Recalls and Back Orders Stretch Propofol Supplies Thin

Anesthesia

By: OSD Staff

Published: 10/30/2009

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Infection concerns prompt Teva recall; many sulfite-free vials on back order.


Teva Parenteral Medicines is recalling a handful of lots of propofol SDV, exacerbating an already "dire" situation for surgical facilities dealing with a nationwide shortage of propofol — particularly sulfite-free vials — over the past few weeks, says pharmacy consultant Sheldon S. Sones, RPh, FASCP.

According to a memo from McKesson Medical-Surgical, Teva has recalled the following lots of propofol SDV because "some of the containers may have been exposed to microbial contamination":

  • Propofol SDV 10 mg/ml, 20 ml vials (NDC 00703-2856-04): lots 31308134B, 31308278B, 31308279B, 31308350B, 31308659B, 31308784B, 31308785B, 31309201B.

  • Propofol SDV 10 mg/ml, 20 ml vials (NDC 00703-2856-01): lots 31308134B, 31308278B, 31308279B, 31308350B, 31308659B, 31308784B, 31308785B, 31309201B.

    The lots being recalled were distributed on or after Sept. 21, 2009.

    Meanwhile, the American Society of Health-System Pharmacists reported last week that several propofol injection products from both Teva and Hospira were on back order. Check with your suppliers and ASHP's Web site for updates on the shortage situation.

    Mr. Sones, who provides pharmacy and medication safety consulting for more than 130 facilities in New England, offers the following tips for maintaining adequate propofol supplies:

  • With many sulfite-free vials on back order, reserve sulfite-free product for use in patients who are truly allergic. Although the Food and Drug Administration estimates that only 1% of the population is sulfite sensitive, you should have some supply of sulfite-free propofol on hand or stock only sulfite-free propofol when possible.

  • Get listed early with your supplier for product delivery upon its availability.

  • If the branded product Diprivan is available, order it.

  • Keep in close contact with your supply representative, and make sure you are on the recall list from your wholesalers and suppliers.

  • If you obtain propofol via your anesthesia providers, assure that they are advised of and act upon recalls in a timely manner.

    "One of the many elements of safe medication management is the ability to quickly quarantine medications involved in recalls," says Mr. Sones. Your supplier should promptly advise you of any drug recalls; if your recall folder or binder is thin, you may not be getting proper updates. "With all of the recalls this industry unfortunately experiences, an empty file is probable evidence of a system that isn't working," says Mr. Sones.

    Irene Tsikitas

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