- The Washington Times - Sunday, October 13, 2002

Shop for an over-the-counter cold or headache remedy, and you find an informative label. Called Drug Facts, it tells what you need to know about ingredients, dosage, purpose, possible major side effects, and interactions with food and other medicines.
Prescription drugs do not routinely reach patients with comparable information in a standardized format, and serious problems can result.
Consider acetaminophen, a common ingredient in OTC remedies for headache, colds and pain as well as in prescription pain meds such as Percocet and Vicodin. Patients on these Rx meds often do not know they are getting acetaminophen. The upshot: potential overdosing that can lead to liver damage and death.
Hearing the evidence at a meeting late in September, a Food and Drug Administration advisory committee recommended all acetaminophen products have a label warning about the dangers of taking too much and how it might happen.
But that will address one medicine. What about all the others? Our health care system generally fails to give patients accurate, useful, understandable information about prescription drugs. While almost 90 percent of patients receive written information about their Rx medicines, only half of that information is accurate and up-to-date, according to a survey commissioned by FDA. Released in July, that survey followed decades of ministeps by government and the private sector toward improving Rx patient information.
Starting in the late 1960s, FDA concentrated on so-called patient package inserts, requiring them first for inhalers and, soon after, for estrogen-containing products. These are close replicas of what physicians get and, for consumers, contain scary details about nearly every possible side effect, too little easy-to-understand information, and type that is too tiny. The PPIs are much the same as the impossible-to-read stuff required for print ads for drugs (you know, that back page behind the drug ad in a magazine or newspaper). Both the PPIs and the ads go largely unread.
In 1995, faced with growing pressure to do more with Rx drug information, FDA proposed Medication Guides, or standardized formats and information, for 10 drugs having serious and significant side effects.
Meanwhile, pharmacies and physicians had begun to give patients drug information leaflets of varying types and quality, and the agency set distribution targets of 75 percent by 2000 and 95 percent by 2006 for all types of patient information about Rx drugs.
In 1996, Congress passed a law ordering the secretary of health and human services to work with the private sector on a plan for useful patient information. The law stymied mandatory requirements until the department knew whether the 2000 and 2006 goals had been met.
That brings us back to the state of affairs reported to the Drug Safety and Risk Management Advisory Committee in July. Med Guides have been created for the 10 serious drugs. For the most part, they are overly detailed and of slight assistance. Beyond that, patients buying new prescriptions often get drug information in leaflets and such, which are printed by the pharmacy for the individual. Pharmacies often hire third parties to prepare and computerize the patient information materials.
FDA has concluded significant progress has been made in reaching the goal for distribution of Rx patient information; therefore, it will continue to work with the private sector to improve quality. Hence, the agency probably will contribute little toward creating a meaningful, unified format and content for Rx drug patient information until after 2006.
In the interim, one novel form of patient information merits attention: six-sided pamphlets, or newsletters, prepared by Health Resource Publishing Co. for printing and distribution by pharmacies. The front section contains personalized information, including the patient's name, the name of the drug, instructions on when to take it, what to do if side effects appear, and advice such as talk to your doctor about all other drugs and dietary supplements you are taking.
Often funded by drug manufacturers, the newsletter also tells about other related therapies, how to manage the patient's disease arthritis or high blood pressure, for instance where to get additional information, such as reputable Web sites. The information is accurate, and the language is clear. More than 17,000 pharmacies nationwide are giving customers the newsletters, which often are stapled to the bag holding the medicine.
As good as these pamphlets are, Health Resource President George Neal agrees "a more unified format [for Rx drug facts] is a desirable goal from a consumer's standpoint," as he told the FDA Advisory Committee in July. If FDA eventually starts to work toward that goal, it would do well to look at the newsletters as a model, perhaps the vehicle, for giving consumers the clear, accurate Rx information they need.

Goody L. Solomon is executive editor of the Food Nutrition Health News Service in Washington.


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