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May 7, 2008 |
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Welcome to ACAAI eNews
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| When prescribing a drug with a Black Box warning, I … |
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MAY
Biologic Immune Response Modifiers in Allergic Disease
NY Allergy and Asthma Society
Pending ACAAI Joint Sponsorship
May 21, New York, N.Y.
Contact: Songhui Ma
Tel: 212-342-7410
Email
JUNE
XXVII EAACI Congress
June 7-11, Barcelona, Spain
Tel: +46 8 459 66 00
Fax: +46 8 661 91 25
Email
Link
Asthma & Allergy Society of Virginia Annual Conference
Pending ACAAI Joint Sponsorship
June 21-22, Virginia Beach, Va.
Contact: Donald Zedalis, M.D.
Tel: 540-552-7226
Email
JULY
26th Annual Aspen Allergy Conference
Pending ACAAI Joint Sponsorship
July 22-26, Aspen, Colo.
Contact: Jill Hibbeln
Tel: 303-733-9590
Email
AUGUST
The Alabama Society of Allergy, Asthma and Immunology's
29th Annual Postgraduate Course
Aug. 8-10, Destin, Fla.
Contact: Richard Carson
Tel: 334-954-2577
Email
OCTOBER
Northwest Allergy Forum 2008
Washington State Society of Asthma, Allergy and Immunology
Pending ACAAI Joint Sponsorship
Oct. 3-5, Seattle, Wash.
Contact: Hannah Scott
Tel: 206-341-1353
Email
ONGOING
World Allergy Organization Society Meetings
ACAAI
CME Website
Contact: Mary Campbell
Tel: 847-427-1200
Email
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Sponsored
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Top
Stories |
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Rhinitis severity, asthma severity linked
Patients whose asthma does not respond well to treatment also are likely to have moderate to severe rhinitis, according to a study in Allergy. Researchers at Universidade Federal de Bahia, Brazil, studied 557 subjects with severe asthma, looking for possible links between asthma and rhinitis. Of the 557 subjects, 31 percent had moderate to severe rhinitis, 54 percent had mild rhinitis and 15 percent did not have rhinitis. Among the three groups, the subjects with moderate to severe rhinitis were more than three times as likely as the other groups to visit an emergency department during the 12-month period. At the end of the study, they were more than 12 times as likely to have uncontrolled asthma. Researchers also saw a positive correlation between rhinitis severity and asthma severity. 
Treed neighborhoods correlate to lower asthma rates
Young children who live in tree-filled neighborhoods have lower asthma rates than children living in areas with fewer trees, according to a study in Epidemiology and Community Health. Scientists at Columbia University, New York, examined asthma rates among 4- to 5-year-olds, as well as asthma-related hospital admissions for children up to 15 years old, in 42 New York service districts. They then compared that data with information about the number of trees in each district, along with other geographic and demographic data. The authors found that asthma rates decreased by nearly 25 percent for every standard deviation increase in tree density, equivalent to 343 trees per square kilometer. Even with pollution sources, socioeconomic status and population density factored in, the pattern continued. However, there was no correlation between tree density and asthma-related hospital admissions among older children.
Study: About 1 in 10 U.S. kids use cough/cold drugs weekly
Just over 10 percent of U.S. children use at least one cough or cold medicine during a given week, according to a study presented recently at the Pediatric Academic Societies meeting in Honolulu. Researchers from Boston University's Slone Epidemiology Center looked at data gathered from 1999 to 2006 via a national telephone survey that included all oral medicines approved by the U.S. Food and Drug Administration to treat children's coughs and colds. The researchers found that during any given week, 10.1 percent of U.S. children took at least one cough and cold medication. Children 2 to 5 years old were given the drugs most often. |
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A message from Dr. Donald W. Aaronson, JCAAI Executive Director
Black Box Warnings
All drugs have side effects! Adverse reactions to drugs are a leading cause of death. On the other hand, drugs are on the market and prescribed for patients because, after study, it is concluded that their benefits outweigh their risks; both in the mind of the prescribing physician and in the mind of the regulator – the Food and Drug Administration (FDA). Patients generally become aware of the benefits and risks (side effects) of drugs from their physician and/or from the drug label (package insert).
The information in the package insert comes from studies done before release and from post-marketing studies. The FDA requires post-marketing studies because they recognize that increased frequency of a drug’s use results in the identification of additional adverse effects. Some of them may be severe and were not identified in the limited exposure from use in the clinical trials leading up to their release. The goals of the post-marketing studies are to catch any problems so the FDA and drug companies can quickly communicate new risk information to consumers and doctors. When the FDA receives reports of significant new adverse events, the agency evaluates them for their seriousness and the likelihood that they were caused by the drug. The agency also considers how the toxicity compares with other treatments for the same disease. The ultimate question that remains is:
Do the benefits of this drug still outweigh its risks to the population, as described on the label?
In many cases, that question cannot be answered immediately, and more reports must be considered. Usually, when new risks are uncovered, they are added to the package insert, and doctors are notified by letter. The package insert is there to inform the physician, who, along with a patient now informed by the physician, must then make a determination if the benefit of the drug for the individual patient still outweighs its risks.
Drugs with Black Box warnings
There are five levels of warnings to the physician beginning with a list of adverse reactions and ending with the most serious – Black Box. Unfortunately, the FDA has never issued rules defining the requirements for the application of a Black Box warning and, therefore, there is no specific level of seriousness that says a Black Box warning should be applied. It is of interest that not all drugs with the potential for serious side effects or death actually carry a Black Box warning.
Currently in the world of allergy, there are five drugs with Black Box warnings:
Long-acting beta agonists (Salmeterol and Formoterol); Topical calcineurin inhibitors (Tacrolimus and Pimecrolimus); and
the biologic response modifier omaluzimab (Xolair).
A sixth drug occasionally used by allergists with a black box is the ketolide antibiotic (Ketek).
While there is little disagreement about the side effects caused by Xolair, there is a fair amount of disagreement about the scope of the side effects resulting from the long-acting beta agonists and/or the topical calcineurin inhibitor.
Obtaining informed consent
American law (usually case law) dictates that physicians must obtain informed consent from patients prior to administering any treatments or procedures. This includes our duty to warn patients about the risks and benefits of any drugs we prescribe. In particular, we must discuss the presence of a Black Box warning with our patients and ensure they understand not only the risks and the benefits of the drug and the apparent reason for a Black Box, but also the risks of alternative treatments or of no treatment at all.
While the form of memorializing the informed consent discussion are subject to debate, the alternatives and recommendations are as follows. A verbal consent is acceptable, but since memories are limited, if the only evidence of consent is physician recall, a consent that was not recorded may not be allowed into evidence in a malpractice trial if it occurs longer than about 4 months after the event. On the other hand, written consents are always admissible; they can be either a progress note by a physician recording the informed consent discussion with the patient or an actual patient-signed consent. While I believe the patient’s signed consent is the best route if you want to prevent a malpractice suit from being filed, either the progress note or the signed consent is quite acceptable in a court of law.
In a recent study done by John Oppenheimer and myself, we found that about 25 percent of allergists do not obtain any consent in the case of Black Boxes. We believe this exposes this group of physicians to unnecessary risks and deprives patients of vital information. There is no suggestion from the 75 percent of people who actually discuss this with patients, that any patients actually refuse treatment because they are frightened by the Black Box warning. Therefore, we urge that anytime you prescribe a drug with a Black Box warning, you obtain an informed consent and document it either with a progress note or an actual signed consent.
Please answer the poll question and comment. |
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Drugs and Devices |
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FDA committee recommends hereditary angioedema drug
The Blood Products Advisory Committee to the U.S. FDA recently recommended approval of Cinryze, a C1 inhibitor, for the prophylactic treatment of hereditary angioedema, according to manufacturer Lev Pharmaceuticals Inc. If approved, Cinryze would be the first C1 inhibitor replacement therapy for patients with hereditary angioedema in the United States.
FDA approves Advair Diskus 250/50 for COPD
The U.S. FDA recently approved Advair Diskus 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease who have a history of exacerbations. The FDA also expanded the use of Advair Diskus 250/50 to a broader patient population that includes not only patients with COPD associated with chronic bronchitis, but also emphysema or both conditions.
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Association
News |
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Tracking immunotherapy, mapping dermatoses
programs to kick off ACAAI Annual Meeting
The 2008 ACAAI Annual Meeting at the Washington State Convention and Trade Center in Seattle, Nov. 6-11, will prepare you for Embracing the Challenges of Change.
A one-day program will kick off the meeting on Thursday, Nov. 6, with a morning session on immunotherapy and an afternoon session devoted to clinical dermatological allergy.
“A highly innovative program on ‘Tracking Immunotherapy’ will take you for a ride on the SLIT express. Experts from around the globe will discuss the merits of SCIT and SLIT, prepare you to avoid a wreck, distinguish
those
‘rolling’ or ‘in transit,’ and decide to get on the train or wait for a better
one,” said ACAAI President-Elect and Program Chair Dr. Richard G. Gower.
“In the second half of this program, dermatological experts will present information vital to the growth of your practice, as they ‘Map Out the Dermatoses: Hand, Foot (Face) and Mouth Diseases’ and teach you how to manage difficult cases. They will discuss dermatitis from medical devices and implants – and in children, the treatment of recalcitrant atopic dermatitis and urticaria – among other topics,” Dr. Gower said.
Join your colleagues in the vibrant city of Seattle for a state-of-the-art, dynamic scientific program built on 65 years of experience. Save the date of the ACAAI Annual Meeting, Nov. 6-11.
A word from the ACAAI CME/CPT Committee
The ACAAI CME/CPD Committee wants to thank each and every person who was involved with the 2007 Annual Meeting in any capacity, whether as a planner, presenter, reviewer, learner/attendee, etc. The provision of CME/CPD credits to the learner/attendee is the very reason for the existence of the CME/CPD Committee. At times the requirements to obtain CME/CPD credits, as outlined by ACAAI policy, may seem onerous, but the policy is based on guidelines outlined in September 2006 by the Accreditation Council for Continuing Medical Education (ACCME). The ACCME guidelines have been provided to maximize learner/attendee assurance that bias, fair-balance, conflict of interest, etc., possibilities have been reviewed and resolved. This also can reassure public confidence in ACAAI and other CME/CPD provider activities. The College looks forward to providing the most excellent CME/CPD activities available for our learner/attendees in the future.
 Allergies in America Web site a valuable tool for physician and patient education
The College recently announced support of the Allergies in America surveys that highlight the importance of improving care for those who suffer from allergies. These survey findings and other important information for physicians and patients are now available online at www.myallergiesinamerica.com.
A complete overview of the entire survey, including executive summaries, downloadable detailed presentations, patient information about allergy management and other resources can be found on the Web site. The surveys are sponsored by Sepracor.
“With so many patients seeking health information online, the Allergies in America Web site offers a plethora of information about allergic rhinitis,” said ACAAI President Dr. Jay M. Portnoy. “Improving both patient care and education about allergic rhinitis are primary goals of our organization, which is why we endorse the Allergies in America Web site as an important tool.”
Join your colleagues at the ACAAI-IAACI Conference in Israel
The College is pleased to jointly sponsor a state-of-the-art CME scientific conference in Jerusalem, Dec. 3-6, 2008, co-sponsored by the Israel Association of Allergy and Clinical Immunology (IAACI) in conjunction with Allergists for Israel (AFI).
Situated high in the Judean Hills, Jerusalem is one of the most extraordinary cities in the world, with its unique combination of ancient history, beautiful architecture, spiritual sanctity and colorful cultures. Sacred to the world’s three main religions, visitors are captivated by the shining glow of its religious shrines, picturesque scenery and magnificent golden limestone.
For assistance with flight reservations, contact Lisa Keller with International Travel Exchange at 800-752-6050. Pre- and post-tour information will be available soon.
Arranging and Scientific Curriculum Committee members include: U.S. – Drs. William Berger, Jonathan Bernstein, Leonard Bielory, James Claflin, William Dolen, Daniel Ein, Gary Gross, Lyndon Mansfield, Jay Portnoy, William Silvers, and Myron Zitt; Israel – Drs. Ilan Dalal, Amos Etzioni, Mona Kidon, Yosi Mekori, Menachem Rottem, Meir Shalit, Yehuda Shoenfeld, and Ben Werner.
Don’t miss this unforgettable experience. Plan to attend the ACAAI – IAACI Conference, Dec. 3-6, in Jerusalem. For information, contact Beth Goldfarb at afiadm@gmail.com.
 In Memoriam: Dr. John G. Leonardy
The College mourns the loss of Dr. John G. Leonardy, of Amelia Island, Fla., ACAAI past president (ACA, 1984-85), who died April 6 at the age of 78. He was president of the American Association of Certified Allergists (1980-81) and the Joint Council of Allergy and Immunology (1986-88).
Dr. Leonardy was a native of Florida, but practiced medicine in Atlanta for more than 40 years before retiring and moving to Amelia Island.
“John Leonardy distinguished himself in everything he did,” said Nathan Segall, Atlanta. “As a physician, he was a scholar, continually developing his skills as an allergist in the first allergy practice established in the Southeast. He taught the allergy-immunology section for the Emory Review Course in Internal Medicine for years. He was one of the first to give the review of literature in asthma in the College’s always popular Literature Review Course.
“As president, he was instrumental in securing the College’s future with many decisions that were made during his period of leadership. Most of all, he was a physician with intellect, compassion and persistence, who helped many patients in his role as internist and allergist,” Dr. Segall said.
During his long career, Dr. Leonardy was affiliated with all the major hospitals in Atlanta. He also held teaching appointments at Emory University School of Medicine, Georgia Baptist Medical Center, Grady Memorial Hospital, and Mercer University School of Pharmacy.
In addition to his enjoyment of, and dedication to, his medical career, Dr. Leonardy also enjoyed astronomy, gardening and collecting medical antiques. After moving to Amelia Island, he became aware of the fact that he is part of the large Leonardy family considered a founding family in St. Augustine, St. Johns County, Florida.
Memorial donations can be made to the Good Shepherd Clinic, 6392 Murphy Drive, Morrow, Georgia 30260. Dr. Leonardy volunteered at the clinic for the uninsured and poor after he retired, working two nights a week.
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AMA Corner |
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Welcome to the AMA Corner prepared by Dr. Alnoor A. Malick, ACAAI Delegate to the AMA House of Delegates, to keep you abreast of important AMA news and developments affecting allergy-immunology.
Payout to doctors pending in BCBS settlement
Several provisions in the national Blue Cross Blue Shield (BCBS) settlement took effect April 21, after a final order was filed by the federal court in Miami.
The development brings eligible physicians one step closer to the $128 million payout and allows the AMA to commence enforcement of the national BCBS settlement as an additional signatory medical society. The AMA joins 27 other participating medical societies that are able to provide direct assistance to physicians when a BCBS plan or subsidiary has failed to honor its commitments under the settlement.
There are special provisions in the settlements that are specific to particular states. You can access the AMA’s online interactive map, which lists the BCBS plans and subsidiaries that have settled, the state-specific provisions of the agreement and the dates the various provisions take effect.
AMA Web conference to cover financing EMR systems
In August 2006, the Centers for Medicare & Medicaid Services (CMS) passed federal rules making it possible for hospitals, health systems and health plans to donate health information technology (HIT) to physician practices. Given this recent trend, it’s important for physicians and practice managers to understand the details associated with HIT donation agreements and Stark law and anti-kickback statute requirements.
That’s why the AMA is hosting the Web conference, “Financing electronic health record (EHR/EMR) systems: Should your practice accept a donation?” All physicians and practice staff are invited to participate in this live, hour-long session from 1 to 2 p.m. Central time, May 14. Registration is $95 for AMA members and $150 for nonmembers.
The program is designed to help physicians comply with subsidized EHR and electronic prescribing technology regulations, recognize regular components of donation agreements and general information technology contracts, and prepare more effectively for any HIT selection. In addition, the program is open for all physicians and their staff members and offers continuing medical education credit.
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Fellows-in-Training |
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Board Review Corner
Welcome to the Board Review Corner prepared by Drs. Bret R. Haymore and Jennifer W. Mbuthia, Senior and Junior Representatives of ACAAI’s fellows-in-training (FITs) to the Board of Regents. The Board Review Corner is an opportunity to help hone your Board preparedness.
To refer to a previous Board Review Corner, click the “FIT Archive” link in the left column.
Review Questions: : Chapter 26 of Pediatric Allergy: Principles & Practices, edited by Donald Y.M. Leung, et al. Review questions were written by Drs. Jennifer W. Mbuthia, Walter Reed Army Medical Center, and Thomas G. Sternberg, Le Bonheur Children’s Medical Center.
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