Take a ride with Mark as he discusses the latest compound medicine kickback scheme to result in prison time.
If the future of surgery is medicine, then the future of medicines is compounding, the individualization of dosages and drug combinations.
Earlier this month, the FDA approved the first 3-D printed drug product, Spritam, developed by Aprecia Pharmaceuticals.
The layering process of 3-D printing allows Apecia to tightly package active ingredients in precise dosages.
A far more complex use of that technology is certainly not far behind. One that will open the door to mechanized compounding of drugs at patient-by-patient, individualized dosages: a customized 3-D printed pill for Mr. Smith and a different one for Ms. Jones.
For compounding pharmacists, the expansion of the use of 3-D printing technology will mean even more demand, whether on a small scale of production (i.e., a local pharmacy) or on a large one (e.g., a centralized facility filling hundreds of thousands or millions of prescriptions for individualized medications).
At the small scale end of this continuum, the move from large scale drug manufacturing to individualized drug compounding via 3-D printing is the equivalent of the morphing of the million dollar printing press into the laser printer or ink jet in your home office. It’s the dematerialization and democratization of drug manufacturing.
For physicians in states that either allow them to own interests in pharmacies or to dispense pharmaceuticals from their practices, the technology opens new doors to patient care and to profit.
Underlying all of this, for physicians and pharmacists alike, is the opportunity to do new types of deals with unique structures. That requires a new way of thinking. It also requires careful compliance with a host of regulatory issues, from the federal Anti-Kickback Statute to Stark to the Federal Food, Drug, and Cosmetic Act.
But those are just the problems on the route to outcomes that will be profitable for patients and profitable for providers.
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Mark F. Weiss