From the Feds. Agency for Healthcare Research and Quality (AHRQ) Author: Laurie Flaherty, RN, MS, Washington, DC

Transcription

1 From the Feds Author: Laurie Flaherty, RN, MS, Washington, DC DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration (FDA) First pneumococcal vaccine approved for infants and toddlers. The FDA recently approved the first vaccine to prevent invasive pneumococcal diseases in infants and toddlers. The vaccine prevents invasive diseases such as bacteremia and meningitis, which are caused by the organism Streptococcus pneumoniae, also known as pneumococcus. It is estimated that approximately 16,000 cases of pneumococcal bacteremia occur every year among children younger than age 5 years. Each year, approximately 1400 children contract pneumococcal meningitis, with children younger than age 2 at greatest risk. In up to half of the cases of meningitis, brain damage and hearing loss occur, and about 10% of children die as a result of contracting the infectious disease. The vaccine will be marketed with the name Prevnar by Wyeth-Ayerst Laboratories, a division of American Home Products Corporation in Philadelphia, Pa. The vaccine targets the 7 most common strains of pneumococcus that account for 80% of invasive disease in infants. Children can receive Prevnar as a series of 4 inoculations administered at 2, 4, 6, and 12 to 15 months of age. This vaccine is not indicated for use in adults or as a substitute for other pneumococcal vaccines approved for high-risk children older than 2 years of age. Its effectiveness in preventing ear infections (another infection caused by pneumococcus) has not been evaluated by the FDA. The clinical trials for this vaccine were controlled and double-blinded and enrolled approximately 38,000 children, approximately half of whom received Laurie Flaherty, Mid-Maryland Chapter, is Emergency Nurse at Suburban Hospital, Bethesda, Md, and a Contract Employee of the National Highway Traffic Safety Administration in Washington, DC. For reprints, write: Laurie Flaherty, RN, MS, 3519 Rittenhouse St, NW, Washington, DC 20015; lflaherty@nhtsa.dot.gov. J Emerg Nurs 2000;26: Copyright 2000 by the Emergency Nurses Association /2000 $ /9/ doi: /men Prevnar. The vaccine, given at 2, 4, 6, and 12 to 15 months of age, was 100% effective in preventing invasive pneumococcal disease caused by the 7 strains of pneumococcus in the vaccine and 90% effective in preventing invasive disease for illnesses caused by all pneumococcal subtypes. Adverse effects were generally mild and included site reactions, irritability, drowsiness, and decreased appetite. Approximately 21% of children experienced fevers higher than F, compared with 14% in the control group that did not receive Prevnar. Researchers urged paramedics to stop using ETI and replace it with BVM to minimize health risks to children, especially because no superiority was demonstrated for ETI as a life-saving intervention. Agency for Healthcare Research and Quality (AHRQ) Research shows simple resuscitation method as best for children in out-of-hospital settings. AHRQ, in collaboration with Health Resources and Services Administration s Maternal and Child Health Bureau, has released the results of a recent study showing bag-valve-mask ventilation (BVM) to be as effective as BVM followed by endotracheal intubation (ETI) in saving the lives of children who have stopped breathing. This 3-year study of 830 patients was conducted at Harbor-UCLA Medical Center in Los Angeles, in cooperation with the emergency medical services agencies of Los Angeles and Orange Counties. It is the first controlled study comparing BVM and ETI in either adults or children, even though both interventions are widely August

2 JOURNAL OF EMERGENCY NURSING/Flaherty used by prehospital personnel and are taught in 97% of paramedic training schools. Researchers compared how the 2 types of emergency breathing affected survival and neurologic outcomes, such as coma or mild to severe disability, in children who stopped breathing because of injury, choking, or critical illness. The children, ranging in age from infants to 12 years old or weighing less than 80 pounds, were assigned to receive either BVM or BVM followed by ETI. More than 2500 licensed paramedics in Los Angeles and Orange Counties received pediatric airway management training prior to the study. The study found no significant difference in survival or in achieving positive outcomes among children receiving either procedure. Because of the potential complications of ETI, including misplacement or dislodgment of the tube, researchers questioned its use and determined that the less risky BVM should be the only paramedic procedure used to keep children who need artificial respiration alive on their way to the hospital. Researchers recommended that ETI be performed in the more controlled hospital setting by anesthesiologists. Researchers urged paramedics to stop using ETI and replace it with BVM to minimize health risks to children, especially because no superiority was demonstrated for ETI as a life-saving intervention. Dr Marianne Gausche was the lead author on the study, entitled Out-of-Hospital Pediatric Endotracheal Intubation The Effect on Survival and Neurological Outcome: A Controlled Clinical Trial, which was published in the Journal of the American Medical Association. Report issued on health care of America s children. AHRQ has released an annual report on access to and use of health care by children and youths in the United States. The report quantifies the most frequent causes of hospitalization and tracks health status with health insurance coverage. The report gathers its data from 2 sources, the Medical Expenditure Panel Survey and the Healthcare Cost and Utilization Project, which to date have not been widely used by the child health research community. The Medical Expenditure Panel Survey contains a level of detail and breadth that is far greater than that of other surveys of health insurance in the United States, and the Healthcare Cost and Utilization Project data used for 1996 comprised more than half of all hospital discharge abstracts in the United States for that year. The report yielded some interesting results. During 1996, children and youths younger than 18 years of age accounted for 17.7% of hospitalizations in the United States, the majority of which were among infants less than 1 year of age. With the exception of infants, about 40% of children and youth were admitted through the emergency department. The principle diagnoses varied by age: Infections and perinatal problems predominated during infancy. Infections and asthma contributed to more than half of all hospitalizations in the 1- to 4-year-old age group. Asthma, injuries, and mental health problems accounted for more hospitalizations of children older than age 5 years than any other conditions. Youths 15 to 17 years of age were hospitalized mostly for problems related to pregnancy and childbearing. Overall, children in excellent or good health were more likely than children in fair or poor health to have private health insurance. Although nearly 90% of children had either private or public insurance for some period of time during 1996, the report showed substantial movement of children on and off insurance. This unstable coverage may have had an effect on access to routine health care for these children. What these data did not discuss were the almost 5 million children who were eligible for public insurance programs but were not enrolled in these programs. When measured at a single point in time, the proportion of children who were uninsured climbed to 15.4%. Facts related to coverage status included the following: Hispanic children were the racial/ethnic group most likely to be uninsured (21.2%). Nearly 4 times as many black children (41.3%) as white children (11.5%) were covered by public health insurance. Children in families with single parents who were not employed were the most likely to be covered by public health insurance (83.7%). Overall, children in excellent or good health were more likely than children in fair or poor health to have private health insurance. Those children with fair or poor health were more likely to have public insurance (46.8%) when compared with children in excellent or good health (19.8%). The report did not conclude that health condition was caused by lack of coverage or 356 Volume 26, Number 4

3 Flaherty/JOURNAL OF EMERGENCY NURSING that the cost of caring for children in fair or poor health drove their family to seek public assistance. Although this report contains few surprises for persons familiar with health care access and use in children and youths, it may provide a baseline for assessing changes in this era of rapidly changing health care. It may also provide a standard against which to measure the success of programs such as the state Child Health Insurance Program. The results reported in this publication may suggest further questions to be explored in more detail and address important access and utilization issues in child health care. Copies of the Annual Report on Access to and Utilization of Health Care for Children and Youth in the United States 1999 (AHRQ 00-R014) are available from the AHRQ Publications Clearinghouse, PO Box 8547, Silver Spring, MD 20907; phone (800) , and from AHRQ InstantFAX at (301) Evaluation and comparison of β-blockers, calcium antagonists, nitrates, and alternative therapies for stable angina. Angina is a major health problem that affects more than 7 million adults in the United States, with an estimated 350,000 cases annually. Therapy to prevent symptoms of stable angina has to date consisted of one or a combination of β-blockers, calcium antagonists, and long-acting nitrates. The choice of a first-line drug has been controversial because all 3 classes have been shown to be effective in relieving symptoms. Few long-term trials compare these drugs in controlled studies, and it is not clear whether any of these drug classes decrease mortality or myocardial infarction. β-blockers were associated with fewer episodes of angina when compared with calcium antagonists in general and with nifedipine in particular. In an attempt to address these issues, the University of California, San Francisco Stanford, Evidence-based Practice Center conducted a review and synthesis of existent literature on the treatment of stable angina and developed an evidence report on the topic. The following questions defined the parameters of the investigation: 1. Is one class of anti-anginal agents superior as monotherapy in terms of occurrence of angina, nitroglycerin use, exercise tolerance, or adverse events leading to study withdrawal in patients with stable angina? 2. Is one class of drugs superior when outcomes over a long period of time such as recurrent myocardial infarction or death are examined? 3. Are any alternative medical treatments including chelation therapy, acupuncture, herbal medications, and garlic superior to placebo in any outcome measure for patients with stable angina? Investigators searched MEDLINE ( ) and EMBASE ( ) and reviewed cited references of retrieved articles to identify published studies. The review was limited to randomized controlled trials that directly compared at least 2 of the 3 major antianginal drug classes. All randomized trials of patients who had stable angina were included. Findings were as follows: β-blockers were associated with fewer episodes of angina when compared with calcium antagonists in general and with nifedipine in particular. Important differences in mortality could not be determined because the trials were short in duration (median 4 weeks). Fewer adverse events leading to study withdrawal occurred with β-blockers compared with calcium antagonists. Commonly reported adverse effects were similar or greater in the calcium antagonists group compared with the β-blocker group. There were no obvious differences in any outcome measures between β-blockers and non-nifedipine calcium antagonists. Few studies compared long-acting nitrates with β-blockers or with calcium antagonists. Randomized trials of alternative therapies for patients with stable angina were too small and too few to provide conclusive findings. Additional large randomized trials are needed to determine if clinically important differences in patient survival exist between classes of anti-anginal medication. In addition, further studies would be helpful in examining the effects of treatments for stable angina in patients with other chronic conditions, such as heart failure or chronic obstructive pulmonary disease. Further study is necessary to reach any conclusions on the efficacy or safety of alternative therapies to treat stable angina. Printed copies of the full evidence report can be obtained from the AHRQ Publications Clearinghouse by calling (800) Requesters should ask for Evidence Report/Technology Assessment Number 10, An Evaluation of Beta-blockers, Calcium Antagonists, Nitrates, and Alternative Therapies for Stable August

4 JOURNAL OF EMERGENCY NURSING/Flaherty Parental presence during invasive procedures Number of parents who want to be present during invasive procedures performed on their children in the emergency department: a survey of 400 parents Data from: Boie ET, Moore GP, Brummett C, Nelson DR. Do parents want to be present during invasive procedures performed on their children in the emergency department? A survey of 400 parents. Ann Emerg Med 1999;34:70-4. Angina (AHRQ Publication No. 00-E0003), or obtain a copy from AHRQ s Web site at clinic/index.html#evidence. Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau Emergency Medical Services for Children (EMSC) National poison control toll-free telephone number. The American Association of Poison Control Centers (AAPCC) has been awarded more than $1 million by HRSA to implement a national poison control toll-free telephone number. The funds will be used to establish the number, enhance the national data collection system for poison exposures, and develop a national public education campaign promoting poison prevention and the new toll-free number. Currently, more than 130 emergency phone numbers exist for poison centers in the United States. These centers answer more than 2 million calls every year. The number of poison centers within a state usually depends on the size of its population. For example, only one center covers the state of New Mexico, but New York City has its own poison control center. The national toll-free number will not change the operation of poison centers. Calls to the toll-free number will be routed to the nearest center, where experts will determine the potential danger associated with the call and recommend treatment. Experts will follow up with the caller to ensure that instructions were followed and to address any questions or problems. The new number, which has been selected but not publicized, will be activated this summer. For more information about AAPCC or its new project, contact Rose Ann Soloway, Associate Director of AAPCC, at ras@poison.org. The American Association of Poison Control Centers has been awarded more than $1 million by HRSA to implement a national poison control tollfree telephone number. Emergency information form unveiled for special needs children. Through a partnership with EMSC, the American Academy of Pediatrics (AAP) and the American College of Emergency Physicians (ACEP) have created an Emergency Information Form (EIF) to ensure that children with special needs receive appropriate care when a parent or pediatrician is unavailable. The 2-page document will provide emergency departments and health care professionals 358 Volume 26, Number 4

5 Flaherty/JOURNAL OF EMERGENCY NURSING with critical information about children with chronic physical, developmental, behavioral, or emotional conditions that are beyond those of normally developed children. The EIF contains the following: Parent or guardian contact information Primary care and specialty physician contact information Diagnoses Allergies Critical procedures to avoid Immunization status Life-saving maneuvers or interventions Relevant past medical history AAP and ACEP have established an agreement with the MedicAlert Foundation to use its 24-hour Emergency Response Center as a central repository for these forms, once they have been completed by the child s physician. Children who are registered with MedicAlert receive a medical identification bracelet or necklace. In the event of an illness or injury, a health care professional can call the MedicAlert Foundation toll-free from anywhere in the world to request information. Within minutes, the EIF can be faxed to the health care professional. The EIF can be downloaded from both the AAP and the ACEP Web sites at and respectively. Forms are also available in packets of 100 for a nominal fee. In addition, camera-ready forms have been published in ACEP s Annals of Emergency Medicine and AAP s Pediatrics. A Look Back: Early ligatures Surgery has played a central role in health and healing and was considered to be both a manual and magical art in the 1800s. Supplies commonplace today, such as ligatures, posed major problems for early surgeons. In 1700, threads used as sewing ligatures were not absorbed by the body and worked their way out, resulting in infections and fistulas. John Hunter s ( ) trick was to leave the ligature threads long enough that they could be pulled out later. Early ligatures were made of animal tissue or parchment. Philip Sung Physick ( ) discovered a superior material, catgut, made of sheep intestines. In the 1800s, preparing ligatures was still time consuming and cumbersome. Ligatures contained silkworm gut, silver wire, and strings or cords made from animal tissue and whalebone. These materials, though, were limited compared with violin strings. A catgut derivative, violin strings were readily available, easily prepared and preserved, and cheap. In 1887, guidelines for transforming a violin string into an antiseptic ligature were developed: Select 4 sizes of the best quality violin strings in this proportion: Violin string Amount Use E and A strings 12 each Best for smaller vessels and bleeding points D strings 6 Best adapted for large vessels (radial, ulnar, tibial) Harp strings 2 or 3 This string is twice as large as the D string and best suited for iliac, subclavian, common carotid, and femoral sutures Place the violin strings in a glass bottle or jar that contains enough pure oil of juniper berries to completely cover them. Tightly cork the bottle to prevent aspiration for 24 hours to ensure asepsis. Figure 1 represents a convenient apparatus, with a perforated cork, for storing these sutures. Threads are drawn out and cut as required. An alternative method to juniper berries was a chromic acid catgut ligature. Violin strings immersed in a chromic acid, water, and glycerine solution for 7 to 8 months and preserved in carbolic acid and glycerin would resist absorption for 20 to 60 days. Linda Manley, RN, BSN, CEN, CCRN References Haeger K. The illustrated history of surgery. New York: Bell Publishing Co; p Wyeth JA. Textbook on surgery. New York: D Appleton and Company; p August