NHLBI asthma guidelines call for aggressive Rx

Experts see disturbing trends in asthma care

Hoping to curb the improper use of asthma medications and increase the quality of patient education, the Bethesda, MD-based National Heart, Lung, and Blood Institute (NHLBI) has released the first major update to its groundbreaking 1991 asthma guidelines.

Stressing the inflammatory nature of the condition, the new guidelines include explicit recommendations designed to change the way in which asthma drugs are prescribed and improve coordination between primary care providers and specialists, says Harold S. Nelson, MD, senior staff physician in the department of medicine at National Jewish Medical and Research Center in Denver.

The initial guidelines, published six years ago, were responsible for a changing view of asthma and how to treat it, explains Reeva Shulruff, MD, section head of pediatrics for Rush Prudential HMO in Chicago. Prior to their publication, she says, few clinicians emphasized prevention. Instead, most asthma treatment occurred after an attack was well under way, Shulruff says.

Those guidelines stressed several ways to improve asthma treatment, including early, accurate diagnosis; early treatment with oral steroids such as prednisone during an acute attack; use of preventive medicines such as cromolyn and inhaled steroids; and peak flow monitoring to catch an asthma attack before it fully develops.

As important and useful as the 1991 guidelines were, however, an update was necessary to correct what many experts saw as disturbing trends in the treatment of the disease, says Nelson. For example, the original guidelines failed to define asthma as an inflammatory disease. While they mentioned the need for anti-inflammatory medication in combating the condition, evidence suggests that many caregivers didn’t get the hint.

"If you look at the total sales of anti-inflammatory drugs in general, whether it’s cromolyn or inhaled steroids, and compare that to sales of bronchodilator drugs, it’s all out of whack based on the appropriate therapy," says H. William Kelly, PharmD, professor of pharmacy and pediatrics at the University of New Mexico at Albuquerque. Like Nelson, Kelly served on the expert panel that helped formulate the new guidelines. "It’s obvious that people aren’t treating it as an inflammatory disease yet," Kelly says. He adds that treating asthma primarily with bronchodilators, which are meant only for temporary relief of symptoms, is not indicated. (For NHLBI’s introduction and summary of the guidelines, see insert.)

"This guideline is much more explicit about where you should introduce anti-inflammatory therapy," says Nelson. "The message was in the last guidelines, but you can’t duck it any longer. It clearly says that if you’ve got someone who’s having more than two spontaneous episodes of asthma per week and whose pulmonary function is abnormal, then he has persistent asthma. And anyone with persistent asthma should be on chronic anti-inflammatory therapy."

Nelson also hopes the guidelines will encourage clinicians to avoid prescribing weaker drugs at the initial stages of treatment. Currently, he says, hospitals and managed care organizations tend to favor the use of the cheapest inhaled corticosteroids. "And it’s now apparent that the cheapest ones are also the weakest," he says. "Although in theory you can give enough to make up for their weakness, in actuality, you reach a certain point where patient compliance starts dropping off remarkably. So you may never get people to use enough of these weaker steroids to achieve what you can achieve with the more potent steroids."

Emergency care is most costly

Kelly adds that the real cost of asthma is not drug therapy costs but emergency care, which increases as patient non-compliance increases.

Because the problem of poor compliance is pervasive among patients with asthma, the guidelines include an expanded section on patient education that emphasizes the role of primary caregivers in counseling patients. Such counseling is crucial, says Kelly, because without education, patients often stop taking their medications once they begin to feel better. The problem is particularly acute among patients on long-term anti-inflammatory therapy. "It may not make them feel better right this second, but two months from now, when they get an upper respiratory tract infection, the fact that they’ve been on it may keep them out of the hospital or out of the emergency room," says Kelly.

Kelly adds that pharmacists can be powerful allies in ensuring patient compliance. For example, a pharmacist can check on patients who have been given inhaled corticosteroids to make sure they’ve been refilling their prescriptions on time. "And if they haven’t, the pharmacist should be calling that patient and saying, ‘How come you’re not coming in and getting your refill?’"

Another change from the 1991 guidelines is an overhaul of the severity classifications for asthma. Originally, patients were classified as having either mild, moderate, or severe asthma, but these broad categories proved to be of little use, says Nelson. "Most people who had mild asthma probably didn’t even see physicians, and there aren’t that many patients with severe asthma," he says. "So you wound up with most patients falling into the moderate category. That didn’t make the classifications very useful." The new guidelines factor in supplementary classifications, so that, in addition to mild, moderate, and severe, asthma is diagnosed as being either intermittent or persistent. (See table, p. 97.)

Asthmatics may require a specialist’s care

In light of the increase in managed care, the recommended criteria for referring patients to a specialist were also revised. Essentially, the guidelines state that if a primary care provider can’t get a patient’s asthma under control within a reasonable period of time, the patient should be referred. "It’s a very strong message," Nelson says. "People should not be sitting on poorly controlled asthmatics and not referring them."

Nelson stresses that despite his confidence in the guideline’s ability to help improve outcomes and decrease costs of care, they can only work if physicians are made aware of them. He contends that it’s possible to boil down the guidelines’ essential messages onto a two-page fold-over handout. These key messages include the following:

Make the diagnosis.

To establish a diagnosis of asthma, you must determine that the patient experiences episodic symptoms of airflow obstruction; that the airflow obstruction is at least partially reversible; and that alternative diagnoses are excluded, according to the guidelines.

Assess the severity.

"If they’ve got persistent asthma, put them on anti-inflammatory therapy," says Nelson. "Probably start out with more aggressive therapy than they may eventually need."

Have patients monitor their peak flows.

"During the honeymoon, when you can get them to do it, monitor their peak flows for the first two or three weeks," Nelson says. "Find out the personal best level for them, so that when you then back off [the medication] you can tell whether they’re at their best or not." (See sample patient diary, p. 98.)

Teach patients about the proper use of their medication.

"You’ve got to teach them about inflammation, how to use a meter-dose inhaler and a peak flow meter, and you’ve got to tell them what to do when they get sick," Nelson says. "That’s not many messages, but it’s the essence of the guidelines. And if people would just do those things, asthma care would get much better."

[Editor’s note: You can download the complete asthma guidelines at the American Health Consultants Web site. The address is: http://www.ahcpub.com. The guidelines can be found in the Special Coverage section of the site.

For more information about the asthma guidelines, contact:

H. William Kelly, PharmD, professor of pharmacy and pediatrics at the University of New Mexico, College of Pharmacy, 2502 Marble NE, Albuquerque, NM 87131. Telephone: (505) 272-3658.

Harold S. Nelson, MD, senior staff physician in the department of medicine at National Jewish Medical and Research Center, 12400 Jackson St., Denver, CO 80206. Telephone: (303) 398-1562.]