Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making.

The Food and Drug Administration is tasked with evaluating the efficacy and safety of a drug. Despite having a regimented appraisal process in place, safety evidence can emerge during clinical trials as well as from observations and studies conducted after the drug has been on the market, which might require a boxed warning. The boxed warning is the most severe warning that the Food and Drug Administration can give to an approved drug.

Prevalence of potential nonallergic rhinitis at a community-based sleep medical center.

Purpose: Nonallergic rhinitis (NAR) is a common condition involving symptomatic nasal congestion, stuffiness, or rhinorrhea, which overlap with symptoms of allergic rhinitis. Scant research has examined NAR and sleep. The aim of this study was to assess the frequency of potential NAR symptoms in a large sample of sleep center patients.

Allergy immunotherapy safety: location matters!

Allergy immunotherapy is a highly effective therapy that has been used in the treatment of allergic rhinitis, asthma, and venom allergy for over a century. Subcutaneous immunotherapy (SCIT) is currently the only US Food and Drug Administration approved form of allergy immunotherapy. In this commentary, we address the safety issues that surround the location of care of SCIT administration in a supervised medical facility versus in the home or other medically unsupervised facility.

Federal guidelines update.

This article reviews laws and regulations that were introduced recently and that will see special application for the allergist/immunologist in 2005. The current work plan of the Office of Inspector General of the Department of Health and Human Services is analyzed New implications of the Medicare Modernization Act of 2003, Health Insurance Portability and Accountability Act (HIPAA) security standards, the Administrative Simplification Compliance Act provider identifier number, and Stark II regulations deserve attention.

Complying with federal guidelines: Medicare Prescription Drug, Improvement, and Modernization Act of 2003: amendments to Social Security Act.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 is the most comprehensive health legislation since the initiation of Medicare. It has many other ramifications in addition to establishing a prescription drug payment. This review outlines the prescription drug benefit and attempts to extract the topics important to practicing physicians from the other eleven titles.

How to avoid fraud and abuse by following compliance guidelines.

Rules of the Health Care Financing Administration, United States Department of Health and Human Services, are reviewed as applied to fraud and abuse. The voluntary compliance guidelines that were released by the Office of the Inspector General in October, 2000 are also reviewed. The author demonstrates that the practicing physician can use these guidelines to enhance a medical practice and protect practitioners from accusations of fraud and abuse.

Mite, cat, and cockroach exposure, allergen sensitisation, and asthma in children: a case-control study of three schools.

Background: The amount of allergen necessary to sensitise genetically "at risk" children is unclear. The relation between allergen exposure and asthma is also uncertain.

Methods: To ensure a wide range of allergen exposures the data from case-control studies of asthma in children aged 12-14 years attending three schools in Los Alamos, New Mexico and Central Virginia were combined.

Quantitative assessment of exposure to dog (Can f 1) and cat (Fel d 1) allergens: relation to sensitization and asthma among children living in Los Alamos, New Mexico.

Background: Our objective was to identify the allergens associated with asthma among schoolchildren in an area of the United States where dust mite growth is expected to be poor. Los Alamos, N.M.

Association of asthma with serum IgE and skin test reactivity to allergens among children living at high altitude. Tickling the dragon's breath.

Asthma in children and young adults is strongly associated with immediate hypersensitivity to indoor allergens, notably those derived from the house dust mite. In addition, outdoor air pollution is considered to aggravate existing asthma. We investigated the prevalence of asthma and the pattern of allergen sensitization in a mite-free environment with low levels of outdoor air pollution.

Dog and cat allergens and asthma among school children in Los Alamos, New Mexico, USA: altitude 7,200 feet.

A survey of the Middle School in Los Alamos, N.M., USA, identified 57 children with symptoms of asthma and 54 controls.