by Sarah Sellers, PharmD and M.P.H.
Johns Hopkins Bloomberg School of Public Health
John Hopkins University
February 21, 2005
Three deaths have now been associated with the use of pharmacy-compounded topical anesthetic pain creams, which may be marketed by pharmacists to niche markets including hospice practices. Pharmacy compounded preparations are not approved for safety and efficacy by the FDA, and they are not manufactured in accordance with federal safety standards-their potency, purity, sterility (if required) and therapeutic effects may be unknown, with significant implications for patients and prescribers.
The Missouri Board of Pharmacy recently found a 19% failure rate for compounded drugs tested for potency, with some drugs having significantly less active ingredient than indicated on the label and some drugs having significantly more active ingredient than indicated on the label. In one case, no active ingredient was found in a compounded product. This analysis was preceded by an FDA survey of compounded products, which found a 34% failure rate for drugs tested for potency and/or purity. For patients, such deviations can result in toxicity from super-potency, inefficacy from sub-potency, and/or infection from contamination.
Because of the uncertainties surrounding their safety and efficacy, compounded drugs should not be substituted for FDA-approved products and they should not be prescribed in order to increase compliance. In such cases, the risks of using the unapproved products are likely to outweigh any purported benefits. If a compounded preparation is recommended by a pharmacist, its use must be authorized by a licensed prescriber. This process should include disclosure of important information to patients and caregivers, including the specific rationale for using the product; intended benefits, known and unknown risks, scientific basis for formulations, quality control and liability. In the absence of such, the use of compounded products should be approached with extreme caution.
For additional information please contact:
Sarah Sellers, PharmD MPH
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