Report: Deaths, illness linked to compounding pharmacies not new

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 Markey statement

Oct 29 Markey report

Oct 29 CDC fungal meningitis outbreak update

Oct 17 CIDRAP News story "Fungal meningitis toll rises as feds raid pharmacy"

Oct 23 CIDRAP News story "Fungal meningitis outbreak cases top 300"

Oct 28 Massachusetts Executive Office of Health and Human Services press briefing transcript

Oct 26 FDH press release

Source found here

Should More State Veterinary Boards Adopt Compounding Rules Similar to Those Adopted In Texas This Year?

 The focus lately has been on the state pharmacy board rules and regulations and the FDA rules and regulations.  However, some states have veterinary rules that address compounded medications.  For example, Texas this year adopted significantly new rules and regulations relating to the veterinary compounding word.  Click here to review blog post regarding Texas Veterinary Rules Relating to Compounding that became effective June 2012.  Should other states be doing something similar? 

The Meningitis Tragedy – More Regulation is Not the Answer

To read this blog post click here

Massachusetts Cracks Down On Unregulated Compounding Pharmacies Linked To Deadly Meningitis Outbreak

By Tara Culp-Ressler on Oct 29, 2012 at 5:30 pm

Now that the current deadly meningitis outbreak — which has infected an estimated 337 Americans across 18 different states, and caused 25 deaths so far — has put a spotlight on compounding pharmacies that currently fall outside the jurisdiction of the Food and Drug Administration’s safety regulations, state officials are beginning to crack down on the pharmacies that produce compounded drugs.

In Massachusetts, where tainted steroid shots produced at the New England Compounding Center (NECC) first exposed thousands of Americans to a rare strain of fungal meningitis, local officials are taking a more serious look at compounding pharmacies that remix and repackage drugs for widespread sale. As the New York Times reports, Massachusetts Gov. Deval Patrick (D) is working to address the public health risks posed by compounding pharmacies in the absence of FDA regulatory oversight, and recently shut down the third compounding pharmacy in his state that did not meet inspection standards:

Gov. Deval Patrick last week directed the state’s Board of Registration in Pharmacy to immediately start unannounced inspections of compounding pharmacies that prepare sterile, injectable medications. There are 25 such pharmacies in Massachusetts, and Mr. Patrick has acknowledged that the state rules governing them were insufficient. Although the Food and Drug Administration can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.

At the news conference on Sunday, Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, said the state was bringing on five additional inspectors to help with unannounced visits to compounding pharmacies. The goal is to inspect all of them by Jan. 1, she added.

Smith told Reuters that the statewide inspections are part of “a series of aggressive and necessary actions to protect public safety and enhance oversight of this industry” after the contaminated steroid shots from the NECC brought on the national meningitis epidemic.

Although public health advocates have called for strengthened FDA regulatory power over compounded drugs for decades — warning that since compounding pharmacies are not currently subject to the FDA’s health and safety guidelines, they are able to distribute products like the tainted steroids that pose serious public health risks — the pharmaceutical industry has lobbied to prevent the agency from having any additional oversight in that area. Some members of Congress have already called for a criminal investigation into the meningitis outbreak.

Source found here