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€‚For the podcast associated with this article, please visit 100mg viagra pill https://academic.oup.com/eurheartj/pages/Podcasts.This issue begins with the female viagra for sale Special Article ‘An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology &. Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group’ by Vijay Kunadian from Newcastle University in the UK, and colleagues.1 While for many years our attention has been focused on coronary stenoses, growing evidence suggests that functional alterations of the coronary circulation play an important role in all clinical manifestations of ischaemic heart disease.2,3 The current contribution is an expert consensus document on ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects female viagra for sale ∼112 million people globally.

Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac, leading to underdiagnosis/investigation female viagra for sale and undertreatment. INOCA can result from several mechanism including coronary vasospasm and microvascular dysfunction, and is not a benign condition.

Compared with asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased healthcare costs. This document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice, noting gaps in knowledge and potential areas for investigation.This issue then continues with female viagra for sale a focus on acute coronary syndromes (ACS) which represent the most dramatic presentation of ischaemic heart disease. The abrupt clinical presentation of ACS gives a strong signal of discontinuity in the natural history of atherothrombosis.4,5 While experimental models of atherogenesis have provided a growing body of information about molecular mechanisms of plaque growth, the transition from coronary stability to instability is less well understood.

This issue female viagra for sale provides novel important information in this fascinating area of cardiovascular medicine.6In a clinical research manuscript entitled ‘Long-term beta-blocker therapy and clinical outcomes after acute myocardial infarction in patients without heart failure. Nationwide cohort study’, Jihoon Kim from the University School of Medicine in Seoul, South Korea and colleagues investigate the association between long-term beta-blocker therapy and clinical outcomes in patients without heart failure (HF) after acute myocardial infarction (MI).7 Between 2010 and 2015, a total of 28 970 patients who underwent coronary revascularization for acute MI with beta-blocker prescription at hospital discharge, and were event-free from death, recurrent MI, or HF for 1 year were enrolled from Korean nationwide medical insurance data. The primary outcome was all-cause death.

The secondary female viagra for sale outcome was a composite of all-cause death, recurrent MI, or hospitalization for new HF. Outcomes were compared between beta-blocker therapy for ≥1 year (n = 22707) and beta-blocker therapy for <1 year (n = 6263) using landmark analysis at 1 year after the index MI. Compared with patients receiving beta-blocker therapy for <1 year, those receiving beta-blocker therapy for ≥1 year had a significant 19% lower risk of all-cause death and a significant 18% lower risk of the female viagra for sale composite of all-cause death, recurrent MI, or hospitalization for new HF.

The lower risk of all-cause death associated with persistent beta-blocker therapy was observed beyond 2 years but not beyond 3 years after MI (Figure 1). Figure 1Cumulative incidences of clinical outcomes since 1 year after myocardial infarction. (A) All-cause death, (B) recurrent MI, (C) hospitalization for new heart failure, and (D) a composite of all-cause death, recurrent MI, or hospitalization for female viagra for sale new heart failure.

MI, myocardial infarction (from Kim J, Kang D, Park H, Kang M, Park TK, Lee JM, Yang JH, Song JB, Choi J-H, Choi S-H, Gwon H-C, Guallar E, Cho J, Hahn J-Y. Long-term β-blocker therapy and clinical outcomes after acute myocardial female viagra for sale infarction in patients without heart failure. Nationwide cohort study.

See pages 3521–3529).Figure 1Cumulative incidences of clinical outcomes since 1 year after myocardial infarction. (A) All-cause death, (B) recurrent MI, (C) hospitalization for new heart failure, female viagra for sale and (D) a composite of all-cause death, recurrent MI, or hospitalization for new heart failure. MI, myocardial infarction (from Kim J, Kang D, Park H, Kang M, Park TK, Lee JM, Yang JH, Song JB, Choi J-H, Choi S-H, Gwon H-C, Guallar E, Cho J, Hahn J-Y.

Long-term β-blocker therapy and clinical outcomes after acute myocardial infarction female viagra for sale in patients without heart failure. Nationwide cohort study. See pages 3521–3529).The authors conclude that in this nationwide cohort, beta-blocker therapy for ≥1 year after MI was associated with reduced all-cause death among patients with acute MI without HF.

The manuscript is accompanied by an Editorial by Rafael Harari and Sripal Bangalore female viagra for sale from the New York University School of Medicine in the USA, who conclude that a drug that has been widely used clinically for over half a century is now in urgent need of reappraisal from contemporary trials.8In a clinical research article entitled ‘Ticagrelor alone versus ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes. TWILIGHT-ACS’, Roxana Mehran from Mount Sinai School of Medicine in New York, USA and colleagues determined the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).9 The authors conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo female viagra for sale vs.

Ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, while the composite of all-cause death, MI, or stroke was the key secondary outcome. Ticagrelor monotherapy significantly reduced BARC 2, 3, or 5 female viagra for sale bleeding by a significant 54% among NSTE-ACS patients and by a non-significant 24% among stable patients (P for interaction 0.03).

Rates of all-cause death, MI, or stroke were similar between treatment arms irrespective of clinical presentation.Mehran et al. Conclude that among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing female viagra for sale ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS.

This manuscript is accompanied by an Editorial by Robert Storey from the University of Sheffield in the UK10 who wonders if one should switch from ticagrelor monotherapy to aspirin monotherapy at 12 months or continue ticagrelor monotherapy long term, and suggests that that part of the journey remains largely unexplored. Figure 2In total, 150 patients female viagra for sale were included into the prospective translational OPTICO-ACS study (A) and the culprit lesions were characterized by OCT as well as by local and systematic immunophenotyping. Culprit lesion assessment revealed differential immunological signature with an enrichment in T-lymphocytes, both CD4+ and CD8+ T-cell subpopulations (B) as well as increased T-cell effector molecules at the culprit site distinguishing acute coronary syndromes with intact fibrous cap from ruptured fibrous cap-acute coronary syndrome.

Since acute coronary syndromes with intact fibrous cap-lesion were often located at bifurcations, endothelial cells were subjected to culture in disturbed laminar flow female viagra for sale conditions (C), i.e. To simulate coronary flow near a bifurcation, demonstrated an enhanced adhesion of CD8+ T cells. Finally, both CD8+ T cells and their cytotoxic effector molecules caused endothelial cell death, a key pathophysiological mechanism in acute coronary syndromes with intact fibrous cap (from Leistner DM, Kränkel N, Meteva D, Abdelwahed YS, Seppelt C, Stähli BE, Rai H, Skurk C, Lauten A, Mochmann H-C, Fröhlich G, Rauch-Kröhnert U, Flores E, Riedel M, Sieronski L, Kia S, Strässler E, Haghikia A, Dirks F, Steiner JK, Mueller DN, Volk H-D, Klotsche J, Joner M, Libby P, Landmesser U.

Differential immunological signature at the culprit site distinguishes acute coronary syndrome with intact from acute coronary syndrome with female viagra for sale ruptured fibrous cap. Results from the prospective translational OPTICO-ACS study. See pages 3549–3560).Figure 2In total, 150 patients were included into the prospective translational OPTICO-ACS study (A) and the culprit lesions were characterized by OCT as well as by local female viagra for sale and systematic immunophenotyping.

Culprit lesion assessment revealed differential immunological signature with an enrichment in T-lymphocytes, both CD4+ and CD8+ T-cell subpopulations (B) as well as increased T-cell effector molecules at the culprit site distinguishing acute coronary syndromes with intact fibrous cap from ruptured fibrous cap-acute coronary syndrome. Since acute coronary syndromes with intact fibrous cap-lesion were often located at female viagra for sale bifurcations, endothelial cells were subjected to culture in disturbed laminar flow conditions (C), i.e. To simulate coronary flow near a bifurcation, demonstrated an enhanced adhesion of CD8+ T cells.

Finally, both CD8+ T cells and their cytotoxic effector molecules caused endothelial cell death, a key pathophysiological mechanism in acute coronary syndromes with intact fibrous cap (from Leistner DM, Kränkel N, Meteva D, Abdelwahed YS, Seppelt C, Stähli BE, Rai H, Skurk C, Lauten A, Mochmann H-C, Fröhlich G, Rauch-Kröhnert U, Flores E, Riedel M, Sieronski L, Kia S, Strässler E, Haghikia A, Dirks F, Steiner JK, Mueller DN, Volk H-D, Klotsche J, Joner M, Libby P, Landmesser U. Differential immunological female viagra for sale signature at the culprit site distinguishes acute coronary syndrome with intact from acute coronary syndrome with ruptured fibrous cap. Results from the prospective translational OPTICO-ACS study.

See pages 3549–3560).ACS with an intact fibrous cap (IFC), female viagra for sale i.e. Caused by coronary plaque erosion, account for approximately one-third of ACS cases. However, the underlying pathophysiological mechanisms as compared with ACS caused by a ruptured fibrous cap (RFC) remain largely undefined.11–14 In a clinical research article entitled ‘Differential immunological signature at the culprit site distinguishes acute coronary syndrome with intact from acute coronary syndrome with ruptured fibrous cap.

Results from the prospective translational OPTICO-ACS study’, David Leistner from female viagra for sale the Charite Universitatsmedizin Berlin in Germany and colleagues compared the microenvironment of culprit lesions (CLs) with IFC vs. Those with RFC.15 The CL of 170 consecutive ACS patients was investigated by optical coherence tomography (OCT) and simultaneous immunophenotyping by flow cytometric analysis as well as by effector molecule concentration measurements across the CL. Within the study cohort, IFC CLs caused 25% of female viagra for sale ACS while RFC CLs caused the remaining 75%, as determined and validated by two independent OCT core laboratories.

IFC CLs were characterized by lower lipid content, less calcification, a thicker overlying fibrous cap, and largely localized near a coronary bifurcation as compared with RFC CLs. The microenvironment of IFC CLs demonstrated selective enrichment in both CD4+ and CD8+ T lymphocytes as compared with RFC CLs. T cell-associated extracellular circulating microvesicles were more pronounced in IFC CLs, and a significantly higher amount of CD8+ T lymphocytes was detectable in female viagra for sale thrombi aspirated from IFC CLs as compared with RFC CLs.

Furthermore, IFC CLs showed significantly increased levels of the T-cell effector molecules granzyme A (+22%), perforin (+59%), and granulysin (+75%) as compared with RFC CLs. Endothelial cells subjected to culture in disturbed laminar flow conditions female viagra for sale to simulate coronary flow near a bifurcation demonstrated an enhanced adhesion of CD8+ T cells. Finally, both CD8+ T cells and their cytotoxic effector molecules caused endothelial cell death, a key potential pathophysiological mechanism in IFC CLs.Thus, the OPTICO-ACS study emphasizes a novel mechanism in the pathogenesis of IFC CLs, favouring participation of the adaptive immune system, particularly CD8+ T cells and their effector molecules.

The manuscript is accompanied by an Editorial by Giovanna Liuzzo and colleagues (myself included) from the Catholic University16 who conclude that we are learning a lot about plaque erosion but we should not forget the words of Winston Churchill. €˜Now this female viagra for sale is not the end. It is not even the beginning of the end.

But it is, perhaps, the end of the beginning.’Balance between inflammatory and reparative leucocytes allows optimal healing after MI.17 In a clinical research article ‘Molecular imaging-guided repair after acute myocardial infarction by targeting the chemokine receptor CXCR4’, Annika Hess from the Hannover Medical School in female viagra for sale Germany and colleagues aimed to characterize infarct chemokine CXC receptor 4 (CXCR4) expression using positron emission tomography (PET) and establish its relationship to cardiac outcome. The authors tested whether image-guided early CXCR4-directed therapy attenuates chronic dysfunction.18 A total of 180 mice underwent coronary ligation or sham surgery and serial PET imaging over 7 days. Infarct CXCR4 content was significantly higher over 3 days after MI compared with sham, confirmed by flow cytometry and histopathology.

Mice that died of left female viagra for sale ventricular (LV) rupture exhibited persistent inflammation at 3 days compared with survivors. Higher CXCR4 signal at 1 and 3 days independently predicted significantly worse functional outcome at 6 weeks assessed by cardiac magnetic resonance. Following the imaging time-course, female viagra for sale mice were treated with AMD3100, a CXCR4 blocker.

CXCR4 blockade at 3 days significantly lowered LV rupture incidence vs. Untreated MI (8% vs. 25%), and significantly improved contractile function at 6 weeks female viagra for sale.

CXCR4 blockade at 7 days failed to improve the outcome. Flow cytometry analysis revealed lower LV neutrophil and Ly6C high female viagra for sale monocyte content after CXCR4 blockade at 3 days. A total of 50 patients underwent CXCR4 PET imaging and functional assessment early after MI.

CXCR4 expression correlated with contractile function.Hess and colleagues conclude that PET imaging identifies early CXCR4 up-regulation which predicts acute rupture and chronic contractile dysfunction. Imaging-guided CXCR4 inhibition accelerates inflammatory resolution and improves outcome female viagra for sale. This supports a molecular imaging-based theranostic approach to guide therapy after MI.

The manuscript is accompanied by an Editorial by Christian Weber from the Ludwig-Maximilians-Universität in Munich, Germany and colleagues.19 The authors point female viagra for sale out that the study of Hess et al. Building on the virtues of molecular PET imaging for non-invasive analysis of biomarker expression within injured tissue, in a pre-clinical as well as in a clinical setting, demonstrates the value of CXCR4 PET imaging in identifying the best time point of anti-inflammatory treatment by CXCR4 antagonism with respect to chronic cardiac function.In a clinical review article entitled ‘Management of non-culprit coronary plaques in patients with acute coronary syndrome’, Rocco Montone from the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, and colleagues (including myself) note that ∼50% of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease, a condition associated with an increased incidence of recurrent ischaemic events and higher mortality.20,21 Based on recent evidence, a strategy of staged PCI of obstructive non-culprit lesions should be considered the gold standard for the management of these patients.22 However, several issues remain unresolved.

Indeed, what the optimal timing of staged PCI is has female viagra for sale not been completely defined. Moreover, assessment of intermediate non-culprit lesions still represents a clinical conundrum, as pressure-wire indexes do not seem able to correctly identify those patients in whom deferral is safe. Intracoronary imaging may help to identify untreated non-culprit lesions containing vulnerable plaques that may portend female viagra for sale a higher risk of future cardiovascular events.

However, there are hitherto no studies demonstrating that preventive PCI of vulnerable plaques or more intensive pharmacological treatment is associated with an improved clinical outcome. In this review, the authors discuss the recent evolving concepts about management of non-culprit plaques in STEMI patients, proposing a diagnostic and therapeutic algorithm to guide physicians in clinical practice. They also underscore the several knowledge gaps which need to be addressed in future studies.This female viagra for sale issue is also complemented by two Discussion Forum contributions.

In a contribution entitled ‘Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest in relation to organ donation’, Stefan Roest from the Erasmus MC in Amsterdam, the Netherlands and colleagues comment on the recent publication entitled ‘Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest. A registry study’ by Wulfran Bougouin from the Paris Cardiovascular Research Center (PARCC) in France, female viagra for sale and his colleagues the Sudden Death Expertise Center investigators.23,24 Bougouin et al. Respond in a separate comment.25The editors hope that readers of this issue of the European Heart Journal will find it of interest.With thanks to Amelia Meier-Batschelet, Johanna Hugger, and Martin Meyer for help with compilation of this article.

References1Kunadian V, Chieffo A, Camici PG, Berry C, Escaned J, Maas A, Prescott E, Karam N, Appelman Y, female viagra for sale Fraccaro C, Louise Buchanan G, Manzo-Silberman S, Al-Lamee R, Regar E, Lansky A, Abbott JD, Badimon L, Duncker DJ, Mehran R, Capodanno D, Baumbach A. An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology &. Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group.

Eur Heart J 2020;41:3504–3520.2Crea F, Camici PG, Bairey Merz CN female viagra for sale. Coronary microvascular dysfunction. An update female viagra for sale.

Eur Heart J 2014;35:1101–1111.3Berry C, Duncker D, Guzik T. Coronary microvascular dysfunction in Cardiovascular Research. Time to female viagra for sale turn on the spotlight!.

Eur Heart J 2020;41:612–613.4Lüscher TF. Improving outcomes female viagra for sale after acute coronary events. What works and what doesn’t.

Eur Heart J 2018;39:2691–2694.5Crea F, Liuzzo G. Anti-inflammatory treatment female viagra for sale of acute coronary syndromes. The need for precision medicine.

Eur Heart J 2016;37:2414–2416.6Collet JP, Thiele H, Barbato E, Barthélémy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Jüni female viagra for sale P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2020;doi:10.1093/eurheartj/ehaa575.7Kim J, Kang D, Park H, Kang M, Park TK, Lee JM, Yang JH, Song YB, Choi JH, Choi SH, Gwon HC, Guallar E, Cho J, Hahn JY.

Long-term beta-blocker therapy and clinical outcomes after acute myocardial infarction in patients without heart failure female viagra for sale. Nationwide cohort study. Eur Heart J 2020;41:3521–3529.8Harari R, Bangalore female viagra for sale S.

Beta-blockers after acute myocardial infarction. An old drug in urgent need of new evidence!. Eur Heart J 2020;41:3530–3532.9Baber U, Dangas G, Angiolillo DJ, Cohen DJ, Sharma SK, Nicolas J, Briguori C, Cha JY, Collier T, Dudek D, Džavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx female viagra for sale SO, Mehta SR, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han Y-L, Pocock S, Gibson CM, Mehran R.

Ticagrelor alone versus ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes. TWILIGHT-ACS. Eur Heart J 2020;41:3533–3545.10Storey RF.

The long journey of individualizing antiplatelet therapy after acute coronary syndromes. Eur Heart J 2020;41:3546–3548.11Partida RA, Libby P, Crea F, Jang IK. Plaque erosion.

A new in vivo diagnosis and a potential major shift in the management of patients with acute coronary syndromes. Eur Heart J 2018;39:2070–2076.12Jia H, Dai J, Hou J, Xing L, Ma L, Liu H, Xu M, Yao Y, Hu S, Yamamoto E, Lee H, Zhang S, Yu B, Jang IK. Effective anti-thrombotic therapy without stenting.

Intravascular optical coherence tomography-based management in plaque erosion (the EROSION study). Eur Heart J 2017;38:792–800.13Libby P. Superficial erosion and the precision management of acute coronary syndromes.

Not one-size-fits-all. Eur Heart J 2017;38:801–803.14Quillard T, Araújo HA, Franck G, Shvartz E, Sukhova G, Libby P. TLR2 and neutrophils potentiate endothelial stress, apoptosis and detachment.

Implications for superficial erosion. Eur Heart J 2015;36:1394–404.15Leistner DM, Kränkel N, Meteva D, Abdelwahed YS, Seppelt C, Stähli, Rai H, Skurk C, Lauten A, Mochmann HC, Fröhlich G, Rauch-Kröhnert U, Flores E, Riedel M, Sieronski L, Kia S, Strässler E, Haghikia A, Dirks F, Steiner J, Mueller DN, Volk HD, Klotsche J, Joner M, Libby P, Landmesser U. Differential immunological signature at the culprit site distinguishes acute coronary syndrome with intact from acute coronary syndrome with ruptured fibrous cap.

Results from the prospective translational OPTICO-ACS study. Eur Heart J 2020;41:3549–3560.16Liuzzo G, Pedicino D, Vinci R, Crea F. CD8 lymphocytes and plaque erosion.

A new piece in the jigsaw. Eur Heart J 2020;41:3561–3563.17Montecucco F, Carbone F, Schindler TH. Pathophysiology of ST-segment elevation myocardial infarction.

Novel mechanisms and treatments. Eur Heart J 2016;37:1268–1283.18Hess A, Derlin T, Koenig T, Diekmann J, Wittneben A, Wang Y, Wester HJ, Ross TL, Wollert KC, Bauersachs J, Bengel FM, Thackeray JT. Molecular imaging-guided repair after acute myocardial infarction by targeting the chemokine receptor CXCR4.

Eur Heart J 2020;41:3564–3575.19Döring Y, Noels H, van der Vorst E, Weber C. Seeing is repairing. How imaging-based timely interference with CXCR4 could improve repair after myocardial infarction.

Eur Heart J 2020;41:3576–3578.20Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimský P. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC).

Eur Heart J 2018;39:119–177.21Montone RA, Niccoli G, Crea F, Jang IK. Management of non-culprit coronary plaques in patients with acute coronary syndrome. Eur Heart J 2020;41:3579–3586.22Pavasini R, Biscaglia S, Barbato E, Tebaldi M, Dudek D, Escaned J, Casella G, Santarelli A, Guiducci V, Gutierrez-Ibanes E, Di Pasquale G, Politi L, Saglietto A, D’Ascenzo F, Campo G.

Complete revascularization reduces cardiovascular death in patients with ST-segment elevation myocardial infarction and multivessel disease. Systematic review and meta-analysis of randomized clinical trials. Eur Heart J 2019;doi:10.1093/eurheartj/ehz896.23Roest S, Bunge JJH, Manintveld OC.

Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest in relation to organ donation. Eur Heart J 2020;41:3587.24Bougouin W, Dumas F, Lamhaut L, Marijon E, Carli P, Combes A, Pirracchio R, Aissaoui N, Karam N, Deye N, Sideris G, Beganton F, Jost D, Cariou A, Jouven X. Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest.

A registry study. Eur Heart J 2020;41:1961–1971.25Bougouin W, Cariou A, Jouven X. Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest.

Do not neglect potential for organ donation!. Eur Heart J 2020;41:3588. Published on behalf of the European Society of Cardiology.

All rights reserved. © The Author(s) 2020. For permissions, please email.

Journals.permissions@oup.com.The Ten ‘Commandments’(1) DiagnosisChest discomfort without persistent ST-segment elevation (NSTE-ACS) is the leading symptom initiating the diagnostic and therapeutic cascade. The correlated pathology at the myocardial level is cardiomyocyte necrosis, measured by troponin release, or, less frequently, myocardial ischaemia without cell damage (unstable angina).(2) Troponin assaysHigh-sensitivity troponin assay (hs-cTn) measurements are recommended over less sensitive ones. However, many cardiac pathologies other than MI may also result in cardiac troponin elevations.(3) Rapid ‘rule-in’ and ‘rule-out’ algorithmsIt is recommended to use the 0 h/1 h algorithm (best option) or the 0 h/2 h algorithm.

Used in conjunction with clinical and ECG findings, the 0 h/1 h and 0 h/2 h hs-cTn algorithms allow identification of appropriate candidates for early discharge and outpatient management.(4) Ischaemic/bleeding risk assessmentInitial hs-cTn levels add prognostic information in terms of short- and long-term mortality to clinical and ECG variables. The Global Registry of Acute Coronary Events (GRACE) risk score is superior to (subjective) physician assessment for the occurrence of death or MI. The Academic Research Consortium-High Bleeding Risk may be used to assess the bleeding risk.(5) Non-invasive imagingEven after the rule-out of MI, elective non-invasive or invasive imaging may be indicated according to clinical assessment.

Coronary computed tomography angiography or stress imaging may be options based on risk assessment.(6) Risk stratification for an invasive approachAn early routine invasive approach within 24 h of admission is recommended for Non ST segment elevation myocardial infarction (NSTEMI) based on hs-cTn measurements, GRACE risk score >140, and dynamic new or presumably new ST-segment changes. Immediate invasive angiography is required in highly unstable patients according to hemodynamic status, arrhythmias, acute heart failure, or persistent chest pain. In all other clinical presentations, a selective invasive approach may be performed according to non-invasive testing or clinical risk assessment.(7) Revascularization strategiesRadial access is recommended as the preferred approach in NSTE-ACS patients undergoing invasive assessment.

Percutaneous coronary intervention of the culprit lesion is the treatment of choice. In multivessel disease, timing and completeness of revascularization should be decided according to the functional relevance of stenoses, age, general patient condition, comorbidities, and left ventricular function.(8) MINOCAMyocardial infarction with non-obstructive coronary arteries incorporates a heterogeneous group of underlying causes that may involve both coronary and non-coronary pathological conditions. Cardiac magnetic resonance imaging is one of the key diagnostic tools as it allows to identify the underlying cause in the majority of patients.(9) Post-treatment antiplatelet therapyDual antiplatelet therapy consisting of a potent P2Y12 receptor inhibitor in addition to aspirin is generally recommended for 12 months unless there are contraindications.

Dual antiplatelet therapy duration can be shortened (<12 months), extended (>12 months), or modified by switching DAPT or de-escalation depending on individual clinical judgement driven by ischaemic and bleeding risk.(10) Triple antithrombotic therapyNon-vitamin K oral anticoagulants (NOACs) are preferred over vitamin K antagonists in patients undergoing PCI with an indication for long-term oral anticoagulation. Dual antithrombotic therapy with a NOAC and single antiplatelet therapy is recommended as the default strategy up to 12 months after a short period of up to 1 week of TAT. Triple antithrombotic therapy may be prolonged up to 1 month when the ischaemic risk outweighs the bleeding risk..

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In this edition HealthCare.gov’s when do you take viagra insurer participation grows while benchmark premiums his comment is here shrinkThis week, CMS published its annual report of insurer participation and premium changes for the 36 states that use the federally-run exchange (HealthCare.gov). It provides a wealth of information, including these highlights:Average benchmark premiums are dropping by 2 percent for 2021 when do you take viagra. This is the third year in a row with a decrease in average benchmark premiums. They fell by 4 percent for 2020 and when do you take viagra by 1.5 percent for 2019.

The benchmark plan is the second-lowest-cost Silver plan in each area, and when do you take viagra premium subsidies are based on the cost of benchmark plans. (When benchmark premiums decrease, so do premium subsidy amounts.)Although overall average benchmark premiums are decreasing, there’s still considerable variation from one state to another. Average benchmark premiums are dropping by 29 percent in when do you take viagra Iowa, but increasing by 29 percent in North Dakota.There are 181 health insurance companies that will offer 2021 coverage in the exchanges in the 36 states that use HealthCare.gov. This is an increase from 175 in 2020 (and up from 159 if we don’t count Pennsylvania and New Jersey, both of which used HealthCare.gov in 2020 but have transitioned to their own enrollment platforms for 2021).Sixteen states that use HealthCare.gov have more participating exchange insurers for 2021 than they had this year.

As we when do you take viagra discussed last week, several of the states that run their own exchanges are also seeing an increase in the number of participating insurers for 2021.As Andrew Sprung has noted, there are likely to be more low-cost and zero-premium gold plans available in 2021, after premium subsidies are applied.It’s important to note that although the CMS report has been widely touted as “premiums decreasing by 2 percent,” that’s only referring to the average benchmark premiums. The benchmark plan isn’t necessarily the same plan from one year to the next, and there are numerous other plans available in each area.If we look at overall average when do you take viagra rate changes from 2020 to 2021, a Kaiser Family Foundation analysis indicates a median increase of 1.1 percent. And Charles Gaba has thus-far calculated a slight overall rate increase as well, although that could change as more states are added to the tally. As we highlighted last week, overall rates in some states are when do you take viagra increasing, while rates in other states are decreasing.

You can click on a state on this map to see our overview of how premiums are changing for 2021.Trump administration approves 1115 waivers for Nebraska, GeorgiaWithin the past week, CMS has approved 1115 waivers that had been submitted last year by Nebraska and Georgia.Nebraska expanded Medicaid as of this month, but the 1115 waiver allows the state to begin adding additional benefits (dental, vision, over-the-counter medications) as of April 2021, for enrollees who comply with various care and case management requirements. Starting in April 2022, the additional benefits will when do you take viagra also be contingent on the enrollees working (or going to school, volunteering, etc.) at least 80 hours per month. While basic Medicaid benefits will not be contingent on working at least 80 hours per month, public health experts have criticized Nebraska’s program for when do you take viagra being too complex, for enrollees and administrators alike. Nebraska has published answers to various FAQs about the approved waiver.Georgia has not yet expanded Medicaid.

The 1115 waiver calls for the state to partially expand Medicaid as of July 2021, and when do you take viagra also incorporates a Medicaid work requirement of at least 80 hours per month. Coverage will only be available to people earning up to 100 percent of the poverty level, as opposed to 138 percent as would be the case if the state fully expanded Medicaid. (In 2020, 100 percent of when do you take viagra the federal poverty level for a single person is $12,760.) Enrollees with income above 50 percent of the poverty level will have to pay premiums for their coverage.Because Georgia is not fully expanding Medicaid, the federal government will only pay 67 percent of the cost. If the state were to fully expand Medicaid, the federal when do you take viagra government would pay 90 percent of the cost.

And due to the complexity of the waiver, Joan Alker, of the Georgetown Center for Children and Families, notes that Georgia “may end up spending more on admin than coverage.”Medicaid work requirements are facing an uphill legal battle after being overturned in other states in recent years. The Trump when do you take viagra administration is asking the Supreme Court to uphold the http://www.voiture-et-handicap.fr/online-pharmacy-viagra/ legality of Medicaid work requirements, but work requirements as a condition of eligibility are also paused at the moment due to the COVID pandemic. (The additional federal funding that states are receiving to address the pandemic comes with a requirement that enrollees’ coverage not be terminated during the emergency period.) Urban Institute projects 69% increase in uninsured rate if ACA is overturnedOn November 10, just a week after election day, the Supreme Court will hear oral arguments in the California v. Texas (Texas v when do you take viagra.

U.S.) lawsuit when do you take viagra. The Trump administration and 18 states, led by Texas, are asking the Court to overturn the ACA, while 21 states, led by California, are working to protect the ACA. A ruling from the court is expected next year.The Urban when do you take viagra Institute published a comprehensive analysis last week, projecting that if the ACA is overturned, the uninsured rate in the U.S. Would increase by 69 percent by 2022, with more than 21 million people joining the ranks of the uninsured.

The report breaks out the projections by income level, state of residence, demographics, and changes in both private coverage and Medicaid.For another take on this, Charles Gaba when do you take viagra has compiled a similar analysis based on projected coverage losses in each Congressional district in the country.KFF examines pandemic’s effect on healthcare utilization, health insurance premiumsThe Kaiser Family Foundation hosted a webinar this week in conjunction with experts from EPIC and IQVIA, discussing what we know —and what we don’t yet know — about the COVID pandemic’s impact on healthcare utilization and health insurance premiums. (Slides from when do you take viagra the presentation are available here.) The entire webinar is well worth watching, but some of the highlights include:Although the median premium change across all individual marketplace plans is an increase of 1.1 percent for 2021, the median rate change associated with the COVID pandemic is 0.0 percent. Some insurers did incorporate small rate increases based on anticipated cost increases due to COVID, but some did not incorporate a COVID rating in their filings and others incorporated in a small rate decrease due to COVID. (These factors include pent-up demand for care that was delayed this year, the cost of vaccines and COVID treatments, changing demographics in the individual market caused by job losses, etc.) But the primary point when do you take viagra is that nearly all of this is still very uncertain at this point.There were sharp decreases in healthcare utilization earlier this year, including preventive care such as cancer screenings and vaccinations.

Much of that has returned to nearly normal levels, but there are still concerns that the missed preventive care could result in worse health outcomes in the months and years ahead.Among people who have lost their employer-sponsored health coverage amid the pandemic, people in states that have expanded Medicaid are three times as likely to enroll in Medicaid as people in states that have not expanded Medicaid.Medicaid enrollment tends to lag behind spikes in unemployment. Unemployment reached record high levels this when do you take viagra year, and Medicaid enrollment is likely to continue to increase in the coming months. It’s worth noting when do you take viagra that the upcoming open enrollment period for individual market coverage could lead to an increase in Medicaid enrollments, particularly in states that have expanded Medicaid under the ACA and thus make it easier for low-income exchange applicants to be directed to the Medicaid system.Telehealth has gone from accounting for about 1 percent of medical claims at the start of the year to about 8 percent now.Black, Hispanic, and Asian Americans have been more likely to be hospitalized due to COVID and more likely to die from it than White Americans. New guide details how Medicare enrollees in each state receive supplemental benefits from MedicaidMedicare is a federal program that provides health coverage for Americans who are at least 65 or who are disabled.

Medicaid is jointly run by the when do you take viagra state and federal governments, and provides coverage to people with limited means. Millions of Americans who have Medicare also receive supplemental benefits from Medicaid, but the specific eligibility details vary from state to state. There’s also state-level variation on things like Medicaid estate recovery and rules for asset transfers prior when do you take viagra to Medicaid eligibility. This fall, Josh Shultz has compiled a particularly useful resource that details how this all works in each when do you take viagra state.

You can click on a state on this map for more details.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and when do you take viagra educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

In this edition HealthCare.gov’s insurer participation grows while benchmark premiums shrinkThis week, CMS published its annual report of insurer participation and premium changes for female viagra for sale the 36 states that use the federally-run exchange (HealthCare.gov). It provides a female viagra for sale wealth of information, including these highlights:Average benchmark premiums are dropping by 2 percent for 2021. This is the third year in a row with a decrease in average benchmark premiums. They fell by 4 percent for female viagra for sale 2020 and by 1.5 percent for 2019. The benchmark plan is the second-lowest-cost Silver plan in each area, and premium subsidies are based on the cost female viagra for sale of benchmark plans.

(When benchmark premiums decrease, so do premium subsidy amounts.)Although overall average benchmark premiums are decreasing, there’s still considerable variation from one state to another. Average benchmark premiums are dropping by 29 percent in Iowa, but increasing by 29 percent in North Dakota.There are 181 female viagra for sale health insurance companies that will offer 2021 coverage in the exchanges in the 36 states that use HealthCare.gov. This is an increase from 175 in 2020 (and up from 159 if we don’t count Pennsylvania and New Jersey, both of which used HealthCare.gov in 2020 but have transitioned to their own enrollment platforms for 2021).Sixteen states that use HealthCare.gov have more participating exchange insurers for 2021 than they had this year. As we discussed last week, several of the states that run their own exchanges are also seeing an increase in the number of participating insurers for 2021.As Andrew Sprung has noted, there are likely to be female viagra for sale more low-cost and zero-premium gold plans available in 2021, after premium subsidies are applied.It’s important to note that although the CMS report has been widely touted as “premiums decreasing by 2 percent,” that’s only referring to the average benchmark premiums. The benchmark plan isn’t necessarily the same plan from one year to the next, and there are female viagra for sale numerous other plans available in each area.If we look at overall average rate changes from 2020 to 2021, a Kaiser Family Foundation analysis indicates a median increase of 1.1 percent.

And Charles Gaba has thus-far calculated a slight overall rate increase as well, although that could change as more states are added to the tally. As we highlighted female viagra for sale last week, overall rates in some states are increasing, while rates in other states are decreasing. You can click on a state on this map to see our overview of how premiums are changing for 2021.Trump administration approves 1115 waivers for Nebraska, GeorgiaWithin the past week, CMS has approved 1115 waivers that had been submitted last year by Nebraska and Georgia.Nebraska expanded Medicaid as of this month, but the 1115 waiver allows the state to begin adding additional benefits (dental, vision, over-the-counter medications) as of April 2021, for enrollees who comply with various care and case management requirements. Starting in April 2022, the additional benefits will also be contingent on the enrollees working (or going to school, volunteering, etc.) at least female viagra for sale 80 hours per month. While basic Medicaid benefits will not be contingent on working at least 80 hours per month, public health experts have criticized Nebraska’s program for being female viagra for sale too complex, for enrollees and administrators alike.

Nebraska has published answers to various FAQs about the approved waiver.Georgia has not yet expanded Medicaid. The 1115 waiver calls for the state to partially expand Medicaid as of July 2021, and also incorporates a Medicaid work requirement of at least 80 hours per female viagra for sale month. Coverage will only be available to people earning up to 100 percent of the poverty level, as opposed to 138 percent as would be the case if the state fully expanded Medicaid. (In 2020, 100 percent of the federal poverty level for a single person is $12,760.) Enrollees with income above female viagra for sale 50 percent of the poverty level will have to pay premiums for their coverage.Because Georgia is not fully expanding Medicaid, the federal government will only pay 67 percent of the cost. If the state were to female viagra for sale fully expand Medicaid, the federal government would pay 90 percent of the cost.

And due to the complexity of the waiver, Joan Alker, of the Georgetown Center for Children and Families, notes that Georgia “may end up spending more on admin than coverage.”Medicaid work requirements are facing an uphill legal battle after being overturned in other states in recent years. The Trump administration is asking the Supreme Court to uphold the legality of Medicaid work requirements, but female viagra for sale work requirements as a condition of eligibility are also paused at the moment due to the COVID pandemic. (The additional federal funding that states are receiving to address the pandemic comes with a requirement that enrollees’ coverage not be terminated during the emergency period.) Urban Institute projects 69% increase in uninsured rate if ACA is overturnedOn November 10, just a week after election day, the Supreme Court will hear oral arguments in the California v. Texas (Texas v female viagra for sale. U.S.) lawsuit female viagra for sale.

The Trump administration and 18 states, led by Texas, are asking the Court to overturn the ACA, while 21 states, led by California, are working to protect the ACA. A ruling from the court is expected next year.The female viagra for sale Urban Institute published a comprehensive analysis last week, projecting that if the ACA is overturned, the uninsured rate in the U.S. Would increase by 69 percent by 2022, with more than 21 million people joining the ranks of the uninsured. The report breaks out the projections by income level, state female viagra for sale of residence, demographics, and changes in both private coverage and Medicaid.For another take on this, Charles Gaba has compiled a similar analysis based on projected coverage losses in each Congressional district in the country.KFF examines pandemic’s effect on healthcare utilization, health insurance premiumsThe Kaiser Family Foundation hosted a webinar this week in conjunction with experts from EPIC and IQVIA, discussing what we know —and what we don’t yet know — about the COVID pandemic’s impact on healthcare utilization and health insurance premiums. (Slides from the presentation are available here.) The entire webinar is well worth female viagra for sale watching, but some of the highlights include:Although the median premium change across all individual marketplace plans is an increase of 1.1 percent for 2021, the median rate change associated with the COVID pandemic is 0.0 percent.

Some insurers did incorporate small rate increases based on anticipated cost increases due to COVID, but some did not incorporate a COVID rating in their filings and others incorporated in a small rate decrease due to COVID. (These factors include pent-up demand for care that was delayed this year, the cost of vaccines and COVID treatments, changing demographics in the individual female viagra for sale market caused by job losses, etc.) But the primary point is that nearly all of this is still very uncertain at this point.There were sharp decreases in healthcare utilization earlier this year, including preventive care such as cancer screenings and vaccinations. Much of that has returned to nearly normal levels, but there are still concerns that the missed preventive care could result in worse health outcomes in the months and years ahead.Among people who have lost their employer-sponsored health coverage amid the pandemic, people in states that have expanded Medicaid are three times as likely to enroll in Medicaid as people in states that have not expanded Medicaid.Medicaid enrollment tends to lag behind spikes in unemployment. Unemployment reached record high levels this year, and Medicaid enrollment is female viagra for sale likely to continue to increase in the coming months. It’s worth noting that the upcoming open enrollment period for individual market coverage could lead to an increase in Medicaid enrollments, particularly in states that have expanded Medicaid under the ACA and thus make it easier for low-income exchange applicants to be directed to the Medicaid system.Telehealth has gone from accounting for about 1 percent of medical claims at the start of the year to about 8 percent now.Black, Hispanic, and Asian Americans have been more likely to be female viagra for sale hospitalized due to COVID and more likely to die from it than White Americans.

New guide details how Medicare enrollees in each state receive supplemental benefits from MedicaidMedicare is a federal program that provides health coverage for Americans who are at least 65 or who are disabled. Medicaid is jointly run by female viagra for sale the state and federal governments, and provides coverage to people with limited means. Millions of Americans who have Medicare also receive supplemental benefits from Medicaid, but the specific eligibility details vary from state to state. There’s also state-level variation on things like Medicaid estate recovery and rules for asset transfers prior female viagra for sale to Medicaid eligibility. This fall, Josh Shultz has compiled a particularly useful resource that details how this all works in female viagra for sale each state.

You can click on a state on this map for more details.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org female viagra for sale. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

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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 infection (the virus that causes AIDS) or other sexually transmitted diseases.

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By Dennis Thompson HealthDay Reporter MONDAY, Oct pills that look like viagra. 19, 2020 (HealthDay News) -- A recently approved rheumatoid arthritis medication appears to be an effective second-line therapy when biologic treatments start to fail, a new clinical trial reports. Arthritis sufferers treated with upadacitinib had a significantly greater reduction in their symptoms and disease activity than people treated with a standard disease-modifying antirheumatic pills that look like viagra drug (DMARD), said co-researcher Dr.

Aileen Pangan. She is executive medical director of immunology clinical development for the pharmaceutical company AbbVie in North Chicago, Ill. The drug, marketed under the brand name Rinvoq, also helped twice as many patients enter remission from their rheumatoid arthritis, according to pills that look like viagra a report in the Oct.

15 issue of the New England Journal of Medicine. "Upadacitinib has shown superiority to one of the current standard-of-care treatment pills that look like viagra options in the clinic for these difficult-to-treat patients," Pangan said. "It is important for physicians to have multiple treatment options available, including medications with different mechanisms of action, to help provide patients with the treatment that is right for them." Rinvoq received U.S.

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All were suffering swollen or tender joints pills that look like viagra even though they were being treated with at least one biologic DMARD, or they had unacceptable side effects from a DMARD. Half were treated with Rinvoq, and half were treated with a standard biologic DMARD called abatacept (Orencia). DMARDs act upon the immune system in different ways to reduce joint inflammation.

Rinvoq belongs in a class of drugs called Janus kinase (JAK) inhibitors, which also pills that look like viagra treat rheumatoid arthritis symptoms by manipulating the immune system, Pangan said. "Janus kinase enzymes play a critical role in the body by transmitting messages from the outside to the inside of cells," she said. "In the immune system, pills that look like viagra a malfunction can lead to the generation of autoimmune inflammatory diseases.

In the immune cells of patients with rheumatoid arthritis, JAK enzymes transmit signals that lead to the inappropriate activation of the immune system to attack and cause inflammation in the joints."By Robert Preidt HealthDay Reporter MONDAY, Oct. 19, 2020 (HealthDay News) -- Parents are usually pleased when their newborn seems big and strong, but new research suggests that large babies may be at higher risk for the heart rhythm disorder atrial fibrillation later in life. Atrial fibrillation (a-fib) is the most common pills that look like viagra heart rhythm disorder, affecting more than 40 million people worldwide.

People with a-fib have a five times increased risk of stroke. The association pills that look like viagra between birth weight and a-fib is controversial, which led the authors of this study to investigate it. Using a special data analysis technique, the researchers concluded that there was a link between greater birth weight and an increased risk of a-fib later in life.

Specifically, people with a birth weight that's 1 pound above the average 7.5 pounds are 30% more likely to develop a-fib, the findings showed. The study is scheduled to be presented Monday at a virtual meeting of the European Society of pills that look like viagra Cardiology (ESC). "Our results suggest that the risk of atrial fibrillation in adulthood may be higher for large newborns [over 8 pounds, 13 ounces] than those with normal birth weight," said study author Songzan Chen, from Zhejiang University, in Hangzhou, China.

"Preventing elevated birth weight could be a novel way to avoid atrial fibrillation in offspring -- pills that look like viagra for example with a balanced diet and regular check-ups during pregnancy, particularly for women who are overweight, obese or have diabetes," Chen suggested in a meeting news release. "People born with a high weight should adopt a healthy lifestyle to lower their likelihood of developing the heart rhythm disorder," Chen recommended. According to Michel Komajda, a past president of the ESC, "Atrial fibrillation is a devastating illness that causes avoidable strokes if left untreated.

We know that people with unhealthy lifestyles are more pills that look like viagra likely to develop atrial fibrillation, and risk can be lowered through physical activity and keeping body weight under control. This study is a welcome addition to our knowledge about how to prevent atrial fibrillation." WebMD News from HealthDay Copyright © 2013-2020 HealthDay. All rights reserved..

By Dennis Thompson HealthDay Reporter MONDAY, Oct female viagra for sale. 19, 2020 (HealthDay News) -- A recently approved rheumatoid arthritis medication appears to be an effective second-line therapy when biologic treatments start to fail, a new clinical trial reports. Arthritis sufferers treated with upadacitinib had a significantly greater reduction in their symptoms and disease activity than people female viagra for sale treated with a standard disease-modifying antirheumatic drug (DMARD), said co-researcher Dr. Aileen Pangan.

She is executive medical director of immunology clinical development for the pharmaceutical company AbbVie in North Chicago, Ill. The drug, marketed under the brand name Rinvoq, also helped twice as many patients enter remission from their rheumatoid arthritis, female viagra for sale according to a report in the Oct. 15 issue of the New England Journal of Medicine. "Upadacitinib has female viagra for sale shown superiority to one of the current standard-of-care treatment options in the clinic for these difficult-to-treat patients," Pangan said.

"It is important for physicians to have multiple treatment options available, including medications with different mechanisms of action, to help provide patients with the treatment that is right for them." Rinvoq received U.S. Food and Drug Administration approval in August 2019 for treatment of moderate to severe rheumatoid arthritis. This 24-week clinical trial aimed to assess Rinvoq's effectiveness female viagra for sale in helping rheumatoid arthritis patients for whom DMARD treatment had failed. More than 600 patients were recruited for the trial.

All were suffering swollen or tender joints even though they were being treated with at least one biologic DMARD, or they had unacceptable side female viagra for sale effects from a DMARD. Half were treated with Rinvoq, and half were treated with a standard biologic DMARD called abatacept (Orencia). DMARDs act upon the immune system in different ways to reduce joint inflammation. Rinvoq belongs female viagra for sale in a class of drugs called Janus kinase (JAK) inhibitors, which also treat rheumatoid arthritis symptoms by manipulating the immune system, Pangan said.

"Janus kinase enzymes play a critical role in the body by transmitting messages from the outside to the inside of cells," she said. "In the immune female viagra for sale system, a malfunction can lead to the generation of autoimmune inflammatory diseases. In the immune cells of patients with rheumatoid arthritis, JAK enzymes transmit signals that lead to the inappropriate activation of the immune system to attack and cause inflammation in the joints."By Robert Preidt HealthDay Reporter MONDAY, Oct. 19, 2020 (HealthDay News) -- Parents are usually pleased when their newborn seems big and strong, but new research suggests that large babies may be at higher risk for the heart rhythm disorder atrial fibrillation later in life.

Atrial fibrillation female viagra for sale (a-fib) is the most common heart rhythm disorder, affecting more than 40 million people worldwide. People with a-fib have a five times increased risk of stroke. The association between birth weight and a-fib is female viagra for sale controversial, which led the authors of this study to investigate it. Using a special data analysis technique, the researchers concluded that there was a link between greater birth weight and an increased risk of a-fib later in life.

Specifically, people with a birth weight that's 1 pound above the average 7.5 pounds are 30% more likely to develop a-fib, the findings showed. The study is scheduled to be presented Monday female viagra for sale at a virtual meeting of the European Society of Cardiology (ESC). "Our results suggest that the risk of atrial fibrillation in adulthood may be higher for large newborns [over 8 pounds, 13 ounces] than those with normal birth weight," said study author Songzan Chen, from Zhejiang University, in Hangzhou, China. "Preventing elevated birth weight could be a novel way to avoid atrial fibrillation in offspring -- for example with a balanced diet and regular check-ups during pregnancy, particularly for women who are overweight, obese female viagra for sale or have diabetes," Chen suggested in a meeting news release.

"People born with a high weight should adopt a healthy lifestyle to lower their likelihood of developing the heart rhythm disorder," Chen recommended. According to Michel Komajda, a past president of the ESC, "Atrial fibrillation is a devastating illness that causes avoidable strokes if left untreated. We know that people with unhealthy lifestyles are more likely to develop atrial fibrillation, and risk can be lowered through physical activity and keeping body weight under control female viagra for sale. This study is a welcome addition to our knowledge about how to prevent atrial fibrillation." WebMD News from HealthDay Copyright © 2013-2020 HealthDay.

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We live in unprecedented where to buy female viagra times. But what makes them without parallel is not the current pandemic crisis nor the continued problems facing minorities in our institutions. Rather, it’s that for the first time, the problems of accessibility, rights where to buy female viagra and freedoms are now invading privileged spaces. There can be no ‘getting back to normal’, because ‘normal’ only ever benefited the white, Western, patriarchal, abled and cis ideals. For many, the world is not suddenly on fire where to buy female viagra.

It has long been burning.The present pandemic lays bare systemic prejudice against the most vulnerable among us. We at Medical Humanities, with our focus on global health and social justice, welcome discussion about how the crisis has disproportionately affected racial and fiscal minorities, those from the disabled community, those who are LGBTQA+ and other vulnerable groups. What we focus on here, now, can lead to greater accessibility and equity in the future.In this expanded issue, we offer some of the incredible work being done across the field of medical humanities prior to the COVID-19 crisis, and we are already reviewing articles where to buy female viagra on the role of health humanities during the pandemic. The process of academic publishing tends not to lend itself to immediacy, however, and the challenges of pandemic means greater pressure on everyone, from the authors to the reviewers and readers.To remedy this, we at Medical Humanities have been increasing the work on our blog platform, a place where content can be quickly updated, and where conversations can occur among readers and writers. We openly invite submissions concerning the virus, as well as topics relevant to our wider CFP (call for posts/papers) this year on social justice and health, to where to buy female viagra both blog and journal.

We will do our best to expedite. Finally, we have also been addressing social justice and access in our podcast, where we interviewed disability activist Alice Wong and most recently Dr Oni Blackstock, primary care physician and HIV specialist in New York. We hope to have many more on these critical subjects.We wish all of where to buy female viagra you good health and safety and know that many of you are yet on the front lines. Thank you for being part of the community of Medical Humanities.IntroductionMinecraft is a computer game with no specific goals to accomplish. The gameworld consists of three-dimensional (3D) cubes and where to buy female viagra objects which the player (Steve) can mine and build into infinitely complex (and logically impossible) structures.

Steve sometimes encounters other characters (‘mobs’), such as animals and hostile creatures. He can ‘spawn’ and destroy them. While it looks like a harmless game of logical construction, it conveys some worryingly delusive ideas about the where to buy female viagra real world. The difference between real and imagined structures is at the heart of the age-old debate around categorising mental disorders.Classification in mental health has had various forms throughout history. Mack and colleagues set out a history of psychiatric classification beginning in 2600 BC with where to buy female viagra Egyptian references to melancholia and hysteria.

Through the Ancient Greeks with Hippocrates’ phrenitis, mania, melancholia, epilepsy, hysteria and Scythian disease. Through the Renaissance period. Through to 19th-century psychiatry featuring Pinel (known as where to buy female viagra the first psychiatrist), Kraepelin (known for observational classification) and Freud (known for classifying neurosis and psychosis).1Although the history of psychiatric classification identifies some common trends such as the labels ‘melancholia’ and ‘hysteria’ which have survived millennia, the label ‘depression’ is relatively new. The earliest usage noted by Snaith is from 1899. €˜in simple pathological depression…the patient exhibits a growing indifference to where to buy female viagra his former pursuits…’.2 Snaith noted that early 20th-century psychiatrists like Adolf Meyer hoped that ‘depression’ would come to encompass a broad category under which descriptions of subtypes would emerge.

This did not happen until the middle of the 20th century. With the publication of the sixth International Classification of Diseases (ICD) in 1948 and the Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1952 and their subsequent revisions, the latter half of the 20th century has seen depression subtype labels proliferate. In their study of the social determinants of diagnostic labels in depression, McPherson and Armstrong illustrate how the codification of depression subtypes in the where to buy female viagra latter half of the 20th century has been shaped by the evolving context of psychiatry, including power struggles within the profession, a move to community care and the development of psychopharmacology.3During this period, McPherson and Armstrong describe how subsequent versions of the DSM served as battlegrounds for professional disputes and philosophical quarrels around categorisation of mental disorders. DSM I and DSM II have been described as products of an American Psychiatric Association dominated by psychoanalytic psychiatrists.4 DSM III and DSM III-R have been described as a radical rejection of psychoanalytic thinking, a ‘neo-Kraepelinian revolution’, a reference to the observational descriptive techniques of 19th-century psychiatrist Emil Kraepelin who classified mental disorders into two broad categories. €˜dementia praecox’ and ‘manic-depression’.5 DSM III was seen by some as a turning point in the use of the medical model of mental illness, through provision of specific inclusion and exclusion criteria, and use of field trials and a multiaxial system.6 These latter technocratic additions to psychiatric labelling served to engender a much closer alignment between psychiatry, science and medicine.The codification of mental disorders in manuals has been described by Thomas Schacht as intrinsic to the where to buy female viagra relationship between science and politics and the way in which psychiatrists gain significant social power by aligning themselves to science.7 His argument drew on Szasz, who saw the mental health establishment as a therapeutic state.

Zimbardo, who described psychiatric care as a controlling force. And Foucault, who described the categorisation of the mentally ill as a force for isolating ‘the other’. Diagnostic critique has been further developed through a cultural relativist lens in that what Western psychiatrists classify as a depression is constructed differently in other cultures.8 Considering these limitations, some critics where to buy female viagra have gone so far as to argue that psychiatric diagnostic systems should be abolished.9Yet architects of DSM manuals have worked hard to ensure the technology of classification is regarded as genuine scientific activity with sound roots in philosophy of science. In their philosophical defence of DSM IV, Allen Frances and colleagues address their critics under the headings ‘nominalism vs realism’, ‘empiricism vs rationalism’ and ‘categorical vs dimensional’.10 The implication is that there are opposing stances in which a choice must be made or a middle ground forged by those reasonable enough to recognise the need for pragmatism in the service of clinical utility. The nominalism–realism debate is illustrated using as where to buy female viagra metaphor three different stances a cricket umpire might take on calling strikes and balls.

The discussion sets out two of these as extreme views. €˜at one extreme…those who take a reductionistically realistic view of the world’ versus ‘the solipsistic nominalists…might content that nothing exists’. Szasz, who is characterised as holding where to buy female viagra particularly extreme views, is named as an archetypal solipsist. There is implied to be a degree of arrogance associated with this view in the illustrative example in which the umpire states ‘there are no balls and there are no strikes until I call them’. Frances therefore sets up a means of grouping two kinds of people as philosophical extremists who can be dismissed, while avoiding addressing the philosophical problems they pose.Frances provides little if any justification for where to buy female viagra the middle ground stance, ‘There are balls and there are strikes and I call them as I see them’, other than to focus on its clinical utility and the lack of clinical utility in the alternatives ‘naïve realism’ and ‘heuristically barren solipsism’.

The natural conclusion the reader is invited to reach is that a middle ground of a heuristic concept is naturally right because it is not extreme and is naturally useful clinically, without specifying in what way this stance is coherent, resolves the two alternatives, and in what way a heuristic construct that is not ‘real’ can be subject to scientific testing.Similarly, in discussing the ‘categorical vs dimensional’, Frances promotes the ‘prototype approach’. Those holding opposing views are labelled as ‘dualists’ or ‘dichotomisers’. The prototypical approach is where to buy female viagra again put forward as a clinically useful middle ground. Illustrations are drawn from natural science. €˜a triangle and a square are never the same’, inciting the reader to consider science as value-free where to buy female viagra.

The prototypical approach emerges as a natural solution, yet the authors do not address how a diagnostic prototype resolves the issues posed by the two alternatives, nor how a prototype can be subjected to natural science methods.The argument presented here is not a defence of solipsism or dualism. Rather it aims to illustrate that if for pragmatic purposes clinicians and policymakers choose to gloss over the philosophical flaws in classification practices, it is then risky to move beyond the heuristic and apply natural science methods to these constructs adding multiple layers of technocratic subclassification. Doing so where to buy female viagra is more like playing Minecraft than cricket. The National Institute for Health and Care Excellence (NICE) guideline for depression is taken as an example of the philosophical errors that can follow from playing Minecraft with unsound heuristic devices, specifically subcategories of persistent forms of depression. As well as serving a clinical purpose, diagnosis in medicine is a way of allocating resources for insurance companies and where to buy female viagra constructing clinical guidelines, which in turn determine rationing within the National Health Service.

The consequences for recipients of healthcare are therefore significant. Clinical utility is arguably not being served at all and patients are left at risk of poor-quality care.Heterogeneity of persistent depressionAndrea Jobst and colleagues note that ‘because of their chronic clinical course, approximately 40% of CD [chronic depression] patients also fulfil criteria for TRD [treatment resistant depression]…usually defined by the number of non-successful biological treatments’.11 This position is reflected in the DSM VAmerican Psychiatric Association (2013), the European Psychiatric Association (EPA) guidance and the ICD-11(World Health Organisation, 2018), which all use a ‘persistent’ depression category, acknowledging a loosely defined mixed group of long-term, difficult-to-treat depressive conditions, often associated with dysthymia and comorbid common mental disorders, various personality traits and psychosocial disability.In contrast, the NICE 2018 draft guideline separates treatments into those for ‘new episodes’ of depression. €˜further-line’ treatment of depression (equivalent to TRD), CD and ‘depression with where to buy female viagra co-morbidities’. The latter is subdivided into treatments for ‘complex depression’ and ‘psychotic depression’. These categories and where to buy female viagra subcategories introduce an unfortunate sense of certainty as though these labels represent real things.

An analysis follows of how these definitions play out in terms of grouping of randomised controlled trials in the NICE evidence review. Specifically, the analysis reveals the overlap between populations in trials which have been separated into discrete categories, revealing significant limitations to the utility of the category labels.The NICE definition of CD requires trial samples to meet the criteria for major depressive disorder (MDD) for 2 years. Dysthymia and double depression (MDD superimposed on dysthymia) where to buy female viagra were included. If 75% of the trial population met these criteria, the trial was reviewed in the CD category.12 The definition of TRD (or ‘further-line treatments’) required that the trial sample had demonstrated a ‘limited response to previous treatment’ and randomised to the further-line treatment at this point. If 80% of the trial participants met these criteria, it was reviewed in the TRD category.13 Complex depression was where to buy female viagra defined as ‘depression co-existing with personality disorder’.

To be classed as complex, 51% of trial participants had to have personality disorder (PD).14It is immediately clear from these definitions that there is a potential problem with attempting to categorise trial populations into just one of these categories. These populations are likely to overlap, whether or not a trial protocol sets out to explicitly record all of this information. The analysis below will illustrate this using examples from within the NICE review.Cataloguing complexity in trial populationsWithin the category of further-line treatments (TRD), 64 trials were reviewed where to buy female viagra. Comparisons within these trials were further subcategorised into ‘dose escalation strategies’, ‘augmentation strategies’ and ‘switching strategies’. In drilling down by way of illustration, where to buy female viagra this analysis considers the 51 trials in the augmentation strategy evidence review.

Of these, two were classified by the reviewers as also fulfilling the criteria for CD but were not analysed in the CD category (Study IDs. Fonagy 2015 and Kocsis 200915). About half of the trials (23/51) did not report the mean duration of episode, meaning that it is where to buy female viagra not possible to know what percentage of participants also met the criteria for CD. Of trials that did report episode duration, 17 reported a mean duration longer than 24 months. While the standard deviations varied in size or were unreported, the mean indicates a good likelihood that a significant proportion of the participants across where to buy female viagra these 51 trials met the criteria for CD.Details of baseline employment, trauma history, suicidality, physical comorbidity, axis I comorbidity and PD (all clinical indicators of complexity, severity and chronicity) were not collated by NICE.

For the present analysis, all 51 publications were examined and data compiled concerning clinical complexity in the trial populations. Only 14 of 51 trials report employment data. Of those where to buy female viagra that do, unemployment ranges from 12% to 56% across trial samples. None of the trials report trauma history. About half of the trials (26/51) excluded people who were where to buy female viagra considered a suicide risk.

The others did not.A large proportion of trials (30/51) did not provide any data on axis 1 comorbidity. Of these, 18 did not exclude any diagnoses, while 12 excluded some (but not all) disorders. The most common diagnoses excluded were psychotic disorders, substance or alcohol abuse, and bipolar disorder (excluded in where to buy female viagra 26, 25 and 23 trials, respectively). Only 7 of 51 trials clearly stated that all axis 1 diagnoses were excluded. This leaves only 13 where to buy female viagra studies providing any data about comorbidity.

Of these, 9 gave partial data on one or two conditions, while 4 reported either the mean number of disorders (range 1.96–2.9) or the percentage of participants (range 68.1–96.7) with any comorbid diagnosis (Nierenberg 2003a, Nierenberg 2006, Watkins 2011a, Town 201715).The majority of trials (46/51) did not report the prevalence of PD. Many stated PD as an exclusion criterion but without defining a threshold for exclusion. For example, PD where to buy female viagra could be excluded if it ‘impacted’ the depression, if it was ‘significant’, ‘severe’ or ‘persistent’. Some excluded certain PDs (such as antisocial or borderline) and not others but without reporting the prevalence of those not excluded. In the five trials where prevalence was clear, prevalence ranged from 0% (Ravindran 2008a15), where all where to buy female viagra PDs were excluded, to 87.5% of the sample (Town 201715).

Two studies reported the mean number of PDs. 2.0 (Nierenberg 2003a) and 0.85 (Watkins 2011a15).The majority of trials (43/51) did not report the prevalence of physical illness. Many stated where to buy female viagra illness as an exclusion criterion, but the definitions and thresholds were vague and could be interpreted in different ways. For example, illness could be excluded if it was ‘unstable’, ‘serious’, ‘significant’, ‘relevant’, or would ‘contraindicate’ or ‘impact’ the medication. Of the eight trials reporting information about physical health, where to buy female viagra there was a wide variation.

Four reported prevalence varying from 7.6% having a disability (Eisendrath 201615) to 90.9% having an illness or disability (Town 201715). Four used scales of physical health. Two indicating mild problems (Nierenberg 2006, Lavretsky 201115) and two indicating moderately high levels of illness (Thase 2007, where to buy female viagra Fang 201015).The NICE review also divided trial populations into a dichotomy of ‘more severe’ and ‘less severe’ on the grounds that this would be a clinically useful classification for general practitioners. NICE applied a bespoke methodology for creating this dichotomy, abandoning validated measure thresholds in order first to generate two ‘homogeneous’ groups to ‘facilitate analysis’, and second to create an algorithm to ‘read across’ different measures (such as the Beck Depression Inventory, the Hamilton Rating Scale for Depression (HRSD) and the Montgomery-Asberg Depression Rating Scale).16 Examining trials which use more than one of these measures reveals problems in the algorithm. Of the 51 trials, there are 6 where to buy female viagra instances in which the study population falls into NICE’s more severe category according to one measure and into the less severe category according to another.

In four of these trials, NICE chose the less severe category (Souza 2016, Watkins 2011a, Fonagy 2015, Town 201715). The other two trials were designated more severe (Barbee 2011, Dunner 200715). Only 17 of 51 trials reported two or more depression scale measures, leaving much unknown about whether other study populations could count as both more severe and less severe.Absence of knowledge where to buy female viagra or knowledge of absence?. A key philosophical error in science is to confuse an absence of knowledge with knowledge of absence. It is likely that some of the study populations deemed lacking in complexity or severity could actually have high degrees of complexity and/or where to buy female viagra severity.

Data to demonstrate this may either fall foul of a guideline committee decision to prioritise certain information over other conflicting information (as in the severity algorithm). The information may be non-existent as it was not collected. It may be somewhere where to buy female viagra in the publication pipeline. Or it may be sitting in a database with a research team that has run out of funds for supplementary analyses. Wherever those data are or where to buy female viagra are not, their absence from published articles does not define the phenomenology of depression for the patients who took part.

As a case in point, data from the Fonagy 2015 trial presented at conferences but not published reveal that PD prevalence data would place the trial well within the NICE complex depression category, and that the sample had high levels of past trauma and physical condition comorbidity. The trial also meets the guideline criteria for CD according to the guideline’s own appendices.17 Reported axis 1 comorbidity was high (75.2% had anxiety disorder, 18.6% had substance abuse disorder, 13.2% had eating disorder).18 The mean depression scores at baseline were 36.5 on the Beck Depression Inventory and 20.1 on the HRSD (severe and very severe, respectively, according to published cut-off scores). NICE categorised this population as less severe TRD, where to buy female viagra not CD and not complex.Notes1. Avram H. Mack et al where to buy female viagra.

(1994), “A Brief History of Psychiatric Classification. From the Ancients to DSM-IV,” Psychiatric Clinics 17, no. 3. 515–9.2. R.

P. Snaith (1987), “The Concepts of Mild Depression,” British Journal of Psychiatry 150, no. 3. 387.3. Susan McPherson and David Armstrong (2006), “Social Determinants of Diagnostic Labels in Depression,” Social Science &.

Medicine 62, no. 1. 52–7.4. Gerald N. Grob (1991), “Origins of DSM-I.

A Study in Appearance and Reality,” The American Journal of Psychiatry. 421–31.5. Wilson M. Compton and Samuel B. Guze (1995), “The Neo-Kraepelinian Revolution in Psychiatric Diagnosis,” European Archives of Psychiatry and Clinical Neuroscience 245, no.

4. 198–9.6. Gerald L. Klerman (1984), “A Debate on DSM-III. The Advantages of DSM-III,” The American Journal of Psychiatry.

539–42.7. Thomas E. Schacht (1985), “DSM-III and the Politics of Truth,” American Psychologist. 513–5.8. Daniel F.

Hartner and Kari L. Theurer (2018), “Psychiatry Should Not Seek Mechanisms of Disorder,” Journal of Theoretical and Philosophical Psychology 38, no. 4. 189–204.9. Sami Timimi (2014), “No More Psychiatric Labels.

Why Formal Psychiatric Diagnostic Systems Should Be Abolished,” Journal of Clinical and Health Psychology 14, no. 3. 208–15.10. Allen Frances et al. (1994), “DSM-IV Meets Philosophy,” The Journal of Medicine and Philosophy.

A Forum for Bioethics and Philosophy of Medicine 19, no. 3. 207–18.11. Andrea Jobst et al. (2016), “European Psychiatric Association Guidance on Psychotherapy in Chronic Depression Across Europe,” European Psychiatry 33.

20.12. National Institute for Health and Care Excellence (2018), Depression in Adults. Treatment and Management. Draft for Consultation, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/full-guideline-updated, 507.13. Ibid., 351–62.14.

Ibid., 597.15. Note that in order to refer to specific trials reviewed in the guideline, rather than the full citation, the Study IDs from column A in appendix J5 have been used. See www.nice.org.uk/guidance/gid-cgwave0725/documents/addendum-appendix-9 for details and full references.16. National Institute for Health and Care Excellence (2018), Depression in Adults. Treatment and Management.

Second Consultation on Draft Guideline – Stakeholder Comments Table, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/consultation-comments-and-responses-2, 420–1.17. National Institute for Health and Care Excellence (2018), Depression in Adults, appendix J5.18. Peter Fonagy et al. (2015), “Pragmatic Randomized Controlled Trial of Long-Term Psychoanalytic Psychotherapy for Treatment-Resistant Depression. The Tavistock Adult Depression Study (TADS),” World Psychiatry 14, no.

3. 312–21.19. American Psychological Association (2018), Clinical Practice Guideline for the Treatment of Depression in Children, Adolescents, and Young, Middle-aged, and Older Adults. Draft.20. Jacqui Thornton (2018), “Depression in Adults.

Campaigners and Doctors Demand Full Revision of NICE Guidance,” BMJ 361. K2681..

We live female viagra for sale https://www.voiture-et-handicap.fr/where-to-buy-female-viagra/ in unprecedented times. But what makes them without parallel is not the current pandemic crisis nor the continued problems facing minorities in our institutions. Rather, it’s female viagra for sale that for the first time, the problems of accessibility, rights and freedoms are now invading privileged spaces. There can be no ‘getting back to normal’, because ‘normal’ only ever benefited the white, Western, patriarchal, abled and cis ideals.

For many, the world female viagra for sale is not suddenly on fire. It has long been burning.The present pandemic lays bare systemic prejudice against the most vulnerable among us. We at Medical Humanities, with our focus on global health and social justice, welcome discussion about how the crisis has disproportionately affected racial and fiscal minorities, those from the disabled community, those who are LGBTQA+ and other vulnerable groups. What we focus on here, now, can lead to greater accessibility female viagra for sale and equity in the future.In this expanded issue, we offer some of the incredible work being done across the field of medical humanities prior to the COVID-19 crisis, and we are already reviewing articles on the role of health humanities during the pandemic.

The process of academic publishing tends not to lend itself to immediacy, however, and the challenges of pandemic means greater pressure on everyone, from the authors to the reviewers and readers.To remedy this, we at Medical Humanities have been increasing the work on our blog platform, a place where content can be quickly updated, and where conversations can occur among readers and writers. We openly invite submissions concerning the virus, as well as topics relevant to our wider CFP (call for posts/papers) this year on social justice and health, to both female viagra for sale blog and journal. We will do our best to expedite. Finally, we have also been addressing social justice and access in our podcast, where we interviewed disability activist Alice Wong and most recently Dr Oni Blackstock, primary care physician and HIV specialist in New York.

We hope to have many more on these critical subjects.We wish all of you good health and female viagra for sale safety and know that many of you are yet on the front lines. Thank you for being part of the community of Medical Humanities.IntroductionMinecraft is a computer game with no specific goals to accomplish. The gameworld female viagra for sale consists of three-dimensional (3D) cubes and objects which the player (Steve) can mine and build into infinitely complex (and logically impossible) structures. Steve sometimes encounters other characters (‘mobs’), such as animals and hostile creatures.

He can ‘spawn’ and destroy them. While it looks like a harmless game of logical construction, it conveys some worryingly delusive ideas about female viagra for sale the real world. The difference between real and imagined structures is at the heart of the age-old debate around categorising mental disorders.Classification in mental health has had various forms throughout history. Mack and colleagues set out a history of psychiatric classification beginning female viagra for sale in 2600 BC with Egyptian references to melancholia and hysteria.

Through the Ancient Greeks with Hippocrates’ phrenitis, mania, melancholia, epilepsy, hysteria and Scythian disease. Through the Renaissance period. Through to 19th-century psychiatry featuring Pinel female viagra for sale (known as the first psychiatrist), Kraepelin (known for observational classification) and Freud (known for classifying neurosis and psychosis).1Although the history of psychiatric classification identifies some common trends such as the labels ‘melancholia’ and ‘hysteria’ which have survived millennia, the label ‘depression’ is relatively new. The earliest usage noted by Snaith is from 1899.

€˜in simple pathological depression…the patient exhibits a growing indifference to his former pursuits…’.2 Snaith noted that early 20th-century psychiatrists female viagra for sale like Adolf Meyer hoped that ‘depression’ would come to encompass a broad category under which descriptions of subtypes would emerge. This did not happen until the middle of the 20th century. With the publication of the sixth International Classification of Diseases (ICD) in 1948 and the Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1952 and their subsequent revisions, the latter half of the 20th century has seen depression subtype labels proliferate. In their study of the social determinants of diagnostic labels in depression, McPherson and Armstrong illustrate how the codification of depression subtypes in the latter half of the 20th century has been shaped by the evolving context of psychiatry, including power struggles within the profession, a move to community care female viagra for sale and the development of psychopharmacology.3During this period, McPherson and Armstrong describe how subsequent versions of the DSM served as battlegrounds for professional disputes and philosophical quarrels around categorisation of mental disorders.

DSM I and DSM II have been described as products of an American Psychiatric Association dominated by psychoanalytic psychiatrists.4 DSM III and DSM III-R have been described as a radical rejection of psychoanalytic thinking, a ‘neo-Kraepelinian revolution’, a reference to the observational descriptive techniques of 19th-century psychiatrist Emil Kraepelin who classified mental disorders into two broad categories. €˜dementia praecox’ and ‘manic-depression’.5 DSM III was seen by some as a turning point in the use of the medical model female viagra for sale of mental illness, through provision of specific inclusion and exclusion criteria, and use of field trials and a multiaxial system.6 These latter technocratic additions to psychiatric labelling served to engender a much closer alignment between psychiatry, science and medicine.The codification of mental disorders in manuals has been described by Thomas Schacht as intrinsic to the relationship between science and politics and the way in which psychiatrists gain significant social power by aligning themselves to science.7 His argument drew on Szasz, who saw the mental health establishment as a therapeutic state. Zimbardo, who described psychiatric care as a controlling force. And Foucault, who described the categorisation of the mentally ill as a force for isolating ‘the other’.

Diagnostic critique has been further developed through a cultural relativist lens in that what Western psychiatrists classify as a depression is constructed differently in other cultures.8 Considering these limitations, some critics have gone so far as to argue that psychiatric diagnostic systems should be abolished.9Yet architects of DSM manuals have worked hard to ensure female viagra for sale the technology of classification is regarded as genuine scientific activity with sound roots in philosophy of science. In their philosophical defence of DSM IV, Allen Frances and colleagues address their critics under the headings ‘nominalism vs realism’, ‘empiricism vs rationalism’ and ‘categorical vs dimensional’.10 The implication is that there are opposing stances in which a choice must be made or a middle ground forged by those reasonable enough to recognise the need for pragmatism in the service of clinical utility. The nominalism–realism debate is illustrated using as metaphor three different female viagra for sale stances a cricket umpire might take on calling strikes and balls. The discussion sets out two of these as extreme views.

€˜at one extreme…those who take a reductionistically realistic view of the world’ versus ‘the solipsistic nominalists…might content that nothing exists’. Szasz, who is characterised as holding particularly extreme views, is named as an archetypal solipsist female viagra for sale. There is implied to be a degree of arrogance associated with this view in the illustrative example in which the umpire states ‘there are no balls and there are no strikes until I call them’. Frances therefore sets up a means of grouping two kinds of people as philosophical extremists female viagra for sale who can be dismissed, while avoiding addressing the philosophical problems they pose.Frances provides little if any justification for the middle ground stance, ‘There are balls and there are strikes and I call them as I see them’, other than to focus on its clinical utility and the lack of clinical utility in the alternatives ‘naïve realism’ and ‘heuristically barren solipsism’.

The natural conclusion the reader is invited to reach is that a middle ground of a heuristic concept is naturally right because it is not extreme and is naturally useful clinically, without specifying in what way this stance is coherent, resolves the two alternatives, and in what way a heuristic construct that is not ‘real’ can be subject to scientific testing.Similarly, in discussing the ‘categorical vs dimensional’, Frances promotes the ‘prototype approach’. Those holding opposing views are labelled as ‘dualists’ or ‘dichotomisers’. The prototypical approach is again put forward female viagra for sale as a clinically useful middle ground. Illustrations are drawn from natural science.

€˜a triangle female viagra for sale and a square are never the same’, inciting the reader to consider science as value-free. The prototypical approach emerges as a natural solution, yet the authors do not address how a diagnostic prototype resolves the issues posed by the two alternatives, nor how a prototype can be subjected to natural science methods.The argument presented here is not a defence of solipsism or dualism. Rather it aims to illustrate that if for pragmatic purposes clinicians and policymakers choose to gloss over the philosophical flaws in classification practices, it is then risky to move beyond the heuristic and apply natural science methods to these constructs adding multiple layers of technocratic subclassification. Doing so is more like playing Minecraft female viagra for sale than cricket.

The National Institute for Health and Care Excellence (NICE) guideline for depression is taken as an example of the philosophical errors that can follow from playing Minecraft with unsound heuristic devices, specifically subcategories of persistent forms of depression. As well as serving a clinical purpose, diagnosis in medicine is a way of allocating resources for female viagra for sale insurance companies and constructing clinical guidelines, which in turn determine rationing within the National Health Service. The consequences for recipients of healthcare are therefore significant. Clinical utility is arguably not being served at all and patients are left at risk of poor-quality care.Heterogeneity of persistent depressionAndrea Jobst and colleagues note that ‘because of their chronic clinical course, approximately 40% of CD [chronic depression] patients also fulfil criteria for TRD [treatment resistant depression]…usually defined by the number of non-successful biological treatments’.11 This position is reflected in the DSM VAmerican Psychiatric Association (2013), the European Psychiatric Association (EPA) guidance and the ICD-11(World Health Organisation, 2018), which all use a ‘persistent’ depression category, acknowledging a loosely defined mixed group of long-term, difficult-to-treat depressive conditions, often associated with dysthymia and comorbid common mental disorders, various personality traits and psychosocial disability.In contrast, the NICE 2018 draft guideline separates treatments into those for ‘new episodes’ of depression.

€˜further-line’ treatment of depression (equivalent to TRD), CD and female viagra for sale ‘depression with co-morbidities’. The latter is subdivided into treatments for ‘complex depression’ and ‘psychotic depression’. These categories female viagra for sale and subcategories introduce an unfortunate sense of certainty as though these labels represent real things. An analysis follows of how these definitions play out in terms of grouping of randomised controlled trials in the NICE evidence review.

Specifically, the analysis reveals the overlap between populations in trials which have been separated into discrete categories, revealing significant limitations to the utility of the category labels.The NICE definition of CD requires trial samples to meet the criteria for major depressive disorder (MDD) for 2 years. Dysthymia and double depression (MDD superimposed female viagra for sale on dysthymia) were included. If 75% of the trial population met these criteria, the trial was reviewed in the CD category.12 The definition of TRD (or ‘further-line treatments’) required that the trial sample had demonstrated a ‘limited response to previous treatment’ and randomised to the further-line treatment at this point. If 80% of the trial participants met female viagra for sale these criteria, it was reviewed in the TRD category.13 Complex depression was defined as ‘depression co-existing with personality disorder’.

To be classed as complex, 51% of trial participants had to have personality disorder (PD).14It is immediately clear from these definitions that there is a potential problem with attempting to categorise trial populations into just one of these categories. These populations are likely to overlap, whether or not a trial protocol sets out to explicitly record all of this information. The analysis below will illustrate this using examples from female viagra for sale within the NICE review.Cataloguing complexity in trial populationsWithin the category of further-line treatments (TRD), 64 trials were reviewed. Comparisons within these trials were further subcategorised into ‘dose escalation strategies’, ‘augmentation strategies’ and ‘switching strategies’.

In drilling down by way of illustration, this analysis considers the 51 trials in the augmentation strategy evidence review female viagra for sale. Of these, two were classified by the reviewers as also fulfilling the criteria for CD but were not analysed in the CD category (Study IDs. Fonagy 2015 and Kocsis 200915). About half of the trials (23/51) did not report the mean duration of episode, meaning that it is not possible to know what female viagra for sale percentage of participants also met the criteria for CD.

Of trials that did report episode duration, 17 reported a mean duration longer than 24 months. While the standard deviations varied in size or were unreported, the mean indicates a good likelihood that a significant proportion of the participants across these 51 trials met the criteria for CD.Details of baseline employment, trauma history, suicidality, physical comorbidity, axis I comorbidity female viagra for sale and PD (all clinical indicators of complexity, severity and chronicity) were not collated by NICE. For the present analysis, all 51 publications were examined and data compiled concerning clinical complexity in the trial populations. Only 14 of 51 trials report employment data.

Of those that do, female viagra for sale unemployment ranges from 12% to 56% across trial samples. None of the trials report trauma history. About half of the trials (26/51) excluded female viagra for sale people who were considered a suicide risk. The others did not.A large proportion of trials (30/51) did not provide any data on axis 1 comorbidity.

Of these, 18 did not exclude any diagnoses, while 12 excluded some (but not all) disorders. The most common diagnoses excluded were female viagra for sale psychotic disorders, substance or alcohol abuse, and bipolar disorder (excluded in 26, 25 and 23 trials, respectively). Only 7 of 51 trials clearly stated that all axis 1 diagnoses were excluded. This leaves female viagra for sale only 13 studies providing any data about comorbidity.

Of these, 9 gave partial data on one or two conditions, while 4 reported either the mean number of disorders (range 1.96–2.9) or the percentage of participants (range 68.1–96.7) with any comorbid diagnosis (Nierenberg 2003a, Nierenberg 2006, Watkins 2011a, Town 201715).The majority of trials (46/51) did not report the prevalence of PD. Many stated PD as an exclusion criterion but without defining a threshold for exclusion. For example, PD could be excluded if it ‘impacted’ the depression, if female viagra for sale it was ‘significant’, ‘severe’ or ‘persistent’. Some excluded certain PDs (such as antisocial or borderline) and not others but without reporting the prevalence of those not excluded.

In the five trials where prevalence was clear, prevalence ranged from 0% (Ravindran 2008a15), where all PDs were excluded, female viagra for sale to 87.5% of the sample (Town 201715). Two studies reported the mean number of PDs. 2.0 (Nierenberg 2003a) and 0.85 (Watkins 2011a15).The majority of trials (43/51) did not report the prevalence of physical illness. Many stated illness as an exclusion criterion, but the definitions and thresholds female viagra for sale were vague and could be interpreted in different ways.

For example, illness could be excluded if it was ‘unstable’, ‘serious’, ‘significant’, ‘relevant’, or would ‘contraindicate’ or ‘impact’ the medication. Of the eight trials reporting information about physical health, there female viagra for sale was a wide variation. Four reported prevalence varying from 7.6% having a disability (Eisendrath 201615) to 90.9% having an illness or disability (Town 201715). Four used scales of physical health.

Two indicating mild problems (Nierenberg 2006, Lavretsky 201115) and two indicating moderately high levels of illness (Thase 2007, Fang 201015).The NICE review also divided trial populations into a dichotomy of ‘more severe’ and ‘less severe’ on the grounds female viagra for sale that this would be a clinically useful classification for general practitioners. NICE applied a bespoke methodology for creating this dichotomy, abandoning validated measure thresholds in order first to generate two ‘homogeneous’ groups to ‘facilitate analysis’, and second to create an algorithm to ‘read across’ different measures (such as the Beck Depression Inventory, the Hamilton Rating Scale for Depression (HRSD) and the Montgomery-Asberg Depression Rating Scale).16 Examining trials which use more than one of these measures reveals problems in the algorithm. Of the 51 trials, there are 6 instances in female viagra for sale which the study population falls into NICE’s more severe category according to one measure and into the less severe category according to another. In four of these trials, NICE chose the less severe category (Souza 2016, Watkins 2011a, Fonagy 2015, Town 201715).

The other two trials were designated more severe (Barbee 2011, Dunner 200715). Only 17 of 51 trials reported two or more depression scale measures, leaving much unknown about whether other study populations could count as both female viagra for sale more severe and less severe.Absence of knowledge or knowledge of absence?. A key philosophical error in science is to confuse an absence of knowledge with knowledge of absence. It is likely that some of the study populations deemed lacking in complexity or severity could actually have high degrees of female viagra for sale complexity and/or severity.

Data to demonstrate this may either fall foul of a guideline committee decision to prioritise certain information over other conflicting information (as in the severity algorithm). The information may be non-existent as it was not collected. It may be somewhere in the female viagra for sale publication pipeline. Or it may be sitting in a database with a research team that has run out of funds for supplementary analyses.

Wherever those data are or are not, their absence from female viagra for sale published articles does not define the phenomenology of depression for the patients who took part. As a case in point, data from the Fonagy 2015 trial presented at conferences but not published reveal that PD prevalence data would place the trial well within the NICE complex depression category, and that the sample had high levels of past trauma and physical condition comorbidity. The trial also meets the guideline criteria for CD according to the guideline’s own appendices.17 Reported axis 1 comorbidity was high (75.2% had anxiety disorder, 18.6% had substance abuse disorder, 13.2% had eating disorder).18 The mean depression scores at baseline were 36.5 on the Beck Depression Inventory and 20.1 on the HRSD (severe and very severe, respectively, according to published cut-off scores). NICE categorised this population as less female viagra for sale severe TRD, not CD and not complex.Notes1.

Avram H. Mack et al female viagra for sale. (1994), “A Brief History of Psychiatric Classification. From the Ancients to DSM-IV,” Psychiatric Clinics 17, no.

Snaith (1987), “The Concepts of Mild Depression,” British Journal of Psychiatry 150, no. 3. 387.3. Susan McPherson and David Armstrong (2006), “Social Determinants of Diagnostic Labels in Depression,” Social Science &.

Grob (1991), “Origins of DSM-I. A Study in Appearance and Reality,” The American Journal of Psychiatry. 421–31.5. Wilson M.

Compton and Samuel B. Guze (1995), “The Neo-Kraepelinian Revolution in Psychiatric Diagnosis,” European Archives of Psychiatry and Clinical Neuroscience 245, no. 4. 198–9.6.

Gerald L. Klerman (1984), “A Debate on DSM-III. The Advantages of DSM-III,” The American Journal of Psychiatry. 539–42.7.

Thomas E. Schacht (1985), “DSM-III and the Politics of Truth,” American Psychologist. 513–5.8. Daniel F.

Hartner and Kari L. Theurer (2018), “Psychiatry Should Not Seek Mechanisms of Disorder,” Journal of Theoretical and Philosophical Psychology 38, no. 4. 189–204.9.

Sami Timimi (2014), “No More Psychiatric Labels. Why Formal Psychiatric Diagnostic Systems Should Be Abolished,” Journal of Clinical and Health Psychology 14, no. 3. 208–15.10.

Allen Frances et al. (1994), “DSM-IV Meets Philosophy,” The Journal of Medicine and Philosophy. A Forum for Bioethics and Philosophy of Medicine 19, no. 3.

207–18.11. Andrea Jobst et al. (2016), “European Psychiatric Association Guidance on Psychotherapy in Chronic Depression Across Europe,” European Psychiatry 33. 20.12.

National Institute for Health and Care Excellence (2018), Depression in Adults. Treatment and Management. Draft for Consultation, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/full-guideline-updated, 507.13. Ibid., 351–62.14.

Ibid., 597.15. Note that in order to refer to specific trials reviewed in the guideline, rather than the full citation, the Study IDs from column A in appendix J5 have been used. See www.nice.org.uk/guidance/gid-cgwave0725/documents/addendum-appendix-9 for details and full references.16. National Institute for Health and Care Excellence (2018), Depression in Adults.

Treatment and Management. Second Consultation on Draft Guideline – Stakeholder Comments Table, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/consultation-comments-and-responses-2, 420–1.17. National Institute for Health and Care Excellence (2018), Depression in Adults, appendix J5.18. Peter Fonagy et al.

(2015), “Pragmatic Randomized Controlled Trial of Long-Term Psychoanalytic Psychotherapy for Treatment-Resistant Depression. The Tavistock Adult Depression Study (TADS),” World Psychiatry 14, no. 3. 312–21.19.

American Psychological Association (2018), Clinical Practice Guideline for the Treatment of Depression in Children, Adolescents, and Young, Middle-aged, and Older Adults. Draft.20. Jacqui Thornton (2018), “Depression in Adults. Campaigners and Doctors Demand Full Revision of NICE Guidance,” BMJ 361.

Viagra for women price

Start Preamble Centers https://www.voiture-et-handicap.fr/where-to-buy-female-viagra/ for viagra for women price Medicare &. Medicaid Services (CMS), HHS. Extension of timeline viagra for women price 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 viagra for women price 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 viagra for women price 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' viagra for women price (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 viagra for women price 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 viagra for women price 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 viagra for women price 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) viagra for women price 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 viagra for women price 31, 2021. Start Signature Dated. August 24, 2020. Wilma M viagra for women price.

Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End viagra for women price 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 viagra for women price 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 viagra for women price 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 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus 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 COVID-19 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 COVID-19 (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 COVID-19 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 vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] 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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus 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 vaccine ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 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 COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines 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 COVID-19 pandemic, 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 infection-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 COVID-19. 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 infections 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 COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines 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 vaccines.[] 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 vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 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 COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine 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 vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.[] 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.[] 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 vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] 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 vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines 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 vaccine.[] 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 vaccines 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 vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines 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 pandemic and epidemic products that “limit the harm such pandemic 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 52140COVID-19 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 Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine 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 COVID-19.

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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus 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 COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, 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), vaccines 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 vaccine 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 vaccines, and the recognition and treatment of emergency reactions to vaccines. 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 vaccines, and the recognition and treatment of emergency reactions to vaccines. 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 vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. 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 Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine 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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus 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.

Start Preamble Centers for female viagra for sale Medicare go now &. Medicaid Services (CMS), HHS. Extension of female viagra for sale 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 female viagra for sale 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 female viagra for sale 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) female viagra for sale 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 female viagra for sale related services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically female viagra for sale 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 female viagra for sale 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 female viagra for sale 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 female viagra for sale until August 31, 2021. Start Signature Dated. August 24, 2020.

Wilma M female viagra for sale. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc female viagra for sale.

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 female viagra for sale 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 female viagra for sale 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 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus 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 COVID-19 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 COVID-19 (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 COVID-19 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 vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] 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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus 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 vaccine ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 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 COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines 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 COVID-19 pandemic, 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 infection-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 COVID-19.

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 infections 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 COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations.

Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines 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 vaccines.[] 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 vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 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 COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine 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 vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.[] 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.[] 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 vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] 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 vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines 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 vaccine.[] 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 vaccines 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 vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines 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 pandemic and epidemic products that “limit the harm such pandemic 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 52140COVID-19 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 Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine 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 COVID-19. 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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus 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 COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, 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), vaccines 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 vaccine 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 vaccines, and the recognition and treatment of emergency reactions to vaccines. 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 vaccines, and the recognition and treatment of emergency reactions to vaccines. 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 vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. 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 Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered countermeasures that are subject to the National Vaccine 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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus 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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Department of Health and Human Services declared it to be a health emergency for the United States.With schools nationwide preparing for fall and the federal government encouraging in-person classes, key concerns for school officials, teachers and parents include the risks that coronavirus poses to children and their role in transmission of the disease.A new KFF brief examines the latest available data and evidence about the issues around COVID-19 and children and what they suggest about the risks posed female viagra for sale for reopening classrooms. The review female viagra for sale concludes that while children are much less likely than adults to become severely ill, they can transmit the virus. Key findings include:Disease severity is significantly less in children, though rarely some do get very sick female viagra for sale. Children under age 18 account for 22% of the population but account for just female viagra for sale 7% of the more than 4 million COVID-19 cases and less than 1% of deaths.The evidence is mixed about whether children are less likely than adults to become infected when exposed. While one prominent study estimates children and teenagers are half as likely as adults over age 20 to catch the virus, other studies find children and adults are about equally likely to have antibodies that develop after a COVID-19 infection.While children do transmit to others, more evidence is needed on the frequency and extent of that transmission.

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There’s a reason for that, does viagra lower your blood pressure too how long does viagra last in your system. For the past few weeks I’ve seen Facebook posts daily from former nursing colleagues in metro Detroit, one of the hardest hit areas in the country, as they provide front-line care to patients with COVID-19. It makes me very proud to call these nurses my friends. As a former emergency department nurse, I recall the feeling of satisfaction knowing that I’ve how long does viagra last in your system helped someone on the worst day of their life. One of the best parts of being a nurse is knowing you matter to the only person in health care that truly matters.

The patient. Several years ago I made the difficult decision to no longer perform bedside nursing and become how long does viagra last in your system a nurse administrator. The biggest loss from my transition is the feeling that what I do matters to the patient. COVID-19 has forced a lot of us to rethink the role we play in health care and what the real priority should be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in how long does viagra last in your system a pandemic or prepare for the unknown future of, “When is our turn?.

€ For me, COVID-19 has reignited the feeling that what I do matters as virtual care has become a powerful tool on the forefront of care during this crisis. It has also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be discarded permanently. When I became the director of virtual care at our organization in how long does viagra last in your system 2015 I knew nothing about telehealth. Sure, I had seen a stroke robot in some Emergency Departments, and I had some friends that told me their insurance company lets them FaceTime a doctor for free (spoiler alert. It’s not FaceTime).

I was tech-savvy from a how long does viagra last in your system consumer perspective and a tech novice from an IT perspective. Nevertheless, my team and I spent the next few years learning as we built one of the higher volume virtual care networks in the state of Michigan. We discovered a lot of barriers that keep virtual care from actually making the lives of patients and providers better and we also became experts in working around those barriers. But, there were two obstacles that we could not how long does viagra last in your system overcome. Government regulation and insurance provider willingness to cover virtual visits.

These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care technologies to provide care outside of our brick-and-mortar facilities, most commonly in the patient home. The how long does viagra last in your system need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in place created instant demand for direct-to-consumer virtual care. In all honesty, I’ve always considered direct-to-consumer virtual care to be the flashy, must-have holiday gift of the year that organizations are convinced will be the way of the future. If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of vendors that will sell them their app and their doctors and put the health system’s logo on it. What a health system will struggle with is to find is enough patient demand to cover the high how long does viagra last in your system cost.

Remember my friends from earlier that told me about the app their insurance gave them?. Nearly all of them followed that up by telling me they’ve never actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how long does viagra last in your system how can we provide care that our patients actually want and need from the doctors they want to see. Ironically, this fiscal year we had a corporate top priority around direct-to-consumer virtual care. We wanted to expand what we thought were some successful pilots and perform 500 direct-to-consumer visits.

This year how long does viagra last in your system has been one of the hardest of my leadership career because, frankly, up until a month ago I was about to fail on this top priority. With only four months left, we were only about halfway there. The biggest problem we ran into was that every great idea a physician brought to me was instantly dead in the water because practically no insurance company would pay for it. There are (prior to COVID-19) a plethora of rules around virtual care billing but the simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health how long does viagra last in your system care facility. It is extremely limited what will be paid for in the patient home and most of it is so specific that the average patient isn’t eligible to get any in-home virtual care.

Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the physician to forgo reimbursement for a visit that would be covered if it happened in office. Add to that the massive capital and operating how long does viagra last in your system expenses it takes to build a virtual care network and you can see why these programs don’t exist. A month ago I was skeptical we’d have a robust direct-to-consumer program any time soon and then COVID-19 hit. When COVID-19 started to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they would temporarily begin reimbursing for virtual visits conducted in the patient’s home how long does viagra last in your system for COVID-19 and non-COVID related visits.

We were already frantically designing a virtual program to handle the wave of COVID-19 screening visits that were overloading our emergency departments and urgent cares. We were having plenty of discussions around reimbursement for this clinic. Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community how long does viagra last in your system benefit and eat the cost?. The CMS waiver gave us hope that we would be compensated for diverting patients away from reimbursed visits to a virtual visit that is more convenient for the patient and aligns with the concept of social distancing. Realistically we don’t know if we will be paid for any of this.

We are holding all of the bills for at least 90 days while the industry sorts out how long does viagra last in your system the rules. I was excited by the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care barriers. However, I was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed. I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that how long does viagra last in your system the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, Facebook, Skype, etc.) that they use every day. The problem is nearly every app the consumer uses on a daily basis is banned by HIPAA because “it’s not secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet again gave me strep throat but apparently the concern is great enough to stifle the entire industry.

Sure, not every health care discussion is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten how long does viagra last in your system regulations surrounding specific health conditions. The idea that regulations change based on medical situation is not new. For example, in my home state of Michigan, adolescents are essentially considered emancipated if it involves sexual health, mental health or does insurance cover viagra substance abuse. Never mind that this same information is freely given over the phone by every office around the country daily how long does viagra last in your system without issue, but I digress.

While my job is to innovate new pathways for care, our lawyer’s job is to protect the organization and he, along with IT security, rightfully shot down my consumer applications idea. A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications. The elimination of billing restrictions and HIPAA regulations changed how long does viagra last in your system what is possible for health care organizations to offer virtually. Unfortunately both changes are listed as temporary and will likely be removed when the pandemic ends. Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any patient that wanted a direct-to-consumer video visit to be screened by a provider for COVID-19.

It allows patients how long does viagra last in your system to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them. They don’t have to download an app, create an account or even be an established patient of our health system. It saw over 900 patients in the first 12 days it was open. That is 900 real patients that received care from a how long does viagra last in your system physician or advanced practice provider without risking personal exposure and without going to an already overwhelmed ED or urgent care. To date, 70 percent of the patients seen by the virtual clinic did not meet CDC testing criteria for COVID-19.

I don’t believe we could have reached even half of these patients had the consumer application restrictions been kept. A program like this almost how long does viagra last in your system certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement in normal times. Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and payors being on the same page is what fueled this fire. During the virtual clinic’s first two weeks, my team turned its attention to getting over 300 providers across 60+ offices virtual so they could see their patients at home. Imagine being an how long does viagra last in your system immunocompromised cancer patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist.

Direct-to-consumer virtual care is the best way to safely care for these patients and without these temporary waivers it wouldn’t be covered by insurance even if you did navigate the clunky apps that are HIPAA compliant. Do we really think the immunocompromised cancer patient feels any more comfortable every normal flu season?. Is it any more appropriate to ask them to risk exposure to the flu than it is how long does viagra last in your system to COVID-19?. And yet we deny them this access in normal times and it quite possibly will be stripped away from them when this crisis is over. Now 300 to 400 patients per day in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits.

Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use the software that how long does viagra last in your system connects us to the patient. Lastly, recall that prior to COVID-19, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. COVID-19 has been a wake-up call to the whole country and health care is no exception. It has put priorities in perspective how long does viagra last in your system and shined a light on what is truly value-added. For direct-to-consumer virtual care it has shown us what is possible when we get out of our own way.

If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first place. HIPAA regulation cannot go back to its antiquated practices if we are how long does viagra last in your system truly going to shift the focus to patient wellness. CMS and private payors must embrace value-added direct-to-consumer virtual care and allow patients the access they deserve. COVID-19 has forced this industry forward, we cannot allow it to regress and be forgotten when this is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division how long does viagra last in your system of the University of Michigan.

The views and opinions expressed in this commentary are his own.When dealing with all of the aspects of diabetes, it’s easy to let your feel fall to the bottom of the list. But daily care and evaluation is one of the best ways to prevent foot complications. It’s important to identify how long does viagra last in your system your risk factors and take the proper steps in limiting your complications. Two of the biggest complications with diabetes are peripheral neuropathy and ulcer/amputation. Symptoms of peripheral neuropathy include numbness, tingling and/or burning in your feet and legs.

You can slow how long does viagra last in your system the progression of developing neuropathy by making it a point to manage your blood sugars and keep them in the normal range. If you are experiencing these symptoms, it is important to establish and maintain a relationship with a podiatrist. Your podiatrist can make sure things are looking healthy and bring things to your attention to monitor and keep a close eye on. Open wounds or how long does viagra last in your system ulcers can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation. If ulcerations do develop, it’s extremely important to identify the cause and address it.

Ulcers can get worse quickly, so it’s necessary to seek immediate medical treatment if you find yourself or a loved one dealing with this complication. Untreated ulcerations often lead to how long does viagra last in your system amputation and can be avoided if proper medical attention is sought right away. There are important things to remember when dealing with diabetic foot care. It’s very important to inspect your feet daily, especially if you have peripheral neuropathy. You may have a cut or a sore on your feet that you can’t feel, so your body doesn’t alarm you to check your feet.

Be gentle when bathing your feet. Moisturize your feet, but not between your toes. Do not treat calluses or corns on your own. Wear clean, dry socks. Never walk barefoot, and consider socks and shoes made specifically for patients with diabetes.

Kristin Raleigh, D.P.M., is a podiatrist who sees patients at Foot &.

The odds are it’s not available to you, and there female viagra for sale is a reason for that. You may be hearing about how virtual care, often described as telehealth or telemedicine, is beneficial during COVID-19 and how health systems are offering virtual access like never before. There’s a reason for that, too.

For the past few weeks I’ve seen Facebook posts daily from former nursing colleagues in metro female viagra for sale Detroit, one of the hardest hit areas in the country, as they provide front-line care to patients with COVID-19. It makes me very proud to call these nurses my friends. As a former emergency department nurse, I recall the feeling of satisfaction knowing that I’ve helped someone on the worst day of their life.

One of the best parts of being a nurse is knowing you matter to female viagra for sale the only person in health care that truly matters. The patient. Several years ago I made the difficult decision to no longer perform bedside nursing and become a nurse administrator.

The biggest loss female viagra for sale from my transition is the feeling that what I do matters to the patient. COVID-19 has forced a lot of us to rethink the role we play in health care and what the real priority should be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a pandemic or prepare for the unknown future of, “When is our turn?.

€ For me, COVID-19 has reignited the feeling that what I do matters as virtual care has become a powerful tool female viagra for sale on the forefront of care during this crisis. It has also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be discarded permanently. When I became the director of virtual care at our organization in 2015 I knew nothing about telehealth.

Sure, I had seen female viagra for sale a stroke robot in some Emergency Departments, and I had some friends that told me their insurance company lets them FaceTime a doctor for free (spoiler alert. It’s not FaceTime). I was tech-savvy from a consumer perspective and a tech novice from an IT perspective.

Nevertheless, my team and I spent the next few years learning as we built one of the higher volume female viagra for sale virtual care networks in the state of Michigan. We discovered a lot of barriers that keep virtual care from actually making the lives of patients and providers better and we also became experts in working around those barriers. But, there were two obstacles that we could not overcome.

Government regulation and insurance provider willingness to cover female viagra for sale virtual visits. These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care technologies to provide care outside of our brick-and-mortar facilities, most commonly in the patient home. The need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in place created instant demand for direct-to-consumer virtual care.

In all female viagra for sale honesty, I’ve always considered direct-to-consumer virtual care to be the flashy, must-have holiday gift of the year that organizations are convinced will be the way of the future. If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of vendors that will sell them their app and their doctors and put the health system’s logo on it. What a health system will struggle with is to find is enough patient demand to cover the high cost.

Remember my female viagra for sale friends from earlier that told me about the app their insurance gave them?. Nearly all of them followed that up by telling me they’ve never actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how can we provide care that our patients actually want and need from the doctors they want to see.

Ironically, this fiscal year we had a female viagra for sale corporate top priority around direct-to-consumer virtual care. We wanted to expand what we thought were some successful pilots and perform 500 direct-to-consumer visits. This year has been one of the hardest of my leadership career because, frankly, up until a month ago I was about to fail on this top priority.

With only four months left, we female viagra for sale were only about halfway there. The biggest problem we ran into was that every great idea a physician brought to me was instantly dead in the water because practically no insurance company would pay for it. There are (prior to COVID-19) a plethora of rules around virtual care billing but the simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health care facility.

It is extremely limited what will be paid for in the patient home female viagra for sale and most of it is so specific that the average patient isn’t eligible to get any in-home virtual care. Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the physician to forgo reimbursement for a visit that would be covered if it happened in office. Add to that the massive capital and operating expenses it takes to build a virtual care network and you can see why these programs don’t exist.

A month ago I was skeptical we’d female viagra for sale have a robust direct-to-consumer program any time soon and then COVID-19 hit. When COVID-19 started to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they would temporarily begin reimbursing for virtual visits conducted in the patient’s home for COVID-19 and non-COVID related visits.

We were already frantically designing a virtual program to handle the wave of COVID-19 screening visits that female viagra for sale were overloading our emergency departments and urgent cares. We were having plenty of discussions around reimbursement for this clinic. Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community benefit and eat the cost?.

The CMS waiver gave us hope that we would be compensated for diverting patients away from reimbursed visits to female viagra for sale a virtual visit that is more convenient for the patient and aligns with the concept of social distancing. Realistically we don’t know if we will be paid for any of this. We are holding all of the bills for at least 90 days while the industry sorts out the rules.

I was excited by the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care barriers female viagra for sale. However, I was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed. I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, Facebook, Skype, etc.) that they use every day.

The problem is nearly every app the consumer uses female viagra for sale on a daily basis is banned by HIPAA because “it’s not secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet again gave me strep throat but apparently the concern is great enough to stifle the entire industry. Sure, not every health care discussion is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten regulations surrounding specific health conditions.

The idea that regulations female viagra for sale change based on medical situation is not new. For example, in my home state of Michigan, adolescents are essentially considered emancipated if it involves sexual health, mental health or substance abuse. Never mind that this same information is freely given over the phone by every office around the country daily without issue, but I digress.

While my job is to innovate new pathways for care, our lawyer’s job is to protect the organization female viagra for sale and he, along with IT security, rightfully shot down my consumer applications idea. A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications. The elimination of billing restrictions and HIPAA regulations changed what is possible for health care organizations to offer virtually.

Unfortunately both changes are listed female viagra for sale as temporary and will likely be removed when the pandemic ends. Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any patient that wanted a direct-to-consumer video visit to be screened by a provider for COVID-19. It allows patients to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them.

They don’t have to download female viagra for sale an app, create an account or even be an established patient of our health system. It saw over 900 patients in the first 12 days it was open. That is 900 real patients that received care from a physician or advanced practice provider without risking personal exposure and without going to an already overwhelmed ED or urgent care.

To date, 70 percent of female viagra for sale the patients seen by the virtual clinic did not meet CDC testing criteria for COVID-19. I don’t believe we could have reached even half of these patients had the consumer application restrictions been kept. A program like this almost certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement in normal times.

Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and payors being on the same page is what fueled this female viagra for sale fire. During the virtual clinic’s first two weeks, my team turned its attention to getting over 300 providers across 60+ offices virtual so they could see their patients at home. Imagine being an immunocompromised cancer patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist.

Direct-to-consumer virtual care is the best way to safely care for these patients and without these temporary waivers it wouldn’t be female viagra for sale covered by insurance even if you did navigate the clunky apps that are HIPAA compliant. Do we really think the immunocompromised cancer patient feels any more comfortable every normal flu season?. Is it any more appropriate to ask them to risk exposure to the flu than it is to COVID-19?.

And female viagra for sale yet we deny them this access in normal times and it quite possibly will be stripped away from them when this crisis is over. Now 300 to 400 patients per day in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits. Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use the software that connects us to the patient.

Lastly, recall female viagra for sale that prior to COVID-19, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. COVID-19 has been a wake-up call to the whole country and health care is no exception. It has put priorities in perspective and shined a light on what is truly value-added.

For direct-to-consumer virtual care it female viagra for sale has shown us what is possible when we get out of our own way. If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first place. HIPAA regulation cannot go back to its antiquated practices if we are truly going to shift the focus to patient wellness.

CMS and private payors must female viagra for sale embrace value-added direct-to-consumer virtual care and allow patients the access they deserve. COVID-19 has forced this industry forward, we cannot allow it to regress and be forgotten when this is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of Michigan.

The views and opinions expressed in female viagra for sale this commentary are his own.When dealing with all of the aspects of diabetes, it’s easy to let your feel fall to the bottom of the list. But daily care and evaluation is one of the best ways to prevent foot complications. It’s important to identify your risk factors and take the proper steps in limiting your complications.

Two of female viagra for sale the biggest complications with diabetes are peripheral neuropathy and ulcer/amputation. Symptoms of peripheral neuropathy include numbness, tingling and/or burning in your feet and legs. You can slow the progression of developing neuropathy by making it a point to manage your blood sugars and keep them in the normal range.

If you are experiencing these symptoms, female viagra for sale it is important to establish and maintain a relationship with a podiatrist. Your podiatrist can make sure things are looking healthy and bring things to your attention to monitor and keep a close eye on. Open wounds or ulcers can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation.

If ulcerations do develop, it’s extremely important female viagra for sale to identify the cause and address it. Ulcers can get worse quickly, so it’s necessary to seek immediate medical treatment if you find yourself or a loved one dealing with this complication. Untreated ulcerations often lead to amputation and can be avoided if proper medical attention is sought right away.

There are important female viagra for sale things to remember when dealing with diabetic foot care. It’s very important to inspect your feet daily, especially if you have peripheral neuropathy. You may have a cut or a sore on your feet that you can’t feel, so your body doesn’t alarm you to check your feet.

Be gentle when female viagra for sale bathing your feet. Moisturize your feet, but not between your toes. Do not treat calluses or corns on your own.

Viagra 200mg

Imaging the encephalopathy of prematurityJulia Kline and colleagues assessed viagra 200mg MRI findings at term in 110 preterm infants born before 32 weeks’ gestation and cared for in four neonatal units url in Columbus, Ohio. Using automated cortical and sub-cortical segmentation they analysed cortical surface area, sulcal depth, gyrification index, inner cortical curvature and thickness. These measures of brain development and maturation were related to the outcomes of viagra 200mg cognitive and language testing undertaken at 2 years corrected age using the Bayley-III. Increased surface area in nearly every brain region was positively correlated with Bayley-III cognitive and language scores.

Increased inner cortical curvature was negatively correlated with both outcomes. Gyrification index and sulcal depth did not viagra 200mg follow consistent trends. These metrics retained their significance after sex, gestational age, socio-economic status and global injury score on structural MRI were included in the analysis. Surface area and inner cortical curvature explained approximately one-third of the variance in Bayley-III scores.In an accompanying editorial, David Edwards characterises the complexity of imaging and interpreting the combined effects of injury and dysmaturation on the developing brain.

Major structural lesions are present in a minority of infants and the problems observed in later childhood require a viagra 200mg much broader understanding of the effects of prematurity on brain development. Presently these more sophisticated image-analysis techniques provide insights at a population level but the variation between individuals is such that they are not sufficiently predictive at an individual patient level to be of practical use to parents or clinicians in prognostication. Studies like this highlight the importance of follow-up programmes and help clinicians to avoid falling into the trap of equating normal (no major structural lesion) imaging studies with normal long term outcomes. See pages F460 and F458Drift at 10 yearsKaren Luuyt and colleagues report the cognitive outcomes at 10 years of the DRIFT (drainage, viagra 200mg irrigation and fibrinolytic therapy) randomised controlled trial of treatment for post haemorrhagic ventricular dilatation.

They are to be congratulated for continuing to track these children and confirming the persistence of the cognitive advantage of the treatment that was apparent from earlier follow-up. Infants who received DRIFT were almost twice as likely to survive viagra 200mg without severe cognitive disability than those who received standard treatment. While the confidence intervals were wide, the point estimate suggests that the number needed to treat for DRIFT to prevent one death or one case of severe cognitive disability was 3. The original trial took place between 2003 and 2006 and was stopped early because of concerns about secondary intraventricular haemorrhage and it was only on follow-up that the advantages of the treatment became apparent.

The study shows that secondary brain viagra 200mg injury can be reduced by washing away the harmful debris of IVH. No other treatment for post-haemorrhagic ventricular dilatation has been shown to be beneficial in a randomised controlled trial. Less invasive approaches to CSF drainage at different thresholds of ventricular enlargement later in the clinical course have not been associated with similar advantage. However the DRIFT treatment is complex and invasive and could only be provided in a small number of specialist referral centres and logistical challenges will need to be overcome to evaluate the viagra 200mg treatment approach further.

See page F466Chest compressionsWith a stable infant in the neonatal unit, it is common to review the events of the initial stabilisation and to speculate on whether chest compressions were truly needed to establish an effective circulation, or whether their use reflected clinician uncertainty in the face of other challenges. Anne Marthe Boldinge and colleagues provide some objective data on the subject. They analysed videos that were recorded during neonatal stabilisation in viagra 200mg a single centre with 5000 births per annum. From a birth population of almost 1200 infants there were good quality video recordings from 327 episodes of initial stabilisation where positive pressure ventilation was provided and 29 of these episodes included the provision of chest compressions, mostly in term infants.

6/29 of the infants who received chest compressions were retrospectively judged to have needed them. 8/29 had viagra 200mg adequate spontaneous respiration. 18/29 received ineffective positive pressure ventilation prior to chest compressions. 5/29 had a heart rate greater than 60 beats per minute at the time of chest viagra 200mg compressions.

A consistent pattern of ventilation corrective actions was not identified. One infant received chest compressions without prior heart rate assessment. See page 545Propofol for neonatal endotracheal intubationMost clinicians provide sedation/analgesia for neonatal intubations but there is viagra 200mg still a lot of uncertainty about the best approach. Ellen de Kort and colleagues set out to identify the dose of propofol that would provide adequate sedation for neonatal intubation without side-effects.

They conducted a dose-finding trial which evaluated a range of doses in infants of different gestations. They ended their study after 91 infants because they only achieved adequate sedation without side effects in 13% of viagra 200mg patients. Hypotension (mean blood pressure below post-mentrual age in the hour after treatment) was observed in 59% of patients. See page 489Growth to early adulthood following extremely preterm birthThe EPICure cohort comprised all babies born at 25 completed weeks of gestation or less in all 276 maternity units in the UK and Ireland from March to December 1995.

Growth data viagra 200mg into adulthood are sparse for such immature infants. Yanyan Ni and colleagues report the growth to 19 years of 129 of the cohort in comparison with contemporary term born controls. The extremely preterm infants were on average 4.0 cm shorter and 6.8 kg lighter with a 1.5 cm smaller head circumference relative to viagra 200mg controls at 19 years. Body mass index was significantly elevated to +0.32 SD.

With practice changing to include the provision of life sustaining treatment to greater numbers of infants born at 22 and 23 weeks of gestation there is a strong case for further cohort studies to include this population of infants. See page F496Premature birth is a worldwide problem, and the most significant cause of loss of disability-adjusted viagra 200mg life years in children. Impairment and disability among survivors are common. Cerebral palsy is diagnosed in around 10% of infants born before 33 weeks of gestation, although the rates approximately double in the smallest and most vulnerable infants, and other motor disturbances are being detected in 25%–40%.

Cognitive, socialisation viagra 200mg and behavioural problems are apparent in around half of preterm infants, and there is increased incidence of neuropsychiatric disorders, which develop as the children grow older. Adults born preterm are approximately seven times more likely to be diagnosed with bipolar disease.1 2The neuropathological basis for these long-term and debilitating disorders is often unclear. Brain imaging by ultrasound or MRI shows that only a relatively small proportion of infants have significant destructive brain lesions, and these major lesions are not detected commonly enough to account for the prevalence of long-term impairments. However, abnormalities of brain growth and maturation are common, and it is now apparent that, in addition to recognisable cerebral damage, adverse neurological, cognitive and psychiatric outcomes are consistently viagra 200mg associated with abnormal cerebral maturation and development.Currently, most clinical decision-making remains focused around a number of well-described cerebral lesions usually detected in routine practice using cranial ultrasound.

Periventricular haemorrhage is common. Severe haemorrhages are associated with long-term adverse outcomes, and in infants born before 33 weeks of gestation, haemorrhagic parenchymal infarction predicts motor deficits ….

Imaging the encephalopathy of prematurityJulia Kline and colleagues assessed MRI female viagra for sale findings at term in 110 preterm infants born before 32 weeks’ gestation and cared for in four neonatal units in Columbus, Ohio. Using automated cortical and sub-cortical segmentation they analysed cortical surface area, sulcal depth, gyrification index, inner cortical curvature and thickness. These measures of brain development and maturation were related to the outcomes of cognitive and language testing undertaken at 2 years corrected female viagra for sale age using the Bayley-III. Increased surface area in nearly every brain region was positively correlated with Bayley-III cognitive and language scores.

Increased inner cortical curvature was negatively correlated with both outcomes. Gyrification index and female viagra for sale sulcal depth did not follow consistent trends. These metrics retained their significance after sex, gestational age, socio-economic status and global injury score on structural MRI were included in the analysis. Surface area and inner cortical curvature explained approximately one-third of the variance in Bayley-III scores.In an accompanying editorial, David Edwards characterises the complexity of imaging and interpreting the combined effects of injury and dysmaturation on the developing brain.

Major structural lesions are present in a minority of infants and the problems observed in later childhood require a much broader female viagra for sale understanding of the effects of prematurity on brain development. Presently these more sophisticated image-analysis techniques provide insights at a population level but the variation between individuals is such that they are not sufficiently predictive at an individual patient level to be of practical use to parents or clinicians in prognostication. Studies like this highlight the importance of follow-up programmes and help clinicians to avoid falling into the trap of equating normal (no major structural lesion) imaging studies with normal long term outcomes. See pages F460 and F458Drift at 10 yearsKaren Luuyt and colleagues report the cognitive outcomes at 10 years of female viagra for sale the DRIFT (drainage, irrigation and fibrinolytic therapy) randomised controlled trial of treatment for post haemorrhagic ventricular dilatation.

They are to be congratulated for continuing to track these children and confirming the persistence of the cognitive advantage of the treatment that was apparent from earlier follow-up. Infants who received DRIFT were almost twice as likely to survive without severe cognitive disability than those who received standard female viagra for sale treatment. While the confidence intervals were wide, the point estimate suggests that the number needed to treat for DRIFT to prevent one death or one case of severe cognitive disability was 3. The original trial took place between 2003 and 2006 and was stopped early because of concerns about secondary intraventricular haemorrhage and it was only on follow-up that the advantages of the treatment became apparent.

The study shows that secondary brain injury can be reduced by washing away the harmful female viagra for sale debris of IVH. No other treatment for post-haemorrhagic ventricular dilatation has been shown to be beneficial in a randomised controlled trial. Less invasive approaches to CSF drainage at different thresholds of ventricular enlargement later in the clinical course have not been associated with similar advantage. However the DRIFT treatment is complex and invasive and could only be provided in a small number of specialist referral centres and logistical challenges will need female viagra for sale to be overcome to evaluate the treatment approach further.

See page F466Chest compressionsWith a stable infant in the neonatal unit, it is common to review the events of the initial stabilisation and to speculate on whether chest compressions were truly needed to establish an effective circulation, or whether their use reflected clinician uncertainty in the face of other challenges. Anne Marthe Boldinge and colleagues provide some objective data on the subject. They analysed videos that were recorded during neonatal stabilisation in a female viagra for sale single centre with 5000 births per annum. From a birth population of almost 1200 infants there were good quality video recordings from 327 episodes of initial stabilisation where positive pressure ventilation was provided and 29 of these episodes included the provision of chest compressions, mostly in term infants.

6/29 of the infants who received chest compressions were retrospectively judged to have needed them. 8/29 had adequate female viagra for sale spontaneous respiration. 18/29 received ineffective positive pressure ventilation prior to chest compressions. 5/29 had female viagra for sale a heart rate greater than 60 beats per minute at the time of chest compressions.

A consistent pattern of ventilation corrective actions was not identified. One infant received chest compressions without prior heart rate assessment. See page 545Propofol for neonatal endotracheal intubationMost clinicians provide sedation/analgesia for neonatal intubations but there is still a lot of uncertainty about female viagra for sale the best approach. Ellen de Kort and colleagues set out to identify the dose of propofol that would provide adequate sedation for neonatal intubation without side-effects.

They conducted a dose-finding trial which evaluated a range of doses in infants of different gestations. They ended their study after 91 infants because they only achieved adequate sedation without side effects in female viagra for sale 13% of patients. Hypotension (mean blood pressure below post-mentrual age in the hour after treatment) was observed in 59% of patients. See page 489Growth to early adulthood following extremely preterm birthThe EPICure cohort comprised all babies born at 25 completed weeks of gestation or less in all 276 maternity units in the UK and Ireland from March to December 1995.

Growth data into adulthood are sparse for such immature female viagra for sale infants. Yanyan Ni and colleagues report the growth to 19 years of 129 of the cohort in comparison with contemporary term born controls. The extremely preterm infants were on average 4.0 cm shorter and 6.8 kg lighter with a 1.5 cm smaller head circumference relative female viagra for sale to controls at 19 years. Body mass index was significantly elevated to +0.32 SD.

With practice changing to include the provision of life sustaining treatment to greater numbers of infants born at 22 and 23 weeks of gestation there is a strong case for further cohort studies to include this population of infants. See page F496Premature birth is a worldwide problem, female viagra for sale and the most significant cause of loss of disability-adjusted life years in children. Impairment and disability among survivors are common. Cerebral palsy is diagnosed in around 10% of infants born before 33 weeks of gestation, although the rates approximately double in the smallest and most vulnerable infants, and other motor disturbances are being detected in 25%–40%.

Cognitive, socialisation and behavioural problems are apparent in around half of preterm infants, and there is increased incidence of neuropsychiatric disorders, which develop as the children grow female viagra for sale older. Adults born preterm are approximately seven times more likely to be diagnosed with bipolar disease.1 2The neuropathological basis for these long-term and debilitating disorders is often unclear. Brain imaging by ultrasound or MRI shows that only a relatively small proportion of infants have significant destructive brain lesions, and these major lesions are not detected commonly enough to account for the prevalence of long-term impairments. However, abnormalities of brain growth and maturation are common, and it is now apparent that, in addition to recognisable cerebral damage, adverse neurological, cognitive and psychiatric outcomes are consistently associated with abnormal female viagra for sale cerebral maturation and development.Currently, most clinical decision-making remains focused around a number of well-described cerebral lesions usually detected in routine practice using cranial ultrasound.

Periventricular haemorrhage is common. Severe haemorrhages are associated with long-term adverse outcomes, and in infants born before 33 weeks of gestation, haemorrhagic parenchymal infarction predicts motor deficits ….

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