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MINIMIZE BISECT RISK
As “pill-cutting” becomes the dispensing norm, improperly
designed or nonfunctional tablet bisects could pose liability issues
By Fred A. Rowley, Solid Dosage Training, Inc.
T
he “bisect” or “score,” that groove or debossed line
that is formed on some drug tablet surfaces, has
been taken for granted for decades [1]. These days,
though, it’s creating quite a stir, one that ripples
from the board rooms of the nation’s largest HMOs right
down to the individual consumer’s medicine chest.
Bisects were originally designed to prevent tablet stress
fractures. Over the years, though, their function has become
more “cosmetic” than functional.
Many patients view them as “guides,” designed to allow
them to cut a more concentrated pill, neatly and evenly,
into two or more dosages of
lower concentration [3].
However, cutting along
nonfunctional tablet
scores will yield
uneven pieces,
compromising
dosage and
potentially
posing
manufacturer
and pharmacist
liability issues
[4-6].
Guidelines exist
for adding a score
to any tablet, but these
deal with the subject from
a purely technical viewpoint.
There are no guidelines for when
to use a bisect, and approaches vary from company to
company, and even country to country.
Some companies put a bisect on their tablets, but don’t
mention what it is used for. Others include a bisect, but
state that the tablet “may be divided for the convenience of
administration” in their inserts and PDR. Still others direct
patients to their pharmacist or doctor for instructions.
GENERICS MANDATE
Further complicating the picture is the fact that generic
drug manufacturers are required to place a bisect on their
tablets “whenever the innovator did so.” Confused? This
article will offer some suggestions for ensuring minimal risk
from improperly designed or nonfunctional tablet bisects.
44
October 2006
PM0610_44_45_DRYERS.indd 44
ENTER COST CONTROL
The prime reason why tablet bisects have become so important today is the fact that HMOs and pharmacies are controlling costs by stocking fewer shelf keeping units (SKUs),
dispensing a single stronger dose and asking their patients
to use pill cutters to adjust the dose [7].
For example, if a pharmacist is out of stock of 5 mg.
lisinopril, he or she might split 10 mg. tablets and dispense
them that way (sometimes for additional cost), or supply a
free pill cutter with the prescription [8].
Because companies sometimes charge different prices for
different strengths, pill cutting can save pharmacists, and
patients, hundreds of dollars a year [9].
Tablet manufacturers, drug distributors and
pharmacists must now ask the following
questions:
• How effective is the bisect in facilitating a
sharp break of the tablet?
• What is the potential liability if the
break is less than perfect and the
resulting dosage is less than what was
prescribed [10]?
The onus is now on the manufacturer
to ensure that bisects will allow safe “pill
cutting,” and to engineer them for success
(Part Two of this article, to be published in
our November/December edition, will deal with
the technical issues involved).
If pill cutting becomes the norm, the requirements
for a functional bisect may change, generating multiple
layers of legal and procedural revisions. Right now, there are
several unanswered questions. For example:
• Will a fully functional bisect become part of the overall
product qualification?
• Will standards for successful cutting of the tablet become an
additional product specification?
• Will both halves of the tablet, with a small variation, need to
contain the same quantity of active ingredient(s)?
• What is the potential impact on low-potency products?
• What is the impact on tablets with multiple active
ingredients?
Immediate answers will likely be needed [12]. But, clearly,
tablet bisects must be engineered for success, particularly if
they’re on a product that was introduced more than 10 years
ago.
Pharmaceutical Manufacturing • www.pharmamanufacturing.com
10/5/06 2:18:37 PM
SK (PART 1)
When reviewing a product, if the tablet features a bisect, verify
that the bisect is fully functional. Distinguish a shallow bisect
from a deep, wide bisect. Define the fully functional bisect as
delivering a drug content equivalent to the full tablet with a small
additional variation for small particles lost. Understand that some
shallow bisects may perform very well due to the nature of the
active ingredient.
For generics, don’t assume that the currently marketed tablet
has a bisect that is fully functional. The drug going off-patent
today may have a cosmetic bisect that was never intended to meet
tomorrow’s standard.
Study the innovator’s bisect and be prepared to engineer a
change. Some products need only a slight but effective bisect
change. And note that this class of product change is usually
considered by the FDA as reportable on an annual basis.
Part Two of this article will discuss pre-emptive thinking and
provide a technical guide to analyzing tablet bisects.
References:
1. Boyles, S: “Cutting Pills in Half Could Pose Problems”, WebMD, May 19,
2004, posted Sept. 26, 2006.webMD.com
2. Tableting Specifications Manual, 7th edition, APhA Tableting Specification
Steering Committee, AphA Publishing, 2005.
3. Dieleman, L: “Is Cutting Your Pills a Safe Way To Save Money?” Consumer
Health Information Corporation Bulletin, consumer-health.com
4. Baker, K: “Pill Splitting–Is it Legal? Is It Covered By Malpractice Insurance?”,
Epothecary, Pharmacy Marketing Group Bulletin, pmgrx.com
5. Parker-Pope, T: “Health Journal: Health Insurers Push Pill Splitting”, Pittsburgh Post Gazette, Nov. 22, 2005. post-gazette.com
6. Merx, K., “Cost Cutting Pill-Splitting Plan Could Be Big Money Saver”,
Detroit Free Press, January 26, 2006. redorbit.com
7. Article: “Freehand Pill Cutting Can Lead to Improper Dosing of Misoprostol.
(Brittle Pills A Problem)”. OB GYN News, Published Oct 15, 2001. Accessmylibrary.com
8. Riklin, S: Letter to the Editor: East Bay Newspapers, on-line edition, Nov. 18,
2004. eastbayri.com
9. Health Issues: “Pill Splitting Can Save Money On Prescription Drugs”, National Center for Policy Analysis, Aug. 1, 2001. NCPA.org.
10. Editorial, Wall Street Journal: “An easy remedy: Cut your drug bills in half
by cutting pills in half.”, July 28, 2001, destinationrx.com
11. Carson, B: “Health industry Divided on Splitting Pills”. July 9, 2005, Herald-Review.com
12. Brody, H: “Split Your Pills and Save money? In Some Cases, Yes”, Feb 19,
2003, Lansing City Pulse, lansingcitypulse.com
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