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Monday, October 29, 2012
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.
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."
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
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
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.
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
Case Count: 354 States: 19 Deaths: 25 --another stated-Rhode Island- added
Cases and Deaths with Fungal Infections Linked to Steroid Injections
| State | Total Case Counts | Peripheral Joint Infections | Deaths |
|---|---|---|---|
| TOTALS | 354* | 7 | 25 |
| Florida (FL) | 22 | 0 | 3 |
| Georgia (GA) | 1 | 0 | 0 |
| Idaho (ID) | 1 | 0 | 0 |
| Illinois (IL) | 1 | 0 | 0 |
| Indiana (IN) | 45 | 0 | 3 |
| Maryland (MD) | 20 | 0 | 1 |
| Michigan (MI) | 89 | 4 | 5 |
| Minnesota (MN) | 9 | 0 | 0 |
| New Hampshire (NH) | 11 | 3 | 0 |
| New Jersey (NJ) | 18 | 0 | 0 |
| New York (NY) | 1 | 0 | 0 |
| North Carolina (NC) | 2 | 0 | 1 |
| Ohio (OH) | 13 | 0 | 0 |
| Pennsylvania (PA) | 1 | 0 | 0 |
| Rhode Island (RI) | 1 | 0 | 0 |
| South Carolina (SC) | 1 | 0 | 0 |
| Tennessee (TN) | 74 | 0 | 10 |
| Texas (TX) | 1 | 0 | 0 |
| Virginia (VA) | 43 | 0 | 2 |
New Markey Report Reveals Before Current Outbreak At Least 23 Deaths, 86 Serious Illnesses, Injuries Associated with Compounding Pharmacy Practices
WASHINGTON, D.C. – With the meningitis outreak death toll reaching 25 and 344
more sickened by injectable steroids manufactured at the New England Compounding
Center (NECC), Congressman Edward J. Markey (D-Mass.) today released a new
comprehensive report documenting more than a decade of violations and problems
at compounding pharmacies throughout the nation. Rep. Markey’s report, “Compounding
Pharmacies, Compounding Risk” describes the nature of regulatory oversight
and gaps in legal authority that, even before the current meningitis outbreak,
led to at least 23 deaths and 86 serious illnesses or injuries in at least 34
states. Violations at compounding facilities included compounding pharmacies
selling copies of commercially-available drugs, selling drugs made using
ingredients that were not Food and Drug Adminsitration (FDA)-approved or were
recalled for safety or effectiveness reasons, cases where sterile facilities
were visibly dirty and contamination of the drug product was known to have
occurred, and either selling drug products without a valid prescription or
manufacturing large quantities of drug products.
Drawn entirely from media reports, publicly-available FDA and state Boards of Pharmacy documents from all 50 states, Puerto Rico and DC, Rep. Markey’s report shows how FDA’s efforts to assure the safety of compounding pharmacies have been challenged at every juncture by some members of the compounding pharmacy sector. The report also reveals that the state Boards of Pharmacy do not typically and consistently oversee the safety of the drugs made by compounding pharmacies and do not always provide records of their enforcement activities in an easily searchable and publicly available format.
“The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years, but a patchwork of state regulation, incomplete and often inaccessible information about serious health issues caused by compounding pharmacies and industry efforts to thwart better government oversight have complicated efforts to understand the true scope of this problem,” said Rep. Markey, senior member of the Energy and Commerce Committee. “The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight. This tragedy demands the strongest response from Congress and federal and state authories to ensure safeguards are in place to protect patients.”
“This analysis provides very useful insight into our understanding of this issue,” said Rep. Henry A. Waxman, Ranking Member of the Energy and Commerce Committee. “The report makes clear that we need to ensure that FDA has the statutory authority to perform meaningiful oversight of compounding pharmacies.”
A copy of Rep. Markey’s report, “Compounding Pharmacies, Compounding Risk” can be found HERE. A timeline of Rep. Markey’s work on compounding pharmacies, including his plan to introduce legislation, can be found HERE.
Other findings from Rep. Markey’s report include:
###
Drawn entirely from media reports, publicly-available FDA and state Boards of Pharmacy documents from all 50 states, Puerto Rico and DC, Rep. Markey’s report shows how FDA’s efforts to assure the safety of compounding pharmacies have been challenged at every juncture by some members of the compounding pharmacy sector. The report also reveals that the state Boards of Pharmacy do not typically and consistently oversee the safety of the drugs made by compounding pharmacies and do not always provide records of their enforcement activities in an easily searchable and publicly available format.
“The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years, but a patchwork of state regulation, incomplete and often inaccessible information about serious health issues caused by compounding pharmacies and industry efforts to thwart better government oversight have complicated efforts to understand the true scope of this problem,” said Rep. Markey, senior member of the Energy and Commerce Committee. “The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight. This tragedy demands the strongest response from Congress and federal and state authories to ensure safeguards are in place to protect patients.”
“This analysis provides very useful insight into our understanding of this issue,” said Rep. Henry A. Waxman, Ranking Member of the Energy and Commerce Committee. “The report makes clear that we need to ensure that FDA has the statutory authority to perform meaningiful oversight of compounding pharmacies.”
A copy of Rep. Markey’s report, “Compounding Pharmacies, Compounding Risk” can be found HERE. A timeline of Rep. Markey’s work on compounding pharmacies, including his plan to introduce legislation, can be found HERE.
Other findings from Rep. Markey’s report include:
- Since June 2001, the FDA has attempted to rein in the activities of dozens of pharmacies through the issuance of warning letters, all of which are publicly available.
- FDA records document 23 deaths and at least 86 serious illnesses or injuries associated with these practices. These totals should be considered to be conservative, since in many cases the reviewed documents noted the existence of adverse events but did not specify the type or quantity; and in other cases, the warning letters may have been issued prior to a full realization of the health impact of the alleged violation.
- State enforcement records related to the safety of compounding pharmacy practices were not typically found in the enforcement records reviewed, because state regulators appear to focus on more traditional pharmacy licensing activities.
- In many cases, the information available on the state Board websites is limited. Most state Board websites do not allow for keyword searches, preventing members of the public from easily locating or downloading enforcement records. State enforcement action records related to pharmacies are often limited to alphabetical or temporal lists or summaries of violations that are not themselves searchable.
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