Compounding Issues in Neuromodulation December 9, 2012 North American Neuromodulation Society 16 th Annual Scientific Meeting Wynn Hotel, Las Vegas Nevada Joshua P. Prager, M.D., M.S.

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.

At-A-Glance Status: Ongoing Investigation Infection: Fungal Facility Type: Outpatient Setting Case Count: 541* States: 19* Deaths: 36* Laboratory Results * Updates will be made on Mondays. Source: CDC December 3, 2012

CDC and FDA advisory announces newly found contamination in NECC products Published on December 5, 2012 by Ted PurlainDecember 5, 2012Ted Purlain

questions How many years’ experience does your facility/team have in sterile compounding?

Sterile Compounding Staff Do you have an employee training and evaluation program in compliance with USP 797/Board of Pharmacy? Please describe.

personnel  What are your policies and procedures for hand washing, gowning, and gloving?

 Does your staff perform media fills in compliance with USP 797?

Facility Is your sterile compounding pharmacy accredited by an acknowledged sterile compounding association (such as PCAB)? PCAB = Pharmacy Compounding Accreditation Board

Facility  Do you have adequate space for compounding sterile products?  Do you have a dedicated, separate, and contained sterile preparation area?

Policies and Procedures  Do you have a set of policies and procedures, or checks and balances, to guide the sterile compounding process?  Please describe

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?

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?

Questions: cleaning and disinfection program for the sterile environment  Will you describe this process?  How often is it employed?

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?

Request references

Other Issues  The FDA and compounding  The impact of compounding on intrathecal hardware

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

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

Questions??