Monday, July 7, 2014

FormularyWatch clinical editor David Calabrese, RPh, MHP, vice president and chief pharmacy officer for Catamaran. List Key Concerns with Compounded Drugs

Compounded ingredient costs: PBMs take action




In response to rising compounding drug costs, pharmacy benefit managers, such as Express Scripts, have made moves to restrict their coverage for active ingredients used by compounding pharmacies.
The Wall Street Journal reported that Express Scripts will block coverage for about 1,000 active ingredients that are used by compounding pharmacies.
But more important than the issue of cost/waste with compounds is a rapidly growing concern relative to the safety of individuals for whom these products are prescribed, according to FormularyWatch clinical editor David Calabrese, RPh, MHP, vice president and chief pharmacy officer for Catamaran.
“Compounds are not FDA approved and as such they are not subject to the same rigorous standards of quality, potency, purity and stability in the manufacturing process as commercially-produced drugs,” Calabrese said. 
“Additionally, there is typically very little, if any, evidence from sound clinical studies supporting the safety and effectiveness of these products,” he said. “And, as compound use has risen, many organizations are seeing compounding practices that are certainly raising eyebrows for all stakeholders as cause for concern.”
According to Calabrese, these practices include, but are not limited to:
  • Utilizing active ingredients in compounds that have never been FDA evaluated or even tested in a dermatologic route of administration  (eg, anticonvulsants, antidepressants, narcotics)
  • Combining upward of 10 to 15 different active ingredients into a single compounded product
  • Combining different drugs from the same drug class in a compound
  • Production of topical compounds with potency of active ingredients 10- to 20-fold that of a commercially manufactured, FDA-approved alternative
  • Bribes/kickbacks to doctors by compounding pharmacies to prescribe compounded products
  • continue to read here

No comments: