CompPharma Research on Compounded Drugs Questions their Efficacy, Safety and Cost

Tampa, Fla. (April 1, 2014)CompPharma, a consortium of workers’ compensation pharmacy benefit managers, has published results of its research on compounded medications. “Compounding is Confounding Workers’ Compensation” is available here.

“The benefits of compounds are uncertain, and the patient safety issues are profound,” said CompPharma’s President Joseph Paduda. “Insurance companies and other work comp payers are struggling with the increase in compounded drug prescriptions and their high costs. Member PBMs researched the safety, efficacy, pricing, regulation, and reimbursement of compounds to help the industry better understand the possible benefits and address the risks.”

The analysis found no clinical evidence that topical compounds commonly used in workers’ compensation are more effective than commercially available, manufactured drugs. Additionally, the research identified significant patient safety concerns, including inconsistent regulatory oversight, inaccurate dosing in sterile preparations as well as sterility concerns, duplicate drug ingredients and excessive concentrations of drugs in topical compounds.

“Topical compounds frequently contain duplicative ingredients such as two muscle relaxants and/or two non-steroidal anti-inflammatories (NSAIDS),” said Phil Walls, RPh, the paper’s lead author. “There is no clinical rationale for these duplications and there are risks of adverse effects.”

Bulk production of compounds raises questions about whether pharmacies are compounders or manufacturers. “Compounds should be prescribed and prepared for an individual with unique needs such as the inability to swallow the manufactured product or an allergy to ingredients in the manufactured drug,” Walls said. “But some pharmacies create bulk batches of topical compounds and then recommend that physicians prescribe them. Is this compounding or manufacturing?” Walls noted that the Federal Drug Administration regulates pharmaceutical manufacturing but not compounded drugs.

CompPharma recommends prescriptions for compounds require pre-authorization to ensure they are used only when there is a patient-specific requirement, as described above. The pre-authorization request should require:

  • Evidence of effectiveness and safety for topical compounds, such as study with a randomized controlled trial published in a peer-reviewed medical journal.
  • A letter of medical necessity demonstrating conventional therapy has been tried and failed.

About CompPharma Established by industry consultants Joseph Paduda and Helen Knight, CompPharma, LLC is a consortium of PBMs active in workers compensation. Member PBMs are Catamaran, Express Scripts, HealthCare Solutions, Healthesystems, myMatrixx, and Progressive Medical & PMSI. More information is available at

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Media Contact:  Helen Knight, 813-837-1701;