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November Legislative Update

Pill Splitting

Kelly Vyzral, Director of Government Affairs

In a letter dated September 2, 2004, the Ohio Medicaid Program outlined plans to begin requiring tablet splitting for certain drugs beginning October 1, 2004. Tablet splitting is the practice of requiring prescribers to issue prescriptions for double- strength tablets, and to require the patient to split the tablets in half to achieve the required dosage. According to the Director of the Ohio Department of Job and Family Services (ODJFS), Tom Hayes, this initiative could save the program as much as $10 million annually. Although the letter was dated September 2, it was not sent out to prescribers and pharmacies until September 30. Because of this, the Director pushed back the date to begin requiring pill splitting to November 1, 2004.

The Ohio Pharmacists Association sent the following letter to the Director of ODJFS in response to tablet splitting directive:

Dear Director Hayes,
I am writing on behalf of the over 3000 pharmacists, residents, and student members of the Ohio Pharmacists Association. We recently became aware of an initiative by the Ohio Medicaid Program to require tablet splitting for certain drugs paid for by the Ohio Medicaid Program beginning October 1, 2004. While this practice may sometimes be necessary if a medication isn't available in the correct dosage needed by the patient, it is never the preferred method, and certainly not when the correct dosages are commercially available. While the Ohio Pharmacists Association understands the Director's need to save money, the welfare of the patient must always remain our prime concern.

It is my understanding that Lexapro 10mg., peroxetine 20mg., paxil 20mg., and Zoloft 50mg. tablets will no longer be available without prior authorization. Prescribers will now be forced to write prescriptions for higher strength tablets which the patient will have to split in order to obtain the recommended dosage. My concerns with the practice of pill splitting are numerous including the fact that not all of the medications mentioned above are scored or easily split. The tablets can be difficult to split, and without scoring, the patient risks breaking a tablet unevenly leading to over or under-dosing. This lack of uniformity in dosage can be life-threatening with some medications. In a study released by the Journal of the American Pharmacists Association (JAPhA) concerning pill splitting, only 31.8% of the tablets split, met United State Pharmacopoeia (USP) standards of weight variation and intact dosage unit.

Some of the other risks factors of pill-splitting include:

* Patients taking medications, whose toxic dose is close to its therapeutic dose, are especially vulnerable to even miniscule variations in amount of drug they receive.

* Some drugs have special dosage forms, such as tablets with coatings designed to protect the stomach, which if split could severely harm the patient.

* Other tablets are especially formulated for timed- or extended-release, and if split, the release mechanism could become ineffective.

* Certain prescription drugs, such as some estrogens, are taken in extremely low dosages and, thus, even minor variations in the amount of a tablet could result in differences in therapeutic value.

This policy is not only potentially harmful to the patient, but it could end up costing ODJFS money in the long run. What happens when a patient crumbles a pill he is trying to split? He is forced to throw that dose away and start over again on another pill. In a hospital or long-term care facility, will the staff be responsible for splitting the medication for all Medicaid patients in that facility? That could be a very time consuming process. After the medication is split and the patient takes half of the pill, what happens to the other half? In a hospital or long-term care facility, this medication cannot be saved and given to the patient the next time; it must be thrown away. With this policy, you are losing half the medication with each dose.

While I understand the difficult position you find yourself in during this time of large budget deficits, I would ask you to reconsider the department's policy to require pill splitting for certain drugs paid for by Medicaid. While saving some money may be the goal of this policy decision, I believe that in the long run, the department will not only lose money, but could be compromising the health of its most vulnerable citizens.

Sincerely,

Ernest Boyd
Executive Director

If you have any questions or comments, please contact Kelly Vyzral, Director of Government Affairs at 614.798.0037 or kvyzral@ohiopharmacists.org.


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