By John Stahl, Esq.
The FDA website defines “pharmacy compounding” as “a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient.” A simpler way of understanding this procedure is that a medical care provider determines that someone would benefit more from a customized medication than an “off-the-rack” drug, and the compounding pharmacy fills the prescription for that “made-to-fit” product.
The portion of the FDA’s description that states that “pharmacy compounding, if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication” illustrates the blessing and the curses regarding these hybrid medications.
The blessing is that a compounded drug is “tailored to the medical needs of an individual patient.” This has particular importance to workers’ compensation because the myriad of factors, such as long-term exposure to toxic substances and a simultaneous combination of physical injuries, often hinders determining the optimal “drug cocktail” for a claimant.
The curses include that compounded drugs have not undergone the FDA approval process and that they are not always “done properly.” Additionally, the pharmacies where the compounding occurs overall are subject to less stringent regulation than the manufacturing of the individual compounded drugs, which require the aforementioned FDA approval, that pharmacists combine to make the custom concoctions.
Another portion of the FDA website concisely summarizes more general concerns regarding compounded drugs. Serious risks associated with that practice include:
- · Improperly compounded drugs lacking appropriate potency;· Patients using a properly prepared but ineffective compounded drug rather than an effective FDA-approved medication;· Pharmacists who are not properly trained to compound drugs combining drugs that should not be compounded; and· Compound pharmacies that lack appropriate levels of quality control.
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