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Indeed, Kaiser is certainly not the only health-care firm to implement pill-splitting. Federal and state agencies around the country are experimenting with the practice, as are other health maintenance organizations. But Ni says the Oakland-based firm is "by far the most aggressive" in implementing the cost-saving strategy.
Susan Pisano, a spokeswoman for the American Association of Health Plans based in Washington, DC, notes that her industry is exploring the program on a very limited basis. "It's not the kind of thing that works for many medications," she says. "There are only some medications for which pill-splitting would be appropriate. It's part of an overall strategy that's designed on behalf of people in managed-care plans to keep the prescription drug benefit safe, comprehensive, and affordable.
Embrace of the practice by one large Nevada HMO, which required doctors and patients to break certain costly tablets in half even though the drugs' manufacturers recommended against it, called pill-splitting to the attention of the American Medical Association.
"If insurance plans or anybody else is mandating pill-splitting, it could be very dangerous," says AMA chairman Dr. Edward Hill. "Medications for lung disease and heart problems have a narrow therapeutic window, and what that means is a small change in the dose could have a profound effect on the patient -- possibly killing someone."
As Hill sees it, doctors should retain the final authority to ensure that tablet-splitting is safe and entirely voluntary for everyone involved. "I don't care who mandates it; a physician's ethical responsibility should override that," he says.
Although the AMA was not directly involved in the suit against Kaiser, when Hill was informed about some of the allegations in the case and Kaiser's defense of its tablet-splitting plan, he said, "Somebody is going to have to bring some facts to the court to prove their point."
But the decision by Alameda County Superior Court Judge Ronald Sabraw to dismiss the lawsuit before it even went to trial suggests that the day of reckoning could be a long way off. Sabraw's final ruling concluded that while the courts are "well-suited to determine whether Kaiser has breached a duty to an individual consumer and caused injury to that consumer," the courtroom is not an appropriate venue to determine "whether an HMO's policies provide adequate care for its consumers."
Scientific inquiries into pill-splitting can be divided into two broad categories: how tablets fare once they are broken apart, and how altering such medications affects patient health. Although no research conclusively points to specific patients who have suffered adverse health effects, some studies conclude that the practice poses increased health risks.
A substantial body of research suggests that pill-splitting is more art than science. In a study of eleven commonly split tablets published in the Journal of the American Pharmaceutical Association, scientists found that eight of the medications routinely failed to yield uniform half-dosages once divided. The dosages were not uniform because of uneven splits or crumbling. Whether the tablet was scored or not made little difference. The person who did the splitting for the research was a 25-year-old pharmacy student who had been specially trained to split tablets with a razor blade. Three tablets split exclusively by hand yielded even worse results than those split with a razor.
In a study on the accuracy of pill-splitting in healthy adults published in the journal Drug Use Insights, researchers found manually broken tablets varied in size by up to 40 percent. Use of a pill-splitter, researchers noted, did not improve the accuracy of splitting. The study's authors hypothesized that such variations "could be clinically relevant" -- or, in other words, make people sick.
Another study, in The Annals of Pharmocotherapy, found that 21 percent of patients surveyed forgot to take their broken-tablet doses more frequently than whole-pill dosages. Still another study, in the American Journal of Hospital Pharmacy, identified several other tablets that, when split, resulted in half-tablets with dosages that varied more than 15 percent from the desired half-dosage.
But research into the actual health effects of these variations is far less clear-cut. Scientists have uncovered health risks when patients split at least one cholesterol-lowering medication, which is on the Kaiser list of accepted medications for tablet-splitting. In the Annals of Pharmocotherapy study, researchers found that patients who split their tablets of simvastatin, which is sold under the brand name Zocor, experienced up to an 18 percent increase in cardiac risk. Yet in the specific patients in this study, researchers conceded that half-tablet therapy appeared to have been as effective as a single dose.
"That study shows there is a serious problem," attorney Ni says. "Kaiser has decided 18 percent risk is acceptable for their membership. I don't think any Kaiser patients are being told of that increased risk."
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