Meningitis outbreak: TN board often went easy on pharmacists despite complaints Tennessee Board of Pharmacy failed to tighten rules on sterile compounding

1:55 AM, Nov 11, 2012

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 pharmacists.

• 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.

As 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 specific patients.

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.

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.

“I believe the board should consider reviewing all rules, especially where it concerns sterile compounding and manufacturing,” McDaniel said.

Tepid response

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 basis.

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.

Since 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.

Board 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.

The complaints

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 process.

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.

In 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.

The 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.

Tennessee’s 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 requirements.

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.

Model standards

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.

Other states, 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 USP 797.

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.

Tennessee 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.

But any 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.”

Contact Nate Rau at 615-259-8094 or nrau@tennessean.com. Follow him on Twitter
@tnnaterau.