The Difference Between Rx and OTC Meds

Andrea Hartley, CPhT
Pharmacy Technician/Central Supply Manager
The GRAND of Dublin

The Difference Between Rx and OTC Meds:
Why some medications are prescription, some are OTC (and some are a little of both).

Have you ever wondered why some medications are prescription only, some are sold over-the-counter, and some are a little of both?  During your stay at The Grand, you don’t need to worry about it: we provide you with all standard medications you are taking, whether prescription or OTC.  While at home however, you may be confused about what you can purchase, and what you need a prescription for, and why.

medicationsLet’s start with the reasons a drug has been designated as Prescription Only.  These medications are also known as Legend drugs, because of the required presence of the Federal Legend: “Caution: Federal Law

Prohibits Dispensing Without a Prescription”, on the label.  In 1997, this was shortened to simply, “Rx Only”.  The foremost reason for an Rx Only designation is safety.  If a product is known to have the potential for harmful effects or is unsafe without the supervision of a physician, it may not be sold without a prescription.  These medications may require diagnosis of a specific illness by a healthcare professional as well.  A drug may also be Rx only because it has the potential for abuse.

Now, on to medications designated as OTC.  An OTC product almost always begins its life as Rx Only.  In order to make the switch, manufacturers must provide proof to the FDA that a medication is very safe and effective and whether the labeling can be written in such a way that consumers can use the products safely without the intervention of a healthcare provider.  Of course the company which developed the drug for prescription use must also be willing to provide this proof, or “sponsor” the transition.

Finally, what about the medications which are sold behind-the-counter (BTC); and the medications that are sold as both Rx only and OTC?  This is where things get a bit more complicated.

Let’s talk about BTC items first.  These items are actually considered over-the-counter because a prescription is not needed, but they can only be purchased from a pharmacy.  Items vary based on location, but chances are you have purchased one of these items before:  pseudoephedrine, codeine-containing cough syrups, syringes and needles, emergency contraceptives, and some insulin.  BTC is not an official classification of drugs in the US, yet it still exists for various reasons.  Pseudoephedrine and codeine cough syrups have quantity restrictions and pharmacies must track who purchases them, and how much; this is required to reduce abuse and diversion.  Emergency contraceptives require age verification; human insulin is OTC because it was thought to be less dangerous than modern formulations but sold behind the counter due to its refrigerated storage requirements.  As for the syringes and needles, some states require proof of need, age and/or records of purchase.

Drugs sold as both prescription and OTC are usually done so due to small differences in either the medication or the way it is packaged.  For example, the FDA has approved the OTC sale of Prilosec only as treatment for frequent heartburn, whereas the Rx Only version is approved for more serious conditions such as such as inflammation of the esophagus and ulcers.  On the other hand, the reasons the FDA approved Miralax for OTC sales, yet still allows the sale of Rx Only PEG 3350 are unclear.  Both medications are identical with nearly identical indications for use.

When you stay with us at The Grand, the nursing staff and I are here to answer your medication questions; if you want to know something, just ask!

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