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U.S. Department of Health and Human Services

Drugs

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Public Health Advisory: Contamination of Multi-dose Bottles of Albuterol Sulfate Solution for Inhalation (0.5%)

4/19/2002

The Agency has become aware of two recent hospital outbreaks of lower respiratory tract colonization and infection with Burkholderia cepacia attributed to contaminated multi-dose bottles of albuterol sulfate. In addition to these recent outbreaks, there have been several previous outbreaks reported in the medical literature. In most cases, colonization or infection occurred in the ICU setting, often in patients receiving mechanical ventilation. In the recent outbreaks, the adverse outcomes attributable to the respiratory tract infections with B. cepacia include prolonged hospitalization, pleural space infection, complications of antibiotic use, and death. Investigations revealed that the source of the exposure was contamination of bottles of multi-dose albuterol sulfate solution, likely due to failure to adhere to good, aseptic technique on the part of the respiratory therapists administering the medication. Additionally, it appears that the practice of using a single bottle for multiple patients over time contributed to the outbreak. Institution of more aggressive infection control training and procedures resulted in a marked reduction in the incidence of these infections.

The medical community, particularly respiratory therapists and ICU staff, is reminded to pay careful attention to proper aseptic technique each time a multi-dose bottle for nebulization is opened and used. Specifically, precautions should be taken to prevent contact of the dropper tip with any surface, including the nebulizer reservoir and associated ventilatory equipment. These instructions are currently included in the product label and the "Patient's Instructions for Use" document provided with the drug product. Additional measures that may be important in reducing the risk of contamination and subsequent outbreaks of infections include avoiding the use of a single bottle for more than one patient, and using a single-use container to dilute the solution prior to placing it in the nebulizer reservoir.

Albuterol sulfate solution for inhalation 0.5% is supplied in 20mL multi-dose glass bottles with accompanying calibrated dropper. Prior to administration, each 0.5mL dose is diluted with 2.5mL of sterile isotonic saline in the nebulizer reservoir. Each bottle can deliver up to 40 doses of albuterol sulfate. Two approaches have been taken in order to avoid microbial contamination of the contents of the bottle once opened. First, the formulation contains the preservative benzalkonium chloride. Second, the product label instructs users to follow aseptic technique when administering the drug. Specifically, the label states that precautions should be taken to prevent contact of the dropper tip of the bottle with any surface.