Worth Noting
Meningitis Vaccine Approved for Children
The U.S. Food and Drug Administration (FDA) October 18 expanded the age range for Menactra, a bacterial meningitis vaccine, to include children 2 to 10 years of age. Previously, Menactra was approved only for ages 11 to 55 years. The vaccine, manufactured by Sanofi Pasteur Inc. of Swiftwater, PA, protects against four groups of Neisseria meningitides, the bacterium that can cause meningitis, an inflammation of the lining that surrounds the brain and spinal cord that can result in death or permanent injury to the brain and spinal system. Addition of the new age range for Menactra makes two vaccines—Menactra and Menoimmune, both manufactured by Sanofi Pasteur--available for children. The FDA cautions that adolescents who have a rare muscular condition known as Guillain-Barre syndrome should not receive the new vaccine. Menactra will be monitored as it comes into general usage through the recently inaugurated Vaccine Adverse Event Reporting System, an oversight system being operated jointly by the FDA and the Centers for Disease Control and Prevention (CDC).
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Being Specific About Being Special
What, exactly, is a "chronic illness" in children? There are many, often conflicting, ways of defining the term, according to a report in the October 2007 issue of the Archives of Pediatrics and Adolescent Medicine, including medical diagnosis, the effects of the health condition on children, or the need for and use of services such as mental health and educational resources. The Maternal and Child Health Bureau has adopted the definition "children with special health care needs" or CSHCN. Using that definition, the 2004 National Survey of Children's Health identified children with special health care needs by asking knowledgeable adults if a child needs prescription medication; needs more medical or mental health care or educational services than is usual for his age; is limited in doing things normal for his age; needs physical, occupational, or speech therapy, or has emotional, developmental, or behavioral problems for which treatment or counseling is needed. Using those criteria, researchers estimate that from 13 percent to 18 percent of children can be considered to be chronically ill.
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OCTOBER NEWS ALERTS
The following information appeared during the month of September 2007 in the News Alerts section of the website of the Center for Health and Health Care in Schools, at www.healthinschools.org.
October 2, 2007
President Bush Vetoes SCHIP Bill
As he had promised to do, President George Bush today vetoed a bill that had been passed by the House and Senate to extend for five more years the state/federal State Children’s Health Insurance Program (SCHIP). The bill would have added $35 billion more in federal matching funds to enable states to enroll additional children in the program, an amount Bush criticized as too large. The President also said the SCHIP enlargement would encroach on private insurance plans and would be an "opening wedge" to what he called "government-run" health care. The vote for the bill in the Senate was large enough to override a veto, but the House vote was not, and supporters said they will try in the coming two weeks to persuade more House Republicans to vote for override, noting that the child insurance program has wide public support.
October 9, 2007
Medicaid Proposes to End Reimbursements to Schools
The federal Centers for Medicare and Medicaid Services (CMS) in a proposed rule issued September 7, 2007, said it plans to eliminate reimbursement for Medicaid administrative activities conducted by school employees or contractors and for the costs of transporting students with disabilities from home to school and back. The proposed rule notes that "a wide range of medical services are furnished to students in school settings," in particular to children who have Individualized Education Plans (IEPs) or Individualized Family Services Plans (IFSPs) under the Individuals with Disabilities Education Act (IDEA). Previous guidance documents have allowed schools "to perform activities that provide support for the Medicaid state plan," specifically including Medicaid outreach, eligibility intake, information and referral, coordination and monitoring of health services, and interagency coordination." The proposed rule would supersede the previous guidance and would represent a determination by the Secretary of Health and Human Services that such school-based administrative activities do not meet the requirements of existing legislation relating to "direct medical services" or support of the state Medicaid plan. The full text of the proposed regulation and opportunities to comment are available at http://origin.www.gaoaccess.fov/fr/.
October 11, 2007
More Generic Drugs to be Available
The U.S. Food and Drug Administration (FDA) announced this month that it is stepping up its procedures for reviewing generic drug applications, with the objective of making more generics available to consumers and health care providers. Generic drugs, which can come into the market after patent exclusivity expires on the brand-name drugs they replace, generally cost less, often much less, than the brand names. To receive FDA permission to market a generic drug, manufacturers must demonstrate that the generic has the same dosage form, strength, route of administration, and conditions of use as an approved brand-name product and must also show that the generic delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Noting that there are increasing numbers of applications for generics approval, the FDA said it will hire and train new generic drug reviewers and will develop electronic programs for handling applications. The FDA approved a record 682 generic drug products in fiscal year 2007.
October 18, 2007
Drug-Resistant Staph Infections Reported in Schools
A strain of staph aureus (MRSA) that is resistant to the drug methicillin has been reported in a number of high schools in the states of Maryland and Virginia, with health authorities speculating that the infections—responsible for the death of one student so far—may result in part from contamination of equipment in locker rooms used by sports teams. Many schools in the affected areas have instituted school-wide cleanings and are informing parents of possible dangers. In a statement October 16, the federal Centers for Disease Control and Prevention (CDC) said methicillin-resistant staph aureua caused more than 94.000 life-threatening infections and nearly 10,000 deaths in the United States in 2005, 85 percent of them associated with health care settings such as hospitals but 15 percent occurring in people without documented health care risk factors. Information about MRSA is available online at www.cdc.gov/ncidod/diseases/submenus/sub_mrsa.htm.
October 19, 2007
House Sustains President's Veto of SCHIP
The U.S. House of Representatives failed October 18 to override a veto by President Bush of a renewal of the State Children's Health Insurance Program (SCHIP). The 273 to 156 vote total was 13 votes short of the two-thirds majority needed to override a veto. In Thursday's vote, 229 Democrats and 44 Republicans supported the effort to override the President's veto, while two Democrats and 154 Republicans voted to sustain it. Advocates for SCHIP immediately announced plans to push for a new bill that would expand the numbers of children eligible for SCHIP by increasing funding for the program over the next five years, but it was considered unlikely that the President would agree to such an expansion, which he has categorized as "an opening wedge to socialized medicine." Meanwhile, SCHIP is slated to continue at its present levels under a continuing resolution adopted by Congress in September that funds programs not yet reauthorized at existing funding and rules until new bills are passed.
October 19, 2007
Pfizer Stops Selling Inhaled Insulin
Less than two years after it was approved as an alternative to injectable insulin for diabetes patients, the inhaled drug Exubera is being withdrawn by its manufacturer, Pfizer, because the drug failed to win acceptance by patients and doctors. The Exubera inhaler, a large canister that many people found inconvenient to carry and use, and questions about whether patients received more or less insulin than they expected because of daily variations in lung capacity, were factors in the decision to withdraw the drug, Pfizer said. Sales of Exubera, which had been expected to be a blockbuster drug, were less than one percent of the insulin market, making it "one of the most expensive failures in the history of the pharmaceutical industry," according to the New York Times. The company said it is working with doctors to move all patients off Exubera within three months.
October 26, 2007
House Passes Revised SCHIP
The U.S. House of Representatives last week passed a revised version of a bill to reauthorize the State Children's Health Insurance Program (SCHIP), but changes made in the legislation after President Bush vetoed an earlier bill were not believed to be enough to overcome an expected second veto. The new bill, H.R. 3963, limits eligibility for SCHIP to children from families making no more than 300 percent of the federal poverty level, or approximately $62,000 for a family of four. It also bars illegal alien children from benefits, and would not allow states to cover childless adults. Those were among the changes asked for by Bush, but the bill still includes two of the President's major objections—a $35 billion increase in funding for SCHIP over the next five years, and an increase in the federal tax on tobacco products—and those differences are expected to spark a veto once the bill comes to the President's desk. The vote in the House was 265 to 142, short of the two-thirds needed to overcome a veto. If the President does veto the new measure, congressional leaders say they may extend the existing SCHIP program through next spring, with further action on renewal possible just before the November elections, when the issue of child health is expected to resonate with voters.
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