Report faults states’ oversight of specialty pharmacies
By Lena H. Sun,
State boards have failed to adequately regulate the safety of practices at specialty pharmacies like the one at the center of the deadly fungal meningitis outbreak, according to a congressional report to be released Monday.
The report by Rep. Edward J. Markey (D-Mass.) looked at enforcement actions against compounding pharmacies in all 50 states and found that only six states had records of taking action. The information was based on what was available on Web sites and through follow-up telephone calls.
By contrast, the federal Food and Drug Administration issued nearly 60 warning letters about unsafe compounded drugs dating to June 2001, the earliest publicly available information, the report found.
“State regulators are not, or cannot, perform the same sort of safety-related oversight of compounding pharmacy practices that FDA has historically undertaken,” the report said. Industry executives said it was the first state-by-state examination of safety issues like the ones raised by the Massachusetts company that made the tainted steroid injections implicated in the outbreak.
In the wake of the worst public health crisis in recent U.S. history, consumer advocates, members of Congress, and some pharmacy professionals are calling for more FDA authority. Twenty-five people have died and 344 others have been infected from batches of contaminated steroid injections for back and joint pain traced to the New England Compounding Center. About 14,000 people received injections.
“The NECC tragedy is clearly just the tip of an industry iceberg that has long needed reform and federal oversight,” Markey said in a statement.
Traditional compounding pharmacies mix or alter ingredients to make custom medications for individual patients. But in the past two decades, this little-known corner of the pharmaceutical industry has expanded to include large compounders that operate like drug manufacturers.
The FDA regulates drug manufacturers, requiring clinical trials and enforcing rigorous manufacturing standards.But compounding pharmacies are regulated by state boards of pharmacy, which often lack resources to conduct regular inspections. And compounded drugs are not FDA-approved.
The FDA has sought greater oversight, but repeated legal challenges by the industry have restricted its authority, the report noted. The FDA can take action under certain conditions: if compounding pharmacies’ drugs are essentially copies of commercially available products, for example, or if the companies are making drugs before receiving specific prescriptions.
In her first public comment since the outbreak, FDA Commissioner Margaret A. Hamburg acknowledged the agency’s limited authority. There has been “substantial debate” in Congress about the appropriate level of FDA oversight of compounding pharmacies, she said in a statement. “But unfortunately there has been a lack of consensus and many challenges from industry,” she said. “FDA is committed to working with Congress and stakeholders to strengthen the authority we need to help prevent tragedies like this from happening again.”
Some industry executives said they now support greater FDA authority over large-scale compounders that operate like manufacturers. But clear distinctions need to be made between them and traditional compounders, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy, which represents state pharmacy regulators.
His group has never conducted a state-by-state analysis of compounding pharmacies. But since the outbreak, some states have done so. “The results are not good,” he said in an e-mail. Four states, which he declined to identify, found that 25 percent of compounding pharmacies failed to meet quality standards and product testing.
The International Academy of Compounding Pharmacists, which has long opposed additional regulation, released a statement Sunday noting that existing law gives the FDA and states authority over compounders. Federal and state regulators can inspect any pharmacy at any time, the statement said.
“Now we must make sure that happens,” the IACP said. The “vast majority” of the 7,500 compounding pharmacies “do not fear inspections; they expect them.”
On Sunday, Massachusetts health officials said that they had shut down another compounding pharmacy, Infusion Resource, last week after concerns about the sterility of medications given to about 40 patients. They didn’t identify the drugs except to say that they were for patients following hospital discharge.There was no evidence of contamination, they said. The company also was cited for administering intravenous treatments on-site without a proper license.
A state commission is being established to look at best practices, and new rules are being developed to require more frequent reporting from compounding pharmacies. The state is adding five inspectors at the Board of Pharmacy, and officials had begun a round of unscheduled visits. The board also is looking into possible conflicts of interest between a board member who is also a pharmacist at Ameridose, a sister company of NECC.
Some of the minutes “call into question” whether the board member recused herself from Ameridose and NECC matters, said Lauren Smith, interim health commissioner.
The NECC knew that its sterile-drug operations were extensively contaminated by mold and bacteria but took no corrective action, the FDA said last week. State regulators inspected the facility in 2011 in connection with a proposed expansion. A newly released report of that inspection said the pharmacy met sanitation standards, according to media reports.
After the outbreak, a state inspection found that the NECC repeatedly failed to follow standard safety and quality standards and was violating its license by shipping high volumes of medications without individual patient prescriptions.
In the congressional report, Markey’s staff assessed the FDA’s actions by searching publicly available data on the agency’s Web site and media reports. It found problematic compounding pharmacy practices that resulted in 23 deaths and at least 86 serious illnesses or injuries in at least 34 states. Those figures are a conservative estimate, the report said, and do not include fatalities and illnesses from the meningitis outbreak.
The FDA sent warning letters to pharmacies in Illinois and Michigan about nicotine lollipops without patient prescriptions; about medications containing a drug linked to cardiac problems in Maryland, New Jersey and Wyoming; and about contaminated magnesium sulfate solution from Texas and Mississippi facilities that caused the death of a South Dakota patient.
To assess state performance, Markey’s staff searched publicly available documents at each state pharmacy board. Only Arizona, California, Missouri, New York, North Carolina and Rhode Island took enforcement action against compounding pharmacies. Violations included improper dosages, expired drugs and lapses in sterile compounding.
When Missouri began conducting annual potency and sterility tests of some compounded drugs, it found that 11.6 to 25 percent of drugs tested had unsatisfactory results. But the state didn’t list which pharmacies were responsible, the report said.
More typically, state enforcement centered on billing and other traditional violations, the report said.
Most state board Web sites also prevent consumers from easily locating or downloading enforcement records for specific pharmacies.They don’t allow for keyword searches. Consumers would have to know the date of the enforcement action or the name of the pharmacy to obtain useful information, the report said.
Howard Schneider contributed to this report.