A Healthesystems publication

Summer 2017

Myth Busters: Private-Label Topicals Edition

Private-label topical (PLT) analgesics are independently manufactured lotions and creams that are increasingly being prescribed to patients for the temporary relief of minor pain associated with injury. The expensive products are often marketed by manufacturers as having unique formulations and special ingredient blends. In reality, most of these products often contain ingredients that can be found in inexpensive, widely accessible over-the-counter (OTC) topical products.

MYTH:

PLTs are reviewed by the FDA for their safety and efficacy

FACT:

While the individual ingredients in PLTs may be approved by the FDA, the combined formulations have not necessarily undergone controlled studies and have not been approved by the FDA.

PLTS OFTEN EXCEED FDA THRESHOLDS FOR INGREDIENT LEVELS BY 2-3X, INCREASING RISK FOR SKIN BURNS1,2

exceed fda levels

MYTH:

PLTs are more effective than OTC lotions and creams

FACT:

PLTs’ ingredient makeup often overlaps heavily with OTC topical products.

PLT: MEDROX® OINTMENT
$750/240 GM

OTC: ZIKS CREAM $26/240 GM

heavy ingredients overlap

MYTH:

PLTs don’t have a significant impact on overall pharmacy costs

FACT:

Although PLTs don’t represent a large portion of workers’ comp prescriptions, their high average wholesale price (AWP)/ unit cost makes a significant impact when they appear in claims.

PLT AWPS OFTEN EXCEED $500.1 COMPARABLE OTC PRODUCTS (E.G., BENGAY®, ICYHOT®) TYPICALLY RETAIL FOR <$10

exceed fda levels

4 Strategies to Manage PLTs in Workers’ Comp Claims

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SOURCES

1 -Healthesystems data.
2 -FDA Drug Safety Communication: Rare cases of serious skin burns with use of over-the-counter topical muscle and joint pain relievers. September 2012. Rockville, MD: US Food and Drug Administration. http://www.fda.gov/drugs/drugsafety/ucm318858.htm. Accessed March 6, 2017.
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