Wednesday, September 08, 1999
Prescription for drug confusion
New labeling for over-the-counter health products aims to keep consumers safe and informed
BY SUE MacDONALD
The Cincinnati Enquirer
It's entirely possible that you'll be able to read and understand the new labels being plastered on everything from over-the-counter antihistamines to laxatives to herbal supplements without the need for:
• High-intensity magnifying glasses.
• Very bright lights.
• A medical jargon-to-English dictionary.
Acting on new rules from the U.S. Food and Drug Administration, makers of over-the-counter (OTC) health products must redesign and rewrite all product labels using the same format. OTC products are those that can be bought without a doctor's prescription.
The new labeling program is similar to the revamped food/nutrition labels that went into effect several years ago, and the goal is to increase the safety and use of OTC products, a market that now totals about $5 billion.
Drug manufacturers have up to six years to implement the new labels and can continue selling old-label products as long as stock holds out, but the FDA expects many to begin making the changes sooner. Some companies already have.
“It's a standardized format that will show the drug's ingredients, purpose, warnings, that sort of information,” says Dr. Wayne Bohenek, director of pharmacy at University Hospital. “It'll be easier for patients to understand the information about the drug's benefits, risks and proper use. I think it'll even help patients ask the right questions.”
The new OTC labels call for an easy-to-follow format, the use of simple language, large type and other graphic elements to make information easier to find and read.
According to the July-August issue of FDA Consumer, some of the highlights of the new label format include
• Clearly stated active ingredients and inactive ingredients.
• Plain English instead of medical jargon on labels. The word “aggravate,” as in “this drug may aggravate the effects of alcohol,” for example, will be rewritten to say “this drug can make the effects of alcohol worse.” The term “discard” will be replaced with “throw away.”
• Directions on how to take the medicine are easier to read, with lines and charts replacing long gray lines of printed words and instructions.
“What's lacking in many OTC labels is readability, consistency — all the things the new food label has,” Dr. Peter Rheinstein, director of the medicine staff in FDA Office of Health Affairs, says in FDA Consumer. “It's not that the information isn't there already. Sometimes it's just hard to find.”
The FDA ruling, issued in March, covers 100,000 nonprescription products, including vitamins, minerals and herbal supplements and products such as sunscreens, which have both cosmetic and drug uses.
Fueling the movement is the increasing complexity of drugs available without prescription. According to the Consumer Healthcare Products Association, more than 600 over-the-counter drugs contain ingredients or are available in doses that were prescription-only just 20 years ago.
“Just because something is sold over-the-counter doesn't mean it can't have the same effect that a prescription drug has,” Dr. Bohenek says. “There are so many drug interactions that even pharmacists cannot keep up with them. That's why the computer systems are now able to keep up with that — drug-drug interactions, drug-food interactions, are all screened in the computer system.”
He encourages patients to continue asking questions of their doctors and their pharmacists about how to take medicine, whether to take it with food, possible interactions with food or other drugs, expected benefits and possible side effects.
The FDA says changing labels will cost drug companies about $58 million, but it doesn't expect price increases because labels are usually changed or reprinted every few years anyway.
The standardized format has some leeway, depending on the type and complexity of the product.
For labels that are too small to contain all the necessary information, the FDA is allowing drug companies to include only the most critical information. Most companies include toll-free numbers where consumers can call for additional help.
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