CompPharma, a consortium of workers' compensation pharmacy benefit managers, has published results of its research on compounded medications.
"The benefits of compounds are uncertain, and the patient safety issues are profound," said CompPharma's President
According to a release, 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
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
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.
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