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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.

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.

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.

Extensive renal pharmacotherapy course for hospital pharmacists

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European Statement

Clinical Pharmacy Services

Why was it done?

Kidney disease carries a significant worldwide health burden. In more the incidence of stage III chronic kidney disease in more than 9%. Many hospitals in Oman have special units of nephrology but clinical pharmacy services for these patients are almost none. It was important to upskill practicing pharmacists’ knowledge and skills to provide comprehensive pharmaceutical care for patients with renal diseases.

What was done?

An online 8-week course was developed by an experienced and certified renal clinical pharmacist with an aim of enhancing the knowledge and skills of pharmacists practising in primary, secondary and tertiary care hospitals in Oman. The course covered all the topics required to develop the skills of the pharmacists to enable them to deal with renal prescriptions and be able to intervene in any medication related problem in patients with kidney diseases. Before and after knowledge assessment was done for the participants to enable justify the benefits of the Course. Towards the end of the course a satisfaction survey was also completed by the participants to provide ensure achieving desired outcomes.

How was it done?

The course was hybrid and the beginning with some sessions carried out face-to-face and some online.
The course included topics such as acute kidney injury, chronic kidney disease, drug induced kidney diseases, medication management in renal replacement therapy and kidney disease complications. The course was interactive with case study discussions, question and answer sessions and some assignments done by the participants at home. The course was designed based on Kirkpatrick foundational principles with consideration of the four levels of learning.

What has been achieved?

Twenty pharmacists participated in the first cohort and 23 in the second cohort. The attendance was more than 90% throughout the course. The pharmacists were keen to learn and ask questions. There was a clear difference in knowledge before and after the course with only 19% of participants passing the pre-course assessment compared to more than 80% of participants passing the post-course assessment.

What next?

The course was highly appreciated by the participants and would run the course and regular intervals with considerations to applications from the Gulf region since they share similar practice and disease burden.

Formation and empowerment for pharmaceutical interview focused on opioids in acute non-cancerous pain

European Statement

Clinical Pharmacy Services

Author(s)

Esteban CHAUMET, Johanna RAYMOND, Eric BARAT, Catherine CHENAILLER, Rémi VARIN

Why was it done?

A clinical study, including a PI focused on the management of acute non-cancerous pain with opioids, was implemented in post-emergency units of our teaching hospital. Formation and empowerment procedures for PIs are little or not described in the literature. Given the multiplicity of actors, which could perform those PIs, it appeared necessary to standardize our practices and key messages delivered to the patient.

What was done?

Create an adapted formation allowing standardization of practices between various actors performing a pharmaceutical interview (PI) focused on the management of acute non-cancerous pain with opioids.

How was it done?

Creation of different tools : a resource pack with opioids literature to train learners; a theoretical and practical formation schedule and an empowerment procedure, supervised by a qualified tutor; an interview frame with topics to be addressed during the PI; two audio simulations of patient interviews; complex questions that the patient might ask during the PI.

What has been achieved?

The resource pack contains 11 documents that provide the learner with relevant concepts and the key messages to deliver to patients. The formation schedule consists of several stages. Firstly, theoretical formation : learning with the resource pack; written restitution of knowledge on the interview frame and identification of the points to be improved with the tutor; completion of the e-learning on performing a PI (currently being created by the French Society of Clinical Pharmacy); listening to the two audio simulations and oral restitution of information to the tutor; restitution by the learner, during a reversed class, of knowledge on opioids and key messages for the patient; answering complex questions. The practical formation consists of observing the tutor during a PI, then performing PIs with a qualified tutor.

What next?

The formation and empowerment will be implemented in November 2021. As part of a quality approach, learner’s satisfaction and general appreciation will be collected in order to optimise the formation. The creation of this procedure will guarantee a uniform, complete and modern formation based on a quality system thus minimising the biases induced by the multiplicity of actors performing the PIs. In the future, this formation schedule and empowerment could be adapted to other PI topics.

FOLLOW-UP OF OFF-LABEL TOCILIZUMAB PRESCRIPTIONS IN COVID-19 IN A FRENCH UNIVERSITY HOSPITAL

European Statement

Education and Research

Author(s)

Caroline TRAN VAN HO, Marie-Anne ESTEVE, Pierre BERTAULT-PERES, Marjorie ROUDOT

Why was it done?

SARS-CoV-2 infection leads to pro-inflammatory molecules production (in particular IL-6). If the immune system is overwhelmed and cytokine production spikes, a hyper-inflammatory phenomenon occurs: the cytokinic storm, which can bring lead to the admission in an intensive care unit. Due to the absence of authorized treatment, several clinical trials (CTs) and off-label use of drugs have been set up.

What was done?

The aim of this study is to analyse the off-label use of tocilizumab in a French university hospital in comparison with different CTs.

How was it done?

A retrospective study of tocilizumab prescriptions in Covid-19 was conducted between 01/03/2020 and 30/04/2021 by extracting data from Computerised Physician Order Entry and Pharmacy Management software (Pharma®). History of patients was recovered by electronic medical records (Axigate®).
Results were compared to (1) RECOVERY Collaborative Group. Lancet. 2021, (2) Hermine O. JAMA. 2021, (3) Rosas IO. N Engl J Med. 2021, (4) Salama C. N Engl J Med. 2021.

What has been achieved?

Between 01/03/2020 and 30/04/2021, 68 patients received tocilizumab.
Seventy-seven percent of patients were in the intensive care unit and 42.6% died, whereas 31.0%, 19.7%, 11.1% and 10.4% died according to (1), (3), (2) and (4), respectively. Mechanical or invasive ventilation at the time of tocilizumab prescription was widely used (84%) compared to CTs (54.0%, 27.9%, 24.0%, 12.2% for (1), (3), (2), (4)). According to (1), there is a synergistic action between tocilizumab and dexamethasone. Eighty-four percent of patients received at least one dose of corticosteroids in agreement with (1) and (4).

What next?

The increase in off-label use of tocilizumab is related to the results of CTs. Because of the low number of patients, the differences in COVID-19 stages at tocilizumab initiation, and the absence of a control group, it is difficult to explain our data. Given the weak iatrogenic effects revealed in CTs and in-label use, the benefit/risk seems in favor of tocilizumab use against COVID-19. Further studies are needed to confirm the first hopes. Since Casirivimab / imdevimab, and amlanivimab / etesevimab have been granted early access in France, the therapeutic strategy will be updated.

Entrustable Professional Activity in Medical Reconciliation as an assessment tool to measure competency of pharmacy pre-registration students

European Statement

Education and Research

Author(s)

Ula Bozic, Matthias Witti , Jan Zottmann , Martin Rudolf Fischer, Yvonne Marina Pudritz

Why was it done?

Among other functions of EPAs (description of activities as a guide for students, function as a curriculum guideline), they can be used as assessment tools – in our case, to identify gaps in students’ knowledge/skills and, depending on the results, to aid guiding curricula development of our educational program to ensure high quality training service.

What was done?

Entrustable professional activities (EPAs) are observable clinical activities consisting of knowledge, skills and attitudes that can be entrusted to learners over time. In German pharmacy education, EPAs have not yet been developed or used. For this project, we developed a Medical Reconciliation EPA for pharmacy pre-registration students taking part in a rotational programme at LMU University Hospital Munich. Four steps were required for the development: (1) Development of content for EPA description and the associated checklist by a working group of clinical pharmacists through literature review and work analysis. (2) Validation of the developed EPA and checklist by an independent expert group of clinical pharmacists from across Germany. (3) Application of the EPA and checklist in an assessment situation to check for inter-rater reliability. (4) Roll-out of EPA and checklist for assessment of pharmacy pre-reg students at LMU.

How was it done?

Since EPAs are a new concept in (German) pharmacy education, their concept as well as their assessment process with entrustment decisions required explanation in detail to facilitators and students alike in several workshops, which we have successfully organised and executed.

What has been achieved?

Through the implementation of this EPA, we can assess students’ competencies in performing medication reconciliation, identify the weaknesses of our training programme and adapt the content to improve students` skills in their performance.

What next?

Further EPAs with a focus on hospital discharge and medication analysis are being developed. With EPAs, it is possible to translate theoretical competencies into observable activities that can be assessed in a clinical setting. As pharmacists in Germany are increasingly involved in clinical practice, there is a need to assess their skills in performing day-to-day clinical tasks. EPAs are an excellent tool for this purpose.

Patient education after Arthroplasty: what about the implants?

European Statement

Education and Research

Author(s)

Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer

Why was it done?

The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.

What was done?

In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.

How was it done?

First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.

What has been achieved?

The results show significant impact of this education session on all items especially those regarding the implants and medicines.

What next?

Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.

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