National standards for asthma self-management education.

BACKGROUND: Asthma education reimbursement continues to be an issue in the United States. Among the greatest barriers is the lack of a standardized curriculum for asthma self-management education recognized by a physician society, non-physician health care professional society or association, or other appropriate source. The applicable Current Procedural Terminology codes for self-management education and training are 98960 through 98962, stating that "if a practitioner has created a training curriculum for educating patients on management of their medical condition, he or she may employ a non-physician health care professional to provide education using a standardized curriculum for patients with that disease." Without a standardized curriculum, reimbursement from payers is beyond reach. OBJECTIVE: Representatives from the Joint Council of Allergy, Asthma, and Immunology; American College of Allergy, Asthma, and Immunology; American Academy of Allergy, Asthma, and Immunology; American Lung Association; American Thoracic Society; National Asthma Educator Certification Board; American College of Chest Physicians; and Association of Asthma Educators gathered to write a standardized curriculum as a guideline for payer reimbursement. METHODS: The Task Force began with a review of the American Lung Association and American Thoracic Society's Operational Standards for Asthma Education. Board members of the National Asthma Educator Certification Board incorporated comments, rationale, and references into the document. RESULTS: This document is the result of final reviews of the standards completed by the Task Force and national health care professional organizations in September 2014. CONCLUSION: This document meets the requirements of Current Procedural Terminology codes 98960 through 98962 and establishes the minimum standard for asthma self-management education when teaching patients or caregivers how to effectively manage asthma in conjunction with the professional health care team.

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.

Impact of newly revised sterile medication compounding guidelines USP {797} on allergy vial preparation.

OBJECTIVES: To highlight newly revised guidelines on sterile medication compounding released by the United States Pharmacopeia (USP 797) in December 2007, and the implications on immunotherapy vial preparation. STUDY DESIGN AND METHODS: A policy review. RESULTS: The newly revised USP chapter on sterile medication guidelines was released December 2007 and becomes effective June 2008. The revised USP 797 now has specific guidelines addressing immunotherapy vial preparation that are a significant change from the previous version. The revised guidelines should be a useful tool for clinicians who are developing and setting office mixing standards. CONCLUSIONS/SIGNIFICANCE: Offices preparing immunotherapy vials should consider formalizing and implementing vial preparation guidelines. These guidelines should be based on expert opinion, experience, and scientific literature.

Pay for performance for the allergist-immunologist: potential promise and problems.

Pay for performance is one component of a growing movement in this country to better align incentives so as to increase the quality of medical care and reduce unnecessary costs. The Physician Consortium for Quality Improvement is a national multistakeholder organization that is developing performance measures. Concerns regarding performance measures include technical concerns (eg, validity, risk adjustment, sample size, and accuracy considerations), concerns regarding the cost of implementation, and concerns regarding unintended consequences. Some data support the effectiveness of pay-for-performance programs, but more and better-designed studies are needed to rigorously assess the effectiveness of pay-for-performance programs. The Institute of Medicine 2006 report supports pay for performance "as a stimulus to foster comprehensive and system-wide improvements in the quality of healthcare." This report also recommends that implementation of pay-for-performance programs should be carefully monitored to be sure that the stated goals are being achieved and that unintended consequences are recognized as early as possible. It is important for the allergist-immunologist to be an active participant in the evolving paradigm of pay for performance, advocating for the best interests of patients and providers alike.

The "black box" warning and allergy drugs.

In the past years, several drugs commonly used by allergy specialists have received a "black box" warning added to their package insert at the direction of the Food and Drug Administration (FDA). A "black box" warning is the highest level of 5 possible warning categories found in the package insert. The FDA has never articulated the basis for "black box" warnings. They generally appear to be based on clinical data, but occasionally can be based on serious animal toxicity. In the last several years, several drugs commonly used by allergists have received recommendations for "black box" warnings. Long-acting beta-agonists (salmeterol and formoterol) received "black box" warnings because of reports of the occurrences of severe asthma exacerbations in some patients with asthma, with some associated death. Topical calcineurin inhibitors (tacrolimus and pimecrolimus) received a recommendation for application of a "black box" warnings because of a possible increase of cancer developing in patients taking these drugs. Although the addition of a "black box" warning was recommended by the FDA Pediatric Advisory Committee for these 2 topical agents, the FDA has not yet implemented this warning. Informed consent principles require that a patient be adequately informed of the risks (among other components) of any recommended treatment. The risks, as described, of the long-acting beta-agonists and topical immunosuppressants should be presented to the patients to aid them in deciding whether they are willing to take these drugs when recommended by their physician.

Incorrect allergy injections: allergists' experiences and recommendations for prevention.

There are several reports of fatalities caused by allergen immunotherapy and skin testing. Patients have been reported who have received incorrect allergy injections. These could put them at risk for anaphylactic reaction and a possible fatality. We performed a survey to determine allergists' experiences with incorrect injections and to identify opportunities for prevention. This study was endorsed by the American Academy of Allergy, Asthma and Immunology and the Joint Council of Allergy, Asthma and Immunology. We conducted an e-mail survey of 1717 allergists, asking whether they knew of an incorrect injection administered within the last 5 years in their offices. An incorrect injection is an injection given to the wrong patient or a correct patient receiving an injection of an incorrect dose. Fifty-eight percent of responders reported an event in which a patient had received an injection meant for another patient. Seventy-four percent of responders reported that patients had received an incorrect amount of vaccine. The effect on patients ranged from local reactions to one fatality. Specific reasons given for the incorrect injections were patient name similar to that of another patient with incorrect name check and nurse error resulting in an incorrect dose. We conclude that allergy injections are a potential safety concern. There are a variety of prevention strategies that could be implemented to reduce or eliminate this risk, such as improved nurse training in the administration of allergy injections and compliance with the recommendations in the "Allergen Immunotherapy: A Practice Parameter" for use of patient-specific vials, standardized dosage sheets, and implementation of triple-checking of identity to make sure the correct patient is receiving the correct injection.