刑事偵緝檔案 iv 結局 相關
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- Overview
- Abstract
- Introduction
- Methods
- Results
- Discussion
- References
In 2021, an 8-mg intranasal naloxone product was approved by the Food and Drug Administration; however, no studies have examined outcomes among persons who receive the 8-mg naloxone product and those who receive the usual 4-mg product. During March 2022–August 2023, New York State Department of Health (NYSDOH) supplied some New York State Police (N...
An 8-mg intranasal naloxone formulation, a higher-concentration product than had previously been available, was approved by the Food and Drug Administration (FDA) in 2021 for emergency treatment of known or suspected opioid overdose (1); however, no real-world data on use of the 8-mg product are available. The approval of the higher-concentration formulation was based on the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act, relying on data from the original FDA approval of naloxone (1) and supported by reports from both the FDA Advisory Committee (2) and the National Institutes of Health (3), which both suggested that higher-dose initial opioid reversal agents were needed to effectively respond to overdoses from synthetic opioids, including fentanyl. For example, one retrospective study of community members noted that the majority administered ≥2 doses in responding to suspected overdoses (4). However, no real-world quantitative data suggest that 4-mg intranasal naloxone is ineffective at reversing such overdoses.*
In 2014, New York began a law enforcement naloxone initiative, which includes developing and delivering training, and supplying naloxone to law enforcement, providing implementation guidance, and having a system for collecting data on naloxone administrations† (5). The New York State Police (NYSP), a statewide law enforcement organization, reports the highest number of annual law enforcement naloxone administrations among New York law enforcement agencies, with approximately 360 reports per year (New York State Department of Health [NYSDOH], unpublished data, 2022). In New York, 4-mg intranasal naloxone is currently the product most commonly used by community responders, including law enforcement. For each person to whom naloxone is administered, law enforcement agencies submit a naloxone administration report to NYSDOH; reports include the following information: 1) date and time of administration, 2) age and perceived gender of the aided person, 3) county and zip code where the overdose occurred, 4) naloxone formulation used, 5) number of naloxone doses administered, 6) response to naloxone, 7) postnaloxone signs and symptoms, 8) emergency medical services disposition, and 9) survival.
Field Test: 8-mg versus 4-mg Intranasal Naloxone
In March 2022, NYSDOH partnered with NYSP to field test 8-mg intranasal naloxone by three of their 11 troops for use at the scene of a suspected opioid overdose. The three troops, located in eastern New York, received only 8-mg naloxone during this period. The other eight state police troops continued to receive the 4-mg intranasal product. All NYSP sworn members (state troopers) undergo standardized annual training on response to possible overdose events including patient assessment, naloxone use, and provision of rescue breathing. In addition, troopers receive biennial training in cardiopulmonary resuscitation, including chest compressions and automated external defibrillator usage. In 2022, the annual training included explanation of the field test and the change made to the reporting form to include dosage of intranasal naloxone administered. This study was reviewed, deemed exempt from human subjects review, and approved by the NYSDOH Institutional Review Board.§ The field test included a review of naloxone administration reports at regular team meetings, including by two physicians. When indicated, review of body-worn camera footage was conducted by study authors in collaboration with NYSP. Exclusion criteria included 1) absence of opioid toxidrome (i.e., respiratory depression or decreased consciousness), 2) more than one naloxone formulation (i.e., both 4-mg and 8-mg products) used by law enforcement responders, and 3) likely death before naloxone administration. Likely death before naloxone administration was ascertained by review of body-worn camera footage, responder reports, and defibrillator demonstration of asystole with no bystander cardiopulmonary resuscitation.
Data Analysis
Average number of naloxone doses administered per patient by formulation were compared using a t-test. Rates of survival and postnaloxone signs, symptoms, and behaviors (opioid withdrawal signs and symptoms including vomiting [reported as “dope sick” or “vomiting” by responders], lethargy, disorientation, perceived anger or combativeness, and hospital transport refusal) were compared using bivariate log-binomial regression for relative risk with associated p-values. Vomiting was also examined as an isolated postnaloxone sign separate from the grouped opioid withdrawal signs and symptoms variable. Persons who received the 4-mg intranasal naloxone product served as the referent group for all comparisons. P-values <0.05 were considered statistically significant. Analyses were conducted using SAS software (version 9.4; SAS Institute).
Naloxone Administration Reports
During March 26, 2022–August 16, 2023, NYSP troopers submitted 436 naloxone administration reports. After review, 354 (81.2%) forms met inclusion criteria, including 101 (29%) 8-mg and 253 (71%) 4-mg intranasal naloxone forms (Table). Overall, 99.0% of persons who received 8 mg and 99.2% of those who received 4-mg intranasal naloxone survived (relative risk [RR] = 0.81; p = 0.86). Recipients of 8-mg intranasal naloxone received an average of 1.58 doses (95% CI = 1.45–1.72), corresponding to a mean of 12.6 mg of naloxone. Recipients of 4-mg intranasal naloxone received an average of 1.67 doses (95% CI = 1.59–1.75), corresponding to a mean of 6.7 mg of naloxone. The mean number of doses administered per patient did not differ significantly by formulation (p = 0.27). Postnaloxone anger or combativeness as perceived by the responding law enforcement officer was reported in 11 of 101 (10.9%) 8-mg recipients and 20 of 253 (7.9%) 4-mg recipients and did not differ by formulation (RR = 1.42; p = 0.37). Most aided persons who were not deceased were transported to the hospital (75.6%; NYSDOH, unpublished data, 2022–2023), and hospital transport refusal did not differ significantly by formulation (RR = 0.65; p = 0.14).
Postnaloxone Signs and Symptoms
The most common postnaloxone signs and symptoms experienced among both groups were disorientation (8-mg recipients: 66.3%; 4-mg recipients: 58.5%) and lethargy (8-mg recipients: 52.5%; 4-mg recipients: 43.5%). RR for postnaloxone disorientation and lethargy did not differ significantly by formulation (p = 0.17 and 0.13, respectively). Opioid withdrawal signs and symptoms including vomiting were significantly more prevalent among 8-mg naloxone recipients (37.6%) than among 4-mg recipients (19.4%), (RR = 2.51; p<0.001). Vomiting, one sign of withdrawal, was observed in 20.8% and 13.8% of 8-mg and 4-mg intranasal naloxone recipients, respectively; this was not significantly different by formulation (RR = 1.64; 95% CI = 0.90–2.98) (p = 0.11).
Despite the increased naloxone concentration in the 8-mg intranasal product, no significant differences were found in the survival of aided persons, or the number of doses administered by law enforcement by formulation, suggesting that, in this field test, the increased dosage did not provide added benefit, even in light of the increased prevalence of synthetic opioids, including fentanyl, in the drug supply.
Other studies have also found that number of naloxone doses administered in response to overdose has not changed over time, even with 4-mg and other lower-potency formulations (8,9). In this study, persons who received the 8-mg product were more than twice as likely to experience postnaloxone opioid withdrawal signs and symptoms including vomiting, compared with those who received the 4-mg intranasal naloxone product. When vomiting was analyzed as an isolated sign, no significant differences between formulations were found. However, the high prevalence of vomiting as an isolated sign in both groups is concerning because of the risk of aspiration in sedated persons.
1.Food and Drug Administration. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose
2.Food and Drug Administration. FDA Advisory Committee on the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in the community settings. Joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2023. https://www.fda.gov/media/100409/download
3.Volkow ND, Collins FS. The role of science in addressing the opioid crisis. N Engl J Med 2017;377:391–4. https://doi.org/10.1056/NEJMsr1706626 PMID:28564549
4.Abdelal R, Raja Banerjee A, Carlberg-Racich S, et al. Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders. Harm Reduct J 2022;19:49. https://doi.org/10.1186/s12954-022-00627-3 PMID:35596213
5.. Pourtaher E, Payne ER, Fera N, et al. Naloxone administration by law enforcement officers in New York State (2015–2020). Harm Reduct J 2022;19:102. https://doi.org/10.1186/s12954-022-00682-w PMID:36123614
6.Farkas A, Lynch MJ, Westover R, et al. Pulmonary complications of opioid overdose treated with naloxone. Ann Emerg Med 2020;75:39–48. https://doi.org/10.1016/j.annemergmed.2019.04.006 PMID:31182316
It is the goal of NIOSH to re-evaluate all IDLH values included in the list below using the guidelines and criteria included in CIB 66. Until this occurs, this list contains IDLH values based on both the 1994 revised criteria and CIB 66 [NIOSH 2014-100]. It is important to note which criteria was applied to develop a specific IDLH value.
2023年3月8日 · In the absence of synthetic opioid coinvolvement, the age-adjusted death rate increased from 2013 to 2019 for psychostimulants (1.1 to 3.2) and cocaine (1.5 to 1.7); however, rates decreased for prescription opioid- (4.1 to 2.4) and heroin-involved deaths (2.6 to 1.
2023年6月29日 · During January 2021–June 2022 in 32 jurisdictions, xylazine was detected in a higher percentage of IMF-involved deaths in the Northeast U.S. Census Bureau region; listing xylazine as cause of death varied across jurisdictions. What are the implications for public health practice?
2024年4月12日 · CDC provides information on infection control and clinical safety to help reduce the risk of infections among healthcare workers, patients, and visitors. View All. This guideline provides recommendations for management of multidrug-resistant organisms in healthcare settings.
Information about systems for collecting and reporting COVID-19 vaccination data to CDC. The federal Advisory Committee on Immunization Practices (ACIP) provides expert advice and guidance on the use of vaccines and related agents for the control of vaccine-preventable disease in the United States.
刑事偵緝檔案 iv 結局 相關
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