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.
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.
Evaluation of microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices
European Statement
Production and Compounding
Author(s)
Timea Botházi, Lone Madsen
Why was it done?
The purpose was to find data for an increased microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf-life from 24 hours to 7 days. Existing data were studied to find evidence to support the prolonged shelf-life.
What was done?
The purpose was to find data for an increased microbiological shelf life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf life from 24 hours to 7 days. Existing data was studied to find evidence to support the prolonged shelf life.
How was it done?
A team from the production and quality assurance departments worked together on writing a report that could provide the rationale for the change of shelf-life.
We collected data from
– supplier qualification of the medical devices
– aseptic process simulations (APS)
– process validations
Data were evaluated and risk assessment was performed.
Six medical devices were included.
All suppliers were qualified as low risk.
APS for the specific production process showed no growth.
Process validation data for two types of medical devices showed no concern regarding sterility of preparations.
What has been achieved?
The increase of shelf life was accepted. First product was Blincyto® in infusion bag with Take Set Swan-Lock ® with shelf life increased to 4 days. Patients now visit the oncology clinic only twice a week instead of daily thus saving time and transportation.
What next?
The result means that new product implementation is quick because the only things to evaluate are the stability of the substance and the compatibility of this with materials in contact with it.
Clinically digital program support for personalised dosing of vancomycin
European Statement
Clinical Pharmacy Services
Author(s)
Wei Wang, Hao Bai
Why was it done?
It depend on the pharmacokinetic (PK)/pharmacodynamic (PD) of vancomycin. Vancomycin can be described as a kinetic model with one compartment connected by a series of first-order kinetic rate processes. The mini programme uses two drug levels during the same dosing interval by the TDM to calculate the area under the curve (AUC) of vancomycin and integrated into patients’ condition and minimal inhibitory concentration of pathogen to provide an optimal dosing regimen of vancomycin.
What was done?
We designed and developed a mini programme support for personalised therapeutic drug monitoring (TDM) of vancomycin. This programme can be easily used in the WeChat by the mobile device.
How was it done?
The traditional vancomycin TDM strategy, which is guided by trough concentrations, has several limitations:
The recommended trough concentration range of 10-15mg/L assumes that the bacteria’s minimum inhibitory concentration (MIC) for vancomycin is ≤1mg/L. However, with the drifting of vancomycin’s MIC values over recent years, this trough concentration has not been able to effectively guide patient prognosis, as has been confirmed by many clinical studies.
There are practical difficulties: for example, the 2009 IDSA guidelines clearly specify that the trough concentration of vancomycin should be sampled half an hour before the fifth dose. However, in reality, due to misunderstandings by nursing staff or excessive workload, sampling times often deviate from this guideline.
After the trough concentration has been determined, there are no explicit measures for dose adjustment. The 2009 IDSA guidelines do not provide recommendations on how to adjust subsequent doses based on trough concentrations.
A decade later, in 2020, the IDSA released new vancomycin TDM guidelines. These guidelines suggest moving away from the trough concentration TDM strategy for vancomycin, and instead recommend using an AUC-guided strategy, determined by two-point blood concentration monitoring of vancomycin.
What has been achieved?
Vancomycin follows first-order pharmacokinetics. To monitor the AUC of vancomycin, it is necessary to measure the serum vancomycin concentration at two steady-state points, then use Monte Carlo simulations and Bayesian software to calculate the AUC and adjust the dosage. This process requires a large number of calculations. Therefore, there is an urgent need for an auxiliary decision making system in clinical practice that can facilitate personalised dosing of vancomycin.
What next?
This mini programme has run above 1 year, providing personalised medicine service of vancomycin to hundreds of patients in China, guiding the precise and rational use of antimicrobial drugs , enhancing the effectiveness of vancomycin and reducing drug toxicity in clinical practice.
Healthcare impact of a digital health programme for patients with chronic or high-frequency episodic migraine
European Statement
Patient Safety and Quality Assurance
Author(s)
Anna de Dios-López, Neus Pagès-Puigdemont, Montserrat Masip-Torné, Pau Riera-Armengol, Rebeca Pelegrín-Cruz, Cristina Martínez-Molina, Noemí Morollón, Robert Belvís-Nieto, Maria Antònia Mangues-Bafalluy, Mar Gomis-Pastor
Why was it done?
Migraine is a neurological disorder characterised by frequent headache. Patients with an episodic migraine pattern have <15 monthly migraine days (MMD), whereas patients with a chronic pattern have ≥15 MMD. Migraine has a high prevalence (15-20% of female and 5-8% of male) and a great impact on their quality of life. Many migraine patients can benefit from preventive treatment. The use of a digital health programme in these patients can allow a real-time monitoring of treatment effectiveness (through the register of migraine attacks frequency) and adverse events. Additionally, it can improve the communication between patients and HCP.
What was done?
We tested a patients’ mobile phone (mHealth) application in chronic and high-frequency episodic migraine patients. This application was synchronically linked with a website for healthcare professionals (HCP) and hospital clinical records.
How was it done?
MyPlan is a mHealth application adapted from another one developed in our hospital for heart transplant patients. Firstly, we conducted a focus group with patients to understand their needs and preferences. This platform fulfils the quality and Data Protection Regulation.
What has been achieved?
13 patients and carers participated in two different focus groups. Another focus group was conducted with the Neurology Department of our institution. The results permitted to adapt the mHealth application with the following functionalities and registers:
• Synchronous (videocall) and asynchronous (direct message) communication between patients and HCP
• Medication adherence
• Treatment adverse events
• MMD and monthly headache days (MHD)
• Monitoring through the register of biomeasures (blood pressure, weight), lifestyle habits (diet, exercise) and questionnaires (MIDAS, HIT-6, EQ-5D, MSQ)
• Information
Data registered by the patient was used to guide clinical management and improve patients’ healthcare route.
What next?
The introduction of mHealth in the healthcare route of patients with migraine could benefit both patients and HCP. This strategy could be incorporated in other health facilities that attend migraine patients in an outpatient setting. Nowadays, a clinical trial is being conducted to demonstrate its clinical benefit.
Application of a supplier qualification program for primary packaging materials regulated as medical devices
European Statement
Patient Safety and Quality Assurance
Author(s)
Andersen Lilli Moeller, Hansen Tove Solveig, Schnor Trine
Why was it done?
The QMS for the hospital pharmacy did not previously include primary packaging systems regulated by MDR. These packaging systems are a prerequisite for supply to patients of vital medicines like Total Parental Nutrition (TPN) and ready-to-use products such as antibiotics, cytostatics and pain reliefs.
What was done?
Several actions to combine Good Manufacturing Practice (GMP) and Medical Device Regulations (MDR1) were implemented. Among others, comprehensive training programmes were conducted, and quality standards as well as supply chain mappings were included in Quality Management Systems (QMS).
How was it done?
A national strategic initiative was launched with actions decided in open dialogue with the Competent Authority and suppliers.
Priority was given to the most GMP-critical devices as TPN-bags and elastomeric pumps. Specifications were established and supply chains mapped.
To fast roll out competences across hospital pharmacies similar workshops with participation of a consultant with special competences within MDR were given.
What has been achieved?
Due to knowledge of the Supply Chain and extended cooperation with suppliers, a quick and effective reaction in relation to for example recalls is obtained.
Easier to explain suppliers how they can support our need for documentation to fulfill GMP related demands New clinical or political demands to ad-hoc compounding can be met fast and effective.
GMP related issues are part of a current national tender for elastomeric pumps.
What next?
More medical devices like transfer-sets, syringes used as utensils and gloves to be included in the supplier qualification program.
GMP related requirements to be a part of tenders on medical devices used as packaging systems.
Continued cooperation with suppliers to develop solutions in the interface between MDR and GMP.