Author(s)

Paola Minghetti, Giuseppe Danilo Norata, Francesca Selmin, Paolo Rocco, Vito Ladisa, Margherita Galassi

Why was it done?

The availability of mAbs to treat different pathologies is steadily growing, causing a steep increase in the level of training needed in different areas of pharmacists’ intervention, including compounding, handling and storage. As this process will be sustained by the increasing availability of biosimilars, pharmacists, the key health professionals responsible for their compounding and handling, will face new challenges.
The aim of this project is to overcome the common problems encountered by hospital pharmacists in obtaining education on biosimilars, included limited financial support, heavy workload or inadequate educational resources.

What was done?

A self-paced educational course has been designed and implemented with the aim of providing a fundamental grounding in the physical chemistry, pharmacology and technology of monoclonal antibodies (mAbs)-based medicines in oncology, both originators and biosimilars and the methodology associated with their compounding and handling.
The primary target audience for this project consists of hospital pharmacists in the EU, though students in the specialization in Hospital Pharmacy and community pharmacists may benefit from the course.

How was it done?

The course has been designed and developed to address, previously assessed, unmet educational needs. The resulting format comprises both theoretical and remote real-world training on the pharmacology, technology and stability of mAbs, the technology and rationale of biosimilars and the regulatory aspects of biotechnological medicinal products.

What has been achieved?

A series of webinars in on demand movie format has been produced. The webinars contain a comprehensive theoretical section – covering biosimilar mAbs pharmacology and formulative and regulatory aspects – and a practice section in which the preparation steps of oncology mAbs are filmed and discussed in a hospital setting. All training activities have been recorded in remote both in Italian and in English. Every module is designed to be used as a single unit and has a duration of approximately 30 minutes. The total duration of the course is 8 hours.

What next?

The course will be CME accredited in Italy through Fondazione Francesco Cannavò, nonprofit CME provider of the Federation of Italian Pharmacists Associations. It will be made available to pharmacists through national and international CME platforms, providing fundamental grounding in the methodology associated with oncology monoclonal antibody biosimilar formulation.

Author(s)

Vincent ARCANI, Stéphane HONORÉ, Guillaume HACHE

Why was it done?

Interprofessional collaboration as an effective means for improving healthcare outcomes. In order to achieve an effective level of collaborative healthcare practice, health care educators must focus attention on interprofessional education in undergraduate programs. Knowledge of professional role of others is a key competency for interprofessional practices and there is a lack of knowledge on hospital pharmacists’ roles among other health care professionals.

What was done?

We developed a workshop focused on the role of hospital pharmacists, to be integrated into the curricula of other health professionals.

How was it done?

The workshop was developed by a resident in hospital pharmacy and a senior hospital pharmacist, and we first targeted medical curriculum. The session integrated: students’ perception of hospital pharmacists’ role, didactic learning on the role of hospital pharmacists according to the European statements in hospital pharmacy, immersion in practice and evaluation. The assessment of the learning effect was performed by a pre-/post-workshop questionnaire, assessing satisfaction, metacognition and acquired knowledge. In addition, students provided open feedback on the workshop.

What has been achieved?

We implemented the workshop during the first year of clinical clerkship in medical education. Preliminary results highlighted (i) a high satisfaction, illustrating the relevance of the initiative; (ii) an increase in perceived knowledge and (iii) an increase in knowledge about hospital pharmacists’ roles, especially about pharmaceutical technologies and medical devices. Verbatim analysis of the feedback suggested that the workshop modified medical students’ perceptions on the role of hospital pharmacists, and that they may be more inclined to seek collaboration with hospital pharmacists.

What next?

To integrate the workshop into the curricula of the other professions in order to raise awareness on hospital pharmacy and promote interprofessional teamwork.

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.

Author(s)

Trudi Hilton

Why was it done?

The Partnership for Research on Ebola VACcination (PREVAC) established a randomised, double-blind, placebo-controlled, phase 2 study evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Pharmacists from all PREVAC participating country teams were introduced at collaborative calls where the study protocol was presented.

What was done?

UK Hospital Pharmacists with clinical trials experience worked with London School of Hygiene and Tropical Medicines (LSHTM) research teams in Sierra Leone and pharmacists from there, France, Guinea, US and Liberia to establish the Standard Operating Procedures and protocols required to compare two novel vaccines for Ebola Virus Disease (EVD).

How was it done?

The trial pharmacy teams met virtually each month to discuss the development of Standard Operating Procedures to store and prepare the vaccines. We started by ensuring an appropriate space within the research site was identified for the pharmacy. We advised on the equipment required for aseptic preparation, temperature monitoring and controlled storage of Investigational Medicinal Products (IMP). Solar fridges were identified for IMP storage at 2-8 deg C and ambient 15-25 deg C products, with freezers being run on generators. We developed protocols and documents for temperature monitoring and back-up plans for the failure of cooling devices. I set up trial dispensing procedures to enable preparation of the vaccine for ‘blind’ administration. The local pharmacy team advised on the equipment required to work aseptically. Sourcing specialist equipment, much of which is not available locally, takes considerable time so this work was undertaken several months before participant recruitment began, ensuring that it could be calibrated and validated before receipt of IMP.

What has been achieved?

Pharmacists from France and the UK have worked with local colleagues to develop best practice for clinical trials in resource-limited, tropical settings. This learning is invaluable for the future development of vaccines.
https://www.semanticscholar.org/paper/Partnership-for-Research-on-Ebola-VACcination-of-a-Badio-Lhomme/e70c6224c89e28481ea278ca43ee51d163645fea

What next?

Clinical trials must be carried out in the context in which the investigational medicinal product is intended for use, at standards required to achieve EMEA and FDA authorisations. EU hospital clinical trials pharmacists working with university research teams can support their pharmacy colleagues in these settings to ensure optimisation of IMP storage, handling and preparation with accurate record keeping..

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Author(s)

Elodie Delavoipière, Marianne Pavard, Anne-Laure Richard, Julien Montreuil, Albane Cherel, Céline Bouglé

Why was it done?

Every year in our country, 10,000 preventable deaths and more than 130,000 preventable hospitalizations are related to drug misuse. This issue is a priority of the national health strategy. Therefore, we developed a CPD training program on the issues and methods of managing the risk of ME.

What was done?

A regional multi-disciplinary Continuing Professional Development (CPD) program was developed, dealing with the risk management of medication errors (ME).

How was it done?

This program was submitted to the National CPD Agency and accepted as a continuing education measure, corresponding to the national orientation: “control of risks associated with healthcare acts and pathways”. The program and the training materials were developed by a 13-member regional working group, including hospital pharmacists and quality managers, the drug observatory and the regional health quality network.

What has been achieved?

The training is intended for any health professional involved in the medication circuit in a health or medico-social institution: physicians, pharmacists, residents, nurses, pharmacy technicians… The first part is an e-learning slide presentation with voice commentary, on the theoretical aspects of ME and on the principles of a priori and a posteriori risk management. Concrete examples of ME are integrated throughout the slide presentation. This e-learning is divided into 4 parts and is accessible for 1 month. It must be validated by the learner before participating in the second part of the training: a face-to-face simulation session with 15 learners and 2 hospital trainers (pharmacist and health quality professional). During half a day, the learners apply a posteriori risk management by analysing a fictional adverse event (ME). The case addresses several themes: never events, drug reconciliation, city-hospital link, lack of communication, human factors. Questionnaires completed before, during and after the training allow for the evaluation of learners’ satisfaction as well as the impact of the training on their knowledge and skills.

What next?

This regional training will promote the link between actors from different institutions and the multi-disciplinary approach around the management of the risks of ME. In addition, we provide an awareness kit on ME reporting, including a customizable slide show and a quiz, which allows short sessions to be conducted in any health facility.

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Author(s)

Daniele Mengato, Federica Milani, Laura Agnoletto, Nicoletta Freddi, Roberta Rampazzo, Vera Damuzzo, Nicola Realdon

Why was it done?

Recently, the national monitoring of Hospital Pharmacy Students (SHP) highlighted a lack of education in clinical research and in designing of independent studies among students. To fill this gap, we established a collaboration between Scientific Associations and Student Organisations.

What was done?

In 2017 the Italian Society for Clinical Pharmacy and Therapeutics (SIFaCT) and the National Association of Hospital Pharmacy Students (ReNaSFO) established a join action to improve students’ research competencies. To this end, we designed the QOSMOS study: “Quality Of life (QoL) in Multiple Sclerosis (MS): a Multicentre Observational Study”.

How was it done?

The study has both educational and scientific objectives. Scientific objectives were to update data on QoL in MS and to correlate QoL to drug therapy. Regarding the educational challenge, every SHP participant received, by a panel of expert colleagues, the methodologic basis on observational studies and how to arrange teamwork activities. SHP could participate either as co-investigators or as members of teams which managed ethical approval, case report form (CRF), study monitor and data analysis. Investigators enrolled patients, collected clinical data and administrated a CRF, consisting of a questionnaire on QoL (MSQoL54).

What has been achieved?

22 SHP from 16 Italian centres, equally distributed from Southern to Northern Italy, joined the project. 20 SHP participated as co-investigators, one was included in the Scientific Committee of the study and 1 participated in the team dedicated to the Ethical Committee. We enrolled 341 patients with relapsing/remitting MS from May 2018 to June 2019 (median=20 per centre). The study achieved primary and secondary endpoints and pointed out a significant decrease in QoL related to physical health in patients treated with teriflunomide compared to other oral drugs (p=0.002).

What next?

Results will be presented in a scientific paper for submission to a peer-reviewed journal. This final aspect of the project has an educational goal once again, namely to bring young colleagues closer to writing and disseminating science. As QOSMOS gained good results, a new study investigating the role of clinical pharmacist in the Infectious Disease Department is starting with the goal to investigate optimisation strategies for treatment of HIV-positive patients.

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Author(s)

Matts Balgård, Maria Swartling, Srebrenka Dobrić, Lena Klarén, Lina Karlsson

Why was it done?

ITWP for healthcare students is established at various teaching hospitals. However, to our knowledge, no such programme in Scandinavia has included pharmacy students. Clinical pharmacy is a growing profession in Sweden and other healthcare students will in the future work alongside clinical pharmacists. Therefore we set out to add pharmacy students to the ITWP team, believing that it would be a valuable experience for them to collaborate and share knowledge with students from other healthcare professions. Equally important, it is a way to promote the pharmacist’s competence and contribution to the multiprofessional healthcare team, prior to graduation.

What was done?

Final year undergraduate pharmacy students, specialising clinical pharmacy, were given the opportunity to spend two weeks of their six months pharmacy practice to participate in an interprofessional training ward placement (ITWP) together with medical, nursing and physiotherapy students. During this two-week clinical placement, the students were collaboratively responsible for managing the care of geriatric inpatients while under supervision of licensed practitioners.

How was it done?

A working group was formed consisting of teachers from the faculty of pharmacy, a student representative and a working clinical pharmacist. The group developed the initiative, including among other things, prerequisites, an evaluation plan, a workflow tool for clinical rounds, and suggested tasks for pharmacy students during the placement.

What has been achieved?

The programme has been running for three semesters and 6–8 pharmacy students have participated in the ITWP each semester. The initiative has been evaluated using surveys. Participating pharmacy students expressed gaining new knowledge and better insight into nursing care and the roles of the other professions. Nursing students appreciated the support in medication management and medical students found the pharmacy students to be valuable discussion partners that could challenge their drug-related decisions. Tutors expressed that the pharmacy students brought a beneficial dynamic to the ITWP team.

What next?

The opportunity for students from different professions to work together with a common objective in a real-life setting gives them valuable insight into each other’s professional roles early in their careers. This good practice initiative could be used in other interprofessional training ward placements wishing to involve pharmacy students.

Author(s)

Agnes Ann Feemster, Nicoletta Zallocco, Carlo Polidori

Why was it done?

Development of pharmacy education on a global scale is an international initiative. Additionally, employers recognise that global experiences positively impact a variety of applicant qualities, including curiosity, willingness to take risks, a non- judgmental attitude, and a broader worldview. The goal of this collaboration is to expose students to the medication distribution system and role of the pharmacist in an international practice setting with an aim of developing a more well-rounded, culturally aware pharmacist.

What was done?

A partnership between the University of Camerino (UNICAM), Camerino, Italy and the University of Maryland School of Pharmacy (UMSOP), Baltimore, Maryland, USA was formed. Under the agreement, the two universities exchange student pharmacists for five-week internships in hospital pharmacy.

How was it done?

A memorandum of understanding was implemented between the two universities in May 2018 with the first UMSOP student visiting in September 2018. A professor from each university co-coordinates the internship. UMSOP students self-fund travel while UNICAM students self-fund and seek university support; funding is a barrier to pursuing the experience. Housing logistics for the students is also challenging. UMSOP students receive academic credit for the experience, requiring that the Italian site meet the advanced practice experience objectives.

What has been achieved?

The programme intended to exchange one-two students annually. After the inaugural student, eight UMSOP students pursued the UNICAM internship, resulting in six student placements at three Italian hospitals. One UNICAM student pursued a cardiology experience at an academic medical centre in Baltimore. UMSOP students perform a preceptor and site evaluation after the internship. 100% of students completed the evaluation with an overall evaluation score of strongly agree that the preceptor and site provided a positive experience. A structured interview with the UNICAM student indicated a greater understanding of clinical pharmacy practice and the role of a pharmacist on an interdisciplinary team, which may be used to further develop hospital pharmacy services in Italy.

What next?

This international exchange demonstrated a high degree of satisfaction among participants. While currently limited to students, this initiative should be considered for practising pharmacists. Sharing of best practices and the interchange of ideas may generate practice enhancements, lead to innovations, and stimulate personal growth.

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Author(s)

ANTONIO PIRRONE, FEDERICA MILANI, LUCA CANCANELLI, VALENTINA MARINI , DANIELE MENGATO , ROBERTO LANGELLA , NICOLA REALDON

Why was it done?

On October 5, 2017 the National Network of Italian Hospital Pharmacy School Students (ReNaSFO) was born with the aim to face the various critical aspects of post-graduate Hospital Pharmacy School (SHP), such as the need to make the different paths homogenous among regional SHPs, improve dialogue between colleagues and encourage a more informed approach focused to the training pathway for specialisation. In particular, little official information is available and hard to find about the different realities present in Italy.

What was done?

“Compendium” project is designed to fill this lack and to gather information on post-graduate SHPs operating in Italy. In addition to outlining a summary description of the SHPs, the Compendium is configured as an official tool to respond and provide targeted information to near-graduates and graduates in Pharmacy (who often contact ReNaSFO) interested to approach the SHPs path.

How was it done?

Two project coordinators prepared a list of items submitted to representative ReNaSFO student in every 21 operating SHPs. The items refer to: available places and admission requirements, type of entry test, organisation of didactic lessons, exams and residency training, health facilities affiliated with SHP, potential availability of scholarships, useful links of the SHP or university. The help of universities was fundamental, in particular the helpfulness of SHP directors to collaborate with students.

What has been achieved?

As many as 18 SHPs out of 21 (85.71%) have joined the project: Bari, Bologna, Catania, Catanzaro, Camerino, Genoa, Florence, Milan, Modena and Reggio Emilia, Messina, Naples, Padua, Parma, Pisa, Rome, Siena, Turin and Sassari; of these, 14 schools have already sent their finished “Compendium” form.

What next?

Thanks to the widespread presence of associated ReNaSFO students, the initiative has immediately found interest and participation, reconfirming once again the active and unconditional collaboration between SHP students throughout Italy. Despite a heterogeneous situation between different SHPs, we keep working together hopeful to achieve national uniformity of SHPs and to improve educational objectives and training pathways.

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Author(s)

A Schils, S Pochet, B Allenet

Why was it done?

The aim of this study was to test the ‘self-efficacy’ concept in order to assess the impact of the session on self-management, once the patient finishes the workshop. The evaluation took place from 1 March 2018 to 31 May 2018.

What was done?

The Grenoble University Hospital Centre has set up a therapeutic education programme in the after-care and cardiac rehabilitation department. Indeed, different educational workshops are offered to the patients on various subjects such as disease, treatment and prevention. The workshop ‘medication’ run by the pharmacist addresses the concept of benefit-risk balance, self-medication, drug mechanisms of action and daily medication. Each group integrates 10 to 15 patients, once a week.

How was it done?

Before and after each workshop, a questionnaire evaluating self-efficacy was filled out by each patient, on 10 modalities likert scales: I felt capable of…:
1. Explaining why I am hospitalised.
2 Explaining to my friends and family what my different medications work on.
3 Taking my medication as prescribed.
4 Manipulating each of my medications (reading instructions, opening bottles, breaking blisters…).
5 Explaining to my friends and family the hazards of self-medication.
6 Discussing freely with my physician all of my problems.

What has been achieved?

Fifty-two patients answered the questionnaire. Statistically significant difference before and after the workshop were observed for questions 2, 5 and 6 using a Student’s t-test. Individual results helped us target patients with specific difficulties, who were seen afterwards, during an individual consultation.

What next?

Self-efficacy assessment can be used as a ‘normative’ way of testing an educational sequence (what works and what doesn’t work?) and also as a ‘clinical pharmacy follow-up tool’, selecting patients experiencing specific difficulties with their treatment.