Slicing certain pills in half could slice a hefty amount off of America's prescription drug costs. While only some types of pills can be split safely, the practice could be used by millions of Americans – including many of those who take popular cholesterol-lowering drugs.
Now, a new University of Michigan study adds more evidence that splitting a high-dose pill and swallowing half of it, rather than taking a whole low-dose pill each time, doesn't change those medicines' impact on cholesterol levels. It is also the first prospective randomized controlled trial of pill-splitting, and the first to look at the impact of out-of-pocket costs on patients' willingness to take the time to split pills.
The study is published in the June issue of the American Journal of Managed Care by a team from the U-M Health System and the U-M College of Pharmacy.
“This study was done in part to see what the impact would be of having some of the cost savings go back to the patient,” says first author Hae Mi Choe, PharmD, CDE, clinical assistant professor in the College and a UMHS clinical pharmacist.
While the study did not find that out-of-pocket costs had an impact on the participants' tendency to split and take their pills in the six-month study, most participants said that reduced co-pays would be needed to entice them to continue splitting pills.
The findings have already had an impact on one large employer's prescription drug plan: U-M used them to justify a pill-splitting program that launched in early 2006. In its first full year, the program saved the University $195,000, and saved more than 500 employees and retirees a total of more than $25,000 in drug co-pay costs.
Pill-splitting relies on the fact that many medicines are manufactured in tablet formulations that contain different doses of the active ingredient. Some of the higher-dose tablets can be cut in half with a blade to produce two lower-dose tablets – for example, 80 milligram tablets can be cut to produce two 40-mg tablets.
Because drug manufacturers and wholesalers don't usually charge twice the price for twice the dose, the cost of half of a high-dose pill is far lower than the cost of buying a whole pill containing the same dose of medicine. So, pill-splitting can save money for the insurance plan or pharmacy-benefit manager that buys the pills for a group of insured patients -- and for the employer or government agency that pays for the plan.
But few prescription plans currently structure their benefits to encourage pill-splitting, by charging lower co-pays to patients who buy high-dose pills they intend to split.
Patients have been splitting pills on their own for years. Some do it without their doctors' knowledge, to try to save money. But others do it with help from physicians who write prescriptions for a higher dose and instruct patients on how to make one month's supply last two months. However, this can result in potentially dangerous confusion, and skew the patient's and doctor's records.
In recent years, pharmacists have worked to determine which tablets can be safely split, and which — such as drugs that exit the body quickly, or that have time-release coatings — cannot.
Cholesterol-lowering drugs called statins are among the most widely-used classes of medicines, with tens of millions of Americans taking the drugs. They're also good candidates for splitting because they linger in the body for a relatively long time, and because small day-to-day dose fluctuations that can happen when pills are split don't make a major difference in cholesterol levels.
The U-M study involved patients who were taking atorvastatin, pravastatin, or simvastatin, which are sold commercially as Lipitor, Pravachol, and Zocor or genetic simvastatin, respectively. The patients were all being treated by physicians at a single UMHS health center. They were also better educated and more likely to be white and female than the general U.S. adult population.
Two hundred eligible patients completed the initial survey regarding their perception on pill splitting, Of them, 111 patients agreed to participate in a 6-month trial of pill splitting in which half were randomized to receive a financial incentive of 50 percent reduction in their co-payment per refill and half did not.
All study participants were given two different pill-splitters to compare and to use for six months. They allowed the researchers to review their prescription information and cholesterol levels for a pre-study period as well as during the study. On average, the co-pay reduction was about $5 to $7 per month.
A total of 103 patients completed the entire six-month randomized study, and 109 completed the survey at the end. The patients who were randomly assigned to receive co-pay reductions were no more likely than the other patients to refill their prescriptions on time or to experience an increase in cholesterol levels.
The follow-up survey showed that 89 percent of all participants would be willing to continue splitting pills if they would receive a co-pay reduction, and 80 percent said that splitting pills had been “no big deal” for them. Most said it would take a 50-percent co-pay reduction to entice them to keep splitting, but 24 percent said they would only keep splitting if the out-of-pocket cost was zero. Few of the patients reported problem with splitting pills, or missing doses because they had to split.
Although the study didn't show that reducing out-of-pocket costs affected patients' adherence to their statins over the six-month study period, the survey at the end of the study showed a clear desire among most participants to save money in return for long-term pill splitting.
That's why the U-M benefits office, which sponsored the study, decided to include a co-pay reduction in the pill-splitting program that it launched for all 80,000 U-M employees, retirees, dependents and survivors in January 2006. So far, more than 500 people who take statins have signed up; further medications are being considered for inclusion in the program.
U-M's use of a single prescription drug plan that provides prescription coverage regardless of which health plan an individual chooses, makes it easier to try programs such as pill splitting. The same is true for large systems such as the federal Department of Veterans Affairs, which requires that nearly all veterans taking statins split their pills — but does not charge co-pays for any medicines.
Still, Choe says, other employers and agencies can re-design their prescription plans to encourage and reward pill-splitting, by restructuring the co-pay for each month's supply of higher-dose pills. “We should always try to find ways to make medications more affordable for patients,” she says.
In addition to Choe, the study's authors are senior author John Piette, Ph.D., an associate professor of internal medicine at the U-M Medical School and member of the Center for Practice Management and Outcomes Research at the VA Ann Arbor Healthcare Center; James Stevenson, PharmD, FASHP, director of the UMHS Pharmacy Services Department and an associate dean at the U-M College of Pharmacy; Daniel Streetman, PharmD, former Researcher at the College of Pharmacy and UMHS clinical pharmacist; and U-M internal medicine faculty Michele Heisler, M.D. and Connie Standiford, M.D.