A dose of clear directions for Rx drug users

FDA Consumer, July-August, 1997 by Tamar Nordenberg

"These drugs are risky--they wouldn't be prescription drugs if they weren't--and patients have a right to know what the risks are."

More than four centuries ago, doctors were considered omnipotent, and the ethical statutes of England's Royal College of Physicians instructed: "Let no physician teach the people about medicines, or even tell them the names of the medicines, particularly the more potent ones ... for the people may be harmed by their improper use."

While doctors today are more forthcoming, many patients still have a hard time getting important information about the drugs their doctors prescribe. In a time when Corn Flakes, over-the-counter Tylenol, and even Alpo dog food come with easy-to-understand information about proper use, many prescription drugs still come with only a "Use as Directed" sticker for patients. The rest of the labeling is for the medical professional, in language that may be difficult for lay people to understand.

This lack of information for patients may be one reason for the recent finding, published in 1992 in the Journal of Clinical Pharmacy and Therapeutics, that about half of prescription drugs don't work as intended because they are improperly used.

Noncompliance can have tragic consequences. Missed doses of heart medications, for example, may lead to cardiac arrest. And missed doses of anti-glaucoma medicines can lead to eye nerve damage and blindness.

To help avoid medication problems, a new "Action Plan for the Provision of Useful Medicine Information" was unveiled in January 1997 to provide more and better information to patients.

Simple, Relevant Information

Under the action plan, health professionals will voluntarily provide prescription drug information to patients in the form of leaflets written in simple language.

Useful prescription drug information must reach at least 75 percent of patients by the year 2000, in keeping with the Department of Health and Human Services goal under its Healthy People 2000 program. By 2006, the information must reach at least 95 percent of patients. If these goals aren't met, FDA may require the information by regulation.

The plan was developed with the input of health professionals and consumer, government and industry representatives.

"Working together and using today's computer technology," said Secretary of Health and Human Services Donna Shalala when she approved the plan, "we can make prescription information more widely available, more understandable, and more relevant for each individual patient."

The action plan calls for the written information to include the condition(s) for which the drug is used, directions for taking the drug correctly, and possible side effects. Doctors or pharmacists can add information about an "off-label" use--a use that is not approved by FDA--if it is written based on an individual patient's needs.

Health professionals are responsible for getting the information to patients. FDA is available for technical assistance and will work to educate the public about the plan, according to Thomas McGinnis, a pharmacist and FDA's associate director of pharmacy affairs.

FDA will survey consumers nationwide in the year 2000 and again in 2006 to determine if the goals have been met. The agency will evaluate samples of the patient labeling to make sure it provides the required information in simple language. (See "Is the Labeling Useful?")

FDA has tried before to provide prescription medicine information to consumers. A rule the agency proposed in 1979 would have required manufacturers to include leaflets known as patient package inserts, or PPIs, with 10 prescription drugs or drug classes. The rule was withdrawn in 1982 to allow private organizations time to provide the information voluntarily.

In the next decade, FDA research showed minimal progress in getting good-quality medication information to patients. So, in 1995, FDA proposed a rule, commonly called MedGuide, that set forth goals for the distribution of useful prescription drug information to consumers and would have required manufacturers to include drug information for the patient when a product posed a serious health risk.

In August 1996, Congress passed legislation that put the MedGuide proposal on hold to provide another opportunity for private achievement of the MedGuide goals. The action plan is the private sector's framework for achieving those goals.

Labeling Lacking

Currently, manufacturers provide patient information for about 40 prescription drugs or drug classes. FDA requires patient information for some drugs, including oral contraceptives and isoproterenol inhalation products used by asthmatics. Manufacturers voluntarily provide FDA-reviewed patient labeling with some other products, such as Accutane (isotretinoin) for acne and Halcion (triazolam) for insomnia.

A 1997 FDA survey found that 67 percent of consumers were getting some written information with their prescription drugs, up from 54 percent in 1994.

But the surveys don't take into consideration the quality of the information. "The materials being given to consumers are very variable," McGinnis says. "Some are very poor, some are very good, and some are in-between. Most of the information out there now is going to have to be beefed up to meet the action plan criteria."