Government and Regulations

New Guidance on Compounded Drugs

As of May 1, 2015, a new screening process will take effect for compounded drugs, which make up only 0.5% of total TRICARE prescriptions but account for > 20% of total pharmacy expenditures.


 

As of May 1, 2015, pharmacy contractor for TRICARE, Express Scripts, will screen all ingredients in compound drug claims to make sure they are safe and effective.

The screening process, already in effect for other prescription drugs, will apply to drugs for which a pharmacist mixes ≥ 2 ingredients, even when altering the drug by adding a flavor to make it more palatable.

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“The changes really are not so much a policy change as really just us enforcing the regulatory guidance that we already have on our books,” said U.S. Army Maj. Gen. Richard W. Thomas, chief medical officer and director of health care operations for the Defense Health Agency (DHA), in an interview with DoD News.

Maj. Gen. Thomas said that in 2012, the pharmacy contractor completed a system upgrade, allowing the DoD to see specific ingredients in compounded drugs. They found that not all the ingredients were approved by the FDA and that safety and effectiveness were not always supported by scientific evidence. In 2014, moreover, a Government Accountability Office report indicated DHA was not in compliance with its own regulation to provide only FDA-approved medicine to beneficiaries, Maj. Gen. Thomas noted.

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The changes may also save money or at least help ensure that money is being spent wisely. According to Maj. Gen. Thomas, compounded drugs make up only 0.5% of the total number of prescriptions provided through TRICARE but account for > 20% of total pharmacy expenditures. Screening, he added, is part of fulfilling the DoD’s obligation to be responsible stewards of taxpayer dollars.

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TRICARE will continue to cover most compound drugs, and most beneficiaries will experience no delay in getting their prescriptions. If a compound doesn’t pass the initial screen, the pharmacist can switch a nonapproved ingredient with an approved one or request that the doctor write a new prescription.

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