Quimioterapia antineoplásica frente al cáncer de mama en mujeres embarazadas: Prevención de Extravasaciones / Antineoplastic chemotherapy against breast cancer in pregnant women: Extravasation Prevention

El cáncer gestacional se puede definir como el cáncer que ocurre durante el embarazo o durante el primer año posterior al parto. Entre ellos, el cáncer de mama ocupa el primer lugar en frecuencia con una incidencia en aumento y que se sitúa cerca de 1 por cada 3.000 mujeres embarazadas. En la mujer embarazada el diagnóstico de cáncer representa un desafío en términos de manejo clínico, debido a la necesidad de garantizar la seguridad materna y asegurar el estado de gestación. Este tiende a retrasarse y detectarse en estadios más tardíos debido a que los síntomas asociados pueden relacionarse fácilmente con una situación normal de gestación. Las embarazadas diagnosticadas de cáncer deben ser evaluadas por un comité multidisciplinario de tumores, especializado en cáncer durante el embarazo. Uno de los tratamientos utilizados para el abordaje del cáncer de mama es la quimioterapia antineoplásica, que debe ser administrada en un hospital, atendiendo a diferentes factores como son el estado general del paciente, las posibles enfermedades previas, el tipo, estadio y localización del tumor, así como la semana de gestación en la que se encuentra la mujer. A partir de la semana 13-14 de gestación puede iniciarse el tratamiento, siendo los regímenes más utilizados a día de hoy: ciclos de 3 semanas de FAC (5-fluorouracilo, doxorrubicina y ciclofosfamida), FEC (5-fluorouracilo, epirubicina y ciclofosfamida), AC (doxorrubicina y ciclofosfamida) y EC (epirubicina y ciclofosfamida) o epirubicina semanal como monoterapia. Asimismo, destaca el uso de los taxanos (paclitaxel como agente único). La enfermera constituye un pilar fundamental dentro del equipo multidisciplinario de tumores, especializado en cáncer de mama durante el embarazo, que atenderá y acompañará a la embarazada durante todo el proceso de la enfermedad. El cáncer de mama, y más en la embarazada, conlleva una serie de cambios en su vida que requieren diferentes procesos de adaptación física, psicológica y social (AU)

Gestational cancer can be defined as cancer that occurs during pregnancy or within the first year after delivery. Among them, breast cancer occupies the first place in frequency with an increasing incidence that is situated at about 1 per 3.000 pregnant women. In pregnant women, the diagnosis of cancer represents a challenge in terms of clinical management, due to the need to guarantee maternal safety and ensure the state of pregnancy. This tends to be delayed and detected at later stages because the associated symptoms can be easily related to a normal pregnancy situation. Pregnant women diagnosed with cancer should be evaluated by a multidisciplinary tumor team, specialized in cancer during pregnancy. One of the treatments used to address breast cancer is antineoplastic chemotherapy, which must be administered in a hospital, taking into account different factors such as the general condition of the patient, possible previous diseases, the type, stage and location of the tumor, as well as the week of gestation in which the woman is. Treatment can be started from week 13-14 of gestation, the most widely used regimens to date are: 3-week cycles of FAC (5-fluorouracil, doxorubicin and cyclophosphamide), FEC (5-fluorouracil, epirubicin and cyclophosphamide), AC (doxorubicin and cyclophosphamide) and EC (epirubicin and cyclophosphamide) or weekly epirubicin as monotherapy. Likewise, the use of taxanes (paclitaxel as a single agent) stands out. The nurse is a fundamental pillar within the multidisciplinary team of tumors, specialized in breast cancer during pregnancy, who will care for and accompany the pregnant woman throughout the disease process. Breast cancer, and more in pregnant women, entails a series of changes in their lives that require different processes of physical, psychological and social adaptation. (AU)

Face-to-face and online teaching experience on experimental animals and alternative methods with nursing students: a research study.

BACKGROUND: Animal models are increasingly used in Nursing science to study care approaches. Despite the scientific relevance and the ethical debate surrounding the use of experimental animals, there is a scarcity of scholarly literature exploring this topic in Nursing Schools. AIM: To evaluate perceptions and attitudes of nursing students enrolled in a Pharmacology course on the use of experimental animals and implementation of alternative methods, by comparing the experience for two academic years. An interdisciplinary collaboration has also been developed. METHODS: A descriptive cross-sectional, quantitative study was developed. Undergraduate nursing students were enrolled in the Pharmacology subject at the University of Leon (Spain). The study was carried out in the Pharmacology facilities. Students followed a two-session practical class regarding experimental animals and alternative methods in the Pharmacology course (Degree in Nursing) in two different academic years (2019-20/2020-21). At the end of the activity, they answered a questionnaire to assess their opinions on the use of experimental animals and alternative methods in Pharmacology and the 3Rs principle. RESULTS: A comparison of the students' perception with and without direct participation in the evaluation of promazine effects in mice was made. A total of 190 students participated in the teaching experience, providing high scores in all items (4-5 out of 5 points) regarding the teaching experience. Students became also aware of the advantages and disadvantages on the use of experimental animals, as well as the ethical considerations to bear in mind for their use and the need for alternative methods. CONCLUSIONS: In the students' opinion, the total replacement of animals by alternative techniques was very difficult, and they preferred to do the practice face-to-face. The alternative method designed was useful for the students to accept the employment of experimental animals in biomedical research and education, and know the legislation applied in the protection of animals.

Detección de la prescripción inadecuada en personas mayores. Papel de la enfermera / Detection of inappropriate prescription in elderly patients. Role of the nurse

En las últimas décadas se han producido una serie de cambios a nivel sanitario y farmacológico que han aumentado la esperanza de vida de la sociedad, dando lugar a un notable incremento de personas mayores.El envejecimiento progresivo junto con las comorbilidades asociadas, se traduce en un perfil de paciente susceptible de sufrir polimedicación y, por consiguiente, fenómenos tales como prescripción inadecuada, reacciones adversas a medicamentos o interacciones farmacológicas. Esta situación genera la mayor parte de las admisiones hospitalarias en personas de más de 65 años, lo que conlleva un aumento del empleo de los recursos sanitarios y un incremento del gasto farmacéutico.Para poder optimizar las prescripciones en los pacientes mayores pluripatológicos, reduciendo la prescripción potencialmente inadecuada y las reacciones adversas a medicamentos, existen diversas herramientas a nivel mundial. Estas las podemos englobar en dos grandes grupos, por una parte, los métodos implícitos que se basan en juicios críticos y, por otro lado, los métodos explícitos en los cuales se emplean criterios definidos basados en datos científicos y creados por grupos de expertos a través de métodos de generación de consenso, generalmente método Delphi. Los criterios STOPP/START representan el método explícito más adecuado para la detección de prescripción potencialmente inadecuada en comparación con el resto de herramientas disponibles, aunque continúan las investigaciones con el objetivo de optimizarse. (AU)

In the last decades there have been a series of changes at the health and pharmacological level that have increased the life expectancy of society, leading to a notable increase in the number of seniors.Progressive aging with associated comorbidities, translates into a patient profile susceptible to polymedication and therefore, phenomena such as inappropriate prescription, adverse drug reactions or drug interactions. This situation generates the majority of hospital admissions in people over 65 years, which leads to an increase in the use of healthcare resources and an increase in pharmaceutical spending.In order to optimize prescriptions in multipathological senior patients, reducing potentially inappropriate prescription and adverse drug reactions, there are various tools worldwide. These can be grouped into two large groups, on the one hand, the implicit methods that are based on critical judgments, and on the other hand, the explicit methods in which defined criteria based on scientific data and created by groups of experts through consensus-building methods, usually the Delphi. The STOPP / START criteria represent the most appropriate explicit method for the detection of potentially inappropriate prescription compared to the rest of the available tools, although research continues with the aim of optimization. (AU)

Medicamentos genéricos, ¿equivalentes a los de referencia? ¿qué está sucediendo? / Generic drugs, equivalent to reference drugs? What is happening?

La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha emitido en los últimos meses una serie de alertas sanitarias retirando del mercado diversos lotes de medicamentos genéricos que contenían el principio activo valsartán, y más recientemente al irbesartán, debido a la presencia de una impureza, la N-nitrosodimetila-mina (NDMA), una sustancia tóxica para el hígado y probablemente carcinogénica. Como consecuencia de esta situación, se ha avivado la polémica que las diferencias entre medicamentos genéricos e innovadores despierta en la opinión pública y en algunos ámbitos profesionales. Los medicamentos genéricos con-tienen los mismos principios activos y se presentan en la misma forma farmacéutica, comparten calidad, seguridad y eficacia, y están sometidos a los mismos controles que los de referencia. Sin embargo, mientras que para acreditar la eficacia y la seguridad de un medicamento de referencia es necesario realizar ensayos clínicos, los genéricos pueden hacerlo demostrando su bioequivalencia con un medicamento ya autorizado. Las alertas emitidas demuestran que el sistema de control rutinario de fármacos funciona bien, pero también ha servido para dar un aviso a las administraciones públicas, quienes deben comprender que no se puede centrar la política de medicamentos únicamente en el ahorro y en precios bajos, ya que esto muchas veces conlleva riesgos para los con-sumidores. Sin duda, deben intensificarse tan-to las regulaciones sanitarias como la farmacovigilancia, para poder identificar a tiempo este tipo de riesgos sanitarios y prevenirlos o, al menos, reducirlos

The Spanish Agency for Medicines and Health Products (AEMPS) has issued a series of health alerts in the last few months removing from the market several batches of generic medicines containing the active ingredient valsartan, and more recently irbesartan, due to the presence of an impurity, N-nitrosodimethylamine (NDMA), toxic to the liver and probably carcinogenic. As a result of this situation, the controversy that the differences between generic and innovative medicines arouse in public opinion and in some professional fields has been stoked. Generic medicines contain the same active ingredients and are presented in the same pharmaceutical form, share quality, safety and efficacy, and are subject to the same controls as the reference ones. However, while accrediting the efficacy and safety of a reference medicine requires clinical trials, generics can do so by demonstrating their bioequivalence with an already authorized medicine. The warnings issued show that the routine drug control system works well, but it has also served to give notice to public administrations, who must understand that the drug policy can not be focused solely on savings and low prices, since that this often entails risks for consumers. Undoubtedly, both sanitary regulations and pharmacovigilance must be intensified in order to identify these types of health risks in time and prevent them or, at least, reduce them

Situación actual de la prescripción enfermera en España / Current situation of the nursing prescription in Spain

La prescripción enfermera es un tema que ha generado controversia en los últimos años. Desde hace tiempo, se viene reclamando un apoyo legal para esta tarea que las enfermeras asumen de manera habitual en su práctica clínica. Las enfermeras realizan tareas asistenciales relacionadas con pacientes crónicos, cuidados paliativos, de atención domiciliaria o de otros procesos y, en muchas ocasiones, deben tomar decisiones sin ningún respaldo legal. La primera regulación en España que hace referencia a la capacidad de las enfermeras para indicar, usar y dispensar determinados medicamentos y productos sanitarios de forma autónoma aparece en la Ley 28/2009, que modificaba la ley de garantías y uso racional de los medicamentos. En ella, también se hacía referencia a que el gobierno regularía esta competencia. El desarrollo de esta normativa no se produjo hasta el año 2015 con el Real Decreto 954/2015, que niega la posibilidad de la prescripción enfermera autónoma y genera de nuevo controversia. En los últimos meses se ha llegado a un acuerdo para modificar este real decreto, de manera que, una vez que se publique en el BOE, las enfermeras podrán prescribir en el ámbito de sus competencias, lo que supondrá el reconocimiento de sus competencias en la práctica profesional y un beneficio tanto para los pacientes como para el sistema sanitario

The nursing prescription is a subject that has generated controversy in recent years. For some time now, legal support has been demanded for this task which nurses usually assume in their clinical practice. The nurses perform care tasks related to chronic patients, palliative care, home care or other processes, and in many cases, they must make decisions without any legal backing. The first regulation in Spain that refers to the ability of nurses to indicate, use and dispense certain medicines and health products autonomously appears in Law 28/2009, which modified the law on guarantees and rational use of medicines. In it, reference was also made to the fact that the government would regulate this competence. The development of this regulation does not occur until 2015 with Royal Decree 954/2015, which denies the possibility of autonomous nurse prescription and generates new controversy. In recent months, an agreement has been reached to modify this royal decree so that, once it is published in the BOE, nurses may prescribe within the scope of their competences, which will mean the recognition of their skills in professional practice and a benefit for both patients and the health system

Correction to: Mixed-method tutoring support improves learning outcomes of veterinary students in basic subjects.

The original article [1] contains an error whereby Fig. 2a and b are mistakenly swapped with each other, and thus do not correspond to their correct respective sub-headings in the caption.

Mixed-method tutoring support improves learning outcomes of veterinary students in basic subjects.

BACKGROUND: Tutoring is a useful tool in the university teaching-learning binomial, although its development is impaired in large classes. Recent improvements in information and communication technologies have made tutoring possible via the Internet. The aim of this study was to evaluate the efficacy of mixed-method academic tutoring in two basic subjects in Veterinary Science studies at the University of León (Spain) to optimize the usefulness of tutoring support in the college environment. This quasi-experimental study was firstly carried out as a pilot study in a small group of tutored students of "Cytology and Histology" (CH) (47/186; 25.3%) and "Veterinary Pharmacology" (VP) (33/141; 23.4%) subjects, and was implemented in a large class of CH the next academic year (150 students) while comparing the results with those obtained in a previous tutorless course (162 students). Tutored students were given access to online questionnaires with electronic feedback on each subject. In addition to traditional tutoring carried out in both tutored and tutorless students, the pilot study included three sessions of face-to-face tutoring in order to monitor the progress of students. Its efficacy was assessed by monitoring students' examination scores and attendance as well as a satisfaction survey. RESULTS: Although the examination attendance rate in the pilot study was not significantly different between tutored and tutorless groups in both subjects, an increase for numerical scores in tutored groups was observed, with a significant higher final score in VP (p = 0.001) and in the CH practice exams (first term, p = 0.009; final, p = 0.023). Good and merit scores were also better in tutored students with significant differences in VP (p = 0.005). Students felt comfortable with the tutoring service (100% in CH; 91.7% in VP). Implementation of this additional support in CH also resulted in a significant increase of attendance at the final exam in tutored courses (87.3% versus 77.2%; p = 0.026), scaled (p = 0.001) and numerical scores (final score, p = 0.001). CONCLUSIONS: Online tutoring support, together with conventional teaching methods, may be a useful method to incorporate student-centered learning in basic subjects in Veterinary Science.

Evaluation of the Association Metformin: Plantago ovata Husk in Diabetic Rabbits.

In this experimental study we have investigated whether the inclusion of the dietary fiber Plantago ovata husk could be recommended as coadjuvant in treatments with oral hypoglycemic drugs. We evaluated the use of Plantago ovata husk-metformin association in diabetic rabbits by determining its effects on glucose and insulin concentrations. Six groups of 6 rabbits were used. Groups 1 to 3 were fed with standard chow and groups 4 to 6 with chow supplemented with Plantago ovata husk (3.5 mg/kg/day). Two groups (numbers 1 and 4) were used as controls (receiving standard or supplemented chow), two groups (numbers 2 and 5) received metformin orally, and the other two (numbers 3 and 6) were treated orally with metformin and psyllium. Plasma glucose concentrations were lower in groups fed with fiber-supplemented chow whereas insulin levels showed important interindividual variations. Glucose pharmacokinetics parameters showed significant differences in Cmax and t(max) in relation to fiber intake. Insulin pharmacokinetics parameters after treatment with oral metformin showed an important increase in Cmax, AUC, and t(max) in animals fed with fiber. We conclude that Plantago ovata husk intake can contribute to the oral antihyperglycemic treatment of type 2 diabetes.

A randomised clinical trial to evaluate the effects of Plantago ovata husk in Parkinson patients: changes in levodopa pharmacokinetics and biochemical parameters.

BACKGROUND: Plantago ovata husk therapy could be used in patients with Parkinson disease to reduce the symptoms of gastrointestinal disorders, but it is important to know whether this compound modifies levodopa pharmacokinetics. The maintenance of constant plasma concentrations of levodopa abolishes the clinical fluctuations in parkinsonian patients. The aim of this randomised clinical trial was to establish the influence of the fiber Plantago ovata husk in the pharmacokinetics of levodopa when administered to Parkinson patients well controlled by their oral medication. METHODS: To evaluate the effects of this fiber on several biochemical parameters. 18 volunteers participated in the study and received alternatively two treatments (Plantago ovata husk or placebo) with their usual levodopa/carbidopa oral dose. On days 0 (initial situation), 14 and 35 of the study, blood samples were taken to assess levodopa pharmacokinetics and to determine biochemical parameters. RESULTS: Levodopa Cmax was very similar in the initial situation (603.2 ng/ml) and after placebo administration (612.0 ng/ml), being slightly lower (547.8 ng/ml) when Plantago ovata husk was given. AUC was very similar in the three groups: initial situation.- 62.87 µg.min/ml, fiber treatment.- 64.47 µg.min/ml and placebo treatment.- 65.10 µg.min/ml. Fiber reduced significantly the number of peaks observed in the levodopa concentrations, maintaining concentrations more stable. No significant differences were found in total cholesterol, LDL-cholesterol and triglycerides with the administration of Plantago ovata husk. CONCLUSIONS: Plantago ovata husk administration caused a smoothing and homogenization of levodopa absorption, providing more stable concentrations and final higher levels, resulting in a great benefit for patients. TRIAL REGISTRATION: EudraCT2006-000491-33.

Enrofloxacin: pharmacokinetics and metabolism in domestic animal species.

Enrofloxacin is a fluorquinolone exclusively developed for use in veterinary medicine (1980). The kinetics of enrofloxacin are characterized, in general terms, by high bioavailability in most species and rapid absorption after IM, SC or oral administration. However, several studies reported that enrofloxacin showed low bioavailability after oral administration in ruminants. This drug has a broad distribution in the organism, excellent tissue penetration and long serum half-life. Also, enrofloxacin is characterized by a low host toxicity, a broad antibacterial spectrum and high bactericidal activity against major pathogenic bacteria (both Gram-positive and Gram-negative), and intracellular organisms found in diseased animals. The kinetics vary according to the route of administration, formulation, animal species, age, body condition, and physiological status, all of which contribute to differences in drug efficacy. The pharmacokinetic properties of drugs are closely related to their pharmacological efficiency, so it is important to know their behavior in each species that is used. This article reviews the pharmacokinetics of enrofloxacin in several domestic animal species.

Tissue distribution of enrofloxacin after intramammary or simulated systemic administration in isolated perfused sheep udders.

OBJECTIVE: To determine the tissue distribution of enrofloxacin after intramammary or simulated systemic administration in isolated perfused sheep udders by measuring its concentration at various sample collection sites. SAMPLE: 26 udders (obtained following euthanasia) from 26 healthy lactating sheep. PROCEDURES: For each isolated udder, 1 mammary gland was perfused with warmed, gassed Tyrode solution. Enrofloxacin (1 g of enrofloxacin/5 g of ointment) was administered into the perfused gland via the intramammary route or systemically via the perfusion fluid (equivalent to a dose of 5 mg/kg). Samples of the perfusate were obtained every 30 minutes for 180 minutes; glandular tissue samples were obtained at 2, 4, 6, and 8 cm from the teat base after 180 minutes. The enrofloxacin content of the perfusate and tissue samples was analyzed via high-performance liquid chromatography with UV detection. RESULTS: After intramammary administration, maximun perfusate enrofloxacin concentration was detected at 180 minutes and, at this time, mean tissue enrofloxacin concentration was detected and mean tissue enrofloxacin concentration was 123.80, 54.48, 36.72, and 26.42 µg/g of tissue at 2, 4, 6, and 8 cm from the teat base, respectively. Following systemic administration, perfusate enrofloxacin concentration decreased with time and, at 180 minutes, tissue enrofloxacin concentrations ranged from 40.38 to 35.58 µg/g of tissue. CONCLUSIONS AND CLINICAL RELEVANCE: By 180 minutes after administration via the intramammary or systemic route in isolated perfused sheep mammary glands, mean tissue concentration of enrofloxacin was greater than the minimum inhibitory concentration required to inhibit growth of 90% of many common mastitis pathogens in sheep. Use of either route of administration (or in combination) appears suitable for the treatment of acute mastitis in sheep.

Pharmacokinetic behavior of doxycycline after intramuscular injection in sheep.

OBJECTIVE: To determine the pharmacokinetics of a commercial formulation of doxycycline hyclate after IM administration of a single dose to sheep. ANIMALS: 11 healthy domestic sheep. PROCEDURES: For each sheep, doxycycline was administered as a single dose of 20 mg/kg, IM. Blood samples were obtained prior to and for 84 hours after doxycycline administration. Plasma concentrations of doxycycline were determined via high-performance liquid chromatography with UV detection. Pharmacokinetic data were analyzed with noncompartmental methods. RESULTS: Mean ± SD values for pharmacokinetic parameters included maximum plasma concentration (2.792 ± 0.791 µg/mL), time to reach maximum plasma concentration (0.856 ± 0.472 hours), mean residence time (91.1 ± 40.78 hours), elimination half-life (77.88 ± 28.45 hours), and area under the curve (65.67 ± 9.877 µg•h/mL). CONCLUSIONS AND CLINICAL RELEVANCE: Results indicated that doxycycline had prolonged absorption and elimination in sheep after IM administration. A daily dose of 20 mg/kg would be sufficient to reach effective plasma concentrations against Chlamydia spp (minimum inhibitory concentration, 0.008 to 0.031 µg/mL) and Staphylococcus aureus (minimum inhibitory concentration, 0.12 µg/mL). Doxycycline administered IM could be an option for therapeutic use in sheep, although further studies are needed.

Seguridad de la ivermectina: toxicidad y reacciones adversas en diversas especies de mamíferos / Safety of ivermectin: toxicity and adverse reactions in several mammal species

La ivermectina es un fármaco antiparasitario muy utilizado en Medicina Veterinaria, dado su espectro de actividad que abarca tanto endo como ectoparásitos, elevada eficacia y amplio margen de seguridad. No obstante, su administración puede dar lugar a efectos tóxicos. La mayoría de ellos derivan de la sobredosificación del compuesto, aunque también se han descrito, a dosis terapéuticas, casos de susceptibilidad extrema a los efectos neurotóxicos del fármaco en determinadas razas o subpoblaciones de animales, así como reacciones anafilácticas por la destrucción masiva de parásitos.

A review of the pharmacological interactions of ivermectin in several animal species.

The antiparasitic activity of ivermectin depends on the presence of an active drug concentration at the site of parasites location for an adapted length of time. Ivermectin interactions with another concurrently administered drug can occur. Concomitant administration of some drugs can increase the bioavailability of simultaneously administered ivermectin. This can, in some cases, become a useful pharmacological strategy to improve its antiparasitic efficacy and to delay the development of resistance in livestock or, in other cases, lead to adverse drug reactions and toxicities. On the other hand, other interactions can result in lower levels of this drug, determining that moderate resistant residual populations of the parasites may persist to contaminate pastures. The characterisation of ivermectin interactions can be used to predict and optimise the value of the parasiticide effects. This article reviews the pharmacological interactions of ivermectin in several domestic animal species.

The pharmacokinetics and metabolism of ivermectin in domestic animal species.

The pharmacokinetic properties of drugs are closely related to their pharmacological efficacy. The kinetics of ivermectin are characterised, in general terms, by a slow absorption process, a broad distribution in the organism, low metabolism, and slow excretion. The kinetics vary according to the route of administration, formulation, animal species, body condition, age, and physiological status, all of which contribute to differences in drug efficacy. Characterisation of ivermectin kinetics can be used to predict and optimise the value of the parasiticide effects and to design programmes for parasite control. This article reviews the pharmacokinetics of ivermectin in several domestic animal species.

The pharmacokinetics and interactions of ivermectin in humans--a mini-review.

Ivermectin is an antiparasitic drug with a broad spectrum of activity, high efficacy as well as a wide margin of safety. Since 1987, this compound has a widespread use in veterinary medicine and it use has been extended in humans. Here we present a brief review of the information available regarding the pharmacokinetics and interactions of ivermectin in humans. Awareness of these characteristics could improve the clinical efficacy of Ivermectin. All Authors declare that they do not have any Conflict of interest and that the work is original. All Authors agree that the contents of the manuscript are confidential and will not be copyrighted, submitted, or published elsewhere (including the Internet), in any language, while acceptance by the Journal is under consideration.