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

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

  • Methyl Salicylate 20%
  • Menthol USP 5%
  • Capsaicin 0.035%

OTC: ZIKS CREAM $26/240 GM

  • Methyl Salicylate 12%
  • Menthol USP 1%
  • Capsaicin 0.25%

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

4 Strategies to Manage PLTs in Workers’ Comp Claims

  • Work with a PBM to create evidence-based criteria that are focused on patient safety and cost thresholds
  • Limit medications not meeting these criteria
  • Require documentation for select cases where there is a demonstrated medical need
  • Provide claims staff with education regarding the safety risks and high costs associated with PLTs

References

  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.

RxInformer

Since 2010, the semi-annual RxInformer clinical journal has been a trusted source of timely information and guidance for workers’ comp payers on how best to manage the care of injured worker claimants and plan for the challenges that lay ahead. The publication is an important part of Healthesystems’ proactive approach to advocating for quality care of injured workers while managing the costs associated with treatment.
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