103 research outputs found

    Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System

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    Background: Despite the risk of bleeding is a well-known adverse effect of oral anticoagulants, there is scarce evidence on the preventability of oral anticoagulant-induced bleedings. Therefore, we investigated the potential risk factors related to preventable cases of oral anticoagulant-induced bleedings. Methods: We performed a study using Individual Case Safety Reports (ICSRs) with an oral anticoagulant as suspected drug among those reported through the spontaneous reporting system of Campania Region from 1 July 2012 to 31 December 2017. The P-method was used for the preventability assessment of all cases of bleeding. Results: In total, 58 cases out of 253 (22.9%) were preventable, and the most reported suspected drug was an indirect oral anticoagulant (warfarin). Sixty-eight critical criteria for preventability were identified, all related to healthcare professionals' practices. The most detected risk factor related to healthcare professionals' practices was the labeled drug-drug interaction for both direct and indirect oral anticoagulants. Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription

    La transversalidad de la ética en la enseñanza de las Ciencias Económicas

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    Mainstreaming in teaching ethics is the core objective of the present project considering the career of public accountant, together with the recognition of values from the philosophical and theological order to establish the feasibility of transmission of ethical values in the classroom and determine their added value for students. It is therefore necessary to identify the variables that influence professional codes of ethics, and analyze whether they reach to promote conduct that meet the expectations of today’s organizations and communities. This paper proposes consideration of principles of conduct that include professional performance oriented sustainable development, including respect for man and the environment within a framework of integrity in personal and professional performance contexts. In this period we have especially considered the implication that ethics has not only for classroom space but rather to the whole university. Teaching ethics is unthinkable without a strong commitment to organizational level also. New reflections on the subject at the international level, progress on understanding no longer an isolated subject, but to a university ethically compromised. In this regard, we have again laying a foundation which involves thinking ethically, but updated in organization view. On the other hand, we have reflected the importance that have the value as new paradigms of academic teaching. Finally, we have seen how the university ethical commitment is anorder of the magisterium of the Church, especially the Latin American and Francis himself, then stop in the fundamental importance of positive leadership as a tool for social change and commitment. Awakening that interest, it is the task not only of teachers of ethics, but for the academia in general. With this approach, we have held meetings with teachers in the area of accounting to promote mainstreaming of teaching ethics in undergraduate courses. We hope from the experience observed during the next school year to approach a model of courtly work that contributes to the quality ofeducation based on values.La transversalidad en la enseñanza de la ética, junto con el reconocimiento de valores, es el principal objetivo del presente proyecto, orientado la carrera de Contador Público. La finalidad es establecerl a viabilidad de la transmisión de valores éticos en el aula y determinar el valor agregado para los alumnos. Para ello, es necesario identificar las variables que influyen en los códigos de ética profesional, y analizar si alcanzan para impulsar una conducta que responda a las expectativas de las organizaciones y de las comunidades actuales. Este trabajo propone la consideración de principios de conducta que contemplen la actuación profesional en contextos orientados hacia el desarrollo sustentable, que incluyen respeto por el hombre y por el ambiente en un marco de integridad en el desempeño personal y profesional, ambiental y de gobernabilidad. En este período hemos ahondado especialmente en la consideración de la implicancia que la ética reviste no solo para espacio áulico sino, antes bien, para la universidad toda. Es impensado enseñar ética si esto no reviste de un fuerte compromiso a nivel también organizacional. Las nuevas reflexiones en la materia, a nivel internacional, avanzan sobre la comprensión no ya de una asignatura aislada, sino hacia una universidad éticamente comprometida. En este sentido, hemos vuelto a sentar las bases sobre qué implica pensar éticamente, pero actualizadas en vista a las organizaciones. Por otro lado, hemos reflexionado sobre la importancia que poseen los valores como nuevos paradigmas de la enseñanza académica. Por último, hemos visto cómo el compromiso ético-universitario es un pedido del magisterio de la Iglesia, especialmente del latinoamericano y del mismo Francisco, para luego detenernos en la fundamental importancia del liderazgo positivo como herramienta de cambio y compromiso social. Despertar ese interés es tarea no solo de los docentes de ética, sino de todos los que hacen al ámbito académico. Con este enfoque, hemos realizado encuentros con docentes del área de Contabilidad para impulsar la transversalidad de la enseñanza de la ética en los cursos de grado. Esperamos, a partir de la experiencia que se observe durante el próximo ciclo lectivo, poder aproximarnos a un modelo de trabajo áulico que contribuya a la calidad de la enseñanza basada en valores

    Gender Differences in Outpatient Pediatric Drug Utilization: A Cohort Study From Southern Italy

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    Objective: The aim of this retrospective population-based cohort study is to in-depth investigate gender-specific drug utilization pattern in pediatric outpatient population.Methods: By using a large administrative database of the Local Health Unit of Caserta (Southern Italy), a pediatric cohort from the birth to 18 years was observed over 6 years (from 1st January 2010 to 31st December 2015). Yearly prevalence of drug use per 100 inhabitants as well as the median number of prescriptions was stratifying by gender. Prevalence of acute and recurrent use of the most frequently used active substances was calculated for the year 2015.Results: A decreasing trend in prevalence of drug use (−3.2%, with a reduction of median number of drugs dispensed) was observed in children for both sexes, from 2010 to 2015. In 2015, the drug classes most commonly used among children of any age were modestly but consistently prescribed more to males than to females: systemic anti-infective drugs (M = 43.5%; F = 42.3%), respiratory tract drugs (M = 29.0%; F = 26.1%), and hormones (M = 13.1%; F = 11.3%). Irrespective of gender, beclomethasone was the most utilized active substance in the first 2 years of life, while thereafter amoxicillin/clavulanate in combination.Conclusions: In a large population of pediatric outpatients no major difference was seen between genders, although commonly used drug classes; in particular, antibiotics, respiratory tract drugs and Hormones with corticosteroids for systemic use prescribed modestly but consistently to larger extent in males than females

    The New Paradigms in Clinical Research: From Early Access Programs to the Novel Therapeutic Approaches for Unmet Medical Needs

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    Despite several innovative medicines gaining worldwide approval in recent years, there are still therapeutic areas for which unsatisfied therapeutic needs persist. For example, high unmet clinical need was observed in patients diagnosed with type 2 diabetes mellitus and hemophilia, as well as in specific age groups, such as the pediatric population. Given the urgent need to improve the therapy of clinical conditions for which unmet clinical need is established, clinical testing, and approval of new medicines are increasingly being carried out through accelerated authorization procedures. Starting from 1992, the Food and Drug Administration and the European Medicines Agency have supported the so-called Early Access Programs (EAPs). Such procedures, which can be based on incomplete clinical data, allow an accelerated marketing authorization for innovative medicines. The growth in pharmaceutical research has also resulted in the development of novel therapeutic approaches, such as biotech drugs and advanced therapy medicinal products, including new monoclonal antibodies for the treatment of asthma, antisense oligonucleotides for the treatment of Duchenne muscular dystrophy and spinal muscular atrophy, and new anticancer drugs that act on genetic biomarkers rather than any specific type of cancer. Even though EAPs and novel therapeutic approaches have brought huge benefits for public health, their implementation is limited by several challenges, including the high risk of safety-related label changes for medicines authorized through the accelerated procedure, the high costs, and the reimbursement and access concerns. In this context, regulatory agencies should provide the best conditions for the implementation of the described new tools
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