To split or not to split?

Sandy H. Yoo March 31, 2006

Why Pill Splitting?

Steadily rising cost of medications Overwhelming cost-burden on the health care system Tablets of the same medication often cost roughly the same regardless of strength Potential for huge savings up to 50% Several studies have shown that pill splitting is as safe and effective as taking a whole pill 1,2,3

What is tablet splitting?

“The practice of cutting tablets in half. The reason is usually financial. To reduce costs, a physician may prescribe pills that have twice the dose a patient needs and then ask the patient to split the pills in half.” http://www.medterms.com/script/main/hp.asp

accessed 3/28/06, search term: tablet splitting

PROS

Save Money (potentially up to 50%) Provide dosages unavailable from manufacturers (i.e. for pediatrics, elderly patients) Flexible dosing schedules (i.e. intermediate dosing, titration)

CONS

Tablet Structure – Certain formulations of tablets should not be split Enteric Coated, moisture-protective coatings, time-release & extended release – Certain shapes, size, thickness, whether tablet is scored or not scored, may make a tablet difficult to split Potential for high variability Special Populations: elderly & disabled patients (i.e. dexterity, cognitive or visual impairment) 1 General patient confusion (i.e. split pills twice, forget to split pills, etc.) Legal Issues

Commonly split tablets

Viagra ® 100mg Clonazepam 1mg

Regulations & FDA Policy

Currently, the federal government and most states have no formal regulations on pill splitting FDA has no formal policy on tablet splitting FDA’s director of pharmacy affairs has commented that the decision to split is up to the discretion of the prescribing physician

“Legal-ese”

Legal issues for physicians, pharmacists, manufacturers FDA’s FD&C Act states manufacturers may only promote drugs for purposes for which the drug was approved for by the FDA. However, the FD&C Act does not limit how a physician may use the drug. Physicians may prescribe drugs for any uses that they believe are appropriate. Tablet splitting falls under the definition of compounding. Under FDA Modernization Act, pharmacists are allowed to compound drugs, under specific conditions.

AMCP Policy

Recognizes that tablet splitting is an accepted practice of the health-care community General criteria for tablets that are acceptable for splitting and those that are not Patient safety is always first Pharmacists play a major role

Advantages of Tablet Splitting

Clinical Advantage: 1. Kids and elderly can get lower doses that are unavailable 2. Patients can receive same efficacy of meds at lower doses and lower side effects 3. Intermediate doses and titration allows for flexible dosing schedule opportunities Economical Advantage: 1. Savings to patients (up to 50%) 2. Savings to payers and hospitals/institutions 3. Help alleviate the cost-burden on the health care system

The bottom line: to split or not to split?

When done properly for appropriate medications, tablet splitting can be a cost effective tool without having to compromise patient safety and quality of care

2.

3.

1.

4.

5.

6.

References

Stafford RS, Radley DC. The potential of pill splitting to achieve cost savings. Am J Manag Care. 2002,Aug;8(8):706 12.

Tablet splitting.

Med Lett Drugs Ther

. 2004 Nov 8;46(1195):89 91. Vivian JC. Splitting hairs and pills.

US Pharm

. 2005;3:68-78. Available at: http://www.uspharmacist.com/index.asp?show=article&page=8 _1454.htm#T AMCP’s professional practice advisory on tablet splitting. Accessed March 28, 2006 from www.amcp.org

under Professional Resources, then Rx Sites and Sources.

Meadows M. Saving money on prescription drugs,

FDA Consumer

, September-October 2005 Vol. 39 No. 5. http://www.fda.gov/fdac/features/2005/505_save.html

ASCP Comments to Ohio Medicaid in Response to tablet splitting initiative. Aug 2004. Available at www.ascp.com/public/ga/2004/docs/OHTabSpl.pdf

.