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If a drug is not labeled for children, pediatricians are faced with two difficult choices: 1 ; not using a medication that could provide relief and help to the child because it is not labeled for use in pediatrics or 2 ; using the medication off-label based on limited studies and or the clinical experience of health professionals. BPCA and PREA have given pediatricians more information to avoid this necessary but inadequate practice. Better labeling has lead to better therapeutics for children, reducing medical errors and adverse effects. Lack of proper information for pediatric patients related to dosing, toxicity, adverse effects, drug interactions, etc. can and has lead to medical errors and potential injury. Medication errors produce a variety of problems, ranging from minor discomfort to substantial morbidity that may prolong hospitalization or lead to death. Another important factor underscoring the need for better labeling is the increasing effort of private and public payors to limit reimbursement for drugs prescribed off-label. Increased pediatric studies also encourage the creation of child-friendly drug formulations. Even the most effective drug cannot improve a child's health if the drug is unavailable in a formulation that a child can take e.g., pills vs. liquid ; or if the taste is unpalatable. Compliance with a prescription often relies on the formulation. If a parent has to struggle with the child every time a dose is needed, the likelihood of completing the full prescription to obtain maximum benefit is greatly reduced. Again, here BPCA and PREA have been successful in informing what pediatric formulations are effective for children. BPCA AND PREA ARE STILL ESSENTIAL TOOLS Despite the advances resulting from BPCA and PREA, there remains much progress to be made. Children remain second-class citizens when it comes to drug safety and efficacy information. Currently, nearly two-thirds of drugs used in children are still not labeled for children.2 Almost 80% of hospitalized children receive at least one drug prescribed to them for an off-label use.3 For children, off-label use is the rule, not the exception, because of the scarcity of prescribing information for this population. Therefore, both BPCA and PREA are still crucially important and must be reauthorized this year, including needed improvements. New drug safety legislation has been passed in the Senate and similar legislation has been introduced in the House. Such legislation is a needed complement to the tools provided by BPCA and PREA and will enhance, not duplicate, the available information families and providers have about drugs used in children. The studies generated under BPCA provide information far beyond safety and produce information on dosing, efficacy and importantly lack of efficacy in off-label use. PREA created a new presumption that all new drugs would be studied in children at the time of application thus preventing the need for a safety problem to trigger studies after the drug is on the market.
International Gorilla Conservation Programme, July 1992. Uganda Wildlife Authority. Bwindi Impenetrable National Park - Management Plan 1995-1999, ed. by Gubelman E, Schoorl J, Achoka E, March 1995. Uganda Wildlife Authority. Mgahinga Gorilla National Park - Management Plan 1996-2000, February 1996. UNICEF. Equity and Vulnerability: A Situational Analysis of Women, Adolescents and Children in Uganda. The Government of Uganda National Council for Children 1994. Ungs TJ. Airborne transmission of infectious diseases aboard aircraft. Aviat Space Environ Med 1995, 66 9 ; : 913-4 Veber B. Pulmonary tuberculosis in 1996. Recent data and practical consequences for the anesthesiologist. Ann Fr Anesth Reanim, 15 7 ; : 1080-7 1996 Vetter RT, Johnson GM. Vaccination update. Diphtheria, tetanus, pertussis, mumps, rubella, measles. Postgrad Med 1995, 98 4 ; : 133-7, 141-2, 144-5 passim Van Kruiningen, HJ, Dobbins, WO, John, G. Bacterial histiocytic colitis in a lowland gorilla Gorilla gorilla gorilla . Veterinary Pathology 1991, 28 6 : 544-6. Wallace MR, Hooper DG, Graves SJ, Malone JL. Measles seroprevalence and vaccine response in HIV-infected adults. Vaccine 1994, 12 13 ; : 1222-4. Wallis J, Lee DR. Primate Conservation and Health: II. Prevention of disease transmission. Unpublished manuscript in prep. Warren KS, Niphuis H, Heriyanto, Verschoor EJ; Swan RA, Heeney JL. Seroprevalence of specific viral infections in confiscated orangutans Pongo pygmaeus ; . Journal of Medical Primatology 1998, 27 1 ; , : 33-37. Watts DP. Strategies of habitat use by mountain gorillas. Folia Primatologica 1991, v.56, n.1: 1-16. Watts DP. Long-term habitat use by mountain gorillas Gorilla gorilla beringei. I. Consistency, variation, and home range size and stability. International Journal of Primatology, 1998, 19 4 ; : 651-680. Webster RG. Influenza virus: Transmission between species and relevance to emergence of the next human pandemic. Archives of Virology, Supplement, n.13, 1997: 105-113. Whitney RA Jr. The conservation of non-human primates and its importance to public health. Arambulo, P. III., et al. Ed. Primates of the Americas: Strategies for Conservation and Sustained Use in Biomedical Research; First Ordinary Meeting of the Regional Primatology Committee for the Americas, Seattle, Washington, USA, October 29-31, 1990. Battelle Press: Columbus, Ohio, USA. Wilson ME. Travel and the emergence of infectious diseases. Emerging Infectious Diseases 1 2 ; : 39-46. Wolfe ND, Escalante AA, Karesh WB, Kilbourn A, Spielman A, Lal AA. Wild primate populations in emerging infectious disease research: The missing link? Emerging Infectious Diseases 1998. 4 2 ; : 149-157. WHO - World Health Organization. Tuberculosis Fact Sheet. October 1998. WHO - World Health Organization Expanded Programme on Immunization EPI ; . Safety and efficacy of measles vaccine vitamin A supplementation. Wkly Epidemiol Rec 1997, 72 44 ; : 329-31 Yamagiwa, J; Mwanza, N; Spangenberg, A; Maruhashi, T; Yumoto, T; Fischer, A; Steinhauer-Burkart, B. A census of the Eastern Lowland Gorillas Gorilla g. graueri ; in Kahuzi-Biega National Park with reference to Mountain Gorillas Gorilla g. beringei ; in the Virunga Region, Zaire. Biological Conservation 1993, v.64, n.1, : 83-89 Zuckerman AJ; Thornton A; Howard CR; Tsiquaye KN; Jones DM; Brambell MR. Hepatitis B outbreak among chimpanzees at the London Zoo. Lancet 1978, 2: 652-4!

Antihypertensives in diabetes in people with diabetes, diuretics work as well as angiotensin converting enzyme inhibitors and calcium channel blockers in protecting against heart attack and improving survival, and offer more protection against congestive heart failure, an analysis of the allhat study suggests archives of internal medicine 2005; 165: 1401.

Daughter. I just kept thinking that she was unhealthy, but I never dreamed that she could have some genetic condition. On February 2, 2004, Caln was born. He is one of her biggest fans. He just loves her to bits. It was around that time we noticed that she started to lose some of her skills. She no longer fed herself, and she didn't have much to "say." We kept telling ourselves, "but she was always so sick." We continued with the neverending series of genetic testing -- for angel man's, multiple fish testing, 22 q deletion, just to name a few. Two years of testing. Two years of blood draws, and never-ending waiting for results. Two years of watching her slip away from us, little by little. She was so sad much of the time. There were days that she just cried and cried. We just couldn't do anything to comfort her sometimes. We simply watched her slip away, and there was NOTHING we could do. We were loosing her. We kept pushing her, taking her to see this doctor and that one. Doing all the therapies that we could get her involved in. She had PT, OT, DT, and Speech, all twice a week. She was a busy little girl. She was also being seen by 2 geneticists, a neurologist, and two GI doctors, every 3 months, just to name a few. As always, her pediatrician was amazing. He did everything he could, and sent us off to see someone else when he thought she.

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Even if prices are reduced funds are still needed. Financing strategies should be based on a careful consideration of the major drug-financing alternatives which include: public financing; health insurance; financing by NGOs, groups of people living with HIV and community organizations, solidarity funds and other private voluntary mechanisms; donor financing: with some exceptions bilateral and multilateral donors are turning more toward funding basic health sector reforms, and away from individual diseases and funding of recurrent costs such as drugs. Convincing arguments must be put forward to secure significant levels of funding; development loans: over the past decade World Bank lending for health has increased dramatically. Pharmaceutical lending is over US$ 300 million per year with an emphasis on providing drugs in support of broader development goals and very cost-effective drugs such as those for tuberculosis and capoten.

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