Workers’ Compensation has seen a steady increase in prescriptions for topical compounded preparations. In fact, the use of compounded drugs in workers’ compensation has increased nearly five-fold in the past five years. Along with increased use, the prices charged for compounds have risen dramatically.

In recent years however, some compounding pharmacies have begun pushing the boundaries by marketing new uses for existing medications. The Internet abounds with compounding companies making “therapeutic” claims for their special topical formulations. These claims have no supporting evidence of safety and efficacy.
The quality of the preparation and the safety and efficacy of these “custom” compounds are largely unknown. Usually formulated with four to six different ingredients, compounded medications can come with staggeringly high costs, running into thousands of dollars per prescription. Compound pharmacy marketing materials tout numerous benefits of topical compounds, which boil down to:

  • Applying topical drugs to the site of the injury theoretically avoids systemic absorption and subsequent side effects
  • Combining multiple agents into a single preparation reduces the number of tablets or capsules needed and helps patients who have trouble swallowing oral preparations
  • Compounds can omit ingredients that cause an allergic or other adverse reaction in the patient
Workers’ Compensation payers are questioning the cost of compounds and struggling with how to assess their efficacy and appropriateness and determine appropriate reimbursement. At the request of payers, clinical pharmacists and government relations professionals sought answers to the following questions:
  • Are compounded medications more effective than manufactured drugs? No, compounds have not been proven to be more effective than commercially available, manufactured drugs that have been approved by the U.S. Food and Drug Administration (FDA) in similar classes.
  • Are compounded drugs safe? There are significant known and unknown risks.
  • What scientific studies should be required to support the use of a compounded drug? None are available.
The determination of whether a compounded medication is being appropriately used requires a comprehensive understanding of information that needs to be gathered from a variety of stakeholders. Cooperation and input from prescribers, patients, pharmacists, and claims handlers are often necessary when determining the appropriateness of compounds.

CompPharma Authors
A. Phillip Walls, RPh, myMatrixx
Seth Johnson, JD Progressive Medical
Michael Nguyen, PharmD, myMatrixx
Kate O’Lenic, RPh, Pharm D, Healthesystems Tim Pokorney, RPh, Express Scripts
Sarah Randolph, PharmD, RPh, Express Scripts