Over the Counter, and Into the Medicine Cabinet

Valerie Azzopardi, PharmD Candidate 2007
Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University
Prepared during Consumer Health Information Corporation Clerkship
McLean, Virginia

Take a look inside your medicine cabinet.  Chances are you will find some old favorites: Advil®, Sudafed®, Claritin®, Nyquil®, Cortizone® cream, and Prilosec OTC®.  Maybe some Monistat®, Lotrimin®, Mucinex®, and Imodium®, too.  We have been using these products for so long that it is hard to imagine our medicine cabinets without them.  But thirty years ago, all of these products were prescription-only (Rx-only).  If you wanted to use Advil® for pain, first you had to see your doctor and tell him your symptoms.  If he thought Advil® was right for you, he would write you a prescription.  Your pharmacist would check the drug, dose, and directions against your other medications and tell you how to take it.

But that is not the case anymore.  Now you can just walk into the drugstore and pick up Advil® right off the shelf without any instruction from your doctor.  The same goes for Nyquil®, Claritin®, and a few of your other medicine cabinet staples.  Over the years, these drugs have been granted over-the-counter (OTC) status by the U.S. Food and Drug Administration (FDA).  The manufacturers of these drugs have all been able to prove to the FDA that consumers can use them safely without doctor supervision.  This is known as an "Rx-to-OTC switch."  The next drug that could make its way into your medicine cabinet without a prescription is a weight loss drug called orlistat.

Your body breaks down the food you eat so that you can absorb it.  If you eat too much fat, your body will store it as extra weight.  Orlistat works by stopping your body from breaking down some of the food you eat, especially fat, so that it does not get absorbed by your body.  Orlistat has been available as a prescription drug called Xenical® for several years.  On February 7th, 2007, the FDA approved a lower dose of orlistat safe for OTC use.

There is no easy formula to use for an Rx-to-OTC switch.  The FDA considers each drug on a case-by-case basis, taking into consideration the following questions:

• Is the drug used to treat a condition that patients can diagnose on their own or symptoms that patients can easily recognize?
• Are any medical exams or laboratory tests needed to diagnose the condition or monitor the drug therapy?
• Will patients be able to understand and follow package label directions?
• Are any serious or toxic effects expected when patients use the product as directed on the label?

This last question might be the most important.  The FDA has determined that drugs that switch from prescription to OTC status are safe and effective when used according to the package instructions.

But it is not always as easy as simply taking “one tablet once a day.”  Here are a few things that consumers can do to make sure they are using these drugs appropriately:

• Read the package label.  Read the “Drug Facts” label carefully before you purchase the product and before you use it.  Here you will find information on instructions for use, side effects, and when you should call your doctor.
• Ask questions.  Sometimes you need more information than what the label provides.  Ask your pharmacist if you have any questions, such as the following:
  
  • Which product will work the best for my symptoms?
  • Will it interact with any of the medications I’m already taking?
  • How long should I use it before I should call my doctor?
  • What other drugs or foods should I avoid while I’m taking it?
  Sometimes the package label can contain statements or abbreviations that may be confusing.  For example, the label on alli^tm might contain some warnings that you may not understand or know how to manage [see “Callout: alli^tm Label Warnings and Explanations”].  Your pharmacist can help fill in the gaps for you.
• Follow instructions.  It is easy to overestimate the safety of OTC products.  Never take a larger dose than recommended on the label.  Doubling a dose will usually only increase your risk of experiencing side effects from the medication without adding any additional benefit.  Also, using a product for longer than recommended could hide the signs of a more serious condition.
• Look inside the box.  Look to see if the manufacturer has included more detailed instructions, such as a information booklet, inside the box.  Some OTC products contain handy reference booklets on how to obtain free information about the drug or the medical condition it is used to treat.

Rx-to-OTC switches allow consumers to have access to certain drugs without having to make a visit to the doctor’s office.  As more and more drugs reach OTC status, the more consumers are able to take control of their own healthcare.  But it is important to remember that these are the same products that once required doctor supervision for use.  When buying an OTC medication, make sure it is right for your symptoms and to use it as directed.  And remember, you are not alone in your fight against minor aches, pains, and ailments.  You still have partners in your self-care—your doctor and your pharmacist.

Callout: alli^tm Label Warnings and Explanations

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