Ohio looking at custom-mix prescription pharmacies


New fungal meningitis cases linked to a contaminated injectable steroid have “slowed down significantly,” said Tessie Pollock, a spokeswoman for the Ohio Department of Health.

Ohio’s case count stood at 11 on Friday, and a new infection hadn’t been reported in about a week.

More than 400 people around the state received injections of methylprednisolone acetate for back or joint pain between May 21 and Oct. 1, when the product prepared by the New England Compounding Center was recalled.

The Centers for Disease Control and Prevention said this week that the greatest risk for infection seems to occur in the first six weeks after receiving the injection.

But in Ohio, state health officials are advising doctors to monitor patients who received the injections — administered through four pain clinics in Dublin, Marion and Cincinnati — for three months, Pollock said.

Ohio is cracking down on pharmacies that custom-mix individualized prescriptions in the wake of a deadly fungal meningitis outbreak tied to a Massachusetts compounding pharmacy.

Statewide, 17 pharmacies are now specially designated as compounding sites, said Jesse L. Wimberly, spokesman and pharmacy inspector for the Ohio State Board of Pharmacy. Inspectors check pharmacies at least every three years, though they will go more often if complaints are filed or violations are reported. “Now we’re going to every one of these pharmacies that are designated for compounding,” he said.

The state now requires pharmacies to spell out how much of their business is strictly retail sales and how much is mixing up custom preparations, Wimberly said. And when a state inspector comes to call, they have to be able to demonstrate both that their facilities meet cleanliness standards set out by the U.S. Pharmacopoeia, a kind of governing board for pharmacists, and to show that their products are being prepared for specific patients — not mixed up in advance and set aside so it’s ready when and if the order comes in.

“The issue we’re having now is are you doing patient-specific compounding,” Wimberly said. “We don’t do manufacturing. We do compounding for specific patients. We check the records and make sure that they’re in compliance so that when you get a prescription it’s for a specific person and you’re compounding that prescription for that person and giving that prescription to that person,” he said.

Not being able to link prescriptions to specific patients “is one of the illegal issues we’re seeing” in the investigation of the New England Compounding Center in Framingham, Mass., he said.

Massachusetts state and federal inspectors have been poring over records and the actual physical plant itself of the pharmacy. NECC closed earlier this month after patients who received injections of the steroid methylprednisolone acetate it prepared began developing fungal meningitis and joint infections. As of Friday, 338 people were sick and 25 were dead in 18 states. Federal investigators found fungus growing both in equipment used to prepare the steroid and in sealed doses of the steroid itself. Civil lawsuits are already being filed, and criminal charges could follow.

Since news of the issues at NECC broke, Ohio has ordered the closure of a compounding pharmacy in Piqua. On Oct. 19, the state ordered JAH Pharmacies Inc. to close its High Street facility. Inspectors visited the site three times, and in August issued 29 citations, most for failure to meet cleanliness standards or for having outdated drug stock.

Compounding is a growing niche for pharmacists, said Jeb Ballentine, an associate professor of pharmacy practice and director of the pharmacy practice lab at Cedarville University. Some pharmacists might make small batches of what are called “orphan” drugs — treatments for rare diseases that large-scale pharmaceutical firms can’t make a profit on — but many compounding pharmacists make up individual doses of hormonal therapy for women or convert medications from one format to another — often a capsule or tablet to a liquid that’s easier for a child to swallow.

“Another big niche is veterinary medicine,” Ballentine said. “If you’ve ever tried to give a pill to a cat, you know why you might want a liquid medicine instead.”

Hospital pharmacies also compound medications. Dan Gueth, director of pharmacy at Dayton’s Miami Valley Hospital, said he and his staff make up “thousands” of doses of medications a day.

Like retail compounding pharmacies, hospitals have “clean” rooms fitted with special air filtration systems and other equipment, where they mix up medications and IV solutions regularly. Hospitals also do a lot of repackaging — breaking medication up from big containers into smaller, individual doses — to meet patients’ daily needs, said Doug Lukens, director of pharmacy for Kettering and Sycamore medical centers, both part of the Kettering Helath Network.

Hospital pharmacies are inspected by the State Board of Pharmacy, but the Ohio Department of Health and hospital accreditation organizations, including the Joint Commission and the Healthcare Facilities Accreditation Program, also have jurisdiction.

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