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Of readers responding, 88 percent say the changes instituted by the Nominating Committee of the ACAAI is a step in the right direction for improving the nominating practice.
 

A word from President Michael Blaiss, M.D.

OTC issues and the Allergist
The following statement, sent to me by Dan Ein, M.D., is from an article, “Statins may be sold over the counter” on the MSNBC Web site: “Statin drugs, widely taken to reduce cholesterol and reduce the risk of heart attack, could be available in Britain without a doctor’s prescription within the next six months, the government said on Monday.”

Why should we care if statins go over-the-counter in Britain? We don’t prescribe these agents in our care of allergy and asthma patients. Is this a sign of things to come in the United States? In all likelihood, the answer is, “yes.” The FDA commissioner, Mark B. McClellan, M.D., Ph.D, a health economist, has said so publicly. One of his missions for this government agency is to move more medications from prescription to OTC status. This will benefit managed care organizations, state governments, and the federal government, who are the biggest purchasers of medications, and shift more medication costs to the patients.

We have gone through the “antihistamine wars” with loratadine finally going OTC. It led to the anguish of many of our patients, as they have had to pay for either OTC loratadine out-of-pocket or endure much higher co-pays for other second-generation prescription antihistamines. If the FDA decides that a disease state doesn’t need a “learned intermediary” and the agent for treatment of that condition is safe, it can go OTC. By the way, did you know that we have gone from physicians, to health care providers, to now “learned intermediaries”? I’m afraid to think of what we will be called next.

You may have been in a television market where the American College of Gastroenterology ran a TV commercial. It addressed the need for physicians to care for patients with GERD, because it is a serious disease. This is in reaction to the recent release of the proton pump inhibitor Prilosec for OTC use. This is not an issue just important to allergists, but to the whole medical community. Why am I bringing up this topic again? Didn’t GlaxoSmithKline representatives state at our annual meeting in New Orleans that they were ceasing all activities to switch Flonase to OTC status in the United States? Yes, that’s great news, though they will pursue the switch to OTC for Flonase in Canada. We will continue to closely monitor the intranasal steroid issue for any changes.

Another concern at this time is the possibility of OTC albuterol. In fact, other countries, such as Australia, have OTC albuterol. In 2004, all chlorofluorocarbons (CFCs) are to be removed from the world market as agreed to by the Montreal Protocol. The College, along with the other national respiratory medical organizations, has favored the banning of CFCs from all inhalers, even though there is a concern that costs will increase as CFC albuterol is replaced by HFA brand-name albuterol. Another concern is the possible removal of OTC CFC epinephrine (Primatene Mist). If this happens, it could lead to a push for a replacement OTC rescue inhaler such as albuterol.

Capitol Associates, the lobbying organization of the Joint Council has released the following information in regards to Primatene OTC. “Per your request for further research and information on Primatene Mist, what follows is a summary of what we have learned so far after speaking with at least a dozen folks at the company, FDA and EPA.

Primatene Mist, an over-the-counter medication sold for the relief of physician-diagnosed, bronchial asthma and manufactured by the Wyeth Corporation, continues to use CFCs as a propellant to deliver the product through the inhaler. Wyeth includes the following information on the label of Primatene Mist: "Contains CFC 12, 114, substances which harm public health and environment by destroying ozone in the upper atmosphere."

According to a representative from the Wyeth Corporation, Primatene Mist, with the inclusion of CFCs, is FDA-approved because of an essential-use exemption for the product granted by the Environmental Protection Agency (EPA). At this point, unless FDA regulations change, Wyeth does not have any intention to reconfigure its inhalers, but said that it will continue to comply with all applicable FDA regulations.

Reformulation of non-CFC-containing products would require submission of new or supplemental new drug applications. Eventually, the FDA, in coordination with EPA clean air standards, will attempt to phase out CFC-containing metered-dose (oral) inhalers, but until alternative non-CFC MDIs are available, over-the-counter products such as Primatene Mist will continue to be produced under the essential-use exemption granted by the EPA. There are no plans, however, either by the EPA or FDA to imminently ban Primatene Mist, and Wyeth plans to continue normal production levels.

It is important that organized allergy be proactive on the OTC issues and monitor closely for changes that could occur in this arena. The College and Academy have a Joint Task Force on OTC issues headed by Estelle Simons and me. Harold Nelson, M.D., from National Jewish Hospital in Denver, is heading up a sub-committee in developing a “white paper” on the safety of albuterol for OTC issue. We believe that albuterol needs to be monitored by learned intermediaries, oops, physicians, and we will be active in this important issue for our members.

Michael Blaiss, M.D.

Who’s moving and shaking in allergy-immunology?
Appointed to a national leadership position in Allergy-Immunology? Authored a new book? Won a prestigious award? Now you can submit such notable achievements and read about those of your peers in ACAAI eNews.

Of recent note:
• Drs. Donna L. Bratton, National Jewish Hospital in Denver, and Mark L. Corbett, private practitioner from Louisville, are newly appointed ABAI Pediatric Board Members.
• Dr. Ernest N. Charlesworth, San Angelo, Texas, was appointed ACAAI alternate delegate to the American Medical Association’s Physician Consortium for Performance Improvement. (Dr. Jean A. Chapman continues as delegate.)
• Drs. Anita Gewurz, Leslie C. Grammer, Paul A. Greenberger, Mark E. Kaplan, Paul M. Kentor and Diane L. Ozog are the allergists-immunologists listed in Top Doctors: Chicago Metro Area. The list of doctors most highly regarded by their peers was compiled by Castle Connolly Medical Ltd.

Don’t be bashful. Please e-mail notices for “Who’s Moving and Shaking” news to joannfaber@acaai.org.

Increase your Online Consultations: Marketing materials available online
Medem’s Online Consultation Resource Center provides free materials to help you raise awareness among patients about the convenient online services you offer. The OC Resource Center features patient education/marketing materials developed and proven effective by physicians actively using Online Consultation in their practices. Why spend time developing letters and e-mails when Medem has done the work for you? The OC Resource Center includes:

• Templates for letters and e-mails to patients announcing Online Consultation
• Announcements for your Web site that you can easily customize
• Detailed descriptions about Medem’s Secure Messaging Service and instructions to help patients get started

These materials cannot replace an actual conversation you have with your patients regarding the availability of secure e-mail and its appropriate use, but Medem is confident they will augment your efforts.
To access the OC Resource Center or build a Medem practice Web site, visit www.medem.com.

Allergy Practice Tip 2: Ping-Pong Effect
Advice from The Patient-Centered Allergy Practice

Put a ping-pong table in your practice. Over impromptu games, physicians and staff can get to know each other better. Win or lose, the result will be a happier, more productive office.

These tips are drawn from site visits in practices nationwide, conducted as part of The Patient-Centered Allergy Practice, a CME Series in Practice Management, supported through an unrestricted educational grant from Aventis Pharmaceuticals and endorsed by the American College of Allergy, Asthma & Immunology.

Join us for our next audioconference, “Don’t Get Stuck with Unsafe Needles: Meet OSHA’s New Requirements” from noon to 1 p.m. Eastern time Feb. 17. Call 800-781-2211, ext. 102, or e-mail info@physicianspractice.com for free registration and to get the handouts.