January 23, 2009 | | Comments 0
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Reconsider Dating Open Multidose Vials

istock_000005943600smallOver my 30 year carreer I’ve reviewed medication storage locations in about 500 hospitals. Guess what I’ve learned? It doesn’t work (except that it gives surveyors a “for sure” citation). I can remember only one hospital that succeeded in putting an outdating process in place for open multi-dose vials — it took tons of leverage from leadership and only lasted until the surveyor came back to clear them. So, what are the options?

Background

  • There is no requirement to place a date on multi-dose vials when the membrane is punctured — unless, of course, you require it in hospital policy.
  • Until recently, there were no recommendations to date these vials, leaving the practice up to manufacturer guidelines.
    • Most manufacturers indicate that puncturing the membrane does not impact the “beyond-use date” for multi-dose vials.
    • Exceptions are PPD, unrefrigerated insulin, and Diprivan (propofol).
  • USP 797 now recommends that open multi-dose vials be discarded after 28 days.

Options

  • OPTION 1: You can ignore the USP and go by manuracturer recommendations. This may cause some lively discussions with surveyrs, so if you choose this option document the heck out of your reasoning and justificaiton.
  • OPTION 2: You can continue to try to get people to date and discard open multi-dose vials. (How’s that working for you?)
  • OPTION 3: You can instruct staff to discard any multi-dose vial once it’s open. However, this is a hard habit to break and you will still have to do inspections.
  • OPTION 4: (RECOMMENDED) You can implement a system where by a technician (preferably a pharmacy technician) inspects all medication storage locations every 4 weeks (e.g. every 4th Friday). The technician discards any open multi-dose vials.¬†
    • Do the inspections have to be documented?
      • There has to be a process to make sure the inspections happen. A calendar with someone’s signature might be enough to convince the manager that the inspection happened.
    • Do we then prohibit¬† dating open multi-dose vials?
      • No. It’s a habit that there is no reason to break. But, believe me, the inspections will work. So, even if someone dates the vial, it will be discarded during the 28 day inspection.

Entry Information

Filed Under: Accreditation Participation RequirementsMedication ManagementSurveillance, Prevention and Control of Infection

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Error: Unable to create directory uploads/2014/12. Is its parent directory writable by the server? About the Author: Mr. Pate serves as Vice President for Content and Development at The Greeley Company. He is a nationally recognized expert in patient flow and in hospital and health system regulation and accreditation with over 25 years experience in high profile problem solving.

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