RESUMO
Gene therapy is becoming increasingly prevalent, with new gene therapy medicinal products (GTMPs) being approved for use every year. Hospital pharmacists are expected to prepare and dispense these products, but there is substantial heterogeneity in the availability of up-to-date, practical guidance at a national level in Europe. Many institutions have no or very limited experience in handling GTMPs. As such, there is a need for updated, practical guidance to aid hospital pharmacy teams in developing institutional standard operating procedures (SOPs) for the safe handling of GTMPs across the entire workflow. Here, we present the European Association of Hospital Pharmacists' updated guidance on the handling of GTMPs, developed by a team of recognised experts from around Europe. Each aspect of the GTMP handling process is addressed, including receipt and storage, dispensing and reconstitution, transportation, administration, waste disposal, decontamination of spills and accidental exposure. A series of figures are provided to aid the development of practical workflows. This guidance document is intended as a framework to help develop institutional SOPs and should always be used in conjunction with local regulations.
RESUMO
Chimeric Antigen Receptor T cells (CAR-T cells) are a type of Advanced Therapy Medicinal Product (ATMP) classified as ex-vivo (cell-based) gene therapy. CAR-T cells constitute an immunotherapy that works by enabling T cells to specifically recognise cancer cells and destroy them [1]. CAR-T cells are currently licensed to treat certain blood cancers including relapsed or refractory lymphomas, B-cell acute lymphoblastic leukaemia or multiple myeloma [2]. The indications for their use are expanding and are expected to encompass other therapeutic areas. CAR-T cells are used both in children and adults [2]. CAR-T cells are biologic drugs and are therefore more complex than traditional medicinal products. T cells collected from the patient (or donor) are sent to a Good manufacturing Practice (GMP) manufacturing facility where they are genetically modified to contain a chimeric antigen receptor (CAR). This receptor is designed to recognise and target a specific protein on cancer cells. Once manufactured, they are delivered to the hospital where they are administered to the designated patient. Hospital pharmacies are central in the process of ensuring appropriate organisational governance, operational handling, clinical suitability, and pharmacovigilance [1, 3]. The GoCART Coalition Pharmacist working group's mission was to develop standards of care to advance the field of cellular therapies in Europe. The purpose of this document is to provide practical guidance on the implementation and safe operational use of marketed CAR-T cell products within hospital pharmacies primarily throughout Europe. This document outlines the key areas where pharmaceutical expertise should focus and the key considerations for the hospital pharmacy. Countries may have different requirements and there may be variation in practice between hospitals. This document is intended as a guide and the recommendations should be adapted to meet local requirements. This document does not provide clinical information relating to the use of CAR-T cell products. The Summary of medicinal Product Characteristics (SmPC) [4, 5], and national and international clinical guidelines (where in place) should be followed for the most up-to-date clinical management of CAR-T cell patients. An example is the UK "institutional readiness documents" for pharmacy which includes detailed checklists for each stage of the pathway [6]. Spain developed the Plan of Advanced Therapies in the National Health System: CAR medicines published in November 2018 [7], the CAR-T Medicines Management Procedure of the Spanish Society of Hospital Pharmacy [8] or the Hospital pharmacist's roles and responsibilities with CAR-T medicines article published also by the Spanish Oncology group of the Spanish Society of Pharmacy [9]. This guide has been designed to support the implementation of marketed CAR-T products; however, the principles may also be applicable to clinical trials. For CAR-T cell products being used in clinical trials, additional trial regulation and clinical trial protocols must be followed. This document is divided into two sections. Section 1 outlines considerations for hospital pharmacies during the implementation of a CAR-T cell service. Section 2 outlines the key operational considerations for hospital pharmacies in the patient and product pathway.
RESUMO
Resumo Enquadramento: O presente estudo analisa uma problemática identificada na prática profissional diária de enfermagem, sendo definido o tema "Prática clínica dos enfermeiros na prevenção da infeção associada ao cateter venoso central (CVC)". Objetivos: Conhecer a prática clínica e o nível de conhecimentos dos enfermeiros sobre a manutenção do CVC. Metodologia: Estudo analítico e transversal, com uma metodologia quantitativa, utilizando um instrumento de recolha de dados aplicado em dezembro de 2018, através da técnica de amostragem por bola de neve, a 272 enfermeiros selecionados aleatoriamente. Resultados: Os resultados obtidos indicam altos níveis de prática clínica (90,1%) e de conhecimentos (85,7%) na realização do penso e na manutenção do CVC e que existe relação estatisticamente significativa entre a prática clínica e o nível de conhecimentos dos enfermeiros. Conclusão: Concluiu-se que a amostra apresenta um nível alto de conhecimentos acerca das normas de manutenção do CVC da prevenção da infeção e uma prática clínica que respeita, na sua maioria, as orientações dos feixes de intervenção acerca das práticas de prevenção da infeção do CVC.
Abstract Background: This study analyzes an issue that has already been identified in daily nursing practice, having defined the theme "Nurses' clinical practice for the prevention of central venous catheter (CVC)-related infections". Objectives: To identify nurses' clinical practice and level of knowledge about CVC maintenance. Methodology: Analytical and cross-sectional study, with a quantitative methodology. A data collection instrument was applied in December 2018, through the snowball sampling technique, to 272 randomly selected nurses. Results: The results indicated high levels of clinical practice (90.1%) and knowledge (85.7%) about CVC dressing change and CVC maintenance. A statistically significant association was also found between nurses' clinical practices and level of knowledge. Conclusion: The study concluded that the nurses have a high level of knowledge about CVC maintenance guidelines for infection prevention and that they follow the majority of the guidelines of the bundles for prevention of CVC-related infections.
Resumen Marco contextual: Este estudio analiza una problemática identificada en la práctica profesional diaria de la enfermería; el tema es Práctica clínica de los enfermeros en la prevención de la infección asociada al catéter venoso central (CVC). Objetivos: Conocer la práctica clínica y el nivel de conocimiento de los enfermeros sobre el mantenimiento del CVC. Metodología: Estudio analítico y transversal, con una metodología cuantitativa, mediante un instrumento de recogida de datos aplicado en diciembre de 2018, a través de la técnica de muestreo por bola de nieve, a 272 enfermeros seleccionados aleatoriamente. Resultados: Los resultados obtenidos indican niveles elevados de práctica clínica (90,1%) y de conocimiento (85,7%) del vendaje y del mantenimiento del CVC, y que existe una relación estadísticamente significativa entre la práctica clínica y el nivel de conocimiento de los enfermeros. Conclusión: Se concluyó que la muestra presenta un nivel alto de conocimiento sobre las normas de mantenimiento del CVC para la prevención de infecciones y una práctica clínica que respeta, en su mayoría, las directrices del paquete de intervención sobre las prácticas de prevención de infecciones del CVC.
RESUMO
A descoberta e implementação das novas práticas e medicamentos não foi suficiente para erradicar as infeções, pela resistência que as bactérias criam aos antimicrobianos e pela dificuldade em descobrir novos antibióticos que colmatem essa lacuna, o que promoveu novas investigações para a criação de estratégias diferenciadoras e que permitissem limitar ou diminuir o aparecimento de infeções especialmente quando associadas ao Cateter Venoso Central. Objetivos: Identificar as intervenções que os enfermeiros realizam na manutenção do cateter venoso central; Analisar a associação entre a prática clínica, o nível de conhecimentos dos enfermeiros sobre normas preconizadas da manutenção do CVC, as suas caraterísticas sociodemográficas e a formação na área da prevenção da infeção; Analisar a relação entre a prática clínica e o nível conhecimentos dos enfermeiros sobre normas preconizadas acerca da manutenção do CVC. Métodos: Estudo transversal analítico, realizado em 272 enfermeiros selecionados recorrendo à técnica de amostragem por bola de neve, com a inserção do instrumento de recolha de dados na rede social Facebook e enviado individualmente a enfermeiros cujos endereços eletrónicos pessoais eram do conhecimento da equipa de investigação, utilizando para o efeito um instrumento de recolha de dados aplicado em Dezembro de 2018. Resultados: Amostra maioritariamente do género feminino, com média de idades de 36,78 anos, casados/as e com licenciatura, como habilitações literárias mais frequentes. Os resultados indicam uma média de tempo na profissão de 13,2 anos, sendo o serviço mais frequente o de Cirurgia, com uma média de tempo no serviço de 7,9 anos, com a maioria tendo formação na área da prevenção da infeção, existindo no serviço onde exercem a profissão uma norma de atuação e padronização de rotina que oriente os cuidados para a prevenção de infeção do CVC. Os resultados indicam ainda que não existe relação entre a prática clínica, o nível de conhecimentos dos enfermeiros sobre normas preconizadas da manutenção do CVC e as suas caraterísticas sociodemográficas, que existe relação entre a prática clínica dos enfermeiros sobre normas preconizadas da manutenção do CVC e a formação na área da prevenção da infeção e que existe relação entre a prática clínica e o nível de conhecimentos dos enfermeiros sobre normas preconizadas sobre a manutenção do CVC. Conclusão: A prevenção da infeção associada ao Cateter Venoso Central é ainda uma área emergente, mas a responsabilização governamental da Direção-Geral de Saúde e o envolvimento direto das organizações e particularmente dos Enfermeiros têm contribuído para a prevenção da infeção associada ao CVC, na aplicabilidade dos protocolos, na concretização de ensinos e na consequente monitorização dos procedimentos de prevenção da infeção associada à manutenção do Cateter Venoso Central. Assim, concluiu-se que a presente investigação apresenta um nível alto de conhecimentos acerca das normas de manutenção do CVC da prevenção da infeção e uma prática clínica que respeita, na sua maioria, as orientações práticas de prevenção da infeção do CVC.
The discovery and implementation of new practices and drugs was not enough to eradicate infections, due to the resistance that bacteria create to antimicrobials and the difficulty in discovering new antibiotics that fill this gap, which promoted new investigations for the creation of differentiating strategies and that allowed to limit or decrease the appearance of infections, especially when associated with the Central Venous Catheter. Objectives: To identify the interventions that nurses perform in the maintenance and manipulation of the central venous catheter; Analyze the association between the clinical practice, the level of knowledge of nurses about the recommended standards for the maintenance and handling of CVC, their sociodemographic characteristics and training in the area of infection prevention; Analyze the relationship between the clinical practice and the level of nurses' knowledge about the recommended standards regarding CVC manipulation and maintenance. Methods: Cross-sectional analytical study carried out on 272 nurses selected using the snowball sampling technique, with the insertion of the data collection instrument in the Facebook social network and sent individually to nurses whose personal email addresses were knowledge of the research team, using a data collection instrument applied in December 2018. Results: Sample mostly female, with an average age of 36.78 years, married and with a degree, as the most frequent educational qualifications. The results indicate an average time in the profession of 13.2 years, with the most frequent service being Surgery, with an average time in service of 7.9 years, with the majority having training in the area of infection prevention, existing in the service where the profession exercises a standard of practice and standardization of routine that guides care for the prevention of CVC infection. The results also indicate that there is no relationship between the clinical practice, the level of knowledge of nurses about the recommended standards for the maintenance and handling of CVC and their sociodemographic characteristics, that there is a relationship between the clinical practice of nurses on the recommended standards for the maintenance and handling of the CVC and the training in the area of infection prevention and that there is a relationship between the clinical practice and the level of knowledge of nurses on the recommended standards on handling and maintenance of the CVC. Conclusion: The prevention of infection associated with the Central Venous Catheter is still an emerging area, but governmental accountability of the Directorate-General for Health and the direct involvement of organizations and particularly nurses has contributed to the prevention of infection associated with CVC, in the applicability of the protocols, in teaching and in the consequent monitoring of infection prevention procedures associated with the manipulation and maintenance of the Central Venous Catheter. Thus, it was concluded that the present investigation presents a high level of knowledge about the CVC maintenance norms for infection prevention and a clinical practice that respects, for the most part, the practical guidelines for preventing CVC infection.
