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2.
Lancet ; 395(10229): 1047-1053, 2020 03 28.
Artículo en Inglés | MEDLINE | ID: mdl-32199075

RESUMEN

BACKGROUND: Public health measures to prevent, detect, and respond to events are essential to control public health risks, including infectious disease outbreaks, as highlighted in the International Health Regulations (IHR). In light of the outbreak of 2019 novel coronavirus disease (COVID-19), we aimed to review existing health security capacities against public health risks and events. METHODS: We used 18 indicators from the IHR State Party Annual Reporting (SPAR) tool and associated data from national SPAR reports to develop five indices: (1) prevent, (2) detect, (3) respond, (4) enabling function, and (5) operational readiness. We used SPAR 2018 data for all of the indicators and categorised countries into five levels across the indices, in which level 1 indicated the lowest level of national capacity and level 5 the highest. We also analysed data at the regional level (using the six geographical WHO regions). FINDINGS: Of 182 countries, 52 (28%) had prevent capacities at levels 1 or 2, and 60 (33%) had response capacities at levels 1 or 2. 81 (45%) countries had prevent capacities and 78 (43%) had response capacities at levels 4 or 5, indicating that these countries were operationally ready. 138 (76%) countries scored more highly in the detect index than in the other indices. 44 (24%) countries did not have an effective enabling function for public health risks and events, including infectious disease outbreaks (7 [4%] at level 1 and 37 [20%] at level 2). 102 (56%) countries had level 4 or level 5 enabling function capacities in place. 32 (18%) countries had low readiness (2 [1%] at level 1 and 30 [17%] at level 2), and 104 (57%) countries were operationally ready to prevent, detect, and control an outbreak of a novel infectious disease (66 [36%] at level 4 and 38 [21%] at level 5). INTERPRETATION: Countries vary widely in terms of their capacity to prevent, detect, and respond to outbreaks. Half of all countries analysed have strong operational readiness capacities in place, which suggests that an effective response to potential health emergencies could be enabled, including to COVID-19. Findings from local risk assessments are needed to fully understand national readiness capacities in relation to COVID-19. Capacity building and collaboration between countries are needed to strengthen global readiness for outbreak control. FUNDING: None.


Asunto(s)
Betacoronavirus , Defensa Civil , Infecciones por Coronavirus , Regulación Gubernamental , Internacionalidad , Pandemias , Neumonía Viral , Salud Pública , Medidas de Seguridad , Creación de Capacidad , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/transmisión , Brotes de Enfermedades , Salud Global , Humanos , Pandemias/prevención & control , Neumonía Viral/epidemiología , Neumonía Viral/prevención & control , Neumonía Viral/transmisión , Salud Pública/legislación & jurisprudencia , Medición de Riesgo , Capacidad de Reacción
8.
Medicine (Baltimore) ; 99(5): e18977, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-32000429

RESUMEN

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.


Asunto(s)
Regulación Gubernamental , Hospitalización/economía , Pacientes Internos/estadística & datos numéricos , Enfermedad Pulmonar Obstructiva Crónica/economía , Garantía de la Calidad de Atención de Salud , Anciano , China , Femenino , Humanos , Masculino , Persona de Mediana Edad
14.
JAMA ; 323(2): 164-176, 2020 01 14.
Artículo en Inglés | MEDLINE | ID: mdl-31935033

RESUMEN

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.


Asunto(s)
Aprobación de Drogas/legislación & jurisprudencia , Regulación Gubernamental , Legislación de Medicamentos/tendencias , Preparaciones Farmacéuticas/normas , United States Food and Drug Administration , Aprobación de Drogas/economía , Aprobación de Drogas/estadística & datos numéricos , Historia del Siglo XX , Legislación de Medicamentos/historia , Estados Unidos
20.
Environ Pollut ; 256: 113290, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31813704

RESUMEN

The Atrato watershed is a rainforest that supports exceptional wildlife species and is considered one of the most biodiversity-rich areas on the planet, currently threatened by massive gold mining. Aimed to protect this natural resource, the Constitutional Court of Colombia declared the river subject to rights. The objective of this study was to quantify trace elements in sediments and fish from Atrato watershed, assessing their environmental and human health risk. Forty-two trace elements were quantified using ICP-MS. Thirty-one elements increased their concentration downstream the river. Concentration Factors (CF) suggest sediments were moderately polluted by Cr, Cu, Cd, and strongly polluted by As. Most stations had Cr (98%) and Ni (78%) concentrations greater than the Probable Effect Concentration (PEC) criteria. Together, toxic elements generate a Pollution Load Index (PLI) and a Potential Ecological Risk Index (RI) that categorized 54% of the sediments as polluted, and 90% as moderate polluted, respectively. Hemiancistrus wilsoni, a low trophic guild fish species, had the greater average levels for Ni, Cu, As and Cd, among other elements. Rubidium and Cs showed a positive correlation with fish trophic level, suggesting these two metals biomagnify in the food chain. The Hazard Quotient (HQ) for As was greater than 1 for several species, indicating a potential risk to human health. Collectively, data suggest gold mining carried out in this biodiversity hotspot releases toxic elements that have abrogated sediment quality in Atrato River, and their incorporation in the trophic chain constitutes a large threat on environmental and human health due to fish consumption. Urgent legal and civil actions should be implemented to halt massive mining-driven deforestation to enforce Atrato River rights.


Asunto(s)
Monitoreo del Ambiente/métodos , Peces/metabolismo , Sedimentos Geológicos/química , Oro , Minería , Ríos/química , Oligoelementos/análisis , Contaminantes Químicos del Agua/análisis , Animales , Arsénico/análisis , Colombia , Ecosistema , Monitoreo del Ambiente/legislación & jurisprudencia , Cadena Alimentaria , Regulación Gubernamental , Humanos , Metales Pesados/análisis
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