By Nate Rau, The Tennessean
Long before a Massachusetts pharmacy distributed tainted drugs that led to a
national meningitis outbreak, the Tennessee Board of Pharmacy had
clear warning signs about the dangers of pharmaceutical compounding as
it considered complaints related to contaminated and expired drugs,
pharmacists operating as unlicensed manufacturers and prescriptions
being wrongly filled.
Despite those complaints, the board apparently did not
crack down on the compounding industry and often responded gently
against the accused pharmacists, according to its meeting minutes.
The Tennessean's review of the Board of Pharmacy found that:
A letter of warning was the typical response to compounding-related
infractions, including issues of sterility, expired drugs and unlicensed
• Because sterile compounding does not require a
separate license, the state Department of Health does not know how many
pharmacists engage in the practice.
• The names of pharmacists
who are sent letters of warning are kept secret, even when they are
found to have committed a possible sterile compounding infraction.
Pharmacists are not named in complaints, and supporting documents for
violations are not posted online.
• Tennessee has not incorporated model regulations for sterile compounding.
• The board has just five inspectors to regulate a statewide industry with more than 10,000 pharmacists.
the pharmacy board prepares to meet on Wednesday and Thursday, there is
no indication that new regulations for sterile compounders are on the
horizon. Though the Tennessee board has already revoked the licenses of
New England Compounding Center and its co-founder, Barry Cadden, the meeting agenda
does not include business related to sterile compounding, which
involves combining multiple medications to fill prescriptions for
Federal and state officials say
Massachusetts-based New England Compounding distributed tainted steroids
used in epidural shots that led to 32 deaths and 438 illnesses in 19 states. Thirteen of those deaths were in Tennessee.
Board of Pharmacy member Joyce McDaniel, who is the board's designated
consumer advocate and only nonpharmacist, said it was appropriate to
consider new regulations on the heels of the outbreak.
the board should consider reviewing all rules, especially where it
concerns sterile compounding and manufacturing," McDaniel said.
It isn't as if the state's pharmacy board has a lenient reputation.
Tennessee ranks roughly in the middle for taking disciplinary action
against practitioners, said Carmen Catizone, executive director of the
National Association of Boards of Pharmacy. The association tries to
compile a report showing disciplinary action for each state on an annual
However, many states do not update the national
association regarding the number of licenses they suspend or revoke each
year. Tennessee falls into that category. The state board has not
provided its updated discipline numbers to the national association for
the past three years.
The Tennessean reviewed disciplinary actions
taken by the state board since 2008 and found that it had revoked 181
licenses and suspended 49.
But in regard to compounding, the state board has had a tepid response.
2007, the board has heard at least 13 complaints related to
compounding. In six cases, the board sent letters of warning or letters
of instruction to the pharmacist. Four cases were either dismissed or
the board elected to take no action. One case resulted in a fine, and
two cases resulted in formal cease-and-desist letters.
President Brenda Warren said last week she could not comment
specifically about new regulations for sterile compounding because of
the evolving situation.
"I think this instance will bring to light
nationally for all states ... opportunities for people that are doing a
very good job to look at what they're doing to see if they could do it
better," she said.
In Tennessee, the most common compounding complaint relates to
pharmacists operating as a manufacturer by preparing medications without
a doctor's prescription, which the law requires. Pharmacists who engage
in this practice must be licensed as manufacturers, triggering
additional federal oversight.
In May, the board considered a
series of complaints levied against a Tennessee pharmacist who was found
compounding commercially available drugs, keeping expired drugs on
shelves and failing to maintain proper conditions for a compounding
hood, a sterile box that keeps products safe during the compounding
For each of those infractions, the pharmacist was sent a
letter of warning and suffered no further discipline. The names of
pharmacists who receive warnings are not made public.
However, the board fined the pharmacist $5,100 for employing a technician who wasn't registered with the state.
January, the board sent a letter of instruction to a pharmacist after a
state inspection uncovered 20 partially filled prescriptions with
expiration dates going back to 2009, and a compounding hood that had not
been recertified with the state since 2007.
In January 2010, the
board considered a complaint alleging that three patients developed eye
infections after being injected with Avastin, a drug that New England
Compounding also produced. After subsequent samples of the drug were
tested and analyzed, no contamination was found and the board took no
action against the pharmacy.
Names kept secret
While Tennessee residents can find records online showing the complaints
considered by the pharmacy board, tracking the state's subsequent
disciplinary action on a specific complaint can be difficult. When the
board hears an initial complaint, the names of the pharmacy and
pharmacist are kept secret.
Letters of warning sent to pharmacies are not public records, according to Health Department spokeswoman Shelley Walker.
Other disciplinary action, such as license revocations and suspensions, are posted in monthly reports on the Department of Health's website, but details and supporting documents are not listed in those reports.
board also has had problems maintaining its own records. The Tennessean
requested minutes from two board meetings that were not posted online,
but Walker said the board was unable to find those minutes and staff
members continue to look for them.
"Some states elect to keep the
name of the pharmacy private so that a pharmacist doesn't have their
name sullied by frivolous complaints," Catizone said.
pharmacy board also has approved licenses for pharmacists with histories
of disciplinary action related to compounding practices in other
states. McDaniel said the board typically mirrors the disciplinary
action of other states when it considers whether to grant a license to
an out-of-state pharmacist.
The pharmacy board approved a license
for Abrams Royal Pharmacy, even though the pharmacy was issued a warning
in Texas for violating the sterile compounding environment control
On Jan. 12, 2009, the board did not take additional
disciplinary action against pharmacist Julian Williams, who had been put
on probation by the Missouri Board of Pharmacy for compounding
potentially contaminated products. The Tennessee pharmacy board followed
Missouri's lead and put him on probation here as well.
The Massachusetts Board of Pharmacy responded to the meningitis
outbreak by instituting emergency regulations, which require pharmacists
operating as manufacturers to report the volume of compounded drugs
they prepare. The board also established stiffer penalties for failing
to conform with sterile compounding regulations.
such as California, require an additional license for pharmacists who
engage in sterile compounding for injections. In 2004, the U.S.
Pharmacopeia developed model standards for sterile compounding called USP 797,
and according to the National Association of Pharmacy Boards, 18 states
have adopted those standards as part of their regulation of
compounding. The standards outline how sterile drugs should be
compounded, handled and stored.
The Tennessee pharmacy board
already has regulations related to "sterile product preparation." Warren
said these regulations would apply to pharmacists who engage in
compounding in Tennessee, but she said the state has not incorporated
The Tennessee Pharmacy Association convened an advisory
committee to study rules and regulations related to compounding on the
heels of the New England Compounding Center situation. One member of the
advisory panel, Nashville pharmacist John Hollis, who was disciplined
in 2009 by the board for preparing medications without a prescription
for specific patients, said the committee probably would recommend the
adoption of USP 797.
Who will pay for tighter rules?
The issue of increasing regulation of sterile compounding could come down to dollars and cents.
has 10,231 pharmacists working at 1,905 licensed pharmacies and 706
licensed manufacturers, wholesalers and distributors. The board of
pharmacy doesn't know how many of them engage in sterile compounding
because no separate license requirement exists.
The state employs
just five inspectors to inspect those operations and respond to
complaints. This year, the board had conducted 1,260 inspections through
Oct. 31, according to the Department of Health. On average, pharmacies
are inspected every 18 to 24 months.
Last month, state Rep. Glen
Casada, R-Franklin, who is chairman of the House Health and Human
Services Committee, said the time has arrived to consider a state law
that would increase regulations on compounding.
conversation about additional regulations will have to answer the
question of how to pay for the necessary inspections and oversight. The
board is funded by licensure fees paid by pharmacists and pharmacist
technicians. For the 2011 fiscal year, those fees generated $1.93
million and the board had total expenditures of $1.39 million, with the
remaining $553,000 going unspent.
This year, with a tighter board
budget, about $85,000 is expected to go unspent. An inspector's salary
is about $90,000 per year.
"I think we would all say that there's
always room for more resources, especially if there's increased
regulation," Warren said. "In fact, increased regulation will not result
in improved oversight unless additional resources are provided."