What Are Compound Drugs? Rule 134.500(4) defines “compounding” as the preparation, mixing,...
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Transcript of What Are Compound Drugs? Rule 134.500(4) defines “compounding” as the preparation, mixing,...
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Compound DrugsCompound Drama
Speaker:Jessica MacCarty
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What Are Compound Drugs?
• Rule 134.500(4) defines “compounding” as the preparation, mixing, assembling, packaging, or labeling of a drug or device per the Occupations Code
• Typically used for patients with allergies, specific medical conditions, and children
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In Workers’ Compensation…
• The primary issue is “topicals” – creams, gels, or ointments that are applied to the skin.
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Problems: Expensive!
• Can cost thousands of dollars, up to $14k
• Not supposed to be manufactured in bulk
• Multiple ingredients
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Problems: Not Proven Effective
• Very little testing or oversight • Not FDA approved• Efficacy of drugs through dermal absorption has
not been proven
Accessed on March 2014. http://training.seer.cancer.gov/melanoma/anatomy
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Problems: Not Medically Necessary
• FDA approved drugs in pill form are typically available with no reason for the potentially ineffective topical cream
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Problems: Duplicative & Risky
• Many compounds contain multiple drugs of the same variety with increased potency
• Compounds have led to deaths and illnesses in some cases
• The potential for large profits has lead to scams and kickback schemes
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Why It’s An Issue Now: Mass Marketing
http://www.comppharma.com/CompoundDrugResearch.pdf
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Why It’s An Issue Now: Increases
http://www.comppharma.com/CompoundDrugResearch.pdf
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Potential Solutions: Pre Authorization
• Required for :
(1)Any compound that contains an “N” drug
(2) Investigational or experimental drugs
• Rule 134.530
Accessed March 2015. http://www.tdi.texas.gov/wc/pharmacy/
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Potential Solutions: Retrospective Review & Non Closed Formulary
• Review for medical necessity afterwards, particularly since compounds are rarely determined necessary
• 134.500 defines “closed formulary” as any FDA approved prescription or nonprescription drug except the three categories that require preauthorization. Compound drugs are not FDA approved.
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Helpful Resources
• http://www.comppharma.com/CompoundDrugResearch.pdf
• http://www.tdi.texas.gov/wc/pharmacy/
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THANK YOU!