US Pharm.
2008;33(5):90.
Recent changes in federal law regarding the stocking of pseudoephedrine
products may present unforeseen communication errors between prescribers and
pharmacies. Health care practitioners must remember to educate consumers who
may be suffering from a case of "separation anxiety," as illustrated by the
following cases reported to the Institute for Safe Medication Practices (ISMP).
A patient went to her local pharmacy and selected what she thought was Sudafed
from the shelf. She took two tablets of the medication, which was consistent
with her usual dose. Later, she realized the active ingredient was
phenylephrine, not pseudoephedrine, and that the dose she should have taken
was one tablet (10 mg) instead of two. The patient had accidentally purchased
Sudafed PE, not recognizing that the active ingredient differed from Sudafed.
A family bought Sudafed PE and took two tablets twice a day for three or four
days, thinking that the active ingredient was pseudoephedrine. Afterwards,
family members started having headaches and became nauseous. About a week
later, one of the family members decided to pick up another box of Sudafed.
The patient noticed that after the name Sudafed it said "PE," so he turned the
box over to try to figure out the difference.
The difference is that "Sudafed
PE" is not pseudoephedrine at all--it's phenylephrine. The new drug is packaged
in the same color and design as the old Sudafed box. The foil bubble packages
are the same as well, with two tablets per perforated section. "Sudafed"
tablets are 30 mg each and taken two at a time. "Sudafed PE" tablets are 10 mg
each and the adult dose is one tablet. Both are the same color red.
While the Sudafed PE box includes labels on the face of the package that state
"New Formula" and "Does not contain Pseudoephedrine,"
these labels may be missed by consumers since they are smaller than the
prominently displayed brand name and "Nasal Decongestant" on the front of both
packages (see photo). The brand names of the two products themselves differ
only in the addition of the "PE" suffix, which could be interpreted to mean
either pseudoephedrine or p
henylephrine.
Compounding this issue, the layout and red coloring of both products'
packaging are similar, as are the small red tablets contained within the foil
blister packs. Collectively, the similarities in the names (both brand and
active ingredients), packaging, and product appearance may lead to
confirmation bias when consumers who expect to purchase the Sudafed product
they are familiar with are presented with only the Sudafed PE formulation.
Given the differences in dosage recommendations between the two products
(www.sudafed.com/formula.html), patients who fail to recognize this could be
at risk for anxiety, irritability, increased blood pressure, or tachycardia
from exceeding the recommended maximum daily dosage of phenylephrine, which is
60 mg or six tablets.
Safe Practice Recommendations
Since many consumers may not go to the pharmacy counter, take steps at your
practice site to help prevent errors and harm with phenylephrine products. In
some pharmacies, signs direct consumers who wish to purchase pseudoephedrine
products to go behind the counter. While these signs may be effective for
those knowingly seeking this active ingredient, it does little for the
consumer who wants to purchase "Sudafed" but sees "Sudafed PE" on the shelf
and mistakenly assumes the products to be the same. Supplementing these signs
with consumer alerts to highlight the product changes may help to prevent some
of this mistaken identification and bring more recognition to the change in
product formulation. For example, consider using brand names along with the
active ingredients (e.g., phenylephrine, found in Sudafed PE). Encourage
patients to ask their pharmacist about the use of any OTC products, especially
whenever they have any doubts.
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