Transcript Arguments Against Tablet

Evaluation of Tablet
Splitting & Cost Effective
Quality Care
By: Hala M. Al-Khalidi, Pharm.D.
Clinical pharmacy Inservice
KAUH
Introduction
Alert health care professionals about
dosage forms that should not be crushed or
split which may result in alteration in its
therapeutic effect.
An overall assessment of tablet-splitting.
Arguments against splitting tablets.
Accuracy with narrow therapeutic index, &
smaller tablets.
Consult with the your Clinical
Pharmacist on Drug
Formulations Q/A’s…..
Introduction
Limitations that may lead to poor patient
compliance.
Older adults with cognitive impairment,
may forget to cut the tablet in half, and
result in toxicity from higher doses.
Studies for stability of medications are
generally dun with intact tablets.
Types of cutters & medication boxes.
Dosage forms that should not be
crushed or split
Crushing or splitting a solid medication is critical
which may lead to loss of efficacy or
pharmacokinetics of the formulation, e.g.
sublingual or buccal, enteric-coated, and
extended-release tablets or capsules.
Abbreviations are affixed to brand names and
tablets, clue that crushing/splliting may effect
formulation.
Some medications can be irritating to oral
mucosa and/or UGIT, bitter, stain oral mucosa &
teeth.
Dosage forms that should not be
crushed or split
Enteric-coated
– Formulated to pass through the stomach intact
with drug being released absorbed in the
intestine to:
a. prevent drug dissolution by stomach acids.
b. prevent stomach irritation.
C.delay onset of action.
Dosage forms that should not be
crushed or split
Extended-release
- formulated to release drugs over an extended
period which may include:
A. multiple-layered tablets which releases the
drug one layer at a time.
B. mixed released pellets that dissolve at different
time intervals.
C. special matrix formulations that are them
selves inert, but slowly release drug from the
matrix.
Dosage Forms that should not be
Crushed or Split
Sublingual
- formulated to dissolve quickly in oral mucosa
giving rapid absorption, by abundant blood
supply of the mouth.
Miscellaneous
- oral mucosa irritation.
- bitter taste
- dyes staining teeth and oral mucosa
- handling carcinogenic drugs.
Common Abbreviations for
Extended-Release products
Abbreviation
CR
CRT
LA
SR
TR
TD
SA
XL
XR
Interpetation
Controlled release
Controlled released tablet
Long acting
Sustained release
Time released
Time delay
Sustained action
Extended release
Extended release
Dosage Forms that should not be
Crushed or Split
Carcinogenic medications require caution/
limited handling these cytotoxic drugs, exposing
handlers to potential health risks
teratogenic/carcinogenic effects, will not ulter
dosage form or delivery.
Capsule contents which can not be crushed may
added to soft food as applesauce or pudding
which will allow proper drug administration.
NG tube contents of capsule may be washed
down
Dosage Forms that Should not
be Crushed or Split
Some patients may crush tablets and separate
powder evenly, but unless the patient has
sensitive scale for proper weight measurement of
the crushed tablet, uncertainties of proper dosage
as tablet splitting can occur.
Capsules should not be opened or split unless
directed by physician or pharmacist
Professional Practice Advisory
on Tablet Splitting
Tablet splitting has been accepted to obtain a
prescribed dose of a medication when it is not
manufactured.
Particularly useful for pediatrics and geriatrics.
The need for gradual increase or decrease of the
dose for effective treatment.
Medications of multiple dose strengths are
priced the same, when tablet splitting can be
means of cost effect treatment (price can be cut in
half).
Selection Criteria
Safety & Accuracy is a concern of
managed health care system to minimize
the chance for errors & ADR these
precautions should include the following:
Consistent splitting tablet (cutter/finger).
A score across the tablet.
Clinical data demonstrating the bioequivalence of
the split tablet or meet weight variation
specification.
Selection Criteria
The health system’s pharmacy and therapeutics
committee should approve the selection criteria
Physicians should report any problems with
tablet splitting.
Patient specific appropriate for tablet splitting.
Exception to tablet splitting with justification.
Tablets that Should not be Split
 Tablets that are not scored.
 Size, thickness, & design.
 Special coating to protect
form moisture.
 Inconsistent splitting into
equal parts.
Why Tablet Splitting Became an
Issue?
Cutting prescription cost by splitting a tablet.
Saving money → Maintaining excellent care →
Increase quality of life (meeting professional and
agency guidelines).
Dosage accuracy of a whole vs. cut tablet.
United state pharmacopoeia required
formulations not vary by >10%.
Arguments against tabletsplitting
Patients can not split tablets accurately, a study
supporting this argument involved:
- healthy volunteers.
- HCTZ tablet split.
- 12% of the split tablet deviated from ideal weight
by 20%.
- a tablet splitter was not studied.
- another report larger tablets were accurately split,
however accuracy was diminished with smaller
tablets.
Arguments Against TabletSplitting
Another research group
- Cut tablets in half by hand.
- Oval tablets with deep score on both sides were
easy to cut.
- The two pieces were rarely > 10% in difference
by weight.
- round tablets with a score on one side broke
unevenly & part of the tablet was often lost as
fragment or powder.
Arguments against tabletsplitting
- The two halves of a small (7mm) tablet often
varied by > 20%. (which is >10% the united state
pharmacopoeia requirement).
McDevitt et al evaluated patients with no
experience of tablet splitting, split tablets by
hand or cutter if necessary.
- HydroDIURIL 25mg (HCTZ), round scored
tablets to cut.
Arguments against tabletsplitting
- About 40% of tablet pieces differed from there
Ideal weight by >10% and, over 12% of tablets
were more then 20% weather cut by hand or
tablet cutter.
Another research group evaluated a pill splitter
(LGS health products), found that it works best
with large, oblong pills then flat sides, rounded
or pointed ends were difficult to position in
cutter, also noticed difficulty to cut small pills in
half.
Arguments Against TabletSplitting
Conclusion of studies:
- because of variability in dosing with
tablet splitting, it may be wise to consider
this practice only with larger tablets that
have deep score lines.
- when accuracy is crucial tablet splitting
should be avoided.
- EC tablets or any coated tablet are not be
split.
Arguments against tabletsplitting
 Contact the manufacture before recommending
tablet splitting, medication formulation may be
compromised, or there may maybe non-apparent
reasons.
 Weight variability.
 Lack dose uniformity.
 Scored-a clearly defined groove in the center of
the tablet the the easiest to split.
 Use caution with small flat tablets
Limitations That May Lead to
Poor Patient Compliance
 Understanding how to take medications properly,
in addition patient should be welling and able to
split tablets and agree to fallow through.
 Almost 50% of adults are >65 yo, which may
show the following:
- lack in manual dexterity
- Arthritis
- visual impairment
Arguments Against TabletSplitting
- Parkinson’s disease (tremors).
- Cognitive impairment that limits there ability to
understand or remember instructions for tablet
splitting.
- Any functional impairment.
 The purpose here is to high light this practice
negative impact on older people who may be
subject to this matter.
Arguments Against TabletSplitting
 Older adults often need lower doses then younger
adults, as a result, these patients may forget to cut
tablets and may take full pill, and experience
toxicity from receiving a higher dose of
medication.
Stability of Medications
 Studies on stability of medications are generally
dun on intact tablets.
 Cutting tablets in advance & exposure of tablet to
the environment when dose is due is unknown.
 Medical literature states medication decompose
rapidly when exposed to air, moister or, sunlight,
therefore cutting a month supply of tablets
ahead by caregivers or patients, is
generally undesirable.
Stability of Medications
 It may be wise to consider daily tablet splitting
with larger tablets and deep score lines.
 Narrow therapeutic index medications as digoxin,
warfrin and, medications that require accuracy in
dosing.
Role of the Pharmacist
Pharmacist should ensure that:
 The patient should understand the purpose of
splitting tablets.
 The patient should understand the intended dose
and treatment.
 The patient is physically able to easily and
accurately split the tablet. The pharmacist should
suggest the use of tablet-cutting device when
needed.
Role of the Pharmacist
 The patient is instructed to take the second half of
the split tablet the next dose.
 The patient is encouraged to report any problems
with splitting tablets or ingesting tablets.
Conclusion
A Split Decision
 Splitting higher doses of medications in half may
save money in the short term.
 Research showed that when splitting tablets, they
often crumble or break a part  incorrect dosage
 potential medication problems  poor patient
compliance.
 Physicians and pharmacist can help determine if
tablet splitting is an option.