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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.

Development and implementation of a simulation programme of study aligned to experiential learning and the initial education and training of the student pharmacist

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European Statement

Education and Research

Author(s)

Sam Ingram, Sian Williams, Stewart Glaspole, Greg Scutt, Railton Scott, Safoora Azimi, Danny Bartlett, Claire May, Lisa Knox, Graham Davies

Why was it done?

The General Pharmaceutical Council in the UK released updated standards in 2021, detailing expected learning outcomes at the end of undergraduate and foundation year training. As many of these new standards explicitly link to pharmacist skills it was important that these were integrated into undergraduate course delivery.

What was done?

An evidence-based strategy was employed to develop a global skills framework which was used, alongside the course structure, to inform a simulation and experiential learning strategy for the initial education and training of undergraduate pharmacists.

How was it done?

An evidence review was conducted, examining established skills frameworks in pharmacy education and the wider healthcare arena, this was thematically analysed, and generation of a 16-skills framework constructed. This was used to guide a series of stakeholder workshops and working groups to structure a spiraled curriculum of simulated activity and assessment and an aligned experiential learning plan.

What has been achieved?

A recognition of the importance of clinical and professional skills development by establishing this at the core of the new degree structure. Through the programme a suite of clinical and professional skills (CAPS) modules focuses on an evidence-based set of core skills, values, attributes, and behaviours. Generation of a suite of simulation workshops which ensures a safe environment to learn and show competence before enhancing these skills on placement(s) supporting pharmacy services in a range of clinical settings.

What next?

The simulation and experiential learning strategy has been implemented into the 2023-24 academic year. Monitoring and feedback generation from students, academic staff, placement providers, and key stakeholders to determine if this new format for learning is generating more engaged and capable student pharmacists.

Development of a podcast for student learning and motivation (the MUG-Hub)

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European Statement

Education and Research

Author(s)

Sian Williams, Connor Thompson

Why was it done?

Podcasts are generally accepted as a valuable tool for enhancing student engagement with course material and motivating students in educational settings. They also offer an exciting opportunity for allowing students to make connections between what is taught on the course and it how applies in the ‘real-world’ through discussion with practicing professionals.

What was done?

The Medicines Use Group (MUG) at the University of Brighton have co-created a series of podcasts (called ‘The MUG-Hub’) to increase student pharmacists’ access to and understanding of current issues related to medicines use and to provide information, inspiration and motivation around future careers in pharmacy.

How was it done?

A small group of teaching staff (including the authors) were matched with a student partner through a digital learning initiative run by the university. Through the process of co-creation a list of topic ideas and format considerations was collated and the podcasts developed and disseminated to the wider student body (podcast titles include ‘My career in pharmacy: reflections of a specialist liver pharmacist’, ‘Working in general practice as a pharmacist’ and ‘Designing an MPharm course fit for future pharmacists’).

What has been achieved?

A series of 30-60 minute podcasts has been created and is disseminated to student pharmacists on a monthly basis through the digital learning environment. The introduction of podcasts to the course enhances students’ development in terms of self-led learning, communication and collaboration and essential digital skills.

What next?

We plan to take the work forward by engaging more students in the creation of future podcasts and compiling topic lists for future episodes and surveying student engagement with the podcast.

Using virtual reality to introduce newly hired nurses

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European Statement

Education and Research

Author(s)

Stine Hygum Sørensen, Henrik Nielsen, Ulla Kloster, Anne Grethe Nørgaard Kyndi, Maja Vad Mortensen, Dorthe Ludvigsen

Why was it done?

The concept of medicine at Gødstrup Hospital is based on Patient involvement in the medicine process. Consequently, the patients bring their own medicine, which is stored in the patient’s room, and additional medicine is supplied in original packages. Medicine dispensing is performed in the patient’s room to allow patient participation. The medicine rooms at the hospital are quite small, because the majority of the medicine is with the patient, but it also makes medicine rooms unsuited for on-site training of new nurses.

What was done?

Virtual Reality (VR) technology was applied for introduction of newly hired nurses to medicine rooms at the hospital.

Newly hired nurses are given a four hour introduction to the concept of medicine at Gødstrup Hospital, Denmark. The introduction is given by an interdisciplinary team of a clinical pharmacist, a pharmacologist and an experienced nurse. The introduction is given in collaboration with the Centre for Research and Education (NIDO) once a month. This ensures that newly hired nurses are given the same, relevant introduction when needed.

Introduction to medicine rooms is part of the training for nurses in introductory positons. Using VR newly hired nurses are given a different and exciting introduction to medicine rooms.

How was it done?

In collaboration with the simulation unit at NIDO we made a VR-video to enable up to 20 new nurses to see the same introduction at the same time. Hospital Pharmacy staff is featured in the VR recording and guides viewers to specific parts of the medicine room, explaining important topics such as waste disposal, hygiene and anatomical therapeutic chemical (ATC) groups.

What has been achieved?

The participants are positive and give the following feedback to the VR segment of the introduction: “It was significantly easier to deal with as a newbie”. “It was very visual as being there in reality”. “There was time to learn in a calm environment”, “It worked fine as a lesson” and “It is a good change from backboard teaching.”

What next?

The monthly introductions continues and further collaboration with NIDO will result in lessons with topics such as pharmaceutical formulations and drug calculations. Perhaps VR will be included in this too.

National competition for pharmacy students in Bulgaria “become a hospital pharmacist”

European Statement

Education and Research

Why was it done?

There are five accredited faculties of pharmacy in Bulgaria – two in Sofia, one in Plovdiv, one in Varna and one in Pleven. The training is only full-time with a duration of 5 years, with 26 compulsory courses in which hospital pharmacy is covered to a very small extent. Only one of the faculties in Sofia offers the opportunity to specialise in clinical pharmacy during the studies, which include 30 hours of lectures and 45 hours of exercises in hospital pharmacy. The disinterest of graduating students in pursuing a career in hospital pharmacy prompted the BAHP Board to organise this competition to bring attention to hospital pharmacy in a non-traditional way.

What was done?

The Bulgarian Association of Hospital Pharmacists /BAHP/ organises during its annual conference a National Competition for Pharmacy Students “Become a Hospital Pharmacist” – for the first time in 2021. Since then, it has been held annually with increasing interest from students.

How was it done?

The areas in which the students will compete – Pharmacology and Pharmacotherapy, Regulation of Hospital Pharmacy and Practical part, as well as the regulations of the competition were determined. An invitation with information was sent to all faculties. For the year 2021, teams from three faculties participated, for 2022 four faculties, and for 2023 all faculties will participate. Each team has a scientific supervisor and the costs of participation are covered by the university.

What has been achieved?

1.Strengthening the links between the BAHP and the faculties
2. Repeatedly increased student interest in hospital pharmacy.
3. Increased number of students wanting to do their pre-graduate internship in hospital pharmacy

What next?

Continuation of the annual competition and deepening the collaboration with the faculties. It is also possible to organise such an event between different countries.

Change of local anaesthesia procedure to avoid suture breakage

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European Statement

Education and Research

Why was it done?

A wide range of women sustain a perineal tear after delivery with a need of perineal repair. If the suture material fails to last as expected, women might experience wound rupture, impaired healing, and inferior functional outcome.
A clinical observation of increased risk of early breakage of the suture material in women anaesthetized with Xylocaine spray for perineal tear repair, compared with women anaesthetized with Xylocaine gel led to this study. Thus, in an observation period of 9 months 79% of the women who had to go through early secondary wound repair due to suture failure, had received local anesthesia in the form of Xylocaine spray.
The Clinical Pharmacy was contacted by the Obstetric Department with the following inquiry; whether there is a pharmaceutical interaction between local anaesthetics and the suture material.

What was done?

An in-vitro experiment to compare the tensile strength of fast absorbable suture material when impregnated with various agents for local anaesthesia was performed.

How was it done?

An in-vitro experiment was performed in collaboration between midwives, pharmacists and the Danish Technological Institute. We impregnated 120 suture materials divided in four groups (Xylocaine Spray, Xylocaine gel, Isotonic Sodium Chloride and Ethanol 96%) for 72 hours at 37 degrees and then measured the tensile strength of the suture material.

What has been achieved?

In the experiment we saw that Ethanol and Xylocaine spray weakened the tensile strength of fast absorbable sutures. Use of Xylocaine spray containing ethanol for local anesthesia might lead to early breakdown of the suture material and wound rupture.
After the experiment the majority of obstetric departments in Denmark changed their procedure for local analgesia/anaesthesia during perineal repair from Xylocaine Spray to Xylocaine gel.

What next?

Observing and registering the suture breakage percentage in a period of 9 months after application of Xylocaine gel.
Publishing the results at a broader level.

Implementation of a simple continuing training programme for retraining operators in a clean room production

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European Statement

Education and Research

Author(s)

Maria Agerboe Sondrup, Anette Sand Østergaard

Why was it done?

Training of operators has previously been performed, however there was no consistent programme for continuing training in the department to secure optimal training of operators. Equally the effectivity and durability of the training was not evaluated. The aim was to establish a thorough system for continuing training focusing on ongoing confirmation of proper training as well as adaptation and optimization throughout.

What was done?

A programme for continuing training of operators was designed and implemented in a clean room production department by GMP-responsible operators and academics.

How was it done?

A template was designed for the programme. One module takes up to 3 months.
The template is the following:
Observation:
– Trainers observe operators in a clean room
– Current technique is observed and if necessary corrected
Training material:
– Developing educational material based on SOPs
– Short videos, PowerPoint presentations etc.
Individual training:
– Operators answer handed out multiple choice questionnaire (MCQ) by themselves
Group training:
– The correct answers to the MCQ are presented by the trainers at a plenary session
– All answers are discussed
Observation:
– Trainers observe operators in a clean room
– Current technique is observed and if necessary corrected
Evaluation:
– Trainers evaluate the training in terms of improvement from the first to the second observation
– Trainers write a report that is presented to the operators

What has been achieved?

A systematic and relatively simple training programme has been implemented. This streamlines the training of operators, thereby making it easier for the trainers to introduce new subjects and ensures that all new operators are trained the same as the experienced operators. The programme also makes the training system recognizable for the operators, which gives a higher compliance.

What next?

The program has only been implemented on processes related to production in clean room, but the training method can easily be applied to subjects outside of the clean room or in other healthcare settings. To involve the operators in the process, the second observation could be delegated to other operators and not just the trainers.

Advancing regulatory sciences closer to the patient care setting: a course development approach

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European Statement

Education and Research

Author(s)

Anthony Serracino Inglott, Maria Mamo, Amar Abbas, Luana Mifsud Buhagiar

Why was it done?

Regulatory science is not some detached activity performed in secluded offices but is applied by pharmacists as an integral part of their daily work, whether thought of as regulatory intelligence or not. This initiative endeavored to offer educational intervention, for streamlining a patient-centric culture and addressing gaps, while waning concerns regarding potential conflicts arising from regulator-stakeholder interactions.

What was done?

The Malta Medicines Authority (MMA), through the MMA Academy for Patient Centred Excellence and Innovation in Regulatory Sciences, implemented a course intended for collaborative synergy with professionals in patient care settings. Strengthening regulatory intelligence may provide substantial return on investment for the ultimate benefit of patients.

How was it done?

In April 2023, the MMA Academy completed registration as a Further and Higher Educational Institution. An accredited 3-day course, leading to an Award in Basic Regulatory Sciences (Malta/European Qualifications Framework Level 4), was launched across stakeholders. Twenty-four experts were engaged to deliver sessions on legislation, ethics, quality, information sources, digitalization, pharmacovigilance, good practices, risk, and avoiding victims of the system. Registrations were initially slow, owing possibly to the holiday season, increasing to maximal venue capacity following reminder mails and media posts. The course was delivered in September and feedback collected through a Likert scale evaluation exercise.

What has been achieved?

Thirty participants (8 from public, 22 from private entities) completed the course successfully. All respondents to the course evaluation exercise (n=24) expressed satisfaction with course content and willingness to attend further courses. Promisingly, 92% of same respondents found the information presented relevant to their practice, anticipating performance improvement. Feedback included recommendations for future initiatives, particularly on regulatory oversight of aesthetic medicine services and integration of artificial intelligence in hospital pharmacy practices. A continuous educational needs exchange is encouraged for course development tailored to respective patient care settings.

What next?

Interest was expressed by the Health Department (Ministry for Health, Malta) to support eligible candidates for participation, auguring well for enhanced prospective engagement by clinical pharmacists and colleagues in the state hospitals. This may also serve as example to other competent authorities. Going forward, the MMA Academy intends to invest in online provision to reach a wider audience through a virtual environment.

Revolutionising pharmacy recognition: evolution of the Australian and New Zealand College of Advanced Pharmacy

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European Statement

Education and Research

Author(s)

Tom Simpson, Kristin Michaels, Kylee Hayward, Nick Sharp-Paul

Why was it done?

The need to establish a recognition framework that resonated with pharmacists, aligned with their career journeys, and held tangible benefits prompted the inception of ANZCAP. Recognising that existing programmes lacked broad appeal, ANZCAP aimed to redefine recognition in a way that was meaningful, inclusive, and motivated pharmacists towards continuous development.

What was done?

The Australian and New Zealand College of Advanced Pharmacy (ANZCAP) represents a pioneering advancement in pharmacy recognition and career progression. Addressing the limitations of previous models that struggled to gain broad support, ANZCAP emerged as a strategic response to bridge the recognition gap within the pharmacy profession.

How was it done?

The development of ANZCAP commenced with the acquisition of the Advancing Practice (AP) credentialing programme by the Society of Hospital Pharmacists of Australia (SHPA). Previous efforts to engage pharmacists with the programme were reassessed, and a comprehensive review process was initiated to devise an innovative and pragmatic model of recognition. Development comprised multiple phases, including qualitative surveys, workshops, focus groups, and expert consultations. An iterative approach was adopted to refine the model, culminating in a prospective, merit-based system that recognises specialty areas and levels of practice. The focus shifted from individual competencies to broader domains within the National Competency Standards Framework for Pharmacists in Australia 2016, fostering flexibility and practicality.

What has been achieved?

ANZCAP has already recognised pharmacists at all levels – Resident, Registrar, and Consultant – through a Prior Professional Experience process. The college also extends its reach globally, welcoming international pharmacists to join its transformative community.

What next?

ANZCAP’s future involves strengthening the alignment of recognition with promotion and remuneration mechanisms, enhancing engagement among pharmacists. By seamlessly integrating learning experiences with Continuing Professional Development (CPD) activities, ANZCAP aims to foster a culture of lifelong learning and advancement. In the broader landscape, ANZCAP’s journey involves cultivating partnerships with international pharmacy associations, leveraging collective expertise, and fostering an inclusive recognition culture. The programme’s evolution will be guided by feedback, research, and a commitment to advancing pharmacy practice globally.

Setting in situation of pharmaceutical validation of paediatric intensive care prescriptions by fifth year students: state of play and assessment

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European Statement

Education and Research

Author(s)

Omar HANAFIA, Pierre BERTAULT-PERES, Stéphane HONORE

Why was it done?

This internship was proposed to diversify the clinical pharmacy internship opportunities and to allow students to discover and understand paediatrics and intensive care, which are less covered in university courses. It will also be a proof of concept to develop this type of internship in other departments.

What was done?

We have proposed a new clinical pharmacy internship in immersion in paediatric intensive care to 5th year students. It is a hospital internship at the interface between the medical and pharmaceutical teams, the student is responsible for establishing a statement to analyse the drug management, its evaluation and improvement.

How was it done?

The clinical pharmacy student is a full-time employee, fully integrated into the medical team. Their day is divided into two parts: in the morning they attend the relief, the staff and the medical visit. In the afternoon, he/she takes over the patients, compiles the main medical, clinical and biological information in order to pharmaceutically prevalidate the medical prescriptions and propose pharmaceutical interventions (PI) to the pharmacist.

What has been achieved?

Since its opening, the position has been systematically chosen by the students, in 3 years 8 students have chosen it. After a training period of 1 month with the senior pharmacist, all students were able to perform the expected readings, prevalidation and PI. More than 78% of the PIs detected by the students were validated by the senior pharmacist and accepted by the physician.

What next?

This proof of concept shows that students are supportive of this type of initiative and are able to meet the high expectations of this internship.