Ohio to inspect more pharmacies this fall Meningitis outbreak leads to scrutiny

DAYTON — Ohio is cracking down on pharmacies that custom-mix individualized prescriptions after a deadly fungal meningitis outbreak linked to a Massachusetts compounding company.

Jesse Wimberly, pharmacy inspector for the Ohio State Board of Pharmacy, said there are 17 specially designated compounding pharmacies statewide. They’re usually inspected at least once every three years, though inspectors will go more often if there are complaints or reported violations.

“Now we’re going to every one of these pharmacies that are designated for compounding,” Mr. Wimberly told the Dayton Daily News.

He said the state now requires pharmacies to specify how much of their business is strictly retail sales and how much is mixing custom preparations. They must demonstrate that they meet cleanliness standards and show that their products are being prepared for specific patients — not mixed up in advance and set aside to fill future orders.

Not being able to link prescriptions to specific patients is one of the issues that officials are finding in the investigation of the New England Compounding Center in Framingham, Mass., he said.

The U.S. Centers for Disease Control and Prevention reports that more than two dozen people have died and more than 300 have been sickened across the country in the outbreak, which has been linked to steroid shots for back pain.

Eleven people have been sickened in Ohio, but no one has died.

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Markey says need for new pharmacy regulations

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CDC: Cases of a rare fungal meningitis rise to 363; deaths at 28

Dr. Allen, Expert on Compounding, Points Out Misrepresentations by the Press

Here is part of Dr. Allen's Editorial that appears in the Compounding Today Newletter:

Editorial: Misrepresentations by the Press

Those keeping up with the events in Massachusetts have no doubt read many accounts of the events and the answers to questions posed to pharmacy leadership by the press. Most reporters have very little, if any, knowledge of pharmacy compounding and are either unaware or seemingly don't care if they are not accurate and complete in their reporting.

A specific comment I would like to address is that some reports have misquoted statements that say that compounders want lower standards. This is absolutely false! Pharmacists, pharmacy compounding leadership, and company CEOs involved in providing support to compounding pharmacies want strong quality standards, and they work hard for strong quality standards.

What many reporters do not understand is that there is a difference in Good Manufacturing Practices (GMPs) that are required for FDA-registered manufacturers and the legal standards for compounding developed by the United States Pharmacopeia (USP) and the state boards of pharmacy. USP standards are enforceable by both the FDA and the state boards of pharmacy.

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2012 Minnesota Statute on Compounding Drugs: 151.5

2151.15 COMPOUNDING DRUGS UNLAWFUL UNDER CERTAIN CONDITIONS.

Subdivision 1.Location.

 

It shall be unlawful for any person to compound, dispense, vend, or sell drugs, medicines, chemicals, or poisons in any place other than a pharmacy, except as provided in this chapter.

Subd. 2.Proprietors of pharmacies.

 

No proprietor of a pharmacy shall permit the compounding or dispensing of prescriptions except by a pharmacist or by a pharmacist intern under the personal supervision of a pharmacist; or the vending or selling of drugs, medicines, chemicals, or poisons in the proprietor's pharmacy except under the personal supervision of a pharmacist.

Subd. 3.Unlicensed persons; veterinary legend drugs.

 

It shall be unlawful for any person other than a licensed veterinarian or pharmacist to compound or dispense veterinary legend drugs except as provided in this chapter.

Subd. 4.Unlicensed persons; legend drugs.

 

It shall be unlawful for any person other than a licensed practitioner or pharmacist to compound or dispense legend drugs except as provided in this chapter.

History: 

(5808-16) 1937 c 354 s 16; 1967 c 377 s 3; 1986 c 444; 1988 c 550 s 10; 1990 c 526 s 4; 1991 c 213 s 2; 1994 c 632 art 2 s 3
7

One View--Regulate Compound Pharmacies With Care

From The Free Press, Mankato, MN

October 30, 2012

Our view: Regulate compound pharmacies with care

— So far, 24 people who have died of fungal meningitis after they were injected with tainted steroids made at a compounding pharmacy in Massachusetts. Another 328 people in 18 states have fallen ill, including nine in Minnesota.

What those patients didn’t know is that the pharmacy that made the steroids and others like it have been largely exempted from Food and Drug Administration oversight.

More FDA oversight in the specialty businesses is needed, but it should be done in a way that does not bring onerous regulation to the many small compounding pharmacies that provide a valuable service for patients and doctors.

Most of the compounding pharmacies are small operations that custom-mix drugs, such as specific compounds to treat children or seniors who can’t easily swallow pills.

The small, specialized industry didn’t come under the same regulation as large drug makers who must ensure they’re operating sterile facilities in a safe manner.

But some compounding pharmacies have grown into mega-drug manufacturers that are pushing the legal limits.

An FDA official warned in 2003 that some large compounders were using “creative marketing” to sell drugs they claimed were superior, without any evidence of support. Still others were manufacturing drugs they claimed were unique, when they were in fact simply cheaper versions of existing drugs.

Regulation of compounding pharmacies has been left to the states, with some assuming that role well while others are unprepared to provide real oversight.       

Congress will need to find ways to rein in so-called compounding pharmacies that are operating in an unsafe manner. But they and the FDA must also be careful not to put needless and costly regulations on legitimate smaller operations.

Source found here

Compounding pharmacies have long evaded the tight oversight governing established drug makers Mass. congressman seeks tougher rules for compounders

Lawmakers’ calls for tougher regulation of compounding pharmacies are nothing new. Over decades, there have been a series of attempts at the federal level to rein in a business that has largely evaded the kind of stringent oversight established drug makers face. 

Read full Boston Globe article here

K-V Pharmaceutical Seeks Extension to File Chapter 11 Plan

By Joseph Checkler 
 

K-V Pharmaceutical Co. (KVPBQ) wants to extend the amount of time it can control its own bankruptcy case without the threat of rival proposals, as the company continues trying to sort out issues regarding its flagship premature birth drug, Makena.

In a Friday filing with the U.S. Bankruptcy Court in Manhattan, K-V said it wants until March 4, to file a plan of reorganization without the threat of competing proposals and until May 2, to solicit votes on that plan. Without court approval, the company's right to file the plan and seek the votes would expire on Dec. 3 and Jan. 31, respectively.

"The purpose of the Debtors' present request for an extension of the Exclusive Periods is, among other things, to ensure that the Debtors have an opportunity to seek to address the concerns of all stakeholders," K-V said in its filing.

K-V's bankruptcy, like its business before it filed for Chapter 11, centers on the success of Makena. K-V bought the rights to Makena from Hologic Inc. (HOLX) in a deal that closed last year. Hologic, which K-V still owes money tied to Makena, is trying to get the rights to the drug back. It claims that K-V has made missteps that have sapped value out of the drug.

When Makena hit the market, K-V sold it for $1,500 per shot, a price that set off protests from detractors who said the drug was too costly. The Food and Drug Administration then decided not to take action against "compounder" companies making cheaper drugs using the same active ingredient as Makena, which hurt the drug's sales. K-V eventually lowered the price.

Although the FDA clarified its statement about Makena in June, the company thought it didn't go far enough and sued. A judge threw out the initial lawsuit, though K-V could appeal.

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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

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

Meningitis Outbreak May Spur U.S. Oversight of Pharmacies

By Anna Edney on October 29, 2012
Inconsistent state oversight of specialty pharmacies that mix their own medicines, like the one linked to the U.S. meningitis outbreak, shows the need for greater federal oversight, Representative Edward Markey said.

State pharmacy boards focus on licensing activities and pay little attention to safety enforcement, said Markey, a Democrat from Massachusetts, where the pharmacy linked to 25 meningitis deaths is located. Markey, in a report released yesterday, said the federal Food and Drug Administration does a better job making information publicly available that may help consumers avoid dangerous medicines.

Markey plans to introduce legislation that would require compounding pharmacies to register with the FDA and comply with minimum safety standards. The move adds to other legislative proposals and two congressional investigations related to New England Compounding Pharmacy Inc., known as NECC, which this month recalled more than 17,000 vials of a steroid for back pain after some tainted doses were linked to a fungal meningitis outbreak that has infected 344 people, including 25 deaths.

“The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight,” Markey said in a statement. “This tragedy demands the strongest response from Congress and federal and state authorities to ensure safeguards are in place to protect patients.”

Compounding pharmacies are supposed to mix drugs on a small scale in response to patient prescriptions for treatments that aren’t available elsewhere, for example for a unique dose of a medicine. Massachusetts regulators have moved to permanently revoke the license of NECC, citing evidence of unsanitary manufacturing conditions and business practices that may have exceeded the scale and scope that is typically allowed.

State Investigation

Massachusetts also has begun a statewide inspection of compounding facilities. It secured the voluntary surrender of the license for Infusion Resource because of conditions at the facility in Waltham, Madeleine Biondolillo, director of the Bureau for Health Care Safety and Quality in Massachusetts, said yesterday at a news conference. Investigators questioned the sterility of injectable drugs at Infusion and said the company had a space set up to give patients intravenous medications on site, even though it doesn’t have a clinic license.

Excluding the latest incidents at NECC, FDA records documented 23 deaths and 86 serious injuries since 2001 associated with compounding pharmacies, which are currently exempt from most federal oversight, according to Markey’s report. The deaths ranged from more meningitis illnesses to overdoses of numbing cream for laser hair removal that was made much more potent than was allowed.

Online Database

While the FDA posts online searchable warning letters about safety violations, only six states post enforcement actions on the Internet that advise consumers a pharmacy may have made contaminated products at one time, according to Markey’s report.

Those states are: Arizona, California, Missouri, New York, North Carolina and Rhode Island.

Meningitis is an inflammation of the lining of the brain and spinal cord. The FDA has said about 14,000 people received shots of the NECC steroid, which is injected into the spinal cavity to relieve neck and back pain.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Source found here