Author(s)

Mª Antonia Meroño Saura
Rebeca Añez Castaño
María García Coronel
Francisco Valiente Borrego
Elena Urbieta Sanz

Why was it done?

Prostate cancer patients are often elderly, frail, and chronically medicated. The introduction of new hormonal therapies has increased treatment complexity and the risk of drug-related problems. Despite evidence linking excessive polypharmacy to poor outcomes, structured deprescribing models are rarely applied in oncology. OPTIM-CP was introduced to address this unmet need by integrating validated stratification tools (Risk stratification model (EM) for the pharmaceutical care of oncology patients with solid or hematologic neoplasms (SEFH)) into routine practice to prioritize patients at highest risk and guide pharmacist-led interventions.

What was done?

The OPTIM-CP initiative was developed to improve the safety and quality of pharmacotherapy in patients with prostate cancer. It implemented a structured pharmaceutical care model based on clinical-pharmacological risk stratification and individualized deprescribing.

How was it done?

A multidisciplinary working group of clinical pharmacists reached consensus on the practical adaptation of the EM to prostate cancer patients, ensuring consistency and clinical validity. Eligible patients receiving oral hormonal therapy were identified and stratified during pharmaceutical care consultations in the Hospital Pharmacy Department through. According to their assigned risk level, follow-up intensity was adapted. Medication reconciliation was performed using the regional electronic prescribing system to ensure accuracy and coherence across hospital and primary care records.

What has been achieved?

The initiative achieved full integration into the hospital’s outpatient pharmacy circuit. A total of 111 patients were stratified during pharmaceutical care consultations. The mean age was 78,25 ± 9,6 years, and most were treated for hormone-sensitive metastatic disease. According to the ME, 4.5% were classified as high risk, 38.7% as intermediate, and 56.8% as low risk. Polypharmacy was present in 73% of patients, and 72% used at least one high-risk medication. Treatment-related variables were the main contributors to overall risk.
The implementation of the stratification model improved communication with patients, reduced medication discrepancies, and allowed prioritization of high-risk patients for closer follow-up.

What next?

OPTIM-CP is now being consolidated as a permanent part of routine care. The next phase focuses on the systematic deprescribing of potentially inappropriate medications identified during stratification, using validated decision-support tools (CheckTheMeds®) and shared decision-making with clinicians. Future steps include expanding the model to other oncologic populations.

Author(s)

Stefanie Fuchs, Michele Tadiotto

Why was it done?

Compounding cytotoxic therapies in hospital pharmacies is a complex and safety-critical process. As part of a planned modernization of the production site, which handles around 40.000 preparations annually, the project was launched to investigate the impact of integrating an automated compounding technology (ACT).
This project also provided decision-makers with structured, data-driven insights to support the selection of the most appropriate technology for the specific production needs.

What was done?

A comprehensive analysis to identify the most suitable ACT for our chemotherapy production was conducted.
The approach taken was twofold: first, production data was used to run simulations, allowing for the evaluation of how the different ACTs would perform in our environment.
Second, interviews with international ACT users with hands-on experience were conducted to gather valuable, pragmatic insights.

How was it done?

A detailed examination of the production data was conducted, assessing each ACT’s compatibility with our portfolio (approx. 100 chemotherapy substances). Customized MS-Excel calculation sheets were developed and used to cross-reference drug-specific production metrics (for each drug: total annual preparations, average production time, average transferred volume, other critical parameters). Based on this analysis, the drugs best suited for compounding with each ACT candidate were identified.
Simulations were then run to compare theoretical performance both against current manual compounding and among ACT candidates.
Additionally, the information collected during the interviews was used to develop a comprehensive evaluation of process impacts including: maintenance of quality standards, personnel requirements, potential contamination risks, software integration, microbiological and cleaning aspects, and GMP compliance requirements.

What has been achieved?

This dual methodology enabled a robust evaluation of both theoretical and practical aspects of each system.
Critical technical limitations that could hinder system applicability were identified and the potential proportion of the total compounding workload realistically manageable by ACTs was assessed.
Furthermore actionable, data-driven insights were collected and provided to decision makers to guide strategic decisions.

What next?

The findings are tailored for management decision-makers, enabling them to select the ACT best suited to the pharmacy’s needs without requiring in-depth pharmacy expertise.
Additionally, the methodology from this project can serve as a replicable framework for other hospital pharmacies interested in adopting an ACT.

Author(s)

J. BERGÉ, S. BRILLOUET, C. LAMESA

Why was it done?

Tripartite consultation (TC) activities are well established in oncology for chemotherapy, and are progressively emerging in radiopharmacy, where there is a clear need to support elderly and polymedicated patients receiving RLT. This therapy is costly and complex, with additional radioprotection requirements, making multidisciplinary coordination essential.

What was done?

A new activity of clinical pharmacy in radiopharmacy is developed as TC for Pluvicto® radioligand therapy (RLT) in our comprehensive cancer center.
This activity was set as TC with the nuclear physician, radiopharmacist, and nuclear medicine technologist. The initiative was done on our institutional software, with dedicated templates creation and harmonized tools.

How was it done?

Three main axes guided implementation: (1) integration into institutional software with customized reporting templates; (2) reorganization and structuring of the patient pathway; (3) harmonization of practices and training, with the involvement of pharmacy residents under senior supervision. Moreover, specific supports were developed to structure patient counseling, including interview templates and patient-oriented documents (radioprotection instructions, explanatory treatment diagrams).

What has been achieved?

The initiative enabled the standardization of reporting, the improvement of patient pathway coordination, and the reinforcement of their educational support. The integration of patient counseling tools strengthened patients’ understanding of a complex therapy, sensitization to radioprotection, and adherence to their care, while improving overall coordination. It also made possible the systematic performance of medication reviews, particularly relevant for an elderly and polymedicated patient population. Since its implementation, 40 patients have already been managed within this framework by residents under systematic senior supervision. Finally, the TC allowed the institutional financial valorization of this activity.

What next?

This activity represents an interesting and transposable example of good practice. Its implementation demonstrates that such an TC structure can be extended to other RLT to improve efficiency and harmonization of both professional practices and patient management. In parallel, we are currently driving a French multicenter study (Pharma-RIV) assessing the impact of pharmaceutical consultations in the management of patients receiving RLT. A broader preliminary effort is in progress to structure the RLT care pathway at the national level, in collaboration with the French Society of Nuclear Medicine.

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Author(s)

Marta Anghilieri, Francesco Guidoni, Vito Ladisa

Why was it done?

The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow the parallel sequencing of many samples producing in short times a big amount of data. To enable comprehensive analysis of the data and develop new specific and clinically useful therapies, we have introduced the approach of evaluating the data by the MTB, which includes pharmacists as experts in drugs and their use.

What was done?

Hospital Pharmacists (HPs) are integrated into the Molecular Tumour Board (MTB), a multidisciplinary group, to select the most appropriated therapy for oncology patients, ensure and facilitate patient access, and demonstrate therapeutic appropriateness found by MTB analisys.

How was it done?

MTB members, including HPs, perform DNA sequencing on each patient using NGS to identify known/unknown alterations. These data are entered into a database available to all MTB members and are the basic tool for selecting potential target therapy. The MTB meets once a week to discuss and integrate the observed DNA alterations with the patient’s clinical history. In this way, the most appropriate target therapy for the patient can ultimately be selected. The HPs then provide the patient with access to medications.

What has been achieved?

In this study, 208 patients affected by Non-Small Cell Lung Cancer were evaluated. DNA sequencing of patients identify 117 altered genes. After an extensive literature search, 15 genes were highlighted as potential targets for available drugs. They marked 116 patients potentially tractable with target therapy, of which 47 patients were candidates to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, among candidates for drugs in clinical practice, treatment was started in 65% and continued in 53%; among those treated with drugs not in clinical practice, treatment was started in 23% and continued in 69%.

What next?

The inclusion of HPs in MTB allows for more deliberate use and better selection of drugs. HPs provide valid support to select drugs and facilitate access to them: HPs individualise the applicable therapy for a larger number of patients through MTB, they analyse the therapeutic outcome (MTB-selected therapy has a bigger chance to last longer) and the cost impact on the NHS.

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Author(s)

Aina Oliver Noguera, Luis Pérez de Amezaga Tomáss, Margarita Nigorra Caro, Fernando Do Pazo Oubiña, Esther Falcó Ferrer, Teresa Fernández Rodriguez, Maria Fiorella Sarubbo, Antònia Obrador de Hevia, Montserrat Vilanova Boltó

Why was it done?

Treatment with fluoropyrimidine produces severe toxicity in about 30% of the patients. This toxicity has been related to a reduction in the activity of DPD, the rate-limiting enzyme for fluoropyrimidine catabolism. This is due to certain genetic variants of DPYD, the gene encoding DPD. For this reason, regulatory agencies such as the European Medicines Agency (EMA) recommend determining DPD deficiency in all patients who are candidates for treatment with fluoropyrimidines.

What was done?

Design of a protocol for the Implementation of dihydropyrimidine dehydrogenase (DPD) genotype tests in our hospital so that the results can be clinically interpreted by the pharmacists, and then used to guide physicians in the dosing of fluoropyrimidines (5-fluorouracil/capecitabine). The project was done with the collaboration of the Genetic and Genomic Laboratory (GGL) located in the reference hospital of our territory.

How was it done?

The elaboration of the protocol took place as follows, coordinated by the oncology pharmacist:
– Informatics. They created a formulary at the electronic prescription programme (HP-HCIS®) for the inclusion of the patients in the testing protocol.
– Oncologists and nursing service. They were trained in the implementation of this new determination, as well as in the procedure for obtaining and sending samples to the GGL.
– GGL. They conducted the DPYD genotype tests and report the results to the oncology pharmacist.
– Oncology pharmacist. They did the clinical interpretation of the result based on the following European Society for Medical Oncology (ESMO) recommendations for heterozygous DPYD variant allele carriers:
-DPYD*2A (rs3918290): dose reduction of 50%
-c.1679T>G (rs55886062): 50%
-c.2846A>T (rs67376798): 25%
-c.1236G>A/HapB3 (rs56038477): 25%

What has been achieved?

Since the implementation of the protocol, 73 determinations of DPYD polymorphisms have been performed (November 202 to August 2022). Three patients (4.1%) were found to be heterozygous DPYD gene variant carriers (two DPYD*2A and one c.2846A>T).
The average time for obtaining the results was 17.5 days. For this reason, in most cases the treatment was started before the result was obtained.

What next?

We are working on the implementation of a new fluorescence technique that will allow us to shorten the time of obtaining the genotype result.

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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)

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

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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.