Incidence and characteristics of adverse drug reactions in a cohort of patients treated with PD-1/PD-L1 inhibitors in real-world practice.

Background: Data related to adverse drug reactions (ADRs), specifically immune-related adverse events (irAEs), in long-term treatment with immunotherapy in real-world practice is scarce, as is general information regarding the management of ADRs. Objectives: To characterize and describe the incidence of ADRs in patients who began immunotherapy treatment in clinical practice. Methods: In a prospective observational study cancer patients ≥18 years of age who were treated with a monotherapy regime of PD-1/PD-L1 inhibitors were evaluated. The study period was from November 2017 to June 2019 and patients were followed up until June 2021. Patients were contacted monthly by telephone and their electronic health records were reviewed. Each ADR was graded according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). Results: Out of 99 patients, 86 met the inclusion criteria. Most were male (67.4%), with a median age of 66 (interquartile range, IQR: 59-76). The most frequent cancer was non-small cellular lung cancer (46 cases, 53.5%), followed by melanoma (22, 25.6%). A total of 74 patients (86%) were treated with anti-PD-1 drugs and 12 (14%) were treated with anti-PD-L1 drugs. The median treatment durations were 4.9 (IQR: 1.9-17.0) and 5.9 months (IQR: 1.2-12.3), respectively. Sixty-three patients (73%) developed from a total of 156 (44% of the total number of ADR) irADRs, wherein the most frequent were skin disorders (50 cases, 32%, incidence = 30.5 irADRs/100 patients per year [p-y]), gastrointestinal disorders (29, 19%, 17.7 irADRs/100 p-y), musculoskeletal disorders (17, 11%, 10.4 irADRs/100 p-y), and endocrine disorders (14, 9%, 8.6 irADRs/100 p-y). A total of 22 irADRs (14%) had a latency period of ≥12 months. Twelve irADRs (7.7%) were categorized as grade 3-4, and while 2 (1.3%) were categorized as grade 5 (death). Sixty-one irADRs (39.1%) in 36 patients required pharmacological treatment and 47 irADRs (30.1%) in 22 patients required treatment with corticosteriods. Conclusion: The majority of patients treated with anti-PD1/PDL1-based immunotherapy experienced adverse reactions. Although most of these reactions were mild, 11.5% were categorized as grade 3 or above. A high percentage of the reactions were immune-related and occurred throughout the treatment, thereby indicating that early identification and close monitoring is essential.

Incompatibilidades en la terapia intravenosa: ¿qué hacer para prevenirlas? / Incompatibilities in intravenous therapy: What can be done to prevent them?

La administración de medicamentos por vía intravenosa es frecuente en el ámbito hospitalario e indispensable si se precisa inicio rápido del efecto farmacológico o no se pueda utilizar otra vía de administración. La elección de la vía intravenosa conlleva unos riesgos asociados, como la aparición de incompatibilidades entre los fármacos administrados. La incompatibilidad es la reacción físico-química no deseada que se produce cuando dos o más medicamentos son mezclados y el producto resultante puede afectar a la eficacia y a la seguridad de la terapia. Estas incompatibilidades se consideran un error de medicación, y conocer sus fundamentos puede ayudar a prevenir su aparición disminuyendo así los riesgos. El presente artículo describe el tipo de incompatibilidades, da ejemplos para algunos fármacos frecuentemente utilizados en la terapia intravenosa cuando se administran en sistema en “Y” y explica los factores relacionados en la producción. Se revisa la información sobre la base teórica que facilita la comprensión de los mecanismos que intervienen en su producción. También se proponen actividades que puede desarrollar enfermería para prevenirlas y que debería incorporar en la planificación del tratamiento farmacológico. La rápida incorporación de nuevos fármacos en el régimen terapéutico de los pacientes obliga al profesional de enfermería a revisar y a actualizar el conocimiento de las incompatibilidades entre los fármacos que maneja. La fácil accesibilidad a fuentes de información fiables por parte de enfermería es una estrategia fundamental que permite la puesta al día y la prevención de los riesgos asociados (AU)

In hospitals, the administration of drugs intravenous is very common and essential in cases where there is a need for rapid onset of pharmacological effect or another administration route cannot be used. The intravenous route may entail risks, such as the incompatibility between the drugs administered. Incompatibility is any unwanted physicochemical reaction that occurs when two or more drugs are mixed and where the resulting product can affect the efficacy and safety of therapy. This phenomenon is considered a medication error and a basic knowledge of this can help prevent its onset, thus reducing the risks. This article describes the types of incompatibilities, gives examples of some drugs commonly used in intravenous therapy in the management of type “Y” and examine the factors related to the occurrence of this event. We review the information on the theoretical basis that aids understanding of the mechanisms involved in their production. This article describes interventions that nursing staff can take to prevent the incompatibility, and should be incorporated in planning the pharmacological treatment of patient in nursing care. The rapid incorporation of new drugs in the therapeutic regime requires nursing professionals to constantly review and update their knowledge on the incompatibility between the drugs that are under their care. Thus, access to sources of reliable information by the nurse, is a key strategy, which will keep them updated and can prevent the risks associated with the occurrence of this unwanted event (AU)

[Incompatibilities in intravenous therapy: What can be done to prevent them?]. / Incompatibilidades en la terapia intravenosa: ¿qué hacer para prevenirlas?

In hospitals, the administration of drugs intravenous is very common and essential in cases where there is a need for rapid onset of pharmacological effect or another administration route cannot be used. The intravenous route may entail risks, such as the incompatibility between the drugs administered. Incompatibility is any unwanted physicochemical reaction that occurs when two or more drugs are mixed and where the resulting product can affect the efficacy and safety of therapy. This phenomenon is considered a medication error and a basic knowledge of this can help prevent its onset, thus reducing the risks. This article describes the types of incompatibilities, gives examples of some drugs commonly used in intravenous therapy in the management of type "Y" and examine the factors related to the occurrence of this event. We review the information on the theoretical basis that aids understanding of the mechanisms involved in their production. This article describes interventions that nursing staff can take to prevent the incompatibility, and should be incorporated in planning the pharmacological treatment of patient in nursing care. The rapid incorporation of new drugs in the therapeutic regime requires nursing professionals to constantly review and update their knowledge on the incompatibility between the drugs that are under their care. Thus, access to sources of reliable information by the nurse, is a key strategy, which will keep them updated and can prevent the risks associated with the occurrence of this unwanted event.

[Adverse drug reactions. Detection]. / Reacciones adversas a medicamentos. Detección.

Adverse reactions to medications create an important health problem and a nursing professional must assume his/her role in detecting them early on, in identifying them, in educating the public about them, in treating them, and finally in serving notice of them. In order to ease the identification of adverse effects which patients may present, the authors provide general information about adverse reactions and factors related to a greater risk occurrence of those reactions. Based on a practical case, the authors respond to five questions on features having casual relationship between a pharmaceutical product and an adverse reaction by means of which it is possible to define the plausibility of suspected adverse effects. By using this simple reasoning method, nurses will be capable of having a grounded criteria in relation to adverse reactions which a patient can present and thus contribute to decision making by the professional team as to what is the procedure to follow.

Reacciones adversas a medicamentos. Detección / Detection of adverse reactions to medication

Las reacciones adversas a medicamentos constituyen un problema de salud importante y el profesional de enfermería debe asumir su rol en la detección precoz, en la identificación, educación, actuación y finalmente en la notificación de éstas. Con el objetivo de facilitar la identificación de efectos adversos que pueden presentar los pacientes se proporciona información general sobre reacciones adversas y factores relacionados con mayor riesgo de aparición. A partir de un caso práctico, se responde a cinco preguntas de atribución de relación causal entre fármaco y reacción adversa, gracias a las cuales se puede llegar a definir la plausibilidad de una sospecha de efecto adverso. Utilizando este sencillo método de razonamiento Enfermería será capaz de tener un criterio fundamentado con relación a la reacción adversa que presenta el paciente, contribuyendo a la toma de decisiones en el equipo sobre la conducta a seguir. (AU)