RESUMO
INTRODUCTION: With the widespread use of anti-programmed death-1 monoclonal antibodies, such as pembrolizumab, rare side effects appear in clinical practice. CASE REPORT: We report the case of a man diagnosed with non-keratinizing squamous lung carcinoma stage IVB with programmed death-ligand 1 70% who developed agranulocytosis 10 days after a single dose of pembrolizumab as monotherapy. MANAGEMENT AND OUTCOME: Pembrolizumab was discontinued immediately. Grade 4 neutrophil decrease is mentioned in the product information sheet as a rare side effect. The patient was admitted in poor physical condition with grade 4 neutropenic fever, mucositis and anemia. Agranulocytosis did not improve despite treatment with granulocyte colony-stimulating factor, intravenous corticosteroids and intravenous immunoglobulins. He experienced a rapid worsening and died 3 weeks after admission. The causal relationship between pembrolizumab and the appearance of agranulocytosis was determined as possible according to Naranjo's modified Karch and Lasagna's imputability algorithm. DISCUSSION: Hematologic immune-related adverse events are uncommon but important side effects among patients treated with immune checkpoint inhibitors. Agranulocytosis and neutropenia are infrequently reported but can be life-threatening. The main approach for agranulocytosis consists of intravenous corticosteroids, granulocyte colony-stimulating factors and blood products. Depending on bone marrow characteristics, treatments for refractory patients include intravenous immunoglobulins or cyclosporine. After an immune-related adverse event, benefits and risks must be considered before continuation with an immune checkpoint inhibitor. Detection and communication of adverse drug reactions to the Pharmacovigilance Systems have special relevance for rare side effects.
Assuntos
Agranulocitose , Anticorpos Monoclonais Humanizados , Neoplasias Pulmonares , Humanos , Masculino , Agranulocitose/induzido quimicamente , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos Imunológicos/efeitos adversos , Antineoplásicos Imunológicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma de Células Escamosas/tratamento farmacológico , Evolução Fatal , Neoplasias Pulmonares/tratamento farmacológicoRESUMO
INTRODUCTION: Capmatinib is a mesenchymal-epithelial transition (MET) inhibitor authorized for metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutation treatment in adult patients. CASE REPORT: We report a case of an elderly female with a diagnosis of metastatic NSCLC with MET exon 14 skipping mutation who developed a severe hepatotoxicity after 7 weeks under treatment with capmatinib. MANAGEMENT & OUTCOME: Capmatinib was immediately discontinued. Hepatotoxicity is included as "warning and precautions" in the product information sheet. The patient was admitted with severe acute hepatitis, secondary hypocoagulability and acute deterioration of renal function. She experienced a rapid worsening with a fatal outcome three days after admission. The causal relationship between capmatinib and the appearance of hepatotoxicity was determined as probable according to Naranjo's modified Karch and Lasagna's imputability algorithm. DISCUSSION: The recognition and diagnosis of drug-induced liver injury (DILI) are often difficult and delayed. Molecularly targeted agents require careful assessment of liver function both prior to and during therapy. Capmatinib hepatotoxicity is an infrequent but severe adverse drug reaction (ADR). Prescribing information includes recommendations about liver function monitoring. The main approachment for DILI is the removal of the causative agent. Detection and communication of ADRs to the Pharmacovigilance Systems have special relevance for novel drugs, with little data in real life setting.
Assuntos
Carcinoma Pulmonar de Células não Pequenas , Doença Hepática Induzida por Substâncias e Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias Pulmonares , Adulto , Humanos , Feminino , Idoso , Carcinoma Pulmonar de Células não Pequenas/genética , Neoplasias Pulmonares/tratamento farmacológico , Doença Hepática Induzida por Substâncias e Drogas/etiologia , MutaçãoRESUMO
Telepharmacy is defined as the practice of remote pharmaceutical care, using information and communication technologies. Given its growing importance in outpatient pharmaceutical care, the Spanish Society of Hospital Pharmacy developed a consensus document, Guía de entrevista telemática en atención farmacéutica, as part of its strategy for the development and expansion of telepharmacy, with key recommendations for effective pharmacotherapeutic monitoring and informed dispensing and delivery of medications through telematic interviews. The document was developed by a working group of hospital pharmacists with experience in the field. It highlights the benefits of telematic interviewing for patients, hospital pharmacy professionals, and the healthcare system as a whole, reviews the various tools for conducting telematic interviews, and provides recommendations for each phase of the interview. These recommendations cover aspects such as tool/platform selection, patient selection, obtaining authorization and consent, assessing technological skills, defining objectives and structure, scheduling appointments, reviewing medical records, and ensuring humane treatment. Telematic interview is a valuable complement to face-to-face consultations but its novelty requires a strategic and formal framework that this consensus document aims to cover. The use of appropriate communication tools and compliance with recommended procedures ensure patient safety and satisfaction. By implementing telematic interviews, healthcare institutions can improve patient care, optimize the use of resources and promote continuity of care.
Assuntos
Serviço de Farmácia Hospitalar , Telemedicina , Humanos , Serviço de Farmácia Hospitalar/organização & administração , Entrevistas como Assunto , Sistemas de Liberação de Medicamentos , FarmacêuticosRESUMO
Telepharmacy is defined as the practice of remote pharmaceutical care, using information and communication technologies. Given its growing importance in outpatient pharmaceutical care, the Spanish Society of Hospital Pharmacy developed a consensus document, "Guía de entrevista telemática en atención farmacéutica," as part of its strategy for the development and expansion of telepharmacy, with key recommendations for effective pharmacotherapeutic monitoring and informed dispensing and delivery of medications through telematic interviews. The document was developed by a working group of hospital pharmacists with experience in the field. It highlights the benefits of telematic interviewing for patients, hospital pharmacy professionals, and the healthcare system as a whole, reviews the various tools for conducting telematic interviews, and provides recommendations for each phase of the interview. These recommendations cover aspects such as tool/platform selection, patient selection, obtaining authorization and consent, assessing technological skills, defining objectives and structure, scheduling appointments, reviewing medical records, and ensuring humane treatment. Telematic interview is a valuable complement to face-to-face consultations but its novelty requires a strategic and formal framework that this consensus document aims to cover. The use of appropriate communication tools and compliance with recommended procedures ensure patient safety and satisfaction. By implementing telematic interviews, healthcare institutions can improve patient care, optimize the use of resources and promote continuity of care.
Assuntos
Serviço de Farmácia Hospitalar , Telemedicina , Humanos , Serviço de Farmácia Hospitalar/organização & administração , Entrevistas como Assunto , Consenso , Monitoramento de Medicamentos/métodos , Sistemas de Liberação de Medicamentos , FarmacêuticosRESUMO
OBJECTIVE: To evaluate adherence and quality of life to oral antineoplastic treatment in patients with chronic lymphocytic leukemia. To compare adherence and QoL according to treatment subgroups and treatment-line subgroups. METHODS: We conducted a descriptive prospective study from June to November 2021 in a tertiary care hospital. Patients treated at the Oncology Pharmacy with a diagnosis of chronic lymphocytic leukemia and treatment with oral antineoplastics for at least 6 months before inclusion in the study were included. Adherence was assessed using Morisky's 8 item Medication Adherence Scale and leftover pills counts, considering adherents if their adherence rate was ≥ 90%. Quality of life was assessed with Euro-Qol EQ-5D-3L questionnaire, Functional Assessment of Chronic Illness Therapy - Fatigue scale and QLQ-C30 questionnaire from European Organization for Research and Treatment of Cancer. Two interviews were scheduled: at the time of inclusion and at 3 months. Variable collected: demographic data, clinical data (disease and treatment); and response (scores obtained from questionnaires and adherence rate). The data statistical analysis was carried out with SPSS® 25.0 software. RESULTS: Twenty three patients were included, all of them showed an adherence rate higher than 90%; 20 patients were considered high adherent, and 3 patients medium adherent to treatment according to Morisky's 8 item Medication Adherence Scale. The results of the EQ-5D-3L questionnaire showed that the patients were all of them autonomous in their personal care and daily activities, 69.6% did not have any mobility problems and 78.3% did not have anxiety/depression; 56.5% had some type of pain. Eighteen patients had no fatigue, and 5 had mild/moderate fatigue according to Functional Assessment of Chronic Illness Therapy - Fatigue scale. The results of the EORTC QLQ-C30 questionnaire showed that patients had a high /healthy functional level, a good quality of life and a low level of symptoms. Analysis by treatment subgroups and by treatment-line subgroups did not show statistically significant differences in adherence or quality of life. CONCLUSIONS: Patients diagnosed with chronic lymphocytic leukemia and treated with oral antineoplastic therapies showed a high adherence rate and referred a good quality of life.
Assuntos
Antineoplásicos , Leucemia Linfocítica Crônica de Células B , Humanos , Qualidade de Vida , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Estudos Prospectivos , Antineoplásicos/efeitos adversos , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To evaluate adherence and quality of life to oral antineoplastic treatment in patients with chronic lymphocytic leukemia. To compare adherence and quality of life according to treatment subgroups and treatment-line subgroups. METHODS: We conducted a descriptive prospective study from June to November 2021 in a tertiary care hospital. â¯Patients with chronic lymphocytic leukaemia, seen at the Oncology Pharmacy and treated with oral antineoplastic drugs for at least 6 months prior to inclusion in the study were included. Adherence was assessed using Morisky's 8 item Medication Adherence Scale and leftover pills counts, considering adherents if their adherence rate was ≥90%. Quality of life was assessed with Euro-Qol EQ-5D-3L questionnaire, Functional Assessment of Chronic Illness Therapy - Fatigue scale and QLQ-C30 questionnaire from European Organization for Research and Treatment of Cancer. Two interviews were scheduled: at the time of inclusion and at 3â¯months. The clinical history was reviewed and demographic and clinical variables were collected. The data statistical analysis was carried out with SPSS® 25.0 software. RESULTS: Twenty three patients were included, all of them showed an adherence rate higher than 90%; 20 patients were considered high adherent, and 3 patients médium adherent to treatment according to Morisky's 8 item Medication Adherence Scale. The results of the EQ-5D-3L questionnaire showed that the patients were all of them autonomous in their personal care and daily activities, 69.6% did not have any mobility problems and 78.3% did not have anxiety/depression; 56.5% had some type of pain. Eighteen patients had no fatigue, and 5 had mild/moderate fatigue according to Functional Assessment of Chronic Illness Therapy - Fatigue scale. The results of the EORTC QLQ-C30 questionnaire showed that patients had a high /healthy functional level, a good quality of life and a low level of symptoms. Analysis by treatment subgroups and by treatment-line subgroups did not show statistically significant differences in adherence or quality of life. CONCLUSIONS: Patients diagnosed with chronic lymphocytic leukemia and treated with oral antineoplastic therapies showed a high adherence rate and referred a good quality of life.
Assuntos
Antineoplásicos , Leucemia Linfocítica Crônica de Células B , Humanos , Qualidade de Vida , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Estudos Prospectivos , Antineoplásicos/efeitos adversos , Inquéritos e QuestionáriosRESUMO
The Spanish Society of Hospital Pharmacy Position Paper on Telepharmacy states that the inclusion of patients should take into account ethical considerations and, therefore, be based on the concept of equity. Thus, it establishes that Telepharmacy should not be limited to specific pathologies or medicines, but should be based on the individual needs of each patient: it also highlights the need to rely on selection or prioritisation models to help identify patients who can benefit from Telepharmacy. The aim of this article is to present the Spanish Society of Hospital Pharmacy Telepharmacy Patient Prioritisation Model, which establishes key recommendations and a reference prioritisation model to guide hospital pharmacists in the identification and prioritisation of patients who are candidates for inclusion in Telepharmacy programmes. This model was developed based on the experience of a group of experts in their clinical practice as well as on a review of the main reference documents available in this field. It comprises 25 criteria, grouped into 8 minimum inclusion criteria, 5 continuity criteria, and 12 recommended criteria. The latter criteria are divided into high, medium, and low priority criteria. Patients are prioritised according to their scores on meeting the recommended criteria, such that those with the highest scores are given the highest priority. As stated in the Spanish Society of Hospital Pharmacy Position Paper on Telepharmacy, pharmacotherapeutic monitoring can be conducted via remote consultation without sending medication, but not vice versa; thus, the 25 criteria defined apply to Telepharmacy programmes in the area of the remote dispensing and informed delivery of medicines, but only 19 of them apply to pharmacotherapeutic monitoring programmes. The model presented is intended to be a reference guide and should be adapted to the particular characteristics and circumstances of each pharmacy service, depending on demand and available resources.
La Sociedad Española de Farmacia Hospitalaria, en su Documento de osicionamiento sobre Telefarmacia, establece que la inclusión de pacientes debe tener en cuenta consideraciones éticas y, por tanto, estar basada en el concepto de equidad. Por ello, establece que la Telefarmacia no debe restringirse por patologías ni medicamentos, sino en función de las necesidades individuales de cada paciente, y destaca la necesidad de apoyarse en modelos de selección o priorización que ayuden en la identificación de los pacientes que puedan beneficiarse de la Telefarmacia. El objetivo de este artículo es presentar el "Modelo de priorización de pacientes en Telefarmacia de la Sociedad Española de Farmacia Hospitalaria", que pretende establecer recomendaciones clave y un modelo de priorización de referencia que sirva de orientación a los farmacéuticos especialistas en farmacia hospitalaria para la identificación y priorización de pacientes candidatos a ser incluidos en programas de Telefarmacia. El modelo a sido desarrollado en base a la experiencia de un grupo de expertos en su práctica clínica y a la revisión de los principales documentos de referencia disponibles en este ámbito y está conformado por un total de 25 criterios, agrupados en 8 criterios mínimos de inclusión, 5 criterios de continuidad y 12 criterios recomendables. Estos últimos se dividen en criterios de alta, media y baja prioridad. En función de las puntuaciones obtenidas del cumplimiento de los criterios recomendables, se establece el orden de prioridad de pacientes, de modo que aquellos que mayor puntuación obtengan serán los más prioritarios. Tal como recoge el "Documento de Posicionamiento sobre Telefarmacia de la Sociedad Española de Farmacia Hospitalaria", puede haber seguimiento farmacoterapéutico por teleconsulta sin envío de medicación, pero no al contrario, por lo que los 25 criterios definidos aplican a programas de Telefarmacia en el ámbito de la dispensación y entrega informada de medicamentos a distancia, pero solamente 19 de ellos aplican para los programas de seguimiento farmacoterapéutico. El modelo que se presenta ha sido concebido como un marco de referencia y deberá adaptarse a las características y circunstancias particulares de cada servicio de farmacia, en función de la demanda y de los recursos disponibles.
Assuntos
Serviço de Farmácia Hospitalar , Telemedicina , Humanos , Farmacêuticos , Pacientes InternadosRESUMO
OBJECTIVES: Several studies have reported the role of immune-related adverse events as a predictor of clinical benefit, but few have properly described these findings in advanced or metastatic non-small cell lung cancer treated with pembrolizumab. This study aimed to evaluate the association between immune-related adverse events development and clinical outcomes in the aforementioned group of patients. METHODS: We conducted a retrospective study in patients with advanced or metastatic non-small cell lung cancer treated with pembrolizumab. Overall response rate, progression-free survival and overall survival were evaluated according to the appearance, subtype and number of immune-related adverse events developed. We report the results of the immune-related adverse events analysis and the potential correlation between immune-related adverse events and clinical outcomes. Univariate and multivariate analyses were performed to evaluate this relationship. RESULTS: A total of 94 patients were analysed; 60 of them developed immune-related adverse events. Patients with immune-related adverse events had a significantly higher overall response rate compared with the non-immune-related adverse events group (34% vs 8.5%, χ2=0.005). Median progression-free survival was statistically significant in favour of patients with at least one immune-related adverse event (p=0.015). Median overall survival was not reached in patients with ≥1 immune-related adverse events, compared with 8 months (95% CI 0.6 to 15.4 months) in those without immune-related adverse events. Patients who developed ≥2 immune-related adverse events had longer median progression-free survival (11 vs 4 months, not statistically significant) and overall survival (not reached vs 11, p=0.022) compared with those with ≤1 immune-related adverse events. CONCLUSIONS: Obtained data showed that patients with immune-related adverse events occurrence had significantly better overall response rate and longer progression-free survival and overall survival. This study highlights the role of immune-related adverse events as a predictor of survival in a real-life setting.