Lisa Schnirring
Staff Writer
Oct 29, 2012 (CIDRAP News) – Safety problems with products from compounding pharmacies even before the current multistate fungal meningitis outbreak led to at least 23 deaths and 86 serious illnesses or injuries in 34 states over the past decade, according to a report today from a Massachusetts congressman.
The 34-page report from Rep Edward Markey, D-Mass., is based on his staff's review of media reports, documents from the Food and Drug Administration (FDA), and records from pharmacy boards in all 50 states, Puerto Rico, and the District of Columbia.
In a press release today Markey said the report documents more than a decade of violations and problems at the nation's compounding pharmacies that are tied to lax oversight and gaps in legal authority.
Tainted methylprednisolone acetate injections from New England Compounding Center (NECC), based in Framingham, Mass., have now been linked to 354 infections, according to an update today from the Centers for Disease Control and Prevention (CDC). Most patients sickened in the outbreak have fungal meningitis, but the recalled injections were also used to treat joint problems, and 7 of the patients have peripheral joint infections.
The latest total reflects 16 more cases from the CDC's previous report on Oct 26.
No new deaths have been reported, holding the fatality number at 25. Rhode Island reported its first case, pushing the number of affected states to 19, according to the CDC.
In a statement today, Markey said violations have included selling copies of commercially available drugs, drugs made from ingredients that are not approved by the FDA, contaminated products, drugs without valid prescriptions, and large quantities of drug produced in a manner that resembles manufacturing.
Markey's report also found that the FDA has been trying to bolster its oversight of the compounding pharmacies since the early 1990s but said some compounding pharmacy trade groups have used the court system to challenge every effort. The report also suggests that state pharmacy boards don't typically or consistently oversee compound pharmacy drug safety and don't always provide enforcement action records that are easily searchable and publicly available.
"The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight," Markey said in the statement. "This tragedy demands the strongest response from Congress and federal and state authorities to ensure safeguards are in place to protect patients."
The report said the deaths and serious illnesses cited in the report are from FDA records and should be considered a conservative estimate, because in many cases documents noted adverse events but didn't specify the type or quantity. In other instances, it noted that the FDA warning letters were sent before the full health impact of the violations were realized.
Safety-related enforcement reports at the state level aren't typically found in the records that Markey's staff reviewed, because regulators appeared to focus mainly on traditional pharmacy licensing activities such as billing violations or having a licensed pharmacist on site.
Markey said in the statement that the compounding pharmacy sector has resisted federal oversight for years, with assurances that state regulators were adequately reviewing their activities. "This report demonstrates that this is simply not true," he said.
His review of media reports of safety problems and FDA enforcement actions since 2001 found 60 instances.
For example, in October 2002 fungus-tainted methylprednisolone injections made by a South Carolina compounder were linked to a meningitis death and at least three other infections. In August 2005, a Minnesota compounder recalled its ophthalmic solution after bacterial contamination was found and the CDC received two reports of lost vision linked to the company's solution.
In August 2011, Alabama's Department of Public Health reported that bacterial contamination in an intravenous nutritional supplement intended for hospitalized patients led to at least 19 illnesses and 9 deaths, according to the report. The investigation found that the compounding facility used tap water to clean a container that used for mixing the drug.
In another example, in July 2012 the FDA sent a warning letter to a Florida compounder after its injectable products were linked to eye infections. Inspectors found unsanitary conditions at the facility, including bacterial and fungal species at several locations.
Markey is a member of the House Energy and Commerce Committee, which has launched a probe of NECC. On Oct 16 Markey asked the Department of Justice to investigate whether NECC violated federal controlled-substance laws.
In related developments, Massachusetts health officials yesterday announced that the state's pharmacy board has shuttered a third compounding pharmacy after an unannounced inspection found environmental problems that pose questions about the company's compliance with nationally accepted pharmacy standards, according to a media briefing transcript.
Madeleine Biondolillo, MD, director of the Massachusetts Department of Health Bureau of Healthcare Safety and Quality, told reporters that no contamination was found and the investigation is still in its early stages, according to the briefing transcript. She added, however, "Due to a variety of notable findings regarding the conditions of the medication production areas, inspectors expressed concern for the sterility of products."
The company, Infusion Resource of Waltham, is managed by a former employee of another pharmacy that had business ties with NECC.
Elsewhere, the Florida Department of Health (FDH) on Oct 26 ordered that Rejuvi Pharmaceuticals based in Boca Raton suspend operations after a routine investigation in early October found several rule violations related to cleanliness, dispensing, compounding, and recordkeeping. The FDA said the company had been warned after an earlier inspection and failed to correct the problems.
See also:
Oct 29 CDC fungal meningitis
outbreak update
Oct 28 Massachusetts Executive Office of Health and Human Services
press briefing transcript