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 Health Sciences
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.