PILL SPLITTING: A HALF-BAKED IDEA?

COVER STORY PILL SPLITTING: A HALF-BAKED IDEA? Chances are, an elderly "Mrs. Jones" has brought you a prescription for 25 mg of a drug whose lowest available strength is 50 mg, so the tablets must be cut in half. Picturing your patient straining her eyes to get a tiny tablet into position in a pill splitter, or fumbling around with a razor blade, you've generously offered to halve the tablets for her. But what happens if you're gone one day when Mrs. Jones comes in for a refill, and your replacement doesn't know you've been splitting the tabs? What if that pharmacist unwittingly fills her Rx with whole tablets, and she can't see well enough to notice the difference? Or, what if Mrs. Jones forgets that you've already cut her tablets, and she cuts them in half again before taking them? It could happen. These are questions R.Ph.s have grappled with for decades. However, attention has mounted in recent years since third parties have realized that some drugs are priced the same, regardless of strength. Some insurers have advised their participants to purchase twice their usual dose and then cut the tablets in half, thereby cutting costs in half as well. A few plans have actually mandated this practice for certain prescriptions. We have to do what? When third parties start mandating things, R.Ph.s get fired up. "The pharmacist doesn't have the time to spend busting up these tabletsunless the patient's willing to pay an extra $20 or $30," said Ernest E. Boyd, R.Ph., C.A.E., executive director of the Ohio Pharmacists Association (OPA). In his state, many R.Ph. positions remain unfilled. So the last thing R.Ph.s want to do is spend time chopping pills in half. "My recommendation is don't do it. Just say No," he said. Boyd is not alone. In response to a question Drug Topics posed on its Web site, "Should pharmacists split dosage forms?" one pharmacist replied, "Nothing like having college-educated people splitting pills for a living. Just another great free service pharmacists can provide." The American Pharmaceutical Association has also spoken out against mandated tablet splitting. Susan C. Winckler, R.Ph., J.D., is APhA's group director of policy and advocacy. "Tablet splitting, as a mandatory issue, is a bad idea," she said. APhA's official position is that the decision about whether to split tablets should not be made by third parties. Mary W. L. Lee, Pharm.D., BCPS, FCCP, dean and professor at the Chicago College of Pharmacy, Midwestern University, agreed. She feels third parties should not require the splitting of tablets unless they allow for some sort of appeal mechanism. To be fair, most insurers with a pill-splitting policy do not make it mandatory. But navigating the policy is not always easy. Sheri Stensland, Pharm.D., a faculty coordinator between Midwestern University and Walgreens, said insurers often reject claims unless they are for the double-strength forms of drugs. "Unless we can get a special override, it's rejected." Then she and her co-workers have to check with patients to see if they are able and willing to split the pills. Next, they have to contact the prescribers to get the Rx changed. "It's a waste of time because we have to make all these extra phone calls." Melinda Joyce, Pharm.D., pharmacy director for The Medical Center and co-owner of an independent pharmacy in Bowling Green, Ky., noted another problem with pill splitting. Insurers may allow patients to opt out of the procedure, but they have to pay for it. "There may be a significant difference in co-pay," she warned. Sounding boards Consumer complaints to the Nevada State Board of Pharmacy prompted the board to look into mandated pill splitting. The board held public hearings with industry representatives, said Louis Ling, general counsel for the board. At the hearings, some elderly patients demonstrated their difficulties using pill splitters. The board did not create a regulation opposing pill splitting, because it does not regulate the insurance industry. The board could have stopped R.Ph.s only from splitting doses, and that would have put R.Ph.s in a bind, said Ling. The board then worked with a legislator to sponsor a bill outlawing mandated pill splitting. Although the bill had lots of consumer appeal, it did not have enough support to be passed by the legislature. In Ohio, last May, the state medical association sponsored a resolution opposing policies that mandate tablet splitting. OPA supported the resolution, and it has been referred to the American Medical Association. Boyd explained that getting national approval of the resolution would probably not spark national legislation, but it would give OPA more clout when approaching the state legislature. The issue has also been looked at in other states. In Alabama, the state board questioned the safety of pill splitting and reminded R.Ph.s that the practice must be approved by prescribers. In Kentucky, a question from a patient prompted the state board to look into the issue. The patient asked whether it was appropriate for insurance to dictate the splitting of tablets. "Pharmacy law doesn't specifically address that," said Joyce, who just happens to be a board member. "Our recommendation to the consumer was to try to avoid it if at all possible." The Kentucky board also discussed whether filling prescriptions with split tablets then resulted in adulteration of the product and misbranding of the Rx. So far, they've come to no conclusions on those subjects. In May, the National Association of Boards of Pharmacy approved a resolution opposing mandated tablet splitting. The resolution was adopted in response to numerous complaints from doctors, patients, and pharmacists. "Patients were complaining that they were not comfortable splitting the tablets and that the splitting often resulted in fragmented, crushed, or uneven dosages," said Carmen Catizone, M.S., R.Ph., executive director for NABP. The pharmacists were as concerned as the physicians. "Prescribers were upset because the changes were not being communicated to them, and their patients were discontinuing their medication [out of] frustration with the pill splitting or receiving inaccurate dosages," he said. As for the AMA, its most recent position on the subject is to oppose mandated pill splitting. Specifically, the group objects to the practice when done solely for cost-reducing reasons and without the input of physicians and manufacturers. The AMA has also suggested that manufacturers make tablets easier to split. The managed care perspective According to Perry Cohen, Pharm.D., who provides consulting services to managed care organizations through his company, The Pharmacy Group, LLC, third parties recognize that pill splitting is not the most desirable way to cut costs. "Nobody, not even managed care, wants splitting pills as the first option," he said. He added that the practice is rarely a formal policy and is more often than not a decision left to patients and their pharmacists. The Academy of Managed Care Pharmacy has written a professional practice advisory about tablet splitting. AMCP is wary of the potential dangers of pill splitting but also recognizes that at times it may be warranted to cut costs. The advisory includes guidelines for health plans for determining which tablets are appropriate for splitting. It also provides instructions for R.Ph.s when counseling patients who will be splitting their doses. The long and short of it Some tablets are scored for easier splitting, and some are actually designed to be broken in order to individualize doses. An example is Buspar Dividose, Bristol-Myers Squibb. However, many other drugs are not. And, even the fact that a tablet is scored is not an indication that it is meant to be split on a regular basis. "I don't think that's always a correct assumption," said Mike Magee, M.D., senior medical adviser, Pfizer Inc. "We don't think that the casual disruption [of a tablet] is a good idea. We make multiple doses, and we try to price them so a person would not have a significant reason not to take the correct dose," he said. Pills are designed to meet specific criteria for swallowing, absorption, and distribution. Furthermore, they are tested and approved by the Food & Drug Administration based on this technology. "Decisions that affect the medical care of a patient should be left to the doctor and the patient," he stressed. If it is decided that a medication should be split, many other issues then come into the picture. For starters, many R.Ph.s and patients have had difficulty cutting large, oblong, unscored, or odd-shaped tablets. "These tablet-splitting devices sometimes do not split the tablet into two equally sized pieces," said Lee. As a result, some patients have been hurt by failing to receive their drugs' full therapeutic effects. In March of 2000, APhA's Winckler appeared on "Good Morning America" to discuss splitting tablets. As an illustration of the difficulty with oddly shaped products, she used a pill cutter to halve an oblong tablet, in this case Paxil (paroxetine, GlaxoSmithKline). The result was not two halves of a pill but a crumbled mess. Winckler said she later received calls from R.Ph.s complaining she had staged the whole thing. Not so, she asserted. If a pharmacist with good vision, dexterity, and training can't successfully cut a pill in two, how then is an elderly patient with poor vision, arthritis, or tremors supposed to do it? That's exactly the point, according to Winckler and many other R.Ph.s who have spoken out about the issue. Pharmacists must assess the patient's ability to cut tablets and then decide whether to cut the pills for the patient accordingly, Stensland said. Patients must have good visual acuity, manual dexterity, mental capacity, and so on. They also need a cutting tool or device, and they must be willing to use it. Or, they need to have a caregiver who can cut the tablets for them. If the R.Ph.s do split the pills, there are also time and equipment constraints. At Walgreens, the staff puts a note in the computer Rx record, but it doesn't print it on the label. Unless the filling technician is alert enough to catch it, refills may not be cut as the original was. The company is looking into correcting that, said Stensland. For now, though, the staff just has to remember to split the pills. She also counsels patients to remind pharmacists when refilling their prescriptions. Pills should be split only if there's no other option. In such cases, Joyce suggested, "See if you can compound the prescription into a liquid or capsules." That way, the labeling will be more accurate. Lee pointed out that certain drugs should not be split, such as sustained- or controlled-release formulations and drugs with a narrow therapeutic range. "If you exceed the range in the least little way, it can be toxic," she said. Putting it to the test Two recent studies have been conducted to assess the practice of pill splitting. James E. Polli, Ph.D., University of Maryland School of Pharmacy, headed up one of these studies. He trained a student to cut tablets with a razor blade. The student also did some hand splitting of a few tablets that were easily broken. Polli used tablets that, through anecdotal evidence, he thought were most commonly split. The tablet halves were then assessed using the U.S. Pharmacopeia's content-uniformity test. This test is designed for whole tablets; there is currently no standardized method for analyzing halved tablets. "Given our expectations, things didn't go well," said Polli. His team found that while three tablets passed the test, most failed"for every reason that tablets could fail." The investigators were unable to relate failure to attributes of the tablets (i.e., size, shape, scoring, etc.). Polli likened the practice of pill splitting to driving a car without a seatbelt. It's probably fine most of the time because most drugs have high therapeutic indexes, and daily dosing variations are probably drowned out in the long run. However, he could not recommend splitting as a general practice because it's not worth the risk in those few instances where it is unsafe. "Given the current standard [of what patients and professionals expect from tablet performance], it would be awfully difficult to argue it as a policy," he said. Another study was done by Jack M. Rosenberg, Pharm.D., Ph.D., professor of pharmacology and pharmacy practice, and his colleagues at Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University. This team determined the weight variation of halved tablets from the theoretical weight of perfectly halved tablets. They analyzed 22 prescriptions of half-tablets dispensed to long-term care facilities. The team found that the majority of prescriptions (17) contained at least some halves that deviated by more than 15% from either the theoretical weight or the mean halved weight. They concluded that cutting tablets resulted in large and unacceptable variations in tablet weights, and they called for standards for pill splitting to be developed. The results of both studies will be published in the Journal of the American Pharmaceutical Association. A better tool? When John Creel saw Winckler's demonstration of pill splitting on TV, he cringed. That's understandable, considering he is the president of Apothecary Products, a leading manufacturer of pill-splitting devices. Creel feared that viewers would see the crumbly result and assume that all pill-cutters are faulty. He claims the tablet crumbled because the device used was not up to par. "You could take any of our tablet cutters and they would cut accurately," he declared. Though pill cutters may look alike, they differ in quality, Creel said. Apothecary products use very hard, steel blades, and "the blade goes all the way into the base." Other products with shorter blades may cut only three-quarters of the way into the tablets, leaving larger fragments and crumbs, which Creel's company refers to as "break-off." He is not aware of any studies of pill-cutter performance, but the company has done its own. "Our own studies show that, for our products, the break-off is never more than a few percent." Creel's advice to consumers is to cut with the score for the cleanest results. He also noted that the most basic model is not designed for oblong tablets. His company sells several different models of cutters, all in the Ezy Dose line, including some that also magnify, crush, or store tablets. The more deluxe models are constructed to cut large and oblong pills. All are priced at less than $5. Consider the patient Let's face it, some patients simply cannot afford their medications, and splitting pills helps them cut costs. Joseph Rogers, M.D., a cardiologist in Detroit, has teamed up with his son, Tobias, to create a Web site aimed at cutting drug costs for patients. The site, Rxaminer.com, allows people to submit the list of their medications and, for a nominal fee, receive a list of alternative medications. The alternatives are a combination of generics, "me-too" drugs, and split pills. "Splitting pills is an easy first step," said Rogers. By combining these strategies, he said, some patients could shave 80% off their drug bill. He added that daily fluctuations in drug levels commonly occur with variations in dosing times, different foods, and varying fluid levels. He estimated the alterations in drug levels due to inexact pill splitting are probably no more than these fluctuations. "If it's 48/52," Rogers said, referring to the proportions of the two halves of a tablet, "I don't think it's a big deal." He added that most of his patients have no problem splitting tablets, or they have a support network that can help. He is working with a company to devise pill splitters for specific products that are odd-shaped. A consensus While everyone who spoke with Drug Topics on this subject had varying viewpoints and concerns, all of them agreed on this point: The decision of whether to split tablets is one that should be made by patients with their medical team. For some patients and some medications, the risks of ill effects are low and the cost savings can be substantial. "When the decision is made with the physician, pharmacist, and patient, then it can be a good idea," concluded Winckler. Jillene Magill-Lewis, R.Ph. Based in Washington State, the author writes frequently on health-related subjects. SOME DRUGS THAT ARE OFTEN SPLIT* Accolate (zafirlukast, AstraZeneca) Accupril (quinapril, Pfizer) Cardura (doxazosin, Pfizer) Celexa (citalopram, Forest) Detrol (tolterodine, Pharmacia) Effexor (venlafaxine, Wyeth-Ayerst) Lipitor (atorvastatin, Pfizer), except 10 mg Lotensin (benazepril, Novartis) Luvox (fluvoxamine, Solvay) Mavik (trandolapril, Knoll) Norvasc (amlodipine, Pfizer) 2.5 and 5 mg Paxil (paroxetine, GlaxoSmithKline) Remeron (mirtazapine, Organon) 15 and 30 mg Risperdal (risperidone, Janssen) 0.25, 0.5, and 1 mg Serzone (nefazodone, Bristol-Myers Squibb) Univasc (moexipril, Schwarz) Viagra (sildenafil, Pfizer) Vioxx (rofecoxib, Merck) 12.5 and 25 mg Zaroxolyn (metolazone, Medeva) Zoloft (sertraline, Pfizer) Zyrtec (cetirizine, Pfizer) *With prices that are the same or very close, regardless of strength, these products are targets for pill splitting. This list is not all-inclusive (e.g., it does not include antibiotics, combination products, antidiabetic agents, specially packaged products, etc.). Source: 2001 Red Book HOW PILL SPLITTING CAN CUT COSTS R.Ph.s UNEASY ABOUT PILL SPLITTING Jillene Lewis. PILL SPLITTING: A HALF-BAKED IDEA?. Drug Topics 2001;21:30.