Transcript Tablet Splitting - Pro Pharma Pharmaceutical Consultants, Inc

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 healthcare 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 pillsplitting is as safe and effective as taking a
whole pill1,2,3
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 healthcare system
The bottom line: to split or not to
split?
When done properly for
appropriate medications,
tablet splitting can be a costeffective tool without having to
compromise patient safety
and quality of care
References
1.
2.
3.
4.
5.
6.
Stafford RS, Radley DC. The potential of pill splitting to
achieve cost savings. Am J Manag Care. 2002,Aug;8(8):70612.
Tablet splitting. Med Lett Drugs Ther. 2004 Nov 8;46(1195):8991.
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.