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Showing posts sorted by relevance for query flu. Sort by date Show all posts
Showing posts sorted by relevance for query flu. Sort by date Show all posts

Monday, October 19, 2009

CDC Reports Flu Widespread - Is the US Workers’ Compensation System Ready?


The US Centers for Disease Control (CDC) has announced that Flu is now “widespread” in 41 States and that deaths attributed to both pneumonia and influenza have increased and exceed what is normally expected for this time of the year.  The workers’ compensation system has never faced a challenge as extensive as what appears unfolding on the horizon. The method and manner of the delivery of benefits will be further complicated by, the broad spectrum of needs from protecting the spread of the disease, as well as treating those who are ill.

Forty-one states are reporting widespread influenza activity at this time according to the CDC. They are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.  

Last month the CDC released a guide to business to prepare for the threat of the Flu. Despite the fact that the CDC has directed ill healthcare workers to stay home, workers’ compensation commentators continue to infer that Flu claims should be absolutely defended, and in fact, ill healthcare workers and sick employees should be held to a higher standard of proof to obtain benefits.

As challenges to mandatory vaccination programs meander thorough the courts, and voluntary/mandatory absenteeism programs are implemented, the ability of the system to quickly reimburse wages for lost time from work and provide medical benefits for treatment of the contagious disease, remains questionable. Should claims be filed by even a percentage of those workers who become ill, the system, which itself is anticipated to be overtaxed, may not be able the handle the volume on an emergent basis.

So far there has been silence about  workers’ compensation flu pandemic planning. While the Federal and State governments have rules and regulations in their arsenal to meet the challenge, this is an issue where workers’ compensation should be first in line to deliver benefits to sick workers.

Friday, September 26, 2014

CDC unveils 6-phase pandemic response blueprint

The Centers for Disease Control and Prevention (CDC) today released a new influenza pandemic response plan that features six phases of activity, with the aim of providing clearer guidance on the timing of key actions, such as school closings and vaccinations.
The "Updated Preparedness and Response Framework for Influenza Pandemics" represents a revision of a framework issued in 2008, which itself was a modification of a 2006 plan. The latest iteration reflects lessons from the 2009 H1N1 pandemic and recent responses to outbreaks of novel flu viruses, such as the swine-origin variant H3N2 (H3N2v).
The six phases outlined in the revised plan are:
  • Investigation of cases of novel flu in humans or animals
  • Recognition of increased potential for ongoing transmission
  • Initiation of a pandemic wave, meaning efficient and sustained transmission
  • Acceleration of a pandemic wave, meaning a consistently increasing number of cases in the United States
  • Deceleration of a pandemic wave, defined as consistently declining cases in the United States
  • Preparation for future pandemic waves, meaning low pandemic flu activity
The framework has been aligned with the pandemic phases of the World Health Organization (WHO) as restructured last year, the document says. It says the WHO phases provide a general view by aggregating epidemic curves from around the world, and the CDC intervals "serve as additional points of reference to provide a...
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Friday, November 27, 2009

OSHA Sets H1N1 Flu Employer Responsibility Standard for Health Care Workers


The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) has  issued a compliance directive that clearly establishes a level of employer responsibility to health care workers to prevent the spread of H1N1 flu. The establishment of the standard may allow some injured workers to circumvent "the exclusivity doctrine" in workers' compensation and hold employers responsible in the civil justice system for resultant injury or death should the employer's fail to comply with is directive.


The "exclusivity doctrine" in workers' compensation limits an employers' responsibility to only scheduled workers' compensation benefits for harm caused to workers that "arises out of" and occurs "within the course of employment." Those benefits have become increasingly difficult to obtain for a multitude of reasons.


The OSGA directive closely follows the prevention guidance issue by The Centers for Disease Control (CDC) to prevent the spread of H1N1 flu. The purpose of the compliance directive is "to ensure uniform procedures when conducting inspections to identify and minimize or eliminate high to very high risk occupational exposures to the 2009 H1N1 influenza A virus."


The CDC has reported that the H1N1 flu activity continues to be widespread in the US and remains above epidemic in proportion for the seventh consecutive week. Over 99% of all subtyped A viruses being reported to the CDC were 2009 influenza A (H1N1) viruses. A total of 171 deaths in children associated with the 2009 influenza A (H1N1) virus infection have been reported to the CDC.


OSHA announced, "In response to complaints, OSHA inspectors will ensure that health care employers implement a hierarchy of controls, and encourage vaccination and other work practices recommended by the CDC. Where respirators are required to be used, the OSHA Respiratory Protection standard must be followed, including worker training and fit testing. The directive also applies to institutional settings where some workers may have similar exposures, such as schools and correctional facilities."


"OSHA has a responsibility to ensure that the more than nine million frontline health care workers in the United States are protected to the extent possible against exposure to the virus," said acting Assistant Secretary of Labor for OSHA Jordan Barab. "OSHA will ensure health care employers use proper controls to protect all workers, particularly those who are at high or very high risk of exposure."


To read more about workers' compensation and the H1N1 Flu click here.

Sunday, December 29, 2013

US flu activity keeps climbing

Today's post was shared by CIDRAP and comes from www.cidrap.umn.edu

Highly magnified, digitally colorized electromicrograph of 2009 H1N1 influenza virus, the predominant strain this season.
Highly magnified, digitally colorized
 electromicrograph of 
2009 H1N1 influenza virus,
 the predominant strain this season.
US influenza activity kept climbing last week, as several states outside the South reported widespread cases, and the 2009 H1N1 virus continued to be the predominant strain, according to the US Centers for Disease Control and Prevention (CDC).
Ten states reported geographically widespread flu activity, up from just four southern states the week before. The ten are Alabama, Alaska, Kansas, Louisiana, Massachusetts, New York, Pennsylvania, Texas, Virginia, and Wyoming.
Also, six states reported high influenza-like illness (ILI) activity as measured by visits to sentinel clinics, up from four states the previous week, the CDC reported. Nationally, 3.0% of medical visits were due to ILI, compared with the national baseline of 2.0%.
States with high ILI activity were Alabama, Louisiana, Mississippi, Missouri, Oklahoma, and Texas. Another eight states cited moderate ILI activity, and the rest had low or minimal numbers.
The CDC also reported a big jump in the percentage of respiratory samples that tested positive for flu: 24.1% (of 6,813 specimens), versus 17.8% a week earlier.

An H1N1 season so far

Of the positive specimens, more than 98% were influenza A viruses, and 2009 H1N1—the former pandemic virus, now a seasonal strain—accounted for nearly all of those that were subtyped. Only 1.8% of the positive specimens were influenza B isolates.
Last week the...
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Saturday, September 20, 2014

Influenza Vaccination Coverage Among Health Care Personnel — United States, 2013–14 Influenza Season

Today post is shared from cdc.com/


Comprehensive worksite intervention strategies that include vaccination promotion and convenient access to vaccination at no cost might increase vaccination coverage among Health Care Personnel (HCP).

Influenza vaccination coverage among HCP during the 2013–14 influenza season, assessed using an opt-in Internet panel survey, was 75.2%, similar to coverage for the 2012–13 season. Vaccination coverage was highest among physicians overall and HCP working in hospital settings; coverage was lowest among assistants/aides overall and HCP working in long-term care settings. Offering vaccination at the workplace at no cost was associated with higher vaccination coverage.


The Advisory Committee on Immunization Practices recommends that all health care personnel (HCP) be vaccinated annually against influenza (1). Vaccination of HCP can reduce influenza-related morbidity and mortality among both HCP and their patients (1–4). To estimate influenza vaccination coverage among HCP during the 2013–14 season, CDC analyzed results of an opt-in Internet panel survey of 1,882 HCP conducted during April 1–16, 2014. Overall, 75.2% of participating HCP reported receiving an influenza vaccination during the 2013–14 season, similar to the 72.0% coverage among participating HCP reported in the 2012–13 season (5). Coverage was highest among HCP working in hospitals (89.6%) and lowest among HCP working in long-term care (LTC) settings (63.0%). By occupation, coverage was highest among physicians (92.2%), nurses (90.5%), nurse practitioners and physician assistants (89.6%), pharmacists (85.7%), and "other clinical personnel" (87.4%) compared with assistants and aides (57.7%) and nonclinical personnel (e.g., administrators, clerical support workers, janitors, and food service workers) (68.6%). HCP working in settings where vaccination was required had higher coverage (97.8%) compared with HCP working in settings where influenza vaccination was not required but promoted (72.4%) or settings where there was no requirement or promotion of vaccination (47.9%). Among HCP without an employer requirement for vaccination, coverage was higher for HCP working in settings where vaccination was offered on-site at no cost for 1 day (61.6%) or multiple days (80.4%) compared with HCP working in settings not offering free on-site vaccination (49.0%). Comprehensive vaccination strategies that include making vaccine available at no cost at the workplace along with active promotion of vaccination might be needed to increase vaccination coverage among HCP and minimize the risk for influenza to HCP and their patients.

Wednesday, October 1, 2014

Germs at the Office Are Often Found on Keyboards and at Coffee Stations

Shared from the http://online.wsj.com/
As cold and flu season nears, is it possible to avoid the germ-filled spots in the office? WSJ's Sumathi Reddy joins Lunch Break with Tanya Rivero to discuss. Photo: iStock/Thomas_EyeDesign
It's almost that time of year when you ever-so-slowly inch away from the person with the hacking cough and infectious sneeze.
Turns out it's pretty hard to avoid the germs of your co-workers, even the ones you don't know personally. Just one door contaminated with a virus spreads the germ to about half the surfaces and hands of about half the employees in the office within four hours, according to a study at the University of Arizona, in Tucson. Germs traveled through the office just as quickly when the researchers infected a single person with the artificial virus.
"The hand is quicker than the sneeze," said Charles Gerba, a professor of microbiology at the University of Arizona who presented the research at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington D.C. earlier this month.

The University of Arizona researchers conducted their study at an office building with 80 employees. They contaminated a push-plate door at the building entrance with a virus called bacteriophage MS-2. It doesn't infect people yet is similar in shape, size and survivability to common cold and stomach flu viruses.
Within two hours, the virus had contaminated the break room—coffee pot, microwave button, fridge door handle—and then spread to restrooms,...
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Wednesday, August 19, 2009

Federal Government Alerts Employers to Prepare for Flu Outbreaks

The Federal government has now taken action to alert employers and business as to what precautions should be taken in anticipation of the anticipated fall Flu outbreak. Yesterday the government revealed that deployment of vaccines would be too slow to prevent or restrain further spread this fall.

In a joint letter from the Secretaries of Commerce, Health and Human Services, Homeland Security and Labor, the Federal government has alerted employers and business of a new web site directed to encouraging prevention and containment for a resurgence in the months ahead of H1N1 Flu.

For more on this topic and workers' compensation benefits, visit the Workers Compensation Blog.

Tuesday, September 15, 2009

The Urgent Need for Workers Compensation Flu Pandemic Planning

The 2009 influenza pandemic (flu) has created a new framework of acts and regulations to respond the World Health Organization’s (WHO) phase 6 pandemic alert. Governmentally imposed employment disruptions resulting from regulatory work disruptions to prevent the spread of disease maybe massive. While workers’ compensation was envisioned as a summary and remedial social insurance program, the challenges facing the workers’ compensation system to deliver benefits as promised may be seriously burdened.


There has been a global reaction to the 2008 influenza pandemic. On April 25, 2009, the WHO director-General Dr. Margaret Chen declared the H1N1 virus outbreak as a “Public Health Emergency of International Concern.” The international declaration indicated that a coordinated international response was potentially necessary to prevent curtail the spread of the disease that was perceived as a public health risk. Recommendations to restrict both trade and travel may follow.


The United States has structured its response on both a State and Federal level to the 2009 influenza alert. The Public Health Service Act (PHS) permits the Secretary of Health and Human Service (HHS) to access a special emergency fund, allows or the use of unapproved medical treatments and tests, and allows waiver of certain reimbursement of Medicare and Medicaid expenses, and waives penalties and sanctions for violation of the HIPAA Privacy Rule requirements. Additionally, the President may issue an emergency declaration under The Stafford Act to co-ordinate emergency relief under State and Federal programs, ie. use and distribution of anti-viral medications.


The Federal government has sweeping powers under the PHS that could disrupt employment throughout the country. Recommendations for school closings will impact children and staff well beyond the approximate 700 facilities that were closed in the Spring of 2009 during the H1N1 initial outbreak. The Federal government under the PHS has authority to quarantine (interstate and border) and to isolate. An Executive Order (E.O. 13375, April 2005) enumerates the “quarantainable diseases.” Travel restrictions may be imposed to limit the spread of a communicable disease. Employees may not be permitted to board flights under either voluntary airline restrictions or through the Federally imposed “Do Not Board” lists.


These closings and restrictions have raised issues as to what programs, if any, will be able to provide benefits to the employees because of the involuntary nature of the closings and disruptions. A recent Harvard School of Public Health study reveals that 80% of businesses foresee severe problems in maintaining operations if there is an outbreak. The workers’ compensation system could be requested to provide temporary disability benefits for occupational disease absences on a massive scale never before experienced. Pre-emption by superseding emergency regulatory actions may curtail employment that will trigger the implementation of State workers’ compensation benefits. The employer and the workers’ compensation insurance carriers will be required to pay temporary disability and medical benefits as a direct consequence of efforts to prevent the spread of a communicable disease. The carefully crafted employee-employer notification structure integrated into the workers’ compensation system may be partially or entirely disrupted by the consequences and chaos of the global health emergency.


Workers’ Compensation claims arising out of the influenza pandemic of 2009 will need to fit into the convoluted framework statutory acts and regulation. Reimbursement from the usual collateral third-party reimbursement sources may be restricted. In addition to the Doctrine of Sovereign Immunity, enjoyed by the Federal and State governments, other legislation including The “Public Readiness and Emergency Preparedness Act" (PREP Act) limits liability of others under certain specific emergency circumstances.


The enormity of the Pandemic presents a new and novel challenge to the system and one that must be considered by both Federal and State planners. Workers’ Compensation programs have adapted to emergencies before including natural disasters and terrorist attacks. The urgency of the situation requires that the system be vaccinated now.


Wednesday, October 28, 2009

Latex Allergy Adverse Reaction Caused by Swine Flu Shot


Just as health care workers and first responders have started to line up for H1N1 flu shots, an adverse reaction to latex has been reported. This development adds further to to the compensable risks resulting from adverse reactions to the vaccine.


Latex allergy claims have long been held compensable in workers' compensation courts throughout the country. The original claims arose out of exposure to latex protein in gloves that came into use as a result of the AIDS epidemic.


A case of latex allergy reaction has been reported in Australia during a vaccination program. While the vaccine and the vial are supposedly latex free, the packing material may not be, and that may have trigger the reaction.  One in 100 people are thought to have an allergy to latex. 


Reactions to latex may be mild or transitory or may be a permanent sensitization causing hives, shortness of breath, total disability and possible death.


For more articles on Workers' Compensation and the Flu Pandemic click here. 


To read more about compensable latex allergy claims click here.

Thursday, October 29, 2009

NIOSH: H1N1 Flu Is A Serious Risk to Healthcare Workers

The National Institute for Occupational Safety and Health (NIOSH) has declared that 2009 H1N1 Influenza poses a serious risk for healthcare personnel. With at least 4 deaths of nurses being reported in the media, NIOSH has stepped up its efforts to gather and analyze the prevalence of illness and fatalities among health workers.

"Healthcare personnel are at increased risk of occupational exposure to the 2009 H1N1 virus based on their likelihood for encountering patients with 2009 H1N1 illness. In contrast to seasonal influenza virus, 2009 H1N1 influenza virus has caused a greater relative burden of disease in younger people, which includes those in the age range of most healthcare personnel. For some healthcare personnel, this higher risk of exposure and illness may be compounded by the presence of underlying illness which places them at higher risk of serious flu complications, such as asthma, diabetes, or neuromuscular disease. Of particular concern to the healthcare workforce, which is largely female, is the fact that pregnant women are among those groups considered to be at higher risk of severe infection from 2009 H1N1."

Wednesday, July 14, 2010

Comp Maybe Going Viral in Florida Over Dengue Fever


The Workers' Compensation in Florida may be in for yet another assault of claims as dengue virus rages from Ket West spreading north.  The Centers for Disease Control has now issued yet another report and alert concerning this wide spread viral condition. 
Viruses have, historically,  been a problematic challenge to the Workers' Compensation systems. Last flu season the government Federalized the flu compensation program. As this virus spreads, especially with the challenge of the Gulf Oil spill on the compensation system, the State of Florida will need to gear up to operationalize a response.
An estimated 5 percent of the Key West, Fla., population—over 1,000 people—showed evidence of recent exposure to dengue virus in 2009, according to a report from the Centers for Disease Control and Prevention (CDC) and the Florida Department of Health.
After three initial locally acquired cases of dengue were reported in 2009, scientists from the CDC and the Florida Department of Health conducted a study to estimate the potential exposure of the Key West population to dengue virus.
Dengue is the most common virus transmitted by mosquitoes in the world. It causes an estimated 50 million-100 million infections and 25,000 deaths each year. From 1946 to 1980, no cases of dengue acquired in the continental United States were reported, and there has not been an outbreak in Florida since 1934.
"We're concerned that if dengue gains a foothold in Key West, it will travel to other southern cities where the mosquito that transmits dengue is present, like Miami," said Harold Margolis, chief of the dengue branch at CDC. "The mosquito that transmits dengue likes to bite in and around houses, during the day and at night when the lights are on. To protect you and your family, CDC recommends using repellent on your skin while indoors or out. And when possible, wear long sleeves and pants for additional protection."
Since 1980, a few locally acquired U.S. cases have been confirmed along the Texas-Mexico border, which coincided with large outbreaks in neighboring Mexican cities. In recent years, there has been an increase in epidemic dengue in the tropics and subtropics, including Puerto Rico.
"These cases represent the reemergence of dengue fever in Florida and elsewhere in the United States after 75 years," Margolis said. "These people had not travelled outside of Florida, so we need to determine if these cases are an isolated occurrence or if dengue has once again become endemic in the continental United States."

Thursday, May 7, 2009

OSHA Head Announces Strategy To Protect American Workers From Flu Pandemic

Testifying before the US Congress, Jordan Barab, Acting Assistant Secretary for Occupational Safety and Health (OSHA), declared that the agency had a strategy for protecting American workers. He declared that, "The full range of OSHA’s training, education, enforcement, and public outreach programs will be used to help employers and workers protect themselves at work."


Barab further stated, " ....addressing an influenza pandemic that threatens the workplaces of this nation, we are confronting an unprecedented hazard. In OSHA’s 38-year history, America has never experienced a flu pandemic. However, I would characterize this situation for the workforce just as the President has described it for the nation: “Cause for deep concern, but not panic.” I am very confident in the expertise of OSHA’s medical, scientific, compliance assistance and enforcement personnel. OSHA is prepared to address this threat and we will protect our workforce. I will keep you informed about OSHA efforts to protect America’s working men and women from pandemic flu exposure."

Friday, September 19, 2014

Definitions of health care personnel groups for National Healthcare Safety Network reporting — United States, 2013–14 influenza season

The Advisory Committee on Immunization Practices recommends annual influenza vaccination for all health care personnel (HCP) to reduce influenza-related morbidity and mortality in health care settings.
What is added by this report?
Nationally, 81.8% of HCP included in National Healthcare Safety Network data were reported as receiving influenza vaccination during the 2013–14 influenza season. Reported proportion of HCP vaccinated was highest among employees (86.1%) and...
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* The American Hospital Association defines community hospitals as all nonfederal, short-term general, and other special hospitals (including obstetrics and gynecology; eye, ear, nose, and throat; rehabilitation; orthopedic; and other individually described specialty services) accessible by the general public.
† Data for the 2012–13 season will not be published by CDC or CMS because reporting was required beginning January 1, 2013; therefore, reported data for 2012–13 might not cover the entire influenza season.
§ Estimates of influenza vaccination coverage among health care personnel working in settings other than acute care hospitals can be obtained for selected states via the optional industry and occupation module of the Behavioral Risk Factor Surveillance System (BRFSS). This module was implemented in the 2013 BRFSS survey; module questions are available at http://www.cdc.gov/brfss/questionnaires/pdf-ques/2013%20brfss_english.pdf.
What is already known on this topic?

Monday, November 16, 2009

Sick Leave Pay Law For H1N1 Advances

US Senator Chris Dodd (D-CT) has announced that he is preparing legislation to pay sick workers 7 days of sick leave for H1N1 flu. While workers' compensation benefits may be paid to disabled H1N1 flu workers, the threat of delay and denial has created an emergency that Senator Dodd indicates requires immediate Congressional attention. 


“This isn’t just a workers’ rights issue – it’s a public health emergency. Families shouldn’t have to choose between staying healthy and making ends meet,” said Dodd. “But if staying home means you don’t get paid, that’s an impossibility, especially for families struggling to make ends meet in this tough economy.”



“Workers should have paid sick leave as a matter of basic fairness,” Dodd continued. “But now sick leave is a matter of keeping Americans safe from this pandemic – and from the next one, whatever it may be.”




He said, "It’s a matter of fairness for workers. It’s a matter of safety."


The CDC reports that H1N1 flu is now widespread in 48 states and may have infected as many as 5.7 million Americans. Fatalities amount to 672 Americans, which includes 129 children.




Wednesday, May 6, 2009

California Workers Compensation Fund Alerts Employers and Employees as to Flu

The California Workers' Compensation Fund has taken the initiative of alerting employers and employees as to preventative measures that should be taken to prevent the spread of Swine Flu. 

"To protect California workers and businesses, State Fund advises employers to educate their employees about swine flu facts, symptoms, and preventative measures and to prepare their business operations should a pandemic outbreak significantly reduce their workforce or disrupt their business operation. "

As of today there are 403 reported cases and one death according to the CDC. Numbers are expected to rise as testing has now been shifted from the CDC to the States. California has 49 reported cases.

The novel influenza outbreak (H1N1) has given rise to concern on the impact what a pandemic would cause. The Department of Homeland Security has posted information that workers' compensation programs would probably become involved in responding to the emergency. NIOSH has issued an alert concerning the impact upon psychological and social workers comparing a potential pandemic to the 911 tragedy.




US Congress to Hold Hearing on Helping Schools and Workplaces Prepare For Flu Virus

Taking urgent actions in light of the threat of a pandemic, The Hon. George Miller, Chairman of the Committee on Education and Labor has scheduled a hearing this week.

On Thursday, May 7, the Committee will hold a hearing to examine how federal agencies can help child care, schools, colleges and workplaces prepare for the H1N1 flu virus and future pandemics. The hearing will also provide an update on how schools and workplaces are being affected by and responding to the current outbreak.

WHAT: Hearing on “Ensuring Preparedness Against the Flu Virus at School and Work"

WHO:
Jordan Barab, Acting Assistant Secretary, Occupational Safety and Health Administration, Washington, DC

Ann Brockhaus, Occupational Safety and Health Consultant, ORC Worldwide, Washington, DC

Jack O'Connell, Superintendent of Public Instruction, California Department of Education, Sacramento, CA

Miguel Garcia, Registered Nurse and member, American Federation of State, County and Municipal Employees, Los Angeles, CA

Bill Modzeleski, Associate Assistant Deputy Secretary, Office of Safe and Drug-Free Schools, Department of Education, Washington, DC

Dr. Anne Schuchat, Deputy Director for Science and Program (Interim), Centers for Disease Control, Atlanta, GA

WHEN: Thursday, May 7, 2009 10:00 a.m. ET
Please check the Committee schedule for potential updates »

WHERE: House Education and Labor Committee Hearing Room 2175 Rayburn House Office Building Washington, D.C.

Wednesday, October 14, 2009

CDC Issues H1N1 Flu Guidance to Healthcare Personnel-"stay home"



In an urgent need to protect healthcare workers from H1N1 Flu, the today CDC has issued guidance on infection control measures to prevent transmission of 2009 H1N1 influenza in healthcare facilities. The CDC continues to recommend that healthcare workers take time away from work if they are ill. The issue unanswered is whether workers' compensation insurance will pay temporary disability benefits for the absence?


The CDC has defined healthcare personnel as, "....For the purposes of this guidance, healthcare personnel are defined as all persons whose occupational activities involve contact with patients or contaminated material in a healthcare, home healthcare, or clinical laboratory setting. Healthcare personnel are engaged in a range of occupations, many of which include patient contact even though they do not involve direct provision of patient care, such as dietary and housekeeping services. This guidance applies to healthcare personnel working in the following settings:  acute care hospitals, nursing homes, skilled nursing facilities, physician’s offices, urgent care centers, outpatient clinics, and home healthcare agencies.  It also includes those working in clinical settings within non-healthcare institutions, such as school nurses or personnel staffing clinics in correctional facilities. The term “healthcare personnel” includes not only employees of the organization or agency, but also contractors, clinicians, volunteers, students, trainees, clergy, and others who may come in contact with patients."



    Healthcare personnel who develop a fever and respiratory symptoms should be:
    • Instructed not to report to work, or if at work, to promptly notify their supervisor and infection control personnel/occupational health.
    • Excluded from work for at least 24 hours after they no longer have a fever, without the use of fever-reducing medicines.



For more articles on Workers' Compensation and the Flu Pandemic click here.

Friday, July 10, 2015

FDA Strengthens NSAIDs Warnings: Chance of Heart Attack & Stroke

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. 

Based on the FDA's comprehensive review of new safety information, it is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

Based on the FDA's review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:


  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.


It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

There is an increased risk of heart failure with NSAID use.

In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class.
Patients and health care professionals should remain alert for heart-related side effects the
entire time that NSAIDs are being taken. The FDA urges you to report side effects involving
NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA”
box at the bottom of the page.

Facts about non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
• NSAIDs are a class of medicines available by prescription and over-the-counter
(OTC). They are some of the most commonly used pain medicines.
• NSAIDs are used to treat pain and fever from medical conditions such as arthritis,
menstrual cramps, headaches, colds, and the flu.
• Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.
See Table 1 for a list of non-aspirin NSAIDs.
Additional Information for Patients and Consumers
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance
of a heart attack or stroke, either of which can lead to death. There are a large
number of studies that support this finding, with varying estimates of how much
the risk is increased, depending on the drugs and the doses studied. These serious
side effects can occur as early as the first weeks of using an NSAID and the risk
may increase the longer you are taking an NSAID.
• The risk appears greater at higher doses; use the lowest effective amount for the
shortest possible time.
• Seek medical attention immediately if you experience symptoms such as:
• Chest pain
• Shortness of breath or trouble breathing
• Sudden weakness or numbness in one part or side of the body
• Sudden slurred speech
• Many medicines contain NSAIDs, including those used for colds, flu, and sleep,
so it is important to read the labels and avoid taking multiple medicines that
contain NSAIDs.
• Patients who take low-dose aspirin for protection against heart attack and stroke
should know that some NSAIDs, including those in over-the-counter (OTC)
products such as ibuprofen and naproxen, can interfere with that protective effect.
• Read the patient Medication Guide you receive with your NSAID prescription. It
explains the risks associated with the use of the medicine. You may access
Medication Guides by clicking on this link.
• Read the Drug Facts label before taking an OTC NSAID. Talk to your health care
professional or pharmacist if you have questions or concerns about NSAIDs or
which medicines contain them.
• Report side effects from NSAIDs to the FDA MedWatch program, using the
information in the "Contact FDA" box at the bottom of this page.
Additional Information for Health Care Professionals
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased
risk of serious cardiovascular thrombotic events, including myocardial infarction
and stroke, either of which can be fatal. There are a large number of studies that
support this finding, with varying estimates of how much the risk is increased.
Estimates of increased risk range from 10 percent to 50 percent or more,
depending on the drugs and the doses studied. This risk may occur as early as the
first weeks of treatment and may increase with duration of use.
• Remain alert for the development of cardiovascular adverse events throughout the
patient’s entire treatment course, even in the absence of previous cardiovascular
symptoms.
• Inform patients to seek medical attention immediately if they experience
symptoms of heart attack or stroke such as chest pain, shortness of breath or
trouble breathing, sudden weakness or numbness in one part or side of the body,
or sudden slurred speech.
• Encourage patients to read the Medication Guide for prescription NSAIDs and the
Drug Facts label for over-the-counter (OTC) NSAIDs.
• Based on available data, it is unclear whether the risk for cardiovascular
thrombotic events is similar for all non-aspirin NSAIDs.
• The increase in cardiovascular thrombotic risk has been observed most
consistently at higher doses.
• The relative increase in serious cardiovascular thrombotic events over baseline
conferred by NSAID use appears to be similar in those with and without known 
cardiovascular disease or risk factors for cardiovascular disease. However,
patients with known cardiovascular disease or risk factors had a higher absolute
incidence of serious cardiovascular thrombotic events due to their increased
baseline rate.
• To minimize the risk for an adverse cardiovascular event in patients treated with
an NSAID, prescribe the lowest effective dose for the shortest duration possible.
• Some NSAIDs, including those in OTC products such as ibuprofen and naproxen,
can interfere with the antiplatelet action of low dose aspirin used for
cardioprotection by blocking aspirin’s irreversible COX-1 inhibition.
• Report adverse events involving NSAIDs to the FDA MedWatch program, using
the information in the "Contact FDA" box at the bottom of this page.

Data Summary
FDA reviewed a meta-analysis of randomized clinical trials of cardiovascular and upper
gastrointestinal events with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs),
conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration of the
Clinical Trial Service and Epidemiological Studies Units at Oxford University.2

We also reviewed observational studies and other scientific publications in the medical literature.1

The findings of these studies were discussed at a joint meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee held on
February 10-11, 2014 (for complete safety reviews, background information, and minutes
of this meeting, click here).

Based on the FDA's  comprehensive review and the recommendations from the advisory committees, we are requiring label changes to reflect the following conclusions:
• A large number of studies support the finding that NSAIDs cause an increased
risk of serious cardiovascular thrombotic events, with varying estimates of how
much the risk is increased. Estimates of increased relative risk range from 10
percent to 50 percent or more, depending on the drugs and the doses studied.
• Several observational studies found a significant cardiovascular risk within days
to weeks of NSAID initiation. Some data also showed a higher risk with longer
NSAID treatment.
• There are observational data indicating that the thrombotic cardiovascular risk
from NSAID use is dose-related. There is also some evidence of this doseresponse
effect from clinical trials of celecoxib.
• Some observational studies and the CNT meta-analysis suggested that naproxen
may have a lower risk for cardiovascular thrombotic events compared to the other
NSAIDs; however, the observational studies and the indirect comparisons used in
the meta-analysis to assess the risk of the nonselective NSAIDs have limitations
that affect their interpretability. The variability in patients’ risk factors,
comorbidities, concomitant medications and drug interactions, doses being used,
duration of treatment, etc., also need to be taken into consideration to make valid 
comparisons. Importantly, these studies were not designed to demonstrate
superior safety of one NSAID compared to another.
• There is evidence of an increased cardiovascular risk from NSAID use by
apparently healthy patients. Data from the CNT meta-analysis, individual
randomized controlled trials, and observational studies showed that the relative
increase in cardiovascular thrombotic events over baseline conferred by NSAID
use appears to be similar in those with and without known cardiovascular disease
or risk factors for cardiovascular disease. However, patients with known
cardiovascular disease or risk factors had a higher absolute incidence of excess
cardiovascular thrombotic events due to their increased baseline rate.
• The CNT meta-analysis demonstrated an approximately two-fold increase in
hospitalizations for heart failure with use of both COX-2 selective and
nonselective NSAIDs. In a Danish National Registry study of patients with heart
failure, NSAID use increased the risk of myocardial infarction, hospitalization for
heart failure, and death.
The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen
or Naproxen (PRECISION) trial, is a large, ongoing randomized safety trial comparing
cardiovascular event rates among patients with high cardiovascular risk who are
randomized to celecoxib, naproxen, or ibuprofen. This trial was also discussed at the
February 2014 Advisory Committee meeting and is expected to provide additional safety
information. 

Table 1. List of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
Generic name Brand name(s)

  • celecoxib Celebrex
  • diclofenac Cambia, Cataflam, Dyloject, Flector,
  • Pennsaid, Solaraze, Voltaren, Voltaren-XR,
  • Zipsor, Zorvolex, Arthrotec (combination
  • with misoprostol)
  • diflunisal No brand name currently marketed
  • etodolac No brand name currently marketed
  • fenoprofen Nalfon
  • flurbiprofen Ansaid
  • ibuprofen* Advil, Caldolor, Children’s Advil,
  • Children’s Elixsure IB, Children’s Motrin,
  • Ibu-Tab, Ibuprohm, Motrin IB, Motrin
  • Migraine Pain, Profen, Tab-Profen, Duexis
  • (combination with famotidine), Reprexain
  • (combination with hydrocodone),
  • Vicoprofen (combination with
  • hydrocodone)
  • indomethacin Indocin, Tivorbex
  • ketoprofen No brand name currently marketed
  • ketorolac Sprix
  • mefenamic acid Ponstel
  • meloxicam Mobic
  • nabumetone No brand name currently marketed
  • naproxen* Aleve, Anaprox, Anaprox DS, ECNaprosyn,
  • Naprelan, Naprosyn, Treximet
  • (combination with sumatriptan), Vimovo
  • (combination with esomeprazole)
  • oxaprozin Daypro
  • piroxicam Feldene
  • sulindac Clinoril
  • tolmetin No brand name currently marketed *There are many over-the-counter (OTC) products that contain this medicine.

References

1. Food and Drug Administration [Internet]. Silver Spring, MD. FDA Briefing
Information for the February 10-11, 2014 Joint Meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee. Available
from:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM383180.pdf. Accessed December 23, 2014.

….

Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.