Rx to OTC? What Gives?

Recently, I stumbled across an advertisement for Prevacid24, an over-the-counter proton pump inhibitor used for the treatment of GERD. After seeing the ad – “OTC Prevacid will be on shelves before Thanksgiving heartburn” I thought – “What gives? Isn’t Prevacid available by prescription only?” To answer this question, I turned to the Internet. The information I discovered was actually quite fascinating:

The journey from Rx to OTC…

Pharmaceutical patents have a lifespan of 20 years from the date the patent was filed. As medications near end of their patent, drug companies will often petition the FDA to switch the medication from Rx to OTC status. Why?

Patents are very unique creations. They don’t give the patent holder the right to do something; rather, they prevent others from doing something. When a Rx patent expires, other companies can manufacture the formula as a “generic.” Normally, when a drug goes off patent, its price falls by 25% within the first 6 months; after that, the price is only 20% of what it had been while on patent. Translation: patent expiration can mean a major impact on profits.

While many drug companies employ questionable schemes to protect their sales after patent expiration such as introducing an “extended release” version, or releasing a “new” brand-name that is simply a modification of the old drug, others maintain their slice of the pie by going OTC. (Remember, OTC’s don’t require a visit to the doctor, and are a lot easier for a patient to get their hands on than a generic medication.)

Who decides if a drug should be made OTC?

The FDA regulates OTC medications, just as it regulates prescription pharmaceuticals. In order for the FDA to approve a drug as an OTC, it must find that:

•    The benefits outweigh the risks: In other words, the health benefit from taking the drug is more important than any negative side effects.
•    The drug has a low potential for misuse and abuse. That is, the drug should not be addictive or promote a cheap “high” that may encourage others to overuse it.
•    The consumer can use it for self-diagnosed conditions. In other words, the drug isn’t used for something that requires testing or a doctor’s diagnosis such as high cholesterol. Rather, the drug treats an obvious symptom such as a headache or cough.
•    The drug can be adequately labeled with warnings and instructions for use that are clear and easy to understand without any medical training.
•    The drug does not need a doctor’s supervision.
Since 1975, the FDA has approved 101 ingredients for Rx to OTC status such as Rogaine for hair loss, Aleve for pain, Tagamet for heartburn, and Monistat for vaginal yeast infections; in May, 2009 Prevacid for heartburn was added to this list.

So, what’s the problem?

A few concerns:

•    Many people have the impression that OTC’s are “safer” than their Rx counterparts though this isn’t necessarily the case.
•    The potential for OTC medication abuse is real. One in 10 teens have used OTC cough medicines to get high, and 28% know someone who has tried it. Dex, Skittling, Tussing, Robo-Tripping, Triple Cs, are all slang words used for DXM (dextromethorphan) cough medication abuse.

However, my real “beef” with the Rx to OTC switch is this: lifestyle changes are never addressed when a patient self medicates. Doctors play a vital role in encouraging patients to make healthy lifestyle changes such as exercising, losing weight, kicking the tobacco habit, and eliminating stress.  While I’m all for cutting out the middleman when it comes to retail, I have to draw the line where medications are concerned.

So, how do you feel about the Rx to OTC switch? Yay, or nay? Drop me a line, or share your comments – I’d love to hear your feedback.

Related Posts: A Healthy Shift in Perspective


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