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Drug Shortages and Compounding Pharmacies What every ASC should know. BY ALISON CHERNEY

The number of back-or- dered medications in the US has continued to rise, and this trend continues to create complications for

ASCs and other health care providers. According to, an online newsletter published by the International Journal of Pharmaceutical Compounding, this trend is expected to continue. Over the past year, this situa- tion has worsened causing surgeries to be delayed and much consternation about how to keep the sterile injectable supply chain in sync so that ASCs and others can continue to operate efficiently. Increasingly, compounding pharmacies are being seen as an alternative source of the medications ASCs and other care providers need for their patients. In light of the recent fungal meningitis outbreak that occurred last year, which media re- ports tied to drugs supplied by a New England compounding pharmacy, how- ever, ASCs need to consider a number of factors to ensure quality compliance. Compounding pharmacies have op- erated in the US since the 1800s. With the growth of commercial drug manu- facturers in the mid-20th century, the percentage of prescriptions that were compounded declined. In the last two decades, the industry has seen signifi- cant growth due to the unique dosages and combinations of medications often required by physicians for their patients. Compounding pharmacies cannot

provide the same formulations of medi- cations that are available commercially. They can, however, provide different formulations or combinations of formu- lations that are required for individual patients. If there is a 2 percent lidocaine gel available, for example, a compound- ing pharmacy cannot copy that formula- tion. If, however, a physician requires a


stronger dose of the product, for example an 8 percent version of the product, or if another drug is required in combination with the lidocaine gel, it can be com- pounded.

Back-ordered medications create an- other product line that can be provided by a compounding pharmacy. A compound- ing pharmacy can provide a particular dosage of medication that is available commercially if it is on back-order and that status can be verified with the US Food and Drug Administration (FDA). The medication can be provided only during the period of back order and not beyond this date. This service provides a great option for ASCs and others that are having trouble sourcing a particular medication.

Back-Order Considerations Let’s first take a look at the considerations of providing back-ordered medications from the compounding pharmacy stand- point. These considerations include: 1. Identifying and confirming the par- ticular back-order situation;


2. Developing a formulation that can be confirmed;

3. Sourcing of FDA-approved active pharmaceutical ingredients (API);

4. Developing a cost model that makes sense for the medication; and

5. Following quality assurance proce- dures during the process.

The management of back-ordered medications is a relatively complex situ- ation for a compounding pharmacy. Typ- ical compounding pharmacy operations are focused on the filling of individual patient prescriptions and ensuring that they are not copying commercial medi- cations. Most compounding pharmacies have particular product lines that they of- fer where most of this work has already been completed. There are two major product lines in compounded pharma- cies: sterile and non-sterile products. Compounding is essentially the mixing of the active and inactive ingredients that go into a prescription. The active ingre- dients are called APIs; the inactive ingre- dients are excipients in which the API is mixed or compounded.

The advice and opinions expressed in this article are those of the author and do not represent official Ambulatory Surgery Center Association policy or opinion.

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