Compounding Issues in Neuromodulation December 9, 2012 North American Neuromodulation Society 16 th...
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Compounding Issues in Neuromodulation
December 9, 2012North American Neuromodulation Society16th Annual Scientific MeetingWynn Hotel, Las Vegas NevadaJoshua P. Prager, M.D., M.S.
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With 36 deaths and 541 case of meningitis reported in 19 states as a result of compounded medications from the New England Compounding Center, the issue of compounding in pain medicine is in the spotlight. This lecture will look at the responsibilities of a physician purchaser and administrator of compounded medications with regard to prevention of future problems.
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At-A-GlanceStatus: Ongoing Investigation
Infection: FungalFacility Type: Outpatient Setting
Case Count: 541*States: 19*Deaths: 36*
Laboratory Results* Updates will be made on Mondays.
Source: CDC December 3, 2012
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CDC and FDA advisory announces newly found contamination in NECC products
Published on December 5, 2012 by Ted Purlain
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questions
How many years’ experience does your facility/team have in sterile compounding?
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Sterile Compounding Staff
Do you have an employee training and evaluation program in compliance with USP 797/Board of Pharmacy? Please describe.
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personnel
What are your policies and procedures for hand washing, gowning, and gloving?
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Does your staff perform media fills in compliance with USP 797?
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Facility
Is your sterile compounding pharmacy accredited by an acknowledged sterile compounding association (such as PCAB)?
PCAB = Pharmacy Compounding Accreditation Board
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Facility
Do you have adequate space for compounding sterile products?
Do you have a dedicated, separate, and contained sterile preparation area?
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Policies and Procedures
Do you have a set of policies and procedures, or checks and balances, to guide the sterile compounding process?
Please describe
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Questions United States Pharmacopoeia (USP) guidelines for the sterile preparation area What is the air quality classification
of your IV hoods or Laminar Air Flow Workbenches? Please explain what this means.
How often are your sterile preparation rooms and IV hoods certified?
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Questions: Environmental Monitoring
Will you describe this process? Do you test for air microbial bioburdens?
How often? Do you test for particulates in the air? How
often? Do you perform surface and fingertip
microbial testing? How often? What equipment, if any, do you utilize?
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Questions:cleaning and disinfection program for the sterile environment
Will you describe this process? How often is it employed?
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Questions: end-product testing program
Describe the program Do you perform sterility testing? How
often? Do you perform quantitative analysis? How
often? Do you perform endotoxin testing? How
often? Do you perform fungal testing? How often? What equipment, if any, do you utilize?
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Request references
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Other Issues
The FDA and compounding The impact of compounding on
intrathecal hardware
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Implantable systems performance registry
On label vs off label Statistically significant difference in
failure Low number of failures
Low event rate Makes it difficult to analyze
Drugs not well understood Which drugs concentrations
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Summary
Compounding is a serious endeavor Compounding issues are complex The prescriber of compounded
medications for intrathecal therapy must be rigorous in evaluating the source of the medications