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By Karen S. Pater and Colleen M. Culley

Karen Pater-finalColleen Culley-finalEach year in the United States, there are over a billion cases of the common cold, affecting all members in the household, including adults and children, leading to missed work and school. Common symptoms of the cold are nasal congestion, coughing, sneezing, and sore throat. Individuals frequently seek remedies for these symptoms at home or the pharmacy. The last thing that you want to do is to stand in line at the pharmacy to purchase an over-the-counter (OTC) medication. This has been the case for the past 10 years with products containing the popular oral decongestant pseudoephedrine, known by its generic name and the brand name Sudafed. What is the rationale for the restrictions?

Congress passed the Combat Methamphetamine Epidemic Act in 2005 in response to the tripling of methamphetamine-related deaths in the early 1990s and national epidemic of methamphetamine use and illegal production in the early 2000s. A 2004 survey found that 4.9% of all U.S. persons aged 12 years and older had used methamphetamine at least once in their lifetime. Methamphetamine is highly addictive and increases the risk of HIV, due to its ability to increase sexual arousal while decreasing inhibitions and increasing energy, and other infections with its common use as an injection. Additional health and safety concerns around clandestine labs included the exposure of bystanders, especially children, and emergency responders due to the explosive and corrosive nature of the materials used to produce methamphetamine. A 590% increase in the number of methamphetamine labs seized by the Drug Enforcement Administration was seen in 2000 of 1,815 compared with the 263 in 1994.

Pseudoephedrine is a critical component in the creation of methamphetamine in clandestine labs. The new law moved pseudoephedrine to a behind-the-counter status, available only at pharmacies, with transaction logs for sales of these agents limits an individual to purchase of 3.6 grams of pseudoephedrine per day and 9 grams per month, requires photo identification, and captures signatures of purchases either written or through use of an electronic log. Several states participate in NPLex, a national database tracking pseudoephedrine purchases, to ensure that individuals are not purchasing from multiple pharmacies in a day or month. Additionally, a few states such as Oregon and Mississippi and some cities in Missouri require a prescription for purchasing pseudoephedrine. What makes this more complicated is that some pharmacies may have corporate policies that require these same requirements (photo IDs, signatures) for other products even though they are not mandated to do so by federal law.

A decrease in the number of methamphetamine-related incidents was seen after the enactment of the restrictions. Unfortunately, new methods for methamphetamine production and ways to circumvent the pseudoephedrine restrictions are being employed by the clandestine labs and causing incidents. The law is unlikely to be changed, so the next time you are at the pharmacy in need of a decongestant, keep in mind that the purchasing process is helping to try to combat illegal drug use and increase safety of children and first responders.

Karen S. Pater is an assistant professor at the University of Pittsburgh School of Pharmacy. She serves as the coordinator for the Self-Care Course and is currently the chair of the AACP Self-Care and Nonprescription Medicines Special Interest Group.
Colleen M. Culley is an associate professor at the University of Pittsburgh School of Pharmacy. She is a drug information specialist and provides clinical services through the UPMC System Formulary Management and Drug Use Policy team as part of the UPMC System Pharmacy Service Line.