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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.

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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.

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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.

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Author(s)

Marie Coenen, Stefanie Goris, Thomas De Rijdt, Isabel Spriet

Why was it done?

These changes were necessitated by the increasing number of (complex) clinical trials conducted at UHL. This Belgian 1995-bed, tertiary care hospital constitutes an attractive setting for clinical trials and a coveted partner for sponsors, due to its specialisation in a wide range of medical fields to treat complex pathologies. Adopting the changing research field whilst ensuring the highest regulatory compliance was challenging.

What was done?

Since 3 years, the clinical trial team of the University Hospitals Leuven (UHL) pharmacy has gone through several metamorphoses. These were realised by introducing an activity based costing (ABC) model enabling financing of staff expansion, extension of the infrastructure, and extensive digitalisation.

How was it done?

In 2016, an ABC-analysis was conducted by the Belgian Association of Hospital Pharmacists to determine the cost of various pharmacy activities within a clinical trial. In 2019, the outcome of the analysis was revised to concur the fast-growing clinical research field.
To affirm the need to apply these updated prices, a retrospective evaluation was performed in 2020 documenting the number of clinical trial protocols, pharmacy staffing and applied prices over the past 4 years.

What has been achieved?

Rapid growth of pharmacy research activities was shown by an increase in the total number of active clinical trial protocols from 964 in 2017 to 1256 in 2020. Until then, quantitative expansion was not followed by qualitative growth since staffing remained steady at 13 full-time equivalents (FTE) and the applied costs were outdated and not cost-effective. To enable this transition, an up-to-date pharmacy budget table was developed based on the latest ABC-analysis and, along with an estimate of future income, approved by the hospital board in 2020. This allowed the pharmacy research staff to be reinforced to 19 FTE and the infrastructure to be extended to integrate extra storage capacity and research dedicated clean rooms. Starting from 2021, the budget table was implemented into practice using computerised support enabling automated billing.

What next?

Future directions include further digitalisation by automating accountability and compounding and focusing on qualitative growth by advancing the role of clinical trial pharmacists into a specialised member of the hospital research development team and of the clinical pharmacy team.

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Author(s)

Matts Balgard, Jeanette Andersson, Per Nydert, Niral Patel, Anna Skrinning, Matilda Soderberg, Simon Tekmen, Celina Sving

Why was it done?

A growing number of pharmacists in Sweden are working in a clinical setting. They often have different responsibilities and tasks, which may seem confusing to other healthcare professionals. There is an interprofessional need to describe different roles for hospital pharmacists. Equally important, there is an intraprofessional need to establish core competencies and progression of those roles and develop a professional framework to advance career structure for hospital pharmacists.

What was done?

Two associations for health system pharmacists in Sweden took the initiative to collaboratively develop a national professional competency framework for clinical pharmacy practice.

How was it done?

A working group of experienced clinical pharmacists was tasked with drafting a first role description and professional framework for clinical pharmacy practice.
The development of the role description was influenced by, and drew upon, previous similar efforts in Sweden – primarily Stockholm, the UK Advanced Pharmacy Framework (APF) and the EAHP Competency Framework for Hospital Pharmacy. A reference group of approximately 40 Swedish clinical pharmacist volunteers provided feedback on the first draft, which improved the revised final role description.

What has been achieved?

The national role description for clinical pharmacy consists of an overview of the role, an outline of formal educational requirements and a competency framework strongly influenced by the APF. The framework has six competency clusters: clinical pharmacy practice, working relationships and communication, leadership and motivation, service development, education and training, research and evaluation and lists four stages of experience: junior, intermediate, senior and consultant.
The role description was launched in April 2022 with an open invitation to practitioners, employers and local union clubs to begin to adopt and try out the professional competency framework. It is too early to evaluate impact, but the initiative has been met with support from employers and the clinical pharmacy community.

What next?

The organisations will further promote and support implementation of the published role description. A revision is planned in 2023–2024 based on real-world feedback. New working groups are being formed to develop similar role descriptions for drug preparation and drug distribution. There is still a need to develop a system of credentialing progression between the experience stages of the professional framework.

Author(s)

Mathieu Fournel, Herve Trout , Jean Eudes Fontan , Marie Cabagnols

Why was it done?

At night, our Pharmacy residents are alone to lead the patient interview, which can be stressful and complex. They currently receive a theoretical course as training, which is insufficient and lead us to reinforce their training by organizing this simulation program.

What was done?

In our hospital, treatments for accidental exposition to blood or other body fluids (AEB) are prescribed by the emergency unit doctors and are delivered by our pharmacy residents who also give associated advices. In order to improve the quality of this procedure and train our pharmacy residents, we created and tested simulation case-scenarios of pharmaceutical interview of AEB’s victims with role-playing game.

How was it done?

We based our training program on the French Health Authority guidelines. Scenarios are based on our real-life experiences and potential clinically relevant situations.

What has been achieved?

First, we evaluated pharmacy residents’ theoretical knowledge and their self-confidence about AEB interview with anonymous questionnaires.
We created five different scenarios and tested them during six role-playing game sessions in two weeks with six pharmacy residents.
Every session lasted approximatively one hour, each resident played one scenario as a resident and one as a patient. Sessions started with briefing and ended with a detailed debriefing. All our scenarios are efficient, and debriefings were interactive and interesting. Evaluation of the sessions by pharmacy residents showed great satisfaction. They evaluated our scenarios as relevant and rated simulation training higher than lecture-based courses. Moreover, informal feedbacks are very positive.

What next?

Our next step is to film a simulated pharmaceutical interview of AEB’s patient for new pharmacy resident as an example before their first interview. Simulation will be part of the training of every new pharmacy resident in our hospital. Furthermore, we would like to extend simulation training to other types of patient’s pharmaceutical interviews.

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.

Author(s)

Trine R. H. Andersen, Trine Graabæk, Ulla Hedegaard, Lene J. Kjeldsen, Charlotte Olesen, Hanne T. Plet, Anne B. Walls, The Danish Hospital Pharmacy Research Network (DanHoPR Network) On behalf of

Why was it done?

A decade ago, collaboration between Danish hospital pharmacies regarding knowledge sharing, information, procurement and development of services already existed. However, research activities were scarce, and peer reviewed publications were rare. While the Danish universities didn’t have hospital pharmacy as a research area, the research unit called SAFE had been formed under The Danish regions’ joint procurement and tendering organization, to encourage hospital pharmacies to increase research activities. Meanwhile, a handful of hospital pharmacists scattered throughout Denmark had been initiating PhD-projects, but with no formal cooperation or awareness of each other.

What was done?

A national network for researchers in hospital pharmacy was established 10 years ago to strengthen the research activities within hospital pharmacies in Denmark.

How was it done?

The network was established at a meeting in October 2011 gathering the five PhD-fellows, SAFE and potential researchers. The overall aim was to strengthen hospital pharmacy research in Denmark. The terms of reference included creating a forum where established as well as upcoming researchers can meet twice a year to share knowledge and provide feedback on each other’s research. To further strengthen the network and research, funding was raised for a fieldtrip to UK hospital pharmacy research groups. After this, the network decided to promote a more international profile. A LinkedIn site was established along with the design of a logo, an English translation, name and acronym (DanHoPR Network).

What has been achieved?

The DanHoPR Network now celebrates its 10th anniversary and counts more than 30 members from all Danish hospital pharmacies and from universities.
The amount of published research from Danish hospital pharmacies has increased considerably during the 10 years. In total, network members have first authored more than 35 articles, co-authored more than 70 publications, co-supervised more than 80 master theses and PhD-fellows have multiplied over the decade.
The DanHoPR network gather 2-3 times/year in full-day virtual or IRL meetings to collaborate on research, share ideas and discuss subjects such as methodology, interpretation of results, funding, challenges or celebrations.

What next?

The network seeks to collaborate internationally and hopes to inspire to similar networks across Europe or connect to exiting fellow networks.

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.

Author(s)

Dearbhla Murphy, Patricia Ging, Jennifer Brown

Why was it done?

The Pharmacy Department at our institution are responsible for the delivery of a number of in-house and University level education sessions to pharmacy, nursing and medical students. In 2020, sessions included: a prescribing workshop for final year undergraduate medical students; nursing induction lectures on parenteral drug therapy; leadership workshops, lectures and site visits for pharmacy students; clinical pharmacist education sessions; and weekly journal club for Pharmacy Department staff. During the COVID19 pandemic, Pharmacy delivered education sessions were challenged with addressing the hospital-wide recommendation that face to face meetings be avoided while maintaining essential training for healthcare staff.

What was done?

Pharmacist led education sessions, both at an in-house and University level, were adapted to virtual platforms during the COVID19 pandemic.

How was it done?

• A pharmacy team of key stakeholders were formed for each education session.
• Educational material was reviewed and revised for suitability for a virtual platform.
• Interactive learning components were explored on the various delivery platforms e.g. Brightspace®, Zoom® and Microsoft Teams®.
• For the pharmacy student virtual site visit, Pharmacy staff prepared short videos about their roles.
• Interactive tools from within and outside the delivery platforms were used e.g. breakout rooms, MCQs, ‘chat’ tools, live quizzes and Menti®.
• Feedback on individual education sessions was sought via email or use of online surveys

What has been achieved?

• All education sessions were successfully delivered virtually.
• Positive feedback was received for all sessions.
• Unexpected benefits gained from virtual delivery, include the availability of recordings which can be used to repeat the session for future students.
• Limitations learned include difficulty retrieving student feedback online.

What next?

The Pharmacy Department successfully adapted the delivery of education sessions, at University and hospital levels, during the COVID19 pandemic to ensure continued delivery of high level education, learning and engagement. The initiatives and learnings from this GPI are transferable to other hospital pharmacy departments.