Jeffrey Potter is proud of his work preparing drug prescriptions customized for patients.
That’s why Potter is doing everything he can to distinguish his locally owned business from corporate-owned facilities, such as the New England Compounding Center that was blamed for dozens of deaths caused by doses of steroids contaminated with meningitis.
Potter, who owns Clinical Apothecaries in Medina, said there’s a big difference between local compounding facilities that work with patients and doctors to develop treatments and those owned by large pharmaceutical companies that create huge batches of medicine for mass distribution.
“Everything we do, a physician has to sign off on,” he said of the custom drug treatments his office designs for patients who haven’t had success with other prescription drugs.
Clinical Apothecaries was established in 1999 and offers treatment for fertility issues, the thyroid, adrenal hormones and pain. Potter has been in the pharmacy business for more than 25 years, and he’s hoping to continue to build his client base at his Medina Road office.
On Thursday, Potter was visited by a representative of the Ohio Board of Pharmacy, who went over his certifications to make sure he was doing everything correctly. The board has the right to shut down offices that are operating unsafely and even arrest and press charges against pharmacists who don’t follow state pharmacy laws.
“It went really well. I think they’re pleased with our facility,” he said.
Right now, Potter is working to become accredited by the Pharmaceutical Compounding Accreditation Board. Though it’s optional to belong to the accreditation agency, Potter said he’s moving quickly to get accreditation to distinguish himself following the shutdown of the New England facility.
“We were already moving in that direction of accreditation,” he said. “But (those events) are speeding us up.”
Potter said he hopes to have the accreditation complete by spring.
Things aren’t going so well for some larger companies, including those that established compounding facilities to conduct mass distribution of drugs. Potter said when companies can’t get their drug approved by the Food Drug Administration, they sometimes establish a compounding facility to mass produce the drug.
That’s exactly what happened in Massachusetts in the fall of 2012.
Ameridose, sister company of the New England Compounding Center and a major hospital drug supplier, agreed in October to recall all of its more than 2,000 unused products after steroid injections produced at its Framingham, Mass., facility were linked to a fungal meningitis outbreak that killed at least
On Jan. 3, the FDA announced the facility would remain closed until at least late February and it is assured conditions at the facility are sterile.
Potter said the key to preventing those drugs from entering the market is better enforcement. He said more oversight could have prevented what happened at the Massachusetts facility.
“I don’t know that we need new laws,” he said. “The rules that we have in place would have prevented it, but they just didn’t push it.”
Potter has served on a rules committee to help write state laws regarding compounding. He said there is some talk of preventing compounding facilities in other states from shipping their goods to Ohio while uniform regulations are decided in Washington.
A batch of drugs from the shuttered New England facility ended up in Medina last year, though no one locally was sickened by them.
In late October, the FDA reported that Trillium Creek Medicine on Wooster Pike had received a tainted batch of the steroid.
“We can regulate what we do here, but you still have drugs being shipped from other states,” he said.
Big vs. small
Potter said his sterile room has been certified, and he sends samples of the drugs he creates to Eagle Analytical Services to test for safety and potency.
“Most drugs should be plus or minus 10 percent (potency),” he said. “We try to shoot for plus or minus 5 percent so we’re sure we hit that benchmark.”
Potter said there’s also a difference in the way the drugs are manufactured at his pharmacy. While the pharmaceutical industry is interested in mass manufacturing and shipping its product, his office is interested only in helping patients on a case-by-case basis.
“The batches we make are very small, detailed to that specific person,” Potter explained. In each case, medicines are discussed with both the patient and the doctor, with the doctor granting final approval on all medicine.
“Everything we do is based on our knowledge of chemistry, it’s based on science,” Potter explained.
Potter said that the drugs from larger facilities are sometimes used by pharmacies and doctors because they are mass produced and therefore a little cheaper.
“We’re doing things the right way. When groups like (New England Compounding Center) come in and undercut us, it makes it harder for us, but people can also be hurt,” he said.
Potter said his office has been able to help treat patients that haven’t had any luck with traditional procedures or drugs.
He said some families who had been struggling with fertility issues and shelled out thousands of dollars on fertility treatments had better success with custom-designed doses from Clinical Apothecaries that cost about $35.
“I’m not anti-pharmaceutical company, because they make great products that help about 80 percent of the population,” Potter said. “But that leaves 20 percent of the population who need our help.”
Potter said his office is one of six compounding facilities in Ohio, and they have worked closely together to support each other and help the state draft rules regulating the industry.
“If someone comes in and I’m puzzled, I can call (other compounding pharmacies) and see what they’ve tried,” he said.
And while Potter and Jackie Mallett, a fellow pharmacist at his Medina practice, are always developing new ways to treat patients, they also have help from the graduate students who participate in a rotation at the facility. Right now, a group of doctorate students are researching and developing a treatment for scars.
“They’ll present their findings to me, and then later to the doctors who are treating the patient,” Potter said.
Clinical Apothecaries has hosted more than 250 graduate students earning a degree in pharmacy.
Contact reporter Loren Genson at (330) 721-4063 or firstname.lastname@example.org.