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.
What role can French hospital Geriatric units play in vaccination coverage of the elderly?
European Statement
Clinical Pharmacy Services
Why was it done?
Vaccination coverage of the French elderly is low. Geriatricians asked for pharmacist’s help in increasing their patients’ vaccination rates.
What was done?
Pharmacist staff investigated the vaccination status of patients admitted to our Short-stay and Long-stay Geriatric Units (SSGU and LSGU). Results of these investigations enabled systematic catch-up vaccinations for patients before discharge.
How was it done?
Pharmacy and medical students were trained to determine SSGU and LSGU patients’ vaccination status and report findings to unit geriatricians. Training and procedures for Admission and Discharge Medication Reconciliation (AMR and DMR) were updated to include the recording of patients’ immunisation status. Furthermore, at discharge patients were supplied with an updated vaccination booklet and apprised of the importance of full vaccination coverage. During 2021, 3 groups were compared to evaluate our practices: before AMR new procedure, after AMR new procedure and after multidisciplinary decisions for AMR and DMR.
What has been achieved?
In SSGU and LSGU, all patient admission leads to an AMR. 45 patients were included in the first group, 39 in the second group and 46 in the final group. Since the 1st of March, AMR help geriatricians regarding vaccination status. Between March and April, 46% (17) of AMR found the entirety of the patient immunisation status compared to 2% (1) in the first group (p<0,01), and 35% (14) of AMR found at least one immunisation status among French recommendation compared to 24% (11) in the first group (p=0,12). In June, multidisciplinary medical team improved AMR et DMR practices to increase patient’s vaccination rates. In July, 51% (23) of all unit patients discharged had an up-to-date vaccination status compared to 2% (1) in the first group (p<0,01). 22 patients required pneumococcal vaccination: 8 received a dose during their stay and 2 had a dose prescribed at discharge. 27 patients required a Tetanus immunisation: 8 were vaccinated during their stay and 1 had a dose prescribed at discharge. Moreover, 46% (21) of patients received a short education from a pharmacist student and an up-date vaccination booklet. To conclude, 42,8% (15 of 35) of SSGU patients with incomplete vaccination coverage benefitted from catch-up vaccinations in July.
What next?
Vaccination coverage of eldery in not only a local public health preoccupation and systematic catch-up vaccination is easy to implement.
Distribution optimization of oral oncology therapy in the treatment of advanced renal cell carcinoma: between environmental impact and indirect costs
European Statement
Introductory Statements and Governance
Author(s)
Nicola Nigri, Maria Antonietta Calzola, Silvia Di Marco, Elisa Di Maio, Benedetta Fagotti, Martina Savoia, Luciana Negroni, Fausto Bartolini
Why was it done?
The 1st line treatment in RCC provides Pembrolizumab 200mg IV/21 days plus Axitinib (56cps/pack) P.O./BIS meaning two journeys. The PT and or CG have to come back to the hospital at different moments from the infusion date for 9 times/year, affecting negatively: the compliance, the IC, the patient’s follow-up and, the environmental impact.
What was done?
In Italy, the 1st line treatment of advanced renal cell carcinoma (RCC) involves 4791 new diagnoses/year. The most innovative therapies imply the association of intravenous therapy (IV) and oral chemotherapy.
In this case, the Hospital Pharmacist (HP) can assist the compliance and help to minimize the impact linked to indirect costs (IC), often unconsidered, through the reduction of the patient (PT) and or caregiver (CG) trips, improving also their quality of life. The HP can participate in decreasing the CO2 emissions that, in 70% of the cases, are generated by road transportations.
How was it done?
On the IV therapy day, is given to the patient, the oral treatment too (42cps), provided with the necessary documents.
To measure the IC has been considered the organizational costs to the PT and or CG. The time commitment was estimated, in the worst case, in a 2h return journey (150km) between the PT/CG location and the dispensation point. It has been considered 30min as the estimated time to park, arrival, waiting time in pharmacy, drug pick-up and back.
The average hourly earnings considered has been 13,6 €/h. The average diesel-engined utility car emits 95g/km of CO2 emissions.
What has been achieved?
Each avoided trip is 2h x 13,6€ = 34€ for missing productivity or 68€ if both are involved. The total IC avoided/year/PT is the number of avoided journeys/year x 34 = 306€ (612€ if both are involved).
The CO2 emissions are equal to 95g x 150km =14,25kg/distribution/PT, 128,25 kg/year/PT, equal almost to 2,3% of CO2 emission perceived in Italy, that, in the worst case, times the incident PTs/year that will become 614.000tonnes/year.
What next?
The HP shows, even more, its influence on more layers: clinic, economic, and environmental to benefit the patient, our NHS, and our planet, hoping in this approach in more combined therapies.
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.
IMPLEMENTATION OF AN APPOINTMENT MANAGEMENT MODULE APPLIED TO THE OUTSIDE PATIENT AREA
European Statement
Patient Safety and Quality Assurance
Author(s)
JUDIT PERALES PASCUAL, ANA PÉREZ LÓPEZ, HERMINIA NAVARRO AZNAREZ, ELENA HERRANZ BAYO, MARIA PEREZ MORENO, CARLOS-IGNACIO DIAZ CALDERON HORCADA, Mª REYES ABAD SAZATORNIL
Why was it done?
In 2019 the UPEX attended a large volume of patients without a scheduled appointment, long waits were generated and the pharmacotherapeutic follow-up was complicated. The purpose was to implement an appointment management module to avoid crowds, excessive waiting times, allowing better organizational management of care and knowledge of patients in each type of consultation.
What was done?
An outpatient is a patient who goes to the outpatient unit of their Hospital Pharmacy Service to collect a drug for hospital use/diagnosis or foreign drug (it will be administered without health personnel intervention).
An appointment management system was implemented in accordance with the objectives of the SAMPA project (Service for Registration and Promotion of Adherence to Medicines for Elderly Patients), included in the European STOPandGo project.
How was it done?
Creating a cross-cutting system for the entire clinical circuit from prescription to dispensing involved a great deal computer involvement. Although it began to be used in November 2018, it was not used by the mostly part of prescribing doctors until the end of 2020.
Now, when the patient leaves medical consultation, he/she will go to the pharmacy and will be seen by a pharmacist. Besides, the program will propose a return appointment when it calculates that the patient has a week’s worth of medication, thus preventing the patient from running out of medication. The pharmacist will decide if the patient needs pharmacotherapeutic follow-up.
What has been achieved?
In 2019, 5 services cited patients while in 2020 it was 14; the percentage of patients attending pharmacy cited increased from 73.2%(2019) to 79.4%(2020).
Currently, the pharmacist knows in advance which scheduled patients he has and can establish a better organizational care management and determine in advance if the patient needs a close pharmacotherapeutic follow-up. Additionally, with this system an average waiting time of 03:55min was achieved (in 2019 appointments with waits >30min were recorded).
What next?
The implementation of the appointment management system has made possible to achieve better organizational management of care,avoid crowds,excessive waiting times, and provide better patient care and pharmacotherapeutic follow-up. The proposed solution can be extended to other hospitals.
Novel vaccine clinical trials in Africa
European Statement
Education and Research
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..
Clinical impact assessment of pharmaceutical intervention during pharmaceutical consultation of oral therapy-treated cancer patients
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Justine Touchard, Elisabeth Angelier, Isabelle Ferry, Marion Lafay, Jean-Stéphane Giraud, Caroline Giard, Mallory Friou, Laurence Escalup, Thomas Genevée
Why was it done?
For more than 15 years, within the Institut Curie, a pharmaceutical consultation (PC) has been offered to patients undergoing anticancer oral therapy, in addition to a medical announcement consultation and a nurse consultation. The pharmacist secures and optimises drug management through a pharmaceutical analysis of the prescription, an explanation to the patient of drug intake and management of the main side effects.
What was done?
The aim is to assess the Clinical Impact (CI) of Pharmaceutical Interventions (PI).
How was it done?
From 1 January 2020 to 17 March 2020, two types of PI could be collected during each PC. One concerned the prescriber and problems of prescription, while the other concerned patients. Patients could misunderstand some of the information explained by their oncologist. The evaluation of the CI of these PI has been documented by an oncologist based on the Cléo scale v3, validated by a French learned society, Société Française de Pharmacie Clinique. CI of each PI was classified as harmful , null, minor, moderate, major, vital, and not determined.
What has been achieved?
140 PC were carried out. 95% of patients were female and mean age was 62 (±13.73) years. 66 PI were recorded. 39 PI with the prescriber were identified. We noted, among others, 8 risks of possible drug interaction, 9 lacks of prescriptions of support treatment, 3 lacks of drug intake advice and 3 lacks of prescription for blood monitoring.
27 PI with the patient were identified and 21 were relevant. We noted that 7 patients misunderstood drug intake, 5 patients did not know that the previous treatment should have been interrupted, 5 patients misunderstood the monitoring and 4 others were not aware of possible side effects related to their treatment.
The CI was assessed for 83% (n=55) of PI. CI was considered to be minor for 20%, moderate for 53%, major for 14% and vital for 13%. Two prescription errors were associated with vital CI. The first referred to a risk of drug interaction between a proton pump inhibitor and capecitabine. The other error was the risk of loperamide overdosage.
What next?
PC help secure medical care of patients. These results will be presented to our oncologists to improve medical practices.
ANALYSIS OF DISCREPANCIES BETWEEN DATABASES OF DRUG-PLANT INTERACTIONS: A NEW TOOL THAT FACILITATES DAILY DECISION MAKING
European Statement
Clinical Pharmacy Services
Author(s)
Belén Serna Serrano, Victoria Lerma Gaude, Ana Valladolid Walsh, Cristina Del Pozo Carlavilla, Juan Manuel Collado Sanz, Héctor Alabort Ayllón, Eduardo Tébar Martínez, Andrea Drozdz Vergara
Why was it done?
In the pharmacist-patient clinical interview (CI), DP-I revision is frequent due to consumption increase of phytotherapy in recent years. The aim of the initiative was to study the degree of discrepancy (DD) based on the severity criteria (SC) found about the recommendations on the management of DP-I. Nowadays there are multiple databases with lack of unification. Patients diagnosed of Multiple Sclerosis (MS) are frequently interviewed by the pharmacist and they often take herbal medicines (HM).
What was done?
We unified the information collected from the commonly consulted databases of drug-plant interactions (DP-I) whose information could be scarce or contradictory, by creating a tool based on the most consulted plants in our clinical practice (CP).
How was it done?
To create our own DP-I tool, the sources consulted were:
– Our own plant database based on CP. A total of 56 plants.
– Six official databases of DP-I: (A)-Phytotherapy official monographs, (B)-MedInteract®, (C)-Micromedex®, (D)-UpToDate-Lexicomp® (E)-Medscape®.
In order to unify the DP-I information consulted and to be able to identify the DD (0 to 2), the SC for all databases were unified in 3 levels: if the database had 5 levels (1=1-2; 2=3-4; 3=5) or 4 levels (1=1-2; 2=3; 3=4). In first place we decided to test this tool with a small sample size of drugs (6 drugs commonly used for the treatment of MS) to check whether the discrepancy between the databases usually consulted was significant or not.
What has been achieved?
Finally, 6 DP-I were detected with Hypericum perforatum (HP) and Echinacea angustifolia (EA):

The DD seems to be similar between A-B databases and greater respect to the rest of them. Depending on the database consulted the pharmacist’s performance could change and consequently, pharmaceutical care may be affected. Since this tool was implemented in our CP, none of our MS patients have taken HP or EA, therefore, it has not been necessary to modify their treatment because of DP-I.
What next?
This tool could speed up the pharmacological review of possible DP-I and improve decision-making for the care of MS patients. Our next step is to increase the sample of analysed drugs commonly used in other pathologies, such as antiretroviral drugs.
Impact of a specialist pharmacist on hepato-pancreatico-biliary (HpB) surgical ward rounds at a large tertiary liver centre.
European Statement
Clinical Pharmacy Services
Author(s)
Connor Thompson, Alison Orr
Why was it done?
Surgical patients are at risk of medication-related adverse events, with some of these patients having co-morbidities requiring long-term medications prior to surgery. Published data suggests pharmacist interventions can reduce adverse drug reactions (ADRs) and medication errors and reduce hospital length of stay.
What was done?
The effect of implementing a pharmacist into the HpB surgical ward round (WR) was unknown, this would also support ongoing service development projects in liver pharmacy on patient pathways.
This study aimed to establish the range and clinical impact of interventions made by the specialist pharmacist when attending HpB post-surgical WR as part of ongoing pharmacy engagement and service development.
How was it done?
A prospective study looking at interventions of a specialist pharmacist on WR over a one-month period, attending two WR per week. Review of all post-surgical HpB on an inpatient ward. All interventions collated and categorised based on commonality.
What has been achieved?
Over the course of data collection, the pharmacist reviewed 140 patients and made 477 interventions as part of the WR. This included 45 history medications being started, identification of 32 ADRs to current treatment, 16 instances of vancomycin dose adjustments, confirmation of anticoagulation for 17 patients and addition of 101 antibiotic stop dates contributing to better antimicrobial stewardship. There were also 70 instances of a nurse/doctor/patient requiring additional information on medication treatments.
What next?
This has highlighted the scale of interventions a pharmacist can make on a WR. Emphasising not only adjustment of medications but also the need for medication related information by healthcare professionals and patients alike.
Moving forward a pharmacist will attend at least two WR per week, with potential scope for support in pre-assessment and post-operative clinics to review weaning of analgesia and long-term management of pancreatic replacement for example.
With the recent announcement regarding new standards for the initial education and training of pharmacists in the UK, it would be valuable to assess the impact of a prescribing pharmacist on these WR.