Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 21.297
Filtrar
1.
Medicine (Baltimore) ; 99(5): e18977, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32000429

RESUMO

To address the remaining medical misconducts after the zero-makeup drug policy (ZMDP), e.g., over-examinations, China has given the priority to government supervision on medical institutions. This study evaluated the effect of government supervision on medical costs among inpatients with chronic obstructive pulmonary disease (COPD) in Sichuan province, the first province in China where the medical supervision was conducted.A linear interrupted time series (ITS) model was employed to analyze data about 72,113 inpatients from 32 hospitals. Monthly average medicine costs, diagnostic costs, and medical services costs, nursing costs from January 2015 to June 2018 were analyzed, respectively.The average hospitalization costs fell with a monthly trend of 42.90Yuan before the implementation of supervision (P < .001), and the declining trend remained with the more dramatic rate (-158.70Yuan, P < .001) after the government audit carried out. For western medicine costs, the monthly decreasing trend remained after the implementation of supervision (-66.44Yuan, P < .001); meanwhile, the monthly upward trend was changed into a downtrend trend for traditional Chinese medicine costs (-11.80Yuan, P = .009). Additionally, the increasing monthly trend in average diagnostics costs disappeared after government supervision, and was inversed to an insignificant decreasing trend at the rate of 26.18Yuan per month. Moreover, the previous upward trends were changed into downward trends for both medical service costs and nursing costs (P = .056, -44.71Yuan; P = .007, -11.17Yuan, respectively) after the supervision carried out.Our findings reveal that government supervision in Sichuan province was applicable to curb the growth of medical costs for inpatients with COPD, which may reflect its role in restraining physicians' compensating behaviors after the ZMDP. The government medical supervision holds promise to dismiss medical misconducts in Sichuan province, the experience of which may offer implications for other regions of China as well as other low- and middle-income countries.


Assuntos
Regulamentação Governamental , Hospitalização/economia , Pacientes Internados/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/economia , Garantia da Qualidade dos Cuidados de Saúde , Idoso , China , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
5.
JAMA ; 323(2): 164-176, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935033

RESUMO

Importance: US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks. Objective: To describe the evolution of laws and standards affecting drug testing, the use of new approval programs and standards, expansions of the role and authority of the FDA, and changes in the number of drugs approved from the 1980s to 2018. Evidence: Sources of evidence included principal federal laws and FDA regulations (1962-2018) and FDA databases of approved new drugs (1984-2018), generic drugs (1970-2018), biologics (1984-2018), and vaccines (1998-2018); special development and approval programs (Orphan drug [1984-2018], Fast-Track [1988-2018], Priority Review and its predecessors [1984-2018], Accelerated Approval [1992-2018], and Breakthrough Therapy [2012-2018]); expanded access (2010-2017) and Risk Evaluation and Mitigation Strategies (2008-2018); and user fees paid to the FDA by industry (1993-2018). Findings: From 1983 to 2018, legislation and regulatory initiatives have substantially changed drug approval at the FDA. The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009, and 41 from 2010-2018. New biologic product approvals increased from a median of 2.5 from 1990-1999, to 5 from 2000-2013, to 12 from 2014-2018. The median annual number of generic drugs approved was 136 from 1970 to the enactment of the Hatch-Waxman Act in 1984; 284 from 1985 to the enactment of the Generic Drug User Fee Act in 2012; and 588 from 2013-2018. Prescription drug user fee funding expanded from new drugs and biologics in 1992 to generic and biosimilar drugs in 2012. The amount of Prescription Drug User Fee Act fees collected from industry increased from an annual mean of $66 million in 1993-1997 to $820 million in 2013-2017, and in 2018, user fees accounted for approximately 80% of the salaries of review personnel responsible for the approval of new drugs. The proportion of drugs approved with an Orphan Drug Act designation increased from 18% (55/304) in 1984-1995, to 22% (82/379) in 1996-2007, to 41% (154/380) in 2008-2018. Use of Accelerated Approval, Fast-Track, and Priority Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period. Conclusions and Relevance: Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged. The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Regulamentação Governamental , Legislação de Medicamentos/tendências , Preparações Farmacêuticas/normas , United States Food and Drug Administration , Aprovação de Drogas/economia , Aprovação de Drogas/estatística & dados numéricos , História do Século XX , Legislação de Medicamentos/história , Estados Unidos
14.
Drugs Today (Barc) ; 55(10): 653-659, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31720562

RESUMO

The Organization for Professionals in Regulatory Affairs (TOPRA) hosted its 2019 Annual Symposium in Dublin and gathered together professionals from regulatory agencies, pharmaceutical companies and associations worldwide. The key topics discussed were related to digital health, Brexit, expedited/facilitated regulatory pathways, European Medicines Agency (EMA) public hearings, medi-cal devices and health technology assessment (HTA).


Assuntos
Indústria Farmacêutica , Avaliação da Tecnologia Biomédica , Congressos como Assunto , Equipamentos e Provisões , Regulamentação Governamental , Humanos , Irlanda , Telemedicina
17.
Am J Law Med ; 45(2-3): 106-129, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31722633

RESUMO

Beginning on inauguration day, President Trump has attempted an executive repeal of the Affordable Care Act. In doing so, he has tested the limits of presidential power. He has challenged the force of institutional and non-institutional constraints. And, ironically, he has helped boost public support for the ACA's central features. The first two sections of this article respectively consider the use of the President's tools to advance and to subvert health reform. The final two sections consider the forces constraining the administration's attempted executive repeal. I argue that the most important institutional constraint, thus far, is found in multifaceted actions by states - and not only blue states. I also highlight the force of public voices. Personal stories, public opinion, and 2018 election results - bolstered by presidential messaging - reflect growing support for government-grounded options and statutory coverage protections. Indeed, in a polarized time, "refine and revise" seems poised to supplant "repeal and replace" as the conservative focus countering liberal pressure for a common option grounded in Medicare.


Assuntos
Pessoal Administrativo , Reforma dos Serviços de Saúde/legislação & jurisprudência , Patient Protection and Affordable Care Act/legislação & jurisprudência , Política , Governo Federal , Financiamento Governamental/legislação & jurisprudência , Financiamento Governamental/organização & administração , Regulamentação Governamental , Reforma dos Serviços de Saúde/história , História do Século XX , História do Século XXI , Humanos , Reembolso de Seguro de Saúde/legislação & jurisprudência , Jurisprudência , Medicaid/legislação & jurisprudência , Medicaid/organização & administração , Medicare/legislação & jurisprudência , Medicare/organização & administração , Patient Protection and Affordable Care Act/organização & administração , Cobertura de Condição Pré-Existente , Opinião Pública , Governo Estadual , Estados Unidos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA