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NEWS: BUSINESS

1107 Online flu seminar for business to prepare for impact of H1N1 flu [Scotland]--Help to enable Scottish businesses prepare for the impacts of swine flu will be offered through an innovative, free-to-access, online seminar.

Scotland is now experiencing a second wave of pandemic flu.

While forecasts for the numbers of people likely to become ill have been revised downwards, businesses are still likely to experience disruption to services and supply chains, as well as potential losses in revenue as a result of higher than average staff absences.

That is why the Scottish Government is working with all the major business organisations to provide guidance on sensible measures to maintain business continuity, to be made available online on Thursday, November 12.

Cabinet Secretary for Finance and Sustainable Growth John Swinney said:

"While recently published UK-wide planning assumptions for the next seven months have been revised downwards, the estimates of the proportion of the population who might become ill at any one time are still significant and every business should have plans in place.

"This is not a time to be complacent. Patterns of infection spread could still change, with hot spots resulting in higher than average staff absences in local areas with a knock-on impact on business.

"The on-line seminar session will communicate key pandemic flu preparedness information which will be of particular benefit to smaller and micro-businesses who may not be getting information through other channels.

"We would encourage firms of all sizes to participate in this event and benefit from free advice to maintain a healthy business."

We all have a responsibility to limit the spread of disease, reducing the risk within the workplace and perhaps reducing the numbers of staff off at one time. You can do so by encouraging all staff to practice good hygiene measures such as regular hand washing.

The seminar will take place at 12:30 on Thursday, November 12 2009

The seminar will consist of a short presentation and an online Q&A session led by David Hutcheson representing the Institute of Directors (Scotland) and the Business Continuity Institute.

To join the seminar, log on to https://www2.gotomeeting.com/register/796534907 from any computer, ideally five or ten minutes beforehand.

The online seminar will be recorded and placed on Scottish Government, Business Gateway and business organisations' websites, ensuring that the guidance continues to be available to businesses across Scotland.

1107 Digital 'plaster' for monitoring vital signs undergoes first clinical trials [London England]--A wireless digital 'plaster' that can monitor vital signs continuously and remotely is being tried out with patients and healthy volunteers at Imperial College Healthcare NHS Trust, in a new clinical trial run by Imperial College London researchers.

Toumaz Technology Ltd's Sensium™ digital 'plaster' or 'patch' is a disposable device that sticks to a patient's chest. It is designed to allow patients to have their health monitored continuously without being wired up to bulky, fixed monitoring machines, potentially freeing some patients from their hospital beds.

The digital plaster is based on innovative technology created by engineers at Imperial College London. It contains a wireless, smart, ultra-low power sensor platform in a silicon chip, which can monitor a range of vital signs like body temperature, heart rate and respiration in real-time.

The intention is that healthcare professionals will be able to download this information using a mobile phone, enabling them to pick up on any critical changes in their patients' status on a 24-7 basis and allowing early detection and treatment of any unforeseen complications.

The data can also be integrated automatically into the patient's electronic medical record.

The team that developed the Sensium™ digital plaster from Toumaz Technology Ltd, a spin-out from Imperial College London, hope that it will enable some patients to recover from surgery and illness at home rather than in hospital. It should also mean that hospital in-patients have greater mobility. In addition, it could allow doctors to extend continuous monitoring of vital signs to a broader range of patients.

The disposable plaster has a working life of several days, after which it can be replaced, ensuring that infection control can be maintained.

Professor Chris Toumazou FRS led the team that developed the plaster and he is the CEO and co-founder of Toumaz Technology Ltd and the Director of the Institute of Biomedical Engineering at Imperial College London. He said:

"We think the digital plaster could revolutionise healthcare and we're really excited to see it being tried out with patients for the first time. Ultimately, the plaster could mean that doctors can keep track of any worrying changes in patients' vital signs 24 hours a day, 7 days a week, and then deal with any problems that arise really quickly. We think that fewer patients will have medical complications if doctors can spot health problems as soon as they arise and then treat each patient accordingly.

"We're hoping that the plaster will improve the health and wellbeing of a vast range of patients – from patients on a general hospital ward to people with chronic diseases like diabetes and cardiovascular disease who want to have their health monitored without having to keep visiting the hospital. At the same time, the plaster should free up doctors and nurses' time by allowing them to keep an eye on patients without continuously checking bits of machinery," added Professor Toumazou.

In the new trial, which is funded by CareFusion, researchers will be exploring whether the physiological data that doctors and nurses can obtain using the digital plaster system is equivalent to that which can be acquired using the current gold-standard monitors in use in hospitals.

The trial is being conducted in three phases: an initial phase with non-patient volunteers, followed by two patient study groups from Imperial College Healthcare NHS Trust - patients recovering from surgery and patients with specific medical conditions in the general wards. Those taking part in the trial will wear the digital plaster and they will also be connected to a state-of-the-art monitoring machine, so that the researchers can compare the performance of the two. Initial results are expected by the end of December 2009.

Dr Stephen Brett, the researcher who is leading the clinical trial, who is an Honorary Senior Lecturer at Imperial College London and a Consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust, said: "This project involves taking an elegant piece of engineering, developing it into a potentially clinically usable system and evaluating it in an acute hospital setting. Currently, unless they are in critical care or are identified as being at particular risk, most patients only have their vital signs measured every few hours. This can't give us a complete picture of a patient's health.

"If the new technology proves effective, it could enable us to collect vital sign information really frequently from large numbers of hospital patients, with minimal inconvenience to them. As the plaster is wireless, we would be able to collect the data without impairing patients' ability to move about. This would be great because it is often important for a patient's recovery to ensure that they can stay mobile."

The trial is taking place within the Academic Health Science Centre (AHSC), a partnership between Imperial College London and Imperial College Healthcare NHS Trust, formed in October 2007. The AHSC's aim is to improve the quality of life of patients and populations by taking new discoveries and translating them into new therapies as quickly as possible.

1103 FDA publishes guidance on diagnostic tests for H1N1 flu virus [United States]--The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA).

If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sebelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA requests.

The EUA authority allows the FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization is revoked by the FDA.

The EUA authority is part of Project BioShield, which became law in July 2004.

While the FDA encourages manufacturers to submit appropriate premarket applications for these tests, the agency also recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application. However, this guidance outlines information the FDA recommends be included, and the FDA gives these requests thorough and careful review to protect the public health.

During this declared public health emergency, manufacturers of 2009 H1N1 influenza virus tests that are unable to submit a complete premarket notification may use the guidance to submit a request for an EUA.

The guidance document is part of the FDA’s ongoing efforts to provide public health authorities managing the pandemic with reliable and accessible diagnostic tests. The guidance is available online and will remain in effect throughout the public health emergency.

For more information:

The FDA’ Emergency Use Authorization of Medical Products
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm
The FDA’s Emergency Use Authorization Questions and Answers
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm153297.htm

1023 Got the flu? Now is not the time for a sick note: Ontario's doctors [Toronto ON]--In advance of what is shaping up to be an unprecedented flu season, Ontario's doctors are encouraging employers to reconsider asking their employees for a sick note from a physician because of an absence from work. While Ontario's doctors are asking employers to trust their employees, they are stressing that employees shouldn't take advantage of this year's flu situation as an opportunity to simply take a day off.

"In order to help reduce the transmission of H1N1 and other illnesses, Ontario's doctors believe it is wise for patients to stay home when they have flu-like symptoms," said Dr. Suzanne Strasberg, President of the Ontario Medical Association (OMA). "Employers need to recognize that by requiring a sick note, they are encouraging those who are experiencing their worst symptoms and are most infectious to go out, when they should just be home in bed."

If a patient has mild flu-like symptoms and no pre-existing illnesses of concern, the most important thing that can be done to prevent others from being infected is to stay home. Going to the doctor's office just to get a note or going to work puts many others at risk.

It is anticipated that while most cases of H1N1 and seasonal influenza will be mild, those who get sick are being asked to protect others who may be more vulnerable to the virus. In addition, while many patients with H1N1 or the seasonal flu will be able to recover under their own care and without needing medical treatment, it is important that a patient see a doctor if symptoms worsen or if they have a chronic and/or pre-existing health condition, or are in a high-risk population group.

"Ontario's doctors know that there will be added pressures and increased work load this flu season but we are ready to care for and treat our patients," Dr. Strasberg said. "It's important for everyone to do as much as possible to help prevent the spread of the H1N1 flu and reduce the strain on the health care system. It's equally important that we continue to focus on patients who need care, rather than those who just need a note."

1020 FDA approves seasonal flu vax Fluarix for pediatric use [Rockville MD]--The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

For more information:

FDA Web site on Influenza Virus Vaccine Safety and Availability
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm

1020 FDA, FTC issue joint warning letter to website offering fraudulent H1N1 flu supplements [Washington DC]--On October 15, 2009, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the 2009 H1N1 influenza virus.

The warning letter, the first to be issued jointly by the agencies, advises the owners of the site that they must discontinue the fraudulent marketing of their product or face legal action. The letter further advises the owners of the site that they have 48 hours to give the agencies a plan to discontinue their fraudulent marketing.

The FDA and the FTC remind consumers to be cautious of promotions or Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. Fraudulent H1N1 influenza products come in many varieties, including dietary supplements, as well as products purporting to be drugs, medical devices or vaccines. Since May 2009, the FDA has warned more than 75 Web sites to stop the sale of more than 135 products with fraudulent H1N1 influenza virus claims.

“Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Unless these products are proven to be safe and effective for the claims that are made, it is not known whether they will prevent the transmission of the virus or offer effective remedies against infection. Furthermore, they can make matters worse by providing consumers with a false sense of protection.”

The FDA and the FTC also warn consumers to take extreme care when buying products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus because, in addition to being fraudulent, they could be dangerous.

In collaboration with the FTC, the FDA will continue to work aggressively to identify, investigate and take regulatory action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products.

This will include taking joint action, when appropriate, such as the issuance of last Thursday's warning letter. Additional legal action could include an injunction or issuance of an administrative order by the FTC or seizure of products, an injunction or criminal prosecution by the FDA.

“The FDA continues to consider the sale and promotion of fraudulent H1N1 influenza products to be a possible threat to the public health and in violation of the Federal Food Drug and Cosmetic Act,” said Michael Chappell, acting associate commissioner for regulatory affairs. “The FDA has an aggressive surveillance program to detect fraudulent H1N1-related products and will take prompt action to stop the marketing of fraudulent H1N1 influenza products and will hold those who are responsible for doing so accountable.”

To view the warning letters, visit: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm.

There are two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus – Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). Tamiflu and Relenza, in addition to their approved labeling, have been issued Emergency Use Authorizations by the FDA that describe specific authorized uses during this public health emergency.

H1N1 Flu Fraud Widget

This week, the FDA enhanced its efforts to warn the public about potentially deceptive H1N1 influenza products and to report suspected criminal activity with the release of an H1N1 flu fraud widget.

The portable application, embedded in a Web page that can be copied onto any other Web site or blog, will allow the public to play an active role in preventing flu fraud, and is available at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm186340.htm

Consumers are urged to report any suspected fraudulent products or criminal activity relating to FDA-regulated products associated with H1N1 influenza virus, including the names of Web sites that may be offering these products for sale, to the FDA by visiting: http://www.accessdata.fda.gov/scripts/email/oc/oci/flucontact.cfm

Consumers are urged to purchase and consume only FDA-approved or authorized medical products to diagnose, treat, prevent, or cure infections caused by the H1N1 virus. Consumers also are urged to contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.

For more information:

FDA 2009 H1N1 (Swine) Flu Page
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm

Centers for Disease Control and Prevention – 2009 H1N1 Flu (Swine Flu)
http://www.cdc.gov/h1n1flu/

Fraudulent 2009 H1N1 Influenza Products List
http://www.accessdata.fda.gov/scripts/h1n1flu/

Influenza Antiviral Drugs and Related Information
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm

The Federal Government’s Influenza Web site
http://www.flu.gov/

FTC Warns Internet Peddlers that Potentially Bogus H1N1 Influenza Products May Violate Federal Law—Press Release, May 5, 2009
http://www2.ftc.gov/opa/2009/05/swineflu2.shtm

1017 DHSS offers online education webinar for H1N1 [New Jersey]--Beginning today, the Department of Health and Senior Services (DHSS) has added to its website a free, online pandemic influenza webinar to educate individuals on pandemic influenza preparations. The webinar is available in both English and Spanish on the DHSS website at www.nj.gov/health/training/panflu.

"Learning the facts about pandemics and planning ahead are important elements of pandemic flu preparedness," said Health and Senior Services Commissioner Heather Howard.

“As we continue to monitor the resurgence of H1N1 influenza this fall, it’s important that all New Jersey residents be as informed and prepared as possible,” she added. “This online program is an important tool that will help businesses, employees and families learn how to protect themselves.”

While appropriate for all New Jerseyans, the webinar specifically targets employees and employers. It can be taken as an online course, downloaded onto CDs or an organization’s intranet, or by printed copy.

Upon completion of the webinar users should:

· Understand the impact a flu pandemic may have in a community and what community leaders may need to do to reduce the impact

· Be able to develop a Pandemic Flu Personal Emergency Plan

· Know how to reduce your risk of getting the flu and spreading it to others

· Know how to provide flu care at home

· Understand where you can get help for the emotional stress a flu pandemic may cause

· Know how to identify reliable sources of public health information

The webinar was funded by the New Jersey Office of Homeland Security and developed by DHSS and Rutgers University.

1015 DHS Sec announces new proposed standards for private sector preparedness [USA]--Department of Homeland Security (DHS) Secretary Janet Napolitano today announced new proposed standards for a 9/11 Commission-recommended program for the private sector to improve preparedness for disasters and emergencies.

"Preparedness is a shared responsibility and everyone—including businesses, universities and non-profit organizations—has a role to play," said Secretary Napolitano. "Ensuring our private sector partners have the information and training they need to respond to disasters will strengthen our efforts to build a culture of preparedness nationwide."

DHS published a notice in the Federal Register today seeking public comment on three new standards identified for adoption under the Voluntary Private Sector Preparedness Accreditation and Certification Program (PS-Prep). PS-Prep is a partnership between DHS and the private sector that enables private entities—including businesses, non-profit organizations and universities—to receive emergency preparedness certification from a DHS accreditation system created in coordination with the private sector.

The notice proposes new PS-Prep standards to enhance operational resilience, business continuity management, and disaster and emergency management among participating private sector partners.

The proposed standards, developed by the National Fire Protection Association, the British Standards Institution and the ASIS International, were selected based on their scalability, balance of interest and relevance to PS-Prep from a group of 25 standards proposed for consideration following the publication of a Federal Register notice in December 2008 announcing the program.

In addition to the standards in the notice posted today, DHS is establishing classifications and methods of certifications that recognize the unique needs and characteristics of small businesses.

Individuals wishing to submit comments on the proposed standards, recommend additional standards for consideration or comment on other programmatic aspects of PS-Prep may obtain a comment form and instructions for submission online at www.regulations.gov, in Docket ID: FEMA-2008-0017. DHS requests comments by Nov. 15, though it will accept submissions at any time thereafter.

For more information, visit http://www.fema.gov/privatesectorpreparedness/.

1009 H1N1 Govt helping workplaces prepare [Saskatchewan]--Beginning today, the government is distributing a new guide to workplace pandemic influenza preparedness.

Advanced Education, Employment and Labour's Occupational Health and Safety Branch is distributing the guide, called Pandemic Planning: Best Practice Guideline for Occupational Health and Safety, by direct mail to workplaces with occupational health committees around the province and to various stakeholder organizations, including those that represent smaller workplaces that don't have committees.

Hard copies of the guide can be requested from Occupational Health and Safety. The guide is also available online.

"Employers and workers have an important role in preparing for and preventing the spread of pandemic influenza in their workplaces," Advanced Education, Employment and Labour Minister Rob Norris said. "This guide identifies the practical steps employers and workers can take together to prepare for and prevent pandemic influenza in their workplaces."

The guide was adapted from a similar guide produced in Alberta with input from their ministries responsible for Occupational Health and Safety and for public health.

Saskatchewan partners consulted in the development of this guide include the Ministry of Health, Regional Health Authorities, and the Occupational Health and Safety Council.

To order copies, or for more information on H1NI influenza and Occupational Health and Safety in Saskatchewan, call toll-free at 1-800-567-7233 or visit www.labour.gov.sk.ca/h1n1-influenza-ohs.

1009 H1N1 Flu communication toolkit for businesses presented [Virginia]--State Health Commissioner Karen Remley, MD, MBA addressed an audience of 725 Human Resource professionals at the Virginia Society for Human Resource Managers (SHRM) conference in Virginia Beach where she presented a novel H1N1 communication toolkit for businesses. Joining Dr. Remley was Cindy Hale, President of Virginia SHRM.

Dr. Remley said “It is difficult to predict the severity of illness the novel H1N1 flu will cause, therefore businesses should plan to respond in a flexible way and be prepared to take additional steps to decrease the spread of flu in the workplace.” Dr. Remley also stated, “Public health communicators realize that in addition to traditional fact sheets, posters and brochures, various forms of templated social media tools such as text messages, eCards, e-mails, and website widgets are needed to meet the demands of today’s audiences.”

“Employers, in general, play a key role in protecting employees' health and safety, as well as in limiting the negative impact of influenza outbreaks on the individual, the community, and the nation’s economy,” stated Ms. Hale. “Employers who have developed pandemic plans should review and revise their plans as outlined in the toolkit in light of the current novel H1N1 influenza outbreak,” she added.

Consistent messaging is important and the Department of Health cannot reach everyone to raise awareness of this issue. “We see it as our obligation as Human Resource professionals to use the recommendations provided in the toolkit to ensure a minimal impact to our staff and our community,” remarked Ms. Hale. Actions employers should take include: Encourage your employees to get their seasonal flu vaccination now and their novel H1N1 vaccination when it becomes available.

Review or establish a flexible pandemic influenza plan and involve your employees in developing and reviewing your plan.
Conduct a focused discussion or exercise using your plan, to find out ahead of time whether the plan has gaps or problems that need to be corrected.
Have an understanding of your organization’s normal seasonal absenteeism rates and know how to monitor for any unusual increases in absenteeism through the fall and winter.
Engage the Virginia Department of Health and local health departments to confirm channels of communication and methods for dissemination of local outbreak information.
Allow sick workers to stay home without fear of losing their jobs.
Develop other flexible leave policies to allow workers to stay home to care for sick family members or for children if schools dismiss students or child care programs close.
Share your pandemic influenza plan with employees and explain what human resources policies, workplace and leave flexibilities, and pay and benefits will be available to them.
Share best practices with other businesses in your communities (especially those in your supply chain), chambers of commerce, and associations to improve community response efforts.

Commissioner Remley added, “We need to remain vigilant against the spread of the disease. We are focused on monitoring the activity of the virus in our state and on reducing its impact, especially among those at highest risk for complications.”

For more information, go to:

Virginia Department of Health – H1N1 Hotline: 1-877-ASK-VDH3 (1-877-275-8343)

SHRM H1N1 Flu Resources

Communication Toolkit for Businesses and Employers

2009 H1N1 Flu Resources for Businesses and Employers

Headlines link directly to articles:

1107 Online flu seminar for business to prepare for impact of H1N1 flu [Scotland]

1107 Digital 'plaster' for monitoring vital signs undergoes first clinical trials [London England]

1103 FDA publishes guidance on diagnostic tests for H1N1 flu virus [United States]

1023 Got the flu? Now is not the time for a sick note: Ontario's doctors [Toronto ON]

1020 FDA approves seasonal flu vax Fluarix for pediatric use [Rockville MD]

1020 FDA, FTC issue joint warning letter to website offering fraudulent H1N1 flu supplements [Washington DC]

1017 DHSS offers online education webinar for H1N1 [New Jersey]

1015 DHS Sec announces new proposed standards for private sector preparedness [USA]

1009 H1N1 Govt helping workplaces prepare [Saskatchewan]

1009 H1N1 Flu communication toolkit for businesses presented [Virginia]

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