A U.S. Senator wants random testing of compounded drugs but state pharmacy boards think such oversight is not workable.
Everybody agrees that the actions of the Kansas City pharmacist who admitted diluting chemotherapy drugs were reprehensible, but having regulators randomly test batches of compounded drugs to halt such criminal activity is not feasible, according to pharmacy board executives.
Random testing of compounded drugs has been proposed by U.S. Sen. Kit Bond in a letter to the Secretary of the Department of Health & Human Services. Against the backdrop of the Kansas City dilution case, the Missouri Republican said he doesn't want to federalize oversight of pharmacies and pharmacists, but he questions the adequacy of current inspection systems.
Perhaps even more problematic for pharmacy boards and pharmacists is a recent directive to the Food & Drug Administration from HHS Secretary Tommy Thompson. In a letter to Senator Bond, Thompson indicated he had asked the FDA to determine if lessons can be learned from the Kansas City case and to identify any changes to FDA's relationship with the state boards in overseeing pharmacies and pharmacists.
Thompson concluded, "If we find the need for new laws to protect public health in this area, I will not hesitate to request such legislation from Congress."
An HHS spokesman declined to expand on Thompson's remarks. And an FDA spokeswoman, who also declined to comment, added that the agency would respond only when it had results to report.
If Thompson is leaning toward the FDA's assuming responsibility for inspecting pharmacies, "we oppose that," said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. Pointing out that compounded scripts account for only about 1% of the 3.5 billion Rxs dispensed annually, he added that "the only way [for testing] to be effective is to have 24-hour surveillance. Nobody has those types of resources, and I don't think it's necessary because of this one admittedly tragic incident."
Thompson's directive is a cause for concern, said Michael Moné, Kentucky pharmacy board executive director. "It indicates the po-tential for federal encroachment into what is traditionally a Tenth Amendment states' rights area," he said. If the secretary is suggesting federal regulation of pharmacies and pharmacists, Moné commented, "I don't particularly like the sound of that."
Many pharmacy board executives agreed that Bond is overreacting to the dilution case. And they agreed that a compounding pharmacist bent on criminal mischief could get around a random inspection system.
Howard Anderson, executive director of the North Dakota pharmacy board, said, "Random testing sometimes uncovers system flaws but seldom catches crooks. When we catch a crook, he was usually going to the pharmacy at odd hours and doing his dirty work when no other employees were around. I do not believe more inspection or testing would have uncovered this case. Every drug would have to be tested just before it was administered. Also, someone would have to stay there to be sure no one tampered with it after testing."
Random testing is not fiscally doable for pharmacy boards with budgets that are already stretched too thin to pay for the added expense of testing, several board executives agreed. As Kendall Lynch, chief of the Tennessee pharmacy board, said, "We can hire the people if [Senator Bond] and Congress provide the funding."
Not only would testing be "very costly and very time consuming," but it would also give rise to questions about whether private lab results would be acceptable legally, said Arizona pharmacy board executive director Llyn Lloyd. "Lawyers may contest the outcomes of noncompliant random tests, and litigation could go on for months," he added.
How to translate random testing from policy to action has Kentucky's Moné puzzled. He just doesn't see how it can be done as a practical matter. How often would the board test? Would pharmacies have to set aside samples of each lot for inspectors? Would the board require end-product testing before the Rx could be dispensed? Would samples have to be collected from each compounding R.Ph.?
"I could build a system like that, but then it would be, 'I'm sorry, Mrs. Jones, you have to wait three weeks until we get the results back,'" Moné said. "The only thing you end up with is trust. When you find that people are violating the public trust, you discipline them."
If Senator Bond is truly concerned about public safety, he should look into another issue that poses even more risk, said Don Williams, Washington pharmacy board executive director. "The emerging problem of counterfeit prescription drugs has a much greater potential to harm people," he said. "Both FDA and the boards of pharmacy are going to need help with this one."
Carol Ukens. Pharmacy boards oppose testing of compounded meds.