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?
References
¹
Wright S. Memorandum Report: High-Risk Compounded Sterile Preparations
and Outsourcing by Hospitals That Use Them, OEI-01-13-00150. http://oig.hhs.gov/oei/reports/oei-01-13-00150.pdf (accessed 2013 April 10).