A Stanford University Medical Center researcher says that pill splitting saves money and is likely to be safe and effective with appropriate screening — even though he didn't specifically study the safety of the procedure.

"When properly implemented, pill-splitting can be a safe, viable cost-saving strategy," says Dr. Randall Stafford, a researcher at the Stanford Center for Research in Disease Prevention and lead author of an article published in the August 2002 issue of the American Journal of Managed Care.

However, the doctor also says: "In no sense did we look at the specific outcomes of pill splitting." Additionally, Stafford says that the follow-up of patients on the safety of pill splitting was outside the scope of his study.

The study has drawn much attention due to the fact that a pill-splitting lawsuit against Kaiser Permanente charges that the company endangers some patients' health solely to enhance the HMO's profits by forcing patients prescribed smaller-dose pills to accept and cut in half the larger-dose pills.

Kaiser says the lawsuit is without merit and says that pill splitting is purely voluntary and only encouraged for a handful of drugs — and then only for those patients who would not be adversely affected by an imprecise dose. But the lawsuit contends that some patients are not given a choice: "They are simply provided the double-dose medications and a pill-splitter, often without direction or instruction."

What the study finds

Using pharmacy claims data from a Massachusetts HMO with 19,000 members, Stafford and his colleagues examined how often pill splitting was used. They found the HMO used the practice infrequently and only saved about $6,200 annually.

The researchers then used a screening process to determine which medications were appropriate for pill splitting, excluding those medications that had time-released formulas or were not in tablet form. Starting with the 256 medications most commonly prescribed both nationwide and within the HMO, the researchers eventually narrowed the list to 11 medications that they deemed could be split "safely and effectively with significant cost savings." Those medications include Lipitor, Paxil, Seerzone, Viagra, Zoloft, and Celexa. They projected the annual savings from splitting these pills could be as high as $259,576 annually for the 19,000-member HMO.

HMOs save money by recommending pill splitting because the wholesale costs of some medications are exactly the same (or nearly the same) for a larger-dose tablet as a smaller-dose tablet. For example, 50-milligram tablets of Zoloft, an antidepressant, cost approximately $227 per 100, so it would ordinarily cost an HMO $454 to prescribe 50 milligrams per day with 200 daily doses. But 100-milligram tablets cost about $233 per 100, so the insurer can save $221 in a single prescription by forcing the patient to accept and split the 100-milligram tablets to obtain 50 milligrams per day.

The safety issue

The study has caused such a stir because both consumers and insurers are demanding relief from skyrocketing health care costs, particularly those related to prescription drugs. Kaiser spokesperson Beverly Hayon says she believes the public's frustration over the high cost of prescription drugs is fueling litigation against insurers. "Pill splitting is one of the few ways, where warranted, that insurers — and therefore their members — can save money on prescription medicine," she says.

Patients can directly save money on pill splitting because they are only paying one co-payment for a prescription that lasts, say two-months, rather than paying two co-payments during the same period.

However, mandatory pill splitting has been condemned by the American Medical Association (AMA), the American Society of Consultant Pharmacists, and the American Pharmaceutical Association due to the health risks involved. These include the chance that patients will divide the pills unevenly and wind up taking incorrect doses or, because some suffer from cognitive impairments, they may forget which pills they must split.

Says lead plaintiff Audrey Timmis, an elderly woman who suffers from emphysema: "When I tried to split the pills — which were slightly smaller than an aspirin — I usually ended up launching them across the room like tiddly-winks or crushing them into powder between my fingers."

Plaintiff Dr. Charles Phillips, formerly under contract with Kaiser, says the study is suspect from a safety viewpoint. "The issue is really simple — the split pieces are not equal," he says. "Dosing may range 40 percent between a small and large fragment. This is not modern medicine but rather an experiment in testing the inaction of regulatory agencies. It is bad pharmacy practice."

Stafford says he does not support mandatory pill splitting. However, he noted that the practice, if done correctly, could help those who pay for prescription drugs out-of-pocket, including the uninsured and some Medicare beneficiaries who do not have prescription drug coverage. For them, pill splitting "may make newer, more expensive medications available to people who might not otherwise afford them."

"Physicians should consider using pill splitting with selected medications and patients," says Stafford, a "pharmo-economist" who studies how physicians use medications. "And patients may want to bring it up with their doctors."