CompPharma Is Bearish on Compound Drugs

Prescriber beware!  That’s the takeaway message from a recent white paper, “Compounding is Confounding Workers’ Compensation” authored by representatives of CompPharma’s member Pharmacy Benefit Managers. Their research looks at the cost, safety and efficacy of compound drugs and concludes that the prudent course of action is to exercise all appropriate due diligence before prescribing and making payment for these drugs.

First of all, what are compound drugs?  There is, apparently, no nationally recognized official definition, but they are generally accepted to be either topical or sterile compound drugs which (a) are not commercially available; and (b) are prescribed to meet the specialized needs of an individual (for example with specialized strengths, allergens removed, or in liquid form for those with difficulty swallowing.)

CompPharma’s white paper claims that compound drugs “have not been proven to be more effective than commercially available, manufactured drugs.” With respect to sterile compounds, it points to the 2012 New England Compounding Center incident where 50 people died and over 700 have recurrent fungal infections following injections from steroids contaminated with mold.  In the wake of this incident, efforts were made to step up regulation.  There is currently a patchwork of state and federal regulations in place, but CompPharma notes recent legislation at the federal level, which may suggest that federal oversight may become more stringent. 

CompPharma suggests the following guidelines for prescribers:

> Vet the credentials of the compounding pharmacy

> Know exactly what individual ingredients are in the compound and review the safety and efficacy data for each

> Have the pharmacist provide data on the physical and chemical stability of the compound

> Do appropriate review to ensure that levels of concentration of each ingredient are safe and effective

As for payers, CompPharma suggests that they should limit approval to a few situations such as where conventional therapy has been tried and failed, where evidence of the effectiveness and safety of the topical compounds has been provided or an informed consent by the patient obtained, and where medical necessity has been established. 

Given the significant increase in usage of compound drugs in workers’ compensation in recent years, this white paper is certain to generate much discussion.

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