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Saturday, January 5, 2013
MASSACHUSETTS PLANS SOME OF STRICTEST CONTROLS OF COMPOUNDING PHARMACIES IN USA
The laws will be among the strongest in the country, said Kevin Outterson, a law professor at Boston University and a member of the expert panel that advised the state on how to curb abuses by companies like the New England Compounding Center, the Framingham pharmacy that made the tainted drug responsible for the nationwide meningitis outbreak.
The legislation would establish strict licensing requirements for compounding sterile drugs; let the state assess fines against pharmacies that break its rules; protect whistle-blowers who work in compounding pharmacies; and reorganize the state pharmacy board to include more members who are independent of the industry and fewer who are part of it.
Alec Loftus, a spokesman for the state’s Office of Health and Human Services, said that Mr. Patrick expected the new legislation to be passed quickly.
Daniel Carpenter, a professor of government at Harvard, said the proposed laws seemed sound and comprehensive. But he warned that if other states did not take similar steps, compounding pharmacies engaging in shoddy practices would just move to places with the weakest laws and the least oversight.
“The remaining question is not what Massachusetts is doing or will do, but will there be a minimum level of regulation like this in the rest of the states?” Professor Carpenter said.
The meningitis outbreak, first detected in September, was caused by contaminated batches of a steroid, methylprednisolone acetate, made by the New England Compounding Center. The drug wasinjected into about 14,000 people’s spinal area to treat back and neck pain.
As of Dec. 28, 656 people in 19 states had become ill with meningitis or other infections, like severe internal abscesses in the area where the drug was injected. Some have had both meningitis and spinal infections. The case count is expected to keep rising. Thirty-nine have died.
The New England Compounding Center was shut down, and inspections found extensive contamination. Investigations uncovered a long history of questionable practices that had drawn warnings from the state and the Food and Drug Administration.
On Dec. 21, the company announced that it had filed for bankruptcy. Numerous lawsuits have been filed against it.
At the heart of the problem have been gaps in regulation that have allowed such companies to avoid both state and federal controls. The company called itself a pharmacy, and pharmacies are generally regulated by states, while large drug companies are regulated federally, by the Food and Drug Administration.
Compounding pharmacies mix their own drug preparations, like skin creams and cough syrups, supposedly for individual patients with special needs. But the New England Compounding Center began to act like a manufacturer, making and shipping large amounts of injectable drugs, for which sterility is essential. No state lawequired it to obtain a license for this type of large-scale compounding, to follow good manufacturing processes or to let the state know it was shipping all over the country.
Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, said the company “was a manufacturer in pharmacy clothing.”
Governor Patrick said, “The tragic meningitis outbreak has shown us all that the board’s governing authority has not kept up with an industry that has evolved from corner drugstores to the types oflarge manufacturers that have been at the center of so much harm.”
Dr. Smith said she thought the most important part of the new legislation was the requirement of a license for sterile compounding. “Now we are going to have the ability to develop specialty licenses that will allow us to track and identify those pharmacies that are engaged in different practices that could potentially put higher numbers of individuals at risk, such as those who engage in sterile compounding,” she said.
Professor Carpenter said a particularly powerful part of the proposal is that it requires licensure for out-of-state pharmacies that ship medication to Massachusetts. The state, he said, is a hugemarket for injectable drugs.“Basically, if you think about the large hospitals, the amount of medical care that goes on in the state, it’s in a sense using the purchasing power of the state of Massachusetts to induce changes elsewhere,” he said.
The state has also taken other steps recently to rein in compounding, apart from the new legislation. It began conducting surprise inspections, and has required compounding pharmacies to report how much medication they are shipping and where, so that it can keep tabs on those that begin acting like manufacturers. It also requires the pharmacies to report when they become subjects of regulatory actions by other states or the federal government.
Abby Goodnough reported from Boston, and Denise Grady from New York.