New Regulations Limit Nurses Preparing IV Admixtures
Each year, nearly one million IV admixtures are prepared and administered at BWH. Of these, nurses and physicians prepare and administer about 650,000, while Pharmacy prepares 350,000.
New federal regulations will limit the preparation and administration of IV admixtures by nurses and physicians. Effective in 2008, Chapter 797 is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia.
“Chapter 797 has a huge impact on what we can do, but overall, this is best for the safety of our patients,” said Bill Churchill, MS, RPh, executive director of Pharmacy.
By 2008, the Pharmacy expects to prepare 800,000 of BWH’s annual one million IV admixtures, limiting physicians and nurses to preparing single use IV admixtures only in emergency situations.
What does 797 mean for BWH?
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All sterile admixtures must be prepared in an appropriate sterile environment except for immediate use situations.
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All staff preparing sterile admixtures must be trained and competency-assessed annually.
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Nurses and physicians can only make sterile products for immediate emergency use.
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End product testing and validation.
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Stringent beyond-date use requirements.
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Clean room environmental monitoring and cleaning.