Coverage Under the Public Readiness and Emergency Preparedness (PREP) Act for H1N1 Vaccination
What is the PREP Act?
The Public Readiness and Emergency Preparedness Act or PREP Act is a federal law that authorizes the Secretary of Health and Human Services to issue a declaration to provide tort liability immunity (except for willful misconduct) to individuals and organizations involved in the development, manufacture, distribution, administration and use of countermeasures against pandemics, epidemics and diseases and health threats caused by chemical, biological, radiological, or nuclear agents of terrorism.
How does the PREP Act work?
On June 15, 2009, Secretary of Health and Human Services Kathleen Sebelius extended the PREP Act declaration for pandemic vaccines to H1N1 vaccines, and amended the declaration on (date) to add provisions that can help H1N1vaccination campaigns.
What is tort liability immunity?
Tort liability immunity means that no legal tort claim related to activities described in the declaration that can be pursued in State or U.S. Federal court. The declaration provides legal liability protections for individuals or entities that are involved in the distribution and administration of H1N1 vaccine.
Who is immune from tort liability under H1N1 vaccine declaration?
The H1N1 vaccine declaration provides tort liability immunity to a group named “program planners.” Program planners include State and local governments, Tribes, other entities that supervise or administer a vaccination program, establish requirements, provide policy guidance, supply technical or scientific advice or assistance, or provide a facility to administer the vaccine. Program planners can include private sector individuals and organizations, community groups, schools, or businesses.
Government program planners only have tort liability immunity when the vaccines are provided to them voluntarily, such as when Federal Government provides vaccines from Federal stockpiles, or when the vaccines are donated or sold.
The H1N1 vaccine declaration also provides tort liability immunity to a group named “qualified persons.” Qualified persons include healthcare professionals or others authorized under State law to prescribe, administer, and dispense vaccines.
The declaration also provides tort liability immunity to individuals or organizations that assist public officials with vaccination programs, even if they are not licensed healthcare professionals. Qualified persons also include individuals or organizations (including their officials, agents, employees, contractors and volunteers) that are part of the public health and medical emergency response of the “Authority Having Jurisdiction” for prescribing, administering, delivering, distributing, or dispensing the vaccine following a declaration of emergency issued by a federal, regional, State, or local official. The “Authority Having Jurisdiction” is the public agency or entity or its delegate with legal responsibility and authority to respond to the incident. These qualified persons can include any public or private person, entity, or organization – such as local businesses, community groups and volunteer groups -- and their officials, agents, employees, contractors and volunteers, assisting in carrying out vaccine programs under agreements, plans, protocols, procedures, policies or other arrangements with any State, local or other public agency or its delegate that has legal responsibility and authority for public health and medical response. The Acting HHS Secretary’s April 26 declaration of nationwide public health emergency caused by H1N1, which was renewed by the HHS Secretary on July 24, can be used by “Authorities Having Jurisdiction” to begin their public health and medical response.
The H1N1 vaccine declaration also provides tort liability immunity to the United States, to vaccine manufacturers, and vaccine distributors.
Officials, agents, and employees of program planners, qualified persons, the United States, manufacturers, and distributors are also immune from tort liability.
Which vaccines are covered under the H1N1 vaccine declaration?
All of the H1N1 vaccine procured by the Department of Health and Human Services and distributed to the states is covered by the declaration.
Vaccines are covered only when they are administered and used as 1) licensed or approved by the Food and Drug Administration (FDA); 2) authorized for investigational use by the FDA; or 3) authorized under an Emergency Use Authorization (EUA) by the FDA. On September 15, 2008, the FDA approved four vaccines against H1N1 that are covered by the declaration.
What tort claims are prevented by the H1N1 vaccine declaration?
The declaration prevents tort liability claims under U.S. Federal law and State law (except for willful misconduct) for losses caused by, arising out of, relating to, or resulting from administration or use by any individual of the vaccine, including any claim with a causal relationship to any stage of development, distribution, dispensing, prescribing, administration or use of the vaccine.
Types of loss include death; physical, mental, or emotional injury, illness, disability or condition; fear of physical, mental, or emotional injury illness, disability, or condition, including any need for medical monitoring; and loss of or damage to property, including business interruption. In addition, by defining “administration” to include “delivery, distribution, and dispensing activities... and management and operation of distribution and dispensing locations” the H1N1 vaccine declaration clarifies that “slip and fall” types of claims are also covered, not just injuries and illnesses arising from actually receiving the vaccine.
What types of claims are not prevented by the H1N1 vaccine declaration?
The declaration does not prevent claims for willful misconduct. Willful misconduct is a term used in the PREP Act, and is beyond any standard of negligence or recklessness. Willful misconduct does not include acts or omissions by program planners and qualified persons who act consistently with the declarations, as long as they notify HHS or a State or local health authority within seven days of discovering any serious physical injury or death from the administration or use of the countermeasure.
The declaration also does not prevent other types of claims, such as claims for negligence in providing medical care unrelated to vaccine administration and use, claims brought under foreign law, or claims for civil rights or labor law violations.
What compensation is available for vaccine injuries?
The U.S. Department of Health and Human Services is establishing a Countermeasures Injury Compensation Program for H1N1 vaccines. Under this program, compensation may be available to eligible individuals who suffer serious physical injuries or death from administration of the vaccine under the declarations. Eligibility, and the types of injuries for which compensation may be available, will be defined by regulations. Compensation can include medical benefits, lost wages and death benefits.
Where can I go for more information?
For a copy of the PREP Act declaration for H1N1 vaccines, please go to: http://edocket.access.gpo.gov/2009/E9-14948.htm.
For more information about PREP Act liability protections, please go to http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html.
For more information about PREP Act Countermeasure Injury Compensation Program, please go to http://www.hrsa.gov/countermeasurescomp/default.htm.
For more information about the H1N1 vaccines approved by FDA, please go to http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm
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Friday, October 30, 2009
Governnor issues Executive Order
FOR IMMEDIATE RELEASE:
October 29, 2009
GOVERNOR PATERSON ISSUES EXECUTIVE ORDER TO ASSIST LOCAL GOVERNMENTS WITH STATEWIDE H1N1 VACCINATION CAMPAIGN
Governor’s State Disaster Emergency Declaration Together with President Obama’s
National Emergency Declaration Provide Increased Flexibility to Local Health Departments and Hospitals to Respond to H1N1 Flu
In response to requests for assistance from local governments across New York State including New York City, Governor David A. Paterson today issued Executive Order 29 declaring a State Disaster Emergency, which will provide additional personnel and flexibility to local governments as they work to implement a statewide vaccination campaign to protect New Yorkers from H1N1 influenza.
“The nationwide H1N1 vaccination campaign represents the first time in 33 years that the United States has attempted to conduct a mass vaccination campaign of this proportion for influenza,” Governor Paterson said. “Local governments are reporting that the current public health workforce is not sufficient to thoroughly execute a vaccination campaign of this magnitude. Those local governments and health care providers specifically requested that we issue this emergency declaration to give them flexibility to use additional personnel and resources in New York’s vaccination campaign.”
Under existing law, physicians, certified nurse practitioners and nurses may administer vaccinations. The Governor’s Executive Order will suspend Section 6902 of the Education Law to permit other health care workers – including physician and specialist assistants, pharmacists, dentists, certain dental hygienists, midwives and emergency medical personnel – to administer vaccinations after they receive training. They will work under the direction of the State or county health departments as part of their sponsored mass vaccination clinics.
To assure local governments’ ability to immunize in the school setting, the Executive Order also authorizes school-based health centers to vaccinate adults and children, and allows hospitals to operate part-time immunization clinics on school campuses.
Governor Paterson’s declaration follows the announcement on Saturday that President Barack Obama has declared a National Emergency related to H1N1 flu. With the President’s declaration in place, the federal government is permitted to waive specific hospital-related legal requirements – allowing hospitals to implement procedures in their emergency disaster plans that allow them to increase their ability, or surge capacity, to triage, treat and care for increased numbers of persons with the flu.
“I commend President Obama for declaring H1N1 a national emergency,” the Governor added. “By doing so, he is providing much-needed federal assistance to states as we respond to this influenza pandemic. Lifting certain legal health care requirements at both the federal and state levels will give local governments and health care facilities the support they need to effectively respond to an influenza pandemic of this magnitude.”
H1N1 flu activity is now considered widespread in New York, with more than 50 percent of counties reporting flu activity. Currently, vaccination in New York and all other states is hindered by a nationwide shortage of the H1N1 flu vaccine due to unexpected delays in vaccine production, according to the federal Centers for Disease Control and Prevention (CDC). The President’s declaration does not increase the pace at which the H1N1 vaccine will become available to the public.
“The next few weeks are critical to countering this H1N1 pandemic,” the Governor said. “While we cannot do anything about the current vaccine shortage, we are doing everything we can to ensure that public health officials around the State can mobilize and vaccinate New Yorkers as more vaccine becomes available. My Executive Order will not only give State and local authorities more access to professionals authorized to administer vaccinations, but it will help significantly increase the number of vaccinators in areas of the State that need them the most.”
Approximately 10 million New Yorkers fall into the priority groups established by the CDC for H1N1 vaccination, including 4.3 million in New York City alone. So far, 460,300 doses of the H1N1 vaccine – the total available to date from the CDC -- have been distributed to clinical sites in New York State outside of New York City, including hospitals, community health centers, physician offices, colleges and universities, and county health departments. Distribution of vaccine within New York City is coordinated by the New York City Department of Health and Mental Hygiene.
The priority groups established by CDC to receive the H1N1 influenza vaccine are:
Pregnant women, who experience four times the rate of hospitalization and six times the rate of death from H1N1 flu compared to the general population;
Persons who live with or provide care for infants under six months of age (infants under 6 months cannot be vaccinated);
Children and young people ages 6 months through 24 years;
Persons age 25 through 64 years old who have medical conditions that put them at higher risk for serious illness and influenza-related complications, including cancer, blood disorders, chronic lung disease (including asthma or heart disease), diabetes, heart disease, kidney disorders, liver disorders, neurological disorders neuromuscular disorders and weakened immune systems; and
Health care workers and emergency medical services personnel.
Due to shortages of both H1N1 and seasonal flu vaccine, Governor Paterson announced last week that State Health Commissioner Richard F. Daines, M.D., has suspended the State Health Department’s requirement that health care workers in certain facilities be vaccinated against the flu.
“The vaccination of health care workers continues to be an important patient safety measure, and I urge hospitals and other health care facilities to continue to encourage employees to be vaccinated against the flu,” Commissioner Daines said. “But with available vaccine in New York State far below the CDC’s original projections, we are adapting to this change in supply so that vaccines can be made available first to individuals in groups at highest risk for serious illness and death.”
With this declaration of a State Disaster Emergency, New York joins nine other states that have already taken emergency action or are in the process of declaring a public health emergency related to the H1N1 outbreak during this fall influenza season. Governor Paterson noted that it is within his power to declare an emergency by Executive Order when a current or imminent threat to public safety hinders local governments’ ability to respond adequately.
Additional information about seasonal and H1N1 flu, including educational resources and direct links to CDC’s website, is available on the New York State Department of Health’s website at www.nyhealth.gov.
--------------------------------------------------------------------------------
October 29, 2009
GOVERNOR PATERSON ISSUES EXECUTIVE ORDER TO ASSIST LOCAL GOVERNMENTS WITH STATEWIDE H1N1 VACCINATION CAMPAIGN
Governor’s State Disaster Emergency Declaration Together with President Obama’s
National Emergency Declaration Provide Increased Flexibility to Local Health Departments and Hospitals to Respond to H1N1 Flu
In response to requests for assistance from local governments across New York State including New York City, Governor David A. Paterson today issued Executive Order 29 declaring a State Disaster Emergency, which will provide additional personnel and flexibility to local governments as they work to implement a statewide vaccination campaign to protect New Yorkers from H1N1 influenza.
“The nationwide H1N1 vaccination campaign represents the first time in 33 years that the United States has attempted to conduct a mass vaccination campaign of this proportion for influenza,” Governor Paterson said. “Local governments are reporting that the current public health workforce is not sufficient to thoroughly execute a vaccination campaign of this magnitude. Those local governments and health care providers specifically requested that we issue this emergency declaration to give them flexibility to use additional personnel and resources in New York’s vaccination campaign.”
Under existing law, physicians, certified nurse practitioners and nurses may administer vaccinations. The Governor’s Executive Order will suspend Section 6902 of the Education Law to permit other health care workers – including physician and specialist assistants, pharmacists, dentists, certain dental hygienists, midwives and emergency medical personnel – to administer vaccinations after they receive training. They will work under the direction of the State or county health departments as part of their sponsored mass vaccination clinics.
To assure local governments’ ability to immunize in the school setting, the Executive Order also authorizes school-based health centers to vaccinate adults and children, and allows hospitals to operate part-time immunization clinics on school campuses.
Governor Paterson’s declaration follows the announcement on Saturday that President Barack Obama has declared a National Emergency related to H1N1 flu. With the President’s declaration in place, the federal government is permitted to waive specific hospital-related legal requirements – allowing hospitals to implement procedures in their emergency disaster plans that allow them to increase their ability, or surge capacity, to triage, treat and care for increased numbers of persons with the flu.
“I commend President Obama for declaring H1N1 a national emergency,” the Governor added. “By doing so, he is providing much-needed federal assistance to states as we respond to this influenza pandemic. Lifting certain legal health care requirements at both the federal and state levels will give local governments and health care facilities the support they need to effectively respond to an influenza pandemic of this magnitude.”
H1N1 flu activity is now considered widespread in New York, with more than 50 percent of counties reporting flu activity. Currently, vaccination in New York and all other states is hindered by a nationwide shortage of the H1N1 flu vaccine due to unexpected delays in vaccine production, according to the federal Centers for Disease Control and Prevention (CDC). The President’s declaration does not increase the pace at which the H1N1 vaccine will become available to the public.
“The next few weeks are critical to countering this H1N1 pandemic,” the Governor said. “While we cannot do anything about the current vaccine shortage, we are doing everything we can to ensure that public health officials around the State can mobilize and vaccinate New Yorkers as more vaccine becomes available. My Executive Order will not only give State and local authorities more access to professionals authorized to administer vaccinations, but it will help significantly increase the number of vaccinators in areas of the State that need them the most.”
Approximately 10 million New Yorkers fall into the priority groups established by the CDC for H1N1 vaccination, including 4.3 million in New York City alone. So far, 460,300 doses of the H1N1 vaccine – the total available to date from the CDC -- have been distributed to clinical sites in New York State outside of New York City, including hospitals, community health centers, physician offices, colleges and universities, and county health departments. Distribution of vaccine within New York City is coordinated by the New York City Department of Health and Mental Hygiene.
The priority groups established by CDC to receive the H1N1 influenza vaccine are:
Pregnant women, who experience four times the rate of hospitalization and six times the rate of death from H1N1 flu compared to the general population;
Persons who live with or provide care for infants under six months of age (infants under 6 months cannot be vaccinated);
Children and young people ages 6 months through 24 years;
Persons age 25 through 64 years old who have medical conditions that put them at higher risk for serious illness and influenza-related complications, including cancer, blood disorders, chronic lung disease (including asthma or heart disease), diabetes, heart disease, kidney disorders, liver disorders, neurological disorders neuromuscular disorders and weakened immune systems; and
Health care workers and emergency medical services personnel.
Due to shortages of both H1N1 and seasonal flu vaccine, Governor Paterson announced last week that State Health Commissioner Richard F. Daines, M.D., has suspended the State Health Department’s requirement that health care workers in certain facilities be vaccinated against the flu.
“The vaccination of health care workers continues to be an important patient safety measure, and I urge hospitals and other health care facilities to continue to encourage employees to be vaccinated against the flu,” Commissioner Daines said. “But with available vaccine in New York State far below the CDC’s original projections, we are adapting to this change in supply so that vaccines can be made available first to individuals in groups at highest risk for serious illness and death.”
With this declaration of a State Disaster Emergency, New York joins nine other states that have already taken emergency action or are in the process of declaring a public health emergency related to the H1N1 outbreak during this fall influenza season. Governor Paterson noted that it is within his power to declare an emergency by Executive Order when a current or imminent threat to public safety hinders local governments’ ability to respond adequately.
Additional information about seasonal and H1N1 flu, including educational resources and direct links to CDC’s website, is available on the New York State Department of Health’s website at www.nyhealth.gov.
--------------------------------------------------------------------------------
QOD
Which one of the following types of viruses is the leading cause of epidemics of gastroenteritis?
A.
Adenoviruses.
B.
Noroviruses.
C.
Norwalk viruses.
D.
Rotaviruses
The Norwalk agent was the first virus that was identified as causing gastroenteritis in humans, but recognition of its importance as a pathogen has been limited because of the lack of available, sensitive, and routine diagnostic methods. Recent advances in understanding the molecular biology of the noroviruses, coupled with applications of novel diagnostic techniques, have radically altered our appreciation of their impact. Noroviruses are now recognized as being the leading cause of epidemics of gastroenteritis and an important cause of sporadic gastroenteritis in both children and adults. Although norovirus gastroenteritis is generally mild and of short duration, new evidence suggests that the illness can be severe and sometimes fatal, especially among vulnerable populations — young children and the elderly — and is a common cause of hospitalization for gastroenteritis. Routine diagnostic methods are still unavailable to most clinicians, but epidemiologic studies have identified both rapid local transmission and the emergence of novel norovirus strains that spread in a global fashion, similar to the epochal patterns of influenza. Controlling outbreaks of norovirus poses major challenges.
Answer: B
A.
Adenoviruses.
B.
Noroviruses.
C.
Norwalk viruses.
D.
Rotaviruses
The Norwalk agent was the first virus that was identified as causing gastroenteritis in humans, but recognition of its importance as a pathogen has been limited because of the lack of available, sensitive, and routine diagnostic methods. Recent advances in understanding the molecular biology of the noroviruses, coupled with applications of novel diagnostic techniques, have radically altered our appreciation of their impact. Noroviruses are now recognized as being the leading cause of epidemics of gastroenteritis and an important cause of sporadic gastroenteritis in both children and adults. Although norovirus gastroenteritis is generally mild and of short duration, new evidence suggests that the illness can be severe and sometimes fatal, especially among vulnerable populations — young children and the elderly — and is a common cause of hospitalization for gastroenteritis. Routine diagnostic methods are still unavailable to most clinicians, but epidemiologic studies have identified both rapid local transmission and the emergence of novel norovirus strains that spread in a global fashion, similar to the epochal patterns of influenza. Controlling outbreaks of norovirus poses major challenges.
Answer: B
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