A Healthesystems publication

Fall 2013

Topical Analgesics: Expensive and Avoidable

Close management of custom compounds has decreased their prevalence in workers’ compensation.  But private-label topicals and homeopathic products have filled the void.  Neither is FDA-approved. Both warrant close monitoring because of their high costs and lack of proven efficacy.  

Some very expensive topical creams and gels are creeping into the workers’ compensation prescription files. Previously, the issue of custom compounds was highlighted and the attention to these prescriptions has resulted in a decrease in the number of prescriptions seen. However, the price of these compounds has increased significantly.

In addition to the compounds that are still being prescribed, other topical products are increasingly seen in the workers’ compensation setting. In this article, a spotlight is turned on to expose more expensive topicals — private-label analgesics and homeopathic products.

Summary of Primary Issues

Issue Custom Compounds Private-Label Analgesics Homeopathic Products
 NDCs Available       
FDA-approved      
Proven clinical benefit      
Prepared by compounding pharmacy for a specific patient   - -
Contain high levels of NSAIDs   - -
Contain 2-3x the FDA-approved concentration of methyl salicylate and/ or menthol     -
Can cause skin burns     -
Prescribers unaware of compound ingredients      
Prescribers unaware of high costs      
Expiration dating required - -  

Topical Private-Label Products

There are private-label companies marketing products similar to inexpensive, over-the-counter products, but with catchy names, inflated claims and prices. Private-label topical compounds are products containing only OTC ingredients such as high-potency methyl salicylate, menthol, camphor and homeopathic agents. These mixtures largely approximate OTC formulations but come with substantially higher prices justified by the manufacturer because they contain higher concentrations of some ingredients than their OTC counterparts.

Financial Concerns

When compared with comparable over-the-counter (OTC) preparations, the private-label products’ prices are stunning. Why would anyone pay $110 per ounce for a private-label product when the over-the-counter product costs just $5 per ounce?

Patient Safety

Another concern is patient safety. The private-label products contain much higher concentrations of ingredients than the over-the-counter products. That does not translate into a better product. What is does is increase the risk for skin burns as announced by the FDA for the lower concentration over-the-counter products.2

Custom Compounds

A mixture of prescription and non-prescription ingredients, these topicals are prepared in a compounding pharmacy for specific patients.

Ingredient Comparison

Product Name & Ingredients Price per
1 ounce
Product Name & Ingredients Price per
1 ounce
Dendracin® Lotion Neurodendraxcin
Methyl Salicylate 30%
Menthol USP 10%
Capsaicin 0.0375%
$110.00 Ziks cream
Methyl Salicylate 12%
Menthol USP 1%
Capsaicin 0.025%
$5.00
Exoten C or Xoten-C lotion
Methyl Salicylate 20%
Menthol USP 10%
Capsaicin 0.002%
$89.00 Flex-All Ultra Plus®
Methyl Salicylate 10%
Menthol USP 16%
Camphor 3.1%
$1.60
Medi-Derm cream
Methyl Salicylate 20%
Menthol USP 5%
Capsaicin 0.035%
$100.00 Rapid Alivio Roll On
Methyl Salicylate 10%
Menthol USP 3.5%
Capsaicin (not specified)
$3.20
Medrox® ointment
Methyl Salicylate 20%
Menthol USP 5%
Capsaicin 0.0375%
 $75.00 Castiva Arthritis Pain Relief cooling lotion
Methyl Salicylate 14%
Menthol USP 5%
$2.80
Medrox® Rx ointment
Methyl Salicylate 20%
Menthol USP 7%
Capsaicin 0.05%
$103.00 Walgreens Ultra Strength Muscle Rub
Methyl Salicylate 30%
Menthol USP 10%
Camphor 4%
$1.75
Medrox® patch/pad
Methyl Salicylate 20%
Menthol USP 5%
Capsaicin 0.0375%
$29.00 per patch/pad Salonpas pain relieving patch
Methyl Salicylate 6.3%
Menthol 5.7%
Camphor 1.2%
$.10 to $.50 per patch
Terocin® lotion
Methyl Salicylate 25%
Menthol USP 10%
Capsaicin 0.025%
Lidocaine 2.5%
 $99.00  No comparable products

 

 

Homeopathic Topicals

Homeopathic topicals contain extremely dilute substances. These are so dilute that the ingredients cannot be detected by laboratory assays.

Recommended Actions

Due to serious patient safety concerns, lack of proven efficacy and the inflated costs associated with these products, Healthesystems recommends advises claims professionals to deny requests for these topicals or request a Letter of Medical Necessity.

 

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SOURCES

1 -FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers 9/13/2012. Rockville, MD: US Food and Drug Administration. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm318858.htm. Accessed July 4, 2013.
2 -FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers 9/13/2012. Rockville, MD: US Food and Drug Administration. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm318858.htm. Accessed July 4, 2013.
3 -FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers 9/13/2012. Rockville, MD: US Food and Drug Administration. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm318858.htm. Accessed July 4, 2013.
4 -Warning Letter dated December 4, 2006 “Hal’s Compounding Pharmacy, Inc.” US Food and Drug Administration, Rockville, MD. Available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm076195.htm. Accessed July 4, 2013.
5 -FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams. Rockville, MD: US Food and Drug Administration. 12/5/2006. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108793.htm. Accessed July 4, 2013.
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