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ISMP Information and Resources on
Sterile Pharmacy Compounding Safety

In September 2012, reports began to emerge that patients in multiple states had contracted a rare form of fungal meningitis from contaminated steroid shots prepared by a compounding pharmacy in Massachusetts. The Institute for Safe Medication Practices (ISMP) has expressed its deepest sympathy to all those affected by this national tragedy.

This is not the first outbreak to be reported. Since the early 1990s, multiple problems with compounded preparations have resulted in recalls, patient injuries, and deaths. ISMP believes that compounding pharmacies perform an important service, but there needs to be improved assurance that all necessary steps are followed when preparing sterile products. FDA-approved commercial products should be used wherever possible. We believe that all pharmacy staff should be following good compounding practices and adhering to the highest standards possible, since even the slightest misstep could result in serious consequences for the patient.

ISMP has advocated for clarification to differentiate sterile product manufacturers from compounders and laws and regulations that will provide improved enforcement. More FDA guidance is needed as is state pharmacy board oversight to help safeguard patients from errors.  We are also supporting the efforts of hospitals, health systems and compounding pharmacies by providing tools and recommendations to enhance current practice. Below are some resources on sterile compounding for health professionals.

  • Overview Article. A cover article in the ISMP Medication Safety Alert! newsletter provides a summary of the issues surrounding compounding pharmacy oversight, a chart of past compounding errors, and ISMP’s Call to Action recommendations. Go here for a copy.
  • Educational Symposium. ISMP is offering a free CE program at the upcoming ASHP meeting entitled “Reducing IV Admixture-Related Safety Risks: A Review of the ISMP Sterile Preparation Compounding Guidelines” on December 3, 2012. For more information or to register, click here.
  • Guidelines for SAFE Preparation of Sterile Compounds . ISMP’s guidance document on the safe production of sterile compounded preparations, drafted following a national summit, will soon be released and posted on www.ismp.org. For a copy of the draft guidelines, click here.

 

OTHER RESOURCES

For more information, contact us. Members of the media should contact Renee Brehio.

 

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