|
AAP Releases Guidelines for Administration of Medication in School In a policy statement released in September, the American Academy of Pediatrics (AAP) is urging school boards and school administrators to "honor policies and establish mechanisms" for the administration of medication in the school setting. Noting that increasing numbers of students require some form of medication as a prerequisite for attending school, and that many schools do not have either full or part-time nurses to administer those medications, the policy statement suggests that school policy makers consult their state laws or guidelines on such issues as delegating medication administration to unauthorized assistive personnel. When state laws or regulations do not exist, "individual school districts may wish to seek legal advice as they assume the responsibility for giving medication during school hours." In addition, school districts should make sure that liability coverage is provided for the staff, including nurses, teachers, athletic staff, principals, superintendents, and members of school boards; and that "any student who must take medication during regular school hours does so in compliance with all federal, state, and district regulations." Among the issues that school administrators and health personnel should consider, the statement lists:
The policy statement offers some guidance for pediatricians. Physicians are cautioned that prescribing drugs on an "as-needed" basis can be problematic for schools where no health professional is on site to assess actual need. And for any medication, the prescribing physician should notify the school of adverse effects that may reasonably be expected, and contraindications for administering it. For administrators and health professionals in schools and school districts, the AAP statement has the following recommendations:
The full text of the American Academy of Pediatrics Policy Statement,
"Guidelines for the Administration of Medication in School,"
appears in the September 2003 issue of the journal Pediatrics. Update on Pediatric Drug Labeling Only one-third of the drugs commonly used to treat children have been studied adequately in the population for which they are being prescribed and have appropriate dosing information on the label, according to a study reported in the August 20 issue of the Journal of the American Medical Association. For the other two-thirds of drugs, information regarding their safety or effectiveness for children is insufficient or absent, leaving physicians to guess at a proper dosage, or whether the medication should be given to children at all. The situation arises because drugs tested and approved for use by adults may be prescribed for children under the "off-label" privilege, which allows doctors to prescribe drugs for uses other than those for which they received Food and Drug Administration (FDA) approval. Assuming that many illnesses follow a similar course in children and adults, doctors have often prescribed for children drugs known to be effective for adults, particularly when no specific pediatric drug exists. That this situation is potentially dangerous was acknowledged by the U.S. Congress in 1997, when it passed the Food and Drug Administration Modernization Act (FDAMA), which encouraged pediatric drug development by providing an incentive in the form of additional marketing exclusivity—in other words, an extension of the period in which no generic competition is allowed—for drugs that manufacturers agreed to test on children. The Best Pharmaceuticals for Children Act, which became law in January 2002, renewed the exclusivity provision. A so-called "Pediatric Rule," a regulation issued by the FDA requiring pediatric studies for drugs likely to be prescribed for children, is currently on hold after being struck down by a U.S. District Court. A bill passed this year by the Senate would give the FDA authority to issue such a regulation, but that legislation has not yet been passed by the House of Representatives. How well the exclusivity carrot is working out was studied by researchers who looked at whether pediatric dosage is now included on the labels of drugs often prescribed for children that previously had no such label information. A change in labeling can occur only after the manufacturer has conducted pediatric tests. The researchers found newly revised dosing and safety information on 12 drugs used for acute conditions in children, including congenital heart disease, malaria, generalized anxiety disorder, and juvenile rheumatoid arthritis. But as an accompanying editorial in the Journal pointed out, that leaves large numbers of drugs commonly prescribed for children without updated label information, implying that they have not yet been tested for pediatric use. The editorial points out that to some extent it is understandable why drugs often are not tested for children. Children consume a relatively small proportion of prescription drugs and provide less financial incentive for pharmaceutical companies to conduct studies specifically for their age group. In addition, there are serious ethical concerns around research on children, where proxy consent must be obtained from parents or guardians. And because children span a wide age range, separate studies may be needed for neonates, toddlers, and adolescents. "The current approach has yielded this critical information (safety, effectiveness, and dosage) for only a fraction of the medications commonly used for children," the editorial points out. Also, patent exclusivity applies only to newly developed drugs, leaving unexamined the many drugs for which patents have already expired. It’s time for everyone—legislators, pharmaceutical manufacturers,
and clinicians--to get together to "collect the necessary scientific
data necessary to learn what works and what does not," the editorial
says. "The too-long deferred goal of having adequate information
on pharmaceuticals for children," should be achieved, and "the
era of prescribing for children by trial and error should come to an
end." The research report, "Pediatric Drug Labeling: Improving the
Safety and Efficacy of Pediatric Therapies," and the editorial,
"Ensuring Safe and Effective Medications for Children," appeared
in the August 20, 2003, issue of the Journal of the American Medical
Association. Institute of Medicine Warns of Problems with Vaccine Supply Asked to come up with a plan for assuring that vaccines will be available in the future for American children, the Institute of Medicine (IOM), which advises the federal government on medical matters, said in August that there are "a host of problems" in the current immunization system and "new difficulties loom on the horizon." Immunization rates for young children have achieved an all-time high, but structural and financial problems plague the vaccine supply system, as exemplified by recent shortages of 8 of the 11 routine childhood vaccines. Those shortages caused serious delays in immunization, and there was much confusion when the vaccines finally became available, as pediatricians and public health officials tried to recall patients to receive missed immunizations. The shortages "highlighted the fragility of vaccine supply," the IOM said. For example, only five companies manufacture vaccines today, compared to 25 companies 30 years ago, and there is nothing to prevent any of the remaining companies from dropping vaccine production completely or falling behind schedule on production. Currently, public funds pay for more than half of all childhood vaccine purchases, and U.S. government purchasing policies have sought to limit the cost of vaccines, thereby reducing financial incentives for pharmaceutical companies to engage in vaccine production. Add to that the fact that there are more recommended childhood vaccinations now than ever before, and new immunizations are in the research pipeline for diseases such as Lyme disease and HIV. Problems also exist in the delivery of vaccines to the public. Nearly 11 percent of children in the United States have insurance that does not include coverage for vaccinations, and others face substantial co-payments and deductions. The financial burden can be considerable for young families--the cost of immunizing children with the 20 recommended doses of vaccines at discounted government prices has jumped from $200 to $400 per child since 1997, and the costs for private sector providers are even higher—around $600 per child. Today, a single shot of peumococcal conjugate vaccine, for example, costs $50, and that’s just one of the four doses needed over an 18-month period. "Immunization is falling between the cracks in an increasingly fragmented health finance system," the IOM charged. "Although many different sources of public funding for immunization exist—including the Vaccinations for Children program(VFC), the State Children’s Health Insurance Program (SCHIP), and individual state programs—each program has different eligibility requirements. Children who have health insurance plans that do not include immunization can receive vaccines in the private physician’s office in some states, but not in others. All Medicaid-eligible children are covered under the VFC, but the working poor who are enrolled in stand-alone SCHIP programs, such as California’s, are not. Providers must store different stocks of the same vaccine according to the source of payment and eligibility and spend time monitoring inventory for different sponsors rather than simply providing the vaccines to all in need. And the fees that clinicians receive for administering vaccines no longer are adequate to cover all the different procedures involved with immunization—compiling the patient’s history, explaining the benefits and risks of certain vaccines, maintaining records for each vaccine series, and monitoring incidents of adverse effects that are rare but need to be recorded." Addressing itself to the single issue of how to finance immunization, the Institute of Medicine recommended:
The Institute of Medicine is also calling for changes in the composition and decision-making process of the Advisory Committee on Immunization Practices, which recommends the annual childhood immunization schedule, as well as nationwide "stakeholder deliberations and vigorous debate" to discuss and formulate solutions for the various immunization problems. The full text of the Institute of Medicine report, "Financing
Vaccines in the 21st Century: Assuring Access and Availability,"
is available online at http://nationalacademies.org/topnews
More parents are turning to herbal remedies, both to maintain their children’s health and to treat illnesses. If parents ask schools to administer such alternative substances to children during school hours, what do school health and administrative personnel need to know about them? Herbal remedies are part of what is termed "complementary and alternative medicine," or CAM, which the National Center for Complementary and Alternative Medicine in the National Institutes of Health defines as "a broad domain of healing resources that encompasses all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period." CAM is widely practiced in the United States, with an estimated 425 million visits annually to providers of unconventional therapies, compared with an estimated 388 million visits to primary care physicians. Americans spent more than $5.1 billion on herbal products and $1.7 billion on dietary supplements in 1997, and it’s believed those figures are much higher now. So what, exactly, is an "herbal remedy"? As the name implies, says the American Academy of Pediatrics, it is an herb used for medicinal purposes, and it may be the leaves, flowers, stems, roots, seeds, or berries of a plant. The substance may be taken internally as pills or powders, dissolved into tinctures or syrups or brewed in teas, or it may be applied to the skin, scalp, or mucous membranes in the form of a salve, ointment, shampoo, or poultice. Many pharmaceuticals in use today were originally derived from plant sources (salicylates from willow bark, quinine from cinchona, digitalis from foxgloves leaves), and that suggests that some herbs may prove to be effective for treating medical diseases, say researchers writing in the July 2003 issue of the journal Pediatrics. But most herbal remedies widely marketed today have never been subjected to rigorous clinical trials to determine if they are effective—or safe--because Congress in 1994 exempted herbal products and dietary supplements from the kind of review and testing by the Food and Drug Administration (FDA) that drugs must pass before they can be marketed. That law, the Dietary Supplement Health and Education Act (DSHEA) "requires no testing of safety and efficacy for herbal products and dietary supplements, specifies few restrictions on product claims or controls on product purity or ingredients, and requires no postmarket surveillance," the researchers point out. DSHEA also makes no provision for centralized reporting of adverse events, though the FDA tracks such events as part of its MedWatch telephone line (800-FDA-0178), and local poison control centers will take reports of adverse herbal-related events. The fact that there are no quality controls on herbal remedies leaves open a number of possibilities, the report notes. For one, plants vary widely in the amount of an allegedly beneficial substance they contain, according to where they grew, the weather in the growing season, time of harvest, soil composition, etc. Once harvested, the leaves, roots, or other elements can then be mixed with others, adulterated, or contaminated, making a given dose of an herbal "variable and unpredictable," a special concern where children are concerned. In advice to clinicians who may be asked to about herbal remedies for children, the researchers suggest parents should be cautioned not to equate "natural" with "safe." Also, parents should be urged to inform the clinician of any herbal remedy or dietary supplement they are giving their children, particularly if the child also receives a prescribed or over-the-counter drug. The article "Herbal Remedies and Children: Do They Work? Are They Harmful?" appeared in the July 2003 issue of the journal Pediatrics. The article notes that information about herbal remedies is available from a variety of sources including: National Center for Complementary and Alternative Medicine (www.nccam.nih.gov)
-------------------------------------------------- Survey Finds Stress, Boredom, Too Much Spending Money Lead to Drug Use High stress, boredom, and too much spending money are "a catastrophic combination" for many American teens that can lead to drug abuse and addiction, according to the National Center on Addiction and Substance Abuse (CASA) at Columbia University. A survey of the attitudes of adolescents and parents concluded that those factors explain why some teens who don’t exhibit the usual warning signs—they haven’t been sexually or physically abused, don’t have a learning disability or eating disorder, and aren’t suffering from depression or other serious mental disorder—often turn to potentially addictive drugs and become serious users and abusers. As one example, the survey found that teens with more than $25 a week in spending money are nearly twice as likely as teens with less money to drink, smoke, and use illegal drugs, and are more than twice as likely to get drunk. The eighth national survey by CASA of American attitudes on substance abuse, "Teens and Parents," is available online at www.casa.columbia.org. Giving Preschoolers Sugary Drinks May Cause Later Cavities Dental caries is a common disease of childhood, and researchers have now found that frequent use of sugar-laden liquids, such as soda pop and many fruit juices, by children two or three years of age is a good predictor of cavities by school age. Milk, on the other hand, had "a neutral association" with caries. Researchers said their data support contemporary dietary guidelines for preschool children, which call for two or more servings of dairy foods daily, limit intake of 100 percent juice to four to six ounces daily, and restrict other sugared beverages to occasional use. The research report, "Dental Caries and Beverage Consumption in Young Children," appeared in the September 2003 issue of the journal Pediatrics. Researchers Find SSRI Effective for Major Depression in Children One of the popular medications known collectively as selective serotonin reuptake inhibitors has been found to be slightly more effective than a placebo in treating major depressive symptoms in children and adolescents. The study of Zoloft, an SSRI manufactured by Pfizer, who financed the study, was carried out from December 1999 to May 2001 at 53 medical centers in the United States, Canada, India, Costa Rica, and Mexico and involved children 6 to 17 years of age who had been suffering from diagnosed clinical depression of at least moderate severity for at least six weeks. It is believed to be the first published research on the effects of SSRIs on childhood depression. Two other selective serotonin reuptake inhibitors—Prozac and Paxil--are currently used to treat depression in adults and children, but one of them—Paxil—is under investigation in Great Britain and the United States after reports that it increased suicidal thinking in young patients. The research report on Zoloft appeared in the August 27 issue of the Journal of the American Medical Association. August News Alerts The following information appeared in August 2003 in the News Alerts section of this website. HHS Distributes Tips for Patients on Health Care Safety The Agency for Healthcare Research and Quality in the U.S. Department of Health and Human Services, in cooperation with the American Medical Association and the American Hospital Association, is distributing posters and fact sheets for patients with tips that individuals can use to help assure the safety of the medical care they receive. The materials, available in both English and Spanish, are intended to improve communication between health care providers and patients in today’s increasingly complex health care system. Copies of "5 Steps to Safer Health Care" are available on the Internet in English at www.ahrq.gov/consumer/5steps.htm or in Spanish at www.ahrq.gov/consumer/cincorec.htm Journal Offers School-Based Intervention for Stress Disorders A school-based intervention for reducing children’s symptoms of post-traumatic stress disorder and depression resulting from exposure to violence was posted free on the August 6, 2003, issue of the Journal of the American Medical Association (JAMA). Researchers who conducted a randomized controlled trial of sixth graders in Los Angeles during school year 2000-2001 describe the components of the interventions and its results. To access the article, go to website www.jama.ama-assn.org, then to "Table of Contents" and check for article "A Mental Health Intervention for Schoolchildren Exposed to Violence." Minnesota to Insure Unborn Children under SCHIP Minnesota has become the fourth state to take advantage of a new U.S. Health and Human Services (HHS) regulation that allows states to provide prenatal services to pregnant women and their unborn children under the State Children’s Health Insurance Program (SCHIP). The option allows states to expand coverage to the women and to their unborn children who would otherwise be eligible for SCHIP or Medicaid only after they were born. Illinois, Michigan, and Rhode Island are the other three states to offer this coverage. In Minnesota, the SCHIP coverage will be available to women with family incomes up to and including 275 percent of the federal poverty level. Once enrolled, women will receive the standard Medicaid benefit package that includes prenatal care for the mother and her unborn child. Once born, the child will be evaluated for SCHIP or Medicaid eligibility and enrolled in the appropriate program. In an announcement of Minnesota’s plans today, HHS noted that substantial portions of available funds for SCHIP are still unused by states. Medical Institute Recommends against Smallpox Vaccination The National Institute of Medicine, which advises the federal government on medical issues, is recommending to the Centers for Disease Control and Prevention (CDC) that efforts to vaccinate the general public and large numbers of health workers against smallpox should be put on hold. Instead, the IOM said, the emphasis in protecting against a possible terrorist smallpox attack should be on coordinating a public health response to the threat. Calling the smallpox vaccine dangerous to those who receive it and persons with whom they may be in contact, the IOM concluded that the threat of a smallpox terrorist attack is too small to warrant widespread vaccination at this time. Although the U.S. military has completed vaccination of 480,000 members of the armed services, a program to vaccinate civilian health workers has lagged, with only an estimated 38,000 of an expected 500,000 emergency health workers now immunized. In a shift from earlier emphasis, the IOM is now suggesting that the CDC should concentrate on developing a flexible and rapid response to a threat of smallpox or any other health hazard. "Smallpox is not the only threat to the nation’s health, and vaccination is not the only tool for preparedness," said the chairman of the IOM committee that prepared the report. The full text of the smallpox recommendations is available online at www.nationalacademies.org/topnews. Satellite Broadcast on Immunization A satellite broadcast on immunization sponsored by the Centers for Disease Control and Prevention (CDC) is available for viewing at www.phppo.cdc.gov/PHTN/webcast/imm-up2003, with topics including influenza vaccine (including recommendations for use of the new live attenuated intranasal vaccine); pneumococcal conjugate vaccine; hepatitis B vaccine; recommendations for the use of new pediatric combination vaccines; an update on the smallpox vaccination program, including recommendations for the use of smallpox vaccine to prevent monkeypox; and an update on global poliomyelitis eradication. Children Ages 9-13 Report Little After-School Physical Activity A survey of children aged 9-13 years and their parents found that 61 percent of children of these ages do not participate in any organized physical activity during their after-school hours or on weekends, and 23 percent do not engage in free-time physical activity during those hours. Intended to develop baseline information for an ongoing campaign by the Centers for Disease Control and Prevention (CDC) to increase the physical activity of middle-schoolers, the survey did not ask children or parents about in-school exercise. For purposes of the survey, "organized physical activity" was defined as "with an organized group that has a coach, instructor, or leader" and free-time activity included any pursuit children engaged in on their own. Across age groups, race/ethnicity, and gender, the three organized activities engaged in most by children 9-13 years old were basketball, softball/baseball, and soccer. Most popular free-time activities were bicycle riding and playing basketball. When asked about barriers to their children’s participation in any of these activities, parents cited transportation problems, lack of opportunities for exercise in their areas, expense, lack of parental time, and concerns about neighborhood safety. The CDC initiated a media campaign—"VERB—It’s What You Do"—in October last year, using ads that portray physical activity as "cool" fun. Information about the campaign is available at www.verbnow.com for children and www.verbparents.com for parents. |