FEDERAL HEALTH UPDATE
Aug 21, 2009Produced by Kate Connelly Theroux in collaboration with the Institute of Federal Health Care (IFHC) To subscribe, please visit http://fedhealthinst.org/subscriber.cfm. Sponsored by
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Executive and Congressional News
The grants will be funded by the American Recovery and Reinvestment Act of 2009 (ARRA) and will help health care providers qualify for new incentives that will be made available in 2010 to doctors and hospitals that meaningfully use electronic health records. The grants made available include:
The Extension Center grants will be awarded on a rolling basis, with the first awards being issued in fiscal year 2010. Grants to States will be made in fiscal year 2010. Those interested in applying for these grants may visit http://HealthIT.HHS.gov for more information. The Department of Health and Human Services also will provide additional assistance to health care providers through the Health Information Technology Research Center (HITRC). The HITRC will gather relevant information on effective practices from a wide variety of sources across the country and help the Regional Extension Centers collaborate with one another and with relevant stakeholders to identify and share best practices in EHR adoption, effective use, and provider support. More information is available within the two fact sheets: Health Information Technology Extension Program and the State Health Information Exchange Cooperative Agreement Program. Military Health Care News
This award honors outstanding female physicians who have made significant contributions to the practice of medicine and who have served as exemplary role models for other female physicians. A workgroup of senior female military leaders recommended the award as a way to recognize increasing numbers of females going into medicine and to capitalize on the opportunity to recruit and retain women in the future physician pipeline. The award will be given yearly at the MHS Conference. The deadline for nominations is 30 October 2009. A panel made up of a senior female physician leader from each service and an OSD/HA representative will meet in November 2009 to screen packages and select the winners. There will be two main categories of award winners: one junior (03-05) winner from each service and one overall MHS-wide senior (06) winner. Winners will be announced at the MHS Conference in January 2010. For more information
on this award, please go to www.health.mil/people and look under "Resources."
This award is the highest level of
recognition an ESGR Field Committee can bestow upon an employer and
is given annually to one employer in each state. Pro Patria awards
are given to employers providing the most exceptional support of national
defense through leadership practices and personnel policies supporting
their employees serving in the National Guard and Reserve. To learn
more about ESGR and this award, please visit www.esgr.mil.
Green had been the Air Force’s deputy surgeon general since August 2006. He replaced Lt. Gen. (Dr.) James G. Roudebush, who retired. Green was commissioned through the Health Professions Scholarship Program and entered active duty in 1978 after completing his Doctorate of Medicine degree at the Medical College of Wisconsin in Milwaukee. He completed residency training in family practice at Eglin Regional Hospital, Eglin AFB, Fla., in 1981, and in aerospace medicine at Brooks AFB, Texas, in 1989. He is board certified in aerospace medicine. An expert in disaster relief operations, he planned and led humanitarian relief efforts in the Philippines after the Baguio earthquake in 1990 and in support of Operation Fiery Vigil following the 1991 eruption of Mount Pinatubo. Green has served as commander of
three hospitals and Wilford Hall Medical Center. As command surgeon
for three major commands, he planned joint medical response for operations
Desert Thunder and Desert Fox, and oversaw aeromedical evacuation for
operations Enduring Freedom and Iraqi Freedom. Prior to assuming his
current position, he served as assistant surgeon general for health
care operations.
This interactive Web site, similar to the social networking site Facebook, will allow soldiers, sailors, airmen, Marines and their families to stay connected in a safe and nurturing environment surrounded by their favorite Sesame Street friends. Whether the distance between military
members and their loved ones is due to deployment or the recovery from
an injury sustained while deployed, the “Family Connections” Web
site offers young children an online environment to stay connected,
while offering tools for the entire family to aid in the recovery of
the visible and invisible wounds of combat.
Selected from nominees from more than 140 programs across the country, the 2009 CORD Resident Academic Achievement Award recognizes an emergency medicine resident who has demonstrated great potential as a future academic faculty member. Qualities that were evaluated include academic productivity, commitment to teaching and service to the program. Littlejohn's extensive work has already directly affected lifesaving technologies and training used on the battlefield and in the United States. After his arrival in residency, he contributed to a new study: Comparison of Three Hemostatic Agents; Chitoflex, Celox and QuickClot. Despite being the junior member of the multi-person research team, his contributions earned author status. This study was presented at several regional and national meetings and won the McDade Award for best emergency medicine resident research in Virginia. He immersed himself in the Trauma Combat Care Course (TCCC) and ultimately became the course director. In this position, he taught 13 classes, preparing more than 250 corpsmen for deployment to Afghanistan and Iraq. Further, he developed the TCCC Instructor Course, the first on the East Coast. Because of his innovations, his staff is rewriting the TCCC training course structure for the entire Navy and Marine Corps. Littlejohn maintains a wide range
of knowledge in emergency medicine, scoring 94th percentile on his in-training
exam. He was elected by all NMCP residents to serve on the Command Quality
Committee, and in a field of more than 250 trainees, he was named Officer
in Training of the Quarter.
The new Web site will provide quick access to those sites that are most sought by Web site visitors, including DoD social media sites, the Pentagon Channel and DoD news stories. Prominent on the new home page is
a new “We Want to Hear From You” feature that will give users the
opportunity to ask questions of DoD leaders, vote on policy issues they
want explained, and explore frequently asked questions and answers.
The new site, http://www.Defense.gov, replaces http://www.DefenseLink.mil as the department’s main Internet entry
portal. DefenseLink will remain a news Web site.
Among active-duty soldiers there were eight potential suicides in July. In June, the Army reported no confirmed suicides and nine potential suicides among active-duty soldiers. Since the June report, four of the nine potential suicides have been confirmed and five remain under investigation. There have been 96 reported active-duty Army suicides during the period Jan. 1 to July 31, 2009. Of these, 62 have been confirmed, and 34 are pending determination of manner of death. For the same period in 2008, there were 79 suicides among active-duty soldiers. During July 2009, among reserve component soldiers not on active duty, there were four potential suicides. During the period Jan. 1 to July 31, 2009, among that same group, there have been 17 confirmed suicides and 28 potential suicides; the potential suicides are currently under investigation to determine the manner of death. For the same period in 2008, there were 32 suicides among reserve soldiers not on active duty. The Army’s Suicide Prevention Task Force in recent weeks has implemented a number of changes designed to improve the Army’s health promotion, risk reduction and suicide prevention programs. These include completion of major revisions to Army health promotion policy and augmenting behavioral health staffs at many installations to enhance access to counseling services for soldiers and families. Soldiers and families in need of
crisis assistance should contact Military
OneSource or the Defense Center of Excellence
for Psychological Health and Traumatic Brain Injury Outreach Center.
The first phase of the $7.84 million project was completed in 18 months and was the first significant renovation of the NICU since it opened in 1988. The renovation increased space, while updating technology. The new NICU also created more of a "family-centered” environment. The previous NICU was an open bay that made noise control challenging, and baby separation was limited due to the smaller space. In the new NICU, a pod room design was incorporated to accommodate four babies per pod, which improved privacy and increased space. In addition, special ceiling tiles and laminate floor were installed to absorb sound for noise reduction; a central monitoring system at the nurse's station allows the staff to easily distinguish which baby needs attention. Breast feeding rooms and quiet rooms for families to talk with medical providers were added to the renovation. Visiting hours have been increased to 24 hours a day, seven days a week. Previously staffed and supplied as two separate areas, the new NICU now allows for social workers, pharmacists, physicians, nurses and hospital corpsman to work in a centralized area. Families can have their questions answered without leaving the ward. The next phase of the project is
expected to be completed six to nine months after patients and staff
members move into the new NICU late August. The old space will be renovated
into a waiting room, staff offices, locker rooms, lounge, call room,
the fetal assessment unit and two rooming-in-rooms where mothers of
NICU patients will be able to spend time with their newborns.
The 526,255 gross square-foot facility will support the USAMRICD mission of developing, testing, and evaluating medical treatments and materiel to prevent and treat casualties of chemical warfare agents. The construction will include headquarters and administrative space; BSL-2 (Bio Safety Level 2) laboratories and associated lab support areas; vivarium and support spaces; veterinary medicine, animal housing and related logistic support areas; gas, electrical and conventional utilities; and a central energy plant. The contract performance period for
execution will be 1,278 calendar days from date the Baltimore District
issues Clark Construction a notice to proceed. Completion is planned
for May 2013.
In the Fort Irwin, Calif., area, Health Net Federal Services will be responsible for verifying and updating registration information in the appointment system, making and canceling patient appointments with Military Treatment Facility providers, and providing performance and management reports on the appointing process for eligible beneficiaries. Delivery of appointment services begins on September 2, 2009. Health Net Federal Services currently
provides Patient Appointing Services for the seven Military Treatment
Facilities in the Puget Sound, Wash., multi-service market, as well
as for the Naval Health Clinic in Great Lakes, Ill.
Roadside bombs cause nearly 65 percent of the wounds suffered in Iraq and Afghanistan, according to Pentagon statistics. These improvised explosive devices, or IEDs, have wounded more than 25,000 troops, records show. By examining blood, body tissue and fluids at the site of a blast wound, scientists were able to identify the biomarkers that predicted how the body’s immune system will react, said Doug Tadaki, an immunologist and co-author of recent naval studies. The markers uncovered by the Navy research can help determine whether the gaping wounds left after a bomb explosion will fail and pull apart after surgery has been done to close the injury. Wound failure happens in about 17 percent of the cases in which troops suffer multiple and severe wounds, commonly from blast, the Navy research shows. When failure occurs it can turn a war injury into a chronic ordeal. The result of the research may ultimately lead to tailored treatment. If doctors can read these biomarkers shortly after wounded troops arrive from the battlefield, they can anticipate how the body will react. Research conducted at the Naval Medical Research Center also uncovered biomarkers that can predict whether troops suffering amputations from blast will develop painful bone spurs or abnormal bone growth at the site of amputation, a problem that occurs in about 60 percent of cases involving orthopedic injuries. Since 2003, about 850 troops have suffered major amputations, statistics show. These growths can interfere with the sizing and fitting of prosthetics and often require further surgery to remove. The Navy scientists found that problems such as wound failures or bone spurs occur when the body’s immune system overreacts to the wide spectrum of physical damage that occurs when a service member is caught in an explosion. Explosions can cause
multiple injuries ranging from direct trauma from the explosion to secondary
wounds from flying debris or from the body being thrown against another
surface, the researchers say. If the biomarkers suggest wounds
could fail after surgery, scientists may soon develop ways to manipulate
the immune system in an effort to control how it reacts.
In October, the Army will require all its active duty, National Guard and reserve soldiers to take a test that will help identify potential problem areas for soldiers. The 170-question test will look at physical, mental, emotional, spiritual and family issues and then recommend follow-on training as needed. The program comes as the Army is tackling rising suicide rates, divorce and depression among thousands of soldiers returning from war. But unlike other programs, which seek to intervene when a soldier's issues have already been flagged by other screening methods, this program aims to be more proactive. About 4,000 soldiers have already taken the test under a pilot program begun with the help of the University of Pennsylvania. The results of the assessment will
remain confidential – withheld even from soldiers' commanders. The
results are intended to help the soldier find appropriate training or
counseling. http://www.csmonitor.com/2009/ Veterans Health Care News
The projects, which include an addition to the medical center, new mental health facility, blind rehabilitation center, extended-care facility, parking garage and utility upgrades, are the result of a Department-wide reorganization of VA's health care resources and the aftermath of Hurricane Katrina. The most recent contracts include construction of a four-story clinical addition to the Biloxi VA Medical Center and a new 26-bed rehabilitation facility to train sight-impaired Veterans in the skills for independent living. The addition will be connected to the existing hospital and provide space for outpatient surgery, a step-down unit, as well as primary and specialty care clinics. The $36.6 million contract was awarded to Hoar Construction of Birmingham, Ala., and was part of an earlier plan to consolidate Gulfport services with Biloxi. The rehabilitation unit is a stand-alone facility to be built on the Biloxi campus by Brasfield & Gorrie LLC, also of Birmingham, at a cost of $14 million. Plans include separate space for training veterans in skills needed for independent living. A new parking garage, surface parking and the associated site work to improve access to the Biloxi campus and its new buildings and services are being constructed under a $12.4 million contract awarded to EASC/LS, a joint venture from Fort Walton Beach, Fla. Sustainable design components for the nearly 98,000-square-foot facility include using recovered materials, reducing waste and improving energy efficiency. The architectural design of the building is intended to preserve the historic beauty of the Biloxi campus. The anticipated completion date for construction of the new mental health facility is June 2011. In January 2009, a contract for more than $35.4 million was awarded to Carothers Construction Inc. of Water Valley, Miss., to build an extended care facility on the campus of the VA medical center. The 105,000-square-foot facility will provide 96 inpatient beds for veterans' care. Site work also includes surface parking, relocating underground utilities, roadwork and landscaping. The first contract for $36.3 million
was awarded to Roy Anderson Corp. of Gulfport, Miss., in September 2008
to construct a new two-story, mental health facility that will house
outpatient mental health care and 64 beds for inpatient mental health
care.
A PSI-led team, which includes EDS,
will provide capacity planning analysis, independent software verification
and validation, testing infrastructure, engineering and operations,
services expansion initiative support and project management support
services. http://www.istockanalyst.com/
PTSD related to military service has been linked to heart disease in the past, but this is the first study to examine the association for veterans of the current Iraq and Afghanistan conflicts. Given the time frame of the recent wars, the study did not look at heart attacks or other events, but examined risk factors for heart disease instead. PTSD and other mental disorders, such anxiety disorder, more than doubled the risk of tobacco use, for example, which is a well-known risk factor. The study from Veterans Affairs Medical Center, San Francisco, included more than 300,000 veterans who began using Veterans Affairs health care from Oct. 7, 2001, to Sept. 30, 2008. Most (88 percent) of the subjects were male, and the average age was 31 years. About a quarter had PTSD. Among those who did, about half also suffered from depression and more than a quarter suffered from anxiety disorder. About a fifth abused alcohol. Men with mental disorders other than PTSD were at increased risk for all of the heart disease risk factors studied, including tobacco use, high blood pressure, obesity, and diabetes. All of those risk factors were also elevated in men with PTSD, except diabetes. In women, PTSD was significantly
linked to all of the risk factors studied. Other mental disorders were
tied to all of the risk factors except diabetes.
The community-based Vet Centers – already in all 50 states – are a key component of VA’s mental health program, providing veterans with mental health screening and post-traumatic stress disorder (PTSD) counseling. The existing 232 centers conduct community outreach to offer counseling on employment, family issues and education to combat veterans and family members, as well as bereavement counseling for families of service members killed on active duty and counseling for veterans who were sexually harassed on active duty. The Vet Center program was established
in 1979 by Congress, recognizing that many Vietnam veterans were still
having readjustment problems. In 2008, the Vet Center program provided
more than 1.1 million visits to over 167,000 veterans, including 53,000
visits by more than 14,500 Veteran families. More information about Vet
Centers can be found at www.vetcenter.va.gov/index.asp A list of the new Vet Center locations
can be found at http://www1.va.gov/opa/
Last year, VA purchased more than $19 billion in services, material and supplies. About $1.6 billion was with businesses owned by service-disabled veterans. Another $400 million in VA contracts went to other veteran-owned businesses. To further this effort, VA's Deputy Secretary W. Scott Gould addressed a VA conference with suppliers in northern Virginia to obtain the private sector's input on measures needed to transform VA's procurement process to meet the needs of veterans in the 21st century. Gould, who serves as VA's chief operating officer, noted the Department is hiring more than 350 contracting and procurement specialists. VA's Acquisitions Academy, the first of its kind among federal civilian agencies, received the 2009 Acquisitions Excellence Award from the Office of Management and Budget. Health Care News
The reports released show reform will:
These reports are the second in a
series of state-by-state reports on health care across the country.
Earlier this summer, Sebelius released The Health Care Status Quo
in Your State, a series of state by state reports on the current
state of health care in America. The reports are available at http://www.healthreform.gov/
The awards come from two programs administered by HHS’ Health Resources and Services Administration (HRSA): the Nurse Education Loan Repayment Program and the Nurse Faculty Loan Program.
For additional information about
the Loan Repayment
Program and other Recovery Act programs for health care professionals,
see http://bhpr.hrsa.gov/recovery/ For a list of facilities employing
the first 100 NELRP award winners from ARRA funds, visit http://newsroom.hrsa.gov/ For a list of universities that received
NFLP funds, visit http://newsroom.hrsa.gov/
The CDC proposed a range of options, depending on how severe the flu may be in their communities. The guidance says officials should balance the risk of flu in their communities with the disruption that school dismissals will cause in education and the wider community. The school guidance is a part of a broader national framework to respond to novel H1N1 influenza, which includes encouraging people to be vaccinated against the virus and to take other actions to avoid infection. The CDC anticipates more illness after the school year starts, because flu typically is transmitted more easily in the fall and winter. The guidelines recommend schools have plans in place to deal with possible infection. For instance, people with flu-like illness should be sent to a room away from other people until they can be sent home. Schools should have plans for continuing the education of students who are at home, through phone calls, homework packets, Internet lessons and other approaches. And schools should have contingency plans to fill important positions such as school nurses. If H1N1 flu causes higher rates of severe illness, hospitalizations and deaths, school officials could add to or intensify their responses. Under these conditions, the guidelines advise parents to check their children every morning for illness, and keep the children home if they have a fever. In addition, schools could begin actively screening students upon arrival and sending ill students home immediately. The CDC recommends that if one family member is ill, students should stay home for five days from the day the illness develops. For more information, visit www.flu.gov.
A recent national survey found that 12.6 million non-elderly adults — 36 percent of those who tried to buy insurance on the private market — were discriminated against in the past three years because an insurance company deemed them ineligible for coverage because of a pre-existing condition, charged them a higher premium or refused to cover their condition. Another survey found 1 in 10 people with cancer said they could not get health coverage, and 6 percent said they lost their coverage because of their diagnosis. According to the report, the insurance company practice of denying coverage because of pre-existing conditions is not confined to serious diseases. Even minor problems such as hay fever could trigger prohibitive responses. An insurer could charge high premiums, deny coverage or set a restriction such as denying any respiratory disease coverage to a person with hay fever, according to the report. Some insurance companies respond to an expensive condition such as cancer by initiating a thorough review of the patient’s health insurance application. If the company discovers that any medical condition, regardless of how minor, was not reported on the application, it could revoke coverage retroactively for the patient and possibly all members of the patient’s family. The practice is known as rescission. Companies can do this even if the condition found is not related to the expensive condition or if the person wasn’t aware of the condition at the time. At least one company encouraged employees to revoke sick people’s health coverage through rescissions, the report said. For more information, please visit www.HealthReform.gov.
Beside the patient registries, AHRQ plans grants and contracts amounting to $300 million in total for comparative effectiveness projects funded by the economic stimulus. Among the projects, the agency of the Health and Human Services Department will provide grants for a coordinated national effort to study and measure the treatment benefits in routine clinical practice. AHRQ will initially concentrate on 14 common conditions, including diabetes, obesity and heart and blood vessel conditions. The agency will also seek $74 million in contracts for analyzing and generating evidence and $19.5 million to establish an infrastructure for identifying treatment issues to review for comparative effectiveness and to involve the public. Identifying what treatments are most successful for specific conditions should improve the quality of health care and reduce costs. Clinical registries, clinical data networks and other health IT can help providers generate or obtain outcomes data. Details about the grants will be
released this fall. AHRQ expects to begin funding the projects
in spring 2010.
This new feature to the equipment will safeguard clinical research patients at the NIH Clinical Center who are exposed to radiation during certain imaging tests. Currently, electronic radiology information systems in hospitals generally do not collect or report radiation exposures. The risk of exposure to low doses of medical radiation from diagnostic medical-imaging tests isn't known, but very high radiation doses have the potential to cause cancer. The ability to keep track of an individual's exposure to radiation through routine imaging tests is needed so that researchers can begin to determine if these exposures pose a health risk. Ultimately, radiation dosage could become a standard element of a universal electronic medical record used to assess radiation risk from life-long medical testing. About 25,000 CT and 1,250 PET/CT
scans are performed at the Clinical Center each year as part of NIH
research protocols. The clinical research hospital currently houses
five CT scanners, and two PET/CT scanners.
Schizophrenia is a chronic, severe and disabling brain disorder that include symptoms such as hearing voices, or seeing things that are not there, having false beliefs, and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence. Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep. Saphris, manufactured by Schering-Plough, is in a class of drugs called atypical antipsychotics. All atypical antipsychotics contain a boxed warning, the FDA’s strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis (a brain disorder that lessens the ability to remember, think, and reason). Saphris is not approved for these patients. The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia. The efficacy of Saphris in the treatment
of bipolar disorder was studied in two short-term placebo-controlled
and active-drug controlled clinical trials in which Saphris was shown
to be superior to placebo in treating symptoms of bipolar disorder.
These “breach notification” regulations implement provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, passed as part of American Recovery and Reinvestment Act of 2009 (ARRA). The regulations, developed by the HHS Office for Civil Rights (OCR), require health care providers and other HIPAA covered entities to promptly notify affected individuals of a breach, as well as the HHS Secretary and the media in cases where a breach affects more than 500 individuals. Breaches affecting fewer than 500 individuals will be reported to the HHS Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate. The regulations were developed after considering public comment received in response to an April 2009 request for information and after close consultation with the Federal Trade Commission (FTC), which has issued companion breach notification regulations that apply to vendors of personal health records and certain others not covered by HIPAA. To determine when information is “unsecured” and notification is required by the HHS and FTC rules, HHS is also issuing in the same document as the regulations an update to its guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable or indecipherable to unauthorized individuals. Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information. This guidance will be updated annually. The HHS interim final regulations
are effective 30 days after publication in the Federal Register and
include a 60-day public comment period.
The Center will oversee the implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in June 2009. The FDA’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, and establishing and enforcing advertising and promotion restrictions. Lawrence Deyton, M.D. M.S.P.H., an expert on veterans’ health issues, public health, tobacco use and a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences, will serve as the Center’s first director. Dr. Deyton has been chief public health and environmental hazards officer in the Veterans Health Administration. The FDA’s Center for Tobacco Products, located on the FDA’s White Oak Campus in Silver Spring, Md., will use the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products. To implement the program, the FDA will start with $5 million from the fiscal year 2009 budget to establish the necessary administrative functions for the Center. As set forth in the Family Smoking Prevention and Tobacco Control Act, funding for the Center and other activities related to the regulation of tobacco will come from user fees paid by manufacturers and importers of tobacco products. According to the
Centers for Disease Control and Prevention, cigarette smoking causes
an estimated 438,000 deaths, or about one of every five deaths, each
year. On average, adults who smoke cigarettes die 14 years earlier than
nonsmokers.
The report, “Deaths: Preliminary Data for 2007,” was issued by CDC’s National Center for Health Statistics. The data are based on nearly 90 percent of death certificates in the United States. The 2007 increase in life expectancy – up from 77.7 in 2006 -- represents a continuation of a trend. Over a decade, life expectancy has increased 1.4 years from 76.5 years in 1997 to 77.9 in 2007. Other findings:
The action, detailed in a notice published in the Aug. 18 Federal Register, does not cover the Medicare/Medicaid incentive programs for meaningful use of electronic health records systems. Blumenthal now has administrative
authority for all but one part of Sections 3011 through 3017 of Subtitle
B, "Incentives for the Use of Health Information Technology,"
in the HITECH Act. The exception is Section 3012 (c) (5), under which
the HHS secretary may provide financial support to health information
technology regional extension centers. Blumenthal has administrative
authority for other extension center activities under that section.
A nationwide shortage of Hib vaccine began in December 2007 due to a voluntary recall by the manufacturer and subsequent production suspension of PedvaxHIB and COMVAX, two of four vaccines licensed in the United States for primary and booster immunization against invasive disease due to Hib. Both PedvaxHIB and COMVAX vaccines are manufactured by Merck & Co. Inc. (Whitehouse Station, N.J.). This shortage resulted in a recommendation by the U.S. Centers for Disease Control and Prevention to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored. This deferral was in effect from Dec. 18, 2007, through June 25, 2009. Hiberix, manufactured by GlaxoSmithKline, was approved under the FDA’s accelerated approval pathway. Although current vaccine supply is sufficient to reinstate the booster dose and begin catch-up vaccination, it is not yet ample enough to support mass vaccination of all children whose boosters were deferred. Before the availability of Hib vaccines, Hib disease was the leading cause of bacterial meningitis among children under five years old in the United States. Meningitis is an infection of the tissue covering the brain and spinal cord, which can lead to lasting brain damage and deafness. Hib disease can also cause pneumonia, severe swelling in the throat, infections of the blood, joints, bones and tissue covering of the heart, as well as death. Hib disease is spread through the air by coughing and sneezing. Hiberix is used in nearly 100 countries. The FDA based its conclusion that Hiberix is safe and effective for use as a booster dose in certain children in the United States on data from seven clinical studies conducted in Europe, Latin America and Canada that involved more than 1,000 children. As part of the approval, the manufacturer, GlaxoSmithKline, will conduct a post-market study in the United States to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix compared to a Hib vaccine already licensed in the United States. Reserve/Guard
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If you need further information on any of the items in the Federal Health Update, please contact Kate Connelly Theroux at (703) 447-3257 or by e-mail at katetheroux@fedhealthinst.org. To subscribe, please visit http://fedhealthinst.org/subscriber.cfm. To unsubscribe, please send an email to newsletter@fedhealthinst.org with UNSUBSCRIBE as the subject. Back issues availiable at Federal Health Update Archives. |
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