In the United States there are two main groups of drugs: prescription drugs and over-the-counter drugs. The definitions of these two terms are pretty simple.
• Prescription drugs require written authorization of a licensed medical provider, such as a physician, dentist, physician’s assistant, or nurse practitioner.
• Over-the-counter (OTC) drugs do not need this written authorization and can be purchased without restriction.
In the middle ground between the two are products designated to be accessed by patients only after discussion with the pharmacist and presenting proof of identification. The reasoning behind putting certain drugs behind the pharmacy counter was to limit their use by those who might misuse them, while still maintaining reasonable access for legitimate patients without making them get a prescription.
It is these drugs in the ‘middle ground’—the behind-the-counter (BTC) medications—that we will address in this article.
In 2006, the FDA announced new legal requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine. This was required by the Combat Methamphetamine Epidemic Act of 2005 which banned over-the-counter sales of cold medicines that contain ingredients commonly used to make methamphetamine, such as pseudoephedrine. Let’s review for a moment these definitions from the FDA website:
“Pseudoephedrine is a drug found in both prescription and over-the-counter products used to relieve nasal or sinus congestion caused by the common cold, sinusitis, hay fever, and other types of respiratory allergies. It can also be used illegally to produce methamphetamine.”
“Methamphetamine is a powerful, highly addictive stimulant. It is manufactured in covert, illegal laboratories throughout the United States. Meth can be ingested by swallowing, inhaling, injecting or smoking. The side effects, which arise from the use and abuse of meth include irritability, nervousness, insomnia, nausea, depression, and brain damage.”
Although a prescription is not needed to buy pseudoephedrine, it can only be purchased from behind the counter. Again, from the FDA website, this law:
• Limits the monthly amount any individual can purchase
• Requires individuals to present photo ID to purchase these medications
• Requires retailers to keep personal information about these customers for at least two years after the purchase of these medicines
You may have had experiences with this BTC drug if you tried to purchase Claritin-D for seasonal allergies. Before purchasing it, the following information was required:
• A valid and current photo ID
• A driver’s license number or a personal identification card number
• Proof that you are 18 years or older
• Street address, state, and ZIP code
• Your signature
Another drug that falls into this BTC category is the emergency contraceptive drug Plan B, and while it is available without a prescription, the FDA has only approved it for women aged 18 and older. Therefore, it still needs to be purchased from behind the counter so the pharmacist can verify the age of the customer.
Although several medications have moved behind the counter in the United States in recent years, it might be some time before an official third group will be implemented. In the meantime, it’s important for you to know where these specific medications are located in your pharmacy and what the regulations are for dispensing them.