- Email: [email protected]
From the Feds
From the Feds Section Editors: Laurie Flaherty, RN, MS, CEN, and Joan A. Snyder, RN, MS, CEN, Washington, DC, and Dahlgren, Va
DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health Federal Office of Alternative Medicine. The Office of Alternative Medicine (OAM), which is part of the National Institutes of Health (NIH), was initiated through a Congressional mandate in 1992. The purpose of the OAM is to facilitate research and evaluation of unconventional medical practices. The Office does not serve as a referral agency for alternative medical treatments or individual practitioners; however, it maintains a national clearinghouse to provide pertinent information to the public. The OAM clearinghouse develops and disseminates fact sheets, information packages, and publications to enhance public understanding about complementary and alternative health care research supported by the NIH. The OAM has funded 10 specialty referral centers to study complementary and alternative treatments for specific health conditions. The centers are to develop a prioritized research agenda, provide technical assistance, provide mechanisms for research development, and conduct collaborative research. The OAM specialty research centers are located at: • Bastyr University (Seattle)—Specialty: HIV/AIDS • Beth Israel Hospital, Harvard Medical School (Boston)—Specialty: general medical conditions • Columbia University College of Physicians and Surgeons (New York)—Specialty: women’s health issues • Kessler Institute for Rehabilitation (West Orange, NJ)—Specialty: stroke and neurologic conditions • Hennepin County Medical Center/University of Minnesota Medical School (Minneapolis)—Specialty: addictions Laurie Flaherty is Emergency Nurse at Suburban Hospital, Bethesda, Md, and a Contract Employee of the National Highway Traffic Safety Administration in Washington, DC. Joan A. Snyder is an EMS and Trauma Systems Consultant in Dahlgren, Va. For reprints, write: Laurie Flaherty, RN, MS, CEN, 3519 Rittenhouse St, NW, Washington, DC 20015. J Emerg Nurs 1998;24:574-6. Copyright © 1998 by the Emergency Nurses Association. 0099-1767/98 $5.00 + 0 18/9/93139
574 Volume 24, Number 6
• Stanford University (Palo Alto, Calif)—Specialty: aging • University of California at Davis (Sacramento)— Specialty: asthma, allergy, and immunology • University of Maryland School of Medicine (Baltimore)—Specialty: pain • University of Texas Health Science Center—Specialty: cancer • University of Virginia School of Nursing—Specialty: pain
The FDA has received 16 unduplicated reports for Viagra in which a fatal outcome occurred. These synopses include cases in which Viagra was a listed, associated drug.
The OAM also maintains a research database program that provides an infrastructure for identifying and organizing the scientific literature on complementary and alternative practices. The literature identified from the database will serve as an ongoing source of information for scientists, researchers, practitioners, and the public. The OAM has an internal research database with more than 100,000 specific citations on complementary and alternative medical topics. In its first few years of inception, the OAM funded several exploratory pilot projects to identify promising areas of future research. The Office continues to screen, prioritize, and provide technical support to the most promising domestic and international research opportunities in complementary and alternative medicine. The OAM also holds regular meetings with the Food and Drug Administration (FDA) to enlist its cooperation in re-evaluating current rules and regulations
Flaherty and Snyder/JOURNAL OF EMERGENCY NURSING
governing research on and use of devices, acupuncture needs, herbs, and homeopathic remedies. Additional information about this office can be obtained by contacting the OAM Clearinghouse at (888) 644-6226 or by visiting their Web site: http:// altmed.od.nih.gov/oam. Food and Drug Administration Synopsis of fatal outcome reports submitted to the FDA regarding the use of sildenafil citrate (Viagra). As of June 8, 1998, the FDA has received 16 unduplicated reports for Viagra in which a fatal outcome occurred. These synopses include cases in which Viagra was a listed, associated drug and do not change the FDA’s perspectives on the safety of this drug as expressed before this posting. In reviewing these reports, it is essential to remember that they are limited by incomplete reported clinical data and that no way exists to determine whether these drugs caused the reported reactions or whether the reactions were the result of some other cause, such as an underlying disease process. To summarize these reports:
tain areas of the penis, leading to an erection. The drug was evaluated in numerous, randomized, placebo-controlled trials that involved more than 3000 men with varying degrees of impotence associated with diabetes, spinal cord injury, and history of prostate surgery. These patients had a wide range of other concomitant illnesses, including hypertension and coronary artery disease. The most common side effects reported in these clinical trials were headache, flushing, and indigestion. Approximately 3% also reported changes in vision, principally altered color perception. Viagra should not be used with organic nitrates such as nitroglycerin, isosorbide, and illicit substances that contain organic nitrates (eg, amyl nitrate), because large and sudden drops in systemic blood pressure can occur. Also, because it is well documented that sexual activity generally involves an increase in cardiac work and myocardial oxygen demand, the FDA advises physicians to consider the cardiac status of patients for whom they are planning to prescribe Viagra, particularly those who take organic nitrates in any form.
Viagra should not be used with organic nitrates such as nitroglycerin, isosorbide, and illicit substances that contain organic nitrates (eg, amyl nitrate), because large and sudden drops in systemic blood pressure can occur.
Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Safety and health precautions for young workers. Results of a new study recently published in the journal Injury Prevention suggest that the 3 leading categories of work-related fatalities claim 16- and 17-year-old workers at rates higher than those for adult workers. The study examined data collected from death certificates under the National Institute for Occupational Safety and Health (NIOSH) national traumatic occupational fatality (NTOF) system for the years 1990-1992. During that time:
• Two fatalities occurred in men who had strokes. • Two fatalities occurred in men who sustained myocardial infarction. • Three reports were made of cardiopulmonary arrest. • Two fatalities occurred in men with lethal dysrrhythmias. • Three men complained of severe chest pain. • Two cases involved severe hypotension. • In several cases, no cause of death was listed, but descriptions included the sudden occurrence of symptoms such as “passing out,” “head dropping and no longer breathing,” “breathing problems,” and “sudden collapse during sexual activity.” Viagra works by enhancing the smooth muscle relaxant effects of nitric oxide, a chemical that is normally released in response to sexual stimulation. This smooth muscle relaxation allows increased blood flow into cer-
• 1.01 of every 100,000 workers aged 16 and 17 years died from work-related motor vehicle injuries, compared with 0.82 deaths per every 100,000 workers aged 35 to 44 years. • Work-related homicides claimed 0.76 per every 100,000 workers aged 16 and 17 years, compared with 0.65 of every 100,000 workers aged 35 to 44 years. • Rates in the 2 age categories for machinery-related workplace deaths were 0.57 and 0.42, respectively. Each year, 70 adolescents die from injuries at work, thousands more are hospitalized, and tens of thousands require treatment in hospital emergency departments. Given that research indicates that only one third of all persons with work-related injuries are seen in emergency departments, NIOSH estimates that nearly 200,000 adolescents experience work-related injuries annually.
December 1998 575
JOURNAL OF EMERGENCY NURSING/Flaherty and Snyder
To address this issue, NIOSH is working with US high schools to distribute a new poster and other information emphasizing safety and health at work for students under 18 years of age. NIOSH is distributing the poster to every high school in the United States, along with copies of a pamphlet, “Are You a Working Teen? What You Should Know About Safety and Health on the Job.” The poster reminds young workers that they have a right to safe and healthy workplaces, including safety clothing, equipment, and training, and the right to know about and be protected from hazards. The pamphlet provides further information about types of hazards to which young workers could be exposed, restrictions on hours and types of work, and resources for further help. Types of work that are especially hazardous to adolescents include working in or around motor vehicles, operating tractors and other heavy equipment, working near electrical hazards, working in retail and service industries in which the risk of robbery-related homicide exists, working around cooking appliances, and continuous manual lifting or the lifting of heavy objects. Young workers may be at particular risk because of inexperience, absence of meaningful safety training, lack of appropriate supervision, learning unsafe work practices from coworkers, and failure of parents, employers, or educators to recognize hazardous or prohibited work tasks. For copies of the young worker poster, DHHS (NIOSH) Publication No. 98-120, and the pamphlet “Are You a Working Teen?”, DHHS (NIOSH) Publication No. 97-132, call 1 (800) 35-NIOSH, or visit the NIOSH web site at www.cdc.gov/niosh.
INDEPENDENT FEDERAL AGENCY Consumer Product Safety Commission Study results show link of soft bedding to infant deaths. According to a recent study conducted by the Consumer Product Safety Commission (CPSC), soft bedding should not be placed under infants, regardless of the way they are placed to sleep, because it has the potential to cover their noses and mouths, blocking their airways. The study, published in the June 1998 issue of the American Medical Association’s Archives of Pediatrics and Adolescent Medicine, examined 206 cases of sudden infant death syndrome to discover what factors were associated with the cause of death. In 30% of these cases, the infants were found with their noses and mouths covered by soft bedding. Most of the infants had been placed on their stomachs to sleep and were found lying face down on top of pillows, comforters, or other bedding with
576 Volume 24, Number 6
enough softness to allow a pocket to form beneath the infant’s head. Pillows were often adult-sized, and comforters were usually placed beneath the infant for additional comfort. Regardless of the original sleep position, however, the researchers found that soft bedding was dangerous. Nine infants in the study had turned from either their backs or their sides onto their stomachs and were found with their airways covered.
Soft bedding should not be placed under infants, regardless of the way they are placed to sleep, because it has the potential to cover their noses and mouths, blocking their airways.
After the deaths of 2 infants in Maryland from suffocation, the CPSC reissued its warning to include putting infants to sleep on top of adult beds. Press reports indicate that on May 13, 1998, two 5-month old boys apparently suffocated on an adult bed with soft bedding while at a home day-care center. Infants should never be put to sleep on top of soft bedding. Whether it is used on cribs or adult beds, soft bedding, such as comforters, pillows, and sheepskins, can mold itself around the infant’s face. In addition, infants placed on adult beds can become wedged between the mattress and the bed frame or wall or between the bed and adjacent pieces of furniture. CPSC and the collaborating researchers from the University of Maryland and Washington University School of Medicine in St Louis recommend the following safety guidelines for infants less than 8 months old: • Place infants to sleep on a firm, flat mattress, in a crib that meets federal safety standards and industry voluntary standards. • Do not place soft, fluffy products, such as pillows, comforters, or sheepskins, under infants while they sleep or nap. • Never place infants to sleep on adult beds, youth beds, waterbeds, day beds, or bunk beds. • Place healthy infants on their backs to sleep, as recommended by the American Academy of Pediatrics.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health Federal Office of Alternative Medicine. The Office of Alternative Medicine (OAM), which is part of the National Institutes of Health (NIH), was initiated through a Congressional mandate in 1992. The purpose of the OAM is to facilitate research and evaluation of unconventional medical practices. The Office does not serve as a referral agency for alternative medical treatments or individual practitioners; however, it maintains a national clearinghouse to provide pertinent information to the public. The OAM clearinghouse develops and disseminates fact sheets, information packages, and publications to enhance public understanding about complementary and alternative health care research supported by the NIH. The OAM has funded 10 specialty referral centers to study complementary and alternative treatments for specific health conditions. The centers are to develop a prioritized research agenda, provide technical assistance, provide mechanisms for research development, and conduct collaborative research. The OAM specialty research centers are located at: • Bastyr University (Seattle)—Specialty: HIV/AIDS • Beth Israel Hospital, Harvard Medical School (Boston)—Specialty: general medical conditions • Columbia University College of Physicians and Surgeons (New York)—Specialty: women’s health issues • Kessler Institute for Rehabilitation (West Orange, NJ)—Specialty: stroke and neurologic conditions • Hennepin County Medical Center/University of Minnesota Medical School (Minneapolis)—Specialty: addictions Laurie Flaherty is Emergency Nurse at Suburban Hospital, Bethesda, Md, and a Contract Employee of the National Highway Traffic Safety Administration in Washington, DC. Joan A. Snyder is an EMS and Trauma Systems Consultant in Dahlgren, Va. For reprints, write: Laurie Flaherty, RN, MS, CEN, 3519 Rittenhouse St, NW, Washington, DC 20015. J Emerg Nurs 1998;24:574-6. Copyright © 1998 by the Emergency Nurses Association. 0099-1767/98 $5.00 + 0 18/9/93139
574 Volume 24, Number 6
• Stanford University (Palo Alto, Calif)—Specialty: aging • University of California at Davis (Sacramento)— Specialty: asthma, allergy, and immunology • University of Maryland School of Medicine (Baltimore)—Specialty: pain • University of Texas Health Science Center—Specialty: cancer • University of Virginia School of Nursing—Specialty: pain
The FDA has received 16 unduplicated reports for Viagra in which a fatal outcome occurred. These synopses include cases in which Viagra was a listed, associated drug.
The OAM also maintains a research database program that provides an infrastructure for identifying and organizing the scientific literature on complementary and alternative practices. The literature identified from the database will serve as an ongoing source of information for scientists, researchers, practitioners, and the public. The OAM has an internal research database with more than 100,000 specific citations on complementary and alternative medical topics. In its first few years of inception, the OAM funded several exploratory pilot projects to identify promising areas of future research. The Office continues to screen, prioritize, and provide technical support to the most promising domestic and international research opportunities in complementary and alternative medicine. The OAM also holds regular meetings with the Food and Drug Administration (FDA) to enlist its cooperation in re-evaluating current rules and regulations
Flaherty and Snyder/JOURNAL OF EMERGENCY NURSING
governing research on and use of devices, acupuncture needs, herbs, and homeopathic remedies. Additional information about this office can be obtained by contacting the OAM Clearinghouse at (888) 644-6226 or by visiting their Web site: http:// altmed.od.nih.gov/oam. Food and Drug Administration Synopsis of fatal outcome reports submitted to the FDA regarding the use of sildenafil citrate (Viagra). As of June 8, 1998, the FDA has received 16 unduplicated reports for Viagra in which a fatal outcome occurred. These synopses include cases in which Viagra was a listed, associated drug and do not change the FDA’s perspectives on the safety of this drug as expressed before this posting. In reviewing these reports, it is essential to remember that they are limited by incomplete reported clinical data and that no way exists to determine whether these drugs caused the reported reactions or whether the reactions were the result of some other cause, such as an underlying disease process. To summarize these reports:
tain areas of the penis, leading to an erection. The drug was evaluated in numerous, randomized, placebo-controlled trials that involved more than 3000 men with varying degrees of impotence associated with diabetes, spinal cord injury, and history of prostate surgery. These patients had a wide range of other concomitant illnesses, including hypertension and coronary artery disease. The most common side effects reported in these clinical trials were headache, flushing, and indigestion. Approximately 3% also reported changes in vision, principally altered color perception. Viagra should not be used with organic nitrates such as nitroglycerin, isosorbide, and illicit substances that contain organic nitrates (eg, amyl nitrate), because large and sudden drops in systemic blood pressure can occur. Also, because it is well documented that sexual activity generally involves an increase in cardiac work and myocardial oxygen demand, the FDA advises physicians to consider the cardiac status of patients for whom they are planning to prescribe Viagra, particularly those who take organic nitrates in any form.
Viagra should not be used with organic nitrates such as nitroglycerin, isosorbide, and illicit substances that contain organic nitrates (eg, amyl nitrate), because large and sudden drops in systemic blood pressure can occur.
Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Safety and health precautions for young workers. Results of a new study recently published in the journal Injury Prevention suggest that the 3 leading categories of work-related fatalities claim 16- and 17-year-old workers at rates higher than those for adult workers. The study examined data collected from death certificates under the National Institute for Occupational Safety and Health (NIOSH) national traumatic occupational fatality (NTOF) system for the years 1990-1992. During that time:
• Two fatalities occurred in men who had strokes. • Two fatalities occurred in men who sustained myocardial infarction. • Three reports were made of cardiopulmonary arrest. • Two fatalities occurred in men with lethal dysrrhythmias. • Three men complained of severe chest pain. • Two cases involved severe hypotension. • In several cases, no cause of death was listed, but descriptions included the sudden occurrence of symptoms such as “passing out,” “head dropping and no longer breathing,” “breathing problems,” and “sudden collapse during sexual activity.” Viagra works by enhancing the smooth muscle relaxant effects of nitric oxide, a chemical that is normally released in response to sexual stimulation. This smooth muscle relaxation allows increased blood flow into cer-
• 1.01 of every 100,000 workers aged 16 and 17 years died from work-related motor vehicle injuries, compared with 0.82 deaths per every 100,000 workers aged 35 to 44 years. • Work-related homicides claimed 0.76 per every 100,000 workers aged 16 and 17 years, compared with 0.65 of every 100,000 workers aged 35 to 44 years. • Rates in the 2 age categories for machinery-related workplace deaths were 0.57 and 0.42, respectively. Each year, 70 adolescents die from injuries at work, thousands more are hospitalized, and tens of thousands require treatment in hospital emergency departments. Given that research indicates that only one third of all persons with work-related injuries are seen in emergency departments, NIOSH estimates that nearly 200,000 adolescents experience work-related injuries annually.
December 1998 575
JOURNAL OF EMERGENCY NURSING/Flaherty and Snyder
To address this issue, NIOSH is working with US high schools to distribute a new poster and other information emphasizing safety and health at work for students under 18 years of age. NIOSH is distributing the poster to every high school in the United States, along with copies of a pamphlet, “Are You a Working Teen? What You Should Know About Safety and Health on the Job.” The poster reminds young workers that they have a right to safe and healthy workplaces, including safety clothing, equipment, and training, and the right to know about and be protected from hazards. The pamphlet provides further information about types of hazards to which young workers could be exposed, restrictions on hours and types of work, and resources for further help. Types of work that are especially hazardous to adolescents include working in or around motor vehicles, operating tractors and other heavy equipment, working near electrical hazards, working in retail and service industries in which the risk of robbery-related homicide exists, working around cooking appliances, and continuous manual lifting or the lifting of heavy objects. Young workers may be at particular risk because of inexperience, absence of meaningful safety training, lack of appropriate supervision, learning unsafe work practices from coworkers, and failure of parents, employers, or educators to recognize hazardous or prohibited work tasks. For copies of the young worker poster, DHHS (NIOSH) Publication No. 98-120, and the pamphlet “Are You a Working Teen?”, DHHS (NIOSH) Publication No. 97-132, call 1 (800) 35-NIOSH, or visit the NIOSH web site at www.cdc.gov/niosh.
INDEPENDENT FEDERAL AGENCY Consumer Product Safety Commission Study results show link of soft bedding to infant deaths. According to a recent study conducted by the Consumer Product Safety Commission (CPSC), soft bedding should not be placed under infants, regardless of the way they are placed to sleep, because it has the potential to cover their noses and mouths, blocking their airways. The study, published in the June 1998 issue of the American Medical Association’s Archives of Pediatrics and Adolescent Medicine, examined 206 cases of sudden infant death syndrome to discover what factors were associated with the cause of death. In 30% of these cases, the infants were found with their noses and mouths covered by soft bedding. Most of the infants had been placed on their stomachs to sleep and were found lying face down on top of pillows, comforters, or other bedding with
576 Volume 24, Number 6
enough softness to allow a pocket to form beneath the infant’s head. Pillows were often adult-sized, and comforters were usually placed beneath the infant for additional comfort. Regardless of the original sleep position, however, the researchers found that soft bedding was dangerous. Nine infants in the study had turned from either their backs or their sides onto their stomachs and were found with their airways covered.
Soft bedding should not be placed under infants, regardless of the way they are placed to sleep, because it has the potential to cover their noses and mouths, blocking their airways.
After the deaths of 2 infants in Maryland from suffocation, the CPSC reissued its warning to include putting infants to sleep on top of adult beds. Press reports indicate that on May 13, 1998, two 5-month old boys apparently suffocated on an adult bed with soft bedding while at a home day-care center. Infants should never be put to sleep on top of soft bedding. Whether it is used on cribs or adult beds, soft bedding, such as comforters, pillows, and sheepskins, can mold itself around the infant’s face. In addition, infants placed on adult beds can become wedged between the mattress and the bed frame or wall or between the bed and adjacent pieces of furniture. CPSC and the collaborating researchers from the University of Maryland and Washington University School of Medicine in St Louis recommend the following safety guidelines for infants less than 8 months old: • Place infants to sleep on a firm, flat mattress, in a crib that meets federal safety standards and industry voluntary standards. • Do not place soft, fluffy products, such as pillows, comforters, or sheepskins, under infants while they sleep or nap. • Never place infants to sleep on adult beds, youth beds, waterbeds, day beds, or bunk beds. • Place healthy infants on their backs to sleep, as recommended by the American Academy of Pediatrics.