Rx & The Law
"Pill Splitting" - Is It Legal? Is It Covered By
Malpractice Insurance?
By Kenneth R. Baker, B.S.Pharm., J.D.
Vice President, General Counsel
Pharmacists Mutual Insurance Company
Several pharmacists have called
asking these questions regarding “pill
splitting”.[1] These pharmacists have indicated they are receiving
requests from third party payers and from physicians, and occasionally from
patients, to split some prescription medications prior to dispensing. In
most cases the questions involve unscored tablets and in most cases, the reason
for the
request is to save money for the patient or the third party payer.
The
real question for the pharmacist involves two considerations – the
law and pharmacy judgement. Whether the pharmacist can “split” unscored
tablets is determined by both considerations. In most states, at present,
there are no laws or pharmacy regulations specifically forbidding “pill
splitting”, although there are warnings in pharmacy literature discouraging
it. The pharmacist, asked to “split” tablets, needs to
know if there is a legal restriction in the state in which he or she practices.
As
part of the legal consideration, the manner in which the prescription is
written becomes important. If the prescription indicates “DrugX,
50 mg”,
it must be filled exactly as written. In order to fill the prescription
with a split DrugX, 100 mg tablet, the pharmacist must be able to split
the tablet in a manner that assures each one-half contains exactly 50 mg
of DrugX. Therein
lies the problem. An unscored tablet cannot be divided exactly equally. Without
the prescriber’s specific orders to split the tablet, the prescription
may not have been filled as ordered. This may be a violation of the
state pharmacy practice act.
Even if the doctor does order or approve
the split “into two parts of approximately
the same strength”, the pharmacist’s act of splitting the
tablets into strengths commercially available, may arguably amount to
illegal compounding
under Section 503A[2] of the FDA Modernization Act of 1997. It
may be argued that the compounding definition is broad enough to include
preparation
of a dose by splitting the tablets. If so, and if the resulting
one-half dose is commercially available, the action could be interpreted
as a violation
of the federal statute which says: “A drug product may
be compounded . . . if the licensed pharmacist . . . (D) does not compound
regularly
or in inordinate amounts (as defined by the Secretary) any drugs products
that are
essentially copies of a commercially available drug product." [3] (emphasis added).
Even if the law allows it, the decision must be made
by the pharmacist based upon professional judgement and patient best
interest. Generally speaking,
pill splitting by the pharmacist is not a good idea and should be avoided,
absent some overriding consideration for a particular patient.
If the pharmacist knows a patient is going to split unscored tablets,
the law will have little to say about the patient’s actions,
but the pharmacist should consider the application of pharmaceutical
care to the situation. The
pharmacist should: warn the patient about the inexactness of the resulting
half table dosage; warn the patient of the possible effects of an inexact
dose – too
high or too low; and tell the patient to let his prescriber know that
he/she is splitting tablets. The pharmacist should also consider
what other advice he/she should give. The pharmacist should be certain
the patient understands
that while cost is a legitimate consideration, it should not be the
primary consideration.
The second question -- “Is it covered?” – is
a product of the first. Most policies contain an exclusion
similar to this: “This
policy does not apply to . . . damages caused by your willful violation
of a regulation or statute pertain to the practice of pharmacy .
. . committed by
you or with your knowledge or consent.” (emphasis
added). If
the action of “pill splitting” is known by the pharmacist
to be a violation of the law, the exclusion applies. If however,
the pharmacist does not willfully violate the law, even if it later
becomes apparent it is a
violation, the policy would cover, in spite of the exclusion, even
if the action is unwise. A board of pharmacy or a court, however,
may not care if the pharmacist was ignorant of the law and will not
excuse the pharmacist who pleads, “I
did not know about that rule”.
The ultimate bottom line
for the professional pharmacist is – if it is
not good pharmacy practice, don’t do it.
[1] See, www.health24news.com, Holton,N., Pill Cutting
for Cost Cutting, (March 2000, Health24)
[2] 21 U.S.C. 353 § 503A
[3] 21 U.S.C. 353 § 503A (b) (1)(D).
This article discusses
general principles of law and risk management. It is not intended
as legal advice. Pharmacists should consult their
own attorneys
and
insurance companies for specific advice. Pharmacists should be familiar
with the policies and procedures of their employers and insurance
companies, and
act accordingly. |