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Barriers Exist to Optimal Asthma Treatment

Posted on: Monday, 7 November 2005, 18:00 CST

MONDAY, Nov. 7 (HealthDay News) -- Preferred drug lists and preauthorization policies are designed to hold down the cost of medical care. But for people with asthma, these tools can sometimes delay -- or even prevent -- patients from getting the most effective treatment for their disease.

Even more alarming, some drug companies are reimbursing pharmacies or home health-care providers for unapproved nebulizer medications that may worsen asthma symptoms.

Those findings come from two presentations this week by the Allergy and Asthma Network/Mothers of Asthmatics (AANMA) at the American College of Allergy, Asthma and Immunology's (ACAAI) annual meeting, in Anaheim, Calif.

The first study included information from both Medicaid patients and health-care providers regarding the medications they used to control their asthma. The second study detailed reports of improper substitution of nebulizer medications.

"The problem with preferred drug lists is that it's all about the dollar, it's not a list that's preferred by physicians or by patients. It's not based on outcome evidence," said Nancy Sander, lead author of both studies and president and founder of AANMA.

"We understand that medical costs are soaring, but when I go see the doctor, I don't ask for a medication that's most expensive, I ask for what's appropriate for my medical needs and that's what physicians are trained to do," she said.

One potential way to save money, she said, is to ensure that people aren't being given counterfeit drugs. In the second study, Sander's team found at least 18 cases of inappropriate medications being reported to AANMA. She said these medications weren't FDA-approved and could even make asthma symptoms worse.

"In the case of budesonide (one of the substituted medications), they're giving a powdered mix made with ethanol, a known airway irritant," she said.

Almost 22 million Americans have been diagnosed with asthma, according to AANMA. Despite significant advances in treatment, asthma can still be deadly. In 2002, more than 4,000 people died from asthma, according to AANMA.

In the first study, Sander and her colleagues conducted two focus groups -- one for patients, one for health-care providers -- in Atlanta; Birmingham, Ala.; and San Antonio, Texas. A total of 19 patients and 24 providers were interviewed.

Both providers and patients said that preauthorization policies and preferred drug lists limited their access to effective asthma treatment. These procedures, both groups said, result in "undue suffering, poorly controlled symptoms, missed work and school days, delays in obtaining prescriptions, emergency department visits," and more.

Dr. Jennifer Kim, an allergist at Children's Memorial Hospital in Chicago, said that preferred drug lists and preauthorization policies, such as Medicaid's, can definitely be a problem.

"For a group of people who already have poor access to health care, this only puts up more barriers and more hoops for them to jump through to get the treatment they need," she said.

The medications Kim has the most trouble obtaining for her patients are non-sedating antihistamines and Xolair (omalizumab), an injectable medication used to treat severe asthma, she said.

The second, and more alarming, of the two studies found that some FDA-approved nebulizer medications -- which are reduced to a fine spray or vapor -- were being substituted with non-approved compounded medications without the knowledge of the patient or doctor. The problem with such medications is that they don't offer the same quality control that FDA-approved medications do.

"We don't know the true strength of these medications," said Dr. Michael Blaiss, the immediate past president of the ACAAI. "Because of quality control, there can be contaminants, such as fungi or bacteria, in these medications and one can get infections. We're talking about something that children and adults with severe lung problems like COPD and asthma are inhaling. This can really be a dangerous thing for patients."

Most of these medications are approved in other forms, such as powder or tablet, according to Blaiss, but not in nebulized form.

"These medications have to be aerosolized at a certain particle size, and if they're not, they won't reach the right portion of the airways to be effective," said Sander.

According to Sander, the FDA is concerned about these reports. Blaiss said the FDA must work with state pharmaceutical boards to change the laws regarding compounding medications.

While the FDA and individual states look into this matter, there are steps asthmatics can take to protect themselves, Sander said. She noted that FDA-approved medications come in plastic vials, on which all the information is embossed onto the vial. Medications that come with a paper label have probably been compounded, Sanders said. Medications should also arrive in sealed, foil containers with prescribing information enclosed. Patients who receive medication that is loosely arranged in the box should check with their doctor or AANMA.

There are two toll-free numbers patients can call for help if they think they may have received improperly compounded medication. Call either 1-800-878-4403 or 1-866-227-2934.

More information

The AANMA Web site has more information and pictures of what approved and unapproved medications look like.

SOURCES: Nancy Sander, president and founder, Allergy and Asthma Network/Mothers of Asthmatics; Jennifer Kim, M.D., attending physician in the division of allergy, Children's Memorial Hospital, and clinical instructor of pediatrics, Northwestern University's Feinberg School of Medicine, Chicago; Michael Blaiss, M.D., immediate past president, American College of Allergy, Asthma and Immunology, and clinical professor of pediatrics, University of Tennessee Health Sciences, Memphis, Tenn.; presentations, Nov. 5, 2005, American College of Allergy, Asthma and Immunology's annual meeting, Anaheim, Calif.~ASTH~~PRES~~DRUG~~FDA-~

Source: HealthSCOUT

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