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Food and Drug Administration and Compliance Issues
Lawmaker to outline legislative proposal, actions needed to address
“regulatory black hole” of compounding pharmacy oversight
MEDFORD,
MA. – With the meningitis outbreak death toll reaching 29 and 377 more sickened
by injectable steroids manufactured at the New England Compounding Center
(NECC), Rep. Markey will outline a legislative strategy to strengthen the
regulations that govern compounding pharmacies and protect patients. Rep. Markey
has been the Congressional leader in investigating the tragedy and addressing
the “regulatory black hole” that currently governs the compounding pharmacy
industry. Earlier this week, Rep. Markey released the report “Compounding
Pharmacies, Compounding Risk”, which revealed that even before the current
outbreak, problems at compounding pharmacies led to at least 23 deaths and 86
illnesses in 34 states.
WHAT: Press conference announcing compounding pharmacy legislation
WHO: Congressman Edward J. Markey (D-Mass.), senior member of the Energy and
Commerce Committee and dean of the Massachusetts Congressional delegation
WHEN: Thursday, November 1, 2012, 1 PM
WHERE: Framingham, Massachusetts
When compounding pharmacies make mistakes, they seldom face
harsh regulatory punishment , a review of legal cases by USA TODAY shows. More
often, the real penalty comes via lawsuits for damages.
The FDA recorded about 200 "adverse events" linked to 71 compounded products
since 1990
Lawsuits are frequently tougher than regulators
Criminal investigations are rare
4:55PM EDT October 31. 2012 - WASHINGTON --
The legal landscape is littered with charges of negligence and misconduct by
compounding pharmacies such as the one implicated in the nation's ongoing
meningitis outbreak, but they rarely result in tough punishments, an examination
of legal records shows.
In some cases, there's almost no penalty for pharmacies that break the rules,
and the people who run them simply continue with business as usual, sometimes
with tragic results.
Compounding pharmacies, which mix specialized and hard-to-get medications
from raw ingredients, have been tied repeatedly to illness outbreaks -- the Food
and Drug Administration has recorded about 200 "adverse events" linked to 71
compounded products since 1990. Some of those cases were eerily similar to the
current meningitis episode, which has killed 28 so far.
USA TODAY reviewed state and federal court records, investigative reports and
regulatory actions on dozens of cases in which compounding pharmacies produced
contaminated or adulterated medication, mismeasured dosages, or manufactured and
distributed drugs that were counterfeit or illegal. In many cases, it wasn't
regulatory action that shut down those operations; it was damage awards they
couldn't afford to pay.
The lightly regulated businesses have been linked through the years in
government investigations to high-profile steroids scandals in sports and major
tragedies involving veterinary drugs.
Through them all, there's a pattern: When a compounding pharmacy commits
serious transgressions -- wrongs that endanger lives or involve large-scale
criminal conspiracies -- the regulatory sanctions often are minimal. Tougher
punishments frequently come in the form of personal injury lawsuits, which can
elicit court-ordered penalties far more potent than, say, the suspension of a
pharmacy's license.
Civil lawsuits are a powerful tool "to make sure the most dangerous
compounding pharmacies are forced out of business," says Joanne Doroshow,
executive director of the Center for Justice & Democracy at New York Law
School. "Nothing else seems to be doing it … because the entire regulatory
system lacks teeth."
At least three personal injury lawsuits have been filed against the
Framingham, Mass.-based New England Compounding Center, which state and federal
investigators have identified as the chief suspect in the current meningitis
outbreak. With more than 300 illnesses in at least 16 states, more claims are
sure to follow.
The investigators have linked the outbreak to fungal contamination in
injectable steroids that were produced by NECC and administered to an estimated
14,000 people for back pain. Last week, the Massachusetts Board of Registration
in Pharmacy permanently revoked NECC's state operating license, as well as the
licenses of its three chief pharmacists, after documenting multiple problems
with sanitary conditions and quality control at NECC's facility.
But that's the board's only bullet: Like many state pharmacy boards that
regulate compounding operations, the Massachusetts panel has no power to issue
fines for wrongdoing. Because compounding pharmacies produce medications outside
the strict federal regulations that govern traditional drug manufacturers, the
FDA has limited authority over them.
Criminal penalties are possible -- criminal investigators from the U.S.
Justice Department and the FDA are involved in the NECC probe. But such
prosecutions are extremely rare, in part because the law makes it very difficult
to hold pharmacists criminally liable for problems with the drugs they produce
or dispense.
Even state license revocations are rare: Among cases reviewed by USA TODAY,
the NECC closure was the only time a state revoked a compounding pharmacy's
license permanently. (Neither NECC nor its pharmacists have appealed the license
revocations, though that option remains.)
"Clearly, (states) have the authority," to shut down a bad operator," says
Sarah Sellers, a former FDA compliance official. "Whether they have the
political will and the resources to pursue those cases is a question in my
mind."
Sellers, who now runs Q-Vigilance, a drug-safety consulting firm, says she
doesn't ever recall seeing another case in which a state shut down a compounding
pharmacy permanently. She believes that might be due partly to the fact that
state pharmacy boards often have members who operate or have interests in
compounding pharmacies.
"If there is conflict of interest at the state level, that may be a
contributing factor in the lack of enforcement," Sellers says. Warnings in an earlier outbreak
In the fall of 2002, a spate of meningitis cases began cropping up in
hospitals and clinics in North Carolina. In many respects, it was strikingly
similar to today's outbreak: All the patients were sickened by a rare fungus
after getting treated with an injectable steroid produced by an out-of-state
compounding pharmacy. Even the drug was the same: methylprednisolone
acetate.
When state and federal investigators inspected the facility where the drug
was prepared, Urgent Care Pharmacy in neighboring South Carolina, they found
faulty sterilization equipment and inadequate sanitary and quality-control
practices. When they tested unopened vials of the suspect medication, they also
found the fungus.
The pharmacy was ordered to stop selling the contaminated drug immediately,
state investigation records show. Warnings went to 11 states where hospitals and
clinics had gotten drug shipments from the facility. Several victims were
hospitalized; one woman died.
The South Carolina Board of Pharmacy directed Urgent Care to halt work until
it corrected major deficiencies in its sterile practices and oversight of
technicians. Exercising an authority many pharmacy boards lack, the panel also
levied a $10,000 fine and suspended the license of the pharmacist in charge.
Facing lawsuits from more than a half-dozen people who claimed injuries from
the contaminated injections, Urgent Care declared bankruptcy three months later.
But the pharmacist who managed the operation moved on and now works at a
different South Carolina pharmacy. Reached at that store, he declined to
comment.
In the same order that suspended the pharmacist, the board immediately issued
a "stay" of that action. He was allowed to continue practicing pharmacy on a
probationary basis, provided he pass a competency exam and refrain from
compounding. Today, his licensure record shows that he continues to work and
lists him "in good standing" with "no disciplinary action."
"The regulatory system failed," says Forest Horne, a Raleigh, N.C.-based
lawyer who won a damage award of about $1 million for the family of the woman
who died in the meningitis outbreak. "If that guy is able to go back and work in
a pharmacy … I think the regulatory system is not working, because the
conditions in that plant were absolutely abysmal.
"If these people aren't stopped through litigation," Horne adds, "they're not
going to be stopped." Dead horses and more lawsuits
But litigation can take years, and it doesn't always succeed.
In April 2009, 21 polo horses from a Venezuela-based team died while
preparing to compete at the U.S. Open Polo Championship in Wellington, Fla. The
deaths later were attributed to a medication that was mixed incorrectly by
Franck's Pharmacy, a high-volume compounding operation that, like many, prepared
veterinary drugs in addition to human medications.
Franck's acknowledged the dosing error even before federal investigators
confirmed it, and owners of the horses filed a lawsuit seeking more than $4
million in damages from the pharmacy. But that case remains unresolved and is
scheduled for a jury trial early next year.
After the horses' death, the FDA also filed suit against Franck's, contending
its operations should be halted because it was acting as a drug manufacturer,
using bulk ingredients to produce drugs on a large scale. As a manufacturer,
Franck's would need FDA approval and be subject to agency inspections for
compliance with strict federal rules on safety and quality.
But the court ruled that the pharmacy was within the boundaries of
compounding, a centuries-old practice that focuses on mixing specialty
medications that aren't available commercially. Franck's remained under the
supervision of Florida's board of pharmacy. After reprimanding and fining
Franck's in the horse incident, the board allowed it to continue operating in
good standing.
It wasn't long before the pharmacy was tied to more problems.
In November, 2011, weeks after the FDA lost its case, a rare fungal infection
began cropping up in the eyes of patients who had received ocular injections of
a special dye used in eye surgery. A subsequent state/federal investigation
conducted earlier this year linked the infections to contamination in vials of
the dye prepared by Franck's.
States appear to be cracking down on compounding pharmacies nationwide, in the wake of a meningitis outbreak linked to contaminated steroid injections that were mixed by a Massachusetts pharmacy and shipped to medical providers throughout the United States.
Compounding pharmacies are designed to supply local health care facilities with tailor-made drugs for specific patients. However, the New England Compounding Center (NECC), which recalled more than 17,000 vials of steroid injections believed to be contaminated with fungus, employed sales representatives throughout the United States and distributed medications to facilities in at least 23 states.
A long history of problems at NECC have now been identified, including failure to maintain a controlled clean room to reduce the risk of microbial contamination during the processing of drugs and a failure to ensure that medications were safe before they were distributed.
Other compounding pharmacies are now starting to see stronger enforcement actions by state regulatory agencies, which many believe are long-overdue in the industry.
In the wake of NECC meningitis scandal, a Congressional report documents a decade of regulatory 'gaps' in protecting public health
News reports over the past month fill in a grim picture of the poor manufacturing practices at New England Compounding Center (NECC; Framingham, MA), the pharmacy at the center of the expanding scandal over contaminated dosages of a steroid, methylprednisolone acetate, that has now caused 25 deaths and 314 cases of fungal meningitis, among over 17,000 units of the drug that have been shipped nationally during the past half-year. While FDA and Massachusetts authorities continue to investigate the now-shuttered plant, Rep. Edward Markey (D-MA) has issued a report on FDA efforts, the constraints it operates under in litigation with pharmacy associations, and the “lax” enforcement of most state boards of pharmacy. Earlier in the month, Markey indicated his intent to propose new legislation to address this regulatory impasse, although the bill has not yet been introduced.
The Markey report, “Compounding Pharmacies, Compounding Risks,” documents 23 deaths and at least 86 serious illnesses since June 2001 involving compounding pharmacies nationally (these do not include the recent NECC case). A 1997 federal law was overturned, partially, in subsequent litigation that had carried through to 2008, after which FDA conceded most enforcement responsibility to state boards of pharmacy. But, based on a search of publicly available documents at these boards, Markey’s investigators found that they “do not, as a general rule, appear to undertake enforcement actions that relate to the safety or scopy of compounding pharmacies,” and that “it is impossible to conclude … that the safety of pharmacy compounding activities has been or can be sufficiently assured” through the boards. While FDA has issued warning letters to more than 50 compounding facilities in 34 states between 2003 and March 2012, only six states have taken enforcement actions over that time period.
Coincidentally, an industry publication, Pharmacy Purchasing and Products (www.ppmag.com; registration required) published in its October issue a second annual survey of compliance practices with the USP General Chapter <797>, which is the usual reference to proper procedures for compounding sterile preparations (CSPs). <797> is up for revision in 2013 under the USP guidance development process. The survey, which solicited voluntary responses (which ultimately came mostly from hospital pharmacies), paints a picture of gradual improvement in compliance practices—but one that is far from universally adhered. Overall, respondents reported an average 77.7% level of compliance. The most common shortcomings were in performing environmental sampling programs (within the working space of the compounding area) and then developing corrective actions when deficiencies were found. Respondents also noted that “financial/budgetary restrictions” were the most common reason for less-than-complete compliance.
It’s hard to say how that 77.7% figure matches up with actual performance industry-wide, since the survey is not a representative one. Still, a sense that compliance is achieved in roughly only three out of four instances—especially at hospital pharmacies where a higher level of oversight might be expected—is a shockingly low expectation. Not only are compounding pharmacies regulated by different means than manufacturers, but they also appear to be held to a lower standard of performance.
Records Reflect Insider Was Involved in Government Policy Allowing Company to Continue Despite Multiple Violations
ROCHESTER, Mich.--(BUSINESS WIRE)-- Alyson Oliver, a Michigan attorney representing several injured victims of the fungal meningitis outbreak and the lead attorney in the effort to consolidate the fungal meningitis cases nationally continues to uncover serious concerns about how the Massachusetts Board of Registration in Pharmacy (BRPh) conducted business and specifically how it dealt with complaints against the New England Compounding Center (NECC) during former Governor Mitt Romney’s administration.
