The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
TRACE AROUND THE BLOCK! VALIDATION OF AUTOMATED INTEGRATION OF IMPLANTABLE MEDICAL DEVICE TRACEABILITY DATA INTO AN ELECTRONIC PATIENT RECORD
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.
DESIGNING A 360° IMMERSIVE VIRTUAL REALITY TOOL FOR TRAINING IN INFUSION SET-UP
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.
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.
OPTIMISING CUSTOM PACKS: A STEP TOWARDS A SUSTAINABLE HOSPITAL?
European Statement
Selection, Procurement and Distribution
Author(s)
A. KANDEL (1), L. CABRIT (1), C. HUMARAUT (1), A. MASSRI (2), C. TAILHADES (1), S. ARRAKI ZAVA (1), V. GRENOUILLEAU (1)
(1) Pharmacy Department, Medical Devices Unit, Pau Hospital Center, France
(2) Intensive care unit, Pau Hospital Center, France
Why was it done?
Medical devices (MDs) and drugs account for 55% of the carbon footprint of a hospital’s French healthcare system, making this sector a key focus for the ecological transition. The MD sector alone is responsible for 32% of our hospital’s CO2 emissions, underlining the need to rethink our practices in order to reduce our environmental impact.
What was done?
Elimination of waste produced unnecessarily by optimising customised packs (CP) containing the MD required for treatment.
How was it done?
After a multidisciplinary team (pharmacists, intensive care units, anaesthetists, nurses) was put together, packs containing unused medical devices (UMD) were identified in 2 pilot departments: anaesthesia and intensive care. The packs were weighed with and without the UMD. The savings in terms of waste weight and carbon footprint were calculated according to the type of waste: general waste or biohazardous waste. In conjunction with the medical teams and suppliers, the re-evaluation of the MD required and the withdrawal of UMDs led to the updating of CP in the pilot departments.
What has been achieved?
The packs identified include: the suture pack (SP), the central venous line pack (CVL) and the epidural pack (EP). Over one year, the weight of waste avoided was: 64 kg for the SP, 87 kg for the CVL pack, 55 kg for the EP. After modifying these packs, annual CO2 emissions were reduced by 55% for the SP, 14% for the CVL pack and 8% for the EP, with a total annual saving of €5,423. The annual weight of waste was reduced by 206 kg, a saving of 92 kg of CO2: the equivalent of 86 Paris-London train journeys.
What next?
The re-evaluation of CP can generate a significant ecological impact. This initiative is intended to be rolled out on an institutional scale, with the active collaboration of the sustainable development department, and as part of future calls for tender. These adjustments save time for care staff, significantly reduce the carbon footprint, and contribute to the ecological transition. It is essential to strike a balance between economic and environmental imperatives, given the financial constraints facing public hospitals.
The current landscape of medical device education for hospital pharmacists: where do we stand?
European Statement
Education and Research
Author(s)
Lorenzo Di Spazio, Daniele Mengato, Andrea Ossato, Vera Damuzzo, Marco Chiumente, Giulia Dusi, Sabrina Trippoli, Andrea Messori, Maria Cecilia Giron, Maria Chiara Silvani, Francesca Venturini
Why was it done?
MD training, both undergraduate and postgraduate, appears to be scarce and, when available, seems to chase rather than anticipate real innovation. As a result, hospital pharmacists often have inconsistent levels of training that need to be investigated and harmonised.
What was done?
Medical devices (MD) are serving an increasingly central role in clinical practice, improving patients’ health and quality of life. In recent years, the MD industry has grown considerably along with its innovation, sophistication and spending. This context requires not only technical, but also management and consulting skills, in particular for pharmacists, that should be adequately trained and continuously updated in order to increase their involvement in the patient care pathway. A special survey has been designed and sent out to hospital pharmacists in order to gauge their level of knowledge on this subject.
How was it done?
A survey, available from 1 October 2022 to 31 December 2022, was created by a pool of experts from an Italian scientific society (Italian Society of Clinical Pharmacy and Therapeutics – SIFaCT) and shared through Google Forms to evaluate the state-of-the-art of MD’s clinical pharmacy practice, characterising the participants on their training background and needs in this field. The questions aimed to describe which courses (curricular or post-university) on MD had been followed by the participants to individuate the best possible interesting topics and the preferred training tools useful for the SIFaCT’s future educational activities.
What has been achieved?
Out of 142 responses, only 36 (25%) declared to have followed specific training courses on MDs while 102 (72%) stated that they were self-taught in this matter. 138 participants (97%) stated the need to broaden their knowledge through: training meeting (34%), sharing of procedures and/or operating instructions (33%), access to short editorial contributions (23%) and scientific studies (10%). The three most requested topics for future trainings were: innovative MDs and innovation governance (HTA), updates on legislation and technical insights on specific classes of MDs.
What next?
These results represent a background for developing a training project aimed to increase pharmacists’ knowledge on MDs.
MD topic, according to Regulation (EU) 2023/607 and 2017/745, is constantly updated and the pharmacist must be able to understand and implement the requirements of the national and European legislation to protect safety, safeguard public health and recognize technological innovation. Finally, these results highlight the need of specific university courses for pharmacists to develop technical and clinical skills on MDs.
A state-of-the-art on medical devices in Italian clinical pharmacy practice: results from the Italian Society of Clinical Pharmacy and Therapeutics (SIFaCT) survey
European Statement
Clinical Pharmacy Services
Author(s)
Lorenzo Di Spazio, Daniele Mengato, Andrea Ossato, Vera Damuzzo, Marco Chiumente, Giulia Dusi, Sabrina Trippoli, Andrea Messori, Maria Cecilia Giron, Maria Chiara Silvani, Francesca Venturini
Why was it done?
Pharmacist’s activities on MDs are mainly linked to governance, management and vigilance but little to clinical pharmacy practice. In order to study and develop interventions aimed at optimizing the use and compliance of medical devices on patients, a national survey was conducted to identify the clinical pharmacy experiences already consolidated in this field.
What was done?
Clinical pharmacy activities that demand specialized expertise in medical devices (MD) constitute a relatively uncharted territory for hospital pharmacists. Our aim, through a nationwide survey, was to delineate the clinical responsibilities overseen and handled by hospital pharmacists that necessitate a specific focus on MDs.
How was it done?
A 54-question survey, available from 1 October 2022 to 31 December 2022, was created by a pool of experts from an Italian scientific society (Italian Society of Clinical Pharmacy and Therapeutics – SIFaCT) and shared through Google Forms. The questions, divided into six sections, were related to five clinical areas defined by the working group: surgery room (SR), wound care (WC), vascular access management (VAM), patient education on diabetes treatment technologies (DTT) and MD in oncology and artificial nutrition (ON).
The questionnaire allowed us to define the state-of-the-art of clinical pharmacy on MDs, highlighting the activities and training needs of the participants.
What has been achieved?
We received 142 responses. In particular, emerged that 42% of participants adopted standard kits in the SR and 76% of them declared the pharmacist involvement.
A specific team for WC was created for 35% of participants, with the involvement of the pharmacist in 90% of cases, in particular as consultant role in 22%.
37% of participants declared the presence of a team dedicated to VAM, with the involvement of the pharmacist in 40% of cases and patient counselling in 9%. Finally, in DTT and ON the pharmacist was involved in 8% and 10% of the responses, respectively.
What next?
This first national survey shows that the pharmacist is often involved in multidisciplinary groups in the five analyzed areas, but less involved in patient’s counselling probably due to the sub-optimal training in the field of MDs. Indeed, almost all the participants declared the need to improve their knowledge in this field and create a network among colleagues.
Making a green and lean choice: evaluating the environmental and economic impacts of reprocessable and single-use medical devices in hospital settings
European Statement
Selection, Procurement and Distribution
Author(s)
Samantha HUYNH, Olivia MAZZASCHI, Valérie TALON, Emilie MOREAU
Why was it done?
Healthcare systems face a growing need to balance patient care with environmental responsibility. This approach was initiated at the request of surgeons and was proposed during institutional committees addressing environmental issues.
What was done?
Our aim was to perform a comprehensive analysis of the potential benefits and challenges associated with the substitution of single-use medical devices (SUDs) with reprocessable medical devices (RMDs) within a hospital setting.
How was it done?
We evaluated environmental, economic and organizational impact of this transition by comparing the carbon footprints and costs associated with the substitution of SUDs (suture and antiseptic trays) with RMDs as well as their acceptance by healthcare professionals.
Environmental impact was evaluated by considering manufacturing origin, transportation, and material composition, calculating carbon equivalence based on weight. The energy and water consumption during the sterilization process of RMDs was also included in the carbon footprint quantification.
Economic considerations included SUDs purchasing and management costs as well as acquisition and sterilization costs for RMDs.
Observational audits (n=30) and user satisfaction surveys (n=7) were conducted to evaluate the acceptance of RMDs.
What has been achieved?
RMDs led to a significant reduction in the carbon footprint for both devices. The carbon equivalence for suture trays was reduced from 7.1 kg eqCO2 for SUDs to 4.0 kg eqCO2 for RMDs; for antiseptic trays, SUDs generated 2.2 kg eqCO2 while RMDs 1.1 kg eqCO2. The potential annual reduction of CO2 emissions is 5.2 tonnes per year.
The economic analysis showed that the initial investment in RMDs could be recovered within a remarkably short timeframe (10 months for antiseptic trays, 5 years for suture trays) making it a viable long-term cost-saving strategy.
User feedback showed a preference for RMDs despite slight inconveniences, with 71% of respondents supporting the reduction of SUDs and 83% perceiving RMDs as of superior quality.
What next?
Our findings underscore the feasibility and benefits of transitioning to RMDs, with a significant reduction in carbon footprint and economic viability. While complete elimination of SUDs presents challenges, a balanced approach prioritizing sustainability without compromising quality of care is possible. We believe that this approach can be replicated in diverse healthcare settings, contributing to a more sustainable future management.
Value-based procurement model for the purchase of hyaluronic acid for intra-articular use
European Statement
Selection, Procurement and Distribution
Author(s)
ERMINIA CACCESE
Why was it done?
The aim is to hold a value-based tender by incorporating the clinical benefit into the competition score for the procurement of Hyaluronic Acid (AI) for intra-articular use.
The main purpose of this tender is to purchase the product with the best cost-effectiveness profile according to the Net Monetary Benefit (NMB) and putting drugs and medical devices in competition.
What was done?
In Italy as well as in Europe medical devices (MDs) procurement is based on construction features and on price. The price of MDs is not negotiated by regulatory authorities, but it’s defined by industry. Today, in a limited resources scenario, it is necessary to implement value-based procurement.
How was it done?
We used the NMB method (1) as an award criterion, a parameter that evaluates the cost-effectiveness of the therapeutic intervention.
A bibliographic search was carried out to support the chosen endpoints and the tender lots. The utility and cost values linked to therapeutic failure were sought and the minimum accepted quality was defined. The starting price was calculated per therapy cycle/patient.
Finally, a software was designed to calculate the value-based competition score.
What has been achieved?
The tender consisting of 3 lots was announced with resolution n.209/2023 (2). The technical evaluation focuses on the enhancement of the clinical benefit based on the following scores: price (30)/clinical benefit (70). The endpoints chosen for the evaluation of clinical benefit are deltaVAS and deltaEQ-5D. Both drugs and MDs can be offered for each therapeutic indication.
What next?
This tender is an example of value-based procurement that uses the evaluation of clinical effectiveness as a quality evaluation criterion.
The aim is to quantitatively link the purchase price of a therapeutic intervention to the extent of the benefit observed in clinical studies, rewarding the interventions that produce the greatest benefits. The innovative nature of our tender lies in putting drugs and MDs in competition in the same tender lot and for the same therapeutic indication, thus purchasing the product with the best cost-effectiveness profile based on scientific evidence. We are awaiting the award of the tender, the results of which we will publish shortly.
Inhaler recycling
European Statement
Selection, Procurement and Distribution
Author(s)
Sam Coombes, Cath Cooksey
Why was it done?
Inhalers account for 3% of the total NHS (National Health Service) carbon footprint and 73 million inhalers are dispensed every year in the UK. There are legal obligations for the NHS to reduce the emissions it can influence and reach net zero by 2045, with an ambition to reach an 80% reduction by 2039. There is no national program to recycle inhalers. We wanted to establish a recycling model which is efficient and can be easily replicated.
What was done?
We established an inhaler recycling model which enables patients to drop off any inhaler at multiple healthcare settings and for these inhalers to be collected and recycled, using a pre-existing logistical model.
How was it done?
This work is part of a collaborative working project in conjunction with NHS Kent and Medway Integrated Care Board and Chiesi Limited. Alliance Healthcare are a sub-contracted service provider in the project to support with the logistical model. We wanted to demonstrate a new model for inhaler recycling using existing infrastructure aiming to improve return rates whilst keeping costs as low as possible. In Kent and Medway, East Kent with a population of 720,000 people, was chosen as a pilot area, as this presented a mixed patient demographic, and the highest volume of acute hospitals, community pharmacies and dispensing GP practices. Inhalers are collected from recycling sites made up of acute hospital sites, community pharmacies and GP dispensing practices, at the same time as medicine supplies are delivered, using a sophisticated logistical model which already exists therefore not requiring any additional transportation. Once collected by a specialist waste management company, from the wholesaler depot, the inhaler components are then recycled and gases from MDI inhalers captured and reused in other industries.
What has been achieved?
A 12-month pilot has been initiated, the infrastructure a logistical model has been put in place and data is being collected.
What next?
The data from the collection process will continue to be collated, the carbon savings calculated, and a toolkit developed so this can be easily adopted in other regions.
A risk-based choice of syringes and associated equipment for compounding and intravitreal administration of drugs for wet age-related macular degeneration
European Statement
Production and Compounding
Author(s)
Espen Gleditsch, Dag Fossum
Why was it done?
There are no available syringes with CE approval for intravitreal administration. The CE approval for sterile single use syringes covers dosage and sterility, but not the special needs associated with intravitreal administration. The choice of syringe and associated equipment therefore have to be based on a risk assessment. The intravitreal administration includes increased patient risk regarding sterility (infection), particles (inflammation), injection volume (ocular pressure), silicone oil (floaters in the vision) and technical performance (leakage and compatibility with needle). The aim of this work was to find the syringes, associated equipment and compounding process that present least risk to the patients.
What was done?
Oslo hospital pharmacy delivers ready to use syringes for intravitreal administration of drugs for wet age-related macular degeneration. The pharmacy has in cooperation with the eye department at Oslo university hospital done a risk assessment in 2023 to decide syringes and associated equipment for compounding and administration.
How was it done?
The syringes historically used for intravitreal administration in Norway are Insulin syringes with prefixed needles (BD), Inject F syringes (BBraun) and Zero Residual syringes (SJJ Solutions). The needles used are TSK Low Dead Space needles and Zero Residual needles. The compounding methods are filling of the ready to use syringe from a bulk syringe by a needle or use of a Zero Residual bubble adaptor. All ready to use syringes are compounded in isolators with grade A in the working chamber, delivered with needle or cap, and packed in sterile bags. The risks associated with each syringe, needle and compounding process were assessed with a Failure Mode Effects Analysis Method.
What has been achieved?
The risk assessment shows that the risk to the patients are lowest when administering drugs for wet age-related macular degeneration with Zero Residual syringes and needles, filling the syringes with bubble adaptor and deliver with cap. This will give the lowest risk score regarding sterility, particles, injection volume, silicone oil and technical performance.
What next?
This work is relevant for other pharmacists and prescribing practitioners when assuring that syringes and associated equipment are of appropriate quality and suitable for intended use.