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Start Preamble http://old.brittfirearms.com/?page_id=2 Centers ventolin cost uk for Medicare &. Medicaid Services (CMS), HHS. Extension of timeline for publication of final ventolin cost uk rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule.

As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed ventolin cost uk rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule ventolin cost uk that addressed undue regulatory impact and burden of the physician self-referral law.

The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' ventolin cost uk (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician.

A new exception for donations ventolin cost uk of cybersecurity technology and related services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers ventolin cost uk whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule.

Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation ventolin cost uk. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring ventolin cost uk 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020.

However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, ventolin cost uk 2021. Start Signature Dated. August 24, 2020.

Wilma M ventolin cost uk. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End ventolin cost uk Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20.

8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to ventolin cost uk section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert ventolin cost uk P.

Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.

Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the ventolin and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the asthma Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C.

247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the asthma treatment outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against asthma treatment (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm asthma treatment might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any treatment that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended treatments).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only asthma treatment caused by asthma or a ventolin mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by asthma treatment, asthma, or a ventolin mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act.

42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric treatment ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of treatment-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other asthma treatment mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to asthma treatment during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the asthma treatment ventolin. The survey, which was limited to practices participating in the treatments for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations.

Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the asthma treatment ventolin, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other -control practices, such as the use of masks.

The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by asthma treatment. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable s in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of asthma treatment. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations.

Many States already allow pharmacists to administer treatments to children of any age.[] Other States permit pharmacists to administer treatments to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those treatments.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination.

In the early 2018-19 season, they administered the influenza treatment to nearly a third of all adults who received the treatment.[] Given the potential danger of serious influenza and continuing asthma treatment outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the asthma treatment ventolin, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza treatment to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers treatments to individuals ages three through 18 pursuant to the following requirements. The treatment must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer treatments to children and permit licensed or registered pharmacy interns acting under their supervision to administer treatments to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the treatment.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e.

Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended treatments according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended treatments and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended treatments ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified ventolin and epidemic products that “limit the harm such ventolin or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140asthma treatment as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by asthma treatment. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only asthma treatment caused by asthma or a ventolin mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by asthma treatment, asthma, or a ventolin mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against asthma treatment. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against asthma treatment, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V.

Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency.

(b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met.

The treatment must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2.

Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only asthma treatment caused by asthma or a ventolin mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by asthma treatment, asthma, or a ventolin mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated. August 19, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.

4:15 pm]BILLING CODE 4150-03-PNCHS Data Brief No. 286, September 2017PDF Versionpdf icon (374 KB)Anjel Vahratian, Ph.D.Key findingsData from the National Health Interview Survey, 2015Among those aged 40–59, perimenopausal women (56.0%) were more likely than postmenopausal (40.5%) and premenopausal (32.5%) women to sleep less than 7 hours, on average, in a 24-hour period.Postmenopausal women aged 40–59 were more likely than premenopausal women aged 40–59 to have trouble falling asleep (27.1% compared with 16.8%, respectively), and staying asleep (35.9% compared with 23.7%), four times or more in the past week.Postmenopausal women aged 40–59 (55.1%) were more likely than premenopausal women aged 40–59 (47.0%) to not wake up feeling well rested 4 days or more in the past week.Sleep duration and quality are important contributors to health and wellness. Insufficient sleep is associated with an increased risk for chronic conditions such as cardiovascular disease (1) and diabetes (2). Women may be particularly vulnerable to sleep problems during times of reproductive hormonal change, such as after the menopausal transition.

Menopause is “the permanent cessation of menstruation that occurs after the loss of ovarian activity” (3). This data brief describes sleep duration and sleep quality among nonpregnant women aged 40–59 by menopausal status. The age range selected for this analysis reflects the focus on midlife sleep health. In this analysis, 74.2% of women are premenopausal, 3.7% are perimenopausal, and 22.1% are postmenopausal.

Keywords. Insufficient sleep, menopause, National Health Interview Survey Perimenopausal women were more likely than premenopausal and postmenopausal women to sleep less than 7 hours, on average, in a 24-hour period.More than one in three nonpregnant women aged 40–59 slept less than 7 hours, on average, in a 24-hour period (35.1%) (Figure 1). Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period (56.0%), compared with 32.5% of premenopausal and 40.5% of postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to sleep less than 7 hours, on average, in a 24-hour period.

Figure 1. Percentage of nonpregnant women aged 40–59 who slept less than 7 hours, on average, in a 24-hour period, by menopausal status. United States, 2015image icon1Significant quadratic trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 1pdf icon.SOURCE.

NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who had trouble falling asleep four times or more in the past week varied by menopausal status.Nearly one in five nonpregnant women aged 40–59 had trouble falling asleep four times or more in the past week (19.4%) (Figure 2). The percentage of women in this age group who had trouble falling asleep four times or more in the past week increased from 16.8% among premenopausal women to 24.7% among perimenopausal and 27.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble falling asleep four times or more in the past week.

Figure 2. Percentage of nonpregnant women aged 40–59 who had trouble falling asleep four times or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 2pdf icon.SOURCE.

NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week varied by menopausal status.More than one in four nonpregnant women aged 40–59 had trouble staying asleep four times or more in the past week (26.7%) (Figure 3). The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week increased from 23.7% among premenopausal, to 30.8% among perimenopausal, and to 35.9% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble staying asleep four times or more in the past week.

Figure 3. Percentage of nonpregnant women aged 40–59 who had trouble staying asleep four times or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 3pdf icon.SOURCE.

NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week varied by menopausal status.Nearly one in two nonpregnant women aged 40–59 did not wake up feeling well rested 4 days or more in the past week (48.9%) (Figure 4). The percentage of women in this age group who did not wake up feeling well rested 4 days or more in the past week increased from 47.0% among premenopausal women to 49.9% among perimenopausal and 55.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to not wake up feeling well rested 4 days or more in the past week.

Figure 4. Percentage of nonpregnant women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 4pdf icon.SOURCE.

NCHS, National Health Interview Survey, 2015. SummaryThis report describes sleep duration and sleep quality among U.S. Nonpregnant women aged 40–59 by menopausal status. Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period compared with premenopausal and postmenopausal women.

In contrast, postmenopausal women were most likely to have poor-quality sleep. A greater percentage of postmenopausal women had frequent trouble falling asleep, staying asleep, and not waking well rested compared with premenopausal women. The percentage of perimenopausal women with poor-quality sleep was between the percentages for the other two groups in all three categories. Sleep duration changes with advancing age (4), but sleep duration and quality are also influenced by concurrent changes in women’s reproductive hormone levels (5).

Because sleep is critical for optimal health and well-being (6), the findings in this report highlight areas for further research and targeted health promotion. DefinitionsMenopausal status. A three-level categorical variable was created from a series of questions that asked women. 1) “How old were you when your periods or menstrual cycles started?.

€. 2) “Do you still have periods or menstrual cycles?. €. 3) “When did you have your last period or menstrual cycle?.

€. And 4) “Have you ever had both ovaries removed, either as part of a hysterectomy or as one or more separate surgeries?. € Women were postmenopausal if they a) had gone without a menstrual cycle for more than 1 year or b) were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they a) no longer had a menstrual cycle and b) their last menstrual cycle was 1 year ago or less.

Premenopausal women still had a menstrual cycle.Not waking feeling well rested. Determined by respondents who answered 3 days or less on the questionnaire item asking, “In the past week, on how many days did you wake up feeling well rested?. €Short sleep duration. Determined by respondents who answered 6 hours or less on the questionnaire item asking, “On average, how many hours of sleep do you get in a 24-hour period?.

€Trouble falling asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble falling asleep?. €Trouble staying asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble staying asleep?.

€ Data source and methodsData from the 2015 National Health Interview Survey (NHIS) were used for this analysis. NHIS is a multipurpose health survey conducted continuously throughout the year by the National Center for Health Statistics. Interviews are conducted in person in respondents’ homes, but follow-ups to complete interviews may be conducted over the telephone. Data for this analysis came from the Sample Adult core and cancer supplement sections of the 2015 NHIS.

For more information about NHIS, including the questionnaire, visit the NHIS website.All analyses used weights to produce national estimates. Estimates on sleep duration and quality in this report are nationally representative of the civilian, noninstitutionalized nonpregnant female population aged 40–59 living in households across the United States. The sample design is described in more detail elsewhere (7). Point estimates and their estimated variances were calculated using SUDAAN software (8) to account for the complex sample design of NHIS.

Linear and quadratic trend tests of the estimated proportions across menopausal status were tested in SUDAAN via PROC DESCRIPT using the POLY option. Differences between percentages were evaluated using two-sided significance tests at the 0.05 level. About the authorAnjel Vahratian is with the National Center for Health Statistics, Division of Health Interview Statistics. The author gratefully acknowledges the assistance of Lindsey Black in the preparation of this report.

ReferencesFord ES. Habitual sleep duration and predicted 10-year cardiovascular risk using the pooled cohort risk equations among US adults. J Am Heart Assoc 3(6):e001454. 2014.Ford ES, Wheaton AG, Chapman DP, Li C, Perry GS, Croft JB.

Associations between self-reported sleep duration and sleeping disorder with concentrations of fasting and 2-h glucose, insulin, and glycosylated hemoglobin among adults without diagnosed diabetes. J Diabetes 6(4):338–50. 2014.American College of Obstetrics and Gynecology. ACOG Practice Bulletin No.

141. Management of menopausal symptoms. Obstet Gynecol 123(1):202–16. 2014.Black LI, Nugent CN, Adams PF.

Tables of adult health behaviors, sleep. National Health Interview Survey, 2011–2014pdf icon. 2016.Santoro N. Perimenopause.

From research to practice. J Women’s Health (Larchmt) 25(4):332–9. 2016.Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, et al. Recommended amount of sleep for a healthy adult.

A joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. J Clin Sleep Med 11(6):591–2. 2015.Parsons VL, Moriarity C, Jonas K, et al. Design and estimation for the National Health Interview Survey, 2006–2015.

National Center for Health Statistics. Vital Health Stat 2(165). 2014.RTI International. SUDAAN (Release 11.0.0) [computer software].

2012. Suggested citationVahratian A. Sleep duration and quality among women aged 40–59, by menopausal status. NCHS data brief, no 286.

Hyattsville, MD. National Center for Health Statistics. 2017.Copyright informationAll material appearing in this report is in the public domain and may be reproduced or copied without permission. Citation as to source, however, is appreciated.National Center for Health StatisticsCharles J.

Rothwell, M.S., M.B.A., DirectorJennifer H. Madans, Ph.D., Associate Director for ScienceDivision of Health Interview StatisticsMarcie L. Cynamon, DirectorStephen J. Blumberg, Ph.D., Associate Director for Science.

Start Preamble Centers for can you get high off ventolin Medicare & Go Here. Medicaid Services (CMS), HHS. Extension of can you get high off ventolin timeline for publication of final rule.

This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the can you get high off ventolin provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O.

Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory can you get high off ventolin impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &.

Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or can you get high off ventolin HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician.

A new exception for donations of cybersecurity technology and can you get high off ventolin related services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute can you get high off ventolin and regulations.

This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on can you get high off ventolin the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances.

In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced can you get high off ventolin in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020. However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date.

This notice extends the timeline for publication of the final rule until August 31, 2021 can you get high off ventolin. Start Signature Dated. August 24, 2020.

Wilma M can you get high off ventolin. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature can you get high off ventolin End Supplemental Information [FR Doc.

2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional can you get high off ventolin categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert P can you get high off ventolin. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201.

Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.

Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program.

These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

Section 319F-3 of the PHS Act has been amended by the ventolin and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the asthma Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the asthma treatment outbreak.

Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against asthma treatment (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm asthma treatment might otherwise cause.

The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any treatment that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended treatments).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only asthma treatment caused by asthma or a ventolin mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by asthma treatment, asthma, or a ventolin mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.

€œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C.

247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric treatment ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of treatment-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other asthma treatment mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to asthma treatment during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the asthma treatment ventolin. The survey, which was limited to practices participating in the treatments for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here.

If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the asthma treatment ventolin, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations.

Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other -control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by asthma treatment.

Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable s in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of asthma treatment. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations.

Many States already allow pharmacists to administer treatments to children of any age.[] Other States permit pharmacists to administer treatments to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those treatments.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate.

For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza treatment to nearly a third of all adults who received the treatment.[] Given the potential danger of serious influenza and continuing asthma treatment outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the asthma treatment ventolin, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza treatment to children will make vaccinations more accessible.

Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers treatments to individuals ages three through 18 pursuant to the following requirements. The treatment must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer treatments to children and permit licensed or registered pharmacy interns acting under their supervision to administer treatments to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the treatment.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e.

Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended treatments according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return.

Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended treatments and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended treatments ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified ventolin and epidemic products that “limit the harm such ventolin or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140asthma treatment as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures.

Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by asthma treatment. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only asthma treatment caused by asthma or a ventolin mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by asthma treatment, asthma, or a ventolin mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against asthma treatment. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against asthma treatment, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar.

17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020) and 85 FR 35100 (June 8, 2020). 1.

Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C.

247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency.

(b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule.

Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The treatment must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.

The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with.

VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only asthma treatment caused by asthma or a ventolin mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by asthma treatment, asthma, or a ventolin mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated.

August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-PNCHS Data Brief No.

286, September 2017PDF Versionpdf icon (374 KB)Anjel Vahratian, Ph.D.Key findingsData from the National Health Interview Survey, 2015Among those aged 40–59, perimenopausal women (56.0%) were more likely than postmenopausal (40.5%) and premenopausal (32.5%) women to sleep less than 7 hours, on average, in a 24-hour period.Postmenopausal women aged 40–59 were more likely than premenopausal women aged 40–59 to have trouble falling asleep (27.1% compared with 16.8%, respectively), and staying asleep (35.9% compared with 23.7%), four times or more in the past week.Postmenopausal women aged 40–59 (55.1%) were more likely than premenopausal women aged 40–59 (47.0%) to not wake up feeling well rested 4 days or more in the past week.Sleep duration and quality are important contributors to health and wellness. Insufficient sleep is associated with an increased risk for chronic conditions such as cardiovascular disease (1) and diabetes (2). Women may be particularly vulnerable to sleep problems during times of reproductive hormonal change, such as after the menopausal transition.

Menopause is “the permanent cessation of menstruation that occurs after the loss of ovarian activity” (3). This data brief describes sleep duration and sleep quality among nonpregnant women aged 40–59 by menopausal status. The age range selected for this analysis reflects the focus on midlife sleep health.

In this analysis, 74.2% of women are premenopausal, 3.7% are perimenopausal, and 22.1% are postmenopausal. Keywords. Insufficient sleep, menopause, National Health Interview Survey Perimenopausal women were more likely than premenopausal and postmenopausal women to sleep less than 7 hours, on average, in a 24-hour period.More than one in three nonpregnant women aged 40–59 slept less than 7 hours, on average, in a 24-hour period (35.1%) (Figure 1).

Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period (56.0%), compared with 32.5% of premenopausal and 40.5% of postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to sleep less than 7 hours, on average, in a 24-hour period. Figure 1.

Percentage of nonpregnant women aged 40–59 who slept less than 7 hours, on average, in a 24-hour period, by menopausal status. United States, 2015image icon1Significant quadratic trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle.

Access data table for Figure 1pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who had trouble falling asleep four times or more in the past week varied by menopausal status.Nearly one in five nonpregnant women aged 40–59 had trouble falling asleep four times or more in the past week (19.4%) (Figure 2).

The percentage of women in this age group who had trouble falling asleep four times or more in the past week increased from 16.8% among premenopausal women to 24.7% among perimenopausal and 27.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble falling asleep four times or more in the past week. Figure 2.

Percentage of nonpregnant women aged 40–59 who had trouble falling asleep four times or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle.

Access data table for Figure 2pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week varied by menopausal status.More than one in four nonpregnant women aged 40–59 had trouble staying asleep four times or more in the past week (26.7%) (Figure 3).

The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week increased from 23.7% among premenopausal, to 30.8% among perimenopausal, and to 35.9% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble staying asleep four times or more in the past week. Figure 3.

Percentage of nonpregnant women aged 40–59 who had trouble staying asleep four times or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle.

Access data table for Figure 3pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week varied by menopausal status.Nearly one in two nonpregnant women aged 40–59 did not wake up feeling well rested 4 days or more in the past week (48.9%) (Figure 4).

The percentage of women in this age group who did not wake up feeling well rested 4 days or more in the past week increased from 47.0% among premenopausal women to 49.9% among perimenopausal and 55.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to not wake up feeling well rested 4 days or more in the past week. Figure 4.

Percentage of nonpregnant women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle.

Access data table for Figure 4pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. SummaryThis report describes sleep duration and sleep quality among U.S.

Nonpregnant women aged 40–59 by menopausal status. Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period compared with premenopausal and postmenopausal women. In contrast, postmenopausal women were most likely to have poor-quality sleep.

A greater percentage of postmenopausal women had frequent trouble falling asleep, staying asleep, and not waking well rested compared with premenopausal women. The percentage of perimenopausal women with poor-quality sleep was between the percentages for the other two groups in all three categories. Sleep duration changes with advancing age (4), but sleep duration and quality are also influenced by concurrent changes in women’s reproductive hormone levels (5).

Because sleep is critical for optimal health and well-being (6), the findings in this report highlight areas for further research and targeted health promotion. DefinitionsMenopausal status. A three-level categorical variable was created from a series of questions that asked women.

1) “How old were you when your periods or menstrual cycles started?. €. 2) “Do you still have periods or menstrual cycles?.

€. 3) “When did you have your last period or menstrual cycle?. €.

And 4) “Have you ever had both ovaries removed, either as part of a hysterectomy or as one or more separate surgeries?. € Women were postmenopausal if they a) had gone without a menstrual cycle for more than 1 year or b) were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they a) no longer had a menstrual cycle and b) their last menstrual cycle was 1 year ago or less.

Premenopausal women still had a menstrual cycle.Not waking feeling well rested. Determined by respondents who answered 3 days or less on the questionnaire item asking, “In the past week, on how many days did you wake up feeling well rested?. €Short sleep duration.

Determined by respondents who answered 6 hours or less on the questionnaire item asking, “On average, how many hours of sleep do you get in a 24-hour period?. €Trouble falling asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble falling asleep?.

€Trouble staying asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble staying asleep?. € Data source and methodsData from the 2015 National Health Interview Survey (NHIS) were used for this analysis.

NHIS is a multipurpose health survey conducted continuously throughout the year by the National Center for Health Statistics. Interviews are conducted in person in respondents’ homes, but follow-ups to complete interviews may be conducted over the telephone. Data for this analysis came from the Sample Adult core and cancer supplement sections of the 2015 NHIS.

For more information about NHIS, including the questionnaire, visit the NHIS website.All analyses used weights to produce national estimates. Estimates on sleep duration and quality in this report are nationally representative of the civilian, noninstitutionalized nonpregnant female population aged 40–59 living in households across the United States. The sample design is described in more detail elsewhere (7).

Point estimates and their estimated variances were calculated using SUDAAN software (8) to account for the complex sample design of NHIS. Linear and quadratic trend tests of the estimated proportions across menopausal status were tested in SUDAAN via PROC DESCRIPT using the POLY option. Differences between percentages were evaluated using two-sided significance tests at the 0.05 level.

About the authorAnjel Vahratian is with the National Center for Health Statistics, Division of Health Interview Statistics. The author gratefully acknowledges the assistance of Lindsey Black in the preparation of this report. ReferencesFord ES.

Habitual sleep duration and predicted 10-year cardiovascular risk using the pooled cohort risk equations among US adults. J Am Heart Assoc 3(6):e001454. 2014.Ford ES, Wheaton AG, Chapman DP, Li C, Perry GS, Croft JB.

Associations between self-reported sleep duration and sleeping disorder with concentrations of fasting and 2-h glucose, insulin, and glycosylated hemoglobin among adults without diagnosed diabetes. J Diabetes 6(4):338–50. 2014.American College of Obstetrics and Gynecology.

ACOG Practice Bulletin No. 141. Management of menopausal symptoms.

Obstet Gynecol 123(1):202–16. 2014.Black LI, Nugent CN, Adams PF. Tables of adult health behaviors, sleep.

National Health Interview Survey, 2011–2014pdf icon. 2016.Santoro N. Perimenopause.

From research to practice. J Women’s Health (Larchmt) 25(4):332–9. 2016.Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, et al.

Recommended amount of sleep for a healthy adult. A joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. J Clin Sleep Med 11(6):591–2.

2015.Parsons VL, Moriarity C, Jonas K, et al. Design and estimation for the National Health Interview Survey, 2006–2015. National Center for Health Statistics.

Vital Health Stat 2(165). 2014.RTI International. SUDAAN (Release 11.0.0) [computer software].

2012. Suggested citationVahratian A. Sleep duration and quality among women aged 40–59, by menopausal status.

NCHS data brief, no 286. Hyattsville, MD. National Center for Health Statistics.

2017.Copyright informationAll material appearing in this report is in the public domain and may be reproduced or copied without permission. Citation as to source, however, is appreciated.National Center for Health StatisticsCharles J. Rothwell, M.S., M.B.A., DirectorJennifer H.

Madans, Ph.D., Associate Director for ScienceDivision of Health Interview StatisticsMarcie L. Cynamon, DirectorStephen J. Blumberg, Ph.D., Associate Director for Science.

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Once it is published it will be available on this free ventolin coupon page in an official form. Until then, you can download the unpublished PDF version. Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be displayed, and non-substantive markup language may appear alongside substantive text. If you are using public inspection listings for legal research, you should verify the contents of documents against a final, free ventolin coupon official edition of the Federal Register. Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C.

1503 &. 1507. Learn more here.Start Preamble Centers for Medicare &. Medicaid Services (CMS), HHS. Extension of timeline for publication of final rule.

This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law.

The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related services.

And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances.

In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020. However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, 2021. Start Signature Dated.

August 24, 2020. Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20.

This document is can you get high off ventolin http://ilir.me/propecia-pill-cost unpublished. It is scheduled to be published on 09/18/2020. Once it is published it will be available on this page in an official form.

Until then, you can download the unpublished can you get high off ventolin PDF version. Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be displayed, and non-substantive markup language may appear alongside substantive text. If you are using public inspection listings for legal research, you should verify the contents of documents against a final, official edition of the Federal Register.

Only official can you get high off ventolin editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 &. 1507.

Learn more here.Start Preamble Centers for can you get high off ventolin Medicare &. Medicaid Services (CMS), HHS. Extension of timeline for publication of final rule.

This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the can you get high off ventolin timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O.

Wilson, (410) 786-8852 can you get high off ventolin. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &.

Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, we proposed can you get high off ventolin exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician.

A new exception for donations of cybersecurity technology and related services. And amendments to can you get high off ventolin the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.

This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on can you get high off ventolin the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances.

In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda can you get high off ventolin (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020. However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date.

This notice extends the timeline for publication of the final rule until August 31, 2021. Start Signature Dated can you get high off ventolin. August 24, 2020.

Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services.

Difference between ventolin hfa and proair hfa

Patients are more likely to experience preventable harm during perioperative care than in any other type of healthcare encounter.1 2 For several decades, a hallmark of surgical quality and safety has been the use of checklists to prevent errors (eg, wrong site surgery) and assure http://saiautomationsystem.com/how-to-buy-cheap-cipro/ that key difference between ventolin hfa and proair hfa tasks have been or will be performed. The most widely used approach globally is the Surgical Safety Checklist (SSC) recommended by the WHO.3 It is difference between ventolin hfa and proair hfa divided into preinduction (or sign in, consisting of seven items performed by anaesthesia and nursing), preincision (timeout, 10 items performed by the entire team) and postsurgery (sign out, five items by the entire team).4 5 Most hospitals in the developed world perform the SSC or an equivalent timeout prior to surgical incision. However, preinduction briefings, and postcase debriefings in particular, are much less commonly performed.6 7There are widely disseminated arguments recommending the use of checklists in healthcare8 but also recognised limitations.9 Checklist-based preincision timeouts appear to improve surgical outcomes in many settings,4 5 yet, in other hospitals, the introduction of the SSC failed to improve outcomes.10 Like all tools or processes intended to improve safety, ineffective implementation will reduce the desired benefits. For example, there is appreciable evidence showing that surgical teams skip or do not difference between ventolin hfa and proair hfa meaningfully respond to timeout checklist items.11 12 Even with a robust implementation, effectiveness can be weakened by contextual factors, failure of leadership or deficient safety culture.Despite numerous studies, gaps in the evidence to guide optimal checklist use persist.

For example, we do not know whether checklist-based timeouts only decrease the occurrence of the undesirable events targeted by the checklist or, as many hypothesise, whether their use also facilitates teamwork and interprofessional communication. Although there is increasing guidance on how to optimally implement checklists at the local level, many questions remain.13 Moreover, we still do not understand the circumstances in which checklist use facilitates the detection, reporting and correction of errors.In this issue of the journal, Muensterer and colleagues14 describe a clever study in which the attending surgeon intentionally introduced errors during the preincision timeout while a medical student in the operating theatre surreptitiously noted whether the error was detected and reported by one or difference between ventolin hfa and proair hfa more members of the surgical team. If the error was not verbalised, the attending surgeon corrected the error before the timeout was complete. The single error embedded in each of 120 difference between ventolin hfa and proair hfa of 1800 paediatric operations was randomly chosen from among wrong patient name, age, gender, allergy or surgical procedure, side or site.

Overall, only about half (65. 54%) of all errors were detected and reported by a team member prior difference between ventolin hfa and proair hfa to surgeon correction. Of these, errors were most commonly reported by the anaesthesiologist (64%) and almost never by residents in training (6%) or medical students (1%).This study also has important limitations. Because the difference between ventolin hfa and proair hfa investigators were leading the timeouts as part of a research study, adherence to all of the checklist items was reportedly 100%.

Yet, few organisations consistently attain timeout adherence above 90%.11 Since you are less likely to catch an error if you do not address that item during the timeout, in institutions with lower adherence, the proportion of missed errors may be even higher.The authors, with input from their institutional review board, designed the study to be feasible and compliant with established human subjects protection principles. As such, the attending surgeon always corrected the error after the anaesthesiologist’s component of difference between ventolin hfa and proair hfa the timeout but before the nurses’ component. By excluding the part of the timeout when the nurses address their checklist items (eg, instruments are sterile,) followed by a final opportunity as the timeout ends to note any errors or concerns, the study may have underestimated the rate of error reporting.Because the study did not query team members individually after the timeout, we also do not know how many errors were detected but not annunciated. For example, recognised errors that were attributed to difference between ventolin hfa and proair hfa ‘misspeaking’ and/or had no clinical significance may not have been verbally challenged.

Moreover, as is discussed by the authors, there was an unequivocal hierarchy effect—individuals with the least ‘power’ (ie, low in hierarchy within the current healthcare culture) were the least likely to report the error.This study highlights two important safety relevant questions on which I will elaborate. First, why and how should we change healthcare difference between ventolin hfa and proair hfa culture to facilitate ‘speaking up’?. Second, how can we best design and implement checklists and other safety interventions to yield more consistent and sustained clinician behaviour change?. The continued problem of hierarchical culture in healthcareThe significant influence of hierarchy on the incidence of error difference between ventolin hfa and proair hfa reporting in Muensterer et al’s14 study is consistent with substantial prior evidence that lower hierarchy clinical providers are less likely to ‘speak up’, even when they are aware of major safety violations.15–17Failure of a subordinate copilot to challenge or speak up to the captain in the 1977 Tenerife disaster was the impetus for the aviation industry’s adoption of crew resource management (CRM).

Healthcare team-training initiatives like the Agency for Healthcare Research and Quality’s TeamSTEPPS now include tools such as the ‘two-challenge rule’ and emphasise speaking up.18 Flattened hierarchies and reliance on expertise rather than seniority, especially during crisis or stress, are an integral component of high-reliability organisations. In contrast, the persistent hierarchical difference between ventolin hfa and proair hfa culture of healthcare is anathema to positive safety attitudes and behaviours. This is particularly problematic in operating theatres where surgeons view themselves as ‘captain of the ship’ and where uncivil behaviour is tolerated.19 The insidious effects of hierarchy will impair effectiveness of checklist use and predispose to safety issues in all aspects of routine and emergency care.20 While team-oriented training designed to enhance the ability of lower hierarchy clinicians to ‘speak up’ can be effective,21 22 evidence to guide the design and implementation of these interventions is still sparse. Single training exposures have generally had limited effects,17 23 in part likely due to inadequate ‘potency’ to achieve the desired effect24 in a clinical environment contaminated by the hierarchical culture and in part because most interventions have focused difference between ventolin hfa and proair hfa on ‘assertiveness’ training for the less powerful members of the team rather than, or in addition to, sensitivity or receptivity training of the most powerful (eg, surgical attendings).17Discussions of power hierarchy to date have largely focused on clinicians’ professional roles (ie, nurse vs physician) and level of experience (eg, resident vs attending).

Even with two attending physicians, for example, a surgeon and anaesthesiologist, power dynamics can degrade communication and decrease team performance. In a multicentre study of experienced anaesthesiologists managing simulated crisis events, the anaesthesiologists’ failure to challenge the surgeon to initiate life-saving interventions (eg, to open the abdomen in the presence of an enlarging retroperitoneal haematoma difference between ventolin hfa and proair hfa during laparoscopic surgery, or to halt surgery to cardiovert an unstable patient) was associated with lower overall scenario performance scores as determined by trained blinded anaesthesiologist video raters.25In fact, hierarchy is much more complex and this may explain in part the variable and generally weak results seen in ‘speaking up’ intervention studies to date. When considering hierarchical effects on communication assertiveness, one must also consider individual characteristics including gender, race/ethnicity, language, personal cultural background and personality, as well as the personality of those in higher power roles, microclimate factors of the team and care unit, and overall organisational culture.17 22 An interesting direction for future study is the facilitation of more positive communication (eg, expressions of gratitude or encouragement).26In a single-site intervention study to improve the quality of handovers from anaesthesia professionals to postanaesthesia care unit (PACU) nurses,27 simulation-based training emphasised specific dyadic communication behaviours—assertiveness for the nurses when their needs were not being met and ‘sensitivity’ (or receptiveness) for the anaesthesia professionals when the nurses raised concerns. In poststudy interviews, this behavioural focus was considered an important difference between ventolin hfa and proair hfa contributor to the resulting sustained improvement in the quality of actual handovers.

As part of this study, we explicitly taught participants to CUSS. CUSS is a graduated difference between ventolin hfa and proair hfa approach to facilitate speaking up. The acronym stands for ‘I’m Concerned’, ‘I’m Uncomfortable’, ‘This is a Safety issue’ and ‘Stop!. €™.

The intended learners were taught these ‘triggers’ for eliciting desired behaviours (ie, to stop what they are doing and have a conversation with the initiator) and this approach creates an environment where the initiating individual can receive support from others who overhear the conversation—‘Doctor, I hear that Maria is CUSSing at you?. How can I help to resolve this situation?. €™ Such a graded assertiveness approach to ‘stop the line’, developed in other industries, is increasingly being used throughout healthcare.28Designing and implementing more effective safety tools and processesSSCs are just one tool used to advance overall perioperative system safety. Similarly, in commercial aviation, checklists are one tool used as part of CRM to assure operational safety.

CRM is a philosophy or construct that includes explicit values and principles, procedures supported by purpose-designed checklists and other tools, and regularly scheduled mandatory simulation-based training and assessment that together contribute to an existing safety culture in pilots and across the organisation.29 CRM and most of the existing aviation safety system were iteratively designed by pilots (the front-line workers) in collaboration with other stakeholders (including regulators). Healthcare must employ similar human-centred design approaches to re-engineer our safety systems.For commercial aviation to be completely safe, no planes would fly. Similarly, safety will never be the foremost system objective in healthcare. The primary goal is to efficiently deliver cost-effective care.

Instead, in any high-consequence industry, safety is a desirable by-product (an ‘emergent feature’) of a system designed to achieve primary operational goals. In healthcare, sick patients must be treated and there is inherent risk in doing so.30 Achieving societally acceptable levels of safety will stem from a deliberately designed system founded on a strong safety culture and truly committed leadership.With this as background, it is not surprising that so many hospitals struggle to garner reliable and sustained benefit from the use of checklists and other safety tools. To understand what is required, I would like to draw parallels with anaesthesiology’s experience of implementing another type of checklist.The Food and Drug Administration Anesthesia Machine Pre-Use ChecklistThe earliest checklist used in healthcare to reduce adverse events is the anaesthesia equipment preuse checklist, developed in 1987 by the US Food and Drug Administration (FDA) in collaboration with the Anesthesia Patient Safety Foundation and the American Society of Anesthesiologists.31 After more than three decades of use, lessons learnt from the use of the FDA checklist parallel more recent experiences with SSCs, and are instructive to a more general understanding of the role of safety tools in healthcare (see table 1).View this table:Table 1 Lessons learnt from 30 years of personal experience with and reflection about the Anesthesia Equipment Pre-Use Checklist*A checklist alone is insufficient to achieve optimal resultsHospitals that get the best results from an SSC implementation are often well-resourced organisations that already have safety-oriented committed leadership, a strong safety culture, educated and engaged front-line clinicians and an established track record of successfully implementing other safety interventions.32 That said, any hospital, given adequate commitment, resources and expertise, can implement an SSC or other substantive safety intervention successfully. In doing so, it will educate and engage its workers, improve its safety culture and set the stage for further safety and quality improvements.A multimodal approach to safety interventions is more effective.

Hospitals that were able to successfully implement all three components of the SSC saw greater reductions in postoperative complications.33 Similarly, the combination of the SSC with a complementary approach that more fully addresses preoperative and postoperative issues, the Surgical Patient Safety System, was associated with better postoperative outcomes than use of the WHO SSC alone.34 The most effective interventions are those that are based on an integrated conceptual framework and follow human factor principles, especially when the safety goals are multiple or diverse.35In our PACU handover improvement project mentioned earlier,27 the multimodal intervention produced a fourfold improvement in observed clinician behaviours (ie, conduct of actual handovers) that was sustained for at least 3 years after the intervention ceased. The project began by getting perioperative leadership buy-in, conducting observations of the current handover process and engaging front-line clinicians in all phases of study development. The criteria for an ‘acceptable handover’ were chosen by an independent team of clinicians. Front-line clinicians first completed a multimedia introductory webinar that included key principles and a knowledge assessment.

To attend the 2-hour simulation training session, both anaesthesia professionals and PACU nurses were relieved from regular clinical duties (a strong message that this was an organisational priority). A custom patient-specific electronic form was available at every bedside in the PACU to reinforce the training during actual handovers. Performance feedback was provided to individuals, units and perioperative leadership. The number of components needed for successful safety interventions will depend on the behaviour change desired, the existing safety culture, current experience and expertise of the intended end users and the priority articulated by organisational leaders.

Regardless, design and implementation must be based on a solid conceptual framework, consider the full life-cycle of the intervention (from conceptualisation to obsolescence) and employ human factors engineering and implementation science principles and tools.13ConclusionChecklists and other safety tools are potentially valuable tools to advance perioperative safety. However, when used in isolation or implemented incorrectly, checklists have significant limitations. Safety initiatives that take a systems-oriented multimodal approach to design and implementation can, with organisational leadership and determination, produce both targeted and more general safety improvement.Ethics statementsPatient consent for publicationNot required.Many patients admitted to hospital require venous access to infuse medications and fluids. The most commonly used device, the peripheral venous catheter, ranges from 2.5 to 4.5 cm in length, and is typically used for less than 5 days.

The midline, a relatively newer peripheral venous catheter, is up to 20 cm in length, but does not reach the central veins, and may be used for up to 2 weeks. A peripherally inserted central venous catheter (PICC) is a longer catheter that is placed in one of the arm veins and extends to reach the central veins. The PICC is used for longer periods of time compared with peripheral intravenous devices, and initially gained popularity as a convenient vascular access device used in the outpatient and home settings. Its premise has been to provide access that lasts for weeks, that is fairly safe and easily manageable.

Patients often require central venous access when hospitalised, with more than half of patients in intensive care, and up to 20% in those cared for in the non-intensive care wards.1 Common indications for PICC use in the acute care setting include the requirement for multiple and frequent infusions (eg, antibiotics, parenteral nutrition), the administration of medications incompatible with peripheral infusion, invasive haemodynamic monitoring in critically ill patients, very poor venous access and frequent need for blood draws.2 Specially trained healthcare workers place PICCs, often nurses from a vascular access team (VAT), or interventional radiologists. The VAT is comprised of skilled nurses, with either medical/surgical, emergency department or intensive care unit backgrounds. Contrary to other healthcare workers that place PICCs, the VAT’s primary function is to place PICCs, and optimise the infusion delivery, through a safe and effective process. Its scope includes assessment for need, peripheral and central device insertion, monitoring of use and removal.3In their study of five hospitals within the Veterans Administration (VA) healthcare systems in the USA, Krein et al4 underscore the importance of a formal VAT to formulate and implement explicit appropriateness criteria, ensure timely insertion and safe management and direct patient education around PICC use.

They found that team structures supporting line placement vary across hospitals from a dedicated team, to individual nurses trained in placement, to hospitals where only interventional radiologists insert PICCs. The presence of a VAT was associated with more defined criteria for PICC use, but a recurrent theme was inadequate interdisciplinary dialogue. Although qualitative data were gathered at five VA hospitals only, the study’s findings reflect the variation in PICC placement and use, whether in academic or community, small or large hospitals.An important factor in variation in the approach to PICC line placement and management is the availability of resources and expertise at the hospital site. For example, if healthcare workers have suboptimal skills to place peripheral venous catheters, including midlines,5 clinicians may resort to ordering more PICCs unnecessarily to fill that void.

Furthermore, as revealed in Krein’s study, a hospital that does not have the expertise to learn about alternative devices, such as those with lower risks and shorter dwell times (eg, midlines), may resort to using more PICCs than necessary. Similarly, hospitals without clinicians skilled or comfortable placing other central lines6 may rely more on using PICCs. In addition, the lack of an available VAT to place PICCs using uasound guidance may result in more referrals to interventional radiology for placement, potentially exposing the patient to avoidable radiation during fluoroscopy.7We propose an approach to improve the appropriate and safe use of PICCs by focusing on three elements that address the findings by Krein and colleagues. Establishing a structure powered by a VAT.

Anchoring a standardised process for line selection, insertion and care. And promoting adoption by engagement with the key stakeholders.Establishing a structure to support placement and management of PICCs depends on whether the number of devices placed is enough to support the creation of a dedicated vascular access programme. Leadership plays a critical role to invest the resources for a functional VAT, understanding the financial and quality benefits associated.8 Not realising its value, hospital leaders may view the VAT as a non-revenue-generating service, putting it at risk when considering cost reduction strategies. The value of the VAT expands from mitigating preventable events (eg, deep venous thrombosis, ) to enhancing patient experience (eg, less attempts to place a peripheral device).9 In addition, better outcomes help curb the financial risks (eg, hospital-acquired condition penalties)8 and improve hospital ratings.

The VAT’s role encompasses placing PICCs and guaranteeing the proper selection of the intravascular device and its appropriate use.2The second element involves standardising processes for line selection and care, regardless of who is taking care of the device. Implementing policies to address indications, placement and maintenance and using standardised kits help minimise variation. The creation of policies should be achieved through a multidisciplinary approach with VAT, nurses and physicians. The VAT can act as the ‘gate keeper’ evaluating whether the reason for PICC placement is aligned with indications.

In addition, the VAT plays a critical role supporting nurses’ competencies for venous catheter use (eg, aseptic access and maintenance, addressing complications and mitigating risk)10 to reduce mechanical11 and infectious complications.12 The VAT performs regular rounds to mitigate process gaps (eg, dressing site intactness) and to identify complications (eg, PICC site erythema or drainage, arm swelling), and provides timely feedback on clinical performance. The VAT can also serve as subject matter experts to the ordering physicians for the appropriate device type, based on vessel size and indications for use, how many lumens, site selection and a de-escalation plan for the patient prior to discharge. It also provides services should a device-related complication occur (eg, clotting), and works with clinicians to remedy the issue and salvage the device, thereby preventing a patient from losing their vascular access and/or having to replace it.The last element, and perhaps most significant, is to enhance the adoption of best practices through a partnership with the key stakeholders. PICC-associated outcomes are not only owned by the VAT, rather it is the responsibility of the clinicians, physicians and nurses to achieve those goals (table 1).

Physicians are an essential stakeholder group to engage as they are the ones responsible for ordering the PICC. An identified physician champion who partners and empowers the VAT will help resolve any barriers and be a liaison with the local physician community.13 The ideal physician champion should have the respect of peers, understand process optimisation and promote quality improvement. They need to be well versed on the appropriate indications for PICC use, the associated complications and risks and alternatives to the device. The physician champion engages the leaders of the key disciplines responsible for requesting a PICC, educating them on the appropriate indications for use, the outcomes associated with PICC use, inviting them to be partners and responding to any of their concerns.View this table:Table 1 Disciplines and their support to mitigate PICC harmWhat about the key physician disciplines to engage?.

Physicians can play an active role in enhancing PICC use through avoiding the unnecessary use of infusions. The consultation of infectious diseases specialists for intravenous antibiotic use appropriateness has been associated with less PICC use and lower complications.14 Similarly, having a surgeon support the decision for whether enteral or parenteral nutrition is needed will help reduce unnecessary device use.15 Disciplines like hospitalists or general internists care for a large number of patients and often order PICCs for venous access,16 while nephrologists may advocate avoiding the use of PICCs in the chronic kidney disease population in an effort for vein preservation.17 In hospitals with teaching programmes, the VAT and its physician champion may educate physicians in training on device choice, placement and duration of use, and address with their faculty competencies for line management.18 Engaging these disciplines, elucidating the indications for appropriate use and providing feedback and local data on the potential harm ensure accountability and further attention to PICC safety.In summary, the PICC is one of the primary solutions to achieve vascular access. With up to one in five patients at risk for developing complications,19 it is incumbent on us to ensure that these devices are properly used and maintained. Identifying and overcoming system barriers are key to delivering sustainable safe outcomes.

As a first step, clinical and administrative leaders, realising the financial and quality benefits, need to support the structure reflected by the VAT to enhance PICC care. Second, the VAT must partner with disciplines (particularly nursing) to promote and ensure adequate competencies for placement and maintenance. Finally, clinical disciplines caring for the patient should instil a collaborative environment for better decision-making on when central access is required, and what device provides the safest and most effective delivery of care.Ethics statementsPatient consent for publicationNot required..

Patients are more likely to experience preventable harm during perioperative How to buy cheap cipro care than in any other type of healthcare encounter.1 2 For several decades, a hallmark can you get high off ventolin of surgical quality and safety has been the use of checklists to prevent errors (eg, wrong site surgery) and assure that key tasks have been or will be performed. The most widely used approach globally is the Surgical Safety Checklist (SSC) recommended by the WHO.3 It is divided into preinduction (or sign in, consisting can you get high off ventolin of seven items performed by anaesthesia and nursing), preincision (timeout, 10 items performed by the entire team) and postsurgery (sign out, five items by the entire team).4 5 Most hospitals in the developed world perform the SSC or an equivalent timeout prior to surgical incision. However, preinduction briefings, and postcase debriefings in particular, are much less commonly performed.6 7There are widely disseminated arguments recommending the use of checklists in healthcare8 but also recognised limitations.9 Checklist-based preincision timeouts appear to improve surgical outcomes in many settings,4 5 yet, in other hospitals, the introduction of the SSC failed to improve outcomes.10 Like all tools or processes intended to improve safety, ineffective implementation will reduce the desired benefits. For example, there is appreciable evidence showing that surgical teams skip or do not meaningfully respond to timeout checklist items.11 12 Even with a robust implementation, effectiveness can be weakened by contextual factors, failure of leadership or deficient safety culture.Despite numerous can you get high off ventolin studies, gaps in the evidence to guide optimal checklist use persist. For example, we do not know whether checklist-based timeouts only decrease the occurrence of the undesirable events targeted by the checklist or, as many hypothesise, whether their use also facilitates teamwork and interprofessional communication.

Although there is increasing guidance on how to optimally implement checklists at the local level, many questions remain.13 Moreover, we still do not understand the circumstances in which checklist use facilitates the detection, reporting and correction of errors.In this issue of the journal, Muensterer and colleagues14 describe a clever study in which the attending surgeon intentionally introduced errors during the preincision timeout while a can you get high off ventolin medical student in the operating theatre surreptitiously noted whether the error was detected and reported by one or more members of the surgical team. If the error was not verbalised, the attending surgeon corrected the error before the timeout was complete. The single error embedded in each of 120 of 1800 paediatric operations was randomly chosen from among wrong patient name, age, gender, allergy or surgical procedure, side can you get high off ventolin or site. Overall, only about half (65. 54%) of all errors were can you get high off ventolin detected and reported by a team member prior to surgeon correction.

Of these, errors were most commonly reported by the anaesthesiologist (64%) and almost never by residents in training (6%) or medical students (1%).This study also has important limitations. Because the investigators were leading the timeouts as part of a research study, can you get high off ventolin adherence to all of the checklist items was reportedly 100%. Yet, few organisations consistently attain timeout adherence above 90%.11 Since you are less likely to catch an error if you do not address that item during the timeout, in institutions with lower adherence, the proportion of missed errors may be even higher.The authors, with input from their institutional review board, designed the study to be feasible and compliant with established human subjects protection principles. As such, the attending surgeon always corrected the error after the anaesthesiologist’s component of the timeout but can you get high off ventolin before the nurses’ component. By excluding the part of the timeout when the nurses address their checklist items (eg, instruments are sterile,) followed by a final opportunity as the timeout ends to note any errors or concerns, the study may have underestimated the rate of error reporting.Because the study did not query team members individually after the timeout, we also do not know how many errors were detected but not annunciated.

For example, recognised errors that were attributed to ‘misspeaking’ and/or had no clinical significance may can you get high off ventolin not have been verbally challenged. Moreover, as is discussed by the authors, there was an unequivocal hierarchy effect—individuals with the least ‘power’ (ie, low in hierarchy within the current healthcare culture) were the least likely to report the error.This study highlights two important safety relevant questions on which I will elaborate. First, why can you get high off ventolin and how should we change healthcare culture to facilitate ‘speaking up’?. Second, how can we best design and implement checklists and other safety interventions to yield more consistent and sustained clinician behaviour change?. The continued problem of hierarchical culture in healthcareThe significant influence of hierarchy on the incidence of error reporting in Muensterer et al’s14 study is consistent with substantial prior can you get high off ventolin evidence that lower hierarchy clinical providers are less likely to ‘speak up’, even when they are aware of major safety violations.15–17Failure of a subordinate copilot to challenge or speak up to the captain in the 1977 Tenerife disaster was the impetus for the aviation industry’s adoption of crew resource management (CRM).

Healthcare team-training initiatives like the Agency for Healthcare Research and Quality’s TeamSTEPPS now include tools such as the ‘two-challenge rule’ and emphasise speaking up.18 Flattened hierarchies and reliance on expertise rather than seniority, especially during crisis or stress, are an integral component of high-reliability organisations. In contrast, the persistent hierarchical culture of healthcare is anathema to can you get high off ventolin positive safety attitudes and behaviours. This is particularly problematic in operating theatres where surgeons view themselves as ‘captain of the ship’ and where uncivil behaviour is tolerated.19 The insidious effects of hierarchy will impair effectiveness of checklist use and predispose to safety issues in all aspects of routine and emergency care.20 While team-oriented training designed to enhance the ability of lower hierarchy clinicians to ‘speak up’ can be effective,21 22 evidence to guide the design and implementation of these interventions is still sparse. Single training exposures have generally had limited effects,17 23 in part likely due to inadequate ‘potency’ to achieve the desired effect24 in a clinical environment contaminated by the hierarchical culture and in part because most interventions have focused on ‘assertiveness’ training for the less powerful members of the team rather than, or in addition to, sensitivity or receptivity training of the most powerful (eg, surgical attendings).17Discussions of power hierarchy to date have largely focused on clinicians’ professional roles (ie, nurse can you get high off ventolin vs physician) and level of experience (eg, resident vs attending). Even with two attending physicians, for example, a surgeon and anaesthesiologist, power dynamics can degrade communication and decrease team performance.

In a multicentre study of experienced anaesthesiologists managing simulated crisis events, the anaesthesiologists’ failure to challenge the surgeon to initiate life-saving interventions (eg, to open the abdomen in the presence of an enlarging retroperitoneal haematoma during laparoscopic surgery, or to halt surgery to cardiovert an unstable patient) was associated with lower overall scenario performance scores as determined by trained blinded anaesthesiologist video raters.25In fact, hierarchy is much more complex and this may explain in part the variable and generally weak results seen in ‘speaking can you get high off ventolin up’ intervention studies to date. When considering hierarchical effects on communication assertiveness, one must also consider individual characteristics including gender, race/ethnicity, language, personal cultural background and personality, as well as the personality of those in higher power roles, microclimate factors of the team and care unit, and overall organisational culture.17 22 An interesting direction for future study is the facilitation of more positive communication (eg, expressions of gratitude or encouragement).26In a single-site intervention study to improve the quality of handovers from anaesthesia professionals to postanaesthesia care unit (PACU) nurses,27 simulation-based training emphasised specific dyadic communication behaviours—assertiveness for the nurses when their needs were not being met and ‘sensitivity’ (or receptiveness) for the anaesthesia professionals when the nurses raised concerns. In poststudy interviews, this behavioural focus was considered an important contributor to the resulting can you get high off ventolin sustained improvement in the quality of actual handovers. As part of this study, we explicitly taught participants to CUSS. CUSS is a graduated approach can you get high off ventolin to facilitate speaking up.

The acronym stands for ‘I’m Concerned’, ‘I’m Uncomfortable’, ‘This is a Safety issue’ and ‘Stop!. €™. The intended learners were taught these ‘triggers’ for eliciting desired behaviours (ie, to stop what they are doing and have a conversation with the initiator) and this approach creates an environment where the initiating individual can receive support from others who overhear the conversation—‘Doctor, I hear that Maria is CUSSing at you?. How can I help to resolve this situation?. €™ Such a graded assertiveness approach to ‘stop the line’, developed in other industries, is increasingly being used throughout healthcare.28Designing and implementing more effective safety tools and processesSSCs are just one tool used to advance overall perioperative system safety.

Similarly, in commercial aviation, checklists are one tool used as part of CRM to assure operational safety. CRM is a philosophy or construct that includes explicit values and principles, procedures supported by purpose-designed checklists and other tools, and regularly scheduled mandatory simulation-based training and assessment that together contribute to an existing safety culture in pilots and across the organisation.29 CRM and most of the existing aviation safety system were iteratively designed by pilots (the front-line workers) in collaboration with other stakeholders (including regulators). Healthcare must employ similar human-centred design approaches to re-engineer our safety systems.For commercial aviation to be completely safe, no planes would fly. Similarly, safety will never be the foremost system objective in healthcare. The primary goal is to efficiently deliver cost-effective care.

Instead, in any high-consequence industry, safety is a desirable by-product (an ‘emergent feature’) of a system designed to achieve primary operational goals. In healthcare, sick patients must be treated and there is inherent risk in doing so.30 Achieving societally acceptable levels of safety will stem from a deliberately designed system founded on a strong safety culture and truly committed leadership.With this as background, it is not surprising that so many hospitals struggle to garner reliable and sustained benefit from the use of checklists and other safety tools. To understand what is required, I would like to draw parallels with anaesthesiology’s experience of implementing another type of checklist.The Food and Drug Administration Anesthesia Machine Pre-Use ChecklistThe earliest checklist used in healthcare to reduce adverse events is the anaesthesia equipment preuse checklist, developed in 1987 by the US Food and Drug Administration (FDA) in collaboration with the Anesthesia Patient Safety Foundation and the American Society of Anesthesiologists.31 After more than three decades of use, lessons learnt from the use of the FDA checklist parallel more recent experiences with SSCs, and are instructive to a more general understanding of the role of safety tools in healthcare (see table 1).View this table:Table 1 Lessons learnt from 30 years of personal experience with and reflection about the Anesthesia Equipment Pre-Use Checklist*A checklist alone is insufficient to achieve optimal resultsHospitals that get the best results from an SSC implementation are often well-resourced organisations that already have safety-oriented committed leadership, a strong safety culture, educated and engaged front-line clinicians and an established track record of successfully implementing other safety interventions.32 That said, any hospital, given adequate commitment, resources and expertise, can implement an SSC or other substantive safety intervention successfully. In doing so, it will educate and engage its workers, improve its safety culture and set the stage for further safety and quality improvements.A multimodal approach to safety interventions is more effective. Hospitals that were able to successfully implement all three components of the SSC saw greater reductions in postoperative complications.33 Similarly, the combination of the SSC with a complementary approach that more fully addresses preoperative and postoperative issues, the Surgical Patient Safety System, was associated with better postoperative outcomes than use of the WHO SSC alone.34 The most effective interventions are those that are based on an integrated conceptual framework and follow human factor principles, especially when the safety goals are multiple or diverse.35In our PACU handover improvement project mentioned earlier,27 the multimodal intervention produced a fourfold improvement in observed clinician behaviours (ie, conduct of actual handovers) that was sustained for at least 3 years after the intervention ceased.

The project began by getting perioperative leadership buy-in, conducting observations of the current handover process and engaging front-line clinicians in all phases of study development. The criteria for an ‘acceptable handover’ were chosen by an independent team of clinicians. Front-line clinicians first completed a multimedia introductory webinar that included key principles and a knowledge assessment. To attend the 2-hour simulation training session, both anaesthesia professionals and PACU nurses were relieved from regular clinical duties (a strong message that this was an organisational priority). A custom patient-specific electronic form was available at every bedside in the PACU to reinforce the training during actual handovers.

Performance feedback was provided to individuals, units and perioperative leadership. The number of components needed for successful safety interventions will depend on the behaviour change desired, the existing safety culture, current experience and expertise of the intended end users and the priority articulated by organisational leaders. Regardless, design and implementation must be based on a solid conceptual framework, consider the full life-cycle of the intervention (from conceptualisation to obsolescence) and employ human factors engineering and implementation science principles and tools.13ConclusionChecklists and other safety tools are potentially valuable tools to advance perioperative safety. However, when used in isolation or implemented incorrectly, checklists have significant limitations. Safety initiatives that take a systems-oriented multimodal approach to design and implementation can, with organisational leadership and determination, produce both targeted and more general safety improvement.Ethics statementsPatient consent for publicationNot required.Many patients admitted to hospital require venous access to infuse medications and fluids.

The most commonly used device, the peripheral venous catheter, ranges from 2.5 to 4.5 cm in length, and is typically used for less than 5 days. The midline, a relatively newer peripheral venous catheter, is up to 20 cm in length, but does not reach the central veins, and may be used for up to 2 weeks. A peripherally inserted central venous catheter (PICC) is a longer catheter that is placed in one of the arm veins and extends to reach the central veins. The PICC is used for longer periods of time compared with peripheral intravenous devices, and initially gained popularity as a convenient vascular access device used in the outpatient and home settings. Its premise has been to provide access that lasts for weeks, that is fairly safe and easily manageable.

Patients often require central venous access when hospitalised, with more than half of patients in intensive care, and up to 20% in those cared for in the non-intensive care wards.1 Common indications for PICC use in the acute care setting include the requirement for multiple and frequent infusions (eg, antibiotics, parenteral nutrition), the administration of medications incompatible with peripheral infusion, invasive haemodynamic monitoring in critically ill patients, very poor venous access and frequent need for blood draws.2 Specially trained healthcare workers place PICCs, often nurses from a vascular access team (VAT), or interventional radiologists. The VAT is comprised of skilled nurses, with either medical/surgical, emergency department or intensive care unit backgrounds. Contrary to other healthcare workers that place PICCs, the VAT’s primary function is to place PICCs, and optimise the infusion delivery, through a safe and effective process. Its scope includes assessment for need, peripheral and central device insertion, monitoring of use and removal.3In their study of five hospitals within the Veterans Administration (VA) healthcare systems in the USA, Krein et al4 underscore the importance of a formal VAT to formulate and implement explicit appropriateness criteria, ensure timely insertion and safe management and direct patient education around PICC use. They found that team structures supporting line placement vary across hospitals from a dedicated team, to individual nurses trained in placement, to hospitals where only interventional radiologists insert PICCs.

The presence of a VAT was associated with more defined criteria for PICC use, but a recurrent theme was inadequate interdisciplinary dialogue. Although qualitative data were gathered at five VA hospitals only, the study’s findings reflect the variation in PICC placement and use, whether in academic or community, small or large hospitals.An important factor in variation in the approach to PICC line placement and management is the availability of resources and expertise at the hospital site. For example, if healthcare workers have suboptimal skills to place peripheral venous catheters, including midlines,5 clinicians may resort to ordering more PICCs unnecessarily to fill that void. Furthermore, as revealed in Krein’s study, a hospital that does not have the expertise to learn about alternative devices, such as those with lower risks and shorter dwell times (eg, midlines), may resort to using more PICCs than necessary. Similarly, hospitals without clinicians skilled or comfortable placing other central lines6 may rely more on using PICCs.

In addition, the lack of an available VAT to place PICCs using uasound guidance may result in more referrals to interventional radiology for placement, potentially exposing the patient to avoidable radiation during fluoroscopy.7We propose an approach to improve the appropriate and safe use of PICCs by focusing on three elements that address the findings by Krein and colleagues. Establishing a structure powered by a VAT. Anchoring a standardised process for line selection, insertion and care. And promoting adoption by engagement with the key stakeholders.Establishing a structure to support placement and management of PICCs depends on whether the number of devices placed is enough to support the creation of a dedicated vascular access programme. Leadership plays a critical role to invest the resources for a functional VAT, understanding the financial and quality benefits associated.8 Not realising its value, hospital leaders may view the VAT as a non-revenue-generating service, putting it at risk when considering cost reduction strategies.

The value of the VAT expands from mitigating preventable events (eg, deep venous thrombosis, ) to enhancing patient experience (eg, less attempts to place a peripheral device).9 In addition, better outcomes help curb the financial risks (eg, hospital-acquired condition penalties)8 and improve hospital ratings. The VAT’s role encompasses placing PICCs and guaranteeing the proper selection of the intravascular device and its appropriate use.2The second element involves standardising processes for line selection and care, regardless of who is taking care of the device. Implementing policies to address indications, placement and maintenance and using standardised kits help minimise variation. The creation of policies should be achieved through a multidisciplinary approach with VAT, nurses and physicians. The VAT can act as the ‘gate keeper’ evaluating whether the reason for PICC placement is aligned with indications.

In addition, the VAT plays a critical role supporting nurses’ competencies for venous catheter use (eg, aseptic access and maintenance, addressing complications and mitigating risk)10 to reduce mechanical11 and infectious complications.12 The VAT performs regular rounds to mitigate process gaps (eg, dressing site intactness) and to identify complications (eg, PICC site erythema or drainage, arm swelling), and provides timely feedback on clinical performance. The VAT can also serve as subject matter experts to the ordering physicians for the appropriate device type, based on vessel size and indications for use, how many lumens, site selection and a de-escalation plan for the patient prior to discharge. It also provides services should a device-related complication occur (eg, clotting), and works with clinicians to remedy the issue and salvage the device, thereby preventing a patient from losing their vascular access and/or having to replace it.The last element, and perhaps most significant, is to enhance the adoption of best practices through a partnership with the key stakeholders. PICC-associated outcomes are not only owned by the VAT, rather it is the responsibility of the clinicians, physicians and nurses to achieve those goals (table 1). Physicians are an essential stakeholder group to engage as they are the ones responsible for ordering the PICC.

An identified physician champion who partners and empowers the VAT will help resolve any barriers and be a liaison with the local physician community.13 The ideal physician champion should have the respect of peers, understand process optimisation and promote quality improvement. They need to be well versed on the appropriate indications for PICC use, the associated complications and risks and alternatives to the device. The physician champion engages the leaders of the key disciplines responsible for requesting a PICC, educating them on the appropriate indications for use, the outcomes associated with PICC use, inviting them to be partners and responding to any of their concerns.View this table:Table 1 Disciplines and their support to mitigate PICC harmWhat about the key physician disciplines to engage?. Physicians can play an active role in enhancing PICC use through avoiding the unnecessary use of infusions. The consultation of infectious diseases specialists for intravenous antibiotic use appropriateness has been associated with less PICC use and lower complications.14 Similarly, having a surgeon support the decision for whether enteral or parenteral nutrition is needed will help reduce unnecessary device use.15 Disciplines like hospitalists or general internists care for a large number of patients and often order PICCs for venous access,16 while nephrologists may advocate avoiding the use of PICCs in the chronic kidney disease population in an effort for vein preservation.17 In hospitals with teaching programmes, the VAT and its physician champion may educate physicians in training on device choice, placement and duration of use, and address with their faculty competencies for line management.18 Engaging these disciplines, elucidating the indications for appropriate use and providing feedback and local data on the potential harm ensure accountability and further attention to PICC safety.In summary, the PICC is one of the primary solutions to achieve vascular access.

With up to one in five patients at risk for developing complications,19 it is incumbent on us to ensure that these devices are properly used and maintained. Identifying and overcoming system barriers are key to delivering sustainable safe outcomes. As a first step, clinical and administrative leaders, realising the financial and quality benefits, need to support the structure reflected by the VAT to enhance PICC care. Second, the VAT must partner with disciplines (particularly nursing) to promote and ensure adequate competencies for placement and maintenance. Finally, clinical disciplines caring for the patient should instil a collaborative environment for better decision-making on when central access is required, and what device provides the safest and most effective delivery of care.Ethics statementsPatient consent for publicationNot required..