Welcome to the Department of Health Care Services Welcome to Medi-Cal Welcome to the Department of Health Care Services
HomearrowReferencesarrowDUR Main MenuarrowEducational Articles

DUR: Use of Long-Acting Beta2-Agonists in the Medi-Cal Fee-For-Service (FFS) Population

Drug Use Review: Educational Information

The Food and Drug Administration (FDA) has issued new warnings for all products containing long-acting beta2-agonists (LABAs). The FDA has requested updates to product labels and a Patient Medication Guide given to patients receiving Serevent Diskus (salmeterol xinafoate), Foradil Aerolizer (formoterol fumarate) and Advair Diskus (salmeterol/fluticasone).

The FDA issued the following warnings about the use of a LABA medicine for the treatment of asthma:

  • Even though LABAs decrease the frequency of asthma episodes, LABAs may increase the chance of severe asthma episodes, and death when those episodes occur.
  • LABAs should not be the first or only medicine used to treat asthma.
  • LABAs should be added to the treatment plan after the use of low- or –medium-dose corticosteroids have failed to control asthma symptoms, as recommended by the National Heart, Lung, and Blood Institute [NHLBI] Guidelines for the Diagnosis and Treatment of Asthma.1
  • Do not use LABA to treat sudden wheezing episodes or wheezing that is getting worse.  

Providers should also be aware of the following:

  • The warning does not apply to chronic obstructive pulmonary disease (COPD).
  • The warning does not pertain to short-acting beta agonists.

For more information about label changes or how to obtain Patient Medication Guides, see the following FDA Web pages:

The NHLBI Guidelines for the Diagnosis and Management of Asthma1 recommends the following “Stepwise Approach” for managing asthma:

Short-acting beta2-agonist* 8 Add inhaled corticosteroid
at low to medium dose 		8 Add long-acting beta2-agonist

*
 All asthma patients should have a bronchodilator (inhaled short-acting beta2-agonist, preferred) to use as needed for symptoms.

Medi-Cal conducted a retrospective study of recipients with a recorded diagnosis of asthma to determine if prescribers/patients are adhering to recommended treatment guidelines. Patients with a diagnosis of asthma (ICD-9-CM code 493) on a billed medical claim, and at least one pharmacy paid claim for a short-acting beta2-agonist (albuterol) between January 1, 2004 and June 30, 2004, were included in the initial analysis. The claims for these recipients were analyzed for a one-year study period between July 1, 2004 and June 30, 2005 to determine if there was appropriate asthma step-therapy with respect to the addition of inhaled corticosteroids and LABA agents. There were a total of 21,369 asthma recipients identified who received only a short-acting beta agonist agent during the six-month, lead-in period.

During the 12-month study period:
  • 12 percent of asthmatics began treatment with a LABA drug before trial/failure of monotherapy with an inhaled corticosteroid.


    • – Of these beneficiaries, over 99 percent moved from Albuterol directly to Advair (salmeterol/fluticasone)

For all non-Medicare FFS Medi-Cal patients with a paid medical claim reporting a diagnosis of asthma in the same study period (N = 113,364), 26,912 recipients received at least one prescription for Advair. The study also yielded the following data:

  • 15 percent of patients receiving Advair did not have a single paid claim in the same 12-month period for a short-acting beta2-agonist agent as a quick reliever.
  • 2 percent of patients receiving Advair had at least one occurrence of an inhaled corticosteroid filled on the same day as their Advair, with many patients showing up to 12 occurrences over the 12-month period.

Prescribers are reminded to refer to the NHLBI guidelines for the management of asthma patients. Pharmacists should carefully screen for duplication of asthma therapy and to consult patients taking LABA about the risk of severe asthma exacerbations.

Medi-Cal is monitoring the use and clinical outcomes of all long-acting beta2-agonists.

To report any unexpected adverse events associated with these agents, contact the FDA Medwatch program at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail to MedWatch; Food and Drug Administration; HFD-410; 5600 Fishers Lane; Rockville, MD 20857-9787.

  1. National Asthma Education and Prevention Program Expert Panel Report. Guidelines for the Diagnosis and Management of Asthma–Update on Selected Topics. Bethesda, MD: NIH/National Heart, Lung, and Blood Institute, (2002). (www.nhlbi.nih.com).