Pharmaceutical care in the screening process of phase I oncohaematological clinical trials.

Objective: To determine the pharmaceutical interventions in patients eligible for phase I cancer clinical trials, focusing specifically on exclusion criteria related to medication or relevant interactions.

Method: Descriptive, observational study conducted at a comprehensive cancer centre. Patients undergoing screening for phase I clinical trials (March 2019-December 2022) were included.

[Translated article] Characteristics, clinical benefit, and reimbursement of new authorisations for oncohaematology drugs in Spain between 2017 and 2020.

Objective: To describe the authorisations and funding resolutions for new onco-haematological drugs in Spain between 2017 and 2020, as well as the results of their main trials.

Methods: Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-haematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.

Characteristics, clinical benefit and reimbursement of new authorisations for oncohaematology drugs in Spain between 2017 and 2020.

Objective: To describe the authorisations and funding resolutions for new onco-hematological drugs in Spain between 2017 and 2020, as well as the results of their main trials.

Methods: Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-hematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.

DPYD genotyping and 5-fluoropyrimidine toxicity: An overview of systematic reviews protocol.

Introduction: The increased risk of severe and life-threatening toxicity in patients with dihydropyridine dehydrogenase deficiency, under treatment with fluoropyrimidines, has been widely studied. An up-to-date overview of systematic reviews summarizing existing literature can add value by highlighting most relevant information and supports decision-making regarding treatment in dihydropyridine dehydrogenase deficient patients. The main objective of this overview is to identify published systematic reviews on the association between germline variations in the DPYD gene and fluoropyrimidine toxicity.

DPYD genotyping and 5-fluoropyrimidine toxicity: An overview of systematic reviews protocol.

Introduction: The increased risk of severe and life-threatening toxicity in patients with dihydropyridine dehydrogenase (DPD) deficiency, under treatment with fluoropyrimidines, has been widely studied. An up-to-date overview of systematic reviews summarizing existing literature can add value by highlighting most relevant information and supports decision-making regarding treatment in DPD deficient patients. The main objective of this overview of systematic reviews is to identify published systematic reviews on the association between germline variations in the DPYD gene and fluoropyrimidine toxicity.

An international comparative analysis and roadmap to sustainable biosimilar markets.

Although biosimilar uptake has increased (at a variable pace) in many countries, there have been recent concerns about the long-term sustainability of biosimilar markets. The aim of this manuscript is to assess the sustainability of policies across the biosimilar life cycle in selected countries with a view to propose recommendations for supporting biosimilar sustainability. The study conducted a comparative analysis across 17 countries from North America, South America, Asia-Pacific, Europe and the Gulf Cooperation Council.

Is ranitidine necessary as premedication for regimens containing paclitaxel? A non-inferiority study.

Background: Histamine type-2-receptor antagonist drugs (H2-antagonists) have been used as standard treatment to prevent hypersensitivity reactions (HRs) in paclitaxel-containing regimens, however, their use has been strongly questioned. Ranitidine has been the most widely used H2-antagonist. Therefore, especially after its withdrawal from the market, the objective of this study is to determine the impact of its elimination from premedication on HR incidence.

Usefulness and Safety Evaluation of Chemotherapy Administration Device for Nurses: Experimental Study.

Objective: Antineoplastic drugs are considered high risk, and computerized systems favor safe administration. The objective of the study was to test the usefulness and safety of a new mobile device compared to the standard device for administering these antineoplastic treatments.

Data Sources: This multicenter, quasi-experimental pre-post study assessed an intervention in two cancer centers in June and July 2020.

Pharmacotherapeutic management of advanced therapy drugs.

Advanced therapy drugs have emerged in recent years as new pharmacotherapeutic strategies. In this context, hospital pharmacy services have had to adapt to the new challenges posed by the  inclusion of advanced therapies in their roster of services against the  background of the complex pharmacotherapeutic process patients typically go through.All the activities carried out in the hospital pharmacy services must abide by  the rules established in the Spanish legislation and ensure both the quality of  the different drugs they manage and the safety of every single patient.

Characterization of the Pharmaceutical Risk-Sharing Arrangement Process in Catalonia.

Pharmaceutical risk-sharing arrangements have emerged as a reasonable tool to promote sustainable access to innovative medicines with uncertain clinical evidence and/or economic impact from the payer perspective. These funding mechanisms pose an alternative option to the traditional fixed-price methods and are intended to align the price of medication with the value delivered in treating patients, balancing clinical need with affordability in the face of increasing therapeutic innovation and ever-tight budgets. The Catalan Health Service (CatSalut) has set up a systematic, traceable, and transparent methodology for the design and implementation of risk-sharing arrangements and 15 of such access schemes have been successfully implemented until December 2019.

Drug evaluation is also a clinical activity.

The addition of a fourth year to the hospital pharmacy residency program has allowed trainees to rotate through various inpatient clinical  units where they can, under the supervision of a specialist pharmacist,  work shoulder to shoulder with other healthcare providers to ensure that  patients receive the care they need. In addition to sharing their  pharmacotherapeutic and pharmacokinetic knowledge (among others) with their colleagues, hospital pharmacists can and should contribute with their  expertise in the areas of drug evaluation, selection and positioning. As no  other healthcare professional masters like a pharmacist the intricacies of  treatment efficacy or effectiveness, or of therapeutic safety, conveying this knowledge is yet another of the many clinical activities a hospital  pharmacist must perform as a member of a multidisciplinary team, while  assisting fellow-team members in deciding what medications are best  suited to each patient.

Survey of oncohematological pharmaceutical care situation in Spain.

Objective: To learn about the baseline of Oncohematological Pharmacy Units in Spanish hospitals in order to identify areas for  improvement.

Method: A survey in line with the objectives set in GEDEFO 2020  Strategic Plan of Pharmaceutical Care for oncohematological patients  was designed. The survey was hosted on GEDEFO's website during  March and April 2017.

Economic evaluation of the GENESIS-SEFH report of olaratumab with doxorubicin in soft tissue sarcoma in advanced stages.

Objective: The economic evaluation of the drug olaratumab is carried out in the treatment of soft tissue sarcoma.

Method: The data were analyzed following the recommendations contained in  the MADRE program of the GENESIS-SEFH report model.

Results: Progression free survival and overall survival results published in the  pivotal clinical trial; Tap, WD.

Nintedanib in combination with docetaxel for second-line treatment of advanced non-small-cell lung cancer; GENESIS-SEFH drug evaluation report.

Nintedanib is a triple angiokinase inhibitor that has been approved by the European Agency Medicines (EMA) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy. In LUME-Lung 1 clinical trial, the combination of nintedanib plus docetaxel vs. placebo plus docetaxel improved progression free survival (PFS) in NSCLC patients, and improved overall survival in the population of adenocarcinoma patients, particularly in those with progression within 9 months after first line treatment initiation, median 10.

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Durante la última década, el conocimiento de nuevos mecanismos implicados en el desarrollo del cáncer ha permitido el diseño de nuevos fármacos para su tratamiento y la mayor parte de ellos son fármacos que se administran por vía oral. Uno de los principales problemas de los pacientes oncohematológicos es la desnutrición, que suele tener causas multifactoriales (de la propia enfermedad, de los pacientes y de los diferentes tratamientos administrados). Para minimizar el impacto de la desnutrición es necesaria una intervención nutricional, ya sea adaptando la dieta o mediante la instauración de soporte nutricional artificial, en función de la gravedad de cada caso.