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    New program aims to improve compound medication safety

    David Calabrese RPh MHPCalabrese, RPh, MHPEven today, the mortar and pestle remains the iconic symbol still representing our great profession.  

    And, while we have witnessed unprecedented advancements in the development of thousands of safe and effective, commercially-manufactured drug products, the practice of drug compounding still remains a valued healthcare service for select individuals who, for various reasons, cannot be treated successfully with a commercially-manufactured, FDA-approved medication.

    Recently however, the practice of compounding has come under enormous scrutiny due to a variety of quality, safety and economic concerns which have drawn significant attention from FDA, lawmakers, PBMs and public and private insurers alike. 

    Related: A properly designed compounding benefit can help control costs and quality

    Most notably, our nation has witnessed the emergence of hundreds of "compounding" pharmacies over the past decade producing, marketing, pricing and dispensing of these unapproved medications in ways that now have clearly stretched the boundaries of traditional compounding practice. 

    In 2012, the subject of compounding was raised to new heights when 64 individuals were killed and another 750 injured due to a fungal meningitis outbreak caused by tainted injectable corticosteroid products made by a MA-based compounding facility.

    Around the same time, PBMs began to witness sharp rises in pricing and utilization of compounded products, unexpectedly elevating these previously low-attention medications into primary focus on our radar screens, as well as those of contracted plan sponsors.

    In light of these concerns, OptumRx developed the SECURE™ (Safe & Effective Compound Use Reassurance Effort) program to assist clients in better monitoring and managing the production, pricing and dispensing of today’s compound medications.  Recognizing that the success of such efforts requires a multi-dimensional effort, SECURE combines benefit design strategies along with utilization management protocols, extensive analytics and the nation’s first and only network compound credentialing program (NCCP). 


    NEXT: SECURE's goals


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