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    How to cite http://www.amisdepasteur.fr/cheap-cialis-pills-for-sale/ this article:Singh where to buy cialis in australia O P. Aftermath of celebrity suicide – Media coverage and role of psychiatrists. Indian J Psychiatry 2020;62:337-8Celebrity suicide is one of the highly publicized where to buy cialis in australia events in our country.

    Indians got a glimpse of this following an unfortunate incident where a popular Hindi film actor died of suicide. As expected, the media went into where to buy cialis in australia a frenzy as newspapers, news channels, and social media were full of stories providing minute details of the suicidal act. Some even going as far as highlighting the color of the cloth used in the suicide as well as showing the lifeless body of the actor.

    All kinds of personal details were dug up, and speculations and hypotheses became the order of the day in the next few days that followed. In the process, reputations of many people associated with the actor where to buy cialis in australia were besmirched and their private and personal details were freely and blatantly broadcast and discussed on electronic, print, and social media. We understand that media houses have their own need and duty to report and sensationalize news for increasing their visibility (aka TRP), but such reporting has huge impacts on the mental health of the vulnerable population.The impact of this was soon realized when many incidents of copycat suicide were reported from all over the country within a few days of the incident.

    Psychiatrists suddenly started where to buy cialis in australia getting distress calls from their patients in despair with increased suicidal ideation. This has become a major area of concern for the psychiatry community.The Indian Psychiatric Society has been consistently trying to engage with media to promote ethical reporting of suicide. Section 24 (1) of Mental Health Care Act, 2017, forbids publication of photograph of mentally ill person without his consent.[1] The Press Council of India has adopted the guidelines of World Health Organization report on Preventing where to buy cialis in australia Suicide.

    A resource for media professionals, which came out with an advisory to be followed by media in reporting cases of suicide. It includes points forbidding them from putting stories in prominent positions and unduly repeating them, explicitly describing the method used, providing details about the site/location, using sensational headlines, or using photographs and video footage of the incident.[2] Unfortunately, the advisory seems to have little effect in the aftermath of celebrity suicides. Channels were full of speculations about the person's mental condition and illness and also his relationships where to buy cialis in australia and finances.

    Many fictional accounts of his symptoms and illness were touted, which is not only against the ethics but is also contrary to MHCA, 2017.[1]It went to the extent that the name of his psychiatrist was mentioned and quotes were attributed to him without taking any account from him. The Indian Psychiatric Society has written to the Press Council of India where to buy cialis in australia underlining this concern and asking for measures to ensure ethics in reporting suicide.While there is a need for engagement with media to make them aware of the grave impact of negative suicide reporting on the lives of many vulnerable persons, there is even a more urgent need for training of psychiatrists regarding the proper way of interaction with media. This has been amply brought out in the aftermath of this incident.

    Many psychiatrists and mental health professionals were called by media houses where to buy cialis in australia to comment on the episode. Many psychiatrists were quoted, or “misquoted,” or “quoted out of context,” commenting on the life of a person whom they had never examined and had no “professional authority” to do so. There were even stories with byline of a psychiatrist where the content provided was not only unscientific but also way beyond the expertise of a psychiatrist.

    These types of viewpoints perpetuate stigma, myths, and “misleading concepts” about psychiatry and are detrimental to the image of psychiatry in addition to doing harm and injustice to our where to buy cialis in australia patients. Hence, the need to formulate a guideline for interaction of psychiatrists with the media is imperative.In the infamous Goldwater episode, 12,356 psychiatrists were asked to cast opinion about the fitness of Barry Goldwater for presidential candidature. Out of 2417 respondents, 1189 psychiatrists reported him to be mentally unfit while none had actually examined him.[3] This led to the formulation of “The Goldwater Rule” by the American Psychiatric Association in 1973,[4] where to buy cialis in australia but we have witnessed the same phenomenon at the time of presidential candidature of Donald Trump.Psychiatrists should be encouraged to interact with media to provide scientific information about mental illnesses and reduction of stigma, but “statements to the media” can be a double-edged sword, and we should know about the rules of engagements and boundaries of interactions.

    Methods and principles of interaction with media should form a part of our training curriculum. Many professional societies where to buy cialis in australia have guidelines and resource books for interacting with media, and psychiatrists should familiarize themselves with these documents. The Press Council guideline is likely to prompt reporters to seek psychiatrists for their expert opinion.

    It is useful for them to have a template ready with suicide rates, emphasizing multicausality of suicide, role of mental disorders, as well as help available.[5]It is about time that the Indian Psychiatric Society formulated its own guidelines laying down the broad principles and boundaries governing the interaction of Indian psychiatrists with the media. Till then, it is desirable to be guided by the following broad principles:It should be assumed that no statement goes “off the record” as the media person is most likely recording the interview, and we should where to buy cialis in australia also record any such conversation from our endIt should be clarified in which capacity comments are being made – professional, personal, or as a representative of an organizationOne should not comment on any person whom he has not examinedPsychiatrists should take any such opportunity to educate the public about mental health issuesThe comments should be justified and limited by the boundaries of scientific knowledge available at the moment. References Correspondence Address:Dr.

    O P SinghAA 304, Ashabari Apartments, O/31, Baishnabghata, Patuli Township, Kolkata - 700 094, West Bengal IndiaSource where to buy cialis in australia of Support. None, Conflict of Interest. NoneDOI.

    10.4103/psychiatry.IndianJPsychiatry_816_20Abstract Electroconvulsive therapy (ECT) is an effective modality of treatment for a variety of psychiatric disorders. However, it has always been accused of being a coercive, unethical, and dangerous modality of treatment. The dangerousness of ECT has been mainly attributed to its claimed ability to cause brain damage.

    This narrative review aims to provide an update of the evidence with regard to whether the practice of ECT is associated with damage to the brain. An accepted definition of brain damage remains elusive. There are also ethical and technical problems in designing studies that look at this question specifically.

    Thus, even though there are newer technological tools and innovations, any review attempting to answer this question would have to take recourse to indirect methods. These include structural, functional, and metabolic neuroimaging. Body fluid biochemical marker studies.

    And follow-up studies of cognitive impairment and incidence of dementia in people who have received ECT among others. The review of literature and present evidence suggests that ECT has a demonstrable impact on the structure and function of the brain. However, there is a lack of evidence at present to suggest that ECT causes brain damage.Keywords.

    Adverse effect, brain damage, electroconvulsive therapyHow to cite this article:Jolly AJ, Singh SM. Does electroconvulsive therapy cause brain damage. An update.

    Indian J Psychiatry 2020;62:339-53 Introduction Electroconvulsive therapy (ECT) as a modality of treatment for psychiatric disorders has existed at least since 1938.[1] ECT is an effective modality of treatment for various psychiatric disorders. However, from the very beginning, the practice of ECT has also faced resistance from various groups who claim that it is coercive and harmful.[2] While the ethical aspects of the practice of ECT have been dealt with elsewhere, the question of harmfulness or brain damage consequent upon the passage of electric current needs to be examined afresh in light of technological advances and new knowledge.[3]The question whether ECT causes brain damage was reviewed in a holistic fashion by Devanand et al. In the mid-1990s.[4],[5] The authors had attempted to answer this question by reviewing the effect of ECT on the brain in various areas – cognitive side effects, structural neuroimaging studies, neuropathologic studies of patients who had received ECT, autopsy studies of epileptic patients, and finally animal ECS studies.

    The authors had concluded that ECT does not produce brain damage.This narrative review aims to update the evidence with regard to whether ECT causes brain damage by reviewing relevant literature from 1994 to the present time. Framing the Question The Oxford Dictionary defines damage as physical harm that impairs the value, usefulness, or normal function of something.[6] Among medical dictionaries, the Peter Collins Dictionary defines damage as harm done to things (noun) or to harm something (verb).[7] Brain damage is defined by the British Medical Association Medical Dictionary as degeneration or death of nerve cells and tracts within the brain that may be localized to a particular area of the brain or diffuse.[8] Going by such a definition, brain damage in the context of ECT should refer to death or degeneration of brain tissue, which results in the impairment of functioning of the brain. The importance of precisely defining brain damage shall become evident subsequently in this review.There are now many more tools available to investigate the structure and function of brain in health and illness.

    However, there are obvious ethical issues in designing human studies that are designed to answer this specific question. Therefore, one must necessarily take recourse to indirect evidences available through studies that have been designed to answer other research questions. These studies have employed the following methods:Structural neuroimaging studiesFunctional neuroimaging studiesMetabolic neuroimaging studiesBody fluid biochemical marker studiesCognitive impairment studies.While the early studies tended to focus more on establishing the safety of ECT and finding out whether ECT causes gross microscopic brain damage, the later studies especially since the advent of advanced neuroimaging techniques have been focusing more on a mechanistic understanding of ECT.

    Hence, the primary objective of the later neuroimaging studies has been to look for structural and functional brain changes which might explain how ECT acts rather than evidence of gross structural damage per se. However, put together, all these studies would enable us to answer our titular question to some satisfaction. [Table 1] and [Table 2] provide an overview of the evidence base in this area.

    Structural and Functional Neuroimaging Studies Devanand et al. Reviewed 16 structural neuroimaging studies on the effect of ECT on the brain.[4] Of these, two were pneumoencephalography studies, nine were computed tomography (CT) scan studies, and five were magnetic resonance imaging (MRI) studies. However, most of these studies were retrospective in design, with neuroimaging being done in patients who had received ECT in the past.

    In the absence of baseline neuroimaging, it would be very difficult to attribute any structural brain changes to ECT. In addition, pneumoencephalography, CT scan, and even early 0.3 T MRI provided images with much lower spatial resolution than what is available today. The authors concluded that there was no evidence to show that ECT caused any structural damage to the brain.[4] Since then, at least twenty more MRI-based structural neuroimaging studies have studied the effect of ECT on the brain.

    The earliest MRI studies in the early 1990s focused on detecting structural damage following ECT. All of these studies were prospective in design, with the first MRI scan done at baseline and a second MRI scan performed post ECT.[9],[11],[12],[13],[41] While most of the studies imaged the patient once around 24 h after receiving ECT, some studies performed multiple post ECT neuroimaging in the first 24 h after ECT to better capture the acute changes. A single study by Coffey et al.

    Followed up the patients for a duration of 6 months and repeated neuroimaging again at 6 months in order to capture any long-term changes following ECT.[10]The most important conclusion which emerged from this early series of studies was that there was no evidence of cortical atrophy, change in ventricle size, or increase in white matter hyperintensities.[4] The next major conclusion was that there appeared to be an increase in the T1 and T2 relaxation time immediately following ECT, which returned to normal within 24 h. This supported the theory that immediately following ECT, there appears to be a temporary breakdown of the blood–brain barrier, leading to water influx into the brain tissue.[11] The last significant observation by Coffey et al. In 1991 was that there was no significant temporal changes in the total volumes of the frontal lobes, temporal lobes, or amygdala–hippocampal complex.[10] This was, however, something which would later be refuted by high-resolution MRI studies.

    Nonetheless, one inescapable conclusion of these early studies was that there was no evidence of any gross structural brain changes following administration of ECT. Much later in 2007, Szabo et al. Used diffusion-weighted MRI to image patients in the immediate post ECT period and failed to observe any obvious brain tissue changes following ECT.[17]The next major breakthrough came in 2010 when Nordanskog et al.

    Demonstrated that there was a significant increase in the volume of the hippocampus bilaterally following a course of ECT in a cohort of patients with depressive illness.[18] This contradicted the earlier observations by Coffey et al. That there was no volume increase in any part of the brain following ECT.[10] This was quite an exciting finding and was followed by several similar studies. However, the perspective of these studies was quite different from the early studies.

    In contrast to the early studies looking for the evidence of ECT-related brain damage, the newer studies were focused more on elucidating the mechanism of action of ECT. Further on in 2014, Nordanskog et al. In a follow-up study showed that though there was a significant increase in the volume of the hippocampus 1 week after a course of ECT, the hippocampal volume returned to the baseline after 6 months.[19] Two other studies in 2013 showed that in addition to the hippocampus, the amygdala also showed significant volume increase following ECT.[20],[21] A series of structural neuroimaging studies after that have expanded on these findings and as of now, gray matter volume increase following ECT has been demonstrated in the hippocampus, amygdala, anterior temporal pole, subgenual cortex,[21] right caudate nucleus, and the whole of the medial temporal lobe (MTL) consisting of the hippocampus, amygdala, insula, and the posterosuperior temporal cortex,[24] para hippocampi, right subgenual anterior cingulate gyrus, and right anterior cingulate gyrus,[25] left cerebellar area VIIa crus I,[29] putamen, caudate nucleus, and nucleus acumbens [31] and clusters of increased cortical thickness involving the temporal pole, middle and superior temporal cortex, insula, and inferior temporal cortex.[27] However, the most consistently reported and replicated finding has been the bilateral increase in the volume of the hippocampus and amygdala.

    In light of these findings, it has been tentatively suggested that ECT acts by inducing neuronal regeneration in the hippocampus – amygdala complex.[42],[43] However, there are certain inconsistencies to this hypothesis. Till date, only one study – Nordanskog et al., 2014 – has followed study patients for a long term – 6 months in their case. And significantly, the authors found out that after increasing immediately following ECT, the hippocampal volume returns back to baseline by 6 months.[19] This, however, was not associated with the relapse of depressive symptoms.

    Another area of significant confusion has been the correlation of hippocampal volume increase with improvement of depressive symptoms. Though almost all studies demonstrate a significant increase in hippocampal volume following ECT, a majority of studies failed to demonstrate a correlation between symptom improvement and hippocampal volume increase.[19],[20],[22],[24],[28] However, a significant minority of volumetric studies have demonstrated correlation between increase in hippocampal and/or amygdala volume and improvement of symptoms.[21],[25],[30]Another set of studies have used diffusion tensor imaging, functional MRI (fMRI), anatomical connectome, and structural network analysis to study the effect of ECT on the brain. The first of these studies by Abbott et al.

    In 2014 demonstrated that on fMRI, the connectivity between right and left hippocampus was significantly reduced in patients with severe depression. It was also shown that the connectivity was normalized following ECT, and symptom improvement was correlated with an increase in connectivity.[22] In a first of its kind DTI study, Lyden et al. In 2014 demonstrated that fractional anisotropy which is a measure of white matter tract or fiber density is increased post ECT in patients with severe depression in the anterior cingulum, forceps minor, and the dorsal aspect of the left superior longitudinal fasciculus.

    The authors suggested that ECT acts to normalize major depressive disorder-related abnormalities in the structural connectivity of the dorsal fronto-limbic pathways.[23] Another DTI study in 2015 constructed large-scale anatomical networks of the human brain – connectomes, based on white matter fiber tractography. The authors found significant reorganization in the anatomical connections involving the limbic structure, temporal lobe, and frontal lobe. It was also found that connection changes between amygdala and para hippocampus correlated with reduction in depressive symptoms.[26] In 2016, Wolf et al.

    Used a source-based morphometry approach to study the structural networks in patients with depression and schizophrenia and the effect of ECT on the same. It was found that the medial prefrontal cortex/anterior cingulate cortex (ACC/MPFC) network, MTL network, bilateral thalamus, and left cerebellar regions/precuneus exhibited significant difference between healthy controls and the patient population. It was also demonstrated that administration of ECT leads to significant increase in the network strength of the ACC/MPFC network and the MTL network though the increase in network strength and symptom amelioration were not correlated.[32]Building on these studies, a recently published meta-analysis has attempted a quantitative synthesis of brain volume changes – focusing on hippocampal volume increase following ECT in patients with major depressive disorder and bipolar disorder.

    The authors initially selected 32 original articles from which six articles met the criteria for quantitative synthesis. The results showed significant increase in the volume of the right and left hippocampus following ECT. For the rest of the brain regions, the heterogeneity in protocols and imaging techniques did not permit a quantitative analysis, and the authors have resorted to a narrative review similar to the present one with similar conclusions.[44] Focusing exclusively on hippocampal volume change in ECT, Oltedal et al.

    In 2018 conducted a mega-analysis of 281 patients with major depressive disorder treated with ECT enrolled at ten different global sites of the Global ECT-MRI Research Collaboration.[45] Similar to previous studies, there was a significant increase in hippocampal volume bilaterally with a dose–response relationship with the number of ECTs administered. Furthermore, bilateral (B/L) ECT was associated with an equal increase in volume in both right and left hippocampus, whereas right unilateral ECT was associated with greater volume increase in the right hippocampus. Finally, contrary to expectation, clinical improvement was found to be negatively correlated with hippocampal volume.Thus, a review of the current evidence amply demonstrates that from looking for ECT-related brain damage – and finding none, we have now moved ahead to looking for a mechanistic understanding of the effect of ECT.

    In this regard, it has been found that ECT does induce structural changes in the brain – a fact which has been seized upon by some to claim that ECT causes brain damage.[46] Such statements should, however, be weighed against the definition of damage as understood by the scientific medical community and patient population. Neuroanatomical changes associated with effective ECT can be better described as ECT-induced brain neuroplasticity or ECT-induced brain neuromodulation rather than ECT-induced brain damage. Metabolic Neuroimaging Studies.

    Magnetic Resonance Spectroscopic Imaging Magnetic resonance spectroscopic imaging (MRSI) uses a phase-encoding procedure to map the spatial distribution of magnetic resonance (MR) signals of different molecules. The crucial difference, however, is that while MRI maps the MR signals of water molecules, MRSI maps the MR signals generated by different metabolites – such as N-acetyl aspartate (NAA) and choline-containing compounds. However, the concentration of these metabolites is at least 10,000 times lower than water molecules and hence the signal strength generated would also be correspondingly lower.

    However, MRSI offers us the unique advantage of studying in vivo the change in the concentration of brain metabolites, which has been of great significance in fields such as psychiatry, neurology, and basic neuroscience research.[47]MRSI studies on ECT in patients with depression have focused largely on four metabolites in the human brain – NAA, choline-containing compounds (Cho) which include majorly cell membrane compounds such as glycerophosphocholine, phosphocholine and a miniscule contribution from acetylcholine, creatinine (Cr) and glutamine and glutamate together (Glx). NAA is located exclusively in the neurons, and is suggested to be a marker of neuronal viability and functionality.[48] Choline-containing compounds (Cho) mainly include the membrane compounds, and an increase in Cho would be suggestive of increased membrane turnover. Cr serves as a marker of cellular energy metabolism, and its levels are usually expected to remain stable.

    The regions which have been most widely studied in MRSI studies include the bilateral hippocampus and amygdala, dorsolateral prefrontal cortex (DLPFC), and ACC.Till date, five MRSI studies have measured NAA concentration in the hippocampus before and after ECT. Of these, three studies showed that there is no significant change in the NAA concentration in the hippocampus following ECT.[33],[38],[49] On the other hand, two recent studies have demonstrated a statistically significant reduction in NAA concentration in the hippocampus following ECT.[39],[40] The implications of these results are of significant interest to us in answering our titular question. A normal level of NAA following ECT could signify that there is no significant neuronal death or damage following ECT, while a reduction would signal the opposite.

    However, a direct comparison between these studies is complicated chiefly due to the different ECT protocols, which has been used in these studies. It must, however, be acknowledged that the three older studies used 1.5 T MRI, whereas the two newer studies used a higher 3 T MRI which offers betters signal-to-noise ratio and hence lesser risk of errors in the measurement of metabolite concentrations. The authors of a study by Njau et al.[39] argue that a change in NAA levels might reflect reversible changes in neural metabolism rather than a permanent change in the number or density of neurons and also that reduced NAA might point to a change in the ratio of mature to immature neurons, which, in fact, might reflect enhanced adult neurogenesis.

    Thus, the authors warn that to conclude whether a reduction in NAA concentration is beneficial or harmful would take a simultaneous measurement of cognitive functioning, which was lacking in their study. In 2017, Cano et al. Also demonstrated a significant reduction in NAA/Cr ratio in the hippocampus post ECT.

    More significantly, the authors also showed a significant increase in Glx levels in the hippocampus following ECT, which was also associated with an increase in hippocampal volume.[40] To explain these three findings, the authors proposed that ECT produces a neuroinflammatory response in the hippocampus – likely mediated by Glx, which has been known to cause inflammation at higher concentrations, thereby accounting for the increase in hippocampal volume with a reduction in NAA concentration. The cause for the volume increase remains unclear – with the authors speculating that it might be due to neuronal swelling or due to angiogenesis. However, the same study and multiple other past studies [21],[25],[30] have demonstrated that hippocampal volume increase was correlated with clinical improvement following ECT.

    Thus, we are led to the hypothesis that the same mechanism which drives clinical improvement with ECT is also responsible for the cognitive impairment following ECT. Whether this is a purely neuroinflammatory response or a neuroplastic response or a neuroinflammatory response leading to some form of neuroplasticity is a critical question, which remains to be answered.[40]Studies which have analyzed NAA concentration change in other brain areas have also produced conflicting results. The ACC is another area which has been studied in some detail utilizing the MRSI technique.

    In 2003, Pfleiderer et al. Demonstrated that there was no significant change in the NAA and Cho levels in the ACC following ECT. This would seem to suggest that there was no neurogenesis or membrane turnover in the ACC post ECT.[36] However, this finding was contested by Merkl et al.

    In 2011, who demonstrated that NAA levels were significantly reduced in the left ACC in patients with depression and that these levels were significantly elevated following ECT.[37] This again is contested by Njau et al. Who showed that NAA levels are significantly reduced following ECT in the left dorsal ACC.[39] A direct comparison of these three studies is complicated by the different ECT and imaging parameters used and hence, no firm conclusion can be made on this point at this stage. In addition to this, one study had demonstrated increased NAA levels in the amygdala following administration of ECT,[34] with a trend level increase in Cho levels, which again is suggestive of neurogenesis and/or neuroplasticity.

    A review of studies on the DLPFC reveals a similarly confusing picture with one study, each showing no change, reduction, and elevation of concentration of NAA following ECT.[35],[37],[39] Here, again, a direct comparison of the three studies is made difficult by the heterogeneous imaging and ECT protocols followed by them.A total of five studies have analyzed the concentration of choline-containing compounds (Cho) in patients undergoing ECT. Conceptually, an increase in Cho signals is indicative of increased membrane turnover, which is postulated to be associated with synaptogenesis, neurogenesis, and maturation of neurons.[31] Of these, two studies measured Cho concentration in the B/L hippocampus, with contrasting results. Ende et al.

    In 2000 demonstrated a significant elevation in Cho levels in B/L hippocampus after ECT, while Jorgensen et al. In 2015 failed to replicate the same finding.[33],[38] Cho levels have also been studied in the amygdala, ACC, and the DLPFC. However, none of these studies showed a significant increase or decrease in Cho levels before and after ECT in the respective brain regions studied.

    In addition, no significant difference was seen in the pre-ECT Cho levels of patients compared to healthy controls.[34],[36],[37]In review, we must admit that MRSI studies are still at a preliminary stage with significant heterogeneity in ECT protocols, patient population, and regions of the brain studied. At this stage, it is difficult to draw any firm conclusions except to acknowledge the fact that the more recent studies – Njau et al., 2017, Cano, 2017, and Jorgensen et al., 2015 – have shown decrease in NAA concentration and no increase in Cho levels [38],[39],[40] – as opposed to the earlier studies by Ende et al.[33] The view offered by the more recent studies is one of a neuroinflammatory models of action of ECT, probably driving neuroplasticity in the hippocampus. This would offer a mechanistic understanding of both clinical response and the phenomenon of cognitive impairment associated with ECT.

    However, this conclusion is based on conjecture, and more work needs to be done in this area. Body Fluid Biochemical Marker Studies Another line of evidence for analyzing the effect of ECT on the human brain is the study of concentration of neurotrophins in the plasma or serum. Neurotrophins are small protein molecules which mediate neuronal survival and development.

    The most prominent among these is brain-derived neurotrophic factor (BDNF) which plays an important role in neuronal survival, plasticity, and migration.[50] A neurotrophic theory of mood disorders was suggested which hypothesized that depressive disorders are associated with a decreased expression of BDNF in the limbic structures, resulting in the atrophy of these structures.[51] It was also postulated that antidepressant treatment has a neurotrophic effect which reverses the neuronal cell loss, thereby producing a therapeutic effect. It has been well established that BDNF is decreased in mood disorders.[52] It has also been shown that clinical improvement of depression is associated with increase in BDNF levels.[53] Thus, serum BDNF levels have been tentatively proposed as a biomarker for treatment response in depression. Recent meta-analytic evidence has shown that ECT is associated with significant increase in serum BDNF levels in patients with major depressive disorder.[54] Considering that BDNF is a potent stimulator of neurogenesis, the elevation of serum BDNF levels following ECT lends further credence to the theory that ECT leads to neurogenesis in the hippocampus and other limbic structures, which, in turn, mediates the therapeutic action of ECT.

    Cognitive Impairment Studies Cognitive impairment has always been the single-most important side effect associated with ECT.[55] Concerns regarding long-term cognitive impairment surfaced soon after the introduction of ECT and since then has grown to become one of the most controversial aspects of ECT.[56] Anti-ECT groups have frequently pointed out to cognitive impairment following ECT as evidence of ECT causing brain damage.[56] A meta-analysis by Semkovska and McLoughlin in 2010 is one of the most detailed studies which had attempted to settle this long-standing debate.[57] The authors reviewed 84 studies (2981 participants), which had used a combined total of 22 standardized neuropsychological tests assessing various cognitive functions before and after ECT in patients diagnosed with major depressive disorder. The different cognitive domains reviewed included processing speed, attention/working memory, verbal episodic memory, visual episodic memory, spatial problem-solving, executive functioning, and intellectual ability. The authors concluded that administration of ECT for depression is associated with significant cognitive impairment in the first few days after ECT administration.

    However, it was also seen that impairment in cognitive functioning resolved within a span of 2 weeks and thereafter, a majority of cognitive domains even showed mild improvement compared to the baseline performance. It was also demonstrated that not a single cognitive domain showed persistence of impairment beyond 15 days after ECT.Memory impairment following ECT can be analyzed broadly under two conceptual schemes – one that classifies memory impairment as objective memory impairment and subjective memory impairment and the other that classifies it as impairment in anterograde memory versus impairment in retrograde memory. Objective memory can be roughly defined as the ability to retrieve stored information and can be measured by various standardized neuropsychological tests.

    Subjective memory or meta-memory, on the other hand, refers to the ability to make judgments about one's ability to retrieve stored information.[58] As described previously, it has been conclusively demonstrated that anterograde memory impairment does not persist beyond 2 weeks after ECT.[57] However, one of the major limitations of this meta-analysis was the lack of evidence on retrograde amnesia following ECT. This is particularly unfortunate considering that it is memory impairment – particularly retrograde amnesia which has received the most attention.[59] In addition, reports of catastrophic retrograde amnesia have been repeatedly held up as sensational evidence of the lasting brain damage produced by ECT.[59] Admittedly, studies on retrograde amnesia are fewer and less conclusive than on anterograde amnesia.[60],[61] At present, the results are conflicting, with some studies finding some impairment in retrograde memory – particularly autobiographical retrograde memory up to 6 months after ECT.[62],[63],[64],[65] However, more recent studies have failed to support this finding.[66],[67] While they do demonstrate an impairment in retrograde memory immediately after ECT, it was seen that this deficit returned to pre-ECT levels within a span of 1–2 months and improved beyond baseline performance at 6 months post ECT.[66] Adding to the confusion are numerous factors which confound the assessment of retrograde amnesia. It has been shown that depressive symptoms can produce significant impairment of retrograde memory.[68],[69] It has also been demonstrated that sine-wave ECT produces significantly more impairment of retrograde memory as compared to brief-pulse ECT.[70] However, from the 1990s onward, sine-wave ECT has been completely replaced by brief-pulse ECT, and it is unclear as to the implications of cognitive impairment from the sine-wave era in contemporary ECT practice.Another area of concern are reports of subjective memory impairment following ECT.

    One of the pioneers of research into subjective memory impairment were Squire and Chace who published a series of studies in the 1970s demonstrating the adverse effect of bilateral ECT on subjective assessment of memory.[62],[63],[64],[65] However, most of the studies conducted post 1980 – from when sine-wave ECT was replaced by brief-pulse ECT report a general improvement in subjective memory assessments following ECT.[71] In addition, most of the recent studies have failed to find a significant association between measures of subjective and objective memory.[63],[66],[70],[72],[73],[74] It has also been shown that subjective memory impairment is strongly associated with the severity of depressive symptoms.[75] In light of these facts, the validity and value of measures of subjective memory impairment as a marker of cognitive impairment and brain damage following ECT have been questioned. However, concerns regarding subjective memory impairment and catastrophic retrograde amnesia continue to persist, with significant dissonance between the findings of different research groups and patient self-reports in various media.[57]Some studies reported the possibility of ECT being associated with the development of subsequent dementia.[76],[77] However, a recent large, well-controlled prospective Danish study found that the use of ECT was not associated with elevated incidence of dementia.[78] Conclusion Our titular question is whether ECT leads to brain damage, where damage indicates destruction or degeneration of nerves or nerve tracts in the brain, which leads to loss of function. This issue was last addressed by Devanand et al.

    In 1994 since which time our understanding of ECT has grown substantially, helped particularly by the advent of modern-day neuroimaging techniques which we have reviewed in detail. And, what these studies reveal is rather than damaging the brain, ECT has a neuromodulatory effect on the brain. The various lines of evidence – structural neuroimaging studies, functional neuroimaging studies, neurochemical and metabolic studies, and serum BDNF studies all point toward this.

    These neuromodulatory changes have been localized to the hippocampus, amygdala, and certain other parts of the limbic system. How exactly these changes mediate the improvement of depressive symptoms is a question that remains unanswered. However, there is little by way of evidence from neuroimaging studies which indicates that ECT causes destruction or degeneration of neurons.

    Though cognitive impairment studies do show that there is objective impairment of certain functions – particularly memory immediately after ECT, these impairments are transient with full recovery within a span of 2 weeks. Perhaps, the single-most important unaddressed concern is retrograde amnesia, which has been shown to persist for up to 2 months post ECT. In this regard, the recent neurometabolic studies have offered a tentative mechanism of action of ECT, producing a transient inflammation in the limbic cortex, which, in turn, drives neurogenesis, thereby exerting a neuromodulatory effect.

    This hypothesis would explain both the cognitive adverse effects of ECT – due to the transient inflammation – and the long-term improvement in mood – neurogenesis in the hippocampus. Although unproven at present, such a hypothesis would imply that cognitive impairment is tied in with the mechanism of action of ECT and not an indicator of damage to the brain produced by ECT.The review of literature suggests that ECT does cause at least structural and functional changes in the brain, and these are in all probability related to the effects of the ECT. However, these cannot be construed as brain damage as is usually understood.

    Due to the relative scarcity of data that directly examines the question of whether ECT causes brain damage, it is not possible to conclusively answer this question. However, in light of enduring ECT survivor accounts, there is a need to design studies that specifically answer this question.Financial support and sponsorshipNil.Conflicts of interestThere are no conflicts of interest. References 1.Payne NA, Prudic J.

    Electroconvulsive therapy. Part I. A perspective on the evolution and current practice of ECT.

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    Correspondence Address:Dr. Shubh Mohan SinghDepartment of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh IndiaSource of Support. None, Conflict of Interest.

    NoneDOI. 10.4103/psychiatry.IndianJPsychiatry_239_19 Tables [Table 1], [Table 2].

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    How to http://www.amisdepasteur.fr/cialis-20mg-price-walmart/ cite cialis 20mg this article:Singh OP. The need for routine psychiatric assessment of COVID-19 survivors. Indian J Psychiatry 2020;62:457-8COVID-19 pandemic is expected to bring cialis 20mg a Tsunami of mental health issues. Public health emergencies may affect the well-being, safety, and security of both individuals and communities, which lead to a range of emotional reactions, unhealthy behavior, and noncompliance, with public health directives (such as home confinement and vaccination) in people who contact the disease as well as in the general population.[1] Thus far, there has been an increased emphasis on psychosocial factors such as loneliness, effect of quarantine, uncertainty, vulnerability to COVID-19 infection, economic factors, and career difficulties, which may lead to increased psychiatric morbidity.Time has now come to pay attention to the direct effect of the virus on brain and psychiatric adverse symptoms, resulting from the treatment provided.

    Viral infections are known to be associated cialis 20mg with psychiatric disorders such as depression, bipolar disorder, obsessive–compulsive disorder (OCD), or schizophrenia. There was an increased incidence of psychiatric disorders following the Influenza Pandemic. Karl Menninger described 100 cialis 20mg cases of influenza presenting with psychiatric sequelae, which could mainly be categorized as dementia praecox, delirium, other psychoses, and unclassified subtypes. Dementia praecox constituted the largest number among all these cases.[2] Neuroinflammation is now known as the key factor in genesis and exacerbation of psychiatric disorders, particularly depression and bipolar disorders.Emerging evidence points toward the neurotropic properties of the SARS-CoV-2 virus.

    Loss of smell and taste as an initial cialis 20mg symptom points toward early involvement of olfactory bulb. The rapid spread to brain has been demonstrated through retrograde axonal transport.[3] The virus can enter the brain through endothelial cells lining the blood–brain barrier and also through other nerves such as the vagus nerve.[4] Cytokine storm, a serious immune reaction to the virus, can activate brain glial cells, leading to delirium, depression, bipolar disorder, and OCD.Studies examining psychiatric disorders in acute patients suffering from COVID-19 found almost 40% of such patients suffering from anxiety, depression, and posttraumatic stress disorder.[5] The data on long-term psychiatric sequelae in patients who have recovered from acute illness are limited. There are anecdotal reports of psychosis and mania occurring in patients of COVID-19 following discharge from hospital. This may be either due to the direct effect of the virus cialis 20mg on the brain or due to the neuropsychiatric effects of drugs used to treat the infection or its complications.

    For example, behavioral toxicity of high-dose corticosteroids which are frequently used during the treatment of severe cases to prevent and manage cytokine storm.The patients with COVID-19 can present with many neuropsychiatric disorders, which may be caused by direct inflammation, central nervous system effects of cytokine storm, aberrant epigenetic modifications of stress-related genes, glial activation, or treatment emergent effects.[6] To assess and manage various neuropsychiatric complications of COVID-19, the psychiatric community at large should equip itself with appropriate assessment tools and management guidelines to effectively tackle this unprecedented wave of psychiatric ailments. References 1.Pfefferbaum B, North cialis 20mg CS. Mental health and the COVID-19 pandemic. N Engl J Med 2020;383:510-2 cialis 20mg.

    2.Lu H, Stratton CW, Tang YW. Outbreak of pneumonia of unknown cialis 20mg etiology in Wuhan, China. The mystery and the miracle. J Med Virol 2020;92:401-2.

    3.Fodoulian L, cialis 20mg Tuberosa J, Rossier D, Landis BN, Carleton A, Rodriguez I. SARS-CoV-2 receptor and entry genes are expressed by sustentacular cells in the human olfactory neuroepithelium. BioRxiv 2020.03.31.013268 cialis 20mg. Doi.

    Https://doi.org/10.1101/2020.03.31.013268. 4.Lochhead JJ, Thorne RG. Intranasal delivery of biologics to the central nervous system. Adv Drug Deliv Rev 2012;64:614-28.

    5.Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, et al. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections. A systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry 2020;7:611-27.

    6.Steardo L Jr., Steardo L, Verkhratsky A. Psychiatric face of COVID-19. Transl Psychiatry 2020;10:261. Correspondence Address:Om Prakash SinghAA 304, Ashabari Apartments, O/31, Baishnabghata, Patuli Township, Kolkata - 700 094, West Bengal IndiaSource of Support.

    None, Conflict of Interest. NoneDOI. 10.4103/indianjpsychiatry.indianjpsychiatry_1169_2Abstract The COVID-19 pandemic has emerged as a major stressor of a global scale, affecting all aspects of our lives, and is likely to contribute to a surge of mental ill health. Ancient Hindu scriptures, notably the Bhagavad Gita, have a wealth of insights that can help approaches to build psychological resilience for individuals at risk, those affected, as well as for caregivers.

    The path of knowledge (Jnana yoga) promotes accurate awareness of nature of the self, and can help reframe our thinking from an “I” to a “we mode,” much needed for collectively mitigating the spread of the coronavirus. The path of action (Karma yoga) teaches the art of selfless action, providing caregivers and frontline health-care providers a framework to continue efforts in the face of uncertain consequences. Finally, the path of meditation (Raja yoga) offers a multipronged approach to healthy lifestyle and mindful meditation, which may improve resilience to the illness and its severe consequences. While more work is needed to empirically examine the potential value of each of these approaches in modern psychotherapy, the principles herein may already help individuals facing and providing care for the COVID-19 pandemic.Keywords.

    Bhagavad Gita, Covid-19, YogaHow to cite this article:Keshavan MS. Building resilience in the COVID-19 era. Three paths in the Bhagavad Gita. Indian J Psychiatry 2020;62:459-61The COVID-19 crisis has changed our world in just a matter of months, thrusting us into danger, uncertainty, fear, and of course social isolation.

    At the time of this writing, over 11 million individuals have been affected worldwide (India is fourth among all countries, 674,515) and over half a million people have died. The COVID-19 pandemic has been an unprecedented global stressor, not only because of the disease burden and mortality but also because of economic upheaval. The very fabric of the society is disrupted, affecting housing, personal relationships, travel, and all aspects of lifestyle. The overwhelmed health-care system is among the most major stressors, leading to a heightened sense of vulnerability.

    No definitive treatments or vaccine is on the horizon yet. Psychiatry has to brace up to an expected mental health crisis resulting from this global stressor, not only with regard to treating neuropsychiatric consequences but also with regard to developing preventive approaches and building resilience.Thankfully, there is a wealth of wisdom to help us in our ancient scriptures such as the Bhagavad Gita[1] for building psychological resilience. The Bhagavad Gita is a dialog between the Pandava prince Arjuna and his charioteer Krishna in the epic Mahabharata, the great tale of the Bharata Dynasty, authored by Sage Vyasa (c. 4–5 B.C.E.).

    The dialog occurs in the 6th chapter of the epic and has over 700 verses. In this epic story, Arjuna, the righteous Pandava hero was faced with the dilemma of waging a war against his cousins, the Kauravas, for territory. Arjuna is confused and has no will to initiate the war. In this context, Krishna, his charioteer and spiritual mentor, counsels him.

    The key principles of this spiritual discourse in the Gita are embodied in the broad concept of yoga, which literally means “Yog” or “to unite.” Applying three tenets of yoga can greatly help developing resilience at individual, group, and societal levels. A fourth path, Bhakti yoga, is a spiritual approach in the Gita which emphasizes loving devotion toward a higher power or principle, which may or may not involve a personal god. In this editorial, I focus on three paths that have considerable relevance to modern approaches to reliance-focused psychotherapy that may be especially relevant in the COVID-19 era. Path of Knowledge The first concept in the Gita is the path of knowledge (Jnana Yoga, chapter 2).

    The fundamental goal of Jnana yoga is to liberate oneself from the limited view of the individual ego, and to develop the awareness of one's self as part of a larger, universal self. Hindu philosophers were among the earliest to ask the question of “who am I” and concluded that the self is not what it seems. The self as we all know is a collection of our physical, mental, and social attributes that we create for ourselves with input from our perceptions, and input by our families and society. Such a world view leads to a tendency to crave for the “I” and for what is mine, and not consider the “We.” As Krishna in the Bhagavad Gita points out, the person who sees oneself in others, and others in oneself, really “sees.” Such awareness, which guides action in service of self as well as others, is critically important in our goals of collectively preventing the spread of the coronavirus.

    A glaring example is the use of face masks, known to effectively slow the viral infection. Using the mask is as important to protecting oneself from the virus as well as protecting others from oneself. Nations such as the USA (and their leaders), who have given mixed messages to the public about the need to wear masks, have been showing a strikingly high number of cases as well as mortality. Unfortunately, such reluctance to wear masks (and thus model protective hygiene for the population), as in the case of the US leader, has stemmed from ego or vanity-related issues (i.e., how he would appear to other leaders!.

    ). This factor may at least partly underlie the worse COVID-19 outcome in the USA. The simple lesson here is that it is important to first flatten the ego if one wants to flatten the pandemic curve!. Path of Action The second key concept is the path of action (Karma yoga, chapter 3).

    Karma yoga is all about taking action without thinking, “what's in it for me.” As such, it seeks to mainly let go of one's ego. In the Bhagavad Gita, Arjuna is ambivalent about fighting because of the conflict regarding the outcome brought on by waging the war, i.e., having to kill some of his own kith and kin. Krishna reminds him that he should not hesitate, because it is his nature and duty (or Dharma), as a warrior, to protect the larger good, though it will have some downside consequences. The frontline health-care worker caring for severely ill patients with COVID-19 is likely to have a similar emotional reaction as Arjuna, facing a lack of adequate treatments, high likelihood of mortality and of unpredictable negative outcomes, and risk to him/herself.

    Compounding this, especially when resources such as ventilators are limited, the doctor may have to make tough decisions of whose life to save and whose not. Adding to this are personal emotions when facing with the death of patients, having to deliver bad news, and dealing with grieving relatives.[2] All these are likely to result in emotional anguish and guilt, leading to burnout and a war “neurosis.”So, what should the frontline health-care provider should do?. Krishna's counsel would be that the doctor should continue to perform his/her own dharma, but do so without desire or attachment, thereby performing action in the spirit of Karma yoga. Such action would be with detachment, without a desire for personal gain and being unperturbed by success or failure.

    Such “Nishkaama Karma” (or selfless action) may help doctors working today in the COVID outbreak to carry forward their work with compassion, and accept the results of their actions with equanimity and without guilt. Krishna points out that training one's mind to engage in selfless action is not easy but requires practice (Abhyasa). Krishna is also emphatic about the need to protect oneself, in order to be able to effectively carry out one's duties. Path of Meditation The third core concept in the Gita is the path of meditation and self-reflection (Raja yoga, or Dhyana yoga, chapter 6).

    It is considered the royal path (Raja means royal) for attaining self-realization, and often considered the 8-fold path of yoga (Ashtanga yoga) designed to discipline lifestyle, the body and mind toward realizing mindfulness and self-reflection. These techniques, which originated in India over two millennia ago, have evolved over recent decades and anticipate several approaches to contemplative psychotherapy, including dialectical behavior therapy, acceptance and commitment therapy, and mindfulness-based stress reduction.[3] These approaches are of particular relevance for stress reduction and resilience building in individuals faced by COVID-19-related emotional difficulties as well as health-care providers.[4]The majority of people affected by the COVID-19 virus recover, but about 20% have severe disease, and the mortality is around 5%. Older individuals, those with obesity and comorbid medical illnesses such as diabetes and lung disease, are particularly prone to developing severe disease. It is possible that a state of chronic low-grade inflammation which underlies each of these conditions may increase the risk of disproportionate host immune reactions (with excessive release of cytokines), characterizing severe disease in those with COVID-19.[4] With this in mind, it is important to note that exercise, some forms of meditation, anti-inflammatory and antioxidant diet (such as turmeric and melatonin), and yoga have known benefits in reducing inflammation.[5],[6],[7],[8],[9] Sleep loss also elevates inflammatory cytokines.

    Healthy sleep may reduce inflammation.[10] Clearly, a healthy lifestyle, including healthy sleep, exercise, and diet, may be protective against developing COVID-19-related severe complications. These principles of healthy living are beautifully summarized in the Bhagavad Gita.Yuktahara-viharasya yukta-cestasya karmasuYukta-svapnavabodhasya yogo bhavati duhkha-haHe who is temperate in his habits of eating, sleeping, working and recreation can mitigate all sorrows by practicing the yoga system.–Bhagavad Gita, Chapter 6, verse 17.The relevance of the Bhagavad Gita for modern psychotherapy has been widely reviewed.[11],[12] However, relatively little empirical literature exists on the effectiveness of versus spiritually integrated psychotherapy incorporating Hindu psychotherapeutic insights. Clearly, more work is needed, and COVID-19 may provide an opportunity for conducting further empirical research.[13] In the meantime, using the principles outlined here may already be of benefit in helping those in need, and may be rapidly enabled in the emerging era of telehealth and digital health.[14]Financial support and sponsorshipNil.Conflicts of interestThere are no conflicts of interest. References 1.Pandurangi AK, Shenoy S, Keshavan MS.

    Psychotherapy in the Bhagavad Gita, the Hindu scriptural text. Am J Psychiatry 2014;171:827-8. 2.Arango C. Lessons learned from the coronavirus health crisis in Madrid, Spain.

    How COVID-19 has changed our lives in the last 2 weeks [published online ahead of print, 2020 Apr 8]. Biol Psychiatry 2020;26:S0006-3223 (20) 31493-1. [doi. 10.1016/j.biopsych.

    2020.04.003]. 3.Keshavan MS, Gangadhar GN, Hinduism PA. In. Spirituality and Mental Health Across Cultures, Evidence-Based Implications for Clinical Practice.

    Oxford, England. Oxford University Press. In Press. 4.Habersaat KB, Betsch C, Danchin M, Sunstein CR, Böhm R, Falk A, et al.

    Ten considerations for effectively managing the COVID-19 transition. Nat Hum Behav 2020;4:677-87. Doi. 10.1038/s41562-020-0906-x.

    Epub 2020 Jun 24. 5.Kumar K. Building resilience to Covid-19 disease severity. J Med Res Pract 2020;9:1-7.

    6.Bushell W, Castle R, Williams MA, Brouwer KC, Tanzi RE, Chopra D, et al. Meditation and Yoga practices as potential adjunctive treatment of SARS-CoV-2 infection and COVID-19. A brief overview of key subjects [published online ahead of print, 2020 Jun 22]. J Altern Complement Med 2020;26:10.1089/acm.

    7.Gupta H, Gupta M, Bhargava S. Potential use of turmeric in COVID-19 [published online ahead of print, 2020 Jul 1]. Clin Exp Dermatol. 2020;10.1111/ced.14357.

    Doi:10.1111/ced.14357. 8.Damiot A, Pinto AJ, Turner JE, Gualano B. Immunological implications of physical inactivity among older adults during the COVID-19 pandemic [published online ahead of print, 2020 Jun 25]. Gerontology 2020:26;1-8.

    [doi. 10.1159/000509216]. 9.El-Missiry MA, El-Missiry ZM, Othman AI. Melatonin is a potential adjuvant to improve clinical outcomes in individuals with obesity and diabetes with coexistence of Covid-19 [published online ahead of print, 2020 Jun 29].

    Eur J Pharmacol 2020;882:173329. 10.Mullington JM, Simpson NS, Meier-Ewert HK, Haack M. Sleep loss and inflammation. Best Pract Res Clin Endocrinol Metab 2010;24:775-84.

    11.Balodhi JP, Keshavan MS. Bhagavad Gita and psychotherapy. Asian J Psychiatr 2011;4:300-2. 12.Bhatia SC, Madabushi J, Kolli V, Bhatia SK, Madaan V.

    The Bhagavad Gita and contemporary psychotherapies. Indian J Psychiatry 2013;55:S315-21. 13.Keshavan MS. Pandemics and psychiatry.

    Repositioning research in context of COVID-19 [published online ahead of print, 2020 May 7]. Asian J Psychiatr 2020;51:102159. [doi. 10.1016/j.ajp.

    2020.102159]. 14.Torous J, Keshavan M. COVID-19, mobile health and serious mental illness. Schizophr Res 2020;218:36-7.

    Correspondence Address:Matcheri S KeshavanRoom 542, Massachusetts Mental Health Center, 75 Fenwood Road, Boston, MA 02115 USASource of Support. None, Conflict of Interest. NoneDOI. 10.4103/psychiatry.IndianJPsychiatry_829_20.

    How to cite straight from the source this where to buy cialis in australia article:Singh OP. The need for routine psychiatric assessment of COVID-19 survivors. Indian J Psychiatry 2020;62:457-8COVID-19 pandemic is expected where to buy cialis in australia to bring a Tsunami of mental health issues.

    Public health emergencies may affect the well-being, safety, and security of both individuals and communities, which lead to a range of emotional reactions, unhealthy behavior, and noncompliance, with public health directives (such as home confinement and vaccination) in people who contact the disease as well as in the general population.[1] Thus far, there has been an increased emphasis on psychosocial factors such as loneliness, effect of quarantine, uncertainty, vulnerability to COVID-19 infection, economic factors, and career difficulties, which may lead to increased psychiatric morbidity.Time has now come to pay attention to the direct effect of the virus on brain and psychiatric adverse symptoms, resulting from the treatment provided. Viral infections are known to be associated with psychiatric where to buy cialis in australia disorders such as depression, bipolar disorder, obsessive–compulsive disorder (OCD), or schizophrenia. There was an increased incidence of psychiatric disorders following the Influenza Pandemic.

    Karl Menninger described 100 cases of influenza presenting with psychiatric sequelae, which could mainly be categorized as dementia praecox, delirium, other psychoses, and unclassified where to buy cialis in australia subtypes. Dementia praecox constituted the largest number among all these cases.[2] Neuroinflammation is now known as the key factor in genesis and exacerbation of psychiatric disorders, particularly depression and bipolar disorders.Emerging evidence points toward the neurotropic properties of the SARS-CoV-2 virus. Loss of smell where to buy cialis in australia and taste as an initial symptom points toward early involvement of olfactory bulb.

    The rapid spread to brain has been demonstrated through retrograde axonal transport.[3] The virus can enter the brain through endothelial cells lining the blood–brain barrier and also through other nerves such as the vagus nerve.[4] Cytokine storm, a serious immune reaction to the virus, can activate brain glial cells, leading to delirium, depression, bipolar disorder, and OCD.Studies examining psychiatric disorders in acute patients suffering from COVID-19 found almost 40% of such patients suffering from anxiety, depression, and posttraumatic stress disorder.[5] The data on long-term psychiatric sequelae in patients who have recovered from acute illness are limited. There are anecdotal reports of psychosis and mania occurring in patients of COVID-19 following discharge from hospital. This may be either due to the direct effect of the virus on the brain or due to the neuropsychiatric effects of drugs used to treat where to buy cialis in australia the infection or its complications.

    For example, behavioral toxicity of high-dose corticosteroids which are frequently used during the treatment of severe cases to prevent and manage cytokine storm.The patients with COVID-19 can present with many neuropsychiatric disorders, which may be caused by direct inflammation, central nervous system effects of cytokine storm, aberrant epigenetic modifications of stress-related genes, glial activation, or treatment emergent effects.[6] To assess and manage various neuropsychiatric complications of COVID-19, the psychiatric community at large should equip itself with appropriate assessment tools and management guidelines to effectively tackle this unprecedented wave of psychiatric ailments. References 1.Pfefferbaum B, North where to buy cialis in australia CS. Mental health and the COVID-19 pandemic.

    N Engl J Med 2020;383:510-2 where to buy cialis in australia. 2.Lu H, Stratton CW, Tang YW. Outbreak of pneumonia of unknown etiology in Wuhan, where to buy cialis in australia China.

    The mystery and the miracle. J Med Virol 2020;92:401-2. 3.Fodoulian L, Tuberosa J, Rossier D, where to buy cialis in australia Landis BN, Carleton A, Rodriguez I.

    SARS-CoV-2 receptor and entry genes are expressed by sustentacular cells in the human olfactory neuroepithelium. BioRxiv 2020.03.31.013268 where to buy cialis in australia. Doi.

    Https://doi.org/10.1101/2020.03.31.013268. 4.Lochhead JJ, Thorne RG. Intranasal delivery of biologics to the central nervous system.

    Adv Drug Deliv Rev 2012;64:614-28. 5.Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, et al. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections.

    A systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry 2020;7:611-27. 6.Steardo L Jr., Steardo L, Verkhratsky A.

    Psychiatric face of COVID-19. Transl Psychiatry 2020;10:261. Correspondence Address:Om Prakash SinghAA 304, Ashabari Apartments, O/31, Baishnabghata, Patuli Township, Kolkata - 700 094, West Bengal IndiaSource of Support.

    None, Conflict of Interest. NoneDOI. 10.4103/indianjpsychiatry.indianjpsychiatry_1169_2Abstract The COVID-19 pandemic has emerged as a major stressor of a global scale, affecting all aspects of our lives, and is likely to contribute to a surge of mental ill health.

    Ancient Hindu scriptures, notably the Bhagavad Gita, have a wealth of insights that can help approaches to build psychological resilience for individuals at risk, those affected, as well as for caregivers. The path of knowledge (Jnana yoga) promotes accurate awareness of nature of the self, and can help reframe our thinking from an “I” to a “we mode,” much needed for collectively mitigating the spread of the coronavirus. The path of action (Karma yoga) teaches the art of selfless action, providing caregivers and frontline health-care providers a framework to continue efforts in the face of uncertain consequences.

    Finally, the path of meditation (Raja yoga) offers a multipronged approach to healthy lifestyle and mindful meditation, which may improve resilience to the illness and its severe consequences. While more work is needed to empirically examine the potential value of each of these approaches in modern psychotherapy, the principles herein may already help individuals facing and providing care for the COVID-19 pandemic.Keywords. Bhagavad Gita, Covid-19, YogaHow to cite this article:Keshavan MS.

    Building resilience in the COVID-19 era. Three paths in the Bhagavad Gita. Indian J Psychiatry 2020;62:459-61The COVID-19 crisis has changed our world in just a matter of months, thrusting us into danger, uncertainty, fear, and of course social isolation.

    At the time of this writing, over 11 million individuals have been affected worldwide (India is fourth among all countries, 674,515) and over half a million people have died. The COVID-19 pandemic has been an unprecedented global stressor, not only because of the disease burden and mortality but also because of economic upheaval. The very fabric of the society is disrupted, affecting housing, personal relationships, travel, and all aspects of lifestyle.

    The overwhelmed health-care system is among the most major stressors, leading to a heightened sense of vulnerability. No definitive treatments or vaccine is on the horizon yet. Psychiatry has to brace up to an expected mental health crisis resulting from this global stressor, not only with regard to treating neuropsychiatric consequences but also with regard to developing preventive approaches and building resilience.Thankfully, there is a wealth of wisdom to help us in our ancient scriptures such as the Bhagavad Gita[1] for building psychological resilience.

    The Bhagavad Gita is a dialog between the Pandava prince Arjuna and his charioteer Krishna in the epic Mahabharata, the great tale of the Bharata Dynasty, authored by Sage Vyasa (c. 4–5 B.C.E.). The dialog occurs in the 6th chapter of the epic and has over 700 verses.

    In this epic story, Arjuna, the righteous Pandava hero was faced with the dilemma of waging a war against his cousins, the Kauravas, for territory. Arjuna is confused and has no will to initiate the war. In this context, Krishna, his charioteer and spiritual mentor, counsels him.

    The key principles of this spiritual discourse in the Gita are embodied in the broad concept of yoga, which literally means “Yog” or “to unite.” Applying three tenets of yoga can greatly help developing resilience at individual, group, and societal levels. A fourth path, Bhakti yoga, is a spiritual approach in the Gita which emphasizes loving devotion toward a higher power or principle, which may or may not involve a personal god. In this editorial, I focus on three paths that have considerable relevance to modern approaches to reliance-focused psychotherapy that may be especially relevant in the COVID-19 era.

    Path of Knowledge The first concept in the Gita is the path of knowledge (Jnana Yoga, chapter 2). The fundamental goal of Jnana yoga is to liberate oneself from the limited view of the individual ego, and to develop the awareness of one's self as part of a larger, universal self. Hindu philosophers were among the earliest to ask the question of “who am I” and concluded that the self is not what it seems.

    The self as we all know is a collection of our physical, mental, and social attributes that we create for ourselves with input from our perceptions, and input by our families and society. Such a world view leads to a tendency to crave for the “I” and for what is mine, and not consider the “We.” As Krishna in the Bhagavad Gita points out, the person who sees oneself in others, and others in oneself, really “sees.” Such awareness, which guides action in service of self as well as others, is critically important in our goals of collectively preventing the spread of the coronavirus. A glaring example is the use of face masks, known to effectively slow the viral infection.

    Using the mask is as important to protecting oneself from the virus as well as protecting others from oneself. Nations such as the USA (and their leaders), who have given mixed messages to the public about the need to wear masks, have been showing a strikingly high number of cases as well as mortality. Unfortunately, such reluctance to wear masks (and thus model protective hygiene for the population), as in the case of the US leader, has stemmed from ego or vanity-related issues (i.e., how he would appear to other leaders!.

    ). This factor may at least partly underlie the worse COVID-19 outcome in the USA. The simple lesson here is that it is important to first flatten the ego if one wants to flatten the pandemic curve!.

    Path of Action The second key concept is the path of action (Karma yoga, chapter 3). Karma yoga is all about taking action without thinking, “what's in it for me.” As such, it seeks to mainly let go of one's ego. In the Bhagavad Gita, Arjuna is ambivalent about fighting because of the conflict regarding the outcome brought on by waging the war, i.e., having to kill some of his own kith and kin.

    Krishna reminds him that he should not hesitate, because it is his nature and duty (or Dharma), as a warrior, to protect the larger good, though it will have some downside consequences. The frontline health-care worker caring for severely ill patients with COVID-19 is likely to have a similar emotional reaction as Arjuna, facing a lack of adequate treatments, high likelihood of mortality and of unpredictable negative outcomes, and risk to him/herself. Compounding this, especially when resources such as ventilators are limited, the doctor may have to make tough decisions of whose life to save and whose not.

    Adding to this are personal emotions when facing with the death of patients, having to deliver bad news, and dealing with grieving relatives.[2] All these are likely to result in emotional anguish and guilt, leading to burnout and a war “neurosis.”So, what should the frontline health-care provider should do?. Krishna's counsel would be that the doctor should continue to perform his/her own dharma, but do so without desire or attachment, thereby performing action in the spirit of Karma yoga http://www.amisdepasteur.fr/cialis-20mg-price-walmart/. Such action would be with detachment, without a desire for personal gain and being unperturbed by success or failure.

    Such “Nishkaama Karma” (or selfless action) may help doctors working today in the COVID outbreak to carry forward their work with compassion, and accept the results of their actions with equanimity and without guilt. Krishna points out that training one's mind to engage in selfless action is not easy but requires practice (Abhyasa). Krishna is also emphatic about the need to protect oneself, in order to be able to effectively carry out one's duties.

    Path of Meditation The third core concept in the Gita is the path of meditation and self-reflection (Raja yoga, or Dhyana yoga, chapter 6). It is considered the royal path (Raja means royal) for attaining self-realization, and often considered the 8-fold path of yoga (Ashtanga yoga) designed to discipline lifestyle, the body and mind toward realizing mindfulness and self-reflection. These techniques, which originated in India over two millennia ago, have evolved over recent decades and anticipate several approaches to contemplative psychotherapy, including dialectical behavior therapy, acceptance and commitment therapy, and mindfulness-based stress reduction.[3] These approaches are of particular relevance for stress reduction and resilience building in individuals faced by COVID-19-related emotional difficulties as well as health-care providers.[4]The majority of people affected by the COVID-19 virus recover, but about 20% have severe disease, and the mortality is around 5%.

    Older individuals, those with obesity and comorbid medical illnesses such as diabetes and lung disease, are particularly prone to developing severe disease. It is possible that a state of chronic low-grade inflammation which underlies each of these conditions may increase the risk of disproportionate host immune reactions (with excessive release of cytokines), characterizing severe disease in those with COVID-19.[4] With this in mind, it is important to note that exercise, some forms of meditation, anti-inflammatory and antioxidant diet (such as turmeric and melatonin), and yoga have known benefits in reducing inflammation.[5],[6],[7],[8],[9] Sleep loss also elevates inflammatory cytokines. Healthy sleep may reduce inflammation.[10] Clearly, a healthy lifestyle, including healthy sleep, exercise, and diet, may be protective against developing COVID-19-related severe complications.

    These principles of healthy living are beautifully summarized in the Bhagavad Gita.Yuktahara-viharasya yukta-cestasya karmasuYukta-svapnavabodhasya yogo bhavati duhkha-haHe who is temperate in his habits of eating, sleeping, working and recreation can mitigate all sorrows by practicing the yoga system.–Bhagavad Gita, Chapter 6, verse 17.The relevance of the Bhagavad Gita for modern psychotherapy has been widely reviewed.[11],[12] However, relatively little empirical literature exists on the effectiveness of versus spiritually integrated psychotherapy incorporating Hindu psychotherapeutic insights. Clearly, more work is needed, and COVID-19 may provide an opportunity for conducting further empirical research.[13] In the meantime, using the principles outlined here may already be of benefit in helping those in need, and may be rapidly enabled in the emerging era of telehealth and digital health.[14]Financial support and sponsorshipNil.Conflicts of interestThere are no conflicts of interest. References 1.Pandurangi AK, Shenoy S, Keshavan MS.

    Psychotherapy in the Bhagavad Gita, the Hindu scriptural text. Am J Psychiatry 2014;171:827-8. 2.Arango C.

    Lessons learned from the coronavirus health crisis in Madrid, Spain. How COVID-19 has changed our lives in the last 2 weeks [published online ahead of print, 2020 Apr 8]. Biol Psychiatry 2020;26:S0006-3223 (20) 31493-1.

    3.Keshavan MS, Gangadhar GN, Hinduism PA. In. Spirituality and Mental Health Across Cultures, Evidence-Based Implications for Clinical Practice.

    Oxford, England. Oxford University Press. In Press.

    4.Habersaat KB, Betsch C, Danchin M, Sunstein CR, Böhm R, Falk A, et al. Ten considerations for effectively managing the COVID-19 transition. Nat Hum Behav 2020;4:677-87.

    Doi. 10.1038/s41562-020-0906-x. Epub 2020 Jun 24.

    5.Kumar K. Building resilience to Covid-19 disease severity. J Med Res Pract 2020;9:1-7.

    6.Bushell W, Castle R, Williams MA, Brouwer KC, Tanzi RE, Chopra D, et al. Meditation and Yoga practices as potential adjunctive treatment of SARS-CoV-2 infection and COVID-19. A brief overview of key subjects [published online ahead of print, 2020 Jun 22].

    J Altern Complement Med 2020;26:10.1089/acm. 2020.0177. [doi.

    10.1089/acm. 2020.0177]. 7.Gupta H, Gupta M, Bhargava S.

    Potential use of turmeric in COVID-19 [published online ahead of print, 2020 Jul 1]. Clin Exp Dermatol. 2020;10.1111/ced.14357.

    Doi:10.1111/ced.14357. 8.Damiot A, Pinto AJ, Turner JE, Gualano B. Immunological implications of physical inactivity among older adults during the COVID-19 pandemic [published online ahead of print, 2020 Jun 25].

    Gerontology 2020:26;1-8. [doi. 10.1159/000509216].

    9.El-Missiry MA, El-Missiry ZM, Othman AI. Melatonin is a potential adjuvant to improve clinical outcomes in individuals with obesity and diabetes with coexistence of Covid-19 [published online ahead of print, 2020 Jun 29]. Eur J Pharmacol 2020;882:173329.

    10.Mullington JM, Simpson NS, Meier-Ewert HK, Haack M. Sleep loss and inflammation. Best Pract Res Clin Endocrinol Metab 2010;24:775-84.

    11.Balodhi JP, Keshavan MS. Bhagavad Gita and psychotherapy. Asian J Psychiatr 2011;4:300-2.

    12.Bhatia SC, Madabushi J, Kolli V, Bhatia SK, Madaan V. The Bhagavad Gita and contemporary psychotherapies. Indian J Psychiatry 2013;55:S315-21.

    13.Keshavan MS. Pandemics and psychiatry. Repositioning research in context of COVID-19 [published online ahead of print, 2020 May 7].

    Asian J Psychiatr 2020;51:102159. [doi. 10.1016/j.ajp.

    2020.102159]. 14.Torous J, Keshavan M. COVID-19, mobile health and serious mental illness.

    Schizophr Res 2020;218:36-7. Correspondence Address:Matcheri S KeshavanRoom 542, Massachusetts Mental Health Center, 75 Fenwood Road, Boston, MA 02115 USASource of Support. None, Conflict of Interest.

    NoneDOI. 10.4103/psychiatry.IndianJPsychiatry_829_20.

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    • certain drugs used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole
    • certain drugs used for seizures like carbamazepine, phenytoin, and phenobarbital
    • grapefruit juice
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    This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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    A persistent buy cialis in montreal falsehood has been circulating cialis vs viagra side effects on social media. The number of COVID deaths is much lower than the official statistic of more than 218,000, and therefore the danger of the disease has been overblown. In August President Trump retweeted a post claiming that only 6 percent of these reported deaths were actually from COVID-19. (The tweet originated from a follower of the debunked buy cialis in montreal conspiracy fantasy QAnon.) Twitter removed the post for containing false information, but fabrications such as these continue to spread.

    U.S. Representative Roger Marshall of Kansas complained in September that Facebook had removed a post in which he claimed that 94 percent of COVID-19 deaths reported by the Centers for Disease Control and Prevention “were the result of 2-3 additional serious illnesses and were of advanced age.” Now some facts. Researchers know beyond a doubt that the number buy cialis in montreal of COVID-19 deaths in the U.S. Have surpassed 200,000.

    These numbers are supported by three lines of evidence, including death certificates. The inaccurate idea that only 6 percent of the buy cialis in montreal deaths were really caused by the coronavirus is “a gross misinterpretation” of how death certificates work, says Robert Anderson, lead mortality statistician at the CDC’s National Center for Health Statistics. The scope of the coronavirus’s deadly toll is clear, even if final numbers will not be known until the pandemic is over. €œWe’re pretty confident about the scale and order of magnitude of deaths, but we’re not clear on the exact number yet,” says Justin Lessler, an infectious disease epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

    To understand why the figures contain some uncertainty, it is important to buy cialis in montreal know how they are collected and calculated. The first source of death data is called case surveillance. Health care providers are required to report cases and deaths from certain diseases, including measles, mumps and now COVID-19, to their state’s health department, which, in turn, passes this information along to the CDC, Anderson says. The surveillance data are a kind of “quick and dirty” accounting, says Shawna Webster, executive director of the National Association for buy cialis in montreal Public Health Statistics and Information Systems.

    The states gather all the information they can on these diseases, but this is the first pass of the accounting—no one has time to double-check the information or look for missing lab tests, she says. For that, you have to look for the next source of information. Vital records buy cialis in montreal. Credit.

    Youyou Zhou. Sources. Centers for Disease Control and Prevention, National Center for Health Statistics This second line of evidence comes from the National Vital Statistics System, which records birth and death certificates. Every time somebody dies, a death certificate is filed in the state where the death occurred.

    And after the records are registered at a state level, they are sent to the National Center for Health Statistics, which tracks deaths at a national level. Death certificates are not filed in the system until outstanding test results are in and the information is as complete as possible. By the time a record gets to the vital records system, “it is as close to perfect as it’s going to get,” Webster says. A physician, medical examiner or coroner fills out the cause of mortality on the death certificate, and they are instructed to include only those conditions that caused or contributed to death, Anderson says.

    One field lists the sequence of events leading to the death. €œWhat we’re really trying to get at is the condition or disease that started the chain of events leading to the death,” Anderson says. €œFor COVID-19, that might be something like acute respiratory distress due to pneumonia due to COVID-19.” A second part of the certificate lists other significant conditions that may have contributed to the death yet were not part of the sequence of events that led up to it, he says. These are called comorbidities, and while they can be contributing factors, they cannot be directly involved in the chain of cause and effect that ended in death.

    Preexisting medical conditions such as diabetes or heart disease are common comorbidities, and they can make a person more vulnerable to the coronavirus, Anderson says, “but the fact is. They’re not dying from that preexisting condition.” “When we ask if COVID killed somebody, it means ‘Did they die sooner than they would have if they didn’t have the virus?. €™â€ Lessler says. Even such a person with a potentially life-shortening preexisting condition such as heart disease or diabetes may have lived another five, 10 or more years, had they not become infected with COVID-19.

    The 6 percent number touted by Trump and QAnon comes from a weekly CDC report stating that in 6 percent of the coronavirus mortality cases it counted, COVID-19 was the only condition listed on the death certificate. That observation likely means that those death certificates were incomplete because the certifiers only gave the underlying cause of death and not the full causal sequence that led to it, Anderson says. Even someone who does not have a preexisting condition and dies from COVID-19 will also have comorbidities in the form of symptoms, such as respiratory failure, caused by the coronavirus. The idea that a death certificate with ailments listed in addition to COVID-19 means that the person did not really die from the virus is simply false, Anderson says.

    The surveillance and vital statistics data provide a pretty good picture of how many deaths are attributable to the coronavirus, but they do not capture all of them, and that is where the final line of evidence come in. Excess deaths. They are the number of deaths that occur above and beyond the historical pattern for that time period, says Steven Woolf, a physician and population health researcher at the Virginia Commonwealth University School of Medicine. In a paper published in JAMA this month, Woolf and his colleagues examined death records in the U.S.

    From March 1 through August 1 and compared them with the expected mortality numbers. They found that there was a 20 percent increase in deaths during this time period—for a total of 225,530 excess deaths—compared with previous years. Two thirds of these cases were attributed to COVID-19 on the death certificates, and Woolf says there are two types of explanations for the rest. Some of them were COVID-19 deaths that simply were not documented as such, perhaps because the person died at home and was never tested or because the certificate was miscoded.

    And some of the extra deaths were probably a consequence of the pandemic yet not necessarily the virus itself. For instance, he says, imagine a patient with chest pain who is scared to go to the hospital because they do not want to get the virus and then dies of a heart attack. Woolf calls this “indirect mortality.” “The deaths aren’t literally caused by the virus itself but the pandemic is claiming lives,” he says. The numbers in Woolf’s study come from provisional death data, the kind that the CDC has not yet checked for miscoding or other issues, so it comes with some degree of imprecision.

    What builds his confidence in these results, however, is the fact that they have been replicated numerous times by his group and others. €œAll serious analyses of these data are showing that the number of deaths we’re hearing on the news is an undercount,” he says. COVID-19 is now the third leading cause of death in the U.S. Whether the number of lives cut short add up to 218,511, 219,681 or 219,541—as reported by the CDC, Johns Hopkins University and the New York Times, respectively, on October 19—it’s a staggering number of lives cut short.

    Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here..

    A persistent falsehood has been circulating on social where to buy cialis in australia media. The number of COVID deaths is much lower than the official statistic of more than 218,000, and therefore the danger of the disease has been overblown. In August President Trump retweeted a post claiming that only 6 percent of these reported deaths were actually from COVID-19. (The tweet originated from a follower of where to buy cialis in australia the debunked conspiracy fantasy QAnon.) Twitter removed the post for containing false information, but fabrications such as these continue to spread.

    U.S. Representative Roger Marshall of Kansas complained in September that Facebook had removed a post in which he claimed that 94 percent of COVID-19 deaths reported by the Centers for Disease Control and Prevention “were the result of 2-3 additional serious illnesses and were of advanced age.” Now some facts. Researchers know beyond a doubt that the number of COVID-19 deaths in the U.S where to buy cialis in australia. Have surpassed 200,000.

    These numbers are supported by three lines of evidence, including death certificates. The inaccurate idea that only 6 percent of the deaths were really caused by the coronavirus is “a gross misinterpretation” of where to buy cialis in australia how death certificates work, says Robert Anderson, lead mortality statistician at the CDC’s National Center for Health Statistics. The scope of the coronavirus’s deadly toll is clear, even if final numbers will not be known until the pandemic is over. €œWe’re pretty confident about the scale and order of magnitude of deaths, but we’re not clear on the exact number yet,” says Justin Lessler, an infectious disease epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

    To understand why the figures contain some uncertainty, it is important to know how where to buy cialis in australia they are collected and calculated. The first source of death data is called case surveillance. Health care providers are required to report cases and deaths from certain diseases, including measles, mumps and now COVID-19, to their state’s health department, which, in turn, passes this information along to the CDC, Anderson says. The surveillance data are a kind of “quick and dirty” accounting, says Shawna Webster, executive director of the National Association for where to buy cialis in australia Public Health Statistics and Information Systems.

    The states gather all the information they can on these diseases, but this is the first pass of the accounting—no one has time to double-check the information or look for missing lab tests, she says. For that, you have to look for the next source of information. Vital records where to buy cialis in australia. Credit.

    Youyou Zhou. Sources. Centers for Disease Control and Prevention, National Center for Health Statistics This second line of evidence comes from the National Vital Statistics System, which records birth and death certificates. Every time somebody dies, a death certificate is filed in the state where the death occurred.

    And after the records are registered at a state level, they are sent to the National Center for Health Statistics, which tracks deaths at a national level. Death certificates are not filed in the system until outstanding test results are in and the information is as complete as possible. By the time a record gets to the vital records system, “it is as close to perfect as it’s going to get,” Webster says. A physician, medical examiner or coroner fills out the cause of mortality on the death certificate, and they are instructed to include only those conditions that caused or contributed to death, Anderson says.

    One field lists the sequence of events leading to the death. €œWhat we’re really trying to get at is the condition or disease that started the chain of events leading to the death,” Anderson says. €œFor COVID-19, that might be something like acute respiratory distress due to pneumonia due to COVID-19.” A second part of the certificate lists other significant conditions that may have contributed to the death yet were not part of the sequence of events that led up to it, he says. These are called comorbidities, and while they can be contributing factors, they cannot be directly involved in the chain of cause and effect that ended in death.

    Preexisting medical conditions such as diabetes or heart disease are common comorbidities, and they can make a person more vulnerable to the coronavirus, Anderson says, “but the fact is. They’re not dying from that preexisting condition.” “When we ask if COVID killed somebody, it means ‘Did they die sooner than they would have if they didn’t have the virus?. €™â€ Lessler says. Even such a person with a potentially life-shortening preexisting condition such as heart disease or diabetes may have lived another five, 10 or more years, had they not become infected with COVID-19.

    The 6 percent number touted by Trump and QAnon comes from a weekly CDC report stating that in 6 percent of the coronavirus mortality cases it counted, COVID-19 was the only condition listed on the death certificate. That observation likely means that those death certificates were incomplete because the certifiers only gave the underlying cause of death and not the full causal sequence that led to it, Anderson says. Even someone who does not have a preexisting condition and dies from COVID-19 will also have comorbidities in the form of symptoms, such as respiratory failure, caused by the coronavirus. The idea that a death certificate with ailments listed in addition to COVID-19 means that the person did not really die from the virus is simply false, Anderson says.

    The surveillance and vital statistics data provide a pretty good picture of how many deaths are attributable to the coronavirus, but they do not capture all of them, and that is where the final line of evidence come in. Excess deaths. They are the number of deaths that occur above and beyond the historical pattern for that time period, says Steven Woolf, a physician and population health researcher at the Virginia Commonwealth University School of Medicine. In a paper published in JAMA this month, Woolf and his colleagues examined death records in the U.S.

    From March 1 through August 1 and compared them with the expected mortality numbers. They found that there was a 20 percent increase in deaths during this time period—for a total of 225,530 excess deaths—compared with previous years. Two thirds of these cases were attributed to COVID-19 on the death certificates, and Woolf says there are two types of explanations for the rest. Some of them were COVID-19 deaths that simply were not documented as such, perhaps because the person died at home and was never tested or because the certificate was miscoded.

    And some of the extra deaths were probably a consequence of the pandemic yet not necessarily the virus itself. For instance, he says, imagine a patient with chest pain who is scared to go to the hospital because they do not want to get the virus and then dies of a heart attack. Woolf calls this “indirect mortality.” “The deaths aren’t literally caused by the virus itself but the pandemic is claiming lives,” he says. The numbers in Woolf’s study come from provisional death data, the kind that the CDC has not yet checked for miscoding or other issues, so it comes with some degree of imprecision.

    What builds his confidence in these results, however, is the fact that they have been replicated numerous times by his group and others. €œAll serious analyses of these data are showing that the number of deaths we’re hearing on the news is an undercount,” he says. COVID-19 is now the third leading cause of death in the U.S. Whether the number of lives cut short add up to 218,511, 219,681 or 219,541—as reported by the CDC, Johns Hopkins University and the New York Times, respectively, on October 19—it’s a staggering number of lives cut short.

    Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here..

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    And Montana, where more than half of is cialis generic available in canada the state’s cases have been announced since August, is averaging more than 500 cases per day.In Cascade County, more than 300 inmates and staff members have been infected in a facility meant to hold 365 people, the county’s first major outbreak in a region where the virus is suddenly surging.The county seat, Great Falls, is seeing its worst case numbers yet. The local hospital and its 27-bed Covid-19 unit is at capacity. The county health department is racing to hire new contact tracers. And Mr is cialis generic available in canada.

    Krogue, who also teaches nursing at Montana State University’s Great Falls campus, has seen attendance in his classes dwindle as students fall ill or quarantine.“I was just scared that I’m not going to be able to see it through, that I’m going to get sick,” said Paul Krogue, the jail’s medical director.Credit...Tailyr Irvine for The New York TimesOne place where the infections have spread has been local jails, which are confined, often crowded spaces. Jails are staples of local communities and tend to have people coming and going more quickly than prisons. Jails can hold everyone from people awaiting criminal trials is cialis generic available in canada for months to those picked up for a suspended driver’s license for a few hours. With so many people filtering in and out, jails pose extra risks for the virus’s spread — not only inside facilities but in potentially feeding outbreaks in the rest of the community.Nationally, jails and prisons have seen disproportionate rates of infection and death, with a mortality rate twice as high as in the general population and an infection rate more than four times as high, according to recent data.

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    } } Latest Updates. The Coronavirus Outbreak 2h ago Senate Republicans push narrow stimulus bills as Pelosi and Mnuchin plan to speak. 3h ago U.S. Records over 70,000 cases in one day for the first time since July.

    4h ago A frozen yogurt shop in Colorado offered maskless customers a 10 percent discount. Uproar ensued. See more updates More live coverage. Markets A New York Times database has tracked clusters of at least 50 coronavirus cases in a dozen rural jails in Montana, Idaho, Utah and New Mexico during the pandemic.

    Among them. The Purgatory Correctional Center in Hurricane, Utah, with 166 infections. The jail in Twin Falls, Idaho, with 279. And, in New Mexico, the Cibola County Correctional Center, which has reported 357 cases.In Cascade County, infections at the jail make up about a quarter of all known virus cases in the county.

    Health authorities say that the jail’s outbreak, which began in mid-August, was not believed to be the main cause of the community’s recent surge, but that it had led to some cases. In the past two months, Mr. Krogue said, the jail released 29 people who were considered actively infected.Infections at the jail make up about a quarter of Cascade County’s known virus cases.Credit...Tailyr Irvine for The New York TimesGreat Falls, home to about 58,000 residents, is in the less mountainous part of Montana, with the Missouri River flowing through and a large oil refinery on its banks. The Cascade County Detention Center sits along a highway at the edge of town.

    Drive five miles in any direction and you are surrounded by wide-open plains.Montana requires that masks be worn inside businesses and indoor public spaces, and many people in Great Falls wear them when walking around downtown’s Central Avenue, where shops and cafes are still recovering from shutting down in the spring. Others go without masks, citing the open space and lack of crowds.Bob Kelly, the mayor, said people had not been overly worried about how the jail outbreak might affect the rest of town when it started.“I think that by the very definition of a jail, hopefully, the disease will be incarcerated, as well as the patients,” he said. €œIs there concern?. Sure, there’s concern.

    But is there overreaction?. No.”The mayor of Great Falls said that residents had considered the jail’s outbreak a distant concern at first.Credit...Tailyr Irvine for The New York TimesSome residents’ nonchalance about the risks of the virus, said Mr. Krogue, the jail’s medical director, can be traced to a spring and early summer when almost no one in Cascade County knew anyone who had been sickened.“We benefited from that early on,” he said. €œBut in some ways, I think it did us a disservice, too, because it also created a certain level of complacency.”That has quickly shifted now, he said, as cases have spiked.The number of active cases known to county officials on any given day has risen sharply to about 600, according to Trisha Gardner, Cascade County’s health officer.

    The county has seen 1,261 cases and six deaths during the pandemic, a Times database shows. Some of the cases have been tied to the jail outbreak, she said, and others have been connected to bars and restaurants. Even figuring out what has led to some cases has been complex, she said, as residents have been reluctant to cooperate with contact tracers.“Our hospitals are at capacity, our public health system is at capacity,” she said. €œIt’s not sustainable at this rate.”When the outbreak at the jail began, social distancing was impossible, the authorities said.

    Three inmates shared cells designed for two. At night, men slept on thin blue pads in every available space. On the floor in the day room, in shower stalls, in stairwells, in hallways outside of cells.Inmates did not receive masks until August, and jail officials said many have refused to wear them.In interviews with more than a dozen inmates and their family members, inmates described the jail during the outbreak as chaotic and unsanitary. They said their pleas for help often went unanswered by nurses and guards.Newly arriving inmates were not always quarantined from one another before their test results were known because of a lack of space, inmates and jail officials said.Owen Hawley, 30, said every inmate in his living area of 38 men had tested positive for the virus.

    He said he had been unable to eat for three days, had intensive body aches and suffered from a headache so powerful it felt as if it was “behind my eyes.”“After the fourth day of like, not eating and stuff, I just shut off, you know?. € he said.A jail area set aside for quarantining new inmates.Credit...Tailyr Irvine for The New York TimesAt one point, Mr. Hawley said, he and other prisoners protested the way the virus was being handled by refusing to leave their living areas and by blocking new inmates from entering. Everyone was ultimately tested, Mr.

    Hawley said, and each prisoner was given a disposable mask.Sierra Jasmine Wells, 25, another inmate, said women in her dormitory had grown ill, one after the next.“Everyone around me was getting sick and it was tough on me,” she said. €œBy then, I had already accepted the fact that I was going to get sick.”When she became infected, she said, she was given cough syrup and Tylenol.“I kind of was just left alone to deal with it,” she said.Jesse Slaughter, the county sheriff who oversees the jail, said that the jail’s medical staff was doing everything it could, and that he had been seeking health care assistance from other counties. Officials defended their handling of the outbreak, noting that all inmates received standard medications including Tylenol twice a day and were taken to area hospitals when they needed added care. Seven inmates, as well as some staff members, were hospitalized.

    No one from the jail has died from the virus, officials said.Sheriff Jesse Slaughter, who oversees the jail, said he had been seeking health care assistance from other counties.Credit...Tailyr Irvine for The New York TimesMr. Krogue said that since the start of the outbreak he had been working up to 16 hours each day and sleeping in his basement, away from his wife and children. He remains healthy but says he fears bringing the virus home. The virus has slowed some in the jail, and officials have moved some inmates to other facilities, but other prisons and jails in the state are now seeing outbreaks.“You can start to see what some of these other places experienced much earlier on, and we just didn’t have that experience, but it’s certainly happening now,” Mr.

    Krogue said. €œIt’s just real in a way that it wasn’t.”Lucy Tompkins reported from Great Falls, Maura Turcotte from Chicago and Libby Seline from Lincoln, Neb. Reporting was contributed by Izzy Colón from Columbia, Mo., Brendon Derr from Phoenix, Rebecca Griesbach from Tuscaloosa, Ala., Danya Issawi and Timothy Williams from New York, Ann Hinga Klein from Des Moines, K.B. Mensah from Silver Spring, Md., and Mitch Smith from Chicago.Start Preamble Food and Drug Administration, HHS.

    Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice.

    The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. The announcement of the guidances is published in the Federal Register on October 16, 2020. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. You may submit either electronic or written comments on Agency guidances at any time as follows.

    Electronic Submissions Submit electronic comments in the following way. Federal eRulemaking Portal. Https://www.regulations.gov. Follow the instructions for submitting comments.

    Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions Submit written/paper submissions as follows. Mail/Hand Delivery/Courier (for written/paper submissions). Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions. All submissions received must include the name of the guidance document that the comments address and the docket number for the guidance (see table 1). Received comments will be placed in the docket(s) and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. And 4 p.m., Monday through Friday, 240-402-7500.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in Start Printed Page 65821its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.

    Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

    Docket. For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of these guidances to the address noted in table 1. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidances. Start Further Info Kimberly Thomas, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.

    51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357. End Further Info End Preamble Start Supplemental Information I. Background On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, Alex M.

    Azar II, Secretary of Health and Human Services, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed since January 27, 2020, nationwide.[] On March 13, 2020, President Donald J. Trump declared that the COVID-19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.[] In the Federal Register of March 25, 2020 (the March 25, 2020, notice) (available at https://www.govinfo.gov/​content/​pkg/​FR-2020-03-25/​pdf/​2020-06222.pdf), FDA announced procedures for making available FDA guidances related to the COVID-19 PHE. These procedures, which operate within FDA's established good guidance practices regulations, are intended to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders.

    The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID-19 PHE, FDA believes that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidances. Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2) (§ 10.115(g)(2))). The guidances are available at FDA's web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” (https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled “Search for FDA Guidance Documents” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents.

    The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID-19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID-19-related guidances that are posted on FDA's website. II. Availability of COVID-19-Related Guidance Documents Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID-19-related guidances.

    Table 1—Guidances Related to the COVID-19 Public Health EmergencyDocket No.CenterTitle of guidanceContact information to request single copiesFDA-2020-D-1136CDERManufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (August 2020)druginfo@fda.hhs.gov. Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1136CDERResuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (September 2020)druginfo@fda.hhs.gov. Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1106CDERFDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (March 2020) (Updated September 2020)Clinicaltrialconduct-COVID19@fda.hhs.gov. Please include the docket number FDA-2020-D-1106 and complete title of the guidance in the request.

    Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)). These guidances are being issued consistent with FDA's good guidance practices regulation (§ 10.115). The Start Printed Page 65822guidances represent the current thinking of FDA. They do not establish any rights for any person and are not binding on FDA or the public.

    You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 CDER Guidances The guidances listed in the table below refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.

    3501-3521) is not required for these guidances. However, these previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table. Table 2—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance title referenced in COVID-19 guidanceOMB control No(s).Guidance for Industry.

    Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency21 CFR 210 and 211, 21 CFR 514.80, 21 CFR 600—Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients —Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. €”Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act. €”Reporting and Mitigating Animal Drug Shortages During the COVID-19 Public Health Emergency.0910-0001, 0910-0032, 0910-0139, 0910-0338, 0910-0669, 0910-0675, 0910-0759, 0910-0806.Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency. Questions and Answers21 CFR 314.50.

    314.95, 314.125, 314.127. 601.2 and 601.20—Prioritization of the Review of Original ANDAs, Amendments, and Supplements —Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes.0910-0001, 0910-0014, 0910-0338, 0910-0045, 0910-0139, 0910-0759. —Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA). —Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. —Changes to an Approved Application. Biological Products. —Changes to an Approved NDA or ANDA. Questions and Answers. —Changes to an Approved NDA or ANDA. —CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports. —Changes to an Approved Application.

    Biological Products. Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. —CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. —Chemistry, Manufacturing, and Controls Changes to an Approved Application. Certain Biological Products. —Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes.

    Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. —SUPAC-IR. Questions and Answers about SUPAC-IR Guidance. —Nonsterile Semisolid Dosage Forms. Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls.

    In Vitro Release Testing and In Vivo Bioequivalence Documentation. —SUPAC-MR. Modified Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls.

    In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.Start Printed Page 65823 —SUPAC. Manufacturing Equipment Addendum. The guidance listed in the table below refers to previously approved FDA collections of information. Therefore, clearance by OMB under the PRA is not required for this guidance.

    However, these collections of information are subject to review by OMB under the PRA. The previously approved collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the table below. This guidance also contains a collection of information not approved under a current collection. This collection of information has been granted a PHE waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act.

    Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/​public-health-emergency-declaration-pra-waivers. Table 3—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance referenced in COVID-19 guidanceOMB control No(s).Collection covered by PHE PRA waiverGuidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (Updated September 21, 2020)21 CFR part 11, 21 CFR part 50, 21 CFR part 56, 21 CFR part 312, 21 CFR part 314, 21 CFR part 320, 21 CFR part 601, 21 CFR part 812Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products. Pediatric Study Plans. Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.

    Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Design. Pregnant Women. Scientific and Ethical Considerations for Inclusion in Clinical Trials.

    Part 11, Electronic Records. Electronic Signatures Scope and Application.0910-0001, 0910-0014, 0910-0130, 0910-0303, 0910-0338, 0910-0119, 0910-0581, 0910-0733, 0910-0078Submission by investigators of informed consent forms to third parties. Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11—Questions and Answers. Safety Reporting Requirements for INDs and BA/BE Studies. Adverse Event Reporting to IRBs—Improving Human Subject Protection.

    Use of Electronic Informed Consent In Clinical Investigations. E6(R2) Good Clinical Practice. Integrated Addendum to ICH E6(R1). Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

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    } } Latest Updates. The Coronavirus Outbreak 2h ago Senate Republicans push narrow stimulus bills as Pelosi and Mnuchin plan to speak. 3h ago U.S.

    Records over 70,000 cases in one day for the first time since July. 4h ago A frozen yogurt shop in Colorado offered maskless customers a 10 percent discount. Uproar ensued.

    See more updates More live coverage. Markets A New York Times database has tracked clusters of at least 50 coronavirus cases in a dozen rural jails in Montana, Idaho, Utah and New Mexico during the pandemic. Among them.

    The Purgatory Correctional Center in Hurricane, Utah, with 166 infections. The jail in Twin Falls, Idaho, with 279. And, in New Mexico, the Cibola County Correctional Center, which has reported 357 cases.In Cascade County, infections at the jail make up about a quarter of all known virus cases in the county.

    Health authorities say that the jail’s outbreak, which began in mid-August, was not believed to be the main cause of the community’s recent surge, but that it had led to some cases. In the past two months, Mr. Krogue said, the jail released 29 people who were considered actively infected.Infections at the jail make up about a quarter of Cascade County’s known virus cases.Credit...Tailyr Irvine for The New York TimesGreat Falls, home to about 58,000 residents, is in the less mountainous part of Montana, with the Missouri River flowing through and a large oil refinery on its banks.

    The Cascade County Detention Center sits along a highway at the edge of town. Drive five miles in any direction and you are surrounded by wide-open plains.Montana requires that masks be worn inside businesses and indoor public spaces, and many people in Great Falls wear them when walking around downtown’s Central Avenue, where shops and cafes are still recovering from shutting down in the spring. Others go without masks, citing the open space and lack of crowds.Bob Kelly, the mayor, said people had not been overly worried about how the jail outbreak might affect the rest of town when it started.“I think that by the very definition of a jail, hopefully, the disease will be incarcerated, as well as the patients,” he said.

    €œIs there concern?. Sure, there’s concern. But is there overreaction?.

    No.”The mayor of Great Falls said that residents had considered the jail’s outbreak a distant concern at first.Credit...Tailyr Irvine for The New York TimesSome residents’ nonchalance about the risks of the virus, said Mr. Krogue, the jail’s medical director, can be traced to a spring and early summer when almost no one in Cascade County knew anyone who had been sickened.“We benefited from that early on,” he said. €œBut in some ways, I think it did us a disservice, too, because it also created a certain level of complacency.”That has quickly shifted now, he said, as cases have spiked.The number of active cases known to county officials on any given day has risen sharply to about 600, according to Trisha Gardner, Cascade County’s health officer.

    The county has seen 1,261 cases and six deaths during the pandemic, a Times database shows. Some of the cases have been tied to the jail outbreak, she said, and others have been connected to bars and restaurants. Even figuring out what has led to some cases has been complex, she said, as residents have been reluctant to cooperate with contact tracers.“Our hospitals are at capacity, our public health system is at capacity,” she said.

    €œIt’s not sustainable at this rate.”When the outbreak at the jail began, social distancing was impossible, the authorities said. Three inmates shared cells designed for two. At night, men slept on thin blue pads in every available space.

    On the floor in the day room, in shower stalls, in stairwells, in hallways outside of cells.Inmates did not receive masks until August, and jail officials said many have refused to wear them.In interviews with more than a dozen inmates and their family members, inmates described the jail during the outbreak as chaotic and unsanitary. They said their pleas for help often went unanswered by nurses and guards.Newly arriving inmates were not always quarantined from one another before their test results were known because of a lack of space, inmates and jail officials said.Owen Hawley, 30, said every inmate in his living area of 38 men had tested positive for the virus. He said he had been unable to eat for three days, had intensive body aches and suffered from a headache so powerful it felt as if it was “behind my eyes.”“After the fourth day of like, not eating and stuff, I just shut off, you know?.

    € he said.A jail area set aside for quarantining new inmates.Credit...Tailyr Irvine for The New York TimesAt one point, Mr. Hawley said, he and other prisoners protested the way the virus was being handled by refusing to leave their living areas and by blocking new inmates from entering. Everyone was ultimately tested, Mr.

    Hawley said, and each prisoner was given a disposable mask.Sierra Jasmine Wells, 25, another inmate, said women in her dormitory had grown ill, one after the next.“Everyone around me was getting sick and it was tough on me,” she said. €œBy then, I had already accepted the fact that I was going to get sick.”When she became infected, she said, she was given cough syrup and Tylenol.“I kind of was just left alone to deal with it,” she said.Jesse Slaughter, the county sheriff who oversees the jail, said that the jail’s medical staff was doing everything it could, and that he had been seeking health care assistance from other counties. Officials defended their handling of the outbreak, noting that all inmates received standard medications including Tylenol twice a day and were taken to area hospitals when they needed added care.

    Seven inmates, as well as some staff members, were hospitalized. No one from the jail has died from the virus, officials said.Sheriff Jesse Slaughter, who oversees the jail, said he had been seeking health care assistance from other counties.Credit...Tailyr Irvine for The New York TimesMr. Krogue said that since the start of the outbreak he had been working up to 16 hours each day and sleeping in his basement, away from his wife and children.

    He remains healthy but says he fears bringing the virus home. The virus has slowed some in the jail, and officials have moved some inmates to other facilities, but other prisons and jails in the state are now seeing outbreaks.“You can start to see what some of these other places experienced much earlier on, and we just didn’t have that experience, but it’s certainly happening now,” Mr. Krogue said.

    €œIt’s just real in a way that it wasn’t.”Lucy Tompkins reported from Great Falls, Maura Turcotte from Chicago and Libby Seline from Lincoln, Neb. Reporting was contributed by Izzy Colón from Columbia, Mo., Brendon Derr from Phoenix, Rebecca Griesbach from Tuscaloosa, Ala., Danya Issawi and Timothy Williams from New York, Ann Hinga Klein from Des Moines, K.B. Mensah from Silver Spring, Md., and Mitch Smith from Chicago.Start Preamble Food and Drug Administration, HHS.

    Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances.

    The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. The announcement of the guidances is published in the Federal Register on October 16, 2020.

    The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. You may submit either electronic or written comments on Agency guidances at any time as follows. Electronic Submissions Submit electronic comments in the following way.

    Federal eRulemaking Portal. Https://www.regulations.gov. Follow the instructions for submitting comments.

    Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows. Mail/Hand Delivery/Courier (for written/paper submissions).

    Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions.

    All submissions received must include the name of the guidance document that the comments address and the docket number for the guidance (see table 1). Received comments will be placed in the docket(s) and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. And 4 p.m., Monday through Friday, 240-402-7500.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in Start Printed Page 65821its consideration of comments.

    The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.

    For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at. Https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. Docket.

    For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of these guidances to the address noted in table 1. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidances.

    Start Further Info Kimberly Thomas, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357.

    End Further Info End Preamble Start Supplemental Information I. Background On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C.

    247d) (PHS Act), determined that a PHE exists and has existed since January 27, 2020, nationwide.[] On March 13, 2020, President Donald J. Trump declared that the COVID-19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.[] In the Federal Register of March 25, 2020 (the March 25, 2020, notice) (available at https://www.govinfo.gov/​content/​pkg/​FR-2020-03-25/​pdf/​2020-06222.pdf), FDA announced procedures for making available FDA guidances related to the COVID-19 PHE. These procedures, which operate within FDA's established good guidance practices regulations, are intended to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders.

    The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID-19 PHE, FDA believes that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidances. Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2) (§ 10.115(g)(2))).

    The guidances are available at FDA's web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” (https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled “Search for FDA Guidance Documents” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents. The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID-19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID-19-related guidances that are posted on FDA's website.

    II. Availability of COVID-19-Related Guidance Documents Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID-19-related guidances. Table 1—Guidances Related to the COVID-19 Public Health EmergencyDocket No.CenterTitle of guidanceContact information to request single copiesFDA-2020-D-1136CDERManufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (August 2020)druginfo@fda.hhs.gov.

    Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1136CDERResuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (September 2020)druginfo@fda.hhs.gov. Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.FDA-2020-D-1106CDERFDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (March 2020) (Updated September 2020)Clinicaltrialconduct-COVID19@fda.hhs.gov. Please include the docket number FDA-2020-D-1106 and complete title of the guidance in the request.

    Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)). These guidances are being issued consistent with FDA's good guidance practices regulation (§ 10.115). The Start Printed Page 65822guidances represent the current thinking of FDA.

    They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III.

    Paperwork Reduction Act of 1995 CDER Guidances The guidances listed in the table below refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for these guidances.

    However, these previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table. Table 2—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance title referenced in COVID-19 guidanceOMB control No(s).Guidance for Industry.

    Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency21 CFR 210 and 211, 21 CFR 514.80, 21 CFR 600—Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients —Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. €”Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act. €”Reporting and Mitigating Animal Drug Shortages During the COVID-19 Public Health Emergency.0910-0001, 0910-0032, 0910-0139, 0910-0338, 0910-0669, 0910-0675, 0910-0759, 0910-0806.Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency.

    Questions and Answers21 CFR 314.50. 314.95, 314.125, 314.127. 601.2 and 601.20—Prioritization of the Review of Original ANDAs, Amendments, and Supplements —Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes.0910-0001, 0910-0014, 0910-0338, 0910-0045, 0910-0139, 0910-0759. —Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA). —Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. —Changes to an Approved Application.

    Biological Products. —Changes to an Approved NDA or ANDA. Questions and Answers. —Changes to an Approved NDA or ANDA. —CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports. —Changes to an Approved Application. Biological Products.

    Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. —CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. —Chemistry, Manufacturing, and Controls Changes to an Approved Application. Certain Biological Products. —Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes.

    Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. —SUPAC-IR. Questions and Answers about SUPAC-IR Guidance. —Nonsterile Semisolid Dosage Forms. Scale-Up and Postapproval Changes.

    Chemistry, Manufacturing, and Controls. In Vitro Release Testing and In Vivo Bioequivalence Documentation. —SUPAC-MR. Modified Release Solid Oral Dosage Forms.

    Scale-Up and Postapproval Changes. Chemistry, Manufacturing, and Controls. In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.Start Printed Page 65823 —SUPAC.

    Manufacturing Equipment Addendum. The guidance listed in the table below refers to previously approved FDA collections of information. Therefore, clearance by OMB under the PRA is not required for this guidance.

    However, these collections of information are subject to review by OMB under the PRA. The previously approved collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the table below. This guidance also contains a collection of information not approved under a current collection.

    This collection of information has been granted a PHE waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/​public-health-emergency-declaration-pra-waivers. Table 3—CDER Guidances and CollectionsCOVID-19 guidance titleCFR cite referenced in COVID-19 guidanceAnother guidance referenced in COVID-19 guidanceOMB control No(s).Collection covered by PHE PRA waiverGuidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (Updated September 21, 2020)21 CFR part 11, 21 CFR part 50, 21 CFR part 56, 21 CFR part 312, 21 CFR part 314, 21 CFR part 320, 21 CFR part 601, 21 CFR part 812Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

    Pediatric Study Plans. Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans. Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.

    Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Design. Pregnant Women. Scientific and Ethical Considerations for Inclusion in Clinical Trials.

    Part 11, Electronic Records. Electronic Signatures Scope and Application.0910-0001, 0910-0014, 0910-0130, 0910-0303, 0910-0338, 0910-0119, 0910-0581, 0910-0733, 0910-0078Submission by investigators of informed consent forms to third parties. Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11—Questions and Answers. Safety Reporting Requirements for INDs and BA/BE Studies.

    Adverse Event Reporting to IRBs—Improving Human Subject Protection. Use of Electronic Informed Consent In Clinical Investigations. E6(R2) Good Clinical Practice.

    Integrated Addendum to ICH E6(R1). Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Best Practices for Communication Between IND Sponsors and FDA During Drug Development.

    Requests for Feedback and Meetings for Medical Device Submissions. The Q-Submission Program. IV.

    Electronic Access Persons with access to the internet may obtain COVID-19-related guidances at. Start Signature Start Printed Page 65824 Dated. October 13, 2020.

    Lauren K. Roth, Acting Principal Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc.

    Cialis pharmacy checker

    NONE

    Start Preamble http://www.amisdepasteur.fr/is-it-safe-to-buy-cialis-online/ Centers cialis pharmacy checker for Medicare &. Medicaid Services (CMS), HHS. Extension of timeline for publication of cialis pharmacy checker 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, cialis pharmacy checker 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O.

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

    Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and cialis pharmacy checker 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 cialis pharmacy checker 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 cialis pharmacy checker the physician self-referral statute and regulations.

    This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of cialis pharmacy checker 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 cialis pharmacy checker 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 cialis pharmacy checker until August 31, 2021. Start Signature Dated. August 24, 2020.

    Wilma M cialis pharmacy checker. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR cialis pharmacy checker Doc.

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

    Start Preamble cialis and headaches Centers for Medicare where to buy cialis in australia &. Medicaid Services (CMS), HHS. Extension of timeline for publication of final where to buy cialis in australia 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 where to buy cialis in australia for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O.

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

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

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

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

    In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we where to buy cialis in australia 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 where to buy cialis in australia timeline for publication of the final rule until August 31, 2021. Start Signature Dated. August 24, 2020.

    Wilma M where to buy cialis in australia. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information where to buy cialis in australia [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 where to buy cialis in australia to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

    This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert P where to buy cialis in australia. 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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