Page 68

66

Despite significant overlap and an expanded gray area, one distinction between drug manufacturers and the large compounding pharmacies remained legally clear. Drug companies (with FDA oversight) manufactured drugs in batches and could distribute them to wholesalers, retailers, and other customers. On the other hand, compounding pharmacies—large and small—were required to prepare medications for individual patients, and in each case, the compounded drug needed a doctor’s prescription (1, 9). This prescription requirement posed a bureaucratic challenge for compounding pharmacies when hospitals and clinics placed orders for large quantities of commonly used injectable solutions. A typical example was methylprednisolone, a steroid that is routinely injected to relieve joint and back pain. Orthopedic practitioners and pain clinics stock ample supplies of methylprednisolone and inject many patients with it every day. Methylprednisolone is manufactured by Pfizer and several generic pharmaceutical companies (1). The St. Thomas Outpatient Neurosurgery Center in Nashville, Tennessee, had been purchasing its methylprednisolone from Clint Pharmaceuticals, a generic drug company. But when Clint raised its price to $8.95 per 1 ml vial in June 2011, Debra Schamberg, the clinic’s director, contacted NECC’s persistent regional salesman. She said if he was still offering a price of $6.50 per vial, they had a deal (17). The large shipments from Clint Pharmaceuticals did not require individual prescriptions, but NECC was a pharmacy and licensed only to sell drugs to patients who presented a prescription. Healthcare providers wanted the convenience of having drugs like methylprednisolone in stock. The pharmacy-prescription process created an additional layer of paperwork and interfered with how they practiced pain management for their patients. To accommodate these customers, NECC began selling large shipments of drugs without prescriptions as early as 2009 (17). Realizing that NECC’s shipments needed prescriptions, Barry Cadden, NECC’s president and head pharmacist, suggested a compromise. He told his national sales manager that perhaps

Reprinted from The Pharmacologist • June 2017

names could be attached to the orders after the drugs were injected. This linked each dose to a patient, but it clearly stretched the intent of the law. NECC assumed that the names they received corresponded to legitimate patients, but clinics that treated many patients each day found shortcuts. They sent NECC names like Calvin Klein, Jimmy Carter, Octavius, Burt Reynolds, Filet O’Fish, and Coco Puff (17). At the St. Thomas Outpatient Neurosurgery Center, they printed out the daily patient schedules and submitted those names with each NECC order (17). But some employees got creative, and one patient name they submitted was Mickey Mouse. Cadden was not amused and issued a stern internal memo saying that the names “must resemble ‘real’ names… no obviously false name! (Mickey Mouse)” (17).

The Index Patient On July 30, 2012, Thomas Rybinski checked in to the Outpatient Neurosurgery Center at St. Thomas Hospital (17). The 56-year-old autoworker from Smyrna, Tennessee, suffered from chronic back pain caused by degenerative spinal disks. His doctor gave him a 1 ml epidural injection of methylprednisolone (17, 18). The St. Thomas Outpatient Center administered thousands of injections each year, and on its website, epidural steroid injections were listed as its “top procedure” (19). Experts say that doctors overprescribe invasive back-pain therapy. Although some patients clearly get much-needed relief, most academic researchers say there is no conclusive

Minnesota Department of Health

No More Mickey Mouse

Vials of methylprednisolone acetate manufactured by NECC

Profile for ASPET

2018 Special Compilation Issue of The Pharmacologist  

ASPET is pleased to present the second in a series of special editions of our quarterly news magazine, The Pharmacologist. This special com...

2018 Special Compilation Issue of The Pharmacologist  

ASPET is pleased to present the second in a series of special editions of our quarterly news magazine, The Pharmacologist. This special com...