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By Serena viagra price per pill Gordon HealthDay Reporter TUESDAY, Sept. 8, 2020 (HealthDay News) -- Continuous positive airway pressure (CPAP) may be the go-to treatment for sleep apnea, but many people struggle to use it every night. For those who cannot tolerate CPAP, new research finds that a combination of surgical techniques may bring relief.

The "multilevel" treatment includes removing the tonsils, repositioning the palate (roof of viagra price per pill the mouth) and using radiofrequency to slightly reduce the size of the tongue. In combination, these procedures open up the airway and reduce breathing obstruction, the researchers said. The study found that the multilevel surgery technique reduced the number of times people stopped breathing (apnea events) during sleep and improved daytime sleepiness.

People also reported better quality of life after the treatment viagra price per pill. "Obstructive sleep apnea is common and many people cannot use the main treatments, like CPAP masks. Surgery is a valid option when an expert surgeon is involved, and it can improve outcomes," said the study's lead author, Dr.

Stuart MacKay viagra price per pill. He's an honorary clinical professor of otolaryngology, head and neck surgery at University of Wollongong, in Australia. The researchers said that nearly one billion people worldwide suffer from sleep apnea.

The airway becomes blocked during sleep, and as a result people stop breathing for short periods of time, viagra price per pill multiple times throughout the night. People with sleep apnea have a higher risk of daytime sleepiness, motor vehicle crashes, and heart disease and stroke. CPAP does a good job at keeping your airway open as you sleep, but the treatment -- including a mask and a long tube -- can be hard to get used to.

The study authors said only about half of viagra price per pill people with sleep apnea try CPAP. For the new study, the researchers recruited 102 overweight or obese people with sleep apnea from six clinical centers in Australia, who were in their 40s, on average. The goal was to see if surgery could help adults with moderate or severe obstructive sleep apnea who weren't able to tolerate or adhere to CPAP devices.

Half of the volunteers were randomly assigned to receive viagra price per pill the sleep apnea surgery, while the other 51 continued with medical treatment. Medical management consisted of encouraging weight loss, drinking less alcohol, changing sleep posture and medical treatment for nasal obstruction. Continued MacKay said the multilevel surgical technique is widely available in many parts of the world.

For the patients in this study, surgeries were performed by viagra price per pill seven experienced surgeons. Six months after the surgical procedures, volunteers in the surgery group had about a 27% decrease in the number of apnea events at night. Those on medical treatment had just a 10% decrease.

People in the surgical group also had major improvements in levels of snoring and daytime viagra price per pill sleepiness, as well as a boost to quality of life. As with any surgical procedure, there are risks. "The main risks of pain and bleeding are confined to the two weeks after surgery.

Bleeding occurs viagra price per pill in about one in every 25 patients. Long-term risks related to taste disturbance, feeling of sticking in the throat, swallow dysfunction are very rare, although they do occur transiently in some," MacKay said. Dr.

Steven Feinsilver is director of the Center for Sleep Medicine at viagra price per pill Lenox Hill Hospital in New York City. He said, "Sleep apnea is a very common disease, about as common as diabetes, and similar to diabetes is associated with increased risk for cardiovascular events, such as stroke and heart disease." He added that "CPAP works, but is a difficult treatment." Feinsilver said that surgery that could provide a permanent cure has long been the goal for treatment. "This study shows that relatively minor surgery, performed in a standardized fashion by skilled surgeons, can significantly improve sleep apnea compared to 'medical treatment' (essentially no treatment)," he said.

But he noted that even though people reported improvement, their nighttime breathing wasn't back in viagra price per pill the normal range. "This is certainly a major improvement, but it remains unclear whether outcomes (such as cardiovascular risk) will be significantly impacted," Feinsilver said. Also, he suggested that this multilevel surgery may only be an option for a select group of patients.

The report was published online viagra price per pill Sept. 4 in the Journal of the American Medical Association. WebMD News from HealthDay Sources SOURCES.

Stuart MacKay, MD, honorary clinical professor, otolaryngology, head and neck surgery, University of viagra price per pill Wollongong, Australia. Steven Feinsilver, MD, director, Center for Sleep Medicine, Lenox Hill Hospital, New York City;Journal of the American Medical Association, Sept. 4, 2020, online Copyright © 2013-2020 HealthDay.

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About This TrackerThis http://www.smhgg.org.uk/where-can-i-buy-female-viagra/ tracker provides the number of confirmed cocaine and viagra cases and deaths from novel erectile dysfunction by country, the trend in confirmed case and death counts by country, and a global map showing which countries have confirmed cases and deaths. The data are drawn from the Johns Hopkins University (JHU) erectile dysfunction Resource Center’s erectile dysfunction treatment Map and the World Health Organization’s (WHO) erectile dysfunction Disease (erectile dysfunction treatment-2019) situation reports.This tracker will be updated regularly, as new data are released.Related Content. About erectile dysfunction treatment cocaine and viagra erectile dysfunctionIn late 2019, a new erectile dysfunction emerged in central China to cause disease in humans.

Cases of this disease, known as erectile dysfunction treatment, have since been reported across around the globe. On January cocaine and viagra 30, 2020, the World Health Organization (WHO) declared the viagra represents a public health emergency of international concern, and on January 31, 2020, the U.S. Department of Health and Human Services declared it to be a health emergency for the United States.Key PointsOn January 23, 2017, President Donald Trump reinstated and expanded the Mexico City Policy via presidential memorandum, renaming it “Protecting Life in Global Health Assistance.” This explainer provides an overview of the policy, including its history, changes over time, and current application.First announced in 1984 by the Reagan administration, the policy has been rescinded and reinstated by subsequent administrations along party lines and has now been in effect for 19 of the past 34 years.The policy requires foreign non-governmental organizations (NGOs) to certify that they will not “perform or actively promote abortion as a method of family planning” using funds from any source (including non-U.S.

Funds) as a condition of receiving cocaine and viagra U.S. Government global family planning assistance and, as of Jan. 23, 2017, most other cocaine and viagra U.S.

Global health assistance.The Trump administration’s application of the policy extends to the vast majority of U.S. Bilateral global health assistance, including funding for HIV under PEPFAR, maternal and child health, malaria, cocaine and viagra nutrition, and other programs. This marks a significant expansion of its scope, potentially encompassing $7.3 billion in FY 2020, to the extent that such funding is ultimately provided to foreign NGOs, directly or indirectly (family planning assistance accounts for approximately $600 million of that total).Additionally, as a result of a March 2019 policy announcement and subsequent information released in June 2019, the policy, for the first time, prohibits foreign NGOs who accept the policy from providing any financial support using any source of funds and for any purpose to other foreign NGOs that perform or actively promote abortion as a method of family planning.

This greatly cocaine and viagra extends its reach to other areas of U.S. Development assistance beyond global health and to other non-U.S. Funding streams.More recently, in September 2020, a cocaine and viagra proposed rule to extend the policy to contracts was published.

If finalized, it would greatly extend the reach of the policy beyond grants and cooperative agreements to also include contracts.KFF analyses have found that:more than half of the countries in which the U.S. Provides bilateral cocaine and viagra global health assistance allow for legal abortion in at least one case not permitted by the policy (analysis). Andhad the expanded policy been in effect during the FY 2013 – FY 2015 period, at least 1,275 foreign NGOs would have been subject to the policy (analysis).What is the Mexico City Policy?.

The Mexico cocaine and viagra City Policy is a U.S. Government policy that – when in effect – has required foreign NGOs to certify that they will not “perform or actively promote abortion as a method of family planning” using funds from any source (including non-U.S. Funds) as cocaine and viagra a condition of receiving U.S.

Global family planning assistance and, as of Jan. 23, 2017, most other cocaine and viagra U.S. Global health assistance.The policy was first announced by the Reagan administration at the 2nd International Conference on Population, which was held in Mexico City, Mexico, on August 6-14, 1984 (hence its name.

See Box cocaine and viagra 1). Under the Trump administration, the policy has been renamed “Protecting Life in Global Health Assistance” (PLGHA). Among opponents, it is also known as the “Global Gag Rule,” because among cocaine and viagra other activities, it prohibits foreign NGOs from using any funds (including non-U.S.

Funds) to provide information about abortion as a method of family planning and to lobby a foreign government to legalize abortion. €œ[T]he United States does not consider abortion an acceptable element of family planning programs and will no longer contribute cocaine and viagra to those of which it is a part. €¦[T]he United States will no longer contribute to separate nongovernmental organizations which perform or actively promote abortion as a method of family planning in other nations.”When first instituted in 1984, the Mexico City Policy marked an expansion of existing legislative restrictions that already prohibited U.S.

Funding for abortion internationally, with some exceptions cocaine and viagra (see below). Prior to the policy, foreign NGOs could use non-U.S. Funds to cocaine and viagra engage in certain voluntary abortion-related activities as long as they maintained segregated accounts for any U.S.

Money received, but after the Mexico City Policy was in place, they were no longer permitted to do so if they wanted to receive U.S. Family planning assistance.The Trump administration’s application cocaine and viagra of the policy to the vast majority of U.S. Bilateral global health assistance, including funding for HIV under the U.S.

President’s Emergency Plan for AIDS cocaine and viagra Relief (PEPFAR), maternal and child health, malaria, nutrition, and other programs, marks a significant expansion of its scope, potentially encompassing $7.3 billion in FY 2020, to the extent that such funding is ultimately provided to foreign NGOs, directly or indirectly (family planning assistance accounted for approximately $600 million of that total). The Administration’s more recent extension of the policy to include any financial support (health or otherwise) provided by foreign NGOs for any purpose to other foreign NGOs that perform or actively promote abortion as a method of family planning is likely to encompass significant additional funding.When has it been in effect?. The Mexico City Policy has been in effect for 19 of the past 34 years, primarily through executive action, and has been instated, rescinded, and reinstated by presidential administrations along party lines (see Table 1).The policy was first instituted in 1984 (taking effect in 1985) by President Ronald Reagan and continued to be in effect through President George H.W.

Bush’s administration cocaine and viagra. It was rescinded by President Bill Clinton in 1993 (although it was reinstated legislatively for one year during his second term. See below) cocaine and viagra.

The policy was reinstated by President George W. Bush in 2001 and then rescinded by cocaine and viagra President Barack Obama in 2009. It is currently in effect, having been reinstated by President Trump in 2017.

YearsIn Effect? cocaine and viagra. Presidential Administration (Party Affiliation)Executive (E) or Congressional (C) Action?. 1985-1989YesReagan (R)E1989-1993YesBush (R)E1993-1999 Sept.NoClinton (D)E1999 Oct.-2000 Sept.Yes*Clinton (D)C2000 Oct.-2001NoClinton (D)E2001-2009YesBush (R)E2009-2017NoObama cocaine and viagra (D)E2017-presentYesTrump (R)ENOTES.

Shaded blue indicate periods when policy was in effect. * There was a cocaine and viagra temporary, one-year legislative imposition of the policy, which included a portion of the restrictions in effect in other years and an option for the president to waive these restrictions in part. However, if the waiver option was exercised (for no more than $15 million in family planning assistance), then $12.5 million of this funding would be transferred to maternal and child health assistance.

The president cocaine and viagra did exercise the waiver option.SOURCES. €œPolicy Statement of the United States of America at the United Nations International Conference on Population (Second Session), Mexico City, Mexico, August 6-14, 1984,” undated. Bill Clinton cocaine and viagra Administration, “Subject.

AID Family Planning Grants/Mexico City Policy,” Memorandum for the Acting Administrator of the Agency for International Development, January 22, 1993, Clinton White House Archives, https://clintonwhitehouse6.archives.gov/1993/01/1993-01-22-aid-family-planning-grants-mexico-city-policy.html. FY 2000 cocaine and viagra Consolidated Appropriations Act, P.L. 106-113.

George W cocaine and viagra. Bush Administration, “Subject. Restoration of the Mexico City Policy,” Memorandum for the Administrator of cocaine and viagra the United States Agency for International Development, January 22, 2001, Bush Administration White House Archives, https://georgewbush-whitehouse.archives.gov/news/releases/20010123-5.html.

€œSubject. Restoration of the Mexico City Policy,” Memorandum for the Administrator of the United States cocaine and viagra Agency for International Development, March 28, 2001, Federal Register, https://www.federalregister.gov/documents/2001/03/29/01-8011/restoration-of-the-mexico-city-policy. George W.

Bush Administration, cocaine and viagra “Subject. Assistance for Voluntary Population Planning,” Memorandum for the Secretary of State, August 29, 2003, Bush Administration White House Archives, http://georgewbush-whitehouse.archives.gov/news/releases/2003/08/20030829-3.html. Barack Obama Administration, “Mexico City Policy and Assistance for Voluntary Population Planning,” cocaine and viagra Memorandum for the Secretary of State, the Administrator of the United States Agency for International Development, January 23, 2009, Obama White House Archives, https://obamawhitehouse.archives.gov/the-press-office/mexico-city-policy-and-assistance-voluntary-population-planning.

White House, “The Mexico City Policy,” Memorandum for the Secretary of State, the Secretary of Health and Human Services, the Administrator of the Agency for International Development, Jan. 23, 2017, https://www.whitehouse.gov/the-press-office/2017/01/23/presidential-memorandum-regarding-mexico-city-policy.How is it cocaine and viagra instituted (and rescinded)?. The Mexico City Policy has, for the most part, been instituted or rescinded through executive branch action (typically via presidential memoranda).

While Congress cocaine and viagra has the ability to institute the policy through legislation, this has happened only once in the past. A modified version of the policy was briefly applied by Congress during President Clinton’s last year in office as part of a broader arrangement to pay the U.S. Debt to cocaine and viagra the United Nations.

(At that time, President Clinton was able to partially waive the policy’s restrictions.) Other attempts to institute the policy through legislation have not been enacted into law, nor have legislative attempts to overturn the policy. See Table 1.Who cocaine and viagra does the policy apply to?. The policy, when in effect, applies to foreign NGOs as a condition for receiving U.S.

Family planning support and, now, other global health assistance, either directly (as the main – or prime – recipient of U.S. Funding) or indirectly (as a recipient of cocaine and viagra U.S. Funding through an agreement with the prime recipient.

Referred to cocaine and viagra as a sub-recipient). Specifically, a foreign NGO “recipient agrees that it will not, during the term of this award, perform or actively promote abortion as a method of family planning in foreign countries or provide financial support to any other foreign non-governmental organization that conducts such activities.”Foreign NGOs include:international NGOs that are based outside the U.S.,regional NGOs that are based outside the U.S., andlocal NGOs in assisted countries.U.S. NGOs, while not directly subject to the Mexico City Policy, must also agree to ensure cocaine and viagra that they do not provide funding to any foreign NGO sub-recipients unless those sub-recipients have first certified adherence to the policy.

Specifically, a U.S. NGO “recipient (A) agrees that it will not furnish health assistance under this award to any foreign non-governmental organization that performs or actively promotes abortion cocaine and viagra as a method of family planning in foreign countries. And (B) further agrees to require that such sub-recipients do not provide financial support to any other foreign non-governmental organization that conducts such activities.”As in the past, the current policy does not apply to funding provided by the U.S.

Government to foreign governments (national or sub-national), cocaine and viagra public international organizations, and other multilateral entities, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria and Gavi, the treatment Alliance. However, this funding is subject to the policy if it flows through a foreign NGO that has accepted the policy. See “What is ‘financial cocaine and viagra support’?.

€ below.To what assistance does it apply?. In the past, foreign NGOs have been required to adhere to cocaine and viagra the Mexico City Policy – when it was in effect – as a condition of receiving support through certain U.S. International funding streams.

Family planning assistance through cocaine and viagra the U.S. Agency for International Development (USAID) and, beginning in 2003, family planning assistance through the U.S. Department of cocaine and viagra State.

In the 2003 memorandum announcing the policy’s expansion to include the Department of State, President Bush stated that the policy did not apply to funding for global HIV/AIDS programs and that multilateral organizations that are associations of governments are not included among “foreign NGOs.”The current policy, reinstated in 2017, applies to the vast majority of U.S. Bilateral global health assistance furnished by all agencies and cocaine and viagra departments. “Assistance” includes “the provision of funds, commodities, equipment, or other in-kind global health assistance.” Specifically, the expanded policy applies to nearly all bilateral global health assistance, including.

family planning and reproductive healthfor the first time:maternal and child health (including household-level water, sanitation, and hygiene (WASH))nutritionHIV under PEPFARtuberculosismalaria under the cocaine and viagra President’s Malaria Initiative (PMI)neglected tropical diseasesglobal health securitycertain types of research activitiesThe policy applies to the assistance described above that is appropriated directly to three agencies and departments. USAID. The Department of State, including cocaine and viagra the Office of the Global AIDS Coordinator, which oversees and coordinates U.S.

Global HIV funding under PEPFAR. And for the first time, the cocaine and viagra Department of Defense (DoD). When such funding is transferred to another agency, including the Centers for Disease Control (CDC) and the National Institutes of Health (NIH), it remains subject to the policy, to the extent that such funding is ultimately provided to foreign NGOs, directly or indirectly.The policy applies to three types of funding agreements for such assistance.

Grants. Cooperative agreements. And, for the first time, contracts, pending necessary rule-making that would be needed to do so (a proposed rule to accomplish this was published in September 2020).The policy does not apply to U.S.

Assistance for. Water supply and sanitation activities, which is usually focused on infrastructure and systems. Humanitarian assistance, including activities related to migration and refugee assistance activities as well as disaster and humanitarian relief activities.

The American Schools and Hospitals Abroad (ASHA) program. And Food for Peace (FFP). However, this funding is subject to the policy if it flows through a foreign NGO that has accepted the policy.

See “What is ‘financial support’?. € below.What activities are prohibited?. The policy prohibits foreign NGOs that receive U.S.

Family planning assistance and, now, most other U.S. Bilateral global health assistance from using funds from any source (including non-U.S. Funds) to “perform or actively promote abortion as a method of family planning.” In addition to providing abortions with non-U.S.

Funds, restricted activities also include the following:providing advice and information about and offering referral for abortion – where legal – as part of the full range of family planning options,promoting changes in a country’s laws or policies related to abortion as a method of family planning (i.e., engaging in lobbying), andconducting public information campaigns about abortion as a method of family planning.The prohibition of these activities are why the policy has been referred to by its critics as the “Global Gag Rule.”Additionally, for the first time, the policy prohibits foreign NGOs from providing any financial support with any source of funds (including non-U.S. Funding) and for any purpose to other foreign NGOs that perform or actively promote abortion as a method of family planning. See “What is “financial support?.

€ below.The policy, however, does not prohibit foreign NGOs from:providing advice and information about, performing, or offering referral for abortion in cases where the pregnancy has either posed a risk to the life of the mother or resulted from incest or rape. Andresponding to a question about where a safe, legal abortion may be obtained when a woman who is already pregnant clearly states that she has already decided to have a legal abortion (passively providing information, versus actively providing medically-appropriate information).In addition, the expanded policy does not apply to healthcare providers who have an affirmative duty required under local law to provide counseling about and referrals for abortion as a method of family planning.Does it restrict direct U.S. Funding for abortion overseas?.

U.S. Funding for abortion is already restricted under several provisions of the law. Specifically, before the Mexico City Policy was first announced in 1984, U.S.

Law already prohibited the use of U.S. Aid:to pay for the performance of abortion as a method of family planning or to motivate or coerce any person to practice abortion (the Helms Amendment, 1973, to the Foreign Assistance Act);for biomedical research related to methods of or the performance of abortion as a means of family planning (the Biden Amendment, 1981, to the Foreign Assistance Act). Andto lobby for or against abortion (the Siljander Amendment, first included in annual appropriations in 1981 and included each year thereafter).Then, shortly after the policy was announced in 1984, the Kemp-Kasten Amendment was passed in 1985, prohibiting the use of U.S.

Aid to fund any organization or program, as determined by the president, that supports or participates in the management of a program of coercive abortion or involuntary sterilization (it is now included in annual appropriations).Before the Mexico City Policy, U.S. Aid recipients could use non-U.S. Funds to engage in certain abortion-related activities but were required to maintain segregated accounts for U.S.

Assistance. The Mexico City Policy reversed this practice. No longer were foreign NGOs allowed to use non-U.S.

Funds, maintained in segregated accounts, for voluntary abortion-related activities if they wished to continue to receive or be able to receive U.S. Family planning funds.Does the policy prohibit post-abortion care?. The Mexico City Policy does not restrict the provision of post-abortion care, which is a supported activity of U.S.

Family planning assistance. Whether or not the Mexico City Policy is in effect, recipients of U.S. Family planning assistance are allowed to use U.S.

And non-U.S. Funding to support post-abortion care, no matter the circumstances of the abortion (whether it was legal or illegal).What has been the impact of the policy?. Several studies have looked at the impact of the policy.

A 2011 quantitative analysis by Bendavid, et. Al, found a strong association between the Mexico City Policy and abortion rates in sub-Saharan Africa. This study was recently updated to include several more years of data, again identifying a strong association.

Specifically, the updated study found that during periods when the policy was in place, abortion rates rose by 40% in countries with high exposure to the Mexico City Policy compared to those with low exposure, while the use of modern contraceptives declined by 14% and pregnancies increased by 12% in high exposure compared to low exposure countries. In other words, it found patterns that “strengthen the case for the role played by the policy” in “a substantial increase in abortions across sub-Saharan Africa among women affected by the U.S. Mexico City Policy … [and] a corresponding decline in the use of modern contraception and increase in pregnancies,” likely because foreign NGOs that declined U.S.

Funding as a result of the Mexico City Policy – often key providers of women’s health services in these areas – had fewer resources to support family planning services, particularly contraceptives. Increased access to and use of contraception have been shown to be key to preventing unintended pregnancies and thereby reducing abortion, including unsafe abortion. The study also found patterns that “suggest that the effects of the policy are reversible” when the policy is not in place.Additionally, there has been anecdotal evidence and qualitative data on the impact of the policy, when it has been in force in the past, on the work of organizations that have chosen not to agree to the policy and, therefore, forgo U.S.

Funding that had previously supported their activities. For example, they have reported that they have fewer resources to support family planning and reproductive health services, including family planning counseling, contraceptive commodities, condoms, and reproductive cancer screenings.While it is likely too early to assess the full effects of the current policy on NGOs and the individuals they serve, as the policy is applied on a rolling basis as new funding agreements or modifications to existing agreements are made, some early data are available. Several early qualitative and quantitative studies have been released, and at least one long-term, quantitative assessment is underway.

Additionally, an official assessment by the U.S. Department of State on implementation during the first six months of the policy has been released (see below). This review acknowledged that it took “place early in the policy’s implementation, when affected U.S.

Government departments and agencies have added a significant portion of the funding affected by the policy to grants and cooperative agreements only recently [i.e., after the period the review examined]. A follow-on analysis would allow an opportunity to address one of the primary concerns presented in feedback from third-party stakeholder organizations, namely that six months is insufficient time to gauge the impacts of” the policy.Nonetheless, it is already clear that the reinstated and expanded version of the policy applies to a much greater amount of U.S. Global health assistance, and greater number of foreign NGOs, across many program areas.

KFF has found that more than half (37) of the 64 countries that received U.S. Bilateral global health assistance in FY 2016 allow for legal abortion in at least one case not permitted by the policy and that had the expanded Mexico City Policy been in effect during the FY 2013 – FY 2015 period, at least 1,275 foreign NGOs would have been subject to the policy. In addition, at least 469 U.S.

NGOs that received U.S. Global health assistance during this period would have been required to ensure that their foreign NGO sub-recipients were in compliance. Additional foreign NGOs are likely to be impacted by the policy due to the revised interpretation of “financial support” announced in March 2019 and implemented beginning June 2019.

See “What is ‘financial support’?. € below.A report released in March 2020 by the U.S. Government Accountability Office (GAO) provided new information on the number of projects (awards) and NGOs affected.

It found that from May 2017 through FY 2018:the policy had been applied to over 1,300 global health projects, with the vast majority of these through USAID and CDC, andNGOs declined to accept the policy in 54 instances, totaling $153 million in declined funding – specifically, seven prime awards amounting to $102 million and 47 sub-awards amounting to $51 million (more than two-thirds of sub-awards were intended for Africa) – across USAID and CDC. The Department of State and DoD did not identify any instances where NGOs declined to accept the policy conditions.What have the U.S. Government’s reviews of the policy found?.

The U.S. Government has published two reviews of the policy to date, with the first examining the initial six months of the policy released in February 2018 and the second examining the first 18 months of the policy released in August 2020.First ReviewIn February 2018, the Department of State announced the findings of an initial six-month review of implementation of the policy through the end of FY 2017 (September 2017). The report directed agencies to provide greater support for improving understanding of implementation among affected organizations and provided guidance to clarify terms included in standard provisions of grants and cooperative agreements.

In the six-month review report, the Department of State report identified a number of “actions” for implementing agencies, such as a need for:more central and field-based training and implementation tools,a clearer explanation of termination of awards for NGOs found to be in violation of the policy, anda clarification of “financial support,” which was not defined in the standard provisions (see “What is financial support?. € below).The six month review also identified the number of affected agreements with prime implementing partners and the number of those that have accepted the Mexico City Policy as part of their agreements through September 2017 (see Table 2). U.S.

Agency or DepartmentPolicy Implementation DateOverall # of Grants and Cooperative Agreements with Global Health Assistance FundingOf Overall #:(From the Policy Implementation Date through 9/30/2017)# That Received New Funding and Accepted Policy# That Received New Funding and Declined to Accept Policy^# That Had Not Received New Funding YetUSAIDMay 15, 20175804193158State*May 15, 2017142108034HHS+May 31, 20174991600339DoDMay 15, 20177742134TOTAL12987294565NOTES. * reflects PEPFAR funding implemented through the Department of State. Other departments and agencies implement the majority of PEPFAR funding.

+ At HHS agencies, only certain assistance funding transferred from USAID, State, and DoD are subject to the policy. ^ As of September 30, 2017, USAID reported it was aware of three centrally funded prime partners, and 12 sub-awardee implementing partners, that declined to agree to the Protecting Life in Global Health Assistance (PLGHA) terms in their awards. DoD reported that one DoD partner, a U.S.

NGO, declined to agree in one country but accepted the PLGHA standard provision in other countries. And HHS reported that no HHS partners declined to agree.SOURCES. KFF analysis of data from Department of State, “Protecting Life in Global Health Assistance Six-Month Review,” report, Feb.

6, 2018, https://www.state.gov/protecting-life-in-global-health-assistance-six-month-review/.Second ReviewOn August 17, 2020, the Department of State released its second review of the policy, updating its initial six-month review (as an action item in the six-month review report, the department stated it would “conduct a further review of implementation of the policy by December 15, 2018, when more extensive experience will enable a more thorough examination of the benefits and challenges”). The long-anticipated review, which examines the period from May 2017 through September 2018, found:the awards declined spanned a variety of program areas, including family planning and reproductive health (FP/RH), HIV and AIDS (HIV/AIDS), maternal and child health (MCH), tuberculosis (TB), and nutrition, in addition to cross-cutting awards;the awards declined spanned geographic areas but many were for activities in sub-Saharan Africa;agencies and departments made efforts to transition projects to another implementer in order to minimize disruption. Butnevertheless, among USAID awards involving health service delivery where prime and sub-award recipients declined to accept the policy, gaps or disruptions in service delivery were sometimes reported.The second review also identified the number of affected agreements with prime implementing partners and the number of those that have accepted the Mexico City Policy as part of their agreements through September 2018 (see Table 3).

U.S. Agency or DepartmentPolicy Implementation Date# of Grants and Cooperative Agreements with Global Health Assistance Funding# of Prime Awardees That Declined to Accept Policy^USAIDMay 15, 20174866State*May 15, 20173350HHS+May 31, 20174661DoDMay 15, 2017531TOTAL13408NOTES. * reflects PEPFAR funding implemented through the Department of State.

Other departments and agencies implement the majority of PEPFAR funding. + At HHS agencies, only certain assistance funding transferred from USAID, State, and DoD are subject to the policy. ^ As of September 30, 2018, USAID reported it was aware of six centrally funded prime partners, and 47 sub-awardee implementing partners, that declined to agree to the Protecting Life in Global Health Assistance (PLGHA) terms in their awards.

DoD reported that one DoD partner, a U.S. NGO, declined to agree in one country but accepted the PLGHA standard provision in other countries. And HHS reported that one HHS partner declined to agree.SOURCES.

KFF analysis of data from Department of State, “Review of the Implementation of the Protecting Life in Global Health Assistance Policy ,” report, Aug. 17, 2020, https://www.state.gov/wp-content/uploads/2020/08/PLGHA-2019-Review-Final-8.17.2020-508.pdf, and Department of State, “Protecting Life in Global Health Assistance Six-Month Review,” report, Feb. 6, 2018, https://www.state.gov/protecting-life-in-global-health-assistance-six-month-review/.Additionally, the review reports that 47 sub-awardees, all under USAID awards, declined to accept the policy.

It is important to note that the review also states that information on sub-awards is not systematically collected by departments and agencies and that DoD was not able to collect information on sub-awards.What is “financial support”?. In February 2018, in the initial six-month review issued when Secretary of State Tillerson led the department, the Department of State report included an “action” statement to clarify the definition of “financial support” as used in the standard provisions for grants and cooperative agreements. At issue was whether it applied more narrowly to certain funding provided by foreign NGOs (i.e., funding other than U.S.

Global health funding) to other foreign NGOs specifically for the purpose of performing or actively promoting abortion as a method of family planning or if it applied more broadly to certain funding provided by foreign NGOs to other foreign NGOs for any purpose, if that foreign NGO happened to perform or actively promote abortion as a method of family planning. The State Department clarified that it was the more narrow interpretation.However, on March 26, 2019, Secretary of State Pompeo reversed this interpretation, announcing further “refinements” to the policy to clarify that it applied to the broader definition of financial support. Specifically, under the policy, U.S.-supported foreign NGOs agree to not provide any financial support (global health-related as well as other support), no matter the source of funds, to any other foreign NGO that performs or actively promotes abortion as a method of family planning.

In June 2019, USAID provided additional information to reflect this broader interpretation of the standard provisions.This marks the first time the policy has been applied this broadly, as it can now affect funding provided by other donors (such as other governments and foundations) and non-global health funding provided by the U.S. Government for a wide range of purposes if this funding is first provided to foreign NGOs who have accepted the policy (as recipients of U.S. Global health assistance) that then in turn provide that donor or U.S.

Non global health funding for any purpose to foreign NGOs that perform or actively promote abortion as a method of family planning. For example, under the prior interpretation, a foreign NGO recipient of U.S. Global health funding could not provide any non-U.S.

Funding to another foreign NGO to perform or actively promote abortion as a method of family planning but could provide funding for other activities, such as education, even if the foreign NGO carried out prohibited activities. Under the broader interpretation, a foreign NGO could not provide any non-U.S. Funding for any activity to a foreign NGO that carried out prohibited activities.

Similarly, while under the prior interpretation a foreign NGO recipient of U.S. Global health funding could provide other U.S. Funding (such as humanitarian assistance) to another foreign NGO for non-prohibited activities, even if the foreign NGO carried out prohibited activities, now under the broader interpretation, it could not do so.What are the next steps in implementing the expanded policy?.

The policy went into effect in May 2017 (see Table 2), although it is applied on a rolling basis, as new funding agreements and modifications to existing agreements occur. While it applies to all grants and cooperative agreements, the Trump administration has indicated that it intends the policy to apply to contracts, which would require a rule-making process (it began this process by publishing a proposed rule in September 2020)..

About This Where can i buy female viagra TrackerThis tracker viagra price per pill provides the number of confirmed cases and deaths from novel erectile dysfunction by country, the trend in confirmed case and death counts by country, and a global map showing which countries have confirmed cases and deaths. The data are drawn from the Johns Hopkins University (JHU) erectile dysfunction Resource Center’s erectile dysfunction treatment Map and the World Health Organization’s (WHO) erectile dysfunction Disease (erectile dysfunction treatment-2019) situation reports.This tracker will be updated regularly, as new data are released.Related Content. About erectile dysfunction treatment erectile dysfunctionIn late 2019, a new erectile dysfunction emerged in central China to cause viagra price per pill disease in humans. Cases of this disease, known as erectile dysfunction treatment, have since been reported across around the globe. On January viagra price per pill 30, 2020, the World Health Organization (WHO) declared the viagra represents a public health emergency of international concern, and on January 31, 2020, the U.S.

Department of Health and Human Services declared it to be a health emergency for the United States.Key PointsOn January 23, 2017, President Donald Trump reinstated and expanded the Mexico City Policy via presidential memorandum, renaming it “Protecting Life in Global Health Assistance.” This explainer provides an overview of the policy, including its history, changes over time, and current application.First announced in 1984 by the Reagan administration, the policy has been rescinded and reinstated by subsequent administrations along party lines and has now been in effect for 19 of the past 34 years.The policy requires foreign non-governmental organizations (NGOs) to certify that they will not “perform or actively promote abortion as a method of family planning” using funds from any source (including non-U.S. Funds) as a condition of receiving viagra price per pill U.S. Government global family planning assistance and, as of Jan. 23, 2017, most other U.S viagra price per pill. Global health assistance.The Trump administration’s application of the policy extends to the vast majority of U.S.

Bilateral global viagra price per pill health assistance, including funding for HIV under PEPFAR, maternal and child health, malaria, nutrition, and other programs. This marks a significant expansion of its scope, potentially encompassing $7.3 billion in FY 2020, to the extent that such funding is ultimately provided to foreign NGOs, directly or indirectly (family planning assistance accounts for approximately $600 million of that total).Additionally, as a result of a March 2019 policy announcement and subsequent information released in June 2019, the policy, for the first time, prohibits foreign NGOs who accept the policy from providing any financial support using any source of funds and for any purpose to other foreign NGOs that perform or actively promote abortion as a method of family planning. This greatly extends its reach to viagra price per pill other areas of U.S. Development assistance beyond global health and to other non-U.S. Funding streams.More recently, in viagra price per pill September 2020, a proposed rule to extend the policy to contracts was published.

If finalized, it would greatly extend the reach of the policy beyond grants and cooperative agreements to also include contracts.KFF analyses have found that:more than half of the countries in which the U.S. Provides bilateral global health assistance allow for legal abortion in at least one case viagra price per pill not permitted by the policy (analysis). Andhad the expanded policy been in effect during the FY 2013 – FY 2015 period, at least 1,275 foreign NGOs would have been subject to the policy (analysis).What is the Mexico City Policy?. The Mexico City Policy is viagra price per pill a U.S. Government policy that – when in effect – has required foreign NGOs to certify that they will not “perform or actively promote abortion as a method of family planning” using funds from any source (including non-U.S.

Funds) as a condition of receiving viagra price per pill U.S. Global family planning assistance and, as of Jan. 23, 2017, most viagra price per pill other U.S. Global health assistance.The policy was first announced by the Reagan administration at the 2nd International Conference on Population, which was held in Mexico City, Mexico, on August 6-14, 1984 (hence its name. See Box viagra price per pill 1).

Under the Trump administration, the policy has been renamed “Protecting Life in Global Health Assistance” (PLGHA). Among opponents, it is also known as the “Global Gag Rule,” because among other activities, it prohibits viagra price per pill foreign NGOs from using any funds (including non-U.S. Funds) to provide information about abortion as a method of family planning and to lobby a foreign government to legalize abortion. €œ[T]he United States does not consider abortion an acceptable element of family planning programs and will no longer contribute viagra price per pill to those of which it is a part. €¦[T]he United States will no longer contribute to separate nongovernmental organizations which perform or actively promote abortion as a method of family planning in other nations.”When first instituted in 1984, the Mexico City Policy marked an expansion of existing legislative restrictions that already prohibited U.S.

Funding for abortion internationally, with some exceptions (see below) viagra price per pill. Prior to the policy, foreign NGOs could use non-U.S. Funds to engage in certain voluntary abortion-related activities viagra price per pill as long as they maintained segregated accounts for any U.S. Money received, but after the Mexico City Policy was in place, they were no longer permitted to do so if they wanted to receive U.S. Family planning assistance.The Trump administration’s application of the policy to the vast majority of viagra price per pill U.S.

Bilateral global health assistance, including funding for HIV under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), maternal and child health, malaria, nutrition, and other programs, marks a significant expansion of its scope, potentially encompassing $7.3 billion in FY 2020, to the extent viagra price per pill that such funding is ultimately provided to foreign NGOs, directly or indirectly (family planning assistance accounted for approximately $600 million of that total). The Administration’s more recent extension of the policy to include any financial support (health or otherwise) provided by foreign NGOs for any purpose to other foreign NGOs that perform or actively promote abortion as a method of family planning is likely to encompass significant additional funding.When has it been in effect?. The Mexico City Policy has been in effect for 19 of the past 34 years, primarily through executive action, and has been instated, rescinded, and reinstated by presidential administrations along party lines (see Table 1).The policy was first instituted in 1984 (taking effect in 1985) by President Ronald Reagan and continued to be in effect through President George H.W. Bush’s administration viagra price per pill.

It was rescinded by President Bill Clinton in 1993 (although it was reinstated legislatively for one year during his second term. See below) viagra price per pill. The policy was reinstated by President George W. Bush in 2001 and then rescinded by President Barack Obama in viagra price per pill 2009. It is currently in effect, having been reinstated by President Trump in 2017.

YearsIn Effect? viagra price per pill. Presidential Administration (Party Affiliation)Executive (E) or Congressional (C) Action?. 1985-1989YesReagan (R)E1989-1993YesBush viagra price per pill (R)E1993-1999 Sept.NoClinton (D)E1999 Oct.-2000 Sept.Yes*Clinton (D)C2000 Oct.-2001NoClinton (D)E2001-2009YesBush (R)E2009-2017NoObama (D)E2017-presentYesTrump (R)ENOTES. Shaded blue indicate periods when policy was in effect. * There viagra price per pill was a temporary, one-year legislative imposition of the policy, which included a portion of the restrictions in effect in other years and an option for the president to waive these restrictions in part.

However, if the waiver option was exercised (for no more than $15 million in family planning assistance), then $12.5 million of this funding would be transferred to maternal and child health assistance. The president did exercise the waiver option.SOURCES viagra price per pill. €œPolicy Statement of the United States of America at the United Nations International Conference on Population (Second Session), Mexico City, Mexico, August 6-14, 1984,” undated. Bill Clinton Administration, viagra price per pill “Subject. AID Family Planning Grants/Mexico City Policy,” Memorandum for the Acting Administrator of the Agency for International Development, January 22, 1993, Clinton White House Archives, https://clintonwhitehouse6.archives.gov/1993/01/1993-01-22-aid-family-planning-grants-mexico-city-policy.html.

FY 2000 Consolidated Appropriations Act, viagra price per pill P.L. 106-113. George W viagra price per pill. Bush Administration, “Subject. Restoration of the Mexico City Policy,” Memorandum for the Administrator of the United States Agency for International Development, viagra price per pill January 22, 2001, Bush Administration White House Archives, https://georgewbush-whitehouse.archives.gov/news/releases/20010123-5.html.

€œSubject. Restoration of the Mexico City Policy,” Memorandum for the Administrator of the United States Agency for International Development, viagra price per pill March 28, 2001, Federal Register, https://www.federalregister.gov/documents/2001/03/29/01-8011/restoration-of-the-mexico-city-policy. George W. Bush Administration, viagra price per pill “Subject. Assistance for Voluntary Population Planning,” Memorandum for the Secretary of State, August 29, 2003, Bush Administration White House Archives, http://georgewbush-whitehouse.archives.gov/news/releases/2003/08/20030829-3.html.

Barack Obama Administration, “Mexico City Policy and Assistance for Voluntary Population Planning,” Memorandum for the viagra price per pill Secretary of State, the Administrator of the United States Agency for International Development, January 23, 2009, Obama White House Archives, https://obamawhitehouse.archives.gov/the-press-office/mexico-city-policy-and-assistance-voluntary-population-planning. White House, “The Mexico City Policy,” Memorandum for the Secretary of State, the Secretary of Health and Human Services, the Administrator of the Agency for International Development, Jan. 23, 2017, https://www.whitehouse.gov/the-press-office/2017/01/23/presidential-memorandum-regarding-mexico-city-policy.How is it instituted viagra price per pill (and rescinded)?. The Mexico City Policy has, for the most part, been instituted or rescinded through executive branch action (typically via presidential memoranda). While Congress has the ability to institute the policy through legislation, this has happened only viagra price per pill once in the past.

A modified version of the policy was briefly applied by Congress during President Clinton’s last year in office as part of a broader arrangement to pay the U.S. Debt to the United viagra price per pill Nations. (At that time, President Clinton was able to partially waive the policy’s restrictions.) Other attempts to institute the policy through legislation have not been enacted into law, nor have legislative attempts to overturn the policy. See Table viagra price per pill 1.Who does the policy apply to?. The policy, when in effect, applies to foreign NGOs as a condition for receiving U.S.

Family planning support and, now, other global health assistance, either directly (as the main – or prime – recipient of U.S. Funding) or indirectly (as a recipient of U.S viagra price per pill. Funding through an agreement with the prime recipient. Referred to as viagra price per pill a sub-recipient). Specifically, a foreign NGO “recipient agrees that it will not, during the term of this award, perform or actively promote abortion as a method of family planning in foreign countries or provide financial support to any other foreign non-governmental organization that conducts such activities.”Foreign NGOs include:international NGOs that are based outside the U.S.,regional NGOs that are based outside the U.S., andlocal NGOs in assisted countries.U.S.

NGOs, while not directly subject viagra price per pill to the Mexico City Policy, must also agree to ensure that they do not provide funding to any foreign NGO sub-recipients unless those sub-recipients have first certified adherence to the policy. Specifically, a U.S. NGO “recipient (A) agrees that it will not furnish health assistance under this award to any foreign non-governmental organization that performs or actively promotes abortion as a method of viagra price per pill family planning in foreign countries. And (B) further agrees to require that such sub-recipients do not provide financial support to any other foreign non-governmental organization that conducts such activities.”As in the past, the current policy does not apply to funding provided by the U.S. Government to viagra price per pill foreign governments (national or sub-national), public international organizations, and other multilateral entities, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria and Gavi, the treatment Alliance.

However, this funding is subject to the policy if it flows through a foreign NGO that has accepted the policy. See “What is ‘financial viagra price per pill support’?. € below.To what assistance does it apply?. In the past, foreign NGOs viagra price per pill have been required to adhere to the Mexico City Policy – when it was in effect – as a condition of receiving support through certain U.S. International funding streams.

Family planning viagra price per pill assistance through the U.S. Agency for International Development (USAID) and, beginning in 2003, family planning assistance through the U.S. Department of viagra price per pill State. In the 2003 memorandum announcing the policy’s expansion to include the Department of State, President Bush stated that the policy did not apply to funding for global HIV/AIDS programs and that multilateral organizations that are associations of governments are not included among “foreign NGOs.”The current policy, reinstated in 2017, applies to the vast majority of U.S. Bilateral global health assistance furnished by all agencies viagra price per pill and departments.

“Assistance” includes “the provision of funds, commodities, equipment, or other in-kind global health assistance.” Specifically, the expanded policy applies to nearly all bilateral global health assistance, including. family planning and reproductive healthfor the first time:maternal and child health (including household-level water, sanitation, and hygiene (WASH))nutritionHIV under PEPFARtuberculosismalaria under the President’s Malaria Initiative (PMI)neglected tropical diseasesglobal health securitycertain types of research activitiesThe policy applies to the assistance described above that is appropriated directly to three agencies viagra price per pill and departments. USAID. The Department of State, including the Office of the Global AIDS viagra price per pill Coordinator, which oversees and coordinates U.S. Global HIV funding under PEPFAR.

And for the first viagra price per pill time, the Department of Defense (DoD). When such funding is transferred to another agency, including the Centers for Disease Control (CDC) and the National Institutes of Health (NIH), it remains subject to the policy, to the extent that such funding is ultimately provided to foreign NGOs, directly or indirectly.The policy applies to three types of funding agreements for such assistance. Grants. Cooperative agreements. And, for the first time, contracts, pending necessary rule-making that would be needed to do so (a proposed rule to accomplish this was published in September 2020).The policy does not apply to U.S.

Assistance for. Water supply and sanitation activities, which is usually focused on infrastructure and systems. Humanitarian assistance, including activities related to migration and refugee assistance activities as well as disaster and humanitarian relief activities. The American Schools and Hospitals Abroad (ASHA) program. And Food for Peace (FFP).

However, this funding is subject to the policy if it flows through a foreign NGO that has accepted the policy. See “What is ‘financial support’?. € below.What activities are prohibited?. The policy prohibits foreign NGOs that receive U.S. Family planning assistance and, now, most other U.S.

Bilateral global health assistance from using funds from any source (including non-U.S. Funds) to “perform or actively promote abortion as a method of family planning.” In addition to providing abortions with non-U.S. Funds, restricted activities also include the following:providing advice and information about and offering referral for abortion – where legal – as part of the full range of family planning options,promoting changes in a country’s laws or policies related to abortion as a method of family planning (i.e., engaging in lobbying), andconducting public information campaigns about abortion as a method of family planning.The prohibition of these activities are why the policy has been referred to by its critics as the “Global Gag Rule.”Additionally, for the first time, the policy prohibits foreign NGOs from providing any financial support with any source of funds (including non-U.S. Funding) and for any purpose to other foreign NGOs that perform or actively promote abortion as a method of family planning. See “What is “financial support?.

€ below.The policy, however, does not prohibit foreign NGOs from:providing advice and information about, performing, or offering referral for abortion in cases where the pregnancy has either posed a risk to the life of the mother or resulted from incest or rape. Andresponding to a question about where a safe, legal abortion may be obtained when a woman who is already pregnant clearly states that she has already decided to have a legal abortion (passively providing information, versus actively providing medically-appropriate information).In addition, the expanded policy does not apply to healthcare providers who have an affirmative duty required under local law to provide counseling about and referrals for abortion as a method of family planning.Does it restrict direct U.S. Funding for abortion overseas?. U.S. Funding for abortion is already restricted under several provisions of the law.

Specifically, before the Mexico City Policy was first announced in 1984, U.S. Law already prohibited the use of U.S. Aid:to pay for the performance of abortion as a method of family planning or to motivate or coerce any person to practice abortion (the Helms Amendment, 1973, to the Foreign Assistance Act);for biomedical research related to methods of or the performance of abortion as a means of family planning (the Biden Amendment, 1981, to the Foreign Assistance Act). Andto lobby for or against abortion (the Siljander Amendment, first included in annual appropriations in 1981 and included each year thereafter).Then, shortly after the policy was announced in 1984, the Kemp-Kasten Amendment was passed in 1985, prohibiting the use of U.S. Aid to fund any organization or program, as determined by the president, that supports or participates in the management of a program of coercive abortion or involuntary sterilization (it is now included in annual appropriations).Before the Mexico City Policy, U.S.

Aid recipients could use non-U.S. Funds to engage in certain abortion-related activities but were required to maintain segregated accounts for U.S. Assistance. The Mexico City Policy reversed this practice. No longer were foreign NGOs allowed to use non-U.S.

Funds, maintained in segregated accounts, for voluntary abortion-related activities if they wished to continue to receive or be able to receive U.S. Family planning funds.Does the policy prohibit post-abortion care?. The Mexico City Policy does not restrict the provision of post-abortion care, which is a supported activity of U.S. Family planning assistance. Whether or not the Mexico City Policy is in effect, recipients of U.S.

Family planning assistance are allowed to use U.S. And non-U.S. Funding to support post-abortion care, no matter the circumstances of the abortion (whether it was legal or illegal).What has been the impact of the policy?. Several studies have looked at the impact of the policy. A 2011 quantitative analysis by Bendavid, et.

Al, found a strong association between the Mexico City Policy and abortion rates in sub-Saharan Africa. This study was recently updated to include several more years of data, again identifying a strong association. Specifically, the updated study found that during periods when the policy was in place, abortion rates rose by 40% in countries with high exposure to the Mexico City Policy compared to those with low exposure, while the use of modern contraceptives declined by 14% and pregnancies increased by 12% in high exposure compared to low exposure countries. In other words, it found patterns that “strengthen the case for the role played by the policy” in “a substantial increase in abortions across sub-Saharan Africa among women affected by the U.S. Mexico City Policy … [and] a corresponding decline in the use of modern contraception and increase in pregnancies,” likely because foreign NGOs that declined U.S.

Funding as a result of the Mexico City Policy – often key providers of women’s health services in these areas – had fewer resources to support family planning services, particularly contraceptives. Increased access to and use of contraception have been shown to be key to preventing unintended pregnancies and thereby reducing abortion, including unsafe abortion. The study also found patterns that “suggest that the effects of the policy are reversible” when the policy is not in place.Additionally, there has been anecdotal evidence and qualitative data on the impact of the policy, when it has been in force in the past, on the work of organizations that have chosen not to agree to the policy and, therefore, forgo U.S. Funding that had previously supported their activities. For example, they have reported that they have fewer resources to support family planning and reproductive health services, including family planning counseling, contraceptive commodities, condoms, and reproductive cancer screenings.While it is likely too early to assess the full effects of the current policy on NGOs and the individuals they serve, as the policy is applied on a rolling basis as new funding agreements or modifications to existing agreements are made, some early data are available.

Several early qualitative and quantitative studies have been released, and at least one long-term, quantitative assessment is underway. Additionally, an official assessment by the U.S. Department of State on implementation during the first six months of the policy has been released (see below). This review acknowledged that it took “place early in the policy’s implementation, when affected U.S. Government departments and agencies have added a significant portion of the funding affected by the policy to grants and cooperative agreements only recently [i.e., after the period the review examined].

A follow-on analysis would allow an opportunity to address one of the primary concerns presented in feedback from third-party stakeholder organizations, namely that six months is insufficient time to gauge the impacts of” the policy.Nonetheless, it is already clear that the reinstated and expanded version of the policy applies to a much greater amount of U.S. Global health assistance, and greater number of foreign NGOs, across many program areas. KFF has found that more than half (37) of the 64 countries that received U.S. Bilateral global health assistance in FY 2016 allow for legal abortion in at least one case not permitted by the policy and that had the expanded Mexico City Policy been in effect during the FY 2013 – FY 2015 period, at least 1,275 foreign NGOs would have been subject to the policy. In addition, at least 469 U.S.

NGOs that received U.S. Global health assistance during this period would have been required to ensure that their foreign NGO sub-recipients were in compliance. Additional foreign NGOs are likely to be impacted by the policy due to the revised interpretation of “financial support” announced in March 2019 and implemented beginning June 2019. See “What is ‘financial support’?. € below.A report released in March 2020 by the U.S.

Government Accountability Office (GAO) provided new information on the number of projects (awards) and NGOs affected. It found that from May 2017 through FY 2018:the policy had been applied to over 1,300 global health projects, with the vast majority of these through USAID and CDC, andNGOs declined to accept the policy in 54 instances, totaling $153 million in declined funding – specifically, seven prime awards amounting to $102 million and 47 sub-awards amounting to $51 million (more than two-thirds of sub-awards were intended for Africa) – across USAID and CDC. The Department of State and DoD did not identify any instances where NGOs declined to accept the policy conditions.What have the U.S. Government’s reviews of the policy found?. The U.S.

Government has published two reviews of the policy to date, with the first examining the initial six months of the policy released in February 2018 and the second examining the first 18 months of the policy released in August 2020.First ReviewIn February 2018, the Department of State announced the findings of an initial six-month review of implementation of the policy through the end of FY 2017 (September 2017). The report directed agencies to provide greater support for improving understanding of implementation among affected organizations and provided guidance to clarify terms included in standard provisions of grants and cooperative agreements. In the six-month review report, the Department of State report identified a number of “actions” for implementing agencies, such as a need for:more central and field-based training and implementation tools,a clearer explanation of termination of awards for NGOs found to be in violation of the policy, anda clarification of “financial support,” which was not defined in the standard provisions (see “What is financial support?. € below).The six month review also identified the number of affected agreements with prime implementing partners and the number of those that have accepted the Mexico City Policy as part of their agreements through September 2017 (see Table 2). U.S.

Agency or DepartmentPolicy Implementation DateOverall # of Grants and Cooperative Agreements with Global Health Assistance FundingOf Overall #:(From the Policy Implementation Date through 9/30/2017)# That Received New Funding and Accepted Policy# That Received New Funding and Declined to Accept Policy^# That Had Not Received New Funding YetUSAIDMay 15, 20175804193158State*May 15, 2017142108034HHS+May 31, 20174991600339DoDMay 15, 20177742134TOTAL12987294565NOTES. * reflects PEPFAR funding implemented through the Department of State. Other departments and agencies implement the majority of PEPFAR funding. + At HHS agencies, only certain assistance funding transferred from USAID, State, and DoD are subject to the policy. ^ As of September 30, 2017, USAID reported it was aware of three centrally funded prime partners, and 12 sub-awardee implementing partners, that declined to agree to the Protecting Life in Global Health Assistance (PLGHA) terms in their awards.

DoD reported that one DoD partner, a U.S. NGO, declined to agree in one country but accepted the PLGHA standard provision in other countries. And HHS reported that no HHS partners declined to agree.SOURCES. KFF analysis of data from Department of State, “Protecting Life in Global Health Assistance Six-Month Review,” report, Feb. 6, 2018, https://www.state.gov/protecting-life-in-global-health-assistance-six-month-review/.Second ReviewOn August 17, 2020, the Department of State released its second review of the policy, updating its initial six-month review (as an action item in the six-month review report, the department stated it would “conduct a further review of implementation of the policy by December 15, 2018, when more extensive experience will enable a more thorough examination of the benefits and challenges”).

The long-anticipated review, which examines the period from May 2017 through September 2018, found:the awards declined spanned a variety of program areas, including family planning and reproductive health (FP/RH), HIV and AIDS (HIV/AIDS), maternal and child health (MCH), tuberculosis (TB), and nutrition, in addition to cross-cutting awards;the awards declined spanned geographic areas but many were for activities in sub-Saharan Africa;agencies and departments made efforts to transition projects to another implementer in order to minimize disruption. Butnevertheless, among USAID awards involving health service delivery where prime and sub-award recipients declined to accept the policy, gaps or disruptions in service delivery were sometimes reported.The second review also identified the number of affected agreements with prime implementing partners and the number of those that have accepted the Mexico City Policy as part of their agreements through September 2018 (see Table 3). U.S. Agency or DepartmentPolicy Implementation Date# of Grants and Cooperative Agreements with Global Health Assistance Funding# of Prime Awardees That Declined to Accept Policy^USAIDMay 15, 20174866State*May 15, 20173350HHS+May 31, 20174661DoDMay 15, 2017531TOTAL13408NOTES. * reflects PEPFAR funding implemented through the Department of State.

Other departments and agencies implement the majority of PEPFAR funding. + At HHS agencies, only certain assistance funding transferred from USAID, State, and DoD are subject to the policy. ^ As of September 30, 2018, USAID reported it was aware of six centrally funded prime partners, and 47 sub-awardee implementing partners, that declined to agree to the Protecting Life in Global Health Assistance (PLGHA) terms in their awards. DoD reported that one DoD partner, a U.S. NGO, declined to agree in one country but accepted the PLGHA standard provision in other countries.

And HHS reported that one HHS partner declined to agree.SOURCES. KFF analysis of data from Department of State, “Review of the Implementation of the Protecting Life in Global Health Assistance Policy ,” report, Aug. 17, 2020, https://www.state.gov/wp-content/uploads/2020/08/PLGHA-2019-Review-Final-8.17.2020-508.pdf, and Department of State, “Protecting Life in Global Health Assistance Six-Month Review,” report, Feb. 6, 2018, https://www.state.gov/protecting-life-in-global-health-assistance-six-month-review/.Additionally, the review reports that 47 sub-awardees, all under USAID awards, declined to accept the policy. It is important to note that the review also states that information on sub-awards is not systematically collected by departments and agencies and that DoD was not able to collect information on sub-awards.What is “financial support”?.

In February 2018, in the initial six-month review issued when Secretary of State Tillerson led the department, the Department of State report included an “action” statement to clarify the definition of “financial support” as used in the standard provisions for grants and cooperative agreements. At issue was whether it applied more narrowly to certain funding provided by foreign NGOs (i.e., funding other than U.S. Global health funding) to other foreign NGOs specifically for the purpose of performing or actively promoting abortion as a method of family planning or if it applied more broadly to certain funding provided by foreign NGOs to other foreign NGOs for any purpose, if that foreign NGO happened to perform or actively promote abortion as a method of family planning. The State Department clarified that it was the more narrow interpretation.However, on March 26, 2019, Secretary of State Pompeo reversed this interpretation, announcing further “refinements” to the policy to clarify that it applied to the broader definition of financial support. Specifically, under the policy, U.S.-supported foreign NGOs agree to not provide any financial support (global health-related as well as other support), no matter the source of funds, to any other foreign NGO that performs or actively promotes abortion as a method of family planning.

In June 2019, USAID provided additional information to reflect this broader interpretation of the standard provisions.This marks the first time the policy has been applied this broadly, as it can now affect funding provided by other donors (such as other governments and foundations) and non-global health funding provided by the U.S. Government for a wide range of purposes if this funding is first provided to foreign NGOs who have accepted the policy (as recipients of U.S. Global health assistance) that then in turn provide that donor or U.S. Non global health funding for any purpose to foreign NGOs that perform or actively promote abortion as a method of family planning. For example, under the prior interpretation, a foreign NGO recipient of U.S.

Global health funding could not provide any non-U.S. Funding to another foreign NGO to perform or actively promote abortion as a method of family planning but could provide funding for other activities, such as education, even if the foreign NGO carried out prohibited activities. Under the broader interpretation, a foreign NGO could not provide any non-U.S. Funding for any activity to a foreign NGO that carried out prohibited activities. Similarly, while under the prior interpretation a foreign NGO recipient of U.S.

Global health funding could provide other U.S. Funding (such as humanitarian assistance) to another foreign NGO for non-prohibited activities, even if the foreign NGO carried out prohibited activities, now under the broader interpretation, it could not do so.What are the next steps in implementing the expanded policy?. The policy went into effect in May 2017 (see Table 2), although it is applied on a rolling basis, as new funding agreements and modifications to existing agreements occur. While it applies to all grants and cooperative agreements, the Trump administration has indicated that it intends the policy to apply to contracts, which would require a rule-making process (it began this process by publishing a proposed rule in September 2020)..

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If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Call your health care provider right away if you have any change in vision. Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Viagra, you should refrain from further activity and call your doctor or health care professional as soon as possible. Using Viagra does not protect you or your partner against HIV (the viagra that causes AIDS) or other sexually transmitted diseases.

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As I write this editorial, it is almost 14 months since I first developed can you buy viagra without a prescription erectile dysfunction treatment symptoms and my journey with long Cheap kamagra supplier uk erectile dysfunction treatment continues. In their guideline on long erectile dysfunction treatment NICE/SIGN define post-erectile dysfunction treatment syndrome as signs and symptoms that develop during or after a can you buy viagra without a prescription erectile dysfunction treatment , continuing for more than 12 weeks, and not explained by an alternative diagnosis. More information about long erectile dysfunction treatment can be found in the blog written by @jakesuett and me in September 2020. Data from the can you buy viagra without a prescription Office for National Statistics in April 2021 estimated that 1.1 million people in the UK reported experiencing some form of long erectile dysfunction treatment symptoms. Despite this, the UK Government continues to focus on the outcomes of erectile dysfunction treatment being binary.

Dying or can you buy viagra without a prescription surviving. Box 1 provides details about some useful sources of information on long erectile dysfunction treatment.Box 1 Useful sources of information about long erectile dysfunction treatmentNICE/SIGN rapid guideline published in December 2020.The NIHR review of evidence. Living with erectile dysfunction treatment—second Review (March 2021).Paper in nature in April 2021 provides a summary of how post acute erectile dysfunction treatment (long erectile dysfunction treatment) can affect different organ systems.Paper published in March 2021 describing the range of signs and symptoms experienced by can you buy viagra without a prescription people with long erectile dysfunction treatment via a social media survey.Everyone’s long erectile dysfunction treatment journey is different. Recovery is not linear with many relapses along the way. Fourteen months on, I am better than I was but still not fit enough to return to work and need to be careful not to do too can you buy viagra without a prescription much.

My ongoing symptoms include:Breathlessness—e.g. After having a shower or walking short distances.Brain fog—unable to read for more than 15–20 min or concentrate on anything for more than 30 min.Headache.Fatigue.Poor temperature control and hot flushes.Deterioration in my eyesight—potentially due to steroids.Tingling in faceSwollen glands.Nausea.I am one of the lucky ones—I was reviewed at a (virtual) long can you buy viagra without a prescription erectile dysfunction treatment clinic in February 2021. As suggested by the NICE/SIGN guidelines, I had some tests ordered to rule out any organic causes for my symptoms. The blood tests can you buy viagra without a prescription showed that I had developed type 2 diabetes. A brain MRI indicated I have had a stroke at some point.Nowadays, there is an expectation that most illnesses can be cured.

This makes can you buy viagra without a prescription it more difficult when there are no answers. As a patient group can you buy viagra without a prescription we struggled, and in many cases, are still struggling, to get access to the tests we needed which exacerbated this situation. This is perhaps not surprising in the middle of a viagra. I always felt slightly uncomfortable fighting for access to tests when I knew the NHS was at crisis point but as a can you buy viagra without a prescription registered nurse had some knowledge as to where to turn for help. This was particularly helpful when I was rung with the results of my tests following my long erectile dysfunction treatment clinic appointment.

Having been told I had developed type 2 diabetes, the advice was to ‘go on a low sugar diet’ and have can you buy viagra without a prescription my bloods tested again in a few months. However, I was able to reach out to friends for advice as well as referring myself to the diabetes nurse at my GP practice. I am now on a low carb diet and have been prescribed metformin that would not have happened can you buy viagra without a prescription if I had just followed the initial advice. Getting advice about my stroke has not been so easy. Over 6 weeks down the line, I am still awaiting my referral to the stroke clinic.On an intellectual level, as can you buy viagra without a prescription someone who has spent much of their nursing career promoting evidence-based practice, it has been interesting having a new disease and observing as information about potential treatments emerge.

People within the long erectile dysfunction treatment community were willing to try almost anything in an attempt to get better. A scene from the recent TV series It’s a sin struck a chord—someone who thought they had AIDS/HIV in can you buy viagra without a prescription the mid 1980s ringing a hotline and asking whether a list of potential cures, including drinking bleach, would cure him.As a registered nurse and editor of Evidence Based Nursing, I found it challenging when other people with long erectile dysfunction treatment appeared to me to be ‘grasping at straws’ and trying any treatment that was available despite a lack of evidence to support it. I understand this is a reaction to the lack of available treatments as well as many people being told by the medical profession their symptoms were ‘all in their head’. But, on can you buy viagra without a prescription occasion, it made it difficult being part of these groups. Going forward, we need robust research to identify treatments for long erectile dysfunction treatment.

An international multistakeholder forum has recently produced a list of research priorities for long erectile dysfunction treatment can you buy viagra without a prescription. Governments are beginning to allocate money for research into long erectile dysfunction treatment—for example, in the USA, the NIH has put US$1.15 billion aside. These are definitely steps in the right direction but more needs to be done worldwide to care for those of us with Long erectile dysfunction treatment.Ethics statementsPatient consent for publicationNot required.Using interpretative phenomenological analysis to explore multiperspectivesInterpretative phenomenological analysis (IPA) was originally developed in 1995 by Johnathan Smith as a method to undertake experiential research in psychology and has gained prominence across health and social sciences as a way to understand and interpret topics that are complex and emotionally laden, such as chronic illness experiences.1 2 IPA aims to uncover what a lived experience means to the individual through a process of in-depth reflective inquiry.3 can you buy viagra without a prescription The IPA draws on phenomenological thinking, with the purpose to return ‘to the things themselves’3 (p168). However, IPA also acknowledges that we are can you buy viagra without a prescription each influenced by the worlds in which we live and the experiences we encounter. Therefore, IPA is an interpretative process between the researcher and researched, influenced predominantly by Heidegger’s interpretive phenomenology, hermeneutics and idiography.

Within IPA, can you buy viagra without a prescription it is typical for researchers to select a small homogenous sample to explore the shared perspectives on a single phenomenon of interest4. Within IPA studies, the focus has been on individual people living within diverse settings and populations such as chronic or long-term illnesses. The focus is on understandings of rich, lived experiences, and, given the small samples, IPA studies have typically can you buy viagra without a prescription not focused on those connected to the person living with diversity or disease. Recently, there has been an interest within IPA to suggest the value of capturing more complex data through multiple perspectives using designs and processes to address this shortcoming in IPA.4 This may involve the use of multiple participants and a range of data collection methods such as the use of dyads or focus groups. The aim of this paper is to explore the utility of IPA approaches using multiperspectives through focusing on a specific case study to illustrate this approach.Case studyThis case study focuses on an IPA study that focused on the lived experiences of adolescents can you buy viagra without a prescription and young adults (AYA) and their family/significant other living with malignant melanoma (MM).

Families and other people important to the experience can provide a logical and insightful perspectives on a shared psychosocial phenomenon. Multiperspective designs are gaining increasing prominence among researchers who can you buy viagra without a prescription recognise that an experience such as living with a long-term disease ‘is not solely located within the accounts of those with the diagnosis’4 (p182). For the purposes of this case study, the family/significant others were seen as integral to the experience for the AYA living with MM and their journey together in supporting one another through this experience.During the 1970s, melanoma in AYA was rare, but over the intervening decades, there has been a marked increase in the reported incidence of MM in AYA around the globe.5–7 There is a significant amount of biomedical empirical research evidence on melanoma but a dearth of qualitative research around the lived experience for AYA and their family/significant other living with this disease.A purposive sample of young participants, 16–26 years, were identified by the Clinical Nurse Specialists that ensured the participants were experiencing the same phenomenon.8–10 Although the intention was to carry out individual interviews with all the participants following the typical IPA approach, most of the AYA lived at home and the young participants expressed the desire for a shared interview, which was accommodated by the first author. The four individuals (n=4) and three-dyad interviews (n=6) allowed for the shared experience and the phenomena to be captured and understood through data analysis and interpretation.4 Although the use of individual and joint interviews had implications for can you buy viagra without a prescription data collection and analysis—such as the parent wishing to have their voice heard over their child—the researcher had to ensure that questions were also directed to the young participant in order to capture both voices. In depth, semistructured interviews were undertaken within the AYAs primary treatment centre on the day of the outpatient appointment and they were often accompanied with someone who was significant in their journey.

Interviews lasted between 90 and 120 min.This study was novel to the experiences of AYA and family/significant other living with MM, which offers a new perspective on can you buy viagra without a prescription the dynamics that are present within the MM experience. Our findings can be valuable for both an AYA, family/significant other and health and social care professionals. Both AYA and the family/significant other seemed to consider the emotional implications of talking about the disease can you buy viagra without a prescription. Throughout this process, participants seemed to strive for a shared understanding of the MM experience, a story that unified rather than divided them.Strengths and challengesA social phenomenological perspective demands an emphasis on understanding the participant’s experience of the world from their situation and then interpreting how that can you buy viagra without a prescription understanding is intersubjectively constructed.4 11 In-depth semistructured interviews, therefore, offered an appropriate and compelling method to generate data that permitted such insights and reflections, allowing participants to reconstruct their understandings of a phenomenon3 through narrative. Qualitative researchers are increasingly using ‘oint interviews’ (dyad) to explore the lived experiences in health and capture the multiperspective.

However, the decision of whether to interview participants separately can you buy viagra without a prescription or together as a dyad is an important consideration because it influences the nature of the data collected and having two different types of data. Each transcript was analysed separately both for the AYA and then the family/significant other, whether as an individual or dyad. This was important as the researcher (first author) was not sure whether the findings for the AYA would be different from that of the can you buy viagra without a prescription family/significant other. There also needs to be time built into the study for the data analysis and IPA founders suggest following the IPA methodology, researchers should follow the key steps.3 Analysing the data individually allowed the narrative to ‘open up’ and reveal the experiences of the participant’s as various ‘individual parts’ and then as a ‘whole’.2 3 Throughout the data analysis, the six key steps supported the rigour, transparency and coherence of the findings.Findings of the case studyThis study was organised hierarchically into themes and following the iterative process of analysis, the 'Life interrupted' meta-narrative was identified from all the participant’s lives. €˜Life interrupted’ speaks to the various ways that participants’ lives were interrupted due to the cancer diagnosis, and can you buy viagra without a prescription the journey this disease took them on as well as the unsettling emotions that were experienced during this journey.

This is woven into the whole journey experience and figure 1 illustrates the core conceptual thread and the interconnection between AYA and the family/significant other. The interconnection between the can you buy viagra without a prescription four super-ordinate and the 12 subthemes is also shown. The ebb and flow of familial relationships can, in some situations, magnify the impact of the physical disease, with the emotional turmoil often rivalling the physical manifestation of the disease.8 11 Conversely, relationships may help the AYA and the family/significant other cope with the disease in a more positive and supportive way. The importance of these unique and can you buy viagra without a prescription changing relationships in living with MM should not be underestimated, and psychosocial research about YPs experiences of cancer would be enhanced through the further use and development of the multiperspective approach underpinned by IPA as used in this study, which is able to capture these dynamic inter-relationships. A visual representation is provided within figure 1 and how the individual voices were captured through the individual and dyad interview.Visual multi-perspective IPA design.

IPA, interpretative phenomenological analysis." data-icon-position data-hide-link-title="0">Figure 1 Visual can you buy viagra without a prescription multi-perspective IPA design. IPA, interpretative phenomenological analysis.ConclusionsThis paper presents experiences of life events and processes that are intersubjective and relational. Meaning is ‘in between’ us but is rarely studied that way in phenomenological inquiry.4 The meanings of events and processes are often contested can you buy viagra without a prescription and can sometimes be understood in a more complex manner when viewed from the multiple perspectives involved in the system that constitutes them. Multiple perspective designs can be a useful way for IPA researchers to address research questions that engage with these phenomena.Ethics statementsPatient consent for publicationNot required..

As I visit this web-site write this editorial, it is almost 14 months since I first viagra price per pill developed erectile dysfunction treatment symptoms and my journey with long erectile dysfunction treatment continues. In their guideline on long erectile dysfunction treatment NICE/SIGN define post-erectile dysfunction treatment syndrome as signs viagra price per pill and symptoms that develop during or after a erectile dysfunction treatment , continuing for more than 12 weeks, and not explained by an alternative diagnosis. More information about long erectile dysfunction treatment can be found in the blog written by @jakesuett and me in September 2020. Data from the Office for National Statistics in April 2021 estimated that 1.1 million people in the UK reported viagra price per pill experiencing some form of long erectile dysfunction treatment symptoms. Despite this, the UK Government continues to focus on the outcomes of erectile dysfunction treatment being binary.

Dying or viagra price per pill surviving. Box 1 provides details about some useful sources of information on long erectile dysfunction treatment.Box 1 Useful sources of information about long erectile dysfunction treatmentNICE/SIGN rapid guideline published in December 2020.The NIHR review of evidence. Living with erectile dysfunction treatment—second Review (March 2021).Paper in nature in April 2021 provides a summary of how post acute erectile dysfunction treatment (long erectile dysfunction treatment) can affect different organ systems.Paper published in March 2021 describing the range of signs and symptoms experienced by people with long erectile dysfunction treatment viagra price per pill via a social media survey.Everyone’s long erectile dysfunction treatment journey is different. Recovery is not linear with many relapses along the way. Fourteen months on, I am better than I was but still not fit enough to return to work and need to be careful not viagra price per pill to do too much.

My ongoing symptoms include:Breathlessness—e.g. After having a shower or walking short distances.Brain fog—unable to read for more than 15–20 min or concentrate on viagra price per pill anything for more than 30 min.Headache.Fatigue.Poor temperature control and hot flushes.Deterioration in my eyesight—potentially due to steroids.Tingling in faceSwollen glands.Nausea.I am one of the lucky ones—I was reviewed at a (virtual) long erectile dysfunction treatment clinic in February 2021. As suggested by the NICE/SIGN guidelines, I had some tests ordered to rule out any organic causes for my symptoms. The blood tests showed that I viagra price per pill had developed type 2 diabetes. A brain MRI indicated I have had a stroke at some point.Nowadays, there is an expectation that most illnesses can be cured.

This makes it more difficult when there are no viagra price per pill answers. As a viagra price per pill patient group we struggled, and in many cases, are still struggling, to get access to the tests we needed which exacerbated this situation. This is perhaps not surprising in the middle of a viagra. I always felt slightly uncomfortable fighting viagra price per pill for access to tests when I knew the NHS was at crisis point but as a registered nurse had some knowledge as to where to turn for help. This was particularly helpful when I was rung with the results of my tests following my long erectile dysfunction treatment clinic appointment.

Having been told I had developed type 2 diabetes, the advice was to ‘go on a low sugar diet’ viagra price per pill and have my bloods tested again in a few months. However, I was able to reach out to friends for advice as well as referring myself to the diabetes nurse at my GP practice. I am now on a low carb diet and have viagra price per pill been prescribed metformin that would not have happened if I had just followed the initial advice. Getting advice about my stroke has not been so easy. Over 6 weeks down the line, I am still awaiting my referral to the stroke clinic.On an intellectual level, as someone who has spent much of their nursing career promoting evidence-based practice, it has been interesting having viagra price per pill a new disease and observing as information about potential treatments emerge.

People within the long erectile dysfunction treatment community were willing to try almost anything in an attempt to get better. A scene viagra price per pill from the recent TV series It’s a sin struck a chord—someone who thought they had AIDS/HIV in the mid 1980s ringing a hotline and asking whether a list of potential cures, including drinking bleach, would cure him.As a registered nurse and editor of Evidence Based Nursing, I found it challenging when other people with long erectile dysfunction treatment appeared to me to be ‘grasping at straws’ and trying any treatment that was available despite a lack of evidence to support it. I understand this is a reaction to the lack of available treatments as well as many people being told by the medical profession their symptoms were ‘all in their head’. But, on occasion, it made it difficult being part of these groups viagra price per pill. Going forward, we need robust research to identify treatments for long erectile dysfunction treatment.

An international multistakeholder forum has recently produced a list of research priorities for long erectile dysfunction treatment viagra price per pill. Governments are beginning to allocate money for research into long erectile dysfunction treatment—for example, in the USA, the NIH has put US$1.15 billion aside. These are definitely steps in the right direction but more needs to be done worldwide to care for those of us with Long erectile dysfunction treatment.Ethics statementsPatient consent for publicationNot required.Using interpretative phenomenological analysis to explore multiperspectivesInterpretative phenomenological analysis (IPA) was originally developed in 1995 by Johnathan Smith as a method to undertake experiential research in psychology and has gained prominence across health and social sciences as a way to understand and interpret topics that are complex and emotionally laden, such as chronic illness experiences.1 2 IPA aims to uncover what a lived experience means to the individual through a process of in-depth reflective inquiry.3 The IPA draws on phenomenological thinking, with the purpose viagra price per pill to return ‘to the things themselves’3 (p168). However, IPA also acknowledges that we viagra price per pill are each influenced by the worlds in which we live and the experiences we encounter. Therefore, IPA is an interpretative process between the researcher and researched, influenced predominantly by Heidegger’s interpretive phenomenology, hermeneutics and idiography.

Within IPA, it is typical for researchers to select a small homogenous sample to explore the shared viagra price per pill perspectives on a single phenomenon of interest4. Within IPA studies, the focus has been on individual people living within diverse settings and populations such as chronic or long-term illnesses. The focus is on understandings of rich, lived experiences, viagra price per pill and, given the small samples, IPA studies have typically not focused on those connected to the person living with diversity or disease. Recently, there has been an interest within IPA to suggest the value of capturing more complex data through multiple perspectives using designs and processes to address this shortcoming in IPA.4 This may involve the use of multiple participants and a range of data collection methods such as the use of dyads or focus groups. The aim of this paper is to explore the utility of IPA approaches using multiperspectives through focusing on a specific case study to illustrate this approach.Case studyThis case study focuses on an viagra price per pill IPA study that focused on the lived experiences of adolescents and young adults (AYA) and their family/significant other living with malignant melanoma (MM).

Families and other people important to the experience can provide a logical and insightful perspectives on a shared psychosocial phenomenon. Multiperspective designs are gaining increasing viagra price per pill prominence among researchers who recognise that an experience such as living with a long-term disease ‘is not solely located within the accounts of those with the diagnosis’4 (p182). For the purposes of this case study, the family/significant others were seen as integral to the experience for the AYA living with MM and their journey together in supporting one another through this experience.During the 1970s, melanoma in AYA was rare, but over the intervening decades, there has been a marked increase in the reported incidence of MM in AYA around the globe.5–7 There is a significant amount of biomedical empirical research evidence on melanoma but a dearth of qualitative research around the lived experience for AYA and their family/significant other living with this disease.A purposive sample of young participants, 16–26 years, were identified by the Clinical Nurse Specialists that ensured the participants were experiencing the same phenomenon.8–10 Although the intention was to carry out individual interviews with all the participants following the typical IPA approach, most of the AYA lived at home and the young participants expressed the desire for a shared interview, which was accommodated by the first author. The four individuals (n=4) and three-dyad viagra price per pill interviews (n=6) allowed for the shared experience and the phenomena to be captured and understood through data analysis and interpretation.4 Although the use of individual and joint interviews had implications for data collection and analysis—such as the parent wishing to have their voice heard over their child—the researcher had to ensure that questions were also directed to the young participant in order to capture both voices. In depth, semistructured interviews were undertaken within the AYAs primary treatment centre on the day of the outpatient appointment and they were often accompanied with someone who was significant in their journey.

Interviews lasted between 90 and 120 min.This study was novel to the experiences of AYA and family/significant other living with viagra price per pill MM, which offers a new perspective on the dynamics that are present within the MM experience. Our findings can be valuable for both an AYA, family/significant other and health and social care professionals. Both AYA and the family/significant other seemed to consider the emotional implications of talking about the disease viagra price per pill. Throughout this process, participants seemed to strive for a shared understanding of the MM experience, a story that unified rather than divided them.Strengths and challengesA social phenomenological perspective demands an emphasis on understanding the participant’s experience of the world from their situation and then interpreting how that understanding is intersubjectively constructed.4 11 In-depth semistructured interviews, therefore, offered an appropriate and compelling method to generate data that permitted such insights and reflections, allowing participants to reconstruct viagra price per pill their understandings of a phenomenon3 through narrative. Qualitative researchers are increasingly using ‘oint interviews’ (dyad) to explore the lived experiences in health and capture the multiperspective.

However, the decision viagra price per pill of whether to interview participants separately or together as a dyad is an important consideration because it influences the nature of the data collected and having two different types of data. Each transcript was analysed separately both for the AYA and then the family/significant other, whether as an individual or dyad. This was important as the researcher (first author) was not sure whether the findings for the AYA viagra price per pill would be different from that of the family/significant other. There also needs to be time built into the study for the data analysis and IPA founders suggest following the IPA methodology, researchers should follow the key steps.3 Analysing the data individually allowed the narrative to ‘open up’ and reveal the experiences of the participant’s as various ‘individual parts’ and then as a ‘whole’.2 3 Throughout the data analysis, the six key steps supported the rigour, transparency and coherence of the findings.Findings of the case studyThis study was organised hierarchically into themes and following the iterative process of analysis, the 'Life interrupted' meta-narrative was identified from all the participant’s lives. €˜Life interrupted’ speaks to the various ways that participants’ lives viagra price per pill were interrupted due to the cancer diagnosis, and the journey this disease took them on as well as the unsettling emotions that were experienced during this journey.

This is woven into the whole journey experience and figure 1 illustrates the core conceptual thread and the interconnection between AYA and the family/significant other. The interconnection between the four super-ordinate and the 12 viagra price per pill subthemes is also shown. The ebb and flow of familial relationships can, in some situations, magnify the impact of the physical disease, with the emotional turmoil often rivalling the physical manifestation of the disease.8 11 Conversely, relationships may help the AYA and the family/significant other cope with the disease in a more positive and supportive way. The importance of these unique and changing relationships in living with MM should not be underestimated, and psychosocial viagra price per pill research about YPs experiences of cancer would be enhanced through the further use and development of the multiperspective approach underpinned by IPA as used in this study, which is able to capture these dynamic inter-relationships. A visual representation is provided within figure 1 and how the individual voices were captured through the individual and dyad interview.Visual multi-perspective IPA design.

IPA, interpretative phenomenological analysis." data-icon-position data-hide-link-title="0">Figure 1 Visual multi-perspective viagra price per pill IPA design. IPA, interpretative phenomenological analysis.ConclusionsThis paper presents experiences of life events and processes that are intersubjective and relational. Meaning is ‘in between’ us but is rarely studied that way viagra price per pill in phenomenological inquiry.4 The meanings of events and processes are often contested and can sometimes be understood in a more complex manner when viewed from the multiple perspectives involved in the system that constitutes them. Multiple perspective designs can be a useful way for IPA researchers to address research questions that engage with these phenomena.Ethics statementsPatient consent for publicationNot required..

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Specificity of erectile dysfunction Antibody Assays Both assays http://www.reise-der-hoffnung.info/how-much-does-generic-zithromax-cost/ measuring pan-Ig antibodies had low numbers of false positives generic viagra 100mg among samples collected in 2017. There were 0 and 1 false positives for the two assays among 472 samples, results that compared favorably generic viagra 100mg with those obtained with the single IgM anti-N and IgG anti-N assays (Table S3). Because of the low prevalence of erectile dysfunction in Iceland, we required positive results from both pan-Ig antibody assays for a sample to be considered seropositive (see Supplementary Methods in Supplementary Appendix 1).

None of the samples collected in generic viagra 100mg early 2020 group were seropositive, which indicates that the viagra had not spread widely in Iceland before February 2020. erectile dysfunction Antibodies among qPCR-Positive Persons Figure 2. Figure 2 generic viagra 100mg.

Antibody Prevalence and Titers among qPCR-Positive Cases as a Function of Time since Diagnosis by qPCR. Shown are the percentages of generic viagra 100mg samples positive for both pan-Ig antibody assays and the antibody titers. Red denotes the count or percentage of samples among persons during their hospitalization (249 samples from 48 persons), and blue denotes the count or percentage of samples among persons after they were declared recovered (1853 samples from 1215 persons).

Vertical bars denote 95% confidence generic viagra 100mg intervals. The dashed lines indicated the thresholds for a test to be declared positive. OD denotes optical density, and generic viagra 100mg RBD receptor binding domain.Table 1.

Table 1. Prevalence of generic viagra 100mg erectile dysfunction Antibodies by Sample Collection as Measured by Two Pan-Ig Antibody Assays. Twenty-five days after diagnosis by qPCR, more than 90% of samples from recovered persons tested positive with both pan-Ig antibody assays, and the percentage of persons testing positive remained stable thereafter (Figure 2 generic viagra 100mg and Fig.

S2). Hospitalized persons generic viagra 100mg seroconverted more frequently and quickly after qPCR diagnosis than did nonhospitalized persons (Figure 2 and Fig. S3).

Of 1215 persons who had recovered (on the basis of results for the generic viagra 100mg most recently obtained sample from persons for whom we had multiple samples), 1107 were seropositive (91.1%. 95% confidence interval [CI], 89.4 to 92.6) (Table 1 and Table S4). Since some diagnoses may have been made on the basis of false positive qPCR generic viagra 100mg results, we determined that 91.1% represents the lower bound of sensitivity of the combined pan-Ig tests for the detection of erectile dysfunction antibodies among recovered persons.

Table 2. Table 2 generic viagra 100mg. Results of Repeated Pan-Ig Antibody Tests among Recovered qPCR-Diagnosed Persons.

Among the 487 recovered persons with two or more samples, 19 (4%) had different pan-Ig antibody test results at different time points (Table generic viagra 100mg 2 and Fig. S4). It is notable that of the 22 persons with generic viagra 100mg an early sample that tested negative for both pan-Ig antibodies, 19 remained negative at the most recent test date (again, for both antibodies).

One person tested positive for both pan-Ig antibodies in the first test and negative for both in the most recent test. The longitudinal changes in antibody levels among recovered persons were consistent with the cross-sectional generic viagra 100mg results (Fig. S5).

Antibody levels were higher in the last sample than in the first sample when the antibodies were measured with the two pan-Ig assays, slightly lower than in the first sample when measured with IgG anti-N and IgG anti-S1 assays, and substantially lower than in the first sample when measured with IgM anti-N and IgA anti-S1 assays. IgG anti-N, IgM anti-N, IgG anti-S1, and IgA anti-S1 antibody levels were correlated among the qPCR-positive persons (Figs. S5 and S6 and Table S5).

Antibody levels measured with both pan-Ig antibody assays increased over the first 2 months after qPCR diagnosis and remained at a plateau over the next 2 months of the study. IgM anti-N antibody levels increased rapidly soon after diagnosis and then fell rapidly and were generally not detected after 2 months. IgA anti-S1 antibodies decreased 1 month after diagnosis and remained detectable thereafter.

IgG anti-N and anti-S1 antibody levels increased during the first 6 weeks after diagnosis and then decreased slightly. erectile dysfunction in Quarantine Table 3. Table 3.

erectile dysfunction among Quarantined Persons According to Exposure Type and Presence of Symptoms. Of the 1797 qPCR-positive Icelanders, 1088 (61%) were in quarantine when erectile dysfunction was diagnosed by qPCR. We tested for antibodies among 4222 quarantined persons who had not tested qPCR-positive (they had received a negative result by qPCR or had simply not been tested).

Of those 4222 quarantined persons, 97 (2.3%. 95% CI, 1.9 to 2.8) were seropositive (Table 1). Those with household exposure were 5.2 (95% CI, 3.3 to 8.0) times more likely to be seropositive than those with other types of exposure (Table 3).

Similarly, a positive result by qPCR for those with household exposure was 5.2 (95% CI, 4.5 to 6.1) times more likely than for those with other types of exposure. When these two sets of results (qPCR-positive and seropositive) were combined, we calculated that 26.6% of quarantined persons with household exposure and 5.0% of quarantined persons without household exposure were infected. Those who had symptoms during quarantine were 3.2 (95% CI, 1.7 to 6.2) times more likely to be seropositive and 18.2 times (95% CI, 14.8 to 22.4) more likely to test positive with qPCR than those without symptoms.

We also tested persons in two regions of Iceland affected by cluster outbreaks. In a erectile dysfunction cluster in Vestfirdir, 1.4% of residents were qPCR-positive and 10% of residents were quarantined. We found that none of the 326 persons outside quarantine who had not been tested by qPCR (or who tested negative) were seropositive.

In a cluster in Vestmannaeyjar, 2.3% of residents were qPCR-positive and 13% of residents were quarantined. Of the 447 quarantined persons who had not received a qPCR-positive result, 4 were seropositive (0.9%. 95% CI, 0.3 to 2.1).

Of the 663 outside quarantine in Vestmannaeyjar, 3 were seropositive (0.5%. 95% CI, 0.1 to 0.2%). erectile dysfunction Seroprevalence in Iceland None of the serum samples collected from 470 healthy Icelanders between February 18 and March 9, 2020, tested positive for both pan-Ig antibodies, although four were positive for the pan-Ig anti-N assay (0.9%), a finding that suggests that the viagra had not spread widely in Iceland before March 9.

Of the 18,609 persons tested for erectile dysfunction antibodies through contact with the Icelandic health care system for reasons other than erectile dysfunction treatment, 39 were positive for both pan-Ig antibody assays (estimated seroprevalence by weighting the sample on the basis of residence, sex, and 10-year age category, 0.3%. 95% CI, 0.2 to 0.4). There were regional differences in the percentages of qPCR-positive persons across Iceland that were roughly proportional to the percentage of people quarantined (Table S6).

However, after exclusion of the qPCR-positive and quarantined persons, the percentage of persons who tested positive for erectile dysfunction antibodies did not correlate with the percentage of those who tested positive by qPCR. The estimated seroprevalence in the random sample collection from Reykjavik (0.4%. 95% CI, 0.3 to 0.6) was similar to that in the Health Care group (0.3%.

95% CI, 0.2 to 0.4) (Table S6). We calculate that 0.5% of the residents of Iceland have tested positive with qPCR. The 2.3% with erectile dysfunction seroconversion among persons in quarantine extrapolates to 0.1% of Icelandic residents.

On the basis of this finding and the seroprevalence from the Health Care group, we estimate that 0.9% (95% CI, 0.8 to 0.9) of the population of Iceland has been infected by erectile dysfunction. Approximately 56% of all erectile dysfunction s were therefore diagnosed by qPCR, 14% occurred in quarantine without having been diagnosed with qPCR, and the remaining 30% of s occurred outside quarantine and were not detected by qPCR. Deaths from erectile dysfunction treatment in Iceland In Iceland, 10 deaths have been attributed to erectile dysfunction treatment, which corresponds to 3 deaths per 100,000 nationwide.

Among the qPCR-positive cases, 0.6% (95% CI, 0.3 to 1.0) were fatal. Using the 0.9% prevalence of erectile dysfunction in Iceland as the denominator, however, we calculate an fatality risk of 0.3% (95% CI, 0.2 to 0.6). Stratified by age, the fatality risk was substantially lower in those 70 years old or younger (0.1%.

95% CI, 0.0 to 0.3) than in those over 70 years of age (4.4%. 95% CI, 1.9 to 8.4) (Table S7). Age, Sex, Clinical Characteristics, and Antibody Levels Table 4.

Table 4. Association of Existing Conditions and erectile dysfunction treatment Severity with erectile dysfunction Antibody Levels among Recovered Persons. erectile dysfunction antibody levels were higher in older people and in those who were hospitalized (Table 4, and Table S8 [described in Supplementary Appendix 1 and available in Supplementary Appendix 2]).

Pan-Ig anti–S1-RBD and IgA anti-S1 levels were lower in female persons. Of the preexisting conditions, and after adjustment for multiple testing, we found that body-mass index, smoking status, and use of antiinflammatory medication were associated with erectile dysfunction antibody levels. Body-mass index correlated positively with antibody levels.

Smokers and users of antiinflammatory medication had lower antibody levels. With respect to clinical characteristics, antibody levels were most strongly associated with hospitalization and clinical severity, followed by clinical symptoms such as fever, maximum temperature reading, cough, and loss of appetite. Severity of these individual symptoms, with the exception of loss of energy, was associated with higher antibody levels.To the Editor.

Rapid and accurate diagnostic tests are essential for controlling the ongoing erectile dysfunction treatment viagra. Although the current standard involves testing of nasopharyngeal swab specimens by quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) to detect erectile dysfunction, saliva specimens may be an alternative diagnostic sample.1-4 Rigorous evaluation is needed to determine how saliva specimens compare with nasopharyngeal swab specimens with respect to sensitivity in detection of erectile dysfunction during the course of . A total of 70 inpatients with erectile dysfunction treatment provided written informed consent to participate in our study (see the Methods section in Supplementary Appendix 1, available with the full text of this letter at NEJM.org).

After erectile dysfunction treatment was confirmed with a positive nasopharyngeal swab specimen at hospital admission, we obtained additional samples from the patients during hospitalization. We tested saliva specimens collected by the patients themselves and nasopharyngeal swabs collected from the patients at the same time point by health care workers. Figure 1.

Figure 1. erectile dysfunction RNA Titers in Saliva Specimens and Nasopharyngeal Swab Specimens. Samples were obtained from 70 hospital inpatients who had a diagnosis of erectile dysfunction treatment.

Panel A shows erectile dysfunction RNA titers in the first available nasopharyngeal and saliva samples. The lines indicate samples from the same patient. Results were compared with the use of a Wilcoxon signed-rank test (P<0.001).

Panel B shows percentages of positivity for erectile dysfunction in tests of the first matched nasopharyngeal and saliva samples at 1 to 5 days, 6 to 10 days, and 11 or more days (maximum, 53 days) after the diagnosis of erectile dysfunction treatment. Panel C shows longitudinal erectile dysfunction RNA copies per milliliter in 97 saliva samples, according to days since symptom onset. Each circle represents a separate sample.

Dashed lines indicate additional samples from the same patient. The red line indicates a negative saliva sample that was followed by a positive sample at the next collection of a specimen. Panel D shows longitudinal erectile dysfunction RNA copies per milliliter in 97 nasopharyngeal swab specimens, according to days since symptom onset.

The red lines indicate negative nasopharyngeal swab specimens there were followed by a positive swab at the next collection of a specimen. The gray area in Panels C and D indicates samples that were below the lower limit of detection of 5610 viagra RNA copies per milliliter of sample, which is at cycle threshold 38 of our quantitative reverse-transcriptase polymerase chain reaction assay targeting the erectile dysfunction N1 sequence recommended by the Centers for Disease Control and Prevention. To analyze these data, we used a linear mixed-effects regression model (see Supplementary Appendix 1) that accounts for the correlation between samples collected from the same person at a single time point (i.e., multivariate response) and the correlation between samples collected across time from the same patient (i.e., repeated measures).

All the data used to generate this figure, including the raw cycle thresholds, are provided in Supplementary Data 1 in Supplementary Appendix 2.Using primer sequences from the Centers for Disease Control and Prevention, we detected more erectile dysfunction RNA copies in the saliva specimens (mean log copies per milliliter, 5.58. 95% confidence interval [CI], 5.09 to 6.07) than in the nasopharyngeal swab specimens (mean log copies per milliliter, 4.93. 95% CI, 4.53 to 5.33) (Figure 1A, and Fig.

S1 in Supplementary Appendix 1). In addition, a higher percentage of saliva samples than nasopharyngeal swab samples were positive up to 10 days after the erectile dysfunction treatment diagnosis (Figure 1B). At 1 to 5 days after diagnosis, 81% (95% CI, 71 to 96) of the saliva samples were positive, as compared with 71% (95% CI, 67 to 94) of the nasopharyngeal swab specimens.

These findings suggest that saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of erectile dysfunction during the course of hospitalization. Because the results of testing of nasopharyngeal swab specimens to detect erectile dysfunction may vary with repeated sampling in individual patients,5 we evaluated viral detection in matched samples over time. The level of erectile dysfunction RNA decreased after symptom onset in both saliva specimens (estimated slope, −0.11.

95% credible interval, −0.15 to −0.06) (Figure 1C) and nasopharyngeal swab specimens (estimated slope, −0.09. 95% credible interval, −0.13 to −0.05) (Figure 1D). In three instances, a negative nasopharyngeal swab specimen was followed by a positive swab at the next collection of a specimen (Figure 1D).

This phenomenon occurred only once with the saliva specimens (Figure 1C). During the clinical course, we observed less variation in levels of erectile dysfunction RNA in the saliva specimens (standard deviation, 0.98 viagra RNA copies per milliliter. 95% credible interval, 0.08 to 1.98) than in the nasopharyngeal swab specimens (standard deviation, 2.01 viagra RNA copies per milliliter.

95% credible interval, 1.29 to 2.70) (see Supplementary Appendix 1). Recent studies have shown that erectile dysfunction can be detected in the saliva of asymptomatic persons and outpatients.1-3 We therefore screened 495 asymptomatic health care workers who provided written informed consent to participate in our prospective study, and we used RT-qPCR to test both saliva and nasopharyngeal samples obtained from these persons. We detected erectile dysfunction RNA in saliva specimens obtained from 13 persons who did not report any symptoms at or before the time of sample collection.

Of these 13 health care workers, 9 had collected matched nasopharyngeal swab specimens by themselves on the same day, and 7 of these specimens tested negative (Fig. S2). The diagnosis in the 13 health care workers with positive saliva specimens was later confirmed in diagnostic testing of additional nasopharyngeal samples by a CLIA (Clinical Laboratory Improvement Amendments of 1988)–certified laboratory.

Variation in nasopharyngeal sampling may be an explanation for false negative results, so monitoring an internal control for proper sample collection may provide an alternative evaluation technique. In specimens collected from inpatients by health care workers, we found greater variation in human RNase P cycle threshold (Ct) values in nasopharyngeal swab specimens (standard deviation, 2.89 Ct. 95% CI, 26.53 to 27.69) than in saliva specimens (standard deviation, 2.49 Ct.

95% CI, 23.35 to 24.35). When health care workers collected their own specimens, we also found greater variation in RNase P Ct values in nasopharyngeal swab specimens (standard deviation, 2.26 Ct. 95% CI, 28.39 to 28.56) than in saliva specimens (standard deviation , 1.65 Ct.

95% CI, 24.14 to 24.26) (Fig. S3). Collection of saliva samples by patients themselves negates the need for direct interaction between health care workers and patients.

This interaction is a source of major testing bottlenecks and presents a risk of nosocomial . Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of erectile dysfunction .

Anne L. Wyllie, Ph.D.Yale School of Public Health, New Haven, CT [email protected]John Fournier, M.D.Yale School of Medicine, New Haven, CTArnau Casanovas-Massana, Ph.D.Yale School of Public Health, New Haven, CTMelissa Campbell, M.D.Maria Tokuyama, Ph.D.Pavithra Vijayakumar, B.A.Yale School of Medicine, New Haven, CTJoshua L. Warren, Ph.D.Yale School of Public Health, New Haven, CTBertie Geng, M.D.Yale School of Medicine, New Haven, CTM.

Catherine Muenker, M.S.Adam J. Moore, M.P.H.Chantal B.F. Vogels, Ph.D.Mary E.

Petrone, B.S.Isabel M. Ott, B.S.Yale School of Public Health, New Haven, CTPeiwen Lu, Ph.D.Arvind Venkataraman, B.S.Alice Lu-Culligan, B.S.Jonathan Klein, B.S.Yale School of Medicine, New Haven, CTRebecca Earnest, M.P.H.Yale School of Public Health, New Haven, CTMichael Simonov, M.D.Rupak Datta, M.D., Ph.D.Ryan Handoko, M.D.Nida Naushad, B.S.Lorenzo R. Sewanan, M.Phil.Jordan Valdez, B.S.Yale School of Medicine, New Haven, CTElizabeth B.

White, A.B.Sarah Lapidus, M.S.Chaney C. Kalinich, M.P.H.Yale School of Public Health, New Haven, CTXiaodong Jiang, M.D., Ph.D.Daniel J. Kim, A.B.Eriko Kudo, Ph.D.Melissa Linehan, M.S.Tianyang Mao, B.S.Miyu Moriyama, Ph.D.Ji E.

Oh, M.D., Ph.D.Annsea Park, B.A.Julio Silva, B.S.Eric Song, M.S.Takehiro Takahashi, M.D., Ph.D.Manabu Taura, Ph.D.Orr-El Weizman, B.A.Patrick Wong, M.S.Yexin Yang, B.S.Santos Bermejo, B.S.Yale School of Medicine, New Haven, CTCamila D. Odio, M.D.Yale New Haven Health, New Haven, CTSaad B. Omer, M.B., B.S., Ph.D.Yale Institute for Global Health, New Haven, CTCharles S.

Dela Cruz, M.D., Ph.D.Shelli Farhadian, M.D., Ph.D.Richard A. Martinello, M.D.Akiko Iwasaki, Ph.D.Yale School of Medicine, New Haven, CTNathan D. Grubaugh, Ph.D.Albert I.

Ko, M.D.Yale School of Public Health, New Haven, CT [email protected], [email protected] Supported by the Huffman Family Donor Advised Fund, a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University, the Yale Institute for Global Health, the Yale School of Medicine, a grant (U19 AI08992, to Dr. Ko) from the National Institute of Allergy and Infectious Diseases, the Beatrice Kleinberg Neuwirth Fund, and a grant (Rubicon 019.181EN.004, to Dr. Vogel) from the Dutch Research Council (NWO).

Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on August 28, 2020, at NEJM.org. Drs.

Grubaugh and Ko contributed equally to this letter. 5 References1. Kojima N, Turner F, Slepnev V, et al.

Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for erectile dysfunction treatment detection. April 15, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.11.20062372v1). Preprint.Google Scholar2.

Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a non-invasive specimen for detection of erectile dysfunction. J Clin Microbiol 2020;58(8):e00776-20-e00776-20.3.

Pasomsub E, Watcharananan SP, Boonyawat K, et al. Saliva sample as a non-invasive specimen for the diagnosis of erectile dysfunction disease 2019. A cross-sectional study.

Clin Microbiol Infect 2020 May 15 (Epub ahead of print).4. Vogels CBF, Brackney D, Wang J, et al. SalivaDirect.

Simple and sensitive molecular diagnostic test for erectile dysfunction surveillance. August 4, 2020 (https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1). Preprint.Google Scholar5.

Zou L, Ruan F, Huang M, et al. erectile dysfunction viral load in upper respiratory specimens of infected patients. N Engl J Med 2020;382:1177-1179.Trial Population Table 1.

Table 1. Demographic Characteristics of the Participants in the NVX-CoV2373 Trial at Enrollment. The trial was initiated on May 26, 2020.

134 participants underwent randomization between May 27 and June 6, 2020, including 3 participants who were to serve as backups for sentinel dosing and who immediately withdrew from the trial without being vaccinated (Fig. S1). Of the 131 participants who received injections, 23 received placebo (group A), 25 received 25-μg doses of rerectile dysfunction (group B), 29 received 5-μg doses of rerectile dysfunction plus Matrix-M1, including three sentinels (group C), 28 received 25-μg doses of rerectile dysfunction plus Matrix-M1, including three sentinels (group D), and 26 received a single 25-μg dose of rerectile dysfunction plus Matrix-M1 followed by a single dose of placebo (group E).

All 131 participants received their first vaccination on day 0, and all but 3 received their second vaccination at least 21 days later. Exceptions include 2 in the placebo group (group A) who withdrew consent (unrelated to any adverse event) and 1 in the 25-μg rerectile dysfunction + Matrix-M1 group (group D) who had an unsolicited adverse event (mild cellulitis. See below).

Demographic characteristics of the participants are presented in Table 1. Of note, missing data were infrequent. Safety Outcomes No serious adverse events or adverse events of special interest were reported, and vaccination pause rules were not implemented.

As noted above, one participant did not receive a second vaccination owing to an unsolicited adverse event, mild cellulitis, that was associated with after an intravenous cannula placement to address an unrelated mild adverse event that occurred during the second week of follow-up. Second vaccination was withheld because the participant was still recovering and receiving antibiotics. This participant remains in the trial.

Figure 2. Figure 2. Solicited Local and Systemic Adverse Events.

The percentage of participants in each treatment group (groups A, B, C, D, and E) with adverse events according to the maximum FDA toxicity grade (mild, moderate, or severe) during the 7 days after each vaccination is plotted for solicited local (Panel A) and systemic (Panel B) adverse events. There were no grade 4 (life-threatening) events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed).

Excluded were the three sentinel participants in groups C (5 μg + Matrix-M1, 5 μg + Matrix-M1) and D (25 μg + Matrix-M1, 25 μg + Matrix-M1), who received the trial treatment in an open-label manner (see Table S7 for complete safety data on all participants).Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local. 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively.

Systemic. 91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7). Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise).

Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local. 100%, 100%, 65%, 67%, and 100% of participants, respectively.

Systemic. 86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events.

The most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination.

Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods. Laboratory abnormalities of grade 2 or higher occurred in 13 participants (10%). 9 after the first vaccination and 4 after the second vaccination (Table S8).

Abnormal laboratory values were not associated with any clinical manifestations and showed no worsening with repeat vaccination. Six participants (5%. Five women and one man) had grade 2 or higher transient reductions in hemoglobin from baseline, with no evidence of hemolysis or microcytic anemia and with resolution within 7 to 21 days.

Of the six, two had an absolute hemoglobin value (grade 2) that resolved or stabilized during the testing period. Four participants (3%), including one who had received placebo, had elevated liver enzymes that were noted after the first vaccination and resolved within 7 to 14 days (i.e., before the second vaccination). Vital signs remained stable immediately after vaccination and at all visits.

Unsolicited adverse events (Table S9) were predominantly mild in severity (in 71%, 91%, 83%, 90%, and 82% of participants in groups A, B, C, D, and E, respectively) and were similarly distributed across the groups receiving adjuvanted and unadjuvanted treatment. There were no reports of severe adverse events. Immunogenicity Outcomes Figure 3.

Figure 3. erectile dysfunction Anti-Spike IgG and Neutralizing Antibody Responses. Shown are geometric mean anti-spike IgG enzyme-linked immunosorbent assay (ELISA) unit responses to recombinant severe acute respiratory syndrome erectile dysfunction 2 (rerectile dysfunction) protein antigens (Panel A) and wild-type erectile dysfunction microneutralization assay at an inhibitory concentration greater than 99% (MN IC>99%) titer responses (Panel B) at baseline (day 0), 3 weeks after the first vaccination (day 21), and 2 weeks after the second vaccination (day 35) for the placebo group (group A), the 25-μg unadjuvanted group (group B), the 5-μg and 25-μg adjuvanted groups (groups C and D, respectively), and the 25-μg adjuvanted and placebo group (group E).

Diamonds and whisker endpoints represent geometric mean titer values and 95% confidence intervals, respectively. The erectile dysfunction treatment human convalescent serum panel includes specimens from PCR-confirmed erectile dysfunction treatment participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%), with geometric mean titer values according to erectile dysfunction treatment severity. The severity of erectile dysfunction treatment is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to erectile dysfunction treatment (with samples collected during contact and exposure assessment).

Mean values (in black) for human convalescent serum are depicted next to (and of same color as) the category of erectile dysfunction treatment patients, with the overall mean shown above the scatter plot (in black). For each trial treatment group, the mean at day 35 is depicted above the scatterplot.ELISA anti-spike IgG geometric mean ELISA units (GMEUs) ranged from 105 to 116 at day 0. By day 21, responses had occurred for all adjuvanted regimens (1984, 2626, and 3317 GMEUs for groups C, D, and E, respectively), and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10 (Figure 3 and Table S10).

Within 7 days after the second vaccination with adjuvant (day 28. Groups C and D), GMEUs had further increased by a factor of 8 (to 15,319 and 20,429, respectively) over responses seen with the first vaccination, and within 14 days (day 35), responses had more than doubled yet again (to 63,160 and 47,521, respectively), achieving GMFRs that were approximately 100 times greater than those observed with rerectile dysfunction alone. A single vaccination with adjuvant achieved GMEU levels similar to those in asymptomatic (exposed) patients with erectile dysfunction treatment (1661), and a second vaccination with adjuvant achieved GMEU levels that exceeded those in convalescent serum from symptomatic outpatients with erectile dysfunction treatment (7420) by a factor of at least 6 and rose to levels similar to those in convalescent serum from patients hospitalized with erectile dysfunction treatment (53,391).

The responses in the two-dose 5-μg and 25-μg adjuvanted treatment regimens were similar, a finding that highlights the role of adjuvant dose sparing. Neutralizing antibodies were undetectable before vaccination and had patterns of response similar to those of anti-spike antibodies after vaccination with adjuvant (Figure 3 and Table S11). After the first vaccination (day 21), GMFRs were approximately 5 times greater with adjuvant (5.2, 6.3, and 5.9 for groups C, D, and E, respectively) than without adjuvant (1.1).

By day 35, second vaccinations with adjuvant induced an increase more than 100 times greater (195 and 165 for groups C and D, respectively) than single vaccinations without adjuvant. When compared with convalescent serum, second vaccinations with adjuvant resulted in GMT levels approximately 4 times greater (3906 and 3305 for groups C and D, respectively) than those in symptomatic outpatients with erectile dysfunction treatment (837) and approached the magnitude of levels observed in hospitalized patients with erectile dysfunction treatment (7457). At day 35, ELISA anti-spike IgG GMEUs and neutralizing antibodies induced by the two-dose 5-μg and 25-μg adjuvanted treatment regimens were 4 to 6 times greater than the geometric mean convalescent serum measures (8344 and 983, respectively).

Figure 4. Figure 4. Correlation of Anti-Spike IgG and Neutralizing Antibody Responses.

Shown are scatter plots of 100% wild-type neutralizing antibody responses and anti-spike IgG ELISA unit responses at 3 weeks after the first vaccination (day 21) and 2 weeks after the second vaccination (day 35) for the two-dose 25-μg unadjuvanted treatment (group B. Panel A), the combined two-dose 5-μg and 25-μg adjuvanted treatment (groups C and D, respectively. Panel B), and convalescent serum from patients with erectile dysfunction treatment (Panel C).

In Panel C, the severity of erectile dysfunction treatment is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to erectile dysfunction treatment (with samples collected during contact and exposure assessment).A strong correlation was observed between neutralizing antibody titers and anti-spike IgG GMEUs with adjuvanted treatment at day 35 (correlation, 0.95) (Figure 4), a finding that was not observed with unadjuvanted treatment (correlation, 0.76) but was similar to that of convalescent serum (correlation, 0.96). Two-dose regimens of 5-μg and 25-μg rerectile dysfunction plus Matrix-M1 produced similar magnitudes of response, and every participant had seroconversion according to either assay measurement. Reverse cumulative-distribution curves for day 35 are presented in Figure S2.

Figure 5. Figure 5. Rerectile dysfunction CD4+ T-cell Responses with or without Matrix-M1 Adjuvant.

Frequencies of antigen-specific CD4+ T cells producing T helper 1 (Th1) cytokines interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), and interleukin-2 and for T helper 2 (Th2) cytokines interleukin-5 and interleukin-13 indicated cytokines from four participants each in the placebo (group A), 25-μg unadjuvanted (group B), 5-μg adjuvanted (group C), and 25-μg adjuvanted (group D) groups at baseline (day 0) and 1 week after the second vaccination (day 28) after stimulation with the recombinant spike protein. €œAny 2Th1” indicates CD4+ T cells that can produce two types of Th1 cytokines at the same time. €œAll 3 Th1” indicates CD4+ T cells that produce IFN-γ, TNF-α, and interleukin-2 simultaneously.

€œBoth Th2” indicates CD4+ T cells that can produce Th2 cytokines interleukin-5 and interleukin-13 at the same time.T-cell responses in 16 participants who were randomly selected from groups A through D, 4 participants per group, showed that adjuvanted regimens induced antigen-specific polyfunctional CD4+ T-cell responses that were reflected in IFN-γ, IL-2, and TNF-α production on spike protein stimulation. A strong bias toward this Th1 phenotype was noted. Th2 responses (as measured by IL-5 and IL-13 cytokines) were minimal (Figure 5).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.

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 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. 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 viagra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction treatment caused by erectile dysfunction or a viagra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a viagra 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 erectile dysfunction treatment mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to erectile dysfunction 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 erectile dysfunction treatment viagra. 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 erectile dysfunction treatment viagra, 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction treatment viagra, 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 viagra and epidemic products that “limit the harm such viagra 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 52140erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction treatment caused by erectile dysfunction or a viagra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a viagra 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 erectile dysfunction treatment.

Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction 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 erectile dysfunction treatment caused by erectile dysfunction or a viagra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a viagra 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-P.

Specificity of erectile dysfunction Antibody Discover More Here Assays Both assays measuring pan-Ig antibodies had low numbers viagra price per pill of false positives among samples collected in 2017. There were 0 and 1 false positives for the two assays among 472 samples, results that compared favorably with viagra price per pill those obtained with the single IgM anti-N and IgG anti-N assays (Table S3). Because of the low prevalence of erectile dysfunction in Iceland, we required positive results from both pan-Ig antibody assays for a sample to be considered seropositive (see Supplementary Methods in Supplementary Appendix 1). None of the samples collected in early 2020 group were seropositive, which indicates that the viagra had not spread widely in Iceland before viagra price per pill February 2020.

erectile dysfunction Antibodies among qPCR-Positive Persons Figure 2. Figure 2 viagra price per pill. Antibody Prevalence and Titers among qPCR-Positive Cases as a Function of Time since Diagnosis by qPCR. Shown are the percentages of samples positive for viagra price per pill both pan-Ig antibody assays and the antibody titers.

Red denotes the count or percentage of samples among persons during their hospitalization (249 samples from 48 persons), and blue denotes the count or percentage of samples among persons after they were declared recovered (1853 samples from 1215 persons). Vertical bars denote 95% viagra price per pill confidence intervals. The dashed lines indicated the thresholds for a test to be declared positive. OD denotes viagra price per pill optical density, and RBD receptor binding domain.Table 1.

Table 1. Prevalence of erectile dysfunction Antibodies by Sample Collection as Measured by Two Pan-Ig Antibody Assays viagra price per pill. Twenty-five days after diagnosis by qPCR, more than 90% of samples from recovered persons tested positive with both pan-Ig antibody assays, and the percentage of persons viagra price per pill testing positive remained stable thereafter (Figure 2 and Fig. S2).

Hospitalized persons seroconverted more frequently and quickly after qPCR diagnosis than viagra price per pill did nonhospitalized persons (Figure 2 and Fig. S3). Of 1215 viagra price per pill persons who had recovered (on the basis of results for the most recently obtained sample from persons for whom we had multiple samples), 1107 were seropositive (91.1%. 95% confidence interval [CI], 89.4 to 92.6) (Table 1 and Table S4).

Since some diagnoses may have been made on the basis of false positive qPCR results, we determined that 91.1% represents the lower bound of sensitivity of the combined pan-Ig tests for the detection of erectile dysfunction antibodies among viagra price per pill recovered persons. Table 2. Table 2 viagra price per pill. Results of Repeated Pan-Ig Antibody Tests among Recovered qPCR-Diagnosed Persons.

Among the 487 recovered persons with two or more samples, 19 (4%) had different pan-Ig antibody test results at different time viagra price per pill points (Table 2 and Fig. S4). It is notable that of the 22 persons with an early sample viagra price per pill that tested negative for both pan-Ig antibodies, 19 remained negative at the most recent test date (again, for both antibodies). One person tested positive for both pan-Ig antibodies in the first test and negative for both in the most recent test.

The longitudinal changes in antibody viagra price per pill levels among recovered persons were consistent with the cross-sectional results (Fig. S5). Antibody levels were higher in the last sample than in the first sample when the antibodies were measured with the two pan-Ig assays, slightly lower than in the first sample when measured with IgG anti-N and IgG anti-S1 assays, and substantially lower than in the first sample when measured with IgM anti-N and IgA anti-S1 assays. IgG anti-N, IgM anti-N, IgG anti-S1, and IgA anti-S1 antibody levels were correlated among the qPCR-positive persons (Figs.

S5 and S6 and Table S5). Antibody levels measured with both pan-Ig antibody assays increased over the first 2 months after qPCR diagnosis and remained at a plateau over the next 2 months of the study. IgM anti-N antibody levels increased rapidly soon after diagnosis and then fell rapidly and were generally not detected after 2 months. IgA anti-S1 antibodies decreased 1 month after diagnosis and remained detectable thereafter.

IgG anti-N and anti-S1 antibody levels increased during the first 6 weeks after diagnosis and then decreased slightly. erectile dysfunction in Quarantine Table 3. Table 3. erectile dysfunction among Quarantined Persons According to Exposure Type and Presence of Symptoms.

Of the 1797 qPCR-positive Icelanders, 1088 (61%) were in quarantine when erectile dysfunction was diagnosed by qPCR. We tested for antibodies among 4222 quarantined persons who had not tested qPCR-positive (they had received a negative result by qPCR or had simply not been tested). Of those 4222 quarantined persons, 97 (2.3%. 95% CI, 1.9 to 2.8) were seropositive (Table 1).

Those with household exposure were 5.2 (95% CI, 3.3 to 8.0) times more likely to be seropositive than those with other types of exposure (Table 3). Similarly, a positive result by qPCR for those with household exposure was 5.2 (95% CI, 4.5 to 6.1) times more likely than for those with other types of exposure. When these two sets of results (qPCR-positive and seropositive) were combined, we calculated that 26.6% of quarantined persons with household exposure and 5.0% of quarantined persons without household exposure were infected. Those who had symptoms during quarantine were 3.2 (95% CI, 1.7 to 6.2) times more likely to be seropositive and 18.2 times (95% CI, 14.8 to 22.4) more likely to test positive with qPCR than those without symptoms.

We also tested persons in two regions of Iceland affected by cluster outbreaks. In a erectile dysfunction cluster in Vestfirdir, 1.4% of residents were qPCR-positive and 10% of residents were quarantined. We found that none of the 326 persons outside quarantine who had not been tested by qPCR (or who tested negative) were seropositive. In a cluster in Vestmannaeyjar, 2.3% of residents were qPCR-positive and 13% of residents were quarantined.

Of the 447 quarantined persons who had not received a qPCR-positive result, 4 were seropositive (0.9%. 95% CI, 0.3 to 2.1). Of the 663 outside quarantine in Vestmannaeyjar, 3 were seropositive (0.5%. 95% CI, 0.1 to 0.2%).

erectile dysfunction Seroprevalence in Iceland None of the serum samples collected from 470 healthy Icelanders between February 18 and March 9, 2020, tested positive for both pan-Ig antibodies, although four were positive for the pan-Ig anti-N assay (0.9%), a finding that suggests that the viagra had not spread widely in Iceland before March 9. Of the 18,609 persons tested for erectile dysfunction antibodies through contact with the Icelandic health care system for reasons other than erectile dysfunction treatment, 39 were positive for both pan-Ig antibody assays (estimated seroprevalence by weighting the sample on the basis of residence, sex, and 10-year age category, 0.3%. 95% CI, 0.2 to 0.4). There were regional differences in the percentages of qPCR-positive persons across Iceland that were roughly proportional to the percentage of people quarantined (Table S6).

However, after exclusion of the qPCR-positive and quarantined persons, the percentage of persons who tested positive for erectile dysfunction antibodies did not correlate with the percentage of those who tested positive by qPCR. The estimated seroprevalence in the random sample collection from Reykjavik (0.4%. 95% CI, 0.3 to 0.6) was similar to that in the Health Care group (0.3%. 95% CI, 0.2 to 0.4) (Table S6).

We calculate that 0.5% of the residents of Iceland have tested positive with qPCR. The 2.3% with erectile dysfunction seroconversion among persons in quarantine extrapolates to 0.1% of Icelandic residents. On the basis of this finding and the seroprevalence from the Health Care group, we estimate that 0.9% (95% CI, 0.8 to 0.9) of the population of Iceland has been infected by erectile dysfunction. Approximately 56% of all erectile dysfunction s were therefore diagnosed by qPCR, 14% occurred in quarantine without having been diagnosed with qPCR, and the remaining 30% of s occurred outside quarantine and were not detected by qPCR.

Deaths from erectile dysfunction treatment in Iceland In Iceland, 10 deaths have been attributed to erectile dysfunction treatment, which corresponds to 3 deaths per 100,000 nationwide. Among the qPCR-positive cases, 0.6% (95% CI, 0.3 to 1.0) were fatal. Using the 0.9% prevalence of erectile dysfunction in Iceland as the denominator, however, we calculate an fatality risk of 0.3% (95% CI, 0.2 to 0.6). Stratified by age, the fatality risk was substantially lower in those 70 years old or younger (0.1%.

95% CI, 0.0 to 0.3) than in those over 70 years of age (4.4%. 95% CI, 1.9 to 8.4) (Table S7). Age, Sex, Clinical Characteristics, and Antibody Levels Table 4. Table 4.

Association of Existing Conditions and erectile dysfunction treatment Severity with erectile dysfunction Antibody Levels among Recovered Persons. erectile dysfunction antibody levels were higher in older people and in those who were hospitalized (Table 4, and Table S8 [described in Supplementary Appendix 1 and available in Supplementary Appendix 2]). Pan-Ig anti–S1-RBD and IgA anti-S1 levels were lower in female persons. Of the preexisting conditions, and after adjustment for multiple testing, we found that body-mass index, smoking status, and use of antiinflammatory medication were associated with erectile dysfunction antibody levels.

Body-mass index correlated positively with antibody levels. Smokers and users of antiinflammatory medication had lower antibody levels. With respect to clinical characteristics, antibody levels were most strongly associated with hospitalization and clinical severity, followed by clinical symptoms such as fever, maximum temperature reading, cough, and loss of appetite. Severity of these individual symptoms, with the exception of loss of energy, was associated with higher antibody levels.To the Editor.

Rapid and accurate diagnostic tests are essential for controlling the ongoing erectile dysfunction treatment viagra. Although the current standard involves testing of nasopharyngeal swab specimens by quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) to detect erectile dysfunction, saliva specimens may be an alternative diagnostic sample.1-4 Rigorous evaluation is needed to determine how saliva specimens compare with nasopharyngeal swab specimens with respect to sensitivity in detection of erectile dysfunction during the course of . A total of 70 inpatients with erectile dysfunction treatment provided written informed consent to participate in our study (see the Methods section in Supplementary Appendix 1, available with the full text of this letter at NEJM.org). After erectile dysfunction treatment was confirmed with a positive nasopharyngeal swab specimen at hospital admission, we obtained additional samples from the patients during hospitalization.

We tested saliva specimens collected by the patients themselves and nasopharyngeal swabs collected from the patients at the same time point by health care workers. Figure 1. Figure 1. erectile dysfunction RNA Titers in Saliva Specimens and Nasopharyngeal Swab Specimens.

Samples were obtained from 70 hospital inpatients who had a diagnosis of erectile dysfunction treatment. Panel A shows erectile dysfunction RNA titers in the first available nasopharyngeal and saliva samples. The lines indicate samples from the same patient. Results were compared with the use of a Wilcoxon signed-rank test (P<0.001).

Panel B shows percentages of positivity for erectile dysfunction in tests of the first matched nasopharyngeal and saliva samples at 1 to 5 days, 6 to 10 days, and 11 or more days (maximum, 53 days) after the diagnosis of erectile dysfunction treatment. Panel C shows longitudinal erectile dysfunction RNA copies per milliliter in 97 saliva samples, according to days since symptom onset. Each circle represents a separate sample. Dashed lines indicate additional samples from the same patient.

The red line indicates a negative saliva sample that was followed by a positive sample at the next collection of a specimen. Panel D shows longitudinal erectile dysfunction RNA copies per milliliter in 97 nasopharyngeal swab specimens, according to days since symptom onset. The red lines indicate negative nasopharyngeal swab specimens there were followed by a positive swab at the next collection of a specimen. The gray area in Panels C and D indicates samples that were below the lower limit of detection of 5610 viagra RNA copies per milliliter of sample, which is at cycle threshold 38 of our quantitative reverse-transcriptase polymerase chain reaction assay targeting the erectile dysfunction N1 sequence recommended by the Centers for Disease Control and Prevention.

To analyze these data, we used a linear mixed-effects regression model (see Supplementary Appendix 1) that accounts for the correlation between samples collected from the same person at a single time point (i.e., multivariate response) and the correlation between samples collected across time from the same patient (i.e., repeated measures). All the data used to generate this figure, including the raw cycle thresholds, are provided in Supplementary Data 1 in Supplementary Appendix 2.Using primer sequences from the Centers for Disease Control and Prevention, we detected more erectile dysfunction RNA copies in the saliva specimens (mean log copies per milliliter, 5.58. 95% confidence interval [CI], 5.09 to 6.07) than in the nasopharyngeal swab specimens (mean log copies per milliliter, 4.93. 95% CI, 4.53 to 5.33) (Figure 1A, and Fig.

S1 in Supplementary Appendix 1). In addition, a higher percentage of saliva samples than nasopharyngeal swab samples were positive up to 10 days after the erectile dysfunction treatment diagnosis (Figure 1B). At 1 to 5 days after diagnosis, 81% (95% CI, 71 to 96) of the saliva samples were positive, as compared with 71% (95% CI, 67 to 94) of the nasopharyngeal swab specimens. These findings suggest that saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of erectile dysfunction during the course of hospitalization.

Because the results of testing of nasopharyngeal swab specimens to detect erectile dysfunction may vary with repeated sampling in individual patients,5 we evaluated viral detection in matched samples over time. The level of erectile dysfunction RNA decreased after symptom onset in both saliva specimens (estimated slope, −0.11. 95% credible interval, −0.15 to −0.06) (Figure 1C) and nasopharyngeal swab specimens (estimated slope, −0.09. 95% credible interval, −0.13 to −0.05) (Figure 1D).

In three instances, a negative nasopharyngeal swab specimen was followed by a positive swab at the next collection of a specimen (Figure 1D). This phenomenon occurred only once with the saliva specimens (Figure 1C). During the clinical course, we observed less variation in levels of erectile dysfunction RNA in the saliva specimens (standard deviation, 0.98 viagra RNA copies per milliliter. 95% credible interval, 0.08 to 1.98) than in the nasopharyngeal swab specimens (standard deviation, 2.01 viagra RNA copies per milliliter.

95% credible interval, 1.29 to 2.70) (see Supplementary Appendix 1). Recent studies have shown that erectile dysfunction can be detected in the saliva of asymptomatic persons and outpatients.1-3 We therefore screened 495 asymptomatic health care workers who provided written informed consent to participate in our prospective study, and we used RT-qPCR to test both saliva and nasopharyngeal samples obtained from these persons. We detected erectile dysfunction RNA in saliva specimens obtained from 13 persons who did not report any symptoms at or before the time of sample collection. Of these 13 health care workers, 9 had collected matched nasopharyngeal swab specimens by themselves on the same day, and 7 of these specimens tested negative (Fig.

S2). The diagnosis in the 13 health care workers with positive saliva specimens was later confirmed in diagnostic testing of additional nasopharyngeal samples by a CLIA (Clinical Laboratory Improvement Amendments of 1988)–certified laboratory. Variation in nasopharyngeal sampling may be an explanation for false negative results, so monitoring an internal control for proper sample collection may provide an alternative evaluation technique. In specimens collected from inpatients by health care workers, we found greater variation in human RNase P cycle threshold (Ct) values in nasopharyngeal swab specimens (standard deviation, 2.89 Ct.

95% CI, 26.53 to 27.69) than in saliva specimens (standard deviation, 2.49 Ct. 95% CI, 23.35 to 24.35). When health care workers collected their own specimens, we also found greater variation in RNase P Ct values in nasopharyngeal swab specimens (standard deviation, 2.26 Ct. 95% CI, 28.39 to 28.56) than in saliva specimens (standard deviation , 1.65 Ct.

95% CI, 24.14 to 24.26) (Fig. S3). Collection of saliva samples by patients themselves negates the need for direct interaction between health care workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial .

Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of erectile dysfunction . Anne L. Wyllie, Ph.D.Yale School of Public Health, New Haven, CT [email protected]John Fournier, M.D.Yale School of Medicine, New Haven, CTArnau Casanovas-Massana, Ph.D.Yale School of Public Health, New Haven, CTMelissa Campbell, M.D.Maria Tokuyama, Ph.D.Pavithra Vijayakumar, B.A.Yale School of Medicine, New Haven, CTJoshua L.

Warren, Ph.D.Yale School of Public Health, New Haven, CTBertie Geng, M.D.Yale School of Medicine, New Haven, CTM. Catherine Muenker, M.S.Adam J. Moore, M.P.H.Chantal B.F. Vogels, Ph.D.Mary E.

Petrone, B.S.Isabel M. Ott, B.S.Yale School of Public Health, New Haven, CTPeiwen Lu, Ph.D.Arvind Venkataraman, B.S.Alice Lu-Culligan, B.S.Jonathan Klein, B.S.Yale School of Medicine, New Haven, CTRebecca Earnest, M.P.H.Yale School of Public Health, New Haven, CTMichael Simonov, M.D.Rupak Datta, M.D., Ph.D.Ryan Handoko, M.D.Nida Naushad, B.S.Lorenzo R. Sewanan, M.Phil.Jordan Valdez, B.S.Yale School of Medicine, New Haven, CTElizabeth B. White, A.B.Sarah Lapidus, M.S.Chaney C.

Kalinich, M.P.H.Yale School of Public Health, New Haven, CTXiaodong Jiang, M.D., Ph.D.Daniel J. Kim, A.B.Eriko Kudo, Ph.D.Melissa Linehan, M.S.Tianyang Mao, B.S.Miyu Moriyama, Ph.D.Ji E. Oh, M.D., Ph.D.Annsea Park, B.A.Julio Silva, B.S.Eric Song, M.S.Takehiro Takahashi, M.D., Ph.D.Manabu Taura, Ph.D.Orr-El Weizman, B.A.Patrick Wong, M.S.Yexin Yang, B.S.Santos Bermejo, B.S.Yale School of Medicine, New Haven, CTCamila D. Odio, M.D.Yale New Haven Health, New Haven, CTSaad B.

Omer, M.B., B.S., Ph.D.Yale Institute for Global Health, New Haven, CTCharles S. Dela Cruz, M.D., Ph.D.Shelli Farhadian, M.D., Ph.D.Richard A. Martinello, M.D.Akiko Iwasaki, Ph.D.Yale School of Medicine, New Haven, CTNathan D. Grubaugh, Ph.D.Albert I.

Ko, M.D.Yale School of Public Health, New Haven, CT [email protected], [email protected] Supported by the Huffman Family Donor Advised Fund, a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University, the Yale Institute for Global Health, the Yale School of Medicine, a grant (U19 AI08992, to Dr. Ko) from the National Institute of Allergy and Infectious Diseases, the Beatrice Kleinberg Neuwirth Fund, and a grant (Rubicon 019.181EN.004, to Dr. Vogel) from the Dutch Research Council (NWO). Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.

This letter was published on August 28, 2020, at NEJM.org. Drs. Grubaugh and Ko contributed equally to this letter. 5 References1.

Kojima N, Turner F, Slepnev V, et al. Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for erectile dysfunction treatment detection. April 15, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.11.20062372v1). Preprint.Google Scholar2.

Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a non-invasive specimen for detection of erectile dysfunction. J Clin Microbiol 2020;58(8):e00776-20-e00776-20.3. Pasomsub E, Watcharananan SP, Boonyawat K, et al.

Saliva sample as a non-invasive specimen for the diagnosis of erectile dysfunction disease 2019. A cross-sectional study. Clin Microbiol Infect 2020 May 15 (Epub ahead of print).4. Vogels CBF, Brackney D, Wang J, et al.

SalivaDirect. Simple and sensitive molecular diagnostic test for erectile dysfunction surveillance. August 4, 2020 (https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1). Preprint.Google Scholar5.

Zou L, Ruan F, Huang M, et al. erectile dysfunction viral load in upper respiratory specimens of infected patients. N Engl J Med 2020;382:1177-1179.Trial Population Table 1. Table 1.

Demographic Characteristics of the Participants in the NVX-CoV2373 Trial at Enrollment. The trial was initiated on May 26, 2020. 134 participants underwent randomization between May 27 and June 6, 2020, including 3 participants who were to serve as backups for sentinel dosing and who immediately withdrew from the trial without being vaccinated (Fig. S1).

Of the 131 participants who received injections, 23 received placebo (group A), 25 received 25-μg doses of rerectile dysfunction (group B), 29 received 5-μg doses of rerectile dysfunction plus Matrix-M1, including three sentinels (group C), 28 received 25-μg doses of rerectile dysfunction plus Matrix-M1, including three sentinels (group D), and 26 received a single 25-μg dose of rerectile dysfunction plus Matrix-M1 followed by a single dose of placebo (group E). All 131 participants received their first vaccination on day 0, and all but 3 received their second vaccination at least 21 days later. Exceptions include 2 in the placebo group (group A) who withdrew consent (unrelated to any adverse event) and 1 in the 25-μg rerectile dysfunction + Matrix-M1 group (group D) who had an unsolicited adverse event (mild cellulitis. See below).

Demographic characteristics of the participants are presented in Table 1. Of note, missing data were infrequent. Safety Outcomes No serious adverse events or adverse events of special interest were reported, and vaccination pause rules were not implemented. As noted above, one participant did not receive a second vaccination owing to an unsolicited adverse event, mild cellulitis, that was associated with after an intravenous cannula placement to address an unrelated mild adverse event that occurred during the second week of follow-up.

Second vaccination was withheld because the participant was still recovering and receiving antibiotics. This participant remains in the trial. Figure 2. Figure 2.

Solicited Local and Systemic Adverse Events. The percentage of participants in each treatment group (groups A, B, C, D, and E) with adverse events according to the maximum FDA toxicity grade (mild, moderate, or severe) during the 7 days after each vaccination is plotted for solicited local (Panel A) and systemic (Panel B) adverse events. There were no grade 4 (life-threatening) events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed).

Excluded were the three sentinel participants in groups C (5 μg + Matrix-M1, 5 μg + Matrix-M1) and D (25 μg + Matrix-M1, 25 μg + Matrix-M1), who received the trial treatment in an open-label manner (see Table S7 for complete safety data on all participants).Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local. 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively. Systemic.

91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7). Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise). Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local.

100%, 100%, 65%, 67%, and 100% of participants, respectively. Systemic. 86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events.

The most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination. Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods.

Laboratory abnormalities of grade 2 or higher occurred in 13 participants (10%). 9 after the first vaccination and 4 after the second vaccination (Table S8). Abnormal laboratory values were not associated with any clinical manifestations and showed no worsening with repeat vaccination. Six participants (5%.

Five women and one man) had grade 2 or higher transient reductions in hemoglobin from baseline, with no evidence of hemolysis or microcytic anemia and with resolution within 7 to 21 days. Of the six, two had an absolute hemoglobin value (grade 2) that resolved or stabilized during the testing period. Four participants (3%), including one who had received placebo, had elevated liver enzymes that were noted after the first vaccination and resolved within 7 to 14 days (i.e., before the second vaccination). Vital signs remained stable immediately after vaccination and at all visits.

Unsolicited adverse events (Table S9) were predominantly mild in severity (in 71%, 91%, 83%, 90%, and 82% of participants in groups A, B, C, D, and E, respectively) and were similarly distributed across the groups receiving adjuvanted and unadjuvanted treatment. There were no reports of severe adverse events. Immunogenicity Outcomes Figure 3. Figure 3.

erectile dysfunction Anti-Spike IgG and Neutralizing Antibody Responses. Shown are geometric mean anti-spike IgG enzyme-linked immunosorbent assay (ELISA) unit responses to recombinant severe acute respiratory syndrome erectile dysfunction 2 (rerectile dysfunction) protein antigens (Panel A) and wild-type erectile dysfunction microneutralization assay at an inhibitory concentration greater than 99% (MN IC>99%) titer responses (Panel B) at baseline (day 0), 3 weeks after the first vaccination (day 21), and 2 weeks after the second vaccination (day 35) for the placebo group (group A), the 25-μg unadjuvanted group (group B), the 5-μg and 25-μg adjuvanted groups (groups C and D, respectively), and the 25-μg adjuvanted and placebo group (group E). Diamonds and whisker endpoints represent geometric mean titer values and 95% confidence intervals, respectively. The erectile dysfunction treatment human convalescent serum panel includes specimens from PCR-confirmed erectile dysfunction treatment participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%), with geometric mean titer values according to erectile dysfunction treatment severity.

The severity of erectile dysfunction treatment is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to erectile dysfunction treatment (with samples collected during contact and exposure assessment). Mean values (in black) for human convalescent serum are depicted next to (and of same color as) the category of erectile dysfunction treatment patients, with the overall mean shown above the scatter plot (in black). For each trial treatment group, the mean at day 35 is depicted above the scatterplot.ELISA anti-spike IgG geometric mean ELISA units (GMEUs) ranged from 105 to 116 at day 0. By day 21, responses had occurred for all adjuvanted regimens (1984, 2626, and 3317 GMEUs for groups C, D, and E, respectively), and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10 (Figure 3 and Table S10).

Within 7 days after the second vaccination with adjuvant (day 28. Groups C and D), GMEUs had further increased by a factor of 8 (to 15,319 and 20,429, respectively) over responses seen with the first vaccination, and within 14 days (day 35), responses had more than doubled yet again (to 63,160 and 47,521, respectively), achieving GMFRs that were approximately 100 times greater than those observed with rerectile dysfunction alone. A single vaccination with adjuvant achieved GMEU levels similar to those in asymptomatic (exposed) patients with erectile dysfunction treatment (1661), and a second vaccination with adjuvant achieved GMEU levels that exceeded those in convalescent serum from symptomatic outpatients with erectile dysfunction treatment (7420) by a factor of at least 6 and rose to levels similar to those in convalescent serum from patients hospitalized with erectile dysfunction treatment (53,391). The responses in the two-dose 5-μg and 25-μg adjuvanted treatment regimens were similar, a finding that highlights the role of adjuvant dose sparing.

Neutralizing antibodies were undetectable before vaccination and had patterns of response similar to those of anti-spike antibodies after vaccination with adjuvant (Figure 3 and Table S11). After the first vaccination (day 21), GMFRs were approximately 5 times greater with adjuvant (5.2, 6.3, and 5.9 for groups C, D, and E, respectively) than without adjuvant (1.1). By day 35, second vaccinations with adjuvant induced an increase more than 100 times greater (195 and 165 for groups C and D, respectively) than single vaccinations without adjuvant. When compared with convalescent serum, second vaccinations with adjuvant resulted in GMT levels approximately 4 times greater (3906 and 3305 for groups C and D, respectively) than those in symptomatic outpatients with erectile dysfunction treatment (837) and approached the magnitude of levels observed in hospitalized patients with erectile dysfunction treatment (7457).

At day 35, ELISA anti-spike IgG GMEUs and neutralizing antibodies induced by the two-dose 5-μg and 25-μg adjuvanted treatment regimens were 4 to 6 times greater than the geometric mean convalescent serum measures (8344 and 983, respectively). Figure 4. Figure 4. Correlation of Anti-Spike IgG and Neutralizing Antibody Responses.

Shown are scatter plots of 100% wild-type neutralizing antibody responses and anti-spike IgG ELISA unit responses at 3 weeks after the first vaccination (day 21) and 2 weeks after the second vaccination (day 35) for the two-dose 25-μg unadjuvanted treatment (group B. Panel A), the combined two-dose 5-μg and 25-μg adjuvanted treatment (groups C and D, respectively. Panel B), and convalescent serum from patients with erectile dysfunction treatment (Panel C). In Panel C, the severity of erectile dysfunction treatment is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to erectile dysfunction treatment (with samples collected during contact and exposure assessment).A strong correlation was observed between neutralizing antibody titers and anti-spike IgG GMEUs with adjuvanted treatment at day 35 (correlation, 0.95) (Figure 4), a finding that was not observed with unadjuvanted treatment (correlation, 0.76) but was similar to that of convalescent serum (correlation, 0.96).

Two-dose regimens of 5-μg and 25-μg rerectile dysfunction plus Matrix-M1 produced similar magnitudes of response, and every participant had seroconversion according to either assay measurement. Reverse cumulative-distribution curves for day 35 are presented in Figure S2. Figure 5. Figure 5.

Rerectile dysfunction CD4+ T-cell Responses with or without Matrix-M1 Adjuvant. Frequencies of antigen-specific CD4+ T cells producing T helper 1 (Th1) cytokines interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), and interleukin-2 and for T helper 2 (Th2) cytokines interleukin-5 and interleukin-13 indicated cytokines from four participants each in the placebo (group A), 25-μg unadjuvanted (group B), 5-μg adjuvanted (group C), and 25-μg adjuvanted (group D) groups at baseline (day 0) and 1 week after the second vaccination (day 28) after stimulation with the recombinant spike protein. €œAny 2Th1” indicates CD4+ T cells that can produce two types of Th1 cytokines at the same time. €œAll 3 Th1” indicates CD4+ T cells that produce IFN-γ, TNF-α, and interleukin-2 simultaneously.

€œBoth Th2” indicates CD4+ T cells that can produce Th2 cytokines interleukin-5 and interleukin-13 at the same time.T-cell responses in 16 participants who were randomly selected from groups A through D, 4 participants per group, showed that adjuvanted regimens induced antigen-specific polyfunctional CD4+ T-cell responses that were reflected in IFN-γ, IL-2, and TNF-α production on spike protein stimulation. A strong bias toward this Th1 phenotype was noted. Th2 responses (as measured by IL-5 and IL-13 cytokines) were minimal (Figure 5).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. 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 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. 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 viagra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction treatment caused by erectile dysfunction or a viagra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a viagra 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 erectile dysfunction treatment mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to erectile dysfunction 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 erectile dysfunction treatment viagra. 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 erectile dysfunction treatment viagra, 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction treatment viagra, 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 viagra and epidemic products that “limit the harm such viagra 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 52140erectile dysfunction 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 erectile dysfunction 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 erectile dysfunction treatment caused by erectile dysfunction or a viagra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a viagra 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 erectile dysfunction treatment. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction 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 erectile dysfunction treatment caused by erectile dysfunction or a viagra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a viagra 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-P.

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