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Author(s)

Vera Pires, Maria Teixeira, António Gouveia

Why was it done?

Cisplatin is a cytotoxic agent used in CT regimens in ST. (1) Nephrotoxicity is the main toxicity, and hydration is always indicated to prevent kidney damage. [1,2] In 2018, when we computerized the ST’s CT protocols, we verified the existence of variations in CH protocols. According to the bibliography, this lack of standardization could lead to sub-optimal treatment of patients, errors and unnecessary use of resources. [1,3] Thus, it was necessary to develop a standardized hydration protocol designed by pharmacists with the collaboration of oncologists.

What was done?

Standardize the cisplatin-based hydration (CH) protocols used in the solid tumors (ST) chemotherapy (CT) regimens in adults in our institution.

How was it done?

Audit of CH protocols used in ST in adults in our institution and literature review to build a standardized evidence-based protocol.

What has been achieved?

We gathered 31 CT regimens with cisplatin. Verified the existence of variations in the volume of hydration (VH) before and after cisplatin, in the volumes of drug dilution, perfusion time, in the use of oral hydration (OH) and in ionic supplementation. We found that all of them were indicated to perform cisplatin only “if urine output >100ml/min”, use of mannitol before cisplatin and furosemide in SOS. Through the consulted bibliography, 4 regimens were made and implemented in 2019, according to the dosage of cisplatin: HC1< 40mg/m2 (Hday) and HC21000ml, and mannitol is only administered if cisplatin ≥60 mg/m2 (RCM). All protocols have magnesium and potassium supplementation.

What next?

Thus, despite the lack of consensus in the bibliography, a standardized protocol was created based on the evidence and clinical practice of our Institution. It is our intention to assess the impact of this intervention, from the perspective of the patient and the Institution.

Author(s)

Mapi Fleury, Januska De Maria-Lee, Alessandra Taiana, Yvan Bourgeois, Sophie Voruz, Olivier Spertini, Pierre-Yves Bochud

Why was it done?

In 2019, procedural changes within unit treating malignant haemopathies raised awareness about unsatisfactory management of NV, particularly CINV. We identified a lack of departmental consensus, leading to heterogeneous therapeutic practices, confusion over the aetiologies of NV and feelings of powerlessness among healthcare professionals. We decided to improve the whole process, from prophylaxis to treatment, by addressing specific knowledge gaps concerning CINV, improving pathophysiological and pharmacological knowledge, and implementing interprofessional management and MASCC/ESMO guidelines.

What was done?

Patient nausea and vomiting (NV)—particularly chemotherapy-induced NV (CINV) in malignant haemopathies—was managed by an interprofessional team.

How was it done?

A multidisciplinary working group was established to create a comprehensive, patient-centred NV management programme. Work sessions focussed on attaining a therapeutic consensus and adapting international guidelines to our context. Different professions learnt about each other’s needs and fields of competency, enabling each to be heard and creating mutual benefits through sharing expertise and knowledge. Pathophysiological/pharmacological leadership was given to clinical pharmacist, including developing and teaching specific protocols and supervising complex clinical situations in the field.

What has been achieved?

Interprofessional consensus was reached, documentation and techniques were implemented including clinical evaluation checklists at patient admission. CINV therapeutic regimens were completely updated and immediately and automatically included in cancer treatment protocols. The clinical pharmacist and specialist nurses give initial interprofessional training to new colleagues and ensure continuous on-site supervision. This transversal work has resulted in fewer patients suffering from NV and better team understanding of pathophysiological mechanisms, differential diagnoses and adverse drug effects—this also ended the use of unsuitable medications and dosages. Overcoming this critical situation also allowed us to begin non-pharmacological integrative care.

What next?

Interprofessional working group proved indispensable to this approach. Including CINV pharmacotherapy directly into cancer treatment plans is one of programme’s strong points and contributes to high adherence to guidelines. Team feels more relaxed and more in control. Monitoring is now done by tracking files and oral feedback, but we aim to implement systematic follow-up of interventions, care evaluations and NV to assess programme’s impact. Next stage will also include patient feedback.

Author(s)

Petra Rozsívalová, Věra Zdanovcová, Lenka Beková, Martina Maříková, Marcela Heislerová, Vladimír Koblížek, Petr Šmahel

Why was it done?

By implementing systematic monitoring in our institution, CPs ensure appropriate and safe use of unlicensed treatment available under Emergency Use Authorisation. The secondary goal is mandatory data input to national register and patient clinical outcome feedback to physicians and hospital management.

What was done?

It is vital to bring focus on appropriate use of COVID-19 monoclonal antibodies (mAbs) in high-risk population when safety and efficacy data are scarce. A team of clinical pharmacists (CPs) helped to set up process flow, monitor prescribing of mAbs and provide systematic follow-up on time course of symptoms reported by SARS-COV-2 positive outpatients since March 2021.

How was it done?

Ethics committee approval was obtained for monitoring of patients. Consented patient data are extracted from electronic prescribing system and patients score subjective symptoms using questionnaire on days 7, 29 and 90 after the infusion. The prescriber, indication criteria, infusion application day with regards to PCR positivity and symptom onset and vaccination status are recorded.

What has been achieved?

Currently our small dataset includes 59 bamlanivimab and 63 casirivimab/imdevimab patients. On average, mAbs are administered within 2 days of positive PCR test and 5 days of COVID-19 symptoms onset. Our patients report subjective improvement in symptoms by 7 days post infusion. None of our patients clinically deteriorated because of COVID-19. 100 % of mAbs administered are reported in the national database. In October 2021 we achieved that laboratory confirmed positive patients receive text message with infectionist contact to discuss eligibility for mAbs on 24/7 basis. CPs also implemented information leaflets on mAbs for patients with chronic conditions.

What next?

To date, there are no published descriptive data on real-life utilisation of COVID-19 mAbs in terms of patient characteristics, disease outcome and vaccination status. Our initiative shows na excellent opportunity for CPs to enhance timely and rational mAbs use.

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)

Marta Anghilieri, Vito Ladisa, Andrea Vingiani, Giancarlo Pruneri

Why was it done?

The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow parallel sequencing of many samples producing a big amount of data. To give a comprehensive analysis of the data in order to develop new specific and clinically useful therapies, we have introduced the approach to evaluate the data by the MTB, where pharmacists are included as experts of drugs and their preparation and application.

What was done?

The integration of pharmacists into the first Molecular Tumor Board (MTB), a multidisciplinary group, to select the most suitable therapy for oncological patients.

How was it done?

For every patient pharmacists, together with the members of MTB, study the results of NGS to identify known and unknown alterations utilizing a database available to all MTB members. These mutations represent the basic tool to select potential target therapies. The MTB meets weekly to discuss and integrate the alterations observed with the patient clinical history. At the end this approach allows to select the most suitable target therapy.

What has been achieved?

In this study 208 patients affected by No Small Cell Lung Cancer (NSCLC) were evaluated. The tumor has an elevated mortality, even if many target drug available or in development, therefore a correct treatment approach is essential to improve the clinical outcome. The NSG identified 117 altered genes. After an extensive literature search, 15 genes were identified as potential target of drugs available. They marked 116 patients potentially tractable with target therapy: 47 patients were candidate to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, in the candidates to drugs in clinical practice the treatment was started in 65% of cases and in 53% was continued, while in the other group the treatment was started in 23% of cases and in 69% continued.

What next?

• The MTB offers a valid support in the clinical practice
• It individuates a target therapy for a greater number of patients
• The selected therapy has a bigger chance to last longer
• The inclusion of Pharmacist in MTB allow a more aware use and a better selection of drugs

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.

Author(s)

Alba María Fernández Varela, Laura López Sandomingo, Nieves Valcarce Pardeiro, Isaura Rodríguez Penín

Why was it done?

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What was done?

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How was it done?

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What has been achieved?

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What next?

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Author(s)

José Luis Revuelta Herrero, Vicente Escudero, Roberto Collado, Belén Marzal, Ana Herranz, María Sanjurjo

Why was it done?

CAR-T cell-based therapies are advanced therapy medicinal products (ATMP) that are considered as drugs by the European regulatory authorities. ATMPs are usually associated with strong logistic and traceability requirements, serious adverse events and a high budget impact. Hospital pharmacists can help ensure a safe and efficient use of these drugs.

What was done?

A chimeric antigen receptor (CAR) T cell Therapy Committee was created in 2019 and it included members from the hematology, oncology, pediatric onco-hematology, hospital pharmacy, neurology, critical care medicine and immunology departments. An operating procedure defined the specific functions of the pharmacy department in the management of these drugs in the CAR-T cell program.

How was it done?

As some responsibilities might be shared with other professionals, it was key to define everyone’s contributions. In our case, an operating procedure with the responsibilities of the pharmacy department was developed based on the national and regional action plans for ATMPs in the national health system and the risk management plans for each drug. This operating procedure was reviewed and approved by the Committee.

What has been achieved?

The operating procedure was fully implemented and included the participation of hospital pharmacists in the following steps:
• Procurement: the inclusion of a patient in the program is agreed upon the Committee. The pharmacists provide a purchase order when all the requirements are met.
• Leukapheresis and shipment to the manufacturer: the apheresis is included in the computerized physician order entry (CPOE) and it is verified to confirm wash-out periods. Before the shipment, the pharmacists record the apheresis unique identifier and patient data.
• Product receipt: the pharmacists verify at receipt that the patient identity chain and the integrity of the product have been preserved.
• Bridge and lymphodepleting chemotherapy, CAR-T administration: specific protocols have been included in the CPOE. Prescriptions are verified by the pharmacists with special attention to the drug-free periods. After transporting the drug to the clinical unit and preparation, a pharmacy label for dispensing and administration is generated. This label includes a barcode for patient identity verification at bedside.
• Outcomes monitoring and pharmacovigilance: kits are provided to the clinical units for the management of CAR-T associated toxicities. Pharmacists are responsible for the adverse reactions reporting in coordination with clinicians.

What next?

We developed verification lists for each of the previous steps that have already been published (DOI: 10.3389/fonc.2021.636068). More ATMPs are expected to come and their management will require the participation of hospital pharmacists from different areas of expertise (procurement, clinical pharmacy, compounding etc).

Author(s)

Laura O’Donnell, Barry Keenan, Laura Loughran, Edel Davidson, Rosemary Donnelly, Sarah McGinnity

Why was it done?

In 2020, it was identified that diabetes specialist pharmacists working within diabetes inpatient teams were able to provide safe, effective and patient-centred care. However, it was equally identified that there was a lack of awareness of these new roles and their potential impact on care improvement. This is a major barrier to ensuring that specialist pharmacists become an integral part of diabetes inpatient teams.

What was done?

Diabetes specialist pharmacists from across Northern Ireland collaborated to define their role, and communicated their scope of practice in improving patient care as an infographic.

How was it done?

Acute hospital trusts in Northern Ireland were allocated temporary funding to demonstrate the benefits of a diabetes specialist pharmacist. There were localised differences in services provided according to the experience, and competence of the individual pharmacist, however as a team, pharmacists across Northern Ireland collaborated to help establish, develop and define the role. Work was mapped to the four guiding principles for medicines optimisation from the Royal Pharmaceutical Society Good Practice Guidance (2013). The comprehensive worklist was then transformed into an infographic to give a quick, visual and easy to understand illustration of the role.

What has been achieved?

The infographic is a unique tool to share the vision of what can be achieved by diabetes specialist inpatient pharmacists, and promotes clinical pharmacy services. The work was used to develop a business case for permanent funding, and is being used to inform a wider diabetes workforce planning strategy within Northern Ireland.

What next?

It is hoped that sharing this work will help inform and inspire teams who would like to incorporate a diabetes specialist pharmacist into their diabetes inpatient team, and provide a roadmap for those who are developing and establishing the role in their own hospital.
Next steps involve expanding the remit to include the other roles in which a diabetes specialist pharmacist can enhance care, for example outpatient clinics, and links with primary and intermediate care, to fully illustrate the role.

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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.