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The development and commercialization of genetically modified T-cell medicines using chimeric antigen receptor (CAR) T cells represents a new challenge for European Union hospital pharmacies. The aim of this article was to review the key aspects of these medicines, particularly those already available in the European Union (axicabtagene ciloleucel and tisagenlecleucel), and to describe the hospital pharmacist’s role within the multidisciplinary health team. Because CAR T-cell medicines are exclusively used at the hospital level, hospital pharmacists have a responsibility to contribute to their rational use, assuming technical responsibility for their ordering, product receipt, storage, preservation, and dispensing, as well as establishing an effective and safe system that ensures correct administration to the patient. This should also include the short- and long-term follow-up of patients treated with this type of therapy, emphasizing on the management of the main adverse effects of this therapy. CAR T-cell therapy offers hospital pharmacists the opportunity to work closely with other health professionals involved in the process, allowing their contribution to the development of procedures, clinical practice guidelines of global use, establishing starting points when facing future therapies of similar complexity, and even improving previously established basic processes in the various phases of this type of medication.

Immune checkpoint inhibitors are a revolution in cancer treatment, having a better toxicity profile than chemotherapy. However, many mechanisms and management of immune-related adverse events are still unknown, and guidelines are a crucial tool to take clinical decisions. However, even the most recent guidelines lack information about alternative treatments for steroid-refractory immune-related adverse events, safety in special populations, biomarkers and therapy reinstitution. The aim of this article is to review the management of immune checkpoint inhibitors immunotoxicity and analyse the possible gaps in the clinical practice guidelines. Search on PubMed, Scopus and Clarivate Analytics of articles related to immune-related adverse events’ management. The summary of product characteristics of each immune checkpoint inhibitor approved by EMA and/or FDA was also considered. Based on this general literature search, an analysis of what is included in the most cited guidelines was made. Overall, 83 records were included in the descriptive review. The least developed topics in guidelines that are important to consider in future versions of the guidelines are the conditions to reinstitute immunotherapy after adverse events, possible biomarkers useful for clinical practice, if special populations such as patients with prior autoimmune diseases and elderly are eligible for treatment and options in the management of steroid-refractory adverse events. Furthermore, the grading system used for immunotoxicity classification may underestimate toxicity, and it is not optimized for immunotherapy. Clinical practice guidelines need to be updated and include information about special populations, biomarkers, treatment reinstitution and steroid-refractory immune adverse events.

Breast cancer (BC) is the most common cancer in women worldwide, and has an undeniable negative impact on public health. The advent of molecular biology and immunotherapy has made targeted therapeutic interventions possible, providing treatments tailored to the individual characteristics of the patient and the disease. The over-expression of human epidermal growth factor receptor (HER) 2 is implicated in the pathophysiology of BC and represents a clinically relevant biomarker for its treatment. Trastuzumab, a recombinant antibody targeting HER2, was the first biological drug approved for the treatment of HER2-positive BC. Although there are currently other anti-HER2 agents available (e.g. pertuzumab and lapatinib), trastuzumab remains the gold standard for treatment of this disease subtype. Nonetheless, concerns have been raised regarding potential cardiotoxicity and treatment resistance. Moreover, several other therapeutic issues remain unclear and have been addressed in an inconsistent way. The current literature lacks a comprehensive review of trastuzumab providing useful information for clinical practice, including pharmacokinetic and pharmacodynamic aspects, its clinical use, existing controversies and future advances. This detailed review of trastuzumab in the pharmacotherapy of BC attempts to fill this gap. info:eu-repo/semantics/publishedVersion

Background Underuse of medication considered beneficial is particularly common in elderly patients. A new Screening Tool to Alert Doctors to the Right Treatment (START) has been published to identify potential prescribing omissions. Objective To quantify and characterize potential prescribing omissions of cardiovascular risk management therapy using START criteria. Setting This study was conducted in the Stroke Unit of the university teaching hospital of Cova da Beira Hospital Centre, Covilha, located in the Eastern Central Region of Portugal. Method During 6 months, the medical files of all elderly patients (age ≥ 65 years) admitted with acute cardiovascular disease were reviewed and the START criteria applied to the information of medication, at admission and at the time of discharge from the hospital Stroke Unit. Main outcome measure Potential prescribing omissions of cardiovascular and endocrine pharmacological therapy were identified and the difference in the potential prescribing omissions between admission and discharge from hospital Stroke Unit was also evaluated. Results At the time of admission to the Stroke Unit, 101 potential prescribing omissions were found in 68.1 % (n = 91) of elderly (average 1.11 omissions per patient), of which 84.2 % (n = 85) were corrected at the time of discharge. In 14 patients, 16 omissions found at admission were not corrected during hospitalization, and in 5 patients 5 new omissions were detected. Conclusion Prescribing omissions of beneficial drugs are highly prevalent in acutely ill admitted to a Stroke Unit. START criteria represent a simple, evidence-based and easy-to-use tool to screen underuse of cardiovascular risk management therapy in elderly patients.