LIMA — The facility responsible for the deadly meningitis outbreak in late 2012 was known as a “compounding pharmacy.”
However, that Massachusetts facility was a commercial prescription manufacturer, and in reality comparing it to a true compounding pharmacy would be like comparing a mass-food producer with someone cooking in his kitchen.
Still, the problems found at the New England Compounding Center have meant increased scrutiny for small compounding pharmacies that mix ingredients for a single prescription. A new report released in December by the National Conference of State Legislatures said several states changed laws regarding regulation of compounding pharmacies and locally, pharmacists report increased inspections.
“You can expect something like that to come out of any event. If there’s an oil spill, everyone gets a closer look,” said John Pack, owner of Pack Pharmacy, which is Lima’s only compounding pharmacy.
Pack said compounding is more complicated than regular pharmacy work.
“We’re doing more, and more is expected of us. People need reassured,” Pack said. “So, two weeks ago, we had the most thorough inspection I’ve ever experienced. It was a surprise visit. You know, business just stops for them. But, it was very positive. We had nothing at fault. They did some educational things; they’re trying to get a more consistent way of keeping records.”
“They” is the State Board of Pharmacy, which regulates compounding pharmacies. Pharmacy regulation is largely left up to the states, while the federal Food and Drug Administration regulates virtually all commercial pharmaceutical manufacturing.
Compounding pharmacies refers to any physical pharmacy licensed to mix or “compound” chemical ingredients into a finished medication ready to use by an individual patient, based on a prescription ordered by a physician or other legally authorized prescriber.
While the NECC was listed as a compounding pharmacy, it was making doses of medicine in the thousands.
In October, the NECC made national headlines as the source of a contaminated compounded injectable medication that was shipped to multiple states. While the environment was supposed to be sterile, federal investigators found widespread evidence of mold and other contamination.
“By any description, it was just horrendous,” Pack said. “You wouldn’t walk into a low-class restaurant like that, and here they’re making sterile products in quantity and shipping them around the country. Compounded medicine is like milk; it has an expiration date. It spoils.”
As of Dec. 20, the medication was responsible for a total of 620 cases, including 39 deaths, in 19 states, according to the Centers for Disease Control and Prevention. The CDC updates the case total each Monday. In the last two reporting periods, December 3-17, states reported to CDC a total of 80 new cases, most of which are spinal/paraspinal infections.
The outbreak of fungal meningitis and other infections is linked to the use of injectable steroids from three recalled lots of preservative-free methylprednisolone acetate.
In Ohio, facilities in Marion, Cincinnati and Dublin received the lots. Facilities in Fort Wayne, Ind. also received them.
At Pack, compounding pharmacists make one prescription at a time, for a single patient, Pack said. When they need to make one in a sterile environment, they use a “glove box,” Pack said. Think of an infant incubator, in which a parent would reach through a glove to touch a newborn. The box is a more cost effective and a safer alternative than trying to maintain an entire sterile room, Pack said.
Pack would like to see more consistency in regulations, but that could be difficult because of the state-by-state nature of them. In Ohio, the pharmacy board is at least working on more consistency within the state and record keeping, said board spokesman Jesse Wimberly.
“We’re now requiring all pharmacies to give a written procedure as to how they’re compounding and whether they are a compounding pharmacy or not,” Wimberly said. “We also require out-of-state locations sending things to medical facilities in Ohio to be certified by an accreditation board. The requirements for the accreditation are similar to our state regulations.”
At the moment, the state’s rules and regulations are not changing as a result of the New England incident. But the pharmacy board is checking all sites that were listed as receiving medication from the NECC, Wimberly said.