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3.
Clin Ther ; 42(8): 1444-1450, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32651020

RESUMO

Against the backdrop of the COVID pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat, and prevent infection with SARS-CoV-2. These activities may only be legally conducted with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly 12 decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of statutory history have led to the regulatory infrastructure we have in place: (1) standardized processes for routine development of medicinal and medical device products for human use; (2) processes for expedited development to shorten time frames and expand patient populations; (3) mechanisms of Expanded Access to make medicinal products available to patients prior to approval of the US Food and Drug Administration; (4) Emergency Use Authorization during public health emergencies; and (5) the development of pathways for bringing generic drugs and biosimilar biologics to market. These mechanisms are being brought to bear to facilitate the defeat of infection with SARS-CoV-2.


Assuntos
Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Aprovação de Drogas/legislação & jurisprudência , Legislação de Dispositivos Médicos , Pneumonia Viral/diagnóstico , Pneumonia Viral/terapia , United States Food and Drug Administration/legislação & jurisprudência , Antivirais/uso terapêutico , Betacoronavirus/imunologia , Técnicas de Laboratório Clínico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Desenvolvimento de Medicamentos/legislação & jurisprudência , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Estados Unidos
5.
Paediatr Respir Rev ; 35: 61-63, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32690356

RESUMO

There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these devices at all, such as in low resource settings. At the peak of the COVID-19 crisis, it was extremely difficult to import medical equipment and supplies, because most countries prohibited the medical industry from selling outside of their own countries. As a consequence, engineering teams worldwide volunteered to develop emergency devices, and medical experts in mechanical ventilation helped to guide the design and evaluation of prototypes. Although regulations vary among countries, given the emergency situation, some Regulatory Agencies facilitated expedited procedures. However, laboratory and animal model testing are crucial to minimize the potential risk for patients when treated with a device that may worsen clinical outcome if poorly designed or misused.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/instrumentação , Infecções por Coronavirus/terapia , Legislação de Dispositivos Médicos , Pneumonia Viral/terapia , Insuficiência Respiratória/terapia , Ventiladores Mecânicos/provisão & distribução , Betacoronavirus , Aprovação de Equipamentos , Reeducação Profissional , Desenho de Equipamento , Equipamentos e Provisões/provisão & distribução , Humanos , Ventilação não Invasiva/instrumentação , Pandemias , Admissão e Escalonamento de Pessoal , Respiração Artificial/instrumentação , Espanha
7.
Washington; Organización Panamericana de la Salud; mayo 14, 2020. 26 p.
Não convencional em Espanhol | LILACS | ID: biblio-1096910

RESUMO

El IMDRF es un grupo voluntario de reguladores de dispositivos médicos de todo el mundo que se han unido con el objetivo de acelerar la armonización y convergencia reguladora internacional de dispositivos médicos. Los miembros actuales son Australia, Brasil, Canadá, China, la Unión Europea, Japón, Rusia, Singapur, Corea del Sur y Estados Unidos de América quienes cuentan con sistemas regulatorios consolidados para dispositivos médicos


Assuntos
Pneumonia Viral/prevenção & controle , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/epidemiologia , Equipamentos e Provisões/normas , Pandemias/prevenção & controle , Legislação de Dispositivos Médicos/normas , Betacoronavirus
10.
Farm. hosp ; 44(1): 26-31, ene.-feb. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-187489

RESUMO

El desarrollo y la comercialización de medicamentos de terapia celular con células T con receptor de antígeno quimérico (CAR-T) suponen un nuevo reto para la farmacia hospitalaria en España. El objetivo de este artículo es revisar los aspectos clave de estos medicamentos y describir el papel del farmacéutico oncohematológico dentro del equipo clínico multidisciplinar en las diferentes fases del proceso transversal que implica el tratamiento con medicamentos CAR-T, desde la indicación hasta el seguimiento a corto y largo plazo de los pacientes tratados con este tipo de terapias, con una importante mención al manejo de sus principales efectos adversos. La terapia tipo CAR-T ofrece al farmacéutico hospitalario la oportunidad de trabajar en estrecha colaboración con el resto de los profesionales clínicos implicados en el proceso, permitiendo su contribución en el desarrollo de procedimientos, guías de práctica clínica de abordaje global y estableciendo puntos de partida para afrontar tratamientos futuros de complejidad similar e incluso mejorar procesos base anteriormente establecidos


The development and commercialization of cell therapy drugs with chimeric antigen receptor T cells (CAR-T) represent a new challenge for Spain's hospital pharmacy. The aim of this article is to review the key aspects of these medicines and to describe the oncohematological pharmacist's role within the multidisciplinary clinical team. This includes the different phases in the transversal process that involves a therapy with CAR-T medicines, ranging from indication to short and long term follow-up of patients treated with this type of therapy, and emphasizing on the management of its main adverse effects. CAR-T therapy offers the hospital pharmacist the opportunity to work closely with the rest of the clinical professionals involved in the process, allowing their contribution to the development of procedures, clinical practice guidelines of global approach, and establishing starting points when facing future therapies of similar complexity -and even improving previously established basic processes


Assuntos
Humanos , Farmacêuticos/organização & administração , Farmacêuticos/normas , Imunoterapia Adotiva/métodos , Serviço de Farmácia Hospitalar , Imunoterapia Adotiva/normas , Legislação de Dispositivos Médicos/normas , Farmacovigilância
13.
Arch Dis Child ; 105(2): 147-154, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31533915

RESUMO

INTRODUCTION: Medical devices (MedDevs) and medicines are assessed (and monitored) differently before and after launch. There are products for repeated oral ingestion that are marketed in the European Union as MedDevs. OBJECTIVES AND METHODS: To illustrate the consequences of these differences in assessment, we compared the leaflet information of three MedDevs with the standards for medicines and with published evidence at launch. As examples, gelatin tannate (GT), its combination with tyndalised probiotics (TP) (GTTP) for diarrhoea and a gel containing hyaluronic acid (HA)/chondroitin sulfate (CS)/poloxamer (Pol407) (HACSPol) for gastro-oesophageal reflux disease were examined. RESULTS: Applying standards for medicines, product composition is insufficiently defined in the MedDev leaflet (eg, plant origin, polymerisation grade, dose and ratio of the relevant constituents). As no age limit is mentioned in the leaflets, all 3 products allow use in children from birth onwards, although published clinical documentation in children was poor (GT) or lacking (GTTP and HACSPol). MedDev leaflets do not mention adverse events (AEs), while literature search suggests safety concerns such as tannic acid (TA) cytotoxicity, potentially more diarrhoea/AEs with TP, use of doses higher than established safe (TA and HA) and lack of chronic toxicity studies for oral Pol407. None refers to interactions with medicines, although some ingredients may affect medicine absorption. CONCLUSION: Although these MedDevs require repeated oral intake as do medicines, their assessment and monitoring differ significantly from the standards for medicines. Compared with medicines, MedDevs for repeated oral use are poorly labelled and rely on very limited clinical information at market release.


Assuntos
Equipamentos e Provisões , Legislação de Dispositivos Médicos , Administração Oral , Criança , Equipamentos e Provisões/efeitos adversos , Europa (Continente) , Humanos , Preparações Farmacêuticas , Rotulagem de Produtos
14.
Drug Saf ; 43(2): 83-93, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31845212

RESUMO

We propose the following definition of a medical device: "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional." Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorporate medicines should be required to meet the same regulatory standards as medicinal products. This would remove the anomaly that some delivery systems that incorporate medicines are classified as devices while other similar systems that deliver the same medicines are classified as medicinal products. Some improvements might also result from more widespread use of registries, such as those used for prosthetic joint replacements. Registries would allow both a prospective examination of the performance of high-risk devices and a retrospective analysis when signals from other sources of information suggest problems. Those who apply for a marketing authorization for a new device should have to assure regulators of its quality of manufacture, safety, and efficacy before licensing. Even the most straightforward device should be shown to be useable in practice. Trials on patients, or at least simulations of use in the real world, should be practicable for most devices.


Assuntos
Equipamentos e Provisões/classificação , Equipamentos e Provisões/normas , Segurança de Equipamentos , União Europeia , Humanos , Legislação de Dispositivos Médicos , Estados Unidos
15.
Health Policy ; 123(12): 1185-1198, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31718855

RESUMO

A large number of medical devices (MDs) is available in Europe. Procedures for market approval and reimbursement have been adopted over recent years to promote accelerating patient access to innovative MDs. However, there remains uncertainty and non-transparency regarding these procedures. We provide a structured overview of market approval and reimbursement procedures and practices regarding access to MDs in the EU. Market approval procedures were found to be uniformly described. Data on reimbursement procedures and practices was both heterogeneous and incomplete. Time to MD access was mainly determined by reimbursement procedures. The influence of the patient on time to access was not reported. Prescription practices varied among device types. Barriers to and facilitators of early patient access that set the agenda for policy implications were also analyzed. Barriers were caused by unclear European legislation, complex market approval procedures, lack of data collection, inconsistency in evidence requirements between countries, regional reimbursement and provision, and factors influencing physicians' prescription including the device costs, waiting times and hospital-physician relationships. Facilitators were: available evidence that meets country-specific requirements for reimbursement, diagnosis-related groups, additional payments and research programs. Further research needs to focus on creating a complete overview of reimbursement procedures and practices by extracting further information from sources such as grey literature and interviews with professionals, and defining clear criteria to objectify time to access.


Assuntos
Equipamentos e Provisões/provisão & distribução , Legislação de Dispositivos Médicos/estatística & dados numéricos , Mecanismo de Reembolso/legislação & jurisprudência , Equipamentos e Provisões/economia , União Europeia , Humanos , Marketing/legislação & jurisprudência , Marketing/métodos , Padrões de Prática Médica/estatística & dados numéricos , Avaliação da Tecnologia Biomédica
18.
Ann Biol Clin (Paris) ; 77(5): 514-516, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31466939

RESUMO

In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.


Assuntos
Equipamentos e Provisões/normas , Indústria Manufatureira/legislação & jurisprudência , Legislação de Dispositivos Médicos , Documentação , Segurança de Equipamentos , Equipamentos e Provisões/economia , União Europeia/organização & administração , Fidelidade a Diretrizes/legislação & jurisprudência , Fidelidade a Diretrizes/organização & administração , Fidelidade a Diretrizes/normas , Humanos , Indústria Manufatureira/normas , Indústria Manufatureira/tendências , Legislação de Dispositivos Médicos/organização & administração , Legislação de Dispositivos Médicos/tendências , Segurança do Paciente
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