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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.

Related: Preparing the Military Health System for the 21st Century

“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.

Related: TRICARE Walk-in Service Eliminated

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.

Related: VA and DoD Set to Share More Patients

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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Federal Practitioner - 32(4)
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e6
Legacy Keywords
compounded drugs, TRICARE, Express Scripts, compound drug claims, drug safety, drug efficacy, prescription drugs, U.S. Army Maj. Gen. Richard W. Thomas, chief medical offer and director of health care operations for the Defense Health Agency, not approved by FDA, Government Accountability Office report
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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, 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.

Related: Preparing the Military Health System for the 21st Century

“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.

Related: TRICARE Walk-in Service Eliminated

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.

Related: VA and DoD Set to Share More Patients

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.

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.

Related: Preparing the Military Health System for the 21st Century

“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.

Related: TRICARE Walk-in Service Eliminated

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.

Related: VA and DoD Set to Share More Patients

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.

Issue
Federal Practitioner - 32(4)
Issue
Federal Practitioner - 32(4)
Page Number
e6
Page Number
e6
Publications
Publications
Article Type
Display Headline
New Guidance on Compounded Drugs
Display Headline
New Guidance on Compounded Drugs
Legacy Keywords
compounded drugs, TRICARE, Express Scripts, compound drug claims, drug safety, drug efficacy, prescription drugs, U.S. Army Maj. Gen. Richard W. Thomas, chief medical offer and director of health care operations for the Defense Health Agency, not approved by FDA, Government Accountability Office report
Legacy Keywords
compounded drugs, TRICARE, Express Scripts, compound drug claims, drug safety, drug efficacy, prescription drugs, U.S. Army Maj. Gen. Richard W. Thomas, chief medical offer and director of health care operations for the Defense Health Agency, not approved by FDA, Government Accountability Office report
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