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Stafford's analysis of pill-splitting for Stanford's Center for Research in Drug Prevention looked at 265 different medications and determined that eleven were good candidates. Many of the other 254 medications were knocked off the list because they were capsules or other forms of medication that could not be split by the average patient. Others were not considered because they treated illnesses in which dose variations could have a serious health impact. Although Stafford's study endorsed the practice, it cautioned that pill-splitting should only be implemented with "careful controls" and only with "selected medications and patients."
"The cost savings from this underused practice are significant and, if implemented judiciously, this strategy presents an opportunity to reduce health-care costs without compromising quality," Stafford says. "Health-care expenditures have increased tremendously in the last decade, particularly in the area of prescription drugs, which have risen 15 percent a year in recent years."
Most medications have yet to be tested for their safety in half-dosages. And the lawyers suing Kaiser argue that its members should not be put in the role of guinea pigs to determine whether the health risks are acceptable.
As if matters weren't already confusing enough, last year a study by the federal Department of Veterans' Affairs reviewed the available research on pill-splitting and concluded that no evidence existed that the practice was harmful to patients. Nonetheless, the agency decided not to recommend it.
As to which patients might safely split pills, professional organizations such as the American Medical Association and the American Society of Consultant Pharmacists strongly oppose pill-splitting for seniors who have any kind of functional impairment that may limit their ability to break a tablet in two. Anyone with arthritis, cognitive or visual problems, Parkinson's disease, or other tremor disorders should not split pills, the pharmaceutical group says. "These limitations may result in patients missing doses of the medication, discontinuing therapy without knowledge of the prescriber, or sometimes receiving excessive doses of the medication," a society policy says.
The society concluded that the practice has many risks, especially for elderly patients in the United States, nearly 50 percent of whom suffer from arthritis. Like the AMA, the society issued a statement "strongly opposing" mandatory pill-splitting. In one paper on the practice, the organization quoted Daniel A. Hussar, a professor of pharmacy at the Philadelphia College of Pharmacy, who concluded that, "Tablet-splitting for economic reasons is bad patient care and bad pharmacy practice."
Phillips and the other plaintiffs in the lawsuit say Kaiser clearly failed to follow the consultant pharmacy organization's guidelines about which patients should not split pills.
In his tentative decision dismissing the lawsuit, Judge Sabraw says the plaintiffs' argument that pill-splitting violates FDA policy is wrong because there is no statute or FDA regulation prohibiting the practice. "Indeed, despite all the state and federal statutes and regulations regarding health services there is no explicit proscription against pill-splitting," the judge wrote. "In the absence of a clear legislative or regulatory mandate, the court is reluctant to infer that pill- splitting is prohibited."
As to whether the pill-splitting scheme violated the state's standard for medical care, the judge wrote that, to prove that a medical practice falls below that threshold, plaintiffs must show there is a "reasonable medical probability" that it causes physical injury. Expert testimony merely suggesting that the policy is "inappropriate and unwise" does not pass legal muster, Sabraw ruled.
And on the assertion that pill-splitting violated state consumer-protection laws, Sabraw wrote, "There is no substantial evidence that Kaiser requires pill-splitting of drugs that are not on its approved list or that any consumer has been injured by having to split pills." Despite the wealth of available testimony from patients such as Yarborough, Cargile, and others, Sabraw ruled that such anecdotal evidence is insufficient for challenging a company's business practices.
Ni says the decision will be appealed. "The evidence demonstrates that the 'written' policy is nothing more than a showpiece that has nothing to do with the reality that Kaiser patients face," she and her colleagues wrote in a memorandum challenging the judge's tentative dismissal.
Phillips, however, says his mission is not tied up with the lawsuit's fate. Whatever happens with the case, he won't back down. "Kaiser promises patients good medications and excellent medicine," he says. "What they give to their members is wrecked medications. I consider stopping pill-splitting is like chasing the money changers out of the temples of healing."
In his final ruling last week, Sabraw reaffirmed that it was not the court's jurisdiction to help fashion an HMO's policy. Oversight of that type is the responsibility of the state Legislature or California's Department of Managed Care, he reasoned. "The courts are not well-suited to determine, in the abstract, whether an HMO's policies provide adequate care for its consumers," he wrote.
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