Directly Speaking - Compounded Sterile Preparations: What’s in Your Pharmacy?

by Scott A. Meyers, Executive Vice President
May 9, 2013

Compounded sterile preparations continue to make the news these days with more recalls from small outsourcing pharmacies around the country, a grand jury determining if criminal charges are appropriate in Michigan, State and federal governments crafting tighter controls for compounding pharmacies and patients still dying or suffering the effects of the NECC debacle of last fall.

To date, 53 patients have now died (16 in Michigan) and 733 patients nationwide have been infected with fungal meningitis as a result of the contaminated products from the New England Compounding Center. As a consequence, the FDA, multiple state boards of pharmacies and other state agencies have been extremely busy inspecting, citing and sometimes shutting down a variety of compounding pharmacies that have been providing products to hospitals, physician offices and other health care facilities.

The results of a study conducted in January of this year by the Office of the Inspector General of the US Department of Health and Human Services were released in early April and the findings, while significant, were not overwhelmingly surprising, but they did have a couple of eye openers for me.¹  The 236 acute care hospitals that replied (out of 298 surveyed), reported that 92% provided patients with compounded sterile products (CSPs) and the same percentage provided sterile-to-sterile CSPs while only 25% provided patients with non-sterile-to-sterile CSPs. Non-sterile-to-sterile CSPs comprised less than1% of all CSPs dispensed from these hospitals in 2012. 75% of the hospitals surveyed reported that they used a combination of outsourcing and onsite preparation to obtain the CSPs.

These responses to the outsourcing survey opened my eyes first. Of the 49 pharmacies that indicated that they provide non-sterile-to-sterile CSPs, 63% reported using one outside pharmacy but 20% reported using two outside pharmacies and 16% reported using three outside pharmacies to obtain their CSPs. 36% used more than one outside pharmacy for these non-sterile-to-sterile CSPs, and of those 16% used out of state outside pharmacies.

The survey asked respondents what steps the pharmacy took to ensure quality from any of these outside pharmacies (for sterile-to-sterile and non-sterile-to-sterile CSPs) and by far the most popular response was that they required the outside pharmacy to be compliant with USP 797 (77% required for all outside pharmacies, 6% for some, 14% did not require that). Second most used quality measure was the review of quality reports provided by the outside pharmacy (49% required all outside pharmacies to provide, 23% requires some, and 26% required none). Only 7% of hospital pharmacies conducted onsite visits to all their outside vendors, while 15% visited some, and 73% visited none of their outside pharmacies. The least frequent step taken was to test product provided by the outside pharmacies (6% tested all outside pharmacy products, 4% tested some, and 86% did not test any products).

What was probably most surprising was what I would consider a poor level of confidence in the steps taken to ensure quality of the outside pharmacies. 42% of the hospital pharmacies that responded were very confident but 46% (almost half) were only somewhat confident and 12% were not confident at all. But they still continued to use outside pharmacies.

After reading the survey report, I went to the ASHP Foundation website to look at their Contractor Assessment Tool for Outsourcing Sterile Product Preparations².  The tool is very complete, but…as I looked through all the questions, it asks to assure that you are selecting the right contractor to produce your sterile compounded products. I found there are many cases in which you are working on a good faith basis when you ask these questions to a prospective contractor.

Sure, you can fairly easily verify that:
  • The contractor is licensed in the state where their compounding facility resides
  • The contractor is licensed to deliver product to your state
  • The contractor is registered if necessary with the DEA and FDA
  • The contractor can provide proof of liability insurance
  • Your facility will be insured if there is no written contract
  • The contractor has policies in place to handle quality assurance problems
  • The contactor provides information regarding the status of latex, DEHP and preservatives in their products
  • The types of containers the contractor prepares (syringes, minibags, etc.) meet your institution’s needs
  • The contractor has business continuity plans (on paper) to deal with natural or manmade disasters
  • The contractor provides quality control reports on a regular or as requested basis
  • The contractor provides customer service on a 24/7 basis
  • The contractor negotiates price with your GPO
  • The delivery options you need are available (same day, next-day)
  • Orders can be placed using the internet
  • The contractor offers E-222 “CSOS” ordering of controlled substances
And with a little more effort you might be able to verify that:
  • All pharmacists working in the facility are licensed in that state
  • All pharmacy technicians working in the facility are licensed or registered in that state
  • If the contractor has faced any recent disciplinary or punitive actions by the State Board of Pharmacy or FDA
But how sure can you be that the contractor meets following:
  • Adheres to USP 797
  • Maintains staff competency in aseptic technique
  • Actually conducts quality control measures as described in their promotional literature
  • Actually conducts regular media fills and reports all findings to customers
  • Properly responds to positive media fills and makes appropriate corrective actions
  • Properly trains pharmacy technician staff and insures that they are certified by an appropriate agency
  • Uses ASHP guidelines for handling of hazardous agents
  • Uses NIOSH guidelines for handling hazardous agents
  • Uses proper cleaning methods including use of appropriate sporicidal agents
  • Conducts appropriate environmental monitoring
  • Hires and maintains staff that is knowledgeable on the products they prepare both clinically and operationally
Unless someone from your facility makes a site visit to the contractor’s facility, there is really no way to be sure some of the questions on the assessment tool are being answered truthfully. That’s a lot of faith in someone who is trying to sell you something! I’m sure those pharmacy directors or buyers who purchased medications asked many of these questions of NECC, Ameridose, and all the other compounding pharmacies who have either gone out of business since last fall or have had complete recalls of their product lines. I’m sure, also that no pharmacy director has time to go visit (or send a staff member to) every potential CSP contractor before purchasing product.

Another option is to test every product received. This can take time, require added expense and may not provide useful results in a timely manner. It may, however, provide some peace of mind if there are initial concerns. And please don’t get me wrong, there are some very reputable and conscientious compounders in the market place. The problem is that they may not compound every product your institution needs or they may be hit by the same product shortages facing the entire nation.

So what other step can be taken to get closer to the truth with potential CSP contractors? Until or perhaps more appropriately if the FDA is given the purview over these compounders with regular inspections and the power to discipline when violations occur, the next best step in my mind, is for the GPOs to step up to the plate. While the staff at the GPO may or may not be qualified to make a site inspection to potential contractors, they can certainly contract with the NABP inspectors used by the Iowa Board of Pharmacy to make the rounds of contractors willing to open their doors. The GPO can provide a tremendous service to its members by compiling a list of approved contractors and unapproved contractors, or for that fact, contractors willing to be inspected and those who are not. They can provide positive observations as well as concerns.  

My hope is that Congress and the President will empower the FDA to step up and meet the need for regular inspections and improved standards that will ensure safe compounded products from registered compounders. Until then, there are steps that can be taken, and it will be interesting to see who steps forward to take those steps. What are you doing to make sure you have safe compounded sterile products in your pharmacy?


¹ Wright S. Memorandum Report: High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them, OEI-01-13-00150. (accessed 2013 April 10).

² ASHP Foundation.  Outsourcing Sterile Product Preparation – Contractor Assessment Tool. (accessed 2013 April 10).

The News Article appears in the following categories: