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

  CompPharma Research on Compounded Drugs Questions their Efficacy, Safety and

Business Wire

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 at

“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 asstudy
    with a randomized controlled trial published in a peer-reviewed medical
  *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


CompPharma, LLC
Helen Knight, 813-690-4787
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