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Updated: Thursday, 11 Oct 2012, 10:48 AM EDT
Published : Wednesday, 10 Oct 2012, 7:41 PM EDT
INDIANAPOLIS (WISH) - As the number of people sickened by a deadly meningitis strain continues to rise, focus continues to grow on the pharmacy that made the injections thought to have caused the outbreak. Similar “compounding” pharmacies in Indiana are taking steps to ensure the medicines they make are safe.
The Centers for Disease Control says at least 137 have now been sickened in nine states, including 15 people in Indiana. At least 12 people have died in the outbreak nationwide.
All of the patients were all given a tainted dose of steroids, made by the New England Compounding Center in Massachusetts. The pharmacy is one of more than 7,500 nationwide who operate as a “compounding” pharmacy, including at least a dozen in Central Indiana.
Pharmacist Jeff Jackson has run one of them for the last 12 years—Custom Med—on Indianapolis’ northwest side.
“We compound medications to order for what the physician needs, and try to solve patients’ problems and issues that may need to be addressed for a medication that may not be commercially available or doesn't fit their needs,” Jackson said. “We don't stock regular medications like a conventional pharmacy. Everything we do, we make here in our lab.”
Jackson's is one of nearly 500 "compounding pharmacies" licensed in Indiana to make custom prescriptions, though not all who are licensed do, said Butler University School of Pharmacy Professor Amy Peak.
“These are places that make dosage forms that typically aren't available from a mainstream drugstore. Let’s say you have a child with heart disease. Well, most heart disease occurs in older people. So, most of those medications are tablets or capsules, and a small child can’t swallow that. So, they would take something that comes from a manufacturer as a tablet or capsule and make it into a different type of dosage form that might be suitable for that child,” Peak said.
That’s precisely what happened in Massachusetts, as the New England Compounding Center made custom, sterile steroid injections for patients with back-pain. But, Peak says that lab was making its medications on a much larger scale. More than 17,000 doses of the steroid were distributed to at least 23 states.
“Most of the compounding pharmacies that I'm familiar with in Indiana work under a business model of getting a prescription for an individual patient, and providing a patient with a product that is not commercially available otherwise. So, it's pretty different than the large scale manufacturing that’s been shown in the recent news stories. That is not the norm for compounding pharmacies,” she said.
There is one similarity between the pharmacies, however.
Because each makes its own compounds, it faces almost no federal oversight. Large-scale drug manufacturers are regulated by the U.S. Food and Drug Administration, while compounding pharmacies are not.
Still, that doesn’t mean no one is watching.
“We are regulated by the Indiana Board of Pharmacy, the same way all the other pharmacies are,” said Nora Apothecary owner Charles Lindstrom. “They have strict regulations. We get inspected. Our equipment gets inspected.”
That regulation includes unannounced spot checks, Lindstrom said, though he stressed that there is far less to regulate.
“My type of pharmacy usually doesn't sell to those types of institutions, especially on that scale,” he said.
Peak is confident state regulation is succeeding.
“It doesn't mean that state oversight isn't working. Just, by default, saying there isn't federal oversight doesn't necessarily mean there's a problem,” she said.
Not everyone agrees.
Two Democratic lawmakers on Tuesday called for stricter federal oversight of compounding pharmacies in the wake a deadly meningitis outbreak linked to contaminated injections made by a Massachusetts specialty pharmacy.
Representatives Rosa DeLauro (D-CT) and Edward Markey (D-MA) said in separate statements that they will draft legislation to give the FDA new authority to police the safety of compounded drugs. Markey said the FDA should have authority to bar compounding pharmacies from using ingredients that haven’t been cleared by the agency. The legislation would also require the pharmacies to report all safety issues to the FDA.
“Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer,” said Markey, who sits on the House Energy and Commerce Committee, which oversees the FDA.
Jackson says many in the industry already self-regulate.
“We have things outside tested by a third party lab on our sterile products,” he said. “We get test results back so we can confirm that the product we produced is clean, the right strength, and doesn't have any contaminants in it. That's important to know.”
Lindstrom argues new regulation could delay lifesaving treatments.
“If they put new regulations in place, we’ll
do our best to comply with them. But, there would be no way we could submit [every compound] to the FDA for approval and get it back 10 years later. It wouldn't do you any good,” he said.
If the industry overreacts, patients could end up suffering even more, Peak warned.
“There still needs to be a mechanism of taking care of a single patient at a single point in time,” she said. “I don't see a need to really be changing what we're doing right now. If those pharmacies would close, there would truly be an unmet medical need.”
Following the airing of this story, Indiana Board of Pharmacy Director Gregory Pachmayr released the following statement:
The Indiana Board of Pharmacy takes patient safety very seriously, and the Indiana Code and our administrative rules are aimed at protecting the public. Compounding is an integral part of the practice of pharmacy. Compounding is safe when conducted within the confines of the law and when it does not extend into the realm of manufacturing.
Sterile compounding is addressed at 856 IAC 1-30, and pharmacies engaging in sterile compounding must comply with the USP 797 national standards. In-state pharmacies, including those engaging in sterile compounding, are subject to inspection by the Board of Pharmacy’s Compliance Officers. The Board’s administrative rules and our inspections of sterile compounding facilities address, among other things: policies and procedures; engineering controls/physical requirements; personnel training; labeling and documentation/records and reports; and quality assurance measures. The Board of Pharmacy works hard to ensure that our licensed facilities are thoroughly inspected.
Non-resident pharmacies registered in Indiana are required by Indiana Code to comply with the laws and rules of the state in which they are domiciled. In order to be registered as an Indiana non-resident pharmacy, an applicant must submit numerous documents and fulfill various duties, including verification of the pharmacy’s licensure in its home state. The Indiana Board of Pharmacy relies on other state Boards of Pharmacy to regulate licensees in their jurisdiction.
The Board is following the developments of the meningitis outbreak closely. The New England Compounding Center is licensed in Indiana as a non-resident pharmacy. The Board has referred the matter to the Office of the Indiana Attorney General for investigation.
Patient safety is of utmost importance to the Indiana Board of Pharmacy. The Board of Pharmacy Compliance Officers thoroughly inspect our licensees with the aim of ensuring patient safety.