One Vaccine Shortage Eases But Others Remain
A shortage of adult tetanus and diphtheria toxoids that began in the last quarter of 2000 has now eased, and adolescents for whom a routine Td booster shot was delayed should be recalled to receive the delayed dose, the Centers for Disease Control and Prevention announced June 21.
But serious shortages remain in the supply of four other vaccines that provide protection against eight of the eleven vaccine-preventable childhood diseases, the director of CDC’s National Immunization Program told a Senate committee June 10. Dr. Walter Orenstein cited current supply problems with the diphtheria, tetanus, pertussis vaccine (DTaP); the pneumococcal infection (PCV-7) vaccine; the measles, mumps, rubella (MMR) vaccine; and the varicella (chickenpox) vaccine.
Calling the current shortage "unique and unprecedented," Orenstein told the Senate Committee on Governmental Affairs that marketplace and economic factors play an important role in vaccine supply. For three of the vaccines now in short supply, there is only one manufacturer, compared with numerous suppliers two decades ago. Vaccines are often less profitable than other pharmaceutical products within a company, leading to business decisions to decrease or stop vaccine production. In the case of the Td vaccine, when one of two producers of Td decided to stop making it, the remaining company was unprepared to immediately fill the resulting supply needs. In the case of the DTaP vaccine, two of the four manufacturers abruptly discontinued production.
Predicting how long the shortages will continue is difficult, Orenstein said, since it depends on manufacturers’ projections, but in general it seems the situation is improving. FDA licensure of a new DTaP vaccine in May this year is bringing new supplies into the market; and manufacturers say the shortages of MMR and varicella vaccine should be resolved by the end of August or September. "Our most significant and enduring problem appears to be with pneumococcal conjugate vaccine, which will be in short supply through this fall and probably into 2003," he said.
But whatever the duration of the shortages, their effect is being felt by health care providers, schools, and parents, Orenstein said. Pediatricians are sending infants and children home without their full course of immunizations, and the process of setting up tickler files and recalling those children when vaccines become available is often unreliable. School immunization requirements—one of the most effective interventions to prevent outbreaks of vaccine-preventable diseases—have also been affected, Orenstein pointed out. School entry requirements for vaccines in shortage have been temporarily suspended in some states—a recent survey found that 48 percent of states have made changes in their entry requirements for Td, and about 10 percent have made changes in their school and daycare requirements for DTaP. "When vaccine supply improves and the rules are reinstated, school staff will have to ensure that children missing required vaccines have received them."
What Can Be Done to Prevent Shortages?
Acknowledging that the causes of vaccine shortages are complex,
Orenstein said the Centers for Disease Control and Prevention is working
with other agencies in the Department of Health and Human Services,
such as the Food and Drug Administration, and with the pharmaceutical
industry to better understand the current situation. Purchases using
public funds, by the CDC and states, account for 52 percent of the national
childhood vaccine supply, and those orders are monitored to try to assure
equitable distribution. CDC is allowed by law to maintain a six-month
vaccine supply in stockpiles, but maintaining stockpiles "presents
unique challenges," he said, including storage problems and replacing
older vaccines when new formulations are approved (as when oral polio
vaccine was replaced with inactivated vaccine, for example).
Speaking for the Food and Drug Administration, Deputy Commissioner Lester Crawford told the Senate committee that his agency is concerned about the "fragility" of the nation’s vaccine supply, but he noted that the FDA "does not have the authority to require manufacturers to stay in the market and produce a given vaccine," nor does the FDA have authority to direct manufacturers to increase production when a shortage occurs. And vaccines are different from most other drugs in some important respects, Crawford said; vaccines are usually derived from living cells or organisms, so the potential for contamination is higher than for most drugs, and the quality and purity of ingredients must be carefully monitored. Even very slight changes in temperature may affect the final vaccine, requiring that each lot be tested for composition and potency.
Speaking for the pharmaceutical manufacturers, the executive vice president of Aventis Pasteur North America, Wayne Pisano, pointed out that four companies make 100 percent of children’s vaccines and 90 percent of all vaccines produced in this country. "Most people are surprised that the industry is so small, but that fact is largely the result of the liability crisis in the 1980s that drove most companies out of the market," he said.
Pisano offered six proposals to ensure a stronger vaccine supply:
Senator Joseph Lieberman (D-CT), chairman of the Senate Committee on
Governmental Affairs, summed up the committee’s concerns. "Just
as we’ve reached vaccination rates of over 90 percent, we now face alarming
shortages of these priceless serums," he said. "Experience
has informed us of the value of vaccines. If we don’t give this our
best shot, our children won’t get the shots they need for healthy lives."
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Anti-vaccination Websites Parents going to the Internet for information about immunization may encounter anti-vaccination websites making claims that vaccines cause illness and erode immunity, and that adverse reactions are underreported. Many of the sites carry emotional stories of children said to have been harmed or killed by vaccines. To determine what exactly is being posted on such websites, researchers from Northwestern University’s Feinberg School of Medicine identified 22 anti-vaccination sites through search engines and links and examined their content. They found that the illnesses most commonly ascribed to vaccination included autism (alleged to result from MMR and/or DTaP vaccine); sudden infant death syndrome; immune dysfunction; diabetes; neurologic disorders including seizures, brain damage, learning disabilities, attention deficit disorder, and antisocial behavior; and atopic conditions such as rhinitis, eczema, and asthma. A number of the sites claimed that contaminated lots of vaccine ("hot lots"), cause adverse reactions and that giving multiple vaccinations at the same time increases risk. Twenty-one of the 22 sites said vaccinations erode or harm the immune system. A frequent claim was that naturally occurring diseases help the immune system, preventing illnesses such as asthma, and that vaccination interferes with that benefit. Eighteen sites alleged that vaccines are ineffective and produce only temporary immunity. Twenty-one sites charged that many adverse reactions to vaccines go unreported, sometimes because physicians fail to recognize delayed reactions as vaccine-related, but also because agencies involved with vaccine production and regulation are believed to be covering up the truth. The researchers concluded that "Typically, arguments connecting vaccination to adverse effects were made using the logical fallacy post hoc ergo propter hoc ("after this, therefore because of this"), which mistakes association for causation. For example, since autism occurs in the first two years of life when many vaccinations are given, many anti-immunization opponents conclude that immunization causes autism. Although controlled studies do not support this association, it remains an area of contention between public health authorities and anti-vaccinationists." Reprints of the research report, "Content and Design of Antivaccination Web Sites," which was published in the June 26 issue of the Journal of the American Medical Association, are available from r-wolfe@northwestern.edu. |
Prescribing Antibiotics for Children and Adolescents
Faced with evidence that many bacteria are becoming resistant to antibiotics, physicians are prescribing antimicrobials for children less often than they did a decade ago, say researchers who reviewed visit record forms completed by physicians over a 12-year period beginning in 1989. Specifically, researchers from the Centers for Disease Control and Prevention looked at the number of times doctors prescribed antibiotics for otitis media, pharyngitis, bronchitis, sinusitis, and upper respiratory tract infections in children and adolescents younger than 15 years.
Reporting their findings in the June 19 issue of the Journal of the American Medical Association, the researchers concluded that after a number of years during which antibiotic use increased steadily, there has been slightly less prescribing in the past decade, possibly as the result of repeated warnings about antibiotic overuse from the biomedical literature, medical and public media, and health insurance companies. Even now, though, doctors often yield to pressure from worried parents who do not understand that antibiotics are not useful for viral infections, and most doctors surveyed said educating parents about appropriate antiobiotic use is the single most important factor in reducing unnecessary prescriptions.
There are other factors, too—a busy office schedule, potential insurance company audits of medical records, and "the omnipresent concern for malpractice litigation"—that may lead a doctor to prescribe antibiotics against his better judgment. Also, it’s true that some bacterial infections preceded by a viral illness have a rapid course, and patients may not return to see the physician if the illness worsens or persists, leading the physician to err on the side of prescribing antibiotics even if the chance of a bacterial infection is low.
In an editorial accompanying the research report, Dr. Michael Pichichero of the University of Rochester Medical Center notes that (1) antibiotic overuse is a major public health problem; (2) approximately half the prescriptions written for children are unnecessary; and (3) the single most important factor in the emergence of antibiotic resistance among respiratory bacterial pathogens is selection pressure from antimicrobial agents.
To achieve more selective, appropriate use of antibiotics for pediatric patients, he counsels delay in prescribing while symptoms are watched, along with laboratory tests such as throat culture for group A streptococcus or chest radiographs. "Faced with an ill child or adolescent and worried parents, most often the right thing is reassurance, symptomatic therapy, and availability for follow-up—not antibiotics."
Reprints of the research report, "Trends in Antimicrobial Prescribing Rates for Children and Adolescents," are available from rbesser@cdec.gov. Reprints of the editorial, "Dynamics of Antibiotic Prescribing for Children," are available from Michael.pichichero@urmc.rochester.edu.
Little Mention of Children in Medicaid Managed Care Regs
States have until June 16, 2003, to bring their Medicaid managed care programs into compliance with final regulations published by the Centers for Medicare and Medicaid Services June 14.
In extensive explanations of the new rules, the Centers pointed out that prior to 1982, 99 percent of Medicaid beneficiaries were covered under fee-for-service arrangements. But increasingly states sought waivers allowing them to provide coverage through contracts with managed care organizations (MCOs), using a payment approach called capitation, in which the MCO is paid a fixed monthly sum for each Medicaid beneficiary enrolled. That trend was accelerated when Congress passed the Balanced Budget Act in 1997, allowing states to require many Medicid beneficiaries to enroll in such managed care arrangements. As of June 2000, approximately 56 percent of the entire Medicaid population received at least some services through an MCO, a prepaid health plan (PHP), or a primary care case management arrangement.
The regulations published in June set new protections for Medicaid recipients enrolled in such plans, including the right to appeal an action, grievance procedures, the right to seek a second opinion, and, for women, the right to directly access a qualified provider of women’s health care services.
Although more than half of Medicaid beneficiaries (54 percent) are children, the managed care regulations make little mention of children, with the following exceptions:
The new Medicaid managed care regulations and 104 pages of background and explanation appeared in the Federal Register for June 14, 2002.
Excerpts from Supreme Court Ruling on School Drug Tests
The following are some of the thoughts expressed by the United States Supreme Court in a five-to-four ruling handed down by the Court June 27, in which the majority determined that the Tecumseh, Oklahoma, school district’s policy of requiring students to consent to random tests for drugs as a condition for participation in interscholastic extracurricular activities is not a violation of the students’ Fourth Amendment right to be free of unreasonable search and seizure.
From the majority opinion (Justices Thomas, Rehnquist, Scalia, Kennedy, and Breyer):
From a concurring but separate opinion by Justice Breyer:
From a dissenting opinion by Justices Ginsburg, Stevens, O’Connor, and Souter:
The case decided June 27 was Board of Education of Independent School District No. 92 of Pottawatomie County et al. v. Earls et al.
Worth Noting
CDC Updates Report on School Rashes
In an update of an earlier report on outbreaks of rashes in schools,
the Centers for Disease Control and Prevention said June 21 that since
October 2001, 27 states have reported investigations of multiple groups
of schoolchildren who developed rashes including a sunburn-like rash
on the cheeks and arms, a burning sensation on the skin, or a hive-like
reaction that moved from one part of the body to another. So far, the
investigations have not identified a common source for the outbreaks,
which occurred between October 2001 and May 2002 in 110 U.S. elementary,
middle, and high schools. The sex distribution of cases varied, ranging
from 33 percent to 100 percent female, and the rashes varied by presentation,
location on the body, and duration. In all but a few cases, there were
no accompanying signs or symptoms such as conjunctivitis, fever, vomiting,
sore throat, or headaches. Rashes tended to be self-limiting and lasted
from one hour to one month. Most children who were evaluated were seen
by school nurses, though some with persistent or recurring rashes were
seen by dermatologists. The CDC said investigation of the outbreaks
is continuing.
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Youth Risk Behavior Study Encouraging, Thompson Says
Surveys of 9th to 12th grade students in 2001
showed teenagers "acting like responsible young men and women,"
Health and Human Services Secretary Tommy Thompson said June 27. The
2001 Youth Risk Behavior Surveillance System report showed continued
positive trends in injury- and violence-related behaviors—more students
wore seatbelts, would not ride with a driver who has been drinking alcohol,
or never carried a weapon. The number of students who had seriously
considered suicide or planned a suicide attempt also declined. Students
were less likely to engage in sexual behaviors that increase the risk
of HIV infection, other STDs, and unintended pregnancy, with the percentage
who had ever had sexual intercourse declining from 54 to 46 percent
of high schoolers. Those who were sexually active were more likely to
have used condoms. The percentage of students who reported current and
frequent cigarette use declined between 1997 and 2001, after a previous
period of increased use, and the number who reported marijuana use also
declined. On one measure of health, the trend was less encouraging:
one in 10 high school students reported they were overweight, and there
has been a significant drop since 1997 in the percentage of students
enrolled in daily physical education classes. More information about
the 2001 report is available at www.cdc.gov/yrbs.
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How Professionals Advise Obese Children, Adolescents
Pediatric professionals who care for obese children and adolescents
generally recommend "changes in eating patterns" and "limitations
of specific foods" to their patients, and almost all (80 percent)
urge the young people to engage in more physical activity, according
to a survey of pediatricians, pediatric nurse practitioners, and registered
dietitians sponsored by the Maternal and Child Health Bureau. Pediatricians
and pediatric nurse practitioners often refer their obese patients to
registered dietitians or to child/adolescent weight programs or camps,
when those are available. A few practitioners will "sometimes"
recommend prescription medication, but none of those in the survey suggested
surgery. The survey was reported in the July 2002 issue of the journal
Pediatrics.
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Weight Worries Affect Girls’ Decision to Smoke
Concern about weight and the drive to be thin increase the risk that
a girl will become a daily smoker by the time she is 18 or 19 years
old, according to a new study sponsored by the National Heart, Lung,
and Blood Institute. Weight concerns increased the risk for both white
and black girls. The study followed 2,379 girls in Richmond, Virginia,
Cincinnati, Ohio, and metropolitan Washington, D.C., for nine years,
beginning when the girls were ages 9 and 10. "The findings show
that we need to offer young teen girls healthy ways of controlling their
weight and dealing with stress," said NHLBI project officer Dr.
Eva Obarzanek. The report appeared in the June issue of Preventive
Medicine.
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2002 Is 20th Anniversary of Hep B Vaccine
Marking the 20th anniversary this year of implementation
in the United States of the world’s first vaccine against hepatitis
B virus, the National Center for Infectious Diseases reported substantial
progress toward eliminating HBV transmission in children and reducing
the risk of infection in adults. Vaccination of infants is now almost
90 percent. Forty-four states have laws mandating hepatitis B vaccination
for children entering elementary school or daycare centers, and 34 states
require vaccination for adolescents in middle school. To maintain the
progress made so far, the Center urges adolescent vaccination, especially
in middle school, as a priority for the next decade, until the vaccinated
cohort of infants reaches adolescence. "Sustaining high vaccine
coverage rates among infants, children, and adolescents will ensure
that future generations are protected from HBV infection and its consequences,"
the Center said. The report, "Achievements in Public Health: Hepatitis
B Vaccination United States, 1982-2002," appeared in the June 28
issue of Morbidity and Mortality Weekly Report.
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The following information appeared during the month of June in the News Alerts section of this website.
HHS Awards $30 Million to Address Nursing Shortage
The Health Resources and Services Administration in the U.S. Department of Health and Human Services announced June 4 that it has made the following awards to increase the number of qualified nurses and the quality of nursing services:
Updated Guidelines for Diagnosis, Management of Asthma
Updated guidelines issued June 10 by the National Asthma Education and Prevention Program, an expert panel coordinated by the National Heart. Lung, and Blood Institute, recommend inhaled corticosteroids as safe, effective, and preferred first-line therapy for children as well as adults with persistent asthma. The update stresses that inhaled corticosteroids, which treat chronic inflammation of the airways, a key characteristic of asthma, are preferred for controlling and preventing asthma symptoms and for improving lung function and quality of life. The update reports that large clinical trials have shown that the risk of delay in growth in children linked to corticosteroids is temporary and possibly reversible, and other potential concerns such as reduced bone mineral density, suppressed adrenal function, and increased incidence of cataracts are not significant risks for children.
For a downloaded version of the Executive Summary of the NAEPP Expert Panel Report, "Guidelines for the Diagnosis and Management of Asthma, Update on Selected Topics, 2002," click on www.nhlbi.nih.gov/guidelines/asthma/index.htm. For an Asthma Management Model System, click on www.nhlbisupport.com/asthma/index.html. Information about the National Asthma Education and Prevention Program is available at www.nhlbi.nih.gov/about/naepp/index.htm.
Medicaid Managed Care Final Regulations
Medicaid recipients who are enrolled in managed care plans are to receive protections comparable to those of participants in private plans, according to regulations issued today by the Department of Health and Human Services. The regulations become effective August 13, and states and health plans must come into full compliance within a year. The new regs supersede regulations published in January last year.
Under the new rules, managed care plans must provide Medicaid recipients the following benefits:
The new rule changes the federal requirements governing payments under state-managed care programs, moving away from fee-for-service to a requirement that the method be actuarially sound. States will be required to approve marketing materials used by managed care plans to enroll Medicaid beneficiaries; plans are prohibited from using door-to-door, telephone, and other forms of "cold call" marketing. Managed care plans will be required to ensure that they have the capacity to serve the expected enrollment in their market areas, and plans may not set restrictions, such as gag rules, that interfere with patient-provider communication.
The final regulation appears in the Federal Register for June 14, 2002.
Supreme Court Limits HMO Rights under ERISA
The United States Supreme Court ruled June 20 that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Illinois HMO Act that allows patients to seek second opinions after their HMOs deny coverage. The Court upheld the right of an Illinois physical therapist to reimbursement for surgery recommended by the doctor from whom she sought a second opinion after Rush Prudential HMO, Inc., denied the procedure on grounds that it was not "medically necessary."As part of its opinion, the five-member Court majority noted that HMOs are not only providers of health services but also insurers, since they spread the risk among their enrollees when they set rates. And since regulation of insurance is a state responsibility, the federal ERISA does not preempt state laws having to do with insurance, the Court said. HMOs have long held that they cannot be sued by enrollees because that they are protected from lawsuits by ERISA, a law passed by Congress to protect employee benefits. The case was Rush Prudential HMO, Inc. v. Moran.
Advisory Committee Rules Out Universal Smallpox Immunization
The Advisory Committee on Immunization Practices recommended June 21 that only a limited number of health and law enforcement workers be vaccinated against smallpox. States would be asked to designate teams made up of selected doctors, nurses, epidemiologists, diagnostic laboratory scientists, and security and law enforcement personnel, to be vaccinated. Those teams would then investigate initial cases in a smallpox outbreak and would care directly for the victims, using a procedure known as "ring vaccination" to isolate infected persons and their contacts. The Advisory Committee encouraged the nation’s 5,000 hospitals to develop plans for responding to a case of smallpox but did not recommend vaccinating all of the estimated 100,000 hospital workers. Secretary of Health and Human Services Secretary Tommy Thompson said the Advisory Committee’s recommendations will now be reviewed by experts in HHS.
AHQR Seeks Ideas for Study of Children’s Health Outcomes The
Agency for Healthcare Research and Quality is asking for recommendations
on priority issues in children’s health services for potential inclusion
as research topics in a planned large-scale longitudinal study of children’s
health outcomes. Comments should be submitted on or before July 2 in
the form of a letter, e-mail, or floppy disk and should be not more
than three pages in length. For details, see the Federal Register for
June 21, 2002, at http://frwebgate.access.gpo.gov
/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-15788-filed
Supreme Court Approves Random Drug Testing in Schools
In a five-to-four decision the United States Supreme Court June 27 upheld a school district’s policy of requiring students to submit to random, suspicionless testing for drugs as a condition for participating in extracurricular activities, saying the testing requirement is "a reasonable means of furthering the school district’s important interest in preventing and deterring drug use among its school children."
The Court found that drug testing as conducted by the Tecumseh, Oklahoma, school district does not violate the Fourth Amendment’s protection against unreasonable search and seizure, because the test procedures do not significantly invade student’s privacy and the test results are not turned over to any law enforcement agency and "do not lead to the imposition of discipline or have any academic consequences. Rather, the only consequence of a failed drug test is to limit the student’s privilege of participating in extracurricular activities."
The school district had presented sufficient evidence of a drug problem—teachers reported that they saw students who appeared to be under the influence of drugs and heard students speaking openly about using drugs—to shore up its decision to require testing, the Court majority said, though "a demonstrated drug problem is not always necessary to the validity of a testing regime."
Four Justices, O’Connor, Souter, Ginsburg, and Stevens, dissented from the majority opinion, saying the school district’s "undoubted purpose to heighten awareness of its abhorrence of and strong stand against drug abuse … does not trump the right of persons—even of children within the schoolhouse gate—to be ‘secure in their persons against unreasonable searches and seizure.’"