Physician prescribing of private-label topical analgesics has increased in workers’ comp, with prescribing rates doubling since 2012.1 Awareness of these expensive and clinically unproven products is becoming increasingly important due to their potential safety and cost implications. From a clinical perspective, private-label topicals offer no greater benefit to the patient than over-the-counter (OTC) alternatives found in national retail chains. Like their OTC counterparts, private-label analgesics have not undergone controlled studies to support their clinical efficacy or safety and have not been approved by the U.S. Food and Drug Administration (FDA). Yet in most cases they are significantly more expensive. While these products typically represent a very small portion of prescriptions written, the potential cost per prescription is disproportionately high. Prices associated with private-label topicals often exceed $500.1 A comparable OTC alternative, which includes brands such as BenGay® or IcyHot®, typically retails for less than $10.00.
What are private-label topical analgesics?
- Independently manufactured OTC products
- Contain similar ingredients as OTC products
- Significantly higher AWP vs OTC products
- Pose an increased risk of skin burns due to high concentrations of specific ingredients (menthol, methyl salicylate, capsaicin)
- Prescribed for temporary relief of minor pain associated with injury, including back & shoulder
- Most commonly dispensed by physicians or smaller, independent pharmacies
What are they NOT?
- Not FDA-approved
- Not clinically tested for safety or efficacy
- Not cost-effective
- Not compounds
- Not available OTC at retail chains
Prescribing and patient safety
So why are these products being prescribed? In some cases, it is based on misperception. Prescribers may believe they are recommending a superior product, without fully realizing the safety or cost implications. In reality, the active ingredients in these products – which frequently include methyl salicylate, menthol, and capsaicin – commonly overlap with inexpensive and widely accessible OTC alternatives. It is important for physicians to recognize that there are suitable alternatives available.
When recommending any topical product, whether prescription or OTC, physicians must consider patient safety and evidence-based guidelines. Private-label topical analgesics are not recommended according to evidence-based guidelines. Additionally, the FDA has previously issued safety communications regarding the occurrence of serious skin burns in products containing high concentrations of menthol and methyl salicylate (concentrations greater than 3% and 10%, respectively).2 Of the 22 private-label topical analgesics Healthesystems has observed being prescribed for injured workers, 19 contain menthol and/or methyl salicylate, and 74 percent contain these ingredients at concentrations twice or even three times higher than the recommended FDA thresholds.1 The Official Disability Guidelines (ODG) include recommendations for OTC alternatives of these pricey and potent topical analgesics.3
Education and awareness
As prescribing of private-label topical analgesics continues to trend upwards, there is a greater need for oversight of these products on the part of the payer and pharmacy benefits manager (PBM). “A PBM can work collaboratively with a payer to define appropriate parameters that can best guide decision-making for the claims professional. These parameters should include factors such as patient safety concerns as well as the fact that evidence-based guidelines do not recommend use of these products. A PBM can also recommend appropriate and cost-effective OTC alternatives,” explains Silvia Sacalis, PharmD, vice president of Clinical Services at Healthesystems. She also emphasizes that further education is needed from a claims professional standpoint, including familiarity with product names, an understanding of the safety and cost implications for these products, and the channels through which private-label topicals are being dispensed; in the majority of cases, by the physician or smaller, independent pharmacies. “Educating the claims professional is essential to the overall strategy for limiting the use of inappropriate therapies to ensure quality care, while reducing costs associated with these products.”
The upcoming Spring 2015 issue of RxInformer clinical journal will include an in-depth look at private-label topical analgesics. Be among the first to access the new issue, available April 2015. Visit www.healthesystems.com/rxinformer to register for free and explore other relevant topics impacting workers’ comp.
About Silvia Sacalis, PharmD
Silvia Sacalis, PharmD, is a clinical pharmacist and vice president of Clinical Services at Healthesystems, a leading PBM and ancillary medical benefits manager serving the workers’ compensation industry. Her experience and clinical expertise span the PBM, retail pharmacy and managed care environments. Leveraging her technology background, clinical skills and management expertise, she helps develop and operationalize strategic clinical initiatives to help workers’ compensation insurance payers maximize the impact of a pharmacy benefit management program. Throughout her career, she has held various leadership roles in which she provided oversight of the development of clinical services programs, and integration of analytics technology with clinical consultative support. Dr. Sacalis received her Bachelor of Science in Computer Science and Doctorate of Pharmacy degrees from the University of Illinois at Chicago.
1Healthesystems data, 2015.
2FDA Drug Safety Communication: Rare cases of serious 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 February 27, 2015.
3Official Disability Guidelines 2015. Work Loss Data Institute.
This is a sponsored post from WorkCompWire marketing partner Healthesystems.