The Meningitis Tragedy – More Regulation is Not the Answer

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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

Second Mass. compounding pharmacy surrenders license

By William Hudson, CNN

updated 5:12 PM EDT, Mon October 29, 2012

(CNN) -- A second Massachusetts compounding pharmacy surrendered its license after state inspectors found "significant" issues that could affect sterility, state health officials said.

The pharmacy, Infusion Resource, was also found to have a center for giving intravenous medications to patients in violation of state regulations, which require a clinic license, Dr. Madeleine Biondolillo, director of the Massachusetts Department of Public Health Bureau of Healthcare Safety and Quality, said Sunday.

The state Board of Pharmacy immediately issued a cease and desist notice to Infusion Resource after the October 23 inspection revealed the violations, she said. Over the weekend, the Department of Public Health "secured the voluntary surrender of Infusion's pharmacy license."

The company, which compounds antibiotic and nutritional IV medications for home use, said in a statement it has since recalled all compounded products dispensed in the past month, effecting 38 patients.

"No issues were cited related to the integrity of our products nor to the quality of our compounding practices," said Bernard Lambrese, Infusion Resource CEO, in a statement.

"It is correct that Infusion Resource does not have a clinic license from the Commonwealth of Massachusetts. The space in our facility is intended for patient education, validation of patient and caregiver skills, medication counseling, medication education, teaching and training."

What is a compounding pharmacy?

Massachusetts Gov. Deval Patrick said last week the state would immediately begin unannounced inspections of all Massachusetts pharmacies and require that they submit annual reports detailing what they produce and distribute.

That announcement came in the wake of the fungal meningitis outbreak that has caused 25 deaths and 354 illnesses, linked to the Massachusetts-based New England Compounding Center. Seven of those illnesses are peripheral joint infections that specifically affect a joint such as a knee, hip, shoulder or elbow.

Infusion Resource is not linked to the outbreak.

The incident began unfolding September 24, when the department was notified about a cluster of six rare fungal meningitis cases in Tennessee. The patients shared several risk factors, including having received an epidural injection of a steroid -- methylprednisolone acetate -- that had been compounded at the NECC in Framingham.

The department soon learned that the suspect product had been distributed to more than 14,000 patients in 23 states.

Source found here

Only four of the 23 states that received some of the medication have not reported cases of fungal meningitis

The four states that have not reported at least one case of meningitis are California, Nevada, West Virginia and Connecticut, the CDC said.

Oklahoma gets few complaints about compounding pharmacies

By SHANNON MUCHMORE World Staff Writer 
Published: 10/29/2012  2:24 AM 
Last Modified: 10/29/2012  6:13 AM

Sterile compounding pharmacies in the state, similar to the one in Massachusetts that has been linked to an outbreak of fungal meningitis, are regulated by the Oklahoma State Board of Pharmacy, which has seen few complaints against them in recent years.

There are about a dozen sterile compounding pharmacies in Oklahoma and the pharmacy board has seen five complaint cases since 2006.

Twenty-five people have died and more than 300 have been sickened in 18 states from potentially contaminated steroid injections that caused fungal meningitis, according to the Centers for Disease Control.

As many as 14,000 people in 23 states have been exposed through the shots meant to ease back pain. The injections came from New England Compounding Center of Framingham, Mass.

None of them was shipped to Oklahoma, although other products from the pharmacy were sent to Oklahoma and have been recalled, according to the U.S. Food and Drug Administration.

The most serious complaint for sterile compounding pharmacies in Oklahoma in the past six years was from a 2008 prescription that was improperly mixed and caused a Paul's Valley man to go into intensive care with respiratory failure, drug overdose and aspiration pneumonia.

The state pharmacy board tries to inspect pharmacies on an annual basis. A pharmacy that creates any compound that will be injected into the body is independently tested for sterility and documentation is checked for the proper calculation of medicines, said Cindy Hamilton, chief compliance officer with the pharmacy board.

"We are here to protect the public, we're not here to protect the pharmacies," she said.

Alyssa Lees-Sanders, co-owner of The Apothecary Shoppe, a compounding pharmacy in Tulsa, said her pharmacy does not ship products to residents of other states and doesn't produce at the level of the Massachusetts pharmacy.

At The Apothecary Shoppe, batches are tested by an independent source, as well as in-house. Equipment is checked every time it is used, surfaces and air are tested and staff are qualified regularly, she said.

The workers can be seen from the front of the shop through large windows as they work. In that front room, the air is as clean as the air in an operating room, she said.

Numerous steps are taken to ensure a sterile environment where one is necessary, she said.

"We take every measure and every precaution," she said.

The company is working on accreditation through the Pharmacy Compounding Accreditation Board. It meets all the qualifications but is still going through the paperwork, she said.

The Apothecary Shoppe had one complaint from 2006 for what the pharmacy board said was filling prescriptions at higher quantities than authorized by a physician.

Lees-Sanders said they did fill some prescriptions at higher rates but it was always approved by a physician. The pharmacists, who no longer work there, didn't properly note the approval.

For example, they might have given two or three suckers to someone who had a prescription for one sucker to be refilled six times but needed extra to make it through the weekend. They would always call the physician for authorization before doing so but didn't always fill out the proper documentation of that authorization, she said.

Other complaints against pharmacies in recent years have included improper supervision of pharmacy technicians and a lack of written records.

A pharmacist in Broken Bow was placed on probation in 2006 after misfilling a prescription, submitting fraudulent billing reports, improperly labeling prescriptions and allowing a non-pharmacist to operate the pharmacy in the absence of a pharmacist.


Original Print Headline: Compounding pharmacies checked often

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Shannon Muchmore 918-581-8378
shannon.muchmore@tulsaworld.com