Evaluating Pseudophedrine and Pheylephrine
Containing Nonprescription Medications
Danielle C. Ezzo, Emily M. Ambizas, and
Maria Marzella Sulli, Department of Clinical Pharmacy
Practice, College of Pharmacy and Allied Health Professions
Abstract: Objective: To develop a
detailed comprehensive list of OTC products that have been affected
by the Combat Methamphetamine Epidemic Act of 2005 and determine
what important changes have been made within the active ingredients
of these products.
Background: Recently the FDA
has restricted the over-the-counter sales of pseudoephedrine in any
single or combination product through the Combat Methamphetamine
Epidemic Act of 2005. Pseudoephedrine is commonly used to
make the illicit drug methamphetamine, and in the hands of the
wrong individuals, can cause serious harm. It is
understandable that the product has serious restrictions in OTC
sales. The majority of products have substituted
phenylephrine as the active ingredient in OTC cold medicines.
However, some products did not solely change from pseudophedrine to
phenylephrine, but may have also changed the dose or strength of
additional active ingredients in the original product. If
left undetected, this switch may cause harm for many
patients. Many pharmacists may not even be aware of these
additional switches in a product’s active ingredients. Since
pharmacists have an important role in providing self-care to
patients with common colds and allergies, it is necessary to ensure
that they are up-to-date on the modified products in order to offer
appropriate recommendations and counseling. The goal of this
project is to compile a list of all OTC products that have been
affected by the Combat Methamphetamine Epidemic Act of 2005 and
determine if there have been adjustments in additional active
ingredients along with the switch from pseudoephedrine to
phenylepherine.
Methods: First, a list of all
products that have been affected by the Combat Methamphetamine
Epidemic Act of 2005 will be assembled. An investigation of
all the new products will be preformed and then compared to the old
product. Precise changes will be determined and recorded in
detail where they occur. A comprehensive list of products and
their ingredients will be compiled in a table format and
distributed to NMA members for inclusion in their personal drug
references and to be shared with student pharmacists.
Conclusions/Implications:
Restriction of pseudoephedrine containing OTC sales has widely
affected many branded products. Changes of this magnitude may
easily incorporate confounding information that may be overlooked
if not studied in detail. An important step in determining
compelling information will be through an extensive review of
various OTC medicines affected by the Combat Methamphetamine
Epidemic Act of 2005. Textbooks, which can take years to
update, may not have the most up-to-date information
available. This detailed, comprehensive list will be
beneficial more quickly to pharmacists and more easily
updated. The information learned here will also be used as a
pilot for more comprehensive research in the future including
patient and pharmacist surveys and knowledge questionnaires to help
determine the true impact of changing ingredients in popular
products without adequate "warning" to the consumer.
Differences in products may change the way patients should be
utilizing the OTC product and may change how pharmacists should be
recommending and instructing the utilization of the OTC
medication. This important information will emphasize
counseling points that pharmacists must be aware of to safely and
effectively treat patients.