Chains' ties run deep on pharmacy boards
1/1/09 3 p.m. (PST)
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Enlarge By Oscar Sosa, for USA TODAY
This is the Walgreens in Jacksonville, Fla., where Terry Paul Smith purchased a mis-filled prescription, which killed him.
RX FOR ERRORS
Regulation: Chains' ties run deep on pharmacy boards; see nationwide graphic
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DAY 3: Many lawsuits against pharmacies settled in silence | Minimizing risks: 9 steps you can take | Pharmacist counseling helps
INSPECTIONS LIMITED
Many state pharmacy boards are hobbled by funding and personnel shortages that allow pharmacies to operate for years at a stretch without undergoing on-site safety inspections, a USA TODAY review found.
At least 25 states lack laws that specify how often the boards' staffs must inspect pharmacies after the stores obtain initial licenses and open for business. Although most of the boards conduct inspections regardless, funding and staffing strains limit their efforts.
For example, the Texas pharmacy board tries to inspect each of the state's more than 4,400 pharmacies every two years. But with just six compliance staffers, some pharmacies go unchecked for as long as four years, says Allison Benz, the board's director of professional services.
Massachusetts said the state's more than 1,000 pharmacies are inspected randomly, and just 124 were checked in 2007.
"We have some places out there where pharmacies have not been inspected for 10 or 15 years," Richard Palombo, president of the National Association of Boards of Pharmacy, warned during the independent group's annual convention in May.
As state agencies nationwide cope with fewer resources, the independent organization is exploring ways to help pharmacy boards fulfill their oversight mission.
"I'll tell you right up front, none of us are ever going to have enough resources for the job," says Virginia Herold, executive officer of the pharmacy board in California, where the state's more than 6,000 pharmacies are inspected roughly once every four years.
By Kevin McCoy
Enlarge By Oscar Sosa for USA TODAY
Pearl Smith's husband, Terry Paul Smith, died of an overdose due to prescription drug mislabeling.
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When the Illinois Board of Pharmacy meets, Philip Burgess, national director of pharmacy affairs at Walgreens (WAG), the Illinois-based firm that's the nation's largest drugstore chain in sales and profits, chairs the sessions.
Michael Podgurski, vice president of pharmacy services for Rite Aid, (RAD) leads pharmacy board meetings in Pennsylvania, the headquarters of the East Coast's largest pharmacy chain.
READ OUR SPECIAL REPORT: Rx for Errors
Bob Dufour, the former director of pharmacy services for Arkansas-based Wal-Mart (WMT), chairs that state's board.
Kay Hanson, the pharmacy regulatory affairs manager for Target (TGT), serves on the board in Minnesota, the firm's corporate base. And James DeVita, CVS' (CVS) quality assurance director, is on the Massachusetts board.
FIND MORE STORIES IN: Florida | Philadelphia | Minnesota | Pennsylvania | Massachusetts | East Coast | District of Columbia | Nevada | Target | Sciences | CVS Corp. | Rite Aid | Illinois-based | National Association of Chain Drug Stores | Michael Polzin | National Association of Boards of Pharmacy
The five executives aren't the only retail chain pharmacists who serve on the state panels assigned to oversee prescription drug safety for the American public. A USA TODAY examination shows employees of major drugstore chains or supermarket pharmacies accounted for nearly one in four of the 295 pharmacists on the panels this year.
The appointments give consumers the benefit of the pharmacists' expertise. But they also give the chains a network with potential say about decisions that affect the pharmacy industry.
Most chain pharmacists abstain from votes that have a direct impact on their firms. DeVita, for instance, didn't vote on a 2005-06 investigation of CVS prescription errors, records show. But USA TODAY's examination, which included a survey of pharmacy boards in the 50 states and the District of Columbia, plus court and government records and information from the firms, found potential or alleged conflicts:
•Two Walgreens pharmacists on Florida's board opposed the maximum fine for another Walgreens pharmacist who failed to catch a prescription error that led to a construction worker's death.
•Before retiring from Wal-Mart in 2007, Dufour took part in discussions and votes on a cost-saving system for filling prescriptions that could benefit retail pharmacies, including Wal-Mart.
•In Nevada, where chain representatives hold four of the six pharmacist seats, the lone member representing the public heads an advocacy group that represents chain pharmacies. She recuses herself from disciplinary matters involving those firms, prompting a complaint that state residents have been deprived of a voice.
•At this year's convention of the National Association of Boards of Pharmacy, an independent organization that helps the state panels develop uniform standards, a chain pharmacy industry group spent more than $21,000 on a reception for pharmacy board delegates.
"The chains aggressively seek as much representation on the boards as they possibly can," says Daniel Hussar, a pharmacy professor at Philadelphia's University of the Sciences and editor of the Pharmacist Activist newsletter.
Burgess testified in a 2007 court deposition that Walgreens encourages its pharmacists to seek board seats because "it's very important for our employees to be actively engaged with their professional associations and their boards of pharmacy."
Who serves
Hussar says he's concerned the chains could "promote individuals who have a high loyalty" to their employers — rather than to consumers — for the posts.
Pharmacy chains and an industry group representing them dispute any such conclusion. "Members of pharmacy boards serve as advocates for public safety, not as representatives of their employers," says CVS spokesman Michael DeAngelis, echoing Walgreens, Rite Aid and Wal-Mart.
"Pharmacists consider it an honor to serve on their board. They make decisions that impact people's lives. It is their duty to protect public health and safety — and they uphold that duty with the utmost sincerity and responsibility," says Chrissy Kopple, a spokeswoman for the National Association of Chain Drug Stores.
The chains say pharmacists use their own judgment on board issues. But Walgreens spokesman Michael Polzin says the firm's pharmacists on the panels may ask for background "on an industry issue the board is debating … and we may supply it."
Noting that most oversight boards include active practitioners, Polzin adds that "someone who practices the profession will be a more valuable resource." More pharmacists work for chains than for any other employer, so "it should not be surprising that they are selected to serve on state boards of pharmacy," Kopple says.
Pharmacy board members, typically appointed by state governors, are assigned to protect public health and safety in the dispensing of prescription drugs. Pharmacists comprise the majority of each board, but the panels also include non-pharmacists appointed to represent the public.
Although duties vary from state to state, the boards typically license pharmacies and pharmacists, set training standards, oversee pharmacy inspections and hold disciplinary proceedings for alleged safety violations.
As drugstore chains grew, their pharmacists have won dozens of board seats. USA TODAY documented that network, finding that Walgreens and CVS, the two largest chains, are tied for the most with at least 21 seats each.
States require board members to obey conflict of interest regulations. But USA TODAY's review of board records, meeting minutes and interviews — which followed February stories that showed pharmacies' policies can contribute to prescription errors — found potential conflicts.
In June 2005, Florida's pharmacy board held a disciplinary hearing for Tonya Pearson, a Walgreens pharmacist in Jacksonville. She was accused of failing to catch a dosage-instruction error on a methadone prescription for Terry Paul Smith, a 46-year-old roofer who was prescribed the drug for pain relief.
The error was made by a pharmacy technician who typed the prescription into a Walgreens computer. Smith died of an overdose within 36 hours after getting the prescription.
During the Florida hearing, Gail Merrell, the Walgreens pharmacist who chaired the panel, said her employment would not "affect my ability to render judgment," a hearing tape shows. Albert Garcia, a board member who also worked for Walgreens, made a similar statement.
As the panel deliberated penalties, board member Eric Alvarez, a pharmacist not affiliated with Walgreens, made a motion to impose the $10,000 maximum state fine. "At least this record would show that this board would be sympathetic to the consumers in the state of Florida, which we're sworn to protect," he said.
But the motion failed for lack of a seconding vote. Merrell, saying she disagreed with the maximum penalty, proposed a $500 fine, the hearing tape shows.
"I think that a misfill by a pharmacist is their worst nightmare, and we've had many people before the board who've had misfills. And I really believe that education is the key here — getting the pharmacist to rethink his steps and to re-educate them," Merrell said.
The board compromised, fining Peters $1,000 and requiring her to complete an education course on avoiding errors. Merrell and Garcia voted with the 5-1 majority, with Alvarez dissenting.
"All I could do was kind of get into my car, and cry, and beat the steering wheel and scream out obscenities," said Smith's widow, Pearl, who attended the hearing and recounted her reaction in a subsequent interview. She called the votes of the Walgreens pharmacists, who declined to discuss the case, "a definite conflict."
Florida guidelines, however, say board members only face a conflict by acting on matters involving a "special private gain" for them or for "a principal by whom the member is retained."
Nonetheless, Walgreens spokesman Polzin says the firm's pharmacists should have recused themselves from the Peters hearing "to avoid even the appearance of a conflict of interest."
Walgreens had no contact with the pharmacists about the hearing, he says.
Workload pondered
During the last two years, the Arkansas Board of Pharmacy weighed a regulatory change that would authorize retail pharmacies to fill prescriptions using a so-called off-site entry process. When a pharmacist in one store is busy with many prescriptions, such systems enable a pharmacist in another store to help with the workload via computer.
Walgreens and Wal-Mart requested the changes, pharmacy board records show. Dufour, the board's chairman and at the time, Wal-Mart's director of pharmacy services, recused himself from a 2006 vote that extended a pilot project to test whether off-site entry systems could increase prescription errors.
But board minutes show he joined in the unanimous June 2007 vote that approved a new regulation authorizing an off-site entry system in retail pharmacies.
Charles Campbell, the board's executive director, says Dufour properly abstained from voting on extending the pilot project because it directly involved Wal-Mart. Dufour's votes on the final approval and other steps "were on motions that applied broadly to the retail pharmacy industry and not solely to Wal-Mart," says Campbell, adding, "I see no reason why he should have recused from those votes."
Dufour did not return an e-mail message seeking comment.
In Nevada, pharmacists employed by Walgreens, CVS, Wal-Mart and Albertsons hold four of the six board seats designated for pharmacists. The relative under-representation of independent pharmacists "does create an appearance problem," says Larry Pinson, the board's executive secretary. However, he says it's difficult to get candidates from Nevada's small roster of non-chain drugstores.
The lone Nevada board member designated as the public representative of the state's residents is Mary Lau, CEO of the Retail Association of Nevada. Her organization represents businesses across the state, including chain pharmacies. To avoid conflicts of interest, Lau has repeatedly abstained from votes that directly affect the association's pharmacy members since she joined the board in late 2007. But that procedure has raised new questions.
"In most cases, she recuses (herself from voting), so it's essentially like not having a public board member," Pinson says. "I suppose the question is, if I were a member of the public, would I feel as though I was being represented? If she has to recuse on everything, probably not."
Khanh Pham, president of the Nevada Pharmacist Association, filed a 2008 complaint with the state ethics commission that said Lau "deprives … constituents of a voice" by abstaining.
"If you have a public member just sit there … what kind of service do you provide to the people?" Pham asked in a recent interview.
The ethics commission, however, dismissed the complaint for lack of jurisdiction. A spokesman for Gov. Jim Gibbons, who appointed Lau, did not return a message seeking comment.
Lau says she abstains only when the board considers disciplinary matters involving a specific pharmacy represented by the retail association. Other board members safeguard the public's interest when she can't participate, she says.
"I bring a very strong perspective from the public side, because I know what pharmacy should do when it is working properly," Lau says.
Tradition rules
During the annual convention of the National Association of Boards of Pharmacy last May, hundreds of state board delegates nibbled spring rolls and sipped cocktails during a reception in Baltimore's Marriott Waterfront Hotel.
The $21,286 event — paid for by the National Association of Chain Drug Stores, whose members are regulated by the state boards — posed what one official called a potential ethics issue.
"We've tried to get rid of it … to avoid the conflict," says Carmen Catizone, executive director of the National Association of Boards of Pharmacy. But, he adds, the reception is a "tradition."
Disputing any suggestion of a conflict, Kopple, the industry group spokeswoman, notes that Catizone's group is not a regulatory agency. "We're pleased to support an effort that has all these pharmacists together looking out for the best interests of the nation's patients," she says.
Hussar, the pharmacy professor, says the tradition should end. "When it comes to a relationship between the regulators and the regulated, I really feel there has to be a separation," he says.
