COMMUNITY PRACTICE

Legal shield vital for pharmacy regulation

If state pharmacy boards are going to shift from punishing pharmacist wrongdoers to regulating for outcomes, the information they gather must be shielded from prying lawyers. That was the opinion of a panel of pharmacy leaders at the recent annual meeting of the National Association of Boards of Pharmacy.

Statutes and regulations must be enacted to put information about pharmacists and medication errors beyond the long arm of attorneys bent on legal discovery, panelists told attendees at the NABP meeting in Seattle. Because of the shift among boards to regulating for outcomes through continuous quality improvement (CQI), such information could include reports on pharmacists generated during peer-review sessions or discussions about medication errors and why they happened.

"It's very important that the data be protected in order to prevent further errors," said Susan Winckler, group director of policy and advocacy, American Pharmaceutical Association.

State boards are going to have to take responsibility to effectively regulate pharmacy as a profession if they expect to win legal immunity, said John Fisk, a Schaumburg, Ill., attorney specializing in medical law.

"The information [boards] gather should be privileged because in order to foster appropriate peer review by the boards or by pharmacists themselves, you must protect it," said Fisk. "I recognize that, but that does not mean I won't attempt to subvert that privilege at every opportunity. Whether I get it is another question."

As if to underscore the importance of putting those data under a blanket of legal immunity, the United States Pharmacopeia announced that Oklahoma is the first state to give legal protection to its national drug error reporting systems. Speaking at the annual USP breakfast at the NABP meeting, attorney Gail Bormel, R.Ph., said that med error reports are now shielded from Oklahoma attorneys.

Focusing on problems created by the system, not the individual, is key to making regulating for outcomes work, said Philip Burgess, Walgreen Corp.'s national director of pharmacy affairs. He believes pharmacists have to feel certain that whatever they reveal about problems in their pharmacies or about med errors is privileged information and off-limits to lawyers.

"Creating a blameless environment is key to making that happen," Burgess said. "How do we create a blameless environment and at the same time have the state boards protect the public health and welfare?"

Part of that balancing act must be the willingness of the profession to get rid of pharmacists who endanger patients, Fisk said. "It's interesting to hear the boards talk about taking responsibility for bad apples and culling them out because that would go a long way toward reducing the type of litigation I do," he added.

Weeding out bad actors isn't easy in the middle of a pharmacist shortage, Burgess noted. He said Walgreens occasionally has to terminate a pharmacist who is error-prone. "When we terminate a pharmacist at 8:00 a.m., he or she has five job offers by noon," he said. "That certainly is something that concerns everyone."

Shifting the culture away from blaming individuals can improve the health-care system and eliminate bad pharmacists, said Henri Manasse Jr., ASHP executive v.p. and CEO.

"Do we want the system of sweeping things under the rug to continue or do we want to change it?" he asked. "We're beginning to look at new mechanisms to ensure full accountability, to ensure the public trust, and to ensure that there aren't bad apples in the profession."

Regulating for outcomes based on CQI will actually help pharmacy boards find and get rid of unsafe pharmacists, according to APhA's Winckler. "As we learn more about where the system's problems are, it helps us identify those people that we really can't have practicing pharmacy anymore," she said. "It's important for pharmacists to remember that a blameless environment does not mean an unregulated environment."

Carol Ukens

Carol Ukens. Legal shield vital for pharmacy regulation.

Drug Topics

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