AS I SEE IT
The Drug Enforcement Administration allows 5 percent of a compounding pharmacy’s overall total controlled substances to be sold pursuant to a purchase order and invoice, as opposed to patient-specific prescriptions.”
—Alison Cherney, Ionia Pharmacy
that when we deliver the medication to an ASC or other health care provider, it is still on back order.
Back-Order Considerations for ASCs Considerations from an ASC standpoint include: 1. confirming that the compounding pharmacy is properly licensed and following procedures that protect the interest of the patient, the physi- cian and the ASC;
2. confirming the back-order situation; 3. developing a back-order procedure within the ASC that follows compli- ance guidelines; and
4. developing a true cost-effective solu- tion for the back-ordered situation. The management team of an ASC needs to ensure that the compounding pharmacy has the appropriate expertise in back-ordered medications and that its process of providing the ASC with the medications is prudent. Keep in mind that back-ordered medications can be more or less expen- sive than the commercial preparations. Work with your pharmacy to ensure that the pricing of these medicines makes sense for your organization. Working with a trusted compounding pharmacy will save your ASC’s staff time since a quality compounding pharmacy will be
proactive in assisting, consulting and an- swering these questions on behalf of the ASC and the ASC’s physicians. When ordering back-ordered con- trolled medications from a compounding pharmacy, be careful. Drugs such as fen- tanyl and midazolam have been on back- order of late. The Drug Enforcement Ad- ministration (DEA) allows 5 percent of a compounding pharmacy’s overall total controlled substances to be sold pursu- ant to a purchase order and invoice, as opposed to patient-specific prescriptions. Determining the 5 percent threshold is ex- tremely difficult to manage and is one of the major reasons that controlled medica- tions are difficult to find, especially with the recent events surrounding the com- pounding pharmacy in New England that was supplying a lot of these drugs. The DEA does not permit “constructive trans- fer” of controlled substances. This means that all medications dispensed pursuant to patient-specific prescriptions may be dis- pensed only directly to the patient and not to that patient’s prescriber. In other words, patient-specific compounded controlled substance medications may not be deliv- ered/shipped to the prescriber, nor to the institution in which that drug will be ad- ministered to the patient. Have your legal counsel take a look at constructive transfer law and understand how your ASC is re- ceiving controlled compounded medica- tions. Compounding pharmacies, facilities and physicians who do not comply with this rule could be subject to suspension or termination of their DEA license.
Alison Cherney is the chief executive officer of Ionia Pharmacy in Tustin, California,
www.ioniapharmacy. com. Write her at
Cherneyaj@aol.com.
10 ASC FOCUS JUNE 2013
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