that categorizes MD into three levels : ‘supercritical’, ‘critical’, and ‘non-critical’. These categories reflect the potential impact on patient care in the event of a shortage. Thresholds, such as the daily consumption rate, were particularly important in defining this score.
What has been achieved?
To validate the scoring method, 33 combinations of criteria and 1,257 threshold variations were tested on a sample of 66 products. These products had previously been rated by expert pharmacists for criticality. Sensitivity and specificity calculations were used to compare the test results with expert evaluations. After testing, three combinations achieved the desired accuracy, and one of these was selected.
The final scoring method was applied to 764 MD in stock at the hospital, identifying 44 as ‘supercritical’. The security storage thresholds were increased for these 44 MD so that they would be less affected in the event of a shortage, and are MD targeted during order delays, so that they can be relaunched as a priority.
What next?
A similar scoring system will be developed for MD managed in non-stock mode to classify the most critical items in the event of a supply shortage.
ANALYTICAL CONTROL OF INJECTABLE PREPARATIONS: TAKE THE TIME TO ANALYZE YOUR ACTIVITY
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European Statement
Production and Compounding
Author(s)
Guillaume BOUGUEON1,2 ; Mélissa WANG1 ; Jean-Marc Bernadou1, Maîté Sangnier 1, Aude BERRONEAU1
1 Pharmaceutical Technology Department, Bordeaux University Hospital, Avenue de Magellan, 33604 Pessac, France
2 ARNA Laboratoire ChemBioPharm U1212 INSERM – UMR 5320 CNRS, Université de Bordeaux, France
Why was it done?
We work within a university hospital, in an injectable drug production unit. We produce around 55,000 preparations a year, and ten years ago decided to implement analytical control (identification and dosing) (i.e. HPLC then followed by UV-Raman spectrophotometry (QCRX®)) as a post-process control method. To date, around one hundred assays are carried out daily (representing 50% of preparations produced), and some thirty different active substances are analyzed.
For the past 4 years, a monthly meeting has been devoted to monitoring the compliance of analytical assays for our preparations.
What was done?
We felt it was essential to take a step back from our control activity, to enable us to monitor and analyze assay compliance in detail, to distinguish between preparation errors and errors linked to control equipment, and to detect upstream any deviations in assay methods or material damage.
How was it done?
Monthly one-hour meetings have been set up. These multidisciplinary meetings are attended by 6 people, including senior and student pharmacists, pharmacy technician and a laboratory technician.
During these meetings, the following are presented: the number of assays and their nature (1st assay or 2nd assay following a 2nd sample); the number of non-compliant assays (outside the limit of +/- 15% of the target concentration), the overall compliance rate; an analysis of rejected and destroyed preparations, with an investigation into the causes of non-compliance.
Corrective action may then be taken: early maintenance of equipment, quarantine of analytical methods and research into the causes of drift, implementation of new dosing methods. Feedback is then given to the whole team.
What has been achieved?
These monthly meetings have enabled us to anticipate analytical drifts and reinforce our team’s compliance to this type of control. They also enable us to limit the downtime of dosing methods and the need for double visual checks, a potential source of errors.
What next?
The aim is to eventually increase the proportion of analytical control to over 50% of preparations produced. This will involve the introduction of new dosing methods for preparations usually controlled by double visual inspection, and the acquisition of additional equipment
DEVELOPMENT OF AN INFORMATIC SYSTEM FOR THE FOLLOW-UP OF PATIENT-REPORTED OUTCOMES FOR PEOPLE LIVING WITH HIV
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Feijoo-Vilanova P (1,3), Cid-Silva P (1,3), Mena de Cea A (3), Sanclaudio-Luhía AI (3), Luaces-Rodríguez A (1,3), Caeiro-Martínez L (1,3), Gómez-Costa E (1,3), Fernández-Diz C (1,3), Torres-Pérez A (1,3), Martín-Herranz I (1,3), Margusino-Framiñán L1,3
1. Pharmacy Department.
2. Informatic Department.
3. Research Group of Hospital Pharmacy. Biomedical Research Institute A Coruña (INIBIC). A Coruña University Hospital (CHUAC), Sergas. A Coruña University (UDC).
Why was it done?
An informatic program was developed for the clinical follow-up of clinical and patient-reported outcomes (PROs) of people living with HIV (PLWH) on antiretroviral treatment (ART).
What was done?
Pharmaceutical follow-up and outcomes research of PLWH must incorporate innovative solutions that allow the data optimization from electronic medical record (EMR) and PROs data, since traditional manual methods are insecure and inefficient.
Our objective is to describe a software (SiMON-PRO: Intelligent Monitoring System; acronym in Spanish) based on EMR data digitization and the PRO telematics data registry, and to describe the data collection procedure since June 2023.
How was it done?
A multidisciplinary group of clinicians (pharmacists and infectologists) transferred the following software requirements to the hospital’s informatic engineers: automatic incorporation of patient data from the EMR; generation of events related to clinical occurrences and alerts regarding the efficacy and safety of ART; documentation of pharmacist consultations; data analytics by business intelligence for investigational purposes.
Regarding the data capture procedure, during each visit to the outpatient clinic at hospital’s pharmacy department, a record is created that incorporates the latest digitized EMR data and the PROs data completed by patients on a mobile device, which is transferred to the software through a cyber-secure Wi-Fi connection and then to the EMR.
What has been achieved?
A software solution, SiMON-PRO, structured into six sections, was developed. 1/demographic data; 2/ epidemiology; 3/events; 4/analytics; 5/ART; 6/PROs questionnaires: about quality of life (EQ-5D-5L, HAT-QoL, MOS-HIV), chronic treatment acceptance (ACCEPT) and injection tolerance (PIN).
The software allows outcomes to be exported to the usual operating systems through Big Data and Business Intelligence. It also automatically generates alerts for assisted prescription validation and produces reports for exporting to the EMR.
What next?
SiMON-PRO is an innovative solution for the clinical follow-up and research of PLWH, increasing the quality, efficiency, and safety of healthcare. The following steps include the use of the data, events and alarms generated for better pharmaceutical care of PLWH and, gradually, design this software for other pathologies.
RELOCATING A UNIVERSITY HOSPITAL’S INJECTABLE CHEMOTHERAPY PREPARATION PROCESS TO A MOBILE UNIT: A CHALLENGE MET!
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European Statement
Production and Compounding
Author(s)
K.LEROUET; M. DELAMOTTE; F.VITET. S.CRAUSTE-MANCIET; A.LEBRETON; F.LAGARCE
Why was it done?
Our Chemotherapy Reconstitution Unit (CRU) needed to replace its two double workstation isolators and high efficiency particulate air filters, taking the unit out of service for six weeks. With 40,000 injectable chemotherapy treatments performed each year, outsourcing was not an option. We had to find a solution to temporarily relocate the activity to a new area within our facility.
What was done?
Our aim was to ensure continuity of the manufacturing process for injectable anticancer drugs in accordance with Good Preparation Practices in a temporary CRU.
How was it done?
Eighteen months ahead of schedule, we set up multidisciplinary working groups consisting of pharmacists, pharmacy technicians, biomedical and technical service staff and health care managers.
Inspired by the few french hospitals that had already carried out this project, we studied the process and the choice of space and equipment required. We also drew up procedures and a backlog schedule.
What has been achieved?
Twenty-three work sessions of 1 hour were organised. We chose a chemo-truck (ModuGuard®), with three workstations inside two positive pressure isolators. We acquired new equipment to adapt to the spaces created specifically for this project (transport crates, walky-talkies, operating room gowns). We planned the qualification of the mobile grade D controlled area and isolators. The production flow was rethought, with extended production hours and more human resources. Our production was divided into 4 zones with different tasks: tray preparation and pharmaceutical validation, chemotherapy preparation, pharmaceutical release and preparation dispatch. Good communication between the different areas was essential to the success of our project. In comparison to the reference process, no additional non-conformity where noticed. We communicated with the care units many months ahead to anticipate logistic issues.
What next?
The overall feedback from the teams was good, thanks to the cohesiveness that was created, although staff were tired. No adverse events were reported, although occasional delays in preparation were noted. Anticipation of needs and day-to-day adaptability were essential to the success of this project. A budget of €80,000 was required to complete our project. This organisation allowed us to maintain a level of production equivalent to our CRU. This publication is intended to help inform healthcare organisations undertaking similar projects.