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MEDICATION ERRORS

Multiple Brand Names for the Same


Generic Drug Can Cause Confusion
Matthew Grissinger, RPh, FASCP

Mr. Grissinger, an editorial


board member of P&T, is
Director of Error Reporting
Programs at the Institute
for Safe Medication
Practices in Horsham, Pa.
(www.ismp.org).
Case Report
A female patient with primary pulmonary
arterial hypertension (PAH) who had been
taking Actelions Tracleer (bosentan) and
Pfizers Revatio (sildenafil citrate) arrived
in the emergency department (ED) with
ischemic chest pain and electrocardiographic changes. The ED physician reviewed the patients medication list but did
not recognize that Revatio was the same
drug as sildenafil and was unaware of its
contraindications. The patient received
aspirin and nitroglycerin sublingually and
later was started on an intravenous nitroglycerin infusion for continued chest pain
and elevated troponin-T levels.

PROBLEM: The use of organic nitrates


in any form and at any time is contraindicated if a patient is taking sildenafil. This
contraindication is listed in product monographs for other selective phosphodiesterase-5 inhibitors such as Cialis (tadalafil,
Eli Lilly) and Levitra (vardenafil, Bayer/
GlaxoSmithKline). Thankfully, the patient
in this case report experienced no adverse
effects or blood pressure changes, because an internist soon recognized the
problem and stopped the infusion.
Sildenafil is more commonly known as
Viagra, which is approved for the treatment of men with erectile dysfunction.
When used for this indication, sildenafil
is typically prescribed in 50-mg doses to
be taken 1 to 4 hours before sexual activity. When used to treat PAH, sildenafil is
typically prescribed in 20-mg doses to be
taken three times daily.
As Viagra, sildenafil has received
widespread professional and direct-toconsumer advertising that mentions
contraindications. Although the drugs

dosage differs for the various indications, if


sildenafil had been prescribed and identified
as Viagra, perhaps the ED physician might
have recognized that simultaneously
prescribing nitroglycerin would cause
a problem. Revatio has the approved indication for the treatment of PAH to improve exercise ability; Viagra does not.
The FDA does not usually approve a new
brand name just because a drug has a new
indication; however, because of the stigma
that patients with PAH might associate with
taking Viagra, Revatio was approved as a
new brand name for sildenafil.
Some physicians who care for patients
with severe PAH might not recognize
that Revatio is the same drug as Viagra.
Dual trademarks for a single product
are particularly problematic when one
of the product names is well established
before the new product is launched. Further, patients with PAH frequently have
concomitant coronary artery disease,
increasing the chances that a nitrate will
be prescribed for them. However, a lifethreatening drop in blood pressure can
result if nitroglycerin is taken with a medication for erectile dysfunction.
In the past, patients have taken the
same drug prescribed or dispensed under
more than one trademark. For example,
my column in the May 2006 issue of P&T
mentioned errors with Zyban and Wellbutrin (both bupropion, GlaxoSmithKline), Propecia and Proscar (both
finasteride, Merck), and Sarafem and
Prozac (both fluoxetine, Eli Lilly).1 It was
pointed out that duplicated therapy can
occur when branded generic products
are available from different manufacturers; when the same drug is dispensed
from two pharmacies under two different
brand names; or when a product is prescribed by its generic name while it is dispensed and labeled by its brand name
for example, Coumadin (Bristol-Myers
Squibb) or Jantoven (Upsher-Smith) for
a patient who is already taking warfarin.

sider whether a dual brand-name drug


or two different brand names would be
safer for a product marketed for two dissimilar indications. If dual brand names
are used, manufacturers could perform
an important service by clearly stating
on the package label and in the patient
information insert that the drug is available under both names.
Clinicians can also reduce the risk of
errors by obtaining a history of all drugs
taken by the patient and by reviewing
all available information about a specific
drug if they encounter unfamiliar product names. To help patients avoid taking
the same drug under different names,
clinicians should encourage patients to
fill all of their prescriptions at the same
pharmacy. The insurance-adjudication
process normally identifies duplicated
therapy, but in an era of $4 generic drugs,
not all prescriptions are handled in this
manner.
For instance, in the outpatient or community pharmacy, when the pharmacist
enters a prescription into the computer
system but before a label is printed, the
prescription information is sent to the
insurance company for approval (i.e.,
adjudication). The company can deny
prescriptions for many reasons, including the fact that the patient had a similar
script filled (e.g., the same generic drug
name). When a pharmacy offers generic
drugs for only $4, it means (behind the
scenes) that the pharmacy does not send
the information to the insurance company
if the patient is paying only $4 in cash.
Therefore, if a pharmacy offers $4 generics, the double-check process (in which
the insurance company could reject the
prescription because the patient is using
something similar) does not take place.
Patients with PAH who take Revatio
should be encouraged to note on their
medication list that the drug is also sold
as Viagra.

SAFE PRACTICE RECOMMENDATION: The


FDA often requires companies to con-

1.

REFERENCE
Grissinger M. A medication-error trifecta! P&T 2006;31(5):244.

Vol. 38 No. 6 June 2013

P&T

305

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