A handful of states across the country are moving swiftly to shore up their regulatory defenses against the possibility of a new pharmacy compounding disaster similar to the fungal meningitis outbreak that by late January had sickened 693 people in 19 states and killed 45.
In Iowa, for example, the Board of Pharmacy issued charges against five out-of-state compounding pharmacies following inspections by National Association of Boards of Pharmacy investigators under a contract with the Iowa board. By year-end, NABP inspectors are expected to visit all 582 nonresident pharmacies licensed by the board.
In California, the Board of Pharmacy is expected to seek the legislature’s go-ahead for new authority and additional staff to conduct random, unannounced inspections of nonresident pharmacies that compound high-risk sterile solutions for practitioners and pharmacies within the state. And in Massachusetts, where the meningitis crisis began, Gov. Deval Patrick is pushing legislation to overhaul the state Board of Pharmacy, compel compounding pharmacies to obtain special licenses, increase penalties for compounding pharmacies that violate state rules, and, for the first time, require a Massachusetts license and proof of regular inspections for all nonresident pharmacies that do business in the state.
Eric Kastango, MBA, RPh, FASHP, president and chief executive of Clinical IQ and a member of the Massachusetts oversight commission that advised the governor, told Pharmacy Practice News that the meningitis catastrophe had shaken “everybody out of their denial coma.” He said that if the Massachusetts compounding bill is enacted, the state “will be taking a leadership role in defining the way boards of pharmacy should be structured and how they should be providing proper oversight to these compounding activities.
“The thing that really made me excited,” Mr. Kastango added, “was the fact that the bandwidth of this oversight will include hospitals and other locations where a pharmacist may or may not be involved in compounding, such as physician offices.”
He added that he could “only imagine the horror show” of physicians or their nurses or office staff compounding, “because they receive no formal training.”
25 Steps Toward Safer Compounding
Gov. Patrick appointed the special compounding oversight commission in late October. Slightly more than two months later, the group delivered a detailed report offering 25 steps for toughening the state’s regulatory authority over compounding pharmacies. Driving the commission’s quick response was the public demand for action following the failure of the Massachusetts Board of Pharmacy to shut down the violations-prone New England Compounding Center (NECC), which recently filed for bankruptcy, long before its name became indelibly linked to the meningitis disaster.
The commission’s chairman, Christian A. Hartman, PharmD, MBA, director of clinical quality and patient safety at Wolters Kluwer, said that panel members, after listening to experts from the FDA, the Centers for Disease Control and Prevention (CDC), the US Pharmacopeia (USP), the Massachusetts Department of Health and others, concluded that one reason no enforcement action had been taken against NECC was that the pharmacy board did not have the funding to hire enough investigators and the ones they did have often lacked the expertise and training required to be effective.
Dr. Hartman also said panel members felt strongly that the state needed to increase the number of pharmacists on the board from the current five to six and that those selected needed to “come from diverse backgrounds and training” reflective of today’s practice of pharmacy. Instead, he noted, the governor is seeking a reduction in the number of pharmacists on the 11-member board to four, with the remaining seats held by a physician, a nurse, a technician, a quality improvement expert and three public members. Dr. Hartman criticized the proposed reduction. “That’s part of the reason there was a failure,” he said. “We need to put more experts on the board.”
The governor did, however, order the Massachusetts Department of Health to reinforce the board’s inspection staff and require that all inspectors be pharmacists with at least five years of clinical training and specific expertise in sterile compounding.
Dr. Hartman also noted that there was still a chance that the legislature, which last month began hearings on the governor’s proposals, would follow the oversight commission’s advice in the final legislation and add pharmacists as board members.
California Pursuing Aggressive Oversight Agenda
In California, the Board of Pharmacy’s executive director, Virginia Herold, said the board was scheduled to meet in early February to review a final legislative proposal that would give its investigators the authority to conduct surprise inspections of any nonresident pharmacy that ships sterile products into the state. Under the proposal, the definition of sterile products would be expanded from injectables alone to include inhalation therapy treatments and products designed for administration into the eye.
Ms. Herold said that 93 of the 468 nonresident pharmacies licensed by California were approved specifically as sterile compounders, but she noted that the board did not know whether any of the other firms are shipping sterile injectables. “Which is another problem for us,” she added.
To carry out the nonresident pharmacy surveillance program, Ms. Herold said the board would need to increase the size of its 37-member investigator staff. “We will charge the individual companies that wish to do business in the state to pay for the cost,” she added. “We’ve already got that built into the existing fees, and then we will charge them separately for travel expenses.”
The board also has broad authority to cite and fine pharmacies for shipping substandard products, she said, and it can block a pharmacy from shipping all sterile products until a problem is corrected, “which is a big advantage.” Ms. Herold said that “in most cases” the board is not as interested in collecting fines as it is in stopping a practice “before it gets to a point where you have massive contamination.”
In Iowa, the Board of Pharmacy has scheduled March 12 hearings for the five out-of-state pharmacies that have received statements of charges. Lloyd Jessen, RPh, JD, executive director of the Iowa board, said the companies had an option. “If they don’t want to go to hearing, they can try and have an informal settlement with the board, and the terms of the settlement would be worked out between the attorney for the company and the attorney for the state of Iowa,” he said. “I don’t know what possible settlement terms might be, but this is generally how things proceed.”
Generally, he said, penalties for pharmacies that violate the law can range anywhere from a warning to the loss of a license. The board also can levy fines of up to $25,000 in an individual case.
Pace of Inspections Could Be Problematic
Originally, Iowa’s contract with NABP called for completion of all 582 out-of-state pharmacy inspections by the end of June. Carmine Catizone, MS, RPh, PD, NABP’s executive director, told Pharmacy Practice News that the group’s 80 staff and contract inspectors—many of them veterans of the FDA, the FBI and the Drug Enforcement Administration—would be working at a rate of 20 to 25 inspections a week to meet the deadline.
However, Dr. Jessen said the board had since realized that the pace was “probably not feasible, so we’ll probably end up extending the contract to the end of 2013. These pharmacies are spread out all across the United States, in virtually all 50 states, and so it involves a lot of travel, and to get them all done in six months would be very difficult.”
Dr. Jessen said the inspection program was “really designed” to prevent another NECC-type of disaster from occurring. “We try to go to every pharmacy every couple of years and check on them,” he said. But he added that out-of-state pharmacies have been the exception because of the traveling distances and cost. “So they’ve been pretty much neglected for about seven years,” he said. “That’s why we felt—especially with what happened in Massachusetts—that it was a high priority to get out there and look at all 582 pharmacies.”
—Bruce and Joan Buckley
Specific details of charges against the five out-of-state pharmacies that were recently cited by the Iowa Board of Pharmacy varied widely, but two common allegations were that they had failed to comply with Iowa pharmacy rules and compounding requirements and that they had engaged in the unlawful manufacture of unapproved drug products.
The five companies reflect the diverse nature of pharmacy compounding practice today, with clients spanning the medical spectrum from hospitals to veterinarians and physicians offices and clinics. They are Talon Compounding Pharmacy of San Antonio; PharMEDium Services LLC of Sugar Land, Texas; Wedgewood Pharmacy of Swedesboro, N.J.; MedQuest Pharmacy of North Salt Lake, Utah; and Unique Pharmaceuticals of Temple, Texas.
Officials or attorneys speaking for four of the companies that responded to Pharmacy Practice News’s requests for comment either denied the allegations or declined to discuss them, noting that their responses would made directly to the board at its scheduled March 12 hearing or to Iowa’s assistant attorney general, Theresa O’Connell Weeg, who represents the board in legal actions. Several of the companies offered background or on-the-record statements contending that their pharmacy compounding practices met or exceeded USP Chapter <795> and <797> standards for nonsterile and sterile products.