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. It is commonly referred to as a Black Box Warning because it is outlined in the package insert by a thick black box to garner the attention of prescribers and patients. There are currently more than 400 medications that have boxed warnings, and the information addressing major risks associated with a particular drug may, appropriately or inappropriately, influence patient and clinician decision making. Health care professionals must use the best evidence and clinical judgment in determining whether to prescribe medications with these warnings. Use of an approved drug at dosages or for indications other than what it was originally licensed for is referred to as "off-label" and is legal, commonplace, and may be evidence-based. All drugs may expose patients to possible harm, so prescribers have an obligation to discuss the best available evidence regarding benefits and harms so that patients can participate in shared decision making.

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. METHODS: A retrospective chart review was conducted on 2658 adult patients at our sleep center from 2008 to 2012; 1703 reported clinically relevant nasal congestion. For this subset, potential NAR status (NAR+ vs NAR-) was determined using a brief survey. NAR groups were further divided into three sub-groups based on presenting chief complaints: insomnia (INS), nonrestorative sleep (NRS), and sleep-disordered breathing (SDB). Patients objectively diagnosed with SDB were also analyzed by NAR status. Validated scales for sleepiness, insomnia, anxiety, and depression were compared among the groups. RESULTS: Potential NAR+ comprised 70 % (1194 of 1703) of patients with congestion and showed significantly higher congestion scores than NAR- status [11.97 (3.62) vs 10.47 (3.37); p = .001; g = 0.42; 95 % CI, 0.32-0.53]. The proportion of potential NAR+ cases for each presenting chief complaint was nearly identical (range 69.6 to 71.2 %). However, the comparison of effects between NAR+ and NAR- cases within each presenting group (INS, NRS, SDB) was more consistently significant on the scales for insomnia, sleepiness, anxiety, and depression only in the SDB category. The same four symptoms, measured in those objectively diagnosed with SDB, were also significantly worse in NAR+ compared to NAR- patients. CONCLUSIONS: Regardless of presenting chief complaint and ultimate diagnosis of sleep-disordered breathing, potential nonallergic rhinitis was common in patients at a sleep medical center at a rate possibly greater than twice that reported in the general population. Potential NAR+ was associated with worse sleep and distress symptoms. In both prevalence and treatment studies, research must further evaluate the potential impact of NAR on specific sleep disorders.

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. Although analysis of the data suggests that SCIT has an excellent safety profile, we believe that this safety is largely due to the safety measures that are implemented when SCIT is administered in a medically supervised setting with appropriate staff and equipment to immediately recognize and treat anaphylaxis. In the home or medically unsupervised setting, the preinjection health assessment may not be adequate and access to immediate emergency medical treatment is unlikely to occur. We strongly urge all health care providers to adhere to the current Allergy Immunotherapy Practice Parameter recommendations and that patients be appropriately assessed before and monitored after allergy immunotherapy injections in a medically supervised facility.

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. We will be seeing the effects of this act for years to come.

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.