Maine Renews Emergency Order To Fight H1N1 Flu

Governor John E. Baldacci renewed a Proclamation of Civil Emergency Due to a Highly Infectious Agent.

The original proclamation was signed on Sept. 1, with renewed proclamations signed Sept. 30 and again on Oct. 29. The proclamation enables the State to continue to respond to the potential dangers of H1N1 flu and to facilitate a statewide vaccination campaign.

The proclamation recognizes the U.S. Food and Drug Administration’s Emergency Use Authorization for the use of the antiviral medications Tamiflu and Relenza, enabling expedited distribution and dispensing of the medications to those who have H1N1.

The federal authorization enables Federally Qualified Health Centers and other people designated by the Maine Emergency Management Agency to distribute the antiviral medications in accordance with applicable law to address the H1N1 public health emergency. Federally Qualified Health Centers are therefore added to the list of entities protected from liability in combating H1N1.

School districts and other vaccination clinic participants are again protected from liability under the proclamation. The proclamation also provides immunity from tort liability for approved health care workers who administer the flu vaccines. The vaccines are voluntary.

“The impact of H1N1 in our schools and other facilities has been great,” said Governor Baldacci. “Nationwide, the federal Centers for Disease Control estimate that 22 million people have become ill with H1N1, with 98,000 people hospitalized. We need to employ every method we can to ensure that Maine people are protected. We must remain aggressive and vigilant in our prevention and response.”

The Maine Center for Disease Control, the Department of Education and the Maine Emergency Management Agency continue to coordinate and facilitate the implementation of school supported vaccine clinics for both the seasonal flu and H1N1.

On April 29, Governor Baldacci signed an executive order that activated the State’s H1N1 Response Committee, which includes the Maine Department of Health and Human Services, Maine Center for Disease Control, MEMA, the Department of Education and the Governor’s Office.

The text of the proclamation follows:

Proclamation of Civil Emergency Due to a Highly Infectious Agent

Pursuant to the authority vested in the Office of the Governor of the State of Maine, and pursuant to the relevant provisions of 37-B M.R.S.A. §§ 703, 741, 742, 743 (2) 784-A and 822, I, John Elias Baldacci, Governor of the State of Maine, renew my Proclamation of Civil Emergency dated October 29, 2009 as follows:

Background and Need
On June 11, 2009 the World Health Organization declared a global pandemic of the 2009 Influenza A (H1N1) virus and raised the pandemic alert level to Phase 6. Since the initial detection of the virus in March and April, 2009, it has rapidly spread throughout the United States and the world. The 2009 Influenza A (H1N1) virus is the predominant influenza virus in circulation worldwide and the U.S. Centers for Disease Control and Prevention (CDC) has predicted a significant increase in cases in the fall of 2009 and winter of 2010. On October 1, 2009, U.S. Department of Health and Human Services Secretary Kathleen Sebelius, acting pursuant to her authority under section 319 of the Public Health Service Act, 42 U.S.C. §247-d-6, renewed prior April 26, 2009 and July 24, 2009 Departmental determinations that a public health emergency exists nationwide involving 2009 Influenza A (H1N1) which affects or has significant potential to affect national security.

Forty-six states, including Maine, are reporting widespread influenza activity at this time. Almost all of the influenza viruses presently circulating have been identified as 2009 Influenza A (H1N1) viruses. On October 24, 2009 President Obama declared a national emergency with respect to the 2009 Influenza A (H1N1) pandemic. Manufacturing delays in the production of 2009 Influenza A (H1N1) vaccine have delayed distribution and administration of the vaccine. Although over 43 million doses of the vaccine have thus far been distributed, the vaccine shortage has required public health authorities to use a variety of countermeasures to prevent transmission of the influenza. CDC is estimating that approximately 22 million Americans have become ill with 2009 Influenza A (H1N1), 98,000 persons have been hospitalized, and up to 3,900 persons have died from the disease.

To prevent the incidence and severity of seasonal influenza and 2009 Influenza A (H1N1), the federal Centers for Disease Control and Prevention have established guidance for the vaccination of at risk populations, based upon the recommendations of the Advisory Committee on Immunization Practices. With respect to seasonal influenza, it is recommended that all children between the ages of 6 months and 19 years be vaccinated for seasonal influenza. With respect to 2009 Influenza A (H1N1), it is recommended that the entire U.S. population be vaccinated, with initial vaccination afforded to high risk groups defined by the federal Centers for Disease Control and Prevention.

Funding for the seasonal influenza vaccination is provided through the American Recovery and Reinvestment Act of 2009 and the Fund for a Healthy Maine. Funding for the 2009 Influenza A (H1N1) vaccine is provided by the federal government Several state agencies are involved in the administration of statewide seasonal influenza and 2009 Influenza A (H1N1) vaccinations. The Maine Center for Disease Control and Prevention and Maine Department of Education are organizing a statewide campaign to provide seasonal influenza and 2009 Influenza A (H1N1) vaccination to children and the general public in school based clinics and other public vaccination sites. As the 2009 Influenza A (H1N1) vaccine has become available, the Maine Center for Disease Control is coordinating and facilitating the distribution and administration of the vaccine throughout the State of Maine in accordance with the guidance of the federal Centers for Disease Control and Prevention. Vaccine production delays will necessitate an intensive effort to distribute and administer the vaccine in Maine once adequate supplies are available.

In order to assure appropriate treatment of individuals who contract the 2009 Influenza A (H1N1), the Commissioner of the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for the antiviral medications oseltamivir (Tamiflu) and zanamivir (Relenza). The Emergency Use Authorizations allow these antiviral medications to be used for 2009 Influenza A (H1N1) patients who are either symptomatic or ill enough to require hospitalization. During an emergency, normal prescribing and dispensing requirements may not be satisfied for either Tamiflu or Relenza. The EUAs issued for these antiviral medications authorize distribution or dispensing of the drugs without all of the FDA-required prescription label information, such as patient’s name, prescribing physician’s name, and date of dispensing. The EUAs also authorize public health officials to distribute Tamiflu and Relenza in accordance with applicable law to address the 2009 Influenza A (H1N1) public health emergency.

Recently, the U.S. Department of Health and Human Services has authorized the distribution of Tamiflu and Relenza from the Strategic National Stockpile to State public health departments to facilitate treatment for individuals afflicted with the 2009 Influenza A (H1N1). On October 31, 2009, the Maine Center for Disease Control and Prevention issued an antiviral treatment and prophylaxis authorizing the distribution of Tamiflu and Relenza to Maine’s Federally Qualified Health Centers (FQHCs) to facilitate distribution of these antiviral medications to symptomatic individuals who fall within U.S. CDC Influenza A (H1N1) treatment guidelines. Use of the FQHCs is vital in order to assure that necessary antiviral medications are available to individuals in Maine who do not have the financial resources to purchase these medications. To address potential tort liability concerns of those Federally Qualified Health Centers which will be distributing Tamiflu and Relenza to individuals other than their patients, it is necessary to extend tort immunity to these centers in order to assure the rapid distribution of these antiviral medications to persons in need of treatment.

The availability of statewide vaccination clinics for seasonal influenza and 2009 Influenza A (H1N1) is threatened due to concerns about potential liability relating to the administration of the vaccines. These current conditions, including the imminent threat of influenza pandemic, constitute a threat to the safety and welfare of the people of the State of Maine and constitute a civil emergency or disaster within the meaning of the relevant emergency management statutes.

Mission and Scope

To respond to the current public health emergency, I order and declare the following:

A. Civil emergency is imminent, caused by the public health emergency.

B. The Department of Health and Human Services, Maine Center for Disease Control and Prevention and Maine Department of Education shall coordinate with the Department of Defense, Veterans and Emergency Management, Maine Emergency Management Agency to identify those health care workers duly licensed and authorized to administer influenza vaccines in the State of Maine who are able and available to participate in the planned vaccinations for seasonal influenza and 2009 Influenza A (H1N1).

C. The Maine Center for Disease Control, Department of Education and Maine Emergency Management Agency shall coordinate and facilitate the establishment, implementation, administration and operation of vaccination clinics in school-based settings and other publicly accessible sites in a manner consistent with the recommendations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices.

D. The relevant provisions of the Maine Pandemic Influenza Plan will be activated to facilitate the distribution and administration of seasonal influenza and 2009 Influenza A (H1N1) vaccines.

E. To the extent necessary to assure the timely provision of seasonal influenza and 2009 Influenza A (H1N1) vaccination in accordance with the guidance of the federal Centers for Disease Control and Prevention, the Maine Center for Disease Control and the Department of Education, the Maine Emergency Management Agency will exercise its authority pursuant to 37-B M.R.S.A. §784-A to designate appropriate health care workers licensed in this State and authorized to administer influenza vaccines to participate in vaccination clinics in accordance with the requirements of this Proclamation.

F. To the extent necessary to assure the timely distribution of the antiviral medications Tamiflu and Relenza to individuals considered at high risk for the H1N1 Influenza, the Maine Emergency Management Agency, upon consultation with the Maine Center for Disease Control and Prevention, will exercise its authority pursuant to 37-B M.R.S.A. §784-A to designate appropriate health care workers licensed in this State and employed by Federally Qualified Health Centers who participate in the distribution of the antiviral medications Tamiflu and Relenza to individuals in accordance with relevant Maine Center for Disease Control and Prevention treatment protocols.

G. All persons designated by the Maine Emergency Management Agency to participate in vaccine administration pursuant to Paragraph E shall, pursuant to 37-B M.R.S.A. §784-A, be deemed to be an employee of the State and entitled to immunity pursuant to 37-B M.R.S.A. §822.

H. All persons designated by the Maine Emergency Management Agency to participate in the distribution of the antiviral medications Tamiflu and Relenza pursuant to Paragraph F shall, pursuant to 37-B M.R.S.A. §784-A, be deemed an employee of the State and entitled to immunity pursuant to 37-B M.R.S.A. §822.

I. All State departments and agencies shall take whatever actions may be required and requested by the Maine Emergency Management Agency, Maine Center for Disease Control and Prevention, and Department of Education to respond to this public health emergency. A record of such actions, if any, shall be compiled and presented to me by the heads of the affected departments and agencies on a reasonable and timely basis throughout the duration of this Emergency Proclamation.

J. The Maine Center for Disease Control, the Department of Education and the Maine Emergency Management Agency shall coordinate with the federal government to secure all appropriate influenza vaccines related to this public health emergency provided for by the American Recovery and Reinvestment Act of 2009 and other federal fund

Duration

Pursuant to 37-B M.R.S.A. §743, this Emergency Proclamation shall expire thirty (30) days from the date of its signature, unless earlier rescinded by the Executive or upon joint resolution of the Legislature terminating the Emergency Proclamation, or unless extended by subsequent action of the Executive.

Given under my hand this 19th day of November, 2009.

Topics: antiviral medications, Centers for Disease Control and Prevention, Emergency Use Authorization, Federally Qualified Health Centers, flu, H1N1, health care, Health Care, infectious agent, influenza, Maine, Maine Emergency Management Agency, public health, relenza, schools, Tamiflu, U.S., U.S. Food and Administration, United States, vaccination, vaccine

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