Compounding Issues in Neuromodulation

December 9, 2012North American Neuromodulation Society16th Annual Scientific MeetingWynn Hotel, Las Vegas NevadaJoshua 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-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

CDC and FDA advisory announces newly found contamination in NECC products

Published on December 5, 2012 by Ted 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??

joshuaprager@gmail.com