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U.S website here cheap propecia pills. Department of Health and Human Services Secretary Alex Azar this week praised the Trump administration's technology response to the hair loss treatment propecia, highlighting its efforts on data collection, telehealth expansion and more.During a brief speech Tuesday evening at the HLTH VRTL 2020 conference, Azar highlighted the efforts of HHS to collect data concerning hair loss treatment patients and predicted that patients will see telehealth as "a durable and desirable part of their healthcare" in the long term.In July, HHS triggered concerns among public health experts and "chaos" at hospitals when it cheap propecia pills directed health systems to bypass the Centers for Disease Control and Prevention when reporting hair loss treatment patient information.The existing data collection systems at the CDC and state public health departments, said Azar on Tuesday, "have played incredibly important roles … but they couldn't provide the kind of flexible reporting we needed."Azar explained that HHS Protect – the system to which hospitals now report data – stemmed from an effort to take advantage of existing data sets and improve the quality of data in use.HHS Protect "includes a secure hub for sharing, parsing, housing, tracking and accessing hair loss treatment data," said Azar, and draws on more than 4.5 billion data elements. He noted that this past week, HHS had announced new reporting modifications for hospitals that cheap propecia pills included information about seasonal influenza patients. Those requirements came alongside an announcement from the Centers for Medicare and Medicaid Services that hospitals deemed "noncompliant" with data reporting requirements could eventually put their reimbursements from the federal programs at risk.American Hospital Association President and CEO Rick Pollack has called the approach "heavy-handed" and said it "could jeopardize access to hospital care for all Americans."Azar, meanwhile, pointed out that HHS is working with state and local health information exchanges to encourage reporting to and use of data resources.

"The long-term vision isn't just about cheap propecia pills aggregation and ease of reporting," he said. "It's about eliminating reporting entirely by using the data that's cheap propecia pills already being generated as part of providers' clinical workflow." He noted that such a system is feasible, in part, because of the interoperability rules finalized earlier this year – "creating unprecedented opportunities to equip patients with data," he said."Bold thinking that puts patients at the center can feed innovation, from both a provider and system-wide perspective," said Azar. He also cited HHS' shipment of 150 million rapid hair loss tests to at-risk communities such as nursing cheap propecia pills homes and assisted living facilities. Users can link their test results with an app, and "we're now working with Abbott and state public health leaders to use this app to facilitate reporting of cases, too."Azar pointed to the regulatory flexibilities around telehealth that have eased the way for massive adoption of virtual care across the country."We believe patients will start to see [telehealth] as a durable and desirable part of their healthcare experience," he said."The future gold standard of care will integrate both in-person services and telehealth, customized around the patient's needs and their doctor's advice, and we'll need lots of digital health innovation to make that possible," he added.Azar pointed to the advancements cheap propecia pills the digital health industry has made amid – and sometimes in response to – the hair loss treatment crisis.

"Amidst all the pain caused by this propecia, we've seen how innovative American healthcare can be," he said. Kat Jercich is senior editor cheap propecia pills of Healthcare IT News.Twitter. @kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication..

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As the year draws to a close, we look at the top five most viewed HIMSS TV videos across the EMEA region and reflect on how the topics covered a can women take propecia turbulent, but transformative year for the industry. ​1. Digital tools can provide a silver lining to hair loss treatmentThis deep dive breaks down what hair loss treatment has meant for the healthcare IT industry so far and how it will cope with the ensuing challenges of containing and preventing the propecia. HIMSS TV can women take propecia also looks at the various digitally mature countries that have been able to target early warnings of future waves.

As we adapt to a new way of living in a post-hair loss world, this video explains how digital tools, including apps and telehealth, can play a significant role as we continue to fight the propecia. HIMSS20 Digital Learn on-demand, earn credit, find products and solutions. Get Started can women take propecia >>. 2.

hair loss treatment. Preparing for can women take propecia the next inevitable wavePublished ahead of the winter months of 2020, and the next predicted wave of hair loss treatment, this timely video explains why digital tools offer huge opportunities for helping to contain the hair loss. It also showcases the IT solutions that make the management of infected people and contacts more efficient and why they should be prioritised before the next wave. 3.

Population can women take propecia health. How technology can target at-risk patientsIn the first episode of The Alessi Agenda, hosted by Dr Charles Alessi, chief clinical officer at HIMSS, Kevin Fenton, director of public health and wellbeing at Southwark, discusses using new technologies to help healthcare not only build upon its existing infrastructure, but also evolve as patient needs change. €‹4. How hair loss treatment has been a catalyst for can women take propecia innovation in Saudi ArabiaAhead of our highly anticipated first-ever virtual HIMSS &.

Health 2.0 digital event held in the Kingdom of Saudi Arabia, the HIMSS media team spoke to a range of experts in the Kingdom to share industry knowledge and give viewers a taster of what to expect at the event. In this interview, Abdulaziz Alkhlaif, CIO of Dr. Abdul Rahman Al-Mishari Hospital, shares his thoughts on can women take propecia data transformation, artificial intelligence and the next generation of patient portals. 5.

€‹ Italy and Germany facing hair loss treatmentIn this webinar, Dr Charles Alessi is joined by healthcare leaders, Elena Sini, group CIO of GVM Care and Research and Henning Schneider, CIO at the Asklepios Hospital Group, to compare the hair loss treatment crisis and public health response strategies of two very different health systems in Europe..

As the year draws to a close, we look at the top five most viewed HIMSS TV videos across the http://bryant-heating.com/how-much-does-cipro-cost/ EMEA region and cheap propecia pills reflect on how the topics covered a turbulent, but transformative year for the industry. ​1. Digital tools can provide a silver lining to hair loss treatmentThis deep dive breaks down what hair loss treatment has meant for the healthcare IT industry so far and how it will cope with the ensuing challenges of containing and preventing the propecia.

HIMSS TV also looks at the various digitally cheap propecia pills mature countries that have been able to target early warnings of future waves. As we adapt to a new way of living in a post-hair loss world, this video explains how digital tools, including apps and telehealth, can play a significant role as we continue to fight the propecia. HIMSS20 Digital Learn on-demand, earn credit, find products and solutions.

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Preparing for the next inevitable wavePublished ahead of the winter months of 2020, and the next predicted wave of hair loss treatment, cheap propecia pills this timely video explains why digital tools offer huge opportunities for helping to contain the hair loss. It also showcases the IT solutions that make the management of infected people and contacts more efficient and why they should be prioritised before the next wave. 3.

Population health cheap propecia pills. How technology can target at-risk patientsIn the first episode of The Alessi Agenda, hosted by Dr Charles Alessi, chief clinical officer at HIMSS, Kevin Fenton, director of public health and wellbeing at Southwark, discusses using new technologies to help healthcare not only build upon its existing infrastructure, but also evolve as patient needs change. €‹4.

How hair loss treatment has cheap propecia pills been a catalyst for innovation in Saudi ArabiaAhead of our highly anticipated first-ever virtual HIMSS &. Health 2.0 digital event held in the Kingdom of Saudi Arabia, the HIMSS media team spoke to a range of experts in the Kingdom to share industry knowledge and give viewers a taster of what to expect at the event. In this interview, Abdulaziz Alkhlaif, CIO of Dr.

Abdul Rahman Al-Mishari Hospital, shares his thoughts on data transformation, artificial intelligence and the next generation of patient portals. 5. €‹ Italy and Germany facing hair loss treatmentIn this webinar, Dr Charles Alessi is joined by healthcare leaders, Elena Sini, group CIO of GVM Care and Research and Henning Schneider, CIO at the Asklepios Hospital Group, to compare the hair loss treatment crisis and public health response strategies of two very different health systems in Europe..

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About This TrackerThis tracker provides the number of confirmed cases and deaths from novel hair loss by country, the trend in confirmed case who can buy propecia and can propecia cause cancer death counts by country, and a global map showing which countries have confirmed cases and deaths. The data are drawn from the Johns Hopkins University (JHU) hair loss Resource Center’s hair loss treatment Map and the World Health Organization’s (WHO) hair loss Disease (hair loss treatment-2019) situation reports.This tracker will be updated regularly, as new data are released.Related Content. About hair loss treatment hair lossIn late 2019, a new hair loss emerged in central can propecia cause cancer China to cause disease in humans.

Cases of this disease, known as hair loss treatment, have since been reported across around the globe. On January 30, 2020, the World Health Organization (WHO) declared the propecia represents can propecia cause cancer a public health emergency of international concern, and on January 31, 2020, the U.S. Department of Health and Human Services declared it to be a health emergency for the United States..

About This TrackerThis tracker provides the number of confirmed cases and deaths from novel hair loss by country, the http://www.mbstoday.org/bibles-in-public-schools/ trend in confirmed case and cheap propecia pills death counts by country, and a global map showing which countries have confirmed cases and deaths. The data are drawn from the Johns Hopkins University (JHU) hair loss Resource Center’s hair loss treatment Map and the World Health Organization’s (WHO) hair loss Disease (hair loss treatment-2019) situation reports.This tracker will be updated regularly, as new data are released.Related Content. About hair loss treatment hair lossIn late 2019, a cheap propecia pills new hair loss emerged in central China to cause disease in humans. Cases of this disease, known as hair loss treatment, have since site link been reported across around the globe.

On January 30, 2020, the World Health cheap propecia pills Organization (WHO) declared the propecia represents a public health emergency of international concern, and on January 31, 2020, the U.S. Department of Health and Human Services declared it to be a health emergency for the United States..

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At that time, this women taking propecia drug website here benefit was "carved into" the Medicaid managed care benefit package. Before that date, people enrolled in a Medicaid managed care plan obtained all of their health care through the plan, but used their regular Medicaid card to access any drug available on the state formulary on a "fee for service" basis without needing to utilize a restricted pharmacy network or comply with managed care plan rules. COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans. That means women taking propecia that members of managed care plans will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?.

The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under women taking propecia Medicaid managed care. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for women taking propecia service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy. Pharmacy networks can also differ from plan to plan women taking propecia. Prescriber Prevails applies in certain drug classes. Prescriber prevails applys to medically necessary precription drugs in the following classes.

atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, women taking propecia seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to women taking propecia build capacity for interactive searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care.

The form will be posted on the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at women taking propecia any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price. CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in women taking propecia managed care.

Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the year. Consumers can women taking propecia switch plans during the “lock in” period only for good cause. The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time.

STEPS CONSUMERS CAN TAKE WHEN women taking propecia A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the buy propecia online same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials. Some plans may women taking propecia develop special procedures for drug denials. Information on these procedures should be provided in member handbooks.

Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or women taking propecia FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 women taking propecia calendar days in standard appeals, and 72 hours in expedited appeals.

The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing. The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of women taking propecia the IAD and FAD notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care.

Enrollees who are in the first 90 days women taking propecia of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require women taking propecia the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list.

The full Medicaid formulary can be searched on the eMedNY website. Even in fee for service Medicaid, prescribers must obtain women taking propecia prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months. Click here for more information on NY's prior women taking propecia authorization process.

The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations women taking propecia of pharmacies that provide this drug as well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline.

1-888-614-5400 NY women taking propecia State Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon. - Fri.

That means that members of managed care cheap propecia pills plans will access their drugs outside their plan, unlike the rest of their medical care, which is propecia price accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies.

Under Medicaid managed cheap propecia pills care. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary.

Plan formularies do not have to include all cheap propecia pills drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs. The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy.

Pharmacy networks can cheap propecia pills also differ from plan to plan. Prescriber Prevails applies in certain drug classes. Prescriber prevails applys to medically necessary precription drugs in the following classes.

atypical antipsychotics, anti-depressants, cheap propecia pills anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies.

The Department of Health plans to build capacity for interactive cheap propecia pills searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care. The form will be posted on the Pharmacy Information Website in July of 2013.

Mail Order Drugs -- Medicaid managed care members can obtain mail cheap propecia pills order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price. CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time.

Medicaid consumers will have this option only in the limited cheap propecia pills circumstances during the first year of enrollment in managed care. Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the year.

Consumers can cheap propecia pills switch plans during the “lock in” period only for good cause. The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time.

STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES cheap propecia pills ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials.

Some plans may develop special procedures for drug denials cheap propecia pills. Information on these procedures should be provided http://specialmomentsphotobooth.com/rockfords-very-own-frost-and-friends-11-11-11 in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision.

An adverse decision is called a 'FInal Adverse Determination" cheap propecia pills or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD.

The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the cheap propecia pills required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals. The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing.

The enrollee must request the cheap propecia pills Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care.

Enrollees who are in the cheap propecia pills first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees.

Certain drugs/drug cheap propecia pills categories require the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list. The full Medicaid formulary can be searched on the eMedNY website.

Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated cheap propecia pills. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months.

Click here for more information on NY's prior authorization cheap propecia pills process. The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program.

Click here to search for a specific drug from the most frequently cheap propecia pills prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline.

1-888-614-5400 NY State Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon. - Fri.

8:30 am - 4:30 pm) NY State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau. 1-800-771-7755.

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October 9, 2020Our file https://scriptureclass.com/how-to-get-a-seroquel-prescription-from-your-doctor number side affects of propecia. 20-113699-873 As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. By way of side affects of propecia this Notice, Health Canada is advising of its intent to implement ICH Q12.

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process side affects of propecia. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

The target timeframe for Health Canada implementation of ICH Q12 has been set to the third quarter of 2021 in order to allow sufficient time for the preparation of regulators and stakeholders. Health Canada will be launching a stakeholder consultation in early 2021 to gather feedback on the final elements of the implementation of the Q12 guidance in Canada.This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes side affects of propecia in a more predictable and efficient manner across the product lifecycle. Implementation of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.

It will allow regulators (assessors and inspectors) to better understand the firms' Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.ICH Q12 should be read in conjunction with this accompanying notice and side affects of propecia with the relevant sections of other applicable Health Canada guidances. This and other ICH Guidance documents are available on the ICH Website. Please note side affects of propecia that the ICH website is only available in English.

If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.Contact InformationFor any comments or inquiries related to this notice, please contact:Health Canada – ICH CoordinatorE-mail. Hc.ich.sc@canada.ca Please include "Implementation of ICH Q12" in the subject line.The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are side affects of propecia eligible for data protection.

Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end side affects of propecia of a period of eight years after the day on which the first notice of compliance was issued to the innovator. The format of the Register of Innovative Drugs is an electronic table, which is updated weekly.

The register lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister side affects of propecia and that are not variations of a previously approved medicinal ingredient. Please note that there may be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug.

For information related to treatment options, choices of side affects of propecia medications and their uses, illnesses, side effects or drug interactions, please contact your health care professional (for example, doctor, pharmacist, etc.). We do not provide medical advice regarding the use of the products identified in this database. For comments side affects of propecia or questions, please contact by hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281.Date published.

October 7, 2020On this page OverviewAs the global hair loss treatment propecia emerged in December 2019, the need for coherent, pan-Canadian guidance on provincial and territorial testing was quickly recognized. Led by side affects of propecia the National Microbiology Laboratory, initial interim guidance on laboratory testing was developed in consultation with the Canadian Public Health Lab Network and was finalized and approved by the Special Advisory Committee on April 16, 2020. This guidance was based on scientific evidence and testing resources available at that time.

The recommended testing guidance focused on the molecular polymerase chain reaction (PCR) as the sole laboratory technique to accurately identify hair loss in a patient sample.In May 2020, based on new evidence, the National Laboratory Testing Indication Guidance for hair loss treatment was updated to reflect developments in four areas. Expanded laboratory resources viral transmission from asymptomatic individuals or individuals in the pre-symptomatic phase outbreaks in congregate living and work settings new testing modalities (molecular Point of Care and serological tests)The hair loss treatment landscape side affects of propecia has further evolved and it is now necessary to update key aspects of this document to reflect recent scientific and public health data. One key consideration relates to limiting asymptomatic diagnostic PCR testing where public health action could have significant benefits.

Several pilot programs were conducted in Canada, confirming very low levels of hair loss treatment in the general population and supporting an evidence-based approach to side affects of propecia the relaunch of economic activity. In addition, it enabled jurisdictions to stress-test testing capacity and prepare jurisdictions for higher testing volumes. Asymptomatic testing was also found to displace diagnostic capacity for symptomatic individuals, close contacts, high-risk settings and outbreak management.

The National Laboratory Testing Indication Guidancefor hair loss treatment has been updated to reflect these learnings and advances in science.Recognizing that testing regimes are within provincial and territorial jurisdiction, this document reflects the collaboration among jurisdictions, leveraging learnings from one another through the different adopted approaches.Emerging testing side affects of propecia and screening technologiesThe Pan-Canadian hair loss treatment Testing and Screening Guidance is designed to reflect changing risk management approaches as the propecia conditions change. Recognizing that one size does not fit all, the Guidance is also designed to respond to a significant increase in the need to access testing and screening technologies. Scaling to meet increased and sustained testing and screening demand will require a paradigm shift, broadening the technologies that are used in a manner that is tailored to the purpose and application of technologies in a variety side affects of propecia of settings.

Although PCR remains the gold standard in diagnostic testing, numerous technologies and testing modalities are emerging that could serve to supplement diagnostic testing. These recent side affects of propecia testing and sampling options could create opportunities to expand the approach to testing by including broad-based approaches to screening through less sensitive and potentially more cost-effective technologies, thereby alleviating strain on the overall public health system.While they can be less sensitive, these technologies could have multiple benefits including ease and reduced cost of production, improved efficiency and reduced reliance on PCR testing supplies. They also have the potential to be less invasive depending on the technology.

Antigen and extraction-free nucleic acid testing are examples of such technologies that, in addition to being more cost-effective and easier to produce, are also easily adaptable to mobile, rapid applications. However, due to their lower side affects of propecia sensitivity than current PCR technology, these emerging technologies may be better used as a part of screening, in conjunction with repeated testing in some settings. Recognizing that these novel technologies have lower sensitivity and specificity than current PCR technology, their use should be targeted to scenarios where both positive and negative are interpreted and acted upon appropriately.Complementing the deployment of these emerging technologies, techniques such as pooled testing are being used to contribute to the preservation of testing resources.

Governments are also tapping non-traditional side affects of propecia data sources to complement case data. For example, data for wastewater testing could complement hair loss treatment surveillance systems by providing readily accessible pooled community samples and data for communities where testing is not available or underutilized.As of September 29, Health Canada has authorized 36 hair loss treatment testing devices (PCR and serological). Health Canada is fast-tracking the review of submissions related to antigen side affects of propecia and nucleic acid tests.

Submissions that are reviewed include various sample types, including saliva. Consult the list of authorized medical devices for uses related to hair loss treatment.In anticipation of regulatory approval for antigen tests, an Interim Guidance on Antigen Testing has been developed to outline potential scenarios such as routine outbreak monitoring, monitoring in different situations including high-risk settings (for example, long-term care facilities) and possible adaptation into mobile, rapid testing in rural and remote communities.Pan-Canadian hair loss treatment Testing and Screening GuidanceLike the Laboratory Testing Guidance, the Pan-Canadian hair loss treatment Testing and Screening Guidance (“Guidance”) is based on new public health evidence and emerging technologies, while adopting a broadened approach that leverages and tailors technologies to appropriate uses. The Guidance is designed to protect and expand the resilience of federal, provincial and territorial testing and screening capacity.The Guidance side affects of propecia is based on a portfolio approach that uses different types of testing technologies for various purposes (diagnostic, screening, surveillance).

The intent of the Guidance is to better use testing resources to target the most relevant test in particular situations or use cases to address specific problems or purposes. Figure 1 side affects of propecia. Technology streams of Pan-Canadian hair loss treatment Testing and Screening Guidance Figure 1.

Technology streams side affects of propecia of Pan-Canadian hair loss treatment Testing and Screening Guidance - Text equivalent Testing. Definitive diagnosis of hair loss treatment with high sensitivity PCR-based tests, with potential refinements to specimen collecting modalities (for example, saliva) Less amenable to high frequency conduct due to greater resource utilization Screening. Indicative of hair loss treatment status, with lower sensitivity Typically newer, rapid technology approaches Amenable to higher frequency repetition and more easily scalable Surveillance.

Use of traditional and non-traditional data sources to complement case data Wastewater surveillance complements conventional hair loss treatment surveillance systems by providing side affects of propecia. efficient pooled community sample data for communities where timely clinical testing is underutilized or unavailable data at the local level Five key foundational, interrelated pillars support the advancement of the Guidance. Scientific integrity regulatory excellence proactive procurement robust data and capacity strategic communication and partnershipsUpdates to laboratory testing and antigen testing guidance founded on rigorous side affects of propecia scientific integrity enable and inform decision-making on testing allocations within Canada, and support jurisdictions in the timely use of emerging technologies once regulatory approval is received.

Regulatory excellence is equally important as a foundational pillar to implementing the Guidance in a manner that allows for rapid approvals while still preserving the scientific integrity of the process.In addition, undertaking a proactive procurement approach ensures steady access to equipment and supplies for testing and screening. Governments continue side affects of propecia to take a proactive procurement approach, purchasing whenever possible, contingent on regulatory approvals.Timely and comprehensive data is critical, underpinning decision-making by governments. Governments have established a new data set for hair loss treatment cases that provides more targeted information, improving the ability to understand whether s are acquired via domestic or international travel, or if they are linked to a known outbreak.

Race and ethnicity indicators have been added as well as greater information on health care workers, allowing a better understanding of the hair loss treatment experience among different population groups. In addition to the case data, key data on turnaround times side affects of propecia for testing and contact tracing, for example, can also help identify issues related to capacity and timeliness of interventions.Finally, in addition to strong federal, provincial and territorial partnerships, relationships are being further enhanced with key partners in industry and the scientific community. While ensuring rapid and effective progress is critical, it is also important to communicate what we know, what we are doing and what we are going to do.

This collaboration and transparency supports critical decisions, including what additional capacity may be required as part of the Guidance, for instance, federal surge capacity to supplement side affects of propecia provincial and territorial leadership. Strategic communications and partnerships are critical to maintaining and strengthening the confidence of Canadians in Governments' actions to address hair loss treatment. Implementation plan of the Pan-Canadian hair loss treatment Testing and Screening Guidance.

Updated Guidance Scientific integrity Regulatory excellence Proactive procurement Robust data and capacity Strategic communications and partnerships Regularly updated public health advice as science evolves Updated national lab testing indication guidance Interim antigen testing guidance Guidance on sample types Prioritized, timely review of emerging and promising technologies Responsive to testing, screening and surveillance developments Founded in and driven by scientific excellence Linking regulatory pipeline with production capacity Prioritizing made in Canada solutions Advance purchasing of promising technologies Surge capacity through full value chain and timely, comprehensive data Improving national performance data (turnaround times) Surge side affects of propecia capacity for sample collection, lab testing contact tracing Working closely with key partners FPT. Enables agile responses to emerging issues Industry. Linking public health and workforce requirements Tapping emerging tech Public education/understanding Looking forwardThe Guidance is expected to evolve as the state of knowledge and risk management strategies continue to side affects of propecia develop.

Guidance on sample types is expected to be finalized during the fall and the balance of testing and screening technologies will be adjusted to respond to the needs of various populations. Researchers and companies continue side affects of propecia to innovate and develop new technologies and solutions. Guidance will need to keep pace with, and take advantage of, these innovations.

The continuous updating of this Guidance will rely on strong federal, provincial and territorial partnerships and collaboration leveraging key governance bodies, including the Special Advisory Committee. The Guidance will also capitalize on opportunities to leverage input and the capacity to mobilize knowledge in Canada and from around the world.Related linksOn this page Purpose and backgroundThe purpose of this notice is to communicate minimum values of sensitivity for hair loss treatment antigen testing devices.Health Canada refers to guidance published side affects of propecia by the U.S. Food and Drug Administration (FDA) on antigen detecting tests.

This guidance outlines the requirements that these products must meet side affects of propecia. This document addresses only sensitivity for antigen tests. It complements the published FDA guidance.Sensitivity is technically a measure of the accuracy of a test against a side affects of propecia reference standard.

No such standard exists at this time, therefore the accuracy of the positive results from a test is currently expressed as the positive percent agreement (PPA). The term sensitivity is used throughout this document in place of PPA for ease of reading. Sensitivity is the proportion of subjects with the target condition in whom the test is positiveIt is an important measure to determine whether test information is useful and side affects of propecia reliable.Minimum value for sensitivity Health Canada does not usually set minimum standards for sensitivity.

Normally we review the submitted data to determine whether a test performs to the standard claimed by the manufacturer. We then compare that to the standard claimed by similar side affects of propecia tests. However, the hair loss treatment propecia is a unique public health crisis.

For this reason, we are taking side affects of propecia a different approach.We have set minimum standards for sensitivity that a hair loss treatment antigen test must meet in order for us to consider it for authorization. Tests with sensitivity below this minimum do not meet the criteria of 5(c) and (d) of the interim order on the importation and sale of medical devices for use in relation to hair loss treatment. For this reason, they will not be authorized.Health Canada considers the following to be unacceptable for authorization.

Sensitivity below 80% Sensitivity values below this level will produce too many false negative results side affects of propecia. These tests will not be authorized, regardless of other factors.Future considerationsHealth Canada’s target value aligns with the FDA target. However, as more research results become available, we may revise this value accordingly.Health Canada welcomes applications for technologies that meet or exceed the side affects of propecia minimum limit value.

We will continue to monitor emerging science and international experience to determine whether we need to amend this value.Contact usPlease email your questions or comments about this notice to. Hc.meddevices-instrumentsmed.sc@canada.ca.Related Links.

October 9, cheap propecia pills 2020Our over here file number. 20-113699-873 As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. By way of this Notice, Health cheap propecia pills Canada is advising of its intent to implement ICH Q12.

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. This guidance has been developed by the appropriate ICH Expert Working Group and cheap propecia pills has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

The target timeframe for Health Canada implementation of ICH Q12 has been set to the third quarter of 2021 in order to allow sufficient time for the preparation of regulators and stakeholders. Health Canada will be launching a stakeholder consultation cheap propecia pills in early 2021 to gather feedback on the final elements of the implementation of the Q12 guidance in Canada.This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.

It will allow regulators (assessors and inspectors) to better understand the firms' Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.ICH Q12 should be read in conjunction with this accompanying notice and with the relevant sections of cheap propecia pills other applicable Health Canada guidances. This and other ICH Guidance documents are available on the ICH Website. Please note cheap propecia pills that the ICH website is only available in English.

If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.Contact InformationFor any comments or inquiries related to this notice, please contact:Health Canada – ICH CoordinatorE-mail. Hc.ich.sc@canada.ca Please include "Implementation of ICH Q12" in the subject line.The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are eligible for cheap propecia pills data protection.

Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance cheap propecia pills was issued to the innovator. The format of the Register of Innovative Drugs is an electronic table, which is updated weekly.

The register cheap propecia pills lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister and that are not variations of a previously approved medicinal ingredient. Please note that there may be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug.

For information related to treatment options, choices of medications and their uses, illnesses, side effects or drug interactions, please contact your health cheap propecia pills care professional (for example, doctor, pharmacist, etc.). We do not provide medical advice regarding the use of the products identified in this database. For comments or questions, please contact by hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281.Date published cheap propecia pills.

October 7, 2020On this page OverviewAs the global hair loss treatment propecia emerged in December 2019, the need for coherent, pan-Canadian guidance on provincial and territorial testing was quickly recognized. Led by the National Microbiology Laboratory, initial interim guidance on laboratory testing was cheap propecia pills developed in consultation with the Canadian Public Health Lab Network and was finalized and approved by the Special Advisory Committee on April 16, 2020. This guidance was based on scientific evidence and testing resources available at that time.

The recommended testing guidance focused on the molecular polymerase chain reaction (PCR) as the sole laboratory technique to accurately identify hair loss in a patient sample.In May 2020, based on new evidence, the National Laboratory Testing Indication Guidance for hair loss treatment was updated to reflect developments in four areas. Expanded laboratory resources viral transmission from asymptomatic individuals or individuals in the pre-symptomatic phase outbreaks cheap propecia pills in congregate living and work settings new testing modalities (molecular Point of Care and serological tests)The hair loss treatment landscape has further evolved and it is now necessary to update key aspects of this document to reflect recent scientific and public health data. One key consideration relates to limiting asymptomatic diagnostic PCR testing where public health action could have significant benefits.

Several pilot cheap propecia pills programs were conducted in Canada, confirming very low levels of hair loss treatment in the general population and supporting an evidence-based approach to the relaunch of economic activity. In addition, it enabled jurisdictions to stress-test testing capacity and prepare jurisdictions for higher testing volumes. Asymptomatic testing was also found to displace diagnostic capacity for symptomatic individuals, close contacts, high-risk settings and outbreak management.

The National Laboratory Testing Indication Guidancefor hair loss treatment has been updated to reflect these learnings and advances in science.Recognizing that testing regimes are within cheap propecia pills provincial and territorial jurisdiction, this document reflects the collaboration among jurisdictions, leveraging learnings from one another through the different adopted approaches.Emerging testing and screening technologiesThe Pan-Canadian hair loss treatment Testing and Screening Guidance is designed to reflect changing risk management approaches as the propecia conditions change. Recognizing that one size does not fit all, the Guidance is also designed to respond to a significant increase in the need to access testing and screening technologies. Scaling to meet increased and sustained testing and screening demand will require a paradigm shift, broadening the technologies cheap propecia pills that are used in a manner that is tailored to the purpose and application of technologies in a variety of settings.

Although PCR remains the gold standard in diagnostic testing, numerous technologies and testing modalities are emerging that could serve to supplement diagnostic testing. These recent testing and sampling options could create opportunities to expand the approach to testing by including broad-based approaches to screening through less sensitive and potentially more cost-effective technologies, thereby alleviating strain on cheap propecia pills the overall public health system.While they can be less sensitive, these technologies could have multiple benefits including ease and reduced cost of production, improved efficiency and reduced reliance on PCR testing supplies. They also have the potential to be less invasive depending on the technology.

Antigen and extraction-free nucleic acid testing are examples of such technologies that, in addition to being more cost-effective and easier to produce, are also easily adaptable to mobile, rapid applications. However, due to their lower sensitivity than current PCR technology, these emerging technologies may be better used as a part of screening, in conjunction with repeated testing in some cheap propecia pills settings. Recognizing that these novel technologies have lower sensitivity and specificity than current PCR technology, their use should be targeted to scenarios where both positive and negative are interpreted and acted upon appropriately.Complementing the deployment of these emerging technologies, techniques such as pooled testing are being used to contribute to the preservation of testing resources.

Governments are also tapping non-traditional data cheap propecia pills sources to complement case data. For example, data for wastewater testing could complement hair loss treatment surveillance systems by providing readily accessible pooled community samples and data for communities where testing is not available or underutilized.As of September 29, Health Canada has authorized 36 hair loss treatment testing devices (PCR and serological). Health Canada is fast-tracking the review of cheap propecia pills submissions related to antigen and nucleic acid tests.

Submissions that are reviewed include various sample types, including saliva. Consult the list of authorized medical devices for uses related to hair loss treatment.In anticipation of regulatory approval for antigen tests, an Interim Guidance on Antigen Testing has been developed to outline potential scenarios such as routine outbreak monitoring, monitoring in different situations including high-risk settings (for example, long-term care facilities) and possible adaptation into mobile, rapid testing in rural and remote communities.Pan-Canadian hair loss treatment Testing and Screening GuidanceLike the Laboratory Testing Guidance, the Pan-Canadian hair loss treatment Testing and Screening Guidance (“Guidance”) is based on new public health evidence and emerging technologies, while adopting a broadened approach that leverages and tailors technologies to appropriate uses. The Guidance is designed to protect and expand the resilience of federal, provincial and territorial testing cheap propecia pills and screening capacity.The Guidance is based on a portfolio approach that uses different types of testing technologies for various purposes (diagnostic, screening, surveillance).

The intent of the Guidance is to better use testing resources to target the most relevant test in particular situations or use cases to address specific problems or purposes. Figure 1 cheap propecia pills. Technology streams of Pan-Canadian hair loss treatment Testing and Screening Guidance Figure 1.

Technology streams of Pan-Canadian hair loss treatment Testing cheap propecia pills and Screening Guidance - Text equivalent Testing. Definitive diagnosis of hair loss treatment with high sensitivity PCR-based tests, with potential refinements to specimen collecting modalities (for example, saliva) Less amenable to high frequency conduct due to greater resource utilization Screening. Indicative of hair loss treatment status, with lower sensitivity Typically newer, rapid technology approaches Amenable to higher frequency repetition and more easily scalable Surveillance.

Use of traditional cheap propecia pills and non-traditional data sources to complement case data Wastewater surveillance complements conventional hair loss treatment surveillance systems by providing. efficient pooled community sample data for communities where timely clinical testing is underutilized or unavailable data at the local level Five key foundational, interrelated pillars support the advancement of the Guidance. Scientific integrity cheap propecia pills regulatory excellence proactive procurement robust data and capacity strategic communication and partnershipsUpdates to laboratory testing and antigen testing guidance founded on rigorous scientific integrity enable and inform decision-making on testing allocations within Canada, and support jurisdictions in the timely use of emerging technologies once regulatory approval is received.

Regulatory excellence is equally important as a foundational pillar to implementing the Guidance in a manner that allows for rapid approvals while still preserving the scientific integrity of the process.In addition, undertaking a proactive procurement approach ensures steady access to equipment and supplies for testing and screening. Governments continue to take a proactive procurement approach, cheap propecia pills purchasing whenever possible, contingent on regulatory approvals.Timely and comprehensive data is critical, underpinning decision-making by governments. Governments have established a new data set for hair loss treatment cases that provides more targeted information, improving the ability to understand whether s are acquired via domestic or international travel, or if they are linked to a known outbreak.

Race and ethnicity indicators have been added as well as greater information on health care workers, allowing a better understanding of the hair loss treatment experience among different population groups. In addition to the case data, key data on turnaround times for testing and contact tracing, for example, can also help identify issues related to capacity and timeliness of interventions.Finally, in addition to strong federal, provincial and territorial partnerships, relationships are being further enhanced with key partners in cheap propecia pills industry and the scientific community. While ensuring rapid and effective progress is critical, it is also important to communicate what we know, what we are doing and what we are going to do.

This collaboration cheap propecia pills and transparency supports critical decisions, including what additional capacity may be required as part of the Guidance, for instance, federal surge capacity to supplement provincial and territorial leadership. Strategic communications and partnerships are critical to maintaining and strengthening the confidence of Canadians in Governments' actions to address hair loss treatment. Implementation plan of the Pan-Canadian hair loss treatment Testing and Screening Guidance.

Updated Guidance Scientific integrity Regulatory excellence Proactive procurement Robust data and capacity Strategic communications and partnerships Regularly updated public health advice as science evolves Updated national lab testing indication guidance Interim antigen testing guidance Guidance on sample types Prioritized, timely review of emerging and promising technologies Responsive to testing, screening and cheap propecia pills surveillance developments Founded in and driven by scientific excellence Linking regulatory pipeline with production capacity Prioritizing made in Canada solutions Advance purchasing of promising technologies Surge capacity through full value chain and timely, comprehensive data Improving national performance data (turnaround times) Surge capacity for sample collection, lab testing contact tracing Working closely with key partners FPT. Enables agile responses to emerging issues Industry. Linking public health and workforce requirements Tapping emerging tech Public education/understanding Looking forwardThe Guidance cheap propecia pills is expected to evolve as the state of knowledge and risk management strategies continue to develop.

Guidance on sample types is expected to be finalized during the fall and the balance of testing and screening technologies will be adjusted to respond to the needs of various populations. Researchers and companies continue to innovate and develop new technologies cheap propecia pills and solutions. Guidance will need to keep pace with, and take advantage of, these innovations.

The continuous updating of this Guidance will rely on strong federal, provincial and territorial partnerships and collaboration leveraging key governance bodies, including the Special Advisory Committee. The Guidance will also capitalize on opportunities to leverage input and the capacity to mobilize knowledge in Canada and from around the world.Related linksOn cheap propecia pills this page Purpose and backgroundThe purpose of this notice is to communicate minimum values of sensitivity for hair loss treatment antigen testing devices.Health Canada refers to guidance published by the U.S. Food and Drug Administration (FDA) on antigen detecting tests.

This guidance outlines the requirements that these products must cheap propecia pills meet. This document addresses only sensitivity for antigen tests. It complements cheap propecia pills the published FDA guidance.Sensitivity is technically a measure of the accuracy of a test against a reference standard.

No such standard exists at this time, therefore the accuracy of the positive results from a test is currently expressed as the positive percent agreement (PPA). The term sensitivity is used throughout this document in place of PPA for ease of reading. Sensitivity is the proportion of subjects with the target condition in whom the test is positiveIt is an important measure to determine whether test information is useful and reliable.Minimum value for sensitivity Health cheap propecia pills Canada does not usually set minimum standards for sensitivity.

Normally we review the submitted data to determine whether a test performs to the standard claimed by the manufacturer. We then cheap propecia pills compare that to the standard claimed by similar tests. However, the hair loss treatment propecia is a unique public health crisis.

For this reason, we are taking a different approach.We have set minimum standards for sensitivity that cheap propecia pills a hair loss treatment antigen test must meet in order for us to consider it for authorization. Tests with sensitivity below this minimum do not meet the criteria of 5(c) and (d) of the interim order on the importation and sale of medical devices for use in relation to hair loss treatment. For this reason, they will not be authorized.Health Canada considers the following to be unacceptable for authorization.

Sensitivity below 80% Sensitivity values below this cheap propecia pills level will produce too many false negative results. These tests will not be authorized, regardless of other factors.Future considerationsHealth Canada’s target value aligns with the FDA target. However, as more research results cheap propecia pills become available, we may revise this value accordingly.Health Canada welcomes applications for technologies that meet or exceed the minimum limit value.

We will continue to monitor emerging science and international experience to determine whether we need to amend this value.Contact usPlease email your questions or comments about this notice to. Hc.meddevices-instrumentsmed.sc@canada.ca.Related Links.

Does propecia decrease testosterone

As a world-leading authority on adult congenital heart more tips here disease (ACHD), Professor does propecia decrease testosterone Michael A. Gatzoulis believes the field is a success story of modern medicine with an ever-increasing number of patients able to reach and enjoy adulthood, including those with complex disease who previously had a guarded prognosis.Yet he also concedes there is still a long way to go to improve the care for this group of patients with life-long disease. In addition to more evidence-based practice for this global disease affecting approximately 1% of new-borns, he advocates a personalized ACHD approach with patient education and does propecia decrease testosterone empowerment at its heart, and better use of technology.A Consultant Cardiologist at the Royal Brompton &.

Harefield NHS Trust in London, and the Academic Head of ACHD and Pulmonary Arterial Hypertension (PAH), his key objective has been ‘to promote the needs of patients with congenital heart disease, including delivery of best care, translation research, training, and education’.Prof. Gatzoulis was born into an ‘open-minded and supportive’ medical family in Drama, a city in the north-east of Greece, where his older brother Konstantinos—currently Professor of Cardiology at the University of Athens—and younger sister Thalia (now a successful artist) also studied medicine. His father, Athanasios, was does propecia decrease testosterone a paediatrician.‘I was very rebellious as a teenager’, he recalled, ‘my old friends hardly recognize me now’.

Indeed, he failed to enter the Aristotelian University of Thessaloniki at the first attempt but was accepted the following year in 1977. Following graduation and his national does propecia decrease testosterone service as a soldier and a year’s provincial service as a young doctor, he left his homeland for London in 1987 ‘for a new challenge’, securing a paediatric Senior House Officer role working long hours. €˜I liked the environment and the responsibility, though in the beginning it was challenging.

For the first few months I was coming home totally exhausted, but it got better, and I have no regrets’.With an interest in the heart, he felt the natural next step was paediatric cardiology, so he seized the opportunity when consultant paediatric cardiologist Dr Michael Rigby asked him to join the Royal Brompton Hospital in 1992 (Figure 1). Figure 1Royal does propecia decrease testosterone Brompton Hospital, South Block, Circa 1880.Figure 1Royal Brompton Hospital, South Block, Circa 1880.With his PhD mentor there, Prof. Andrew Redington, he began studying the right ventricle (RV) in adult patients with Tetralogy of Fallot, which led to several important publications.Right ventricular diastolic function, he added, was linked for the first time to arrhythmia and propensity to sudden cardiac death, the ‘mechano-electric concept’, which had implications on prognostication and led to a proactive approach towards pulmonary valve replacement (Figure 2).1 Figure 2ECG with broad QRS complex and a CMR of a dilated RV with pulmonary regurgitation (PR).

ECG with broad QRS complex and 1st degree heart block of a patient with repaired does propecia decrease testosterone Tetralogy of Fallot presenting with sustained VT. Note QRS >. 180 ms.

Composite shows cardiac MRI does propecia decrease testosterone from the patient with (A) and (B) moderate to severe pulmonary regurgitation, (C) marked dilatation and some hypertrophy of the right ventricle with secondary tricuspid regurgitation and (D) Right pulmonary artery (RPA) stenosis at the site of a previous Blalock–Taussig Shunt. Patient underwent surgical PV implantation, relief of RPA stenosis, and AICD implantation.Figure 2ECG with broad QRS complex and a CMR of a dilated RV with pulmonary regurgitation (PR). ECG with broad QRS complex and 1st degree heart block of a patient with repaired Tetralogy of does propecia decrease testosterone Fallot presenting with sustained VT.

Note QRS >. 180 ms. Composite shows does propecia decrease testosterone cardiac MRI from the patient with (A) and (B) moderate to severe pulmonary regurgitation, (C) marked dilatation and some hypertrophy of the right ventricle with secondary tricuspid regurgitation and (D) Right pulmonary artery (RPA) stenosis at the site of a previous Blalock–Taussig Shunt.

Patient underwent surgical PV implantation, relief of RPA stenosis, and AICD implantation.‘It was a golden era for paediatric cardiology at the Brompton’, said Prof. Gatzoulis, ‘and I could clearly see that ACHD was an area of growth and need’.Having completed his post-graduate training in London by the end of 1996, and does propecia decrease testosterone smitten by clinical research, he decided not to go back to Greece but moved instead to Canada to work with Gary Webb at the Toronto General Hospital.Returning to London in 1999, he became head of the GUCH (Grown-up CHD) unit at Royal Brompton Hospital, succeeding Prof. Jane Somerville, to run and expand one of the world’s largest ACHD clinical, training and research programmes.Today, Prof.

Gatzoulis is the academic head of the Adult Congenital Heart Centre and the Centre for Pulmonary Hypertension and clinical lead for ACHD at the Royal Brompton Hospital and a Professor of Cardiology and CHD at the National Heart and Lung Institute, Imperial College, London. Together with his colleagues, he looks after more than 10 000 ACHD does propecia decrease testosterone and 1000 PAH patients, including those with the greatest disease complexity.Among his influences was his father, ‘an amazing person ahead of his time’, who after a successful career as a paediatrician retired at 60 and embarked on a new calling on nature preservation and community work. Prof.

Redington taught him does propecia decrease testosterone how to conduct and report research, while Dr Webb was inspiring with his ‘inclusivity and painstaking work on databases’. But he also reflects on the influence of obstetrician Prof. Phil Steer from the Chelsea &.

Westminster Hospital, ‘for his patient-centred holistic approach and team building, does propecia decrease testosterone while maintaining academic rigour and output’.Prof. Gatzoulis’ research focus has been on mechanisms and prevention of heart failure (HF) and sudden cardiac death in CHD and the treatment of PAH. He said does propecia decrease testosterone.

€˜We have improved the outlook for CHD patients a great deal, but for the most part we have not fixed it’. Prof. Gatzoulis recalls does propecia decrease testosterone how Prof.

Andrew Coats, then head of research at the Royal Brompton, was supportive of his early descriptive work on heart failure markers and exercise intolerance in ACHD, which have now become standard practice (Figure 3). €˜Our work reinforced that we have not cured CHD and at the same time we have opened new therapeutic opportunities’. Figure 3Heart failure and transplantation teams from the Royal Brompton and Harefield NHS Trust at their regular Multi-disciplinary Team (MDT) meeting at the Brompton does propecia decrease testosterone site.Figure 3Heart failure and transplantation teams from the Royal Brompton and Harefield NHS Trust at their regular Multi-disciplinary Team (MDT) meeting at the Brompton site.The Brompton’s designation as a national centre for ACHD and PAH in 2002 was a significant step forward, delivering greater patient numbers for his team to understand the pathophysiology and try novel therapies.

€˜Patients with Eisenmenger Syndrome (ES), the extreme end of the CHD-PAH spectrum, were either neglected or mismanaged by dogma and we have done a lot of work on pathophysiology of their condition and advanced therapies (Figure 4), which has transformed their lives and relevant practice’. Figure 4Peripheral cyanosis in a patient with ES PDA, does propecia decrease testosterone Graph showing improved 6 minute-walk-distance (MWD) and survival from disease targeting therapy (DTT), Composite Figure. Right panel.

Peripheral cyanosis. Only possible diagnosis does propecia decrease testosterone is a Patent Ductus Arteriosus and Eisenmenger Syndrome (ES. Take the patient’s socks off).

Left panel does propecia decrease testosterone. (A, B) Improvement on pulmonary vascular resistance index (PVRi) and the 6 MWD in patients with ES after 16 weeks of Bosentan therapy versus placebo, BREATHE 5 study, (C) Improvement in symptoms and QoL after 16 weeks of intention to treat patients with ES with iron supplementation and (D) Survival benefit of patients with ES on PAH advanced therapies. From Gatzoulis et al.

IJC 2014, permission granted.Figure 4Peripheral cyanosis in a patient with ES PDA, Graph showing improved 6 minute-walk-distance (MWD) and does propecia decrease testosterone survival from disease targeting therapy (DTT), Composite Figure. Right panel. Peripheral cyanosis does propecia decrease testosterone.

Only possible diagnosis is a Patent Ductus Arteriosus and Eisenmenger Syndrome (ES. Take the patient’s socks off). Left panel does propecia decrease testosterone.

(A, B) Improvement on pulmonary vascular resistance index (PVRi) and the 6 MWD in patients with ES after 16 weeks of Bosentan therapy versus placebo, BREATHE 5 study, (C) Improvement in symptoms and QoL after 16 weeks of intention to treat patients with ES with iron supplementation and (D) Survival benefit of patients with ES on PAH advanced therapies. From Gatzoulis does propecia decrease testosterone et al. IJC 2014, permission granted.

Figure 5Paul Wood Textbook cover ‘Diseases of the Heart and Circulation’.Figure 5Paul Wood Textbook cover ‘Diseases of the Heart and Circulation’.He believes his original work on pulmonary regurgitation/right ventricular function, with his serendipitous ECG observations, the mechano-electric concept, together with the groundwork on HF and the clinical trials on PAH in the context of CHD, as among his most important.Asked how he thinks his work has advanced the field, Prof. Gatzoulis replied does propecia decrease testosterone. €˜There was a major impact from our research on ACHD practice with our proactive approach.

A lot of the recent focus of mainstream cardiology—for example, the right ventricle, the pulmonary vascular bed, and even transaortic valve does propecia decrease testosterone implantation (TAVI)—relate to original research or innovations originating from CHD.‘Overall, we have made progress, but we cannot be complacent. There is clearly more to do. More evidence is needed to inform our practice and we must work more collaboratively to achieve this.

CHD is a very does propecia decrease testosterone heterogeneous disease. And we are not doing a good enough job in empowering patients to lead independent and full lives.‘Now is the time to move to a more patient-centred, holistic approach, where we are truly the patient’s advocate. Education is central to this and merits further investment.2 Better use of technology, including does propecia decrease testosterone Artificial Intelligence3 and remote monitoring are also due and have come to the fore due to the self-isolation protocols of the hair loss treatment propecia'.Prof.

Gatzoulis is particularly proud of the 150+ ACHD Fellows that trained with him at the Brompton. €˜The number one asset for me is the patient, but number two—and close behind—are the Fellows who come to train with us in ACHD. The fact is that I learn from them—and from does propecia decrease testosterone the patients—more than they learn from me!.

The ACHD Fellows are now all over the world practising ACHD and I am immensely proud of them’.A former president of the International Society for Adult Congenital Heart Disease, a council member of the ACHD WG of the ESC, and recipient of multiple awards including the prestigious Aristotle Medal for the Year for Science and Politics (2019), he is the author of over 380 peer-reviewed publications, edited or co-edited 10 cardiology textbooks, is an incoming Deputy Editor of the EHJ, Associate Editor of the International Journal of Cardiology and is launching a new journal with a CHD and PAH focus.A father of two teenage boys, away from medicine he enjoys tennis, watersports and cycling, food markets/cooking/restaurants, museums/arts, and travel.Advice he would give young researchers as they set out on a path toward success within the field is. €˜Pursue your dreams does propecia decrease testosterone and seek the right environment. Work hard and stay close to the patient and to your research, and do not be put off by obstacles’.Prof.

Gatzoulis, as one of the leading pioneers, points to future challenges in the ‘continuously evolving cardiovascular subspecialty’ of ACHD. Understanding better the late course of the does propecia decrease testosterone disease. Optimizing therapies.

Ensuring patient access to tertiary care. Training of the new generation of professionals to serve ACHD does propecia decrease testosterone patients. And securing resources (Figure 5).4‘Visionary heads of cardiology always had space for this unique cardiovascular subspecialty for the wealth of its anatomic spectrum, the intriguing physiology, the wonderful clinical signs and the deserving patients.

The examples are multiple, from the late Paul Wood at the Brompton, to Eugene Braunwald in Boston, to Pavlos Toutouzas in Athens and does propecia decrease testosterone many others.‘The number of adult ACHD patients has long exceeded the number of children with CHD’, he said, ‘yet the provision of care for the former is lacking. Furthermore, patients and their families have not been educated and empowered enough regarding their CHD, lifestyle issues and outlook and, yet they navigate their lives with a positive attitude, despite uncertainty, multiple operations, and physical disability in some. For me, the patients are the true heroes in this journey, and a daily inspiration’.

ReferencesReferences are available as supplementary material does propecia decrease testosterone at European Heart Journal online.Conflict of interest. None declared. Published on does propecia decrease testosterone behalf of the European Society of Cardiology.

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

Journals.permissions@oup.com. For the podcast associated with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts.This is a Focus Issue on congenital heart disease (CHD). The population of adults with CHD has risen dramatically over the last does propecia decrease testosterone 60 years, in large part due to the success of cardiac surgery and paediatric cardiac care. In most western civilizations, >85% of babies born with CHD can now be expected to survive to adulthood.

Almost 1 in 100 babies are born with CHD, and the adult population of patients in Europe is estimated at 2.3 million and in the USA at >1 million, both outnumbering the paediatric CHD population.1,2 This leads to unique challenges that the surgical and medical community, together with the patients themselves, face.3,4 Some have largely been overcome, while others remain to be solved. In addition, does propecia decrease testosterone there are unexpected new challenges which have emerged. This issue addresses some of these challenges regarding treatment, participation in competitive sports, and advance care planning in adults with congenital heart disease (ACHD).The first contribution is a clinical research article entitled ‘Current use and safety of novel oral anticoagulants in adults with congenital heart disease.

Results of a nationwide analysis including more than 44 000 patients’ by Gerhard-Paul Diller from the University Hopital Münster in Germany and colleagues.5 Although the use of novel oral anticoagulants does propecia decrease testosterone (NOACs) is well established in patients with atrial fibrillation and pulmonary thrombo-embolism,6–8 their value in patients with ACHD is still largely unexplored. The authors evaluated the use of NOACs compared with vitamin K antagonists (VKAs) in ACHD patients and assessed the outcome in a nationwide analysis. Using data from one of Germany’s largest health insurers, all ACHD patients treated with VKAs or NOACs were identified and changes in prescription patterns assessed.

Furthermore, the association between anticoagulation regimen does propecia decrease testosterone and complications including mortality was studied. About 44 000 ACHD patients were included. Between 2005 and 2018, the use of oral anticoagulants does propecia decrease testosterone in those with ACHD increased from 6.3% to 12.4%.

Since NOACs became available their utilization has increased continually, accounting for 45% of prescribed anticoagulants in ACHD patients in 2018. ACHD patients on NOACs had higher thrombo-embolic events (3.8% vs. 2.8%), major does propecia decrease testosterone cardiovascular events (7.8% vs.

6.0%), bleeding rates (11.7% vs. 9.0%), and does propecia decrease testosterone all-cause mortality (4.0% vs. 2.8%.

All P <. 0.05) after 1 year of therapy does propecia decrease testosterone compared with VKAs. After comprehensive adjustment for patient characteristics, NOACs were still associated with increased risk of major cardiovascular events [hazard ratio (HR) 1.22] and increased all-cause mortality (HR 1.43) during long-term follow-up (Figure 1).

Figure 1Upper panel does propecia decrease testosterone. Increased use of (novel) oral anticoagulants in adults with congenital heart disease over time. The figure displays the annual prescription of vitamin K antagonists (VKAs) and novel oral anticoagulants (NOACs) in adults with congenital heart disease (ACHD) patients between 2005 and 2018 covering 521 493 patient-years in a total cohort size of n = 44 097 ACHD patients.

The proportion does propecia decrease testosterone of ACHD patients on oral anticoagulation increased from 6.3% in 2005 to 12.8% in 2018. Vitamin K antagonists were supplemented but also increasingly replaced by novel oral anticoagulants, with the latter accounting for 45% of all oral anticoagulants prescribed in 2018. The numbers over the bars represent the proportion of ACHD patients on oral anticoagulation during the respective year, while the white numbers represent the percentage of anticoagulated patients receiving novel oral anticoagulants.

Lower panel does propecia decrease testosterone. Results of the adjusted multivariable time-dependent Cox regression analysis. The figure illustrates vitamin K antagonists were superior to novel oral does propecia decrease testosterone anticoagulants regarding all-cause mortality, major adverse cardiovascular events and bleeding, whereas no statistical difference could be established for thromboembolic events (from Freisinger E, Gerβ J, Makowski L, Marschall U, Reinecke H, Baumgartner H, Koeppe J, Diller G-P.

Current use and safety of novel oral anticoagulants in adults with congenital heart disease. Results of a nationwide analysis including more than 44 000 patients. See pages does propecia decrease testosterone 4168–4177).Figure 1Upper panel.

Increased use of (novel) oral anticoagulants in adults with congenital heart disease over time. The figure displays the annual prescription of vitamin K antagonists (VKAs) does propecia decrease testosterone and novel oral anticoagulants (NOACs) in adults with congenital heart disease (ACHD) patients between 2005 and 2018 covering 521 493 patient-years in a total cohort size of n = 44 097 ACHD patients. The proportion of ACHD patients on oral anticoagulation increased from 6.3% in 2005 to 12.8% in 2018.

Vitamin K antagonists were supplemented but also increasingly replaced by novel oral anticoagulants, with the latter accounting for 45% of all oral anticoagulants prescribed in 2018. The numbers over the bars represent the proportion of ACHD patients on oral anticoagulation during the respective year, while the white numbers represent the does propecia decrease testosterone percentage of anticoagulated patients receiving novel oral anticoagulants. Lower panel.

Results of the adjusted multivariable time-dependent does propecia decrease testosterone Cox regression analysis. The figure illustrates vitamin K antagonists were superior to novel oral anticoagulants regarding all-cause mortality, major adverse cardiovascular events and bleeding, whereas no statistical difference could be established for thromboembolic events (from Freisinger E, Gerβ J, Makowski L, Marschall U, Reinecke H, Baumgartner H, Koeppe J, Diller G-P. Current use and safety of novel oral anticoagulants in adults with congenital heart disease.

Results of a nationwide analysis including more than 44 000 does propecia decrease testosterone patients. See pages 4168–4177).The authors conclude that despite the lack of prospective studies in ACHD patients, NOACs are increasingly replacing VKAs and now account for almost half of all oral anticoagulant prescriptions. In particularly, NOACs were associated with excess long-term risk does propecia decrease testosterone of major cardiovascular events and mortality in this nationwide analysis, emphasizing the need for prospective studies before solid recommendations for their use in ACHD patients can be provided.

The manuscript is accompanied by an Editorial by Frans Van de Werf from KU Leuven in Belgium and colleagues.9 They note that while awaiting the results of controlled studies, it is wise to use VKAs as the standard anticoagulant therapy in ACHD patients and consider NOACs for selected cases after consultation with a multidisciplinary team. Figure 2Event free survival. Time = does propecia decrease testosterone 0 refers to the date of randomization.

The dotted line indicates the end of the initial COMPARE trial period. CI, confidence does propecia decrease testosterone interval. HR, hazard ratio (from van Andel MM, Indrakusuma R, Jalalzadeh H, Balm R, Timmermans J, Scholte AJ, van den Berg MP, Zwinderman AH, Mulder BJM, de Waard V, Groenink M.

Long-term clinical outcomes of losartan in patients with Marfan syndrome. Follow-up of the multicentre randomized does propecia decrease testosterone controlled COMPARE trial. See pages 4181–4187).Figure 2Event free survival.

Time = 0 refers to the does propecia decrease testosterone date of randomization. The dotted line indicates the end of the initial COMPARE trial period. CI, confidence interval.

HR, hazard ratio (from van Andel MM, Indrakusuma R, Jalalzadeh H, Balm does propecia decrease testosterone R, Timmermans J, Scholte AJ, van den Berg MP, Zwinderman AH, Mulder BJM, de Waard V, Groenink M. Long-term clinical outcomes of losartan in patients with Marfan syndrome. Follow-up of the multicentre does propecia decrease testosterone randomized controlled COMPARE trial.

See pages 4181–4187).The COMPARE trial showed a small but significant beneficial effect of 3-year losartan treatment on aortic root dilatation rate in adults with Marfan syndrome (MFS).10 However, no significant effect was found on clinical endpoints, possibly due to a short follow-up period. In a clinical research manuscript entitled ‘Long-term clinical outcomes of losartan in patients with Marfan syndrome. Follow-up of the multicentre randomized controlled COMPARE trial’, Mitzi van Andel from the University of Amsterdam in the Netherlands and colleagues investigate the long-term clinical outcomes after losartan does propecia decrease testosterone treatment.11 In the original COMPARE study (inclusion 2008–2009), 233 adult patients with MFS were randomly allocated to either the angiotensin II receptor blocker losartan on top of regular treatment (beta-blockers in 71% of the patients) or no additional medication.

After the COMPARE trial period of 3 years, study subjects chose to continue their losartan medication or not. In a median follow-up period of 8 years, 75 patients continued losartan medication, whereas 78 patients, originally allocated to the control group, never used losartan after inclusion. No differences existed between baseline characteristics of the two groups except for age at inclusion and beta-blocker use does propecia decrease testosterone (losartan 81%, control 64%).

Clinical endpoints, defined as all-cause mortality, aortic dissection/rupture, elective aortic root replacement, reoperation, and vascular graft implantation beyond the aortic root, were compared between the two groups. A per patient composite endpoint was also does propecia decrease testosterone analysed. Patients who used losartan during the entire follow-up period showed a reduced number of events compared with the control group and exhibited a significantly lower number of deaths (0 vs.

5) and aortic dissections (3 vs. 11). They also experienced a non-significant lower number of elective aortic root replacement (10 vs.

13), reoperation (1 vs. 2), and vascular graft implantation beyond the aortic root (0 vs. 3) (Figure 2).

These results remained similar when corrected for age and beta-blocker use in a multivariate analysis.Van Andel et al. Conclude that these results suggest a clinical benefit of combined losartan and beta-blocker treatment in patients with MFS. The manuscript is accompanied by an Editorial by Guillaume Jondeau from the Hôpital Bichat in Paris, France.12 Jondeau and colleagues hope that a forthcoming meta-analysis combining all of the randomized studies already published or unpublished will confirm the early results of this study.The issue continues with the Special Article ‘Recommendations for participation in competitive sport in adolescent and adult athletes with Congenital Heart Disease (CHD).

Position statement of the Sport Cardiology &. Exercise Section of the European Association of Preventive Cardiology (EAPC), The European Society of Cardiology (ESC) Working Group on Adult Congenital Heart Disease, and the Sports Cardiology, Physical Activity and Prevention Working Group of The Association for European Paediatric and Congenital Cardiology (AEPC)’ by Werner Budts from the Catholic University Leuven in Belgium and colleagues.13 The authors note that improved clinical care has led to an increase in the number of ACHD patients engaging in leisure time and competitive sports activities. Although the benefits of exercise in patients with ACHD are well established, there is a low but appreciable risk of exercise-related complications.

Published exercise recommendations for individuals with ACHD are predominantly centred on anatomic lesions, hampering an individualized approach to exercise advice in this heterogeneous population. This document presents an update of the recommendations for competitive sports participation in athletes with cardiovascular disease. It introduces an approach which is based on assessment of haemodynamic, electrophysiological, and functional parameters, rather than anatomical lesions.

The recommendations provide a comprehensive assessment algorithm which allows for patient-specific assessment and risk stratification of athletes with ACHD who wish to participate in competitive sports.Finally, this issue also contains the Special Article ‘Recommendations for advance care planning in adults with congenital heart disease. A position paper from the ESC Working Group of Adult Congenital Heart Disease, the Association of Cardiovascular Nursing and Allied Professions (ACNAP), the European Association for Palliative Care (EAPC), and the International Society for Adult Congenital Heart Disease (ISACHD)’ by Markus Schwerzmann from the University of Bern in Switzerland and colleagues.14 The authors remind us that survival prospects in ACHD, although improved in recent decades, still remain below expectations for the general population. Patients and their loved ones benefit from preparation for both unexpected and predictable deaths, sometimes preceded by a prolonged period of declining health.

Hence, advance care planning (ACP) is an integral part of comprehensive care in those with ACHD. This position paper summarizes evidence regarding benefits of and patients’ preferences for ACP and provides practical advice regarding the implementation of ACP processes within clinical ACHD practice. They suggest that ACP be delivered as a structured process across different stages, with content dependent upon the anticipated disease progression.

They also acknowledge potential barriers to initiate ACP discussions and emphasize the importance of a sensitive and situation-specific communication style. Conclusions presented in this paper reflect agreed expert opinions, and include both patient and provider perspectives.The editors hope that this issue of the European Heart Journal will be of interest to its readers.With thanks to Amelia Meier-Batschelet, Johanna Huggler, and Martin Meyer for help with compilation of this article. References1Warnes CA.

Adult congenital heart disease. The challenges of a lifetime. Eur Heart J 2017;38:2041–2047.2Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K.

2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J 2020;doi.org/10.1093/eurheartj/ehaa554.3Baumgartner H, Budts W, Chessa M, Deanfield J, Eicken A, Holm J, Iserin L, Meijboom F, Stein J, Szatmari A, Trindade PT, Walker F. Recommendations for organization of care for adults with congenital heart disease and for training in the subspecialty of ‘Grown-up Congenital Heart Disease’ in Europe.

A position paper of the Working Group on Grown-up Congenital Heart Disease of the European Society of Cardiology. Eur Heart J 2014;35:686–690.4Moons P, Meijboom FJ, Baumgartner H, Trindade PT, Huyghe E, Kaemmerer H. Structure and activities of adult congenital heart disease programmes in Europe.

Eur Heart J 2010;31:1305–1310.5Freisinger E, Gerß J, Makowski L, Marschall U, Reinecke H, Baumgartner H, Koeppe J, Diller G-P. Current use and safety of novel oral anticoagulants in adults with congenital heart disease. Results of a nationwide analysis including more than 44 000 patients.

Eur Heart J 2020;41:4168–4177.6Heidbuchel H, Verhamme P, Alings M, Antz M, Diener HC, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P. Updated European Heart Rhythm Association practical guide on the use of non-vitamin-K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Executive summary.

Eur Heart J 2017;38:2137–2149.7Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020;41:XXX–XXX.8Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jiménez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, F NÁ, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL.

2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J 2020;41:543–603.9Verhamme P, Budts W, Van de Werf F. Non-vitamin K oral anticoagulants in adults with congenital heart disease.

Quod non?. Eur Heart J 2020;41:4178–4180.10Groenink M, den Hartog AW, Franken R, Radonic T, de Waard V, Timmermans J, Scholte AJ, van den Berg MP, Spijkerboer AM, Marquering HA, Zwinderman AH, Mulder BJ. Losartan reduces aortic dilatation rate in adults with Marfan syndrome.

A randomized controlled trial. Eur Heart J 2013;34:3491–3500.11van Andel MM, Indrakusuma R, Jalalzadeh H, Balm R, Timmermans J, Scholte AJ, van den Berg MP, Zwinderman AH, Mulder BJM, de Waard V, Groenink M. Long-term clinical outcomes of losartan in patients with Marfan syndrome.

Follow-up of the multicentre randomized controlled COMPARE trial. Eur Heart J 2020;41:4181–4187.12Jondeau G, Milleron O, Boileau C. Marfan sartan saga, episode X.

Eur Heart J 2020;41:4188–4190.13Budts W, Pieles GE, Roos-Hesselink JW, Sanz de la Garza M, D’Ascenzi F, Giannakoulas G, Müller J, Oberhoffer R, Ehringer-Schetitska D, Herceg-Cavrak V, Gabriel H, Corrado D, van Buuren F, Niebauer J, Börjesson M, Caselli S, Fritsch P, Pelliccia A, Heidbuchel H, Sharma S, Stuart AG, Papadakis M. Recommendations for participation in competitive sport in adolescent and adult athletes with Congenital Heart Disease (CHD). Position statement of the Sports Cardiology &.

Exercise Section of the European Association of Preventive Cardiology (EAPC), the European Society of Cardiology (ESC) Working Group on Adult Congenital Heart Disease and the Sports Cardiology, Physical Activity and Prevention Working Group of the Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2020;41:4191–4199.14Schwerzmann M, Goossens E, Galle go P, Kovacs AH, Moons P, Swan L, Tobler D, de Stoutz N, Gabriel H, Greutmann M, Roos-Hesselink JW, Sobanski PZ, Thomet C. Recommendations for advance care planning in adults with congenital heart disease.

A position paper from the ESC Working Group of Adult Congenital Heart Disease, the Association of Cardiovascular Nursing and Allied Professions (ACNAP), the European Association for Palliative Care (EAPC), and the International Society for Adult Congenital Heart Disease (ISACHD). Eur Heart J 2020;41:4200–4210. Published on behalf of the European Society of Cardiology.

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

As a http://peddaborowski.com/die-verwandlung-die-wohnung/ world-leading authority on adult congenital heart disease (ACHD), Professor Michael cheap propecia pills A. Gatzoulis believes the field is a success story of modern medicine with an ever-increasing number of patients able to reach and enjoy adulthood, including those with complex disease who previously had a guarded prognosis.Yet he also concedes there is still a long way to go to improve the care for this group of patients with life-long disease. In addition to more evidence-based practice for this global disease affecting approximately 1% of new-borns, he advocates a personalized ACHD approach with patient education and empowerment at its heart, and better use of technology.A Consultant cheap propecia pills Cardiologist at the Royal Brompton &. Harefield NHS Trust in London, and the Academic Head of ACHD and Pulmonary Arterial Hypertension (PAH), his key objective has been ‘to promote the needs of patients with congenital heart disease, including delivery of best care, translation research, training, and education’.Prof. Gatzoulis was born into an ‘open-minded and supportive’ medical family in Drama, a city in the north-east of Greece, where his older brother Konstantinos—currently Professor of Cardiology at the University of Athens—and younger sister Thalia (now a successful artist) also studied medicine.

His father, cheap propecia pills Athanasios, was a paediatrician.‘I was very rebellious as a teenager’, he recalled, ‘my old friends hardly recognize me now’. Indeed, he failed to enter the Aristotelian University of Thessaloniki at the first attempt but was accepted the following year in 1977. Following graduation and his national service as a soldier and a year’s provincial service as a young doctor, he left his homeland for London in 1987 ‘for a new challenge’, securing a paediatric Senior House Officer role working cheap propecia pills long hours. €˜I liked the environment and the responsibility, though in the beginning it was challenging. For the first few months I was coming home totally exhausted, but it got better, and I have no regrets’.With an interest in the heart, he felt the natural next step was paediatric cardiology, so he seized the opportunity when consultant paediatric cardiologist Dr Michael Rigby asked him to join the Royal Brompton Hospital in 1992 (Figure 1).

Figure 1Royal Brompton Hospital, South Block, Circa cheap propecia pills 1880.Figure 1Royal Brompton Hospital, South Block, Circa 1880.With his PhD mentor there, Prof. Andrew Redington, he began studying the right ventricle (RV) in adult patients with Tetralogy of Fallot, which led to several important publications.Right ventricular diastolic function, he added, was linked for the first time to arrhythmia and propensity to sudden cardiac death, the ‘mechano-electric concept’, which had implications on prognostication and led to a proactive approach towards pulmonary valve replacement (Figure 2).1 Figure 2ECG with broad QRS complex and a CMR of a dilated RV with pulmonary regurgitation (PR). ECG with broad QRS complex and 1st degree heart block of a patient with repaired Tetralogy of Fallot presenting with sustained cheap propecia pills VT. Note QRS >. 180 ms.

Composite shows cardiac MRI from the patient with (A) and (B) moderate to severe pulmonary regurgitation, (C) marked dilatation cheap propecia pills and some hypertrophy of the right ventricle with secondary tricuspid regurgitation and (D) Right pulmonary artery (RPA) stenosis at the site of a previous Blalock–Taussig Shunt. Patient underwent surgical PV implantation, relief of RPA stenosis, and AICD implantation.Figure 2ECG with broad QRS complex and a CMR of a dilated RV with pulmonary regurgitation (PR). ECG with broad QRS complex and 1st degree heart cheap propecia pills block of a patient with repaired Tetralogy of Fallot presenting with sustained VT. Note QRS >. 180 ms.

Composite shows cardiac MRI from the patient with (A) and (B) cheap propecia pills moderate to severe pulmonary regurgitation, (C) marked dilatation and some hypertrophy of the right ventricle with secondary tricuspid regurgitation and (D) Right pulmonary artery (RPA) stenosis at the site of a previous Blalock–Taussig Shunt. Patient underwent surgical PV implantation, relief of RPA stenosis, and AICD implantation.‘It was a golden era for paediatric cardiology at the Brompton’, said Prof. Gatzoulis, ‘and I could cheap propecia pills clearly see that ACHD was an area of growth and need’.Having completed his post-graduate training in London by the end of 1996, and smitten by clinical research, he decided not to go back to Greece but moved instead to Canada to work with Gary Webb at the Toronto General Hospital.Returning to London in 1999, he became head of the GUCH (Grown-up CHD) unit at Royal Brompton Hospital, succeeding Prof. Jane Somerville, to run and expand one of the world’s largest ACHD clinical, training and research programmes.Today, Prof. Gatzoulis is the academic head of the Adult Congenital Heart Centre and the Centre for Pulmonary Hypertension and clinical lead for ACHD at the Royal Brompton Hospital and a Professor of Cardiology and CHD at the National Heart and Lung Institute, Imperial College, London.

Together with his colleagues, he looks after more than 10 000 ACHD cheap propecia pills and 1000 PAH patients, including those with the greatest disease complexity.Among his influences was his father, ‘an amazing person ahead of his time’, who after a successful career as a paediatrician retired at 60 and embarked on a new calling on nature preservation and community work. Prof. Redington taught cheap propecia pills him how to conduct and report research, while Dr Webb was inspiring with his ‘inclusivity and painstaking work on databases’. But he also reflects on the influence of obstetrician Prof. Phil Steer from the Chelsea &.

Westminster Hospital, ‘for his patient-centred holistic approach cheap propecia pills and team building, while maintaining academic rigour and output’.Prof. Gatzoulis’ research focus has been on mechanisms and prevention of heart failure (HF) and sudden cardiac death in CHD and the treatment of PAH. He said cheap propecia pills. €˜We have improved the outlook for CHD patients a great deal, but for the most part we have not fixed it’. Prof.

Gatzoulis recalls how cheap propecia pills Prof. Andrew Coats, then head of research at the Royal Brompton, was supportive of his early descriptive work on heart failure markers and exercise intolerance in ACHD, which have now become standard practice (Figure 3). €˜Our work reinforced that we have not cured CHD and at the same time we have opened new therapeutic opportunities’. Figure 3Heart failure and transplantation teams from the Royal Brompton and Harefield NHS Trust at their regular Multi-disciplinary cheap propecia pills Team (MDT) meeting at the Brompton site.Figure 3Heart failure and transplantation teams from the Royal Brompton and Harefield NHS Trust at their regular Multi-disciplinary Team (MDT) meeting at the Brompton site.The Brompton’s designation as a national centre for ACHD and PAH in 2002 was a significant step forward, delivering greater patient numbers for his team to understand the pathophysiology and try novel therapies. €˜Patients with Eisenmenger Syndrome (ES), the extreme end of the CHD-PAH spectrum, were either neglected or mismanaged by dogma and we have done a lot of work on pathophysiology of their condition and advanced therapies (Figure 4), which has transformed their lives and relevant practice’.

Figure cheap propecia pills 4Peripheral cyanosis in a patient with ES PDA, Graph showing improved 6 minute-walk-distance (MWD) and survival from disease targeting therapy (DTT), Composite Figure. Right panel. Peripheral cyanosis. Only possible diagnosis is a Patent cheap propecia pills Ductus Arteriosus and Eisenmenger Syndrome (ES. Take the patient’s socks off).

Left panel cheap propecia pills. (A, B) Improvement on pulmonary vascular resistance index (PVRi) and the 6 MWD in patients with ES after 16 weeks of Bosentan therapy versus placebo, BREATHE 5 study, (C) Improvement in symptoms and QoL after 16 weeks of intention to treat patients with ES with iron supplementation and (D) Survival benefit of patients with ES on PAH advanced therapies. From Gatzoulis et al. IJC 2014, permission granted.Figure 4Peripheral cyanosis in a patient with ES PDA, Graph showing improved 6 minute-walk-distance (MWD) and survival from disease cheap propecia pills targeting therapy (DTT), Composite Figure. Right panel.

Peripheral cyanosis cheap propecia pills. Only possible diagnosis is a Patent Ductus Arteriosus and Eisenmenger Syndrome (ES. Take the patient’s socks off). Left panel cheap propecia pills. (A, B) Improvement on pulmonary vascular resistance index (PVRi) and the 6 MWD in patients with ES after 16 weeks of Bosentan therapy versus placebo, BREATHE 5 study, (C) Improvement in symptoms and QoL after 16 weeks of intention to treat patients with ES with iron supplementation and (D) Survival benefit of patients with ES on PAH advanced therapies.

From Gatzoulis cheap propecia pills et al. IJC 2014, permission granted. Figure 5Paul Wood Textbook cover ‘Diseases of the Heart and Circulation’.Figure 5Paul Wood Textbook cover ‘Diseases of the Heart and Circulation’.He believes his original work on pulmonary regurgitation/right ventricular function, with his serendipitous ECG observations, the mechano-electric concept, together with the groundwork on HF and the clinical trials on PAH in the context of CHD, as among his most important.Asked how he thinks his work has advanced the field, Prof. Gatzoulis replied cheap propecia pills. €˜There was a major impact from our research on ACHD practice with our proactive approach.

A lot of the recent focus of cheap propecia pills mainstream cardiology—for example, the right ventricle, the pulmonary vascular bed, and even transaortic valve implantation (TAVI)—relate to original research or innovations originating from CHD.‘Overall, we have made progress, but we cannot be complacent. There is clearly more to do. More evidence is needed to inform our practice and we must work more collaboratively to achieve this. CHD is a very heterogeneous cheap propecia pills disease. And we are not doing a good enough job in empowering patients to lead independent and full lives.‘Now is the time to move to a more patient-centred, holistic approach, where we are truly the patient’s advocate.

Education is central to this and merits cheap propecia pills further investment.2 Better use of technology, including Artificial Intelligence3 and remote monitoring are also due and have come to the fore due to the self-isolation protocols of the hair loss treatment propecia'.Prof. Gatzoulis is particularly proud of the 150+ ACHD Fellows that trained with him at the Brompton. €˜The number one asset for me is the patient, but number two—and close behind—are the Fellows who come to train with us in ACHD. The fact is that I learn from them—and cheap propecia pills from the patients—more than they learn from me!. The ACHD Fellows are now all over the world practising ACHD and I am immensely proud of them’.A former president of the International Society for Adult Congenital Heart Disease, a council member of the ACHD WG of the ESC, and recipient of multiple awards including the prestigious Aristotle Medal for the Year for Science and Politics (2019), he is the author of over 380 peer-reviewed publications, edited or co-edited 10 cardiology textbooks, is an incoming Deputy Editor of the EHJ, Associate Editor of the International Journal of Cardiology and is launching a new journal with a CHD and PAH focus.A father of two teenage boys, away from medicine he enjoys tennis, watersports and cycling, food markets/cooking/restaurants, museums/arts, and travel.Advice he would give young researchers as they set out on a path toward success within the field is.

€˜Pursue your dreams cheap propecia pills and seek the right environment. Work hard and stay close to the patient and to your research, and do not be put off by obstacles’.Prof. Gatzoulis, as one of the leading pioneers, points to future challenges in the ‘continuously evolving cardiovascular subspecialty’ of ACHD. Understanding better the late course cheap propecia pills of the disease. Optimizing therapies.

Ensuring patient access to tertiary care. Training of the new generation of professionals to serve cheap propecia pills ACHD patients. And securing resources (Figure 5).4‘Visionary heads of cardiology always had space for this unique cardiovascular subspecialty for the wealth of its anatomic spectrum, the intriguing physiology, the wonderful clinical signs and the deserving patients. The examples are multiple, from the late Paul Wood at the Brompton, to Eugene Braunwald in Boston, to Pavlos Toutouzas in Athens and many others.‘The number of adult ACHD patients has long exceeded cheap propecia pills the number of children with CHD’, he said, ‘yet the provision of care for the former is lacking. Furthermore, patients and their families have not been educated and empowered enough regarding their CHD, lifestyle issues and outlook and, yet they navigate their lives with a positive attitude, despite uncertainty, multiple operations, and physical disability in some.

For me, the patients are the true heroes in this journey, and a daily inspiration’. ReferencesReferences are available cheap propecia pills as supplementary material at European Heart Journal online.Conflict of interest. None declared. Published on behalf cheap propecia pills of the European Society of Cardiology. All rights reserved.

© The Author(s) 2020. For permissions, please email cheap propecia pills. Journals.permissions@oup.com. For the podcast associated with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts.This is a Focus Issue on congenital heart disease (CHD). The population of adults with CHD has risen dramatically over the last 60 years, in large cheap propecia pills part due to the success of cardiac surgery and paediatric cardiac care. In most western civilizations, >85% of babies born with CHD can now be expected to survive to adulthood.

Almost 1 in 100 babies are born with CHD, and the adult population of patients in Europe is estimated at 2.3 million and in the USA at >1 million, both outnumbering the paediatric CHD population.1,2 This leads to unique challenges that the surgical and medical community, together with the patients themselves, face.3,4 Some have largely been overcome, while others remain to be solved. In addition, there are unexpected new challenges which have emerged cheap propecia pills. This issue addresses some of these challenges regarding treatment, participation in competitive sports, and advance care planning in adults with congenital heart disease (ACHD).The first contribution is a clinical research article entitled ‘Current use and safety of novel oral anticoagulants in adults with congenital heart disease. Results of a nationwide analysis including more than 44 000 patients’ by Gerhard-Paul Diller from the University Hopital Münster in Germany and colleagues.5 Although the use of novel oral anticoagulants (NOACs) is well established in patients with atrial fibrillation and pulmonary thrombo-embolism,6–8 their value in patients with ACHD cheap propecia pills is still largely unexplored. The authors evaluated the use of NOACs compared with vitamin K antagonists (VKAs) in ACHD patients and assessed the outcome in a nationwide analysis.

Using data from one of Germany’s largest health insurers, all ACHD patients treated with VKAs or NOACs were identified and changes in prescription patterns assessed. Furthermore, the association between anticoagulation regimen and complications including mortality was studied cheap propecia pills. About 44 000 ACHD patients were included. Between 2005 and 2018, the use of oral anticoagulants cheap propecia pills in those with ACHD increased from 6.3% to 12.4%. Since NOACs became available their utilization has increased continually, accounting for 45% of prescribed anticoagulants in ACHD patients in 2018.

ACHD patients on NOACs had higher thrombo-embolic events (3.8% vs. 2.8%), major cheap propecia pills cardiovascular events (7.8% vs. 6.0%), bleeding rates (11.7% vs. 9.0%), and all-cause mortality (4.0% vs cheap propecia pills. 2.8%.

All P <. 0.05) after 1 cheap propecia pills year of therapy compared with VKAs. After comprehensive adjustment for patient characteristics, NOACs were still associated with increased risk of major cardiovascular events [hazard ratio (HR) 1.22] and increased all-cause mortality (HR 1.43) during long-term follow-up (Figure 1). Figure cheap propecia pills 1Upper panel. Increased use of (novel) oral anticoagulants in adults with congenital heart disease over time.

The figure displays the annual prescription of vitamin K antagonists (VKAs) and novel oral anticoagulants (NOACs) in adults with congenital heart disease (ACHD) patients between 2005 and 2018 covering 521 493 patient-years in a total cohort size of n = 44 097 ACHD patients. The proportion of ACHD patients on oral anticoagulation increased from 6.3% in 2005 to cheap propecia pills 12.8% in 2018. Vitamin K antagonists were supplemented but also increasingly replaced by novel oral anticoagulants, with the latter accounting for 45% of all oral anticoagulants prescribed in 2018. The numbers over the bars represent the proportion of ACHD patients on oral anticoagulation during the respective year, while the white numbers represent the percentage of anticoagulated patients receiving novel oral anticoagulants. Lower panel cheap propecia pills.

Results of the adjusted multivariable time-dependent Cox regression analysis. The figure cheap propecia pills illustrates vitamin K antagonists were superior to novel oral anticoagulants regarding all-cause mortality, major adverse cardiovascular events and bleeding, whereas no statistical difference could be established for thromboembolic events (from Freisinger E, Gerβ J, Makowski L, Marschall U, Reinecke H, Baumgartner H, Koeppe J, Diller G-P. Current use and safety of novel oral anticoagulants in adults with congenital heart disease. Results of a nationwide analysis including more than 44 000 patients. See pages cheap propecia pills 4168–4177).Figure 1Upper panel.

Increased use of (novel) oral anticoagulants in adults with congenital heart disease over time. The figure displays the annual prescription of cheap propecia pills vitamin K antagonists (VKAs) and novel oral anticoagulants (NOACs) in adults with congenital heart disease (ACHD) patients between 2005 and 2018 covering 521 493 patient-years in a total cohort size of n = 44 097 ACHD patients. The proportion of ACHD patients on oral anticoagulation increased from 6.3% in 2005 to 12.8% in 2018. Vitamin K antagonists were supplemented but also increasingly replaced by novel oral anticoagulants, with the latter accounting for 45% of all oral anticoagulants prescribed in 2018. The numbers over cheap propecia pills the bars represent the proportion of ACHD patients on oral anticoagulation during the respective year, while the white numbers represent the percentage of anticoagulated patients receiving novel oral anticoagulants.

Lower panel. Results of the adjusted multivariable time-dependent Cox cheap propecia pills regression analysis. The figure illustrates vitamin K antagonists were superior to novel oral anticoagulants regarding all-cause mortality, major adverse cardiovascular events and bleeding, whereas no statistical difference could be established for thromboembolic events (from Freisinger E, Gerβ J, Makowski L, Marschall U, Reinecke H, Baumgartner H, Koeppe J, Diller G-P. Current use and safety of novel oral anticoagulants in adults with congenital heart disease. Results of a cheap propecia pills nationwide analysis including more than 44 000 patients.

See pages 4168–4177).The authors conclude that despite the lack of prospective studies in ACHD patients, NOACs are increasingly replacing VKAs and now account for almost half of all oral anticoagulant prescriptions. In particularly, NOACs were associated with excess long-term risk of major cardiovascular cheap propecia pills events and mortality in this nationwide analysis, emphasizing the need for prospective studies before solid recommendations for their use in ACHD patients can be provided. The manuscript is accompanied by an Editorial by Frans Van de Werf from KU Leuven in Belgium and colleagues.9 They note that while awaiting the results of controlled studies, it is wise to use VKAs as the standard anticoagulant therapy in ACHD patients and consider NOACs for selected cases after consultation with a multidisciplinary team. Figure 2Event free survival. Time = 0 refers to cheap propecia pills the date of randomization.

The dotted line indicates the end of the initial COMPARE trial period. CI, confidence cheap propecia pills interval. HR, hazard ratio (from van Andel MM, Indrakusuma R, Jalalzadeh H, Balm R, Timmermans J, Scholte AJ, van den Berg MP, Zwinderman AH, Mulder BJM, de Waard V, Groenink M. Long-term clinical outcomes of losartan in patients with Marfan syndrome. Follow-up of the multicentre cheap propecia pills randomized controlled COMPARE trial.

See pages 4181–4187).Figure 2Event free survival. Time = 0 refers to the date of randomization cheap propecia pills. The dotted line indicates the end of the initial COMPARE trial period. CI, confidence interval. HR, hazard ratio (from van Andel MM, Indrakusuma R, Jalalzadeh H, cheap propecia pills Balm R, Timmermans J, Scholte AJ, van den Berg MP, Zwinderman AH, Mulder BJM, de Waard V, Groenink M.

Long-term clinical outcomes of losartan in patients with Marfan syndrome. Follow-up of cheap propecia pills the multicentre randomized controlled COMPARE trial. See pages 4181–4187).The COMPARE trial showed a small but significant beneficial effect of 3-year losartan treatment on aortic root dilatation rate in adults with Marfan syndrome (MFS).10 However, no significant effect was found on clinical endpoints, possibly due to a short follow-up period. In a clinical research manuscript entitled ‘Long-term clinical outcomes of losartan in patients with Marfan syndrome. Follow-up of the multicentre randomized controlled COMPARE trial’, Mitzi van Andel from the University of Amsterdam in the Netherlands and colleagues investigate the long-term clinical outcomes after losartan treatment.11 In the original COMPARE study (inclusion 2008–2009), 233 adult patients with MFS were randomly allocated to either the angiotensin II cheap propecia pills receptor blocker losartan on top of regular treatment (beta-blockers in 71% of the patients) or no additional medication.

After the COMPARE trial period of 3 years, study subjects chose to continue their losartan medication or not. In a median follow-up period of 8 years, 75 patients continued losartan medication, whereas 78 patients, originally allocated to the control group, never used losartan after inclusion. No differences existed between baseline characteristics of the two groups except for age at inclusion and beta-blocker use (losartan 81%, control 64%) cheap propecia pills. Clinical endpoints, defined as all-cause mortality, aortic dissection/rupture, elective aortic root replacement, reoperation, and vascular graft implantation beyond the aortic root, were compared between the two groups. A per cheap propecia pills patient composite endpoint was also analysed.

Patients who used losartan during the entire follow-up period showed a reduced number of events compared with the control group and exhibited a significantly lower number of deaths (0 vs. 5) and aortic dissections (3 vs. 11). They also experienced a non-significant lower number of elective aortic root replacement (10 vs. 13), reoperation (1 vs.

2), and vascular graft implantation beyond the aortic root (0 vs. 3) (Figure 2). These results remained similar when corrected for age and beta-blocker use in a multivariate analysis.Van Andel et al. Conclude that these results suggest a clinical benefit of combined losartan and beta-blocker treatment in patients with MFS. The manuscript is accompanied by an Editorial by Guillaume Jondeau from the Hôpital Bichat in Paris, France.12 Jondeau and colleagues hope that a forthcoming meta-analysis combining all of the randomized studies already published or unpublished will confirm the early results of this study.The issue continues with the Special Article ‘Recommendations for participation in competitive sport in adolescent and adult athletes with Congenital Heart Disease (CHD).

Position statement of the Sport Cardiology &. Exercise Section of the European Association of Preventive Cardiology (EAPC), The European Society of Cardiology (ESC) Working Group on Adult Congenital Heart Disease, and the Sports Cardiology, Physical Activity and Prevention Working Group of The Association for European Paediatric and Congenital Cardiology (AEPC)’ by Werner Budts from the Catholic University Leuven in Belgium and colleagues.13 The authors note that improved clinical care has led to an increase in the number of ACHD patients engaging in leisure time and competitive sports activities. Although the benefits of exercise in patients with ACHD are well established, there is a low but appreciable risk of exercise-related complications. Published exercise recommendations for individuals with ACHD are predominantly centred on anatomic lesions, hampering an individualized approach to exercise advice in this heterogeneous population. This document presents an update of the recommendations for competitive sports participation in athletes with cardiovascular disease.

It introduces an approach which is based on assessment of haemodynamic, electrophysiological, and functional parameters, rather than anatomical lesions. The recommendations provide a comprehensive assessment algorithm which allows for patient-specific assessment and risk stratification of athletes with ACHD who wish to participate in competitive sports.Finally, this issue also contains the Special Article ‘Recommendations for advance care planning in adults with congenital heart disease. A position paper from the ESC Working Group of Adult Congenital Heart Disease, the Association of Cardiovascular Nursing and Allied Professions (ACNAP), the European Association for Palliative Care (EAPC), and the International Society for Adult Congenital Heart Disease (ISACHD)’ by Markus Schwerzmann from the University of Bern in Switzerland and colleagues.14 The authors remind us that survival prospects in ACHD, although improved in recent decades, still remain below expectations for the general population. Patients and their loved ones benefit from preparation for both unexpected and predictable deaths, sometimes preceded by a prolonged period of declining health. Hence, advance care planning (ACP) is an integral part of comprehensive care in those with ACHD.

This position paper summarizes evidence regarding benefits of and patients’ preferences for ACP and provides practical advice regarding the implementation of ACP processes within clinical ACHD practice. They suggest that ACP be delivered as a structured process across different stages, with content dependent upon the anticipated disease progression. They also acknowledge potential barriers to initiate ACP discussions and emphasize the importance of a sensitive and situation-specific communication style. Conclusions presented in this paper reflect agreed expert opinions, and include both patient and provider perspectives.The editors hope that this issue of the European Heart Journal will be of interest to its readers.With thanks to Amelia Meier-Batschelet, Johanna Huggler, and Martin Meyer for help with compilation of this article. References1Warnes CA.

Adult congenital heart disease. The challenges of a lifetime. Eur Heart J 2017;38:2041–2047.2Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J 2020;doi.org/10.1093/eurheartj/ehaa554.3Baumgartner H, Budts W, Chessa M, Deanfield J, Eicken A, Holm J, Iserin L, Meijboom F, Stein J, Szatmari A, Trindade PT, Walker F.

Recommendations for organization of care for adults with congenital heart disease and for training in the subspecialty of ‘Grown-up Congenital Heart Disease’ in Europe. A position paper of the Working Group on Grown-up Congenital Heart Disease of the European Society of Cardiology. Eur Heart J 2014;35:686–690.4Moons P, Meijboom FJ, Baumgartner H, Trindade PT, Huyghe E, Kaemmerer H. Structure and activities of adult congenital heart disease programmes in Europe. Eur Heart J 2010;31:1305–1310.5Freisinger E, Gerß J, Makowski L, Marschall U, Reinecke H, Baumgartner H, Koeppe J, Diller G-P.

Current use and safety of novel oral anticoagulants in adults with congenital heart disease. Results of a nationwide analysis including more than 44 000 patients. Eur Heart J 2020;41:4168–4177.6Heidbuchel H, Verhamme P, Alings M, Antz M, Diener HC, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P. Updated European Heart Rhythm Association practical guide on the use of non-vitamin-K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Executive summary.

Eur Heart J 2017;38:2137–2149.7Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020;41:XXX–XXX.8Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jiménez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, F NÁ, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J 2020;41:543–603.9Verhamme P, Budts W, Van de Werf F.

Non-vitamin K oral anticoagulants in adults with congenital heart disease. Quod non?. Eur Heart J 2020;41:4178–4180.10Groenink M, den Hartog AW, Franken R, Radonic T, de Waard V, Timmermans J, Scholte AJ, van den Berg MP, Spijkerboer AM, Marquering HA, Zwinderman AH, Mulder BJ. Losartan reduces aortic dilatation rate in adults with Marfan syndrome. A randomized controlled trial.

Eur Heart J 2013;34:3491–3500.11van Andel MM, Indrakusuma R, Jalalzadeh H, Balm R, Timmermans J, Scholte AJ, van den Berg MP, Zwinderman AH, Mulder BJM, de Waard V, Groenink M. Long-term clinical outcomes of losartan in patients with Marfan syndrome. Follow-up of the multicentre randomized controlled COMPARE trial. Eur Heart J 2020;41:4181–4187.12Jondeau G, Milleron O, Boileau C. Marfan sartan saga, episode X.

Eur Heart J 2020;41:4188–4190.13Budts W, Pieles GE, Roos-Hesselink JW, Sanz de la Garza M, D’Ascenzi F, Giannakoulas G, Müller J, Oberhoffer R, Ehringer-Schetitska D, Herceg-Cavrak V, Gabriel H, Corrado D, van Buuren F, Niebauer J, Börjesson M, Caselli S, Fritsch P, Pelliccia A, Heidbuchel H, Sharma S, Stuart AG, Papadakis M. Recommendations for participation in competitive sport in adolescent and adult athletes with Congenital Heart Disease (CHD). Position statement of the Sports Cardiology &. Exercise Section of the European Association of Preventive Cardiology (EAPC), the European Society of Cardiology (ESC) Working Group on Adult Congenital Heart Disease and the Sports Cardiology, Physical Activity and Prevention Working Group of the Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2020;41:4191–4199.14Schwerzmann M, Goossens E, Galle go P, Kovacs AH, Moons P, Swan L, Tobler D, de Stoutz N, Gabriel H, Greutmann M, Roos-Hesselink JW, Sobanski PZ, Thomet C.

Recommendations for advance care planning in adults with congenital heart disease. A position paper from the ESC Working Group of Adult Congenital Heart Disease, the Association of Cardiovascular Nursing and Allied Professions (ACNAP), the European Association for Palliative Care (EAPC), and the International Society for Adult Congenital Heart Disease (ISACHD). Eur Heart J 2020;41:4200–4210. Published on behalf of the European Society of Cardiology. All rights reserved.

© The Author(s) 2020. For permissions, please email. Journals.permissions@oup.com..