Design and implementation of a course on “Improving the understanding of biosimilar formulation science through Real-World Training”
European Statement
Education and Research
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.
Implementation of a workshop about the role of the hospital pharmacist role during the clinical clerkship in medical training
European Statement
Education and Research
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.
MANAGING THE RISK OF MEDICATION ERRORS: A MULTI-DISCIPLINARY CONTINUING PROFESSIONAL DEVELOPMENT PROGRAMME
Pdf
European Statement
Education and Research
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.
DEVELOPMENT OF AN INTERNATIONAL EXCHANGE PROGRAMME IN HOSPITAL PHARMACY PRACTICE (submitted in 2019)
European Statement
Education and Research
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.
EVALUATION OF THE IMPACT OF PATIENT EDUCATION WORKSHOP ON CARDIOVASCULAR PATIENTS USING THE SELF-EFFICACY CONCEPT
Pdf
European Statement
Education and Research
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.
PHARMACISTS ROLE IN THE DEVELOPMENT OF A THERAPEUTIC PATIENT EDUCATION (TPE) PROGRAM BASED ON THE DIRECT ACTING ANTIVIRALS (DAA) USED IN CHRONIC HEPATITIS C TREATMENT.
Pdf
European Statement
Clinical Pharmacy Services
Why was it done?
It is now usual to dispense hepatitis C DAA to outpatients, whose virological success rate is high in the general population. However, subpopulations are at risk of re-infection or noncompliance for which an individualized approach with TPE is required. Role of the pharmacist is to transmit skills for starting and to assist the patient during treatment. SE are sometimes more easily disclosed to pharmacist, thereby allowing to take them into account so that the treatment can be adapted until completion. TPE benefits for these subpopulations are expected in the short term with regards to compliance and empowering the patient during treatment and in the long term to eliminate risky practices and leaving additions.
What was done?
setting up and running TPE sessions for hepatitis C by pharmacists
How was it done?
Hepatology department, based on multidisciplinary team (hepatologist physicians, psychiatrists, addiction specialists, pharmacists, nurses and psychologists), developed a TPE program on viral hepatitis in april 2016. Following written consent, entry into the program was systematically offered to vulnerable patients (background of substance abuse, active alcohol consumption, risk of non-compliance).
Pharmacists were involved in individual sessions concomitantly to DAA dispensing, since the day when patient started TPE program. Pharmaceutical sessions aimed outpatients to acquire following competencies:
– DAA’s name, action mechanism,
– Terms of administration, what to do if forgotten,
– Side effects (SE) and their management,
– Drug interactions (adapted to outpatient treatment).
Pharmacists also answered to questions concerning the patient and monitored compliance and SE.
Interactive practical tools were developed: treatment logbook (also allowed evaluating objectives at each session), cards about known and preconceived SE, timetable for drug intake. Patients fulfilled a satisfaction survey at last session.
What has been achieved?
31 outpatients were included. Pharmacists conducted 65 sessions, 2 or 3 individual meetings per patient (one hour-long total per pharmaceutical session) depending on treatment length (8-24 weeks). 6 patients were still ongoing and 25 achieved the program. Among them, 12 had an undetectable viral load after 12 weeks (Sustained Virological Response 12) and 1 relapsed. 100% of goals were achieved as from the first pharmaceutical session. 100% of patients were satisfied about pharmaceutical session
What next?
Evaluation of program’s benefits in terms of virological success need to be continued.