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."

By increasing patients' knowledge about their drug therapies, the action plan aims to help patients take their drugs correctly. Improper use of prescription drugs leads to unnecessary illnesses, emergency room visits, hospital admissions, and deaths. FDA estimates extra health-care costs from preventable drug-related illnesses to be at least $20 billion a year. (See "Medication Mishaps.")

In addition to instructions for proper use, the information sheets will address a drug's risks and side effects, according to McGinnis. By telling patients what to look for and what to do if they see warning signs, the information may help patients recognize side effects earlier, before serious damage is done.

"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," McGinnis says.

Some groups representing the pharmaceutical industry and health professionals have expressed concern to FDA that informing patients of risks and side effects may hurt compliance by scaring consumers out of taking the drug as prescribed. To this, McGinnis replies, "We've heard that argument, but we've never seen it supported scientifically."

Empowering the Patient
Written information sheets cannot replace the advice of a health professional. But there are some barriers to communication between patients and health professionals, according to David Schulke, director of policy and regulatory affairs at the American Pharmaceutical Association. "There are financial pressures that cause doctors and pharmacists to talk to more patients in less time, giving less time to each patient."

Because of the competing demands on health professionals' time, written information is especially important. "The piece of paper becomes a back-up, a safety net that patients can keep with them and refer to for information," says consumer advocate Arthur Levin, director of the Center for Medical Consumers.

Patients sometimes need to take on a very active role in their own health care, according to McGinnis. "FDA is hoping the additional information will help the patient feel less inhibited about asking questions," he says. "We hope it will encourage patients to become more involved, along with their physician, pharmacist or nurse."

Medication Mishaps
Accupril and Accutane. The drug names sound pretty similar, but they are prescribed for very different conditions. Accupril (quinapril hydrochloride) is used to treat high blood pressure and heart failure. Accutane (isotretinoin) is for certain types of severe acne.

You wouldn't want to take Accutane for a heart condition by mistake. But a patient could be given the wrong drug by accident. Confusion can arise from similar drug names or packaging, a prescriber's poor handwriting, misinterpretation of an abbreviated drug name, or an incorrect data entry into the computer.

To prevent avoidable accidents, FDA's Center for Drug Evaluation and Research compares drug names to see if a change is needed to avoid confusion.

"FDA's goal is to try to catch the potential for error before the product is marketed," says Sharon Smith Holston, FDA's deputy commissioner for external affairs. "Later, if we get reports of errors, we will work with the manufacturer to correct the problem by making a change in the packaging, labeling or name."

Patients themselves can prevent certain types of drug errors. The National Council on Patient Information and Education recommends asking your health professional at least these six questions about a prescription medication:

  • What is the name of the medicine and what is it supposed to do?
  • How and when do I take it, and for how long?
  • What foods, drinks, other medicines, or activities should I avoid while taking this medicine?
  • Are there any side effects, and what should I do if they occur?
  • Will this new prescription work safely with the other prescription and nonprescription medicines I am taking?
  • Is there any written information available about the medicine?
Patients who get drug information in writing as well as orally, says FDA pharmacist Thomas McGinnis, are much more likely to notice if the drug they got isn't for the condition they went to the doctor about or if it may be dangerous if taken with certain foods or another medication.

If a medication error occurs or is suspected, a health professional may report it, in confidence, to FDA's MedWatch program at (1-800) FDA-0178 or the U.S. Pharmacopeia's Medication Errors Reporting Program at (1-800) 23-ERROR.

Is the Labeling Useful?
To be acceptable under the action plan, the information given to patients must be scientifically accurate, unbiased, specific, complete, understandable, up-to-date, and useful.

"The criteria aren't set in stone," says FDA pharmacist Thomas McGinnis. For example, the format may have to be adjusted for some populations. For the elderly, whose eyesight may be declining, the type may have to be larger.

How will FDA determine if labeling is "useful"? The agency will look for specific information, including:

  • medicine name
  • critical warnings (prominently displayed)
  • conditions for which the product is used
  • circumstances under which the product shouldn't be used and directions about what to do if one of these circumstances applies (for example, "Talk to your health care professional before taking this medication if any of these apply to you.")
  • drugs, foods and activities that should be avoided while taking the medication, and other precautions necessary to take the medicine properly
  • symptoms of adverse reactions possibly related to the drug
  • risk, if any, of developing a drug tolerance or dependence
  • instructions for proper use, including the usual doses, instructions if a scheduled dose is missed, special instructions (for example, whether to take with food or water), and what to do in case of an overdose
  • storage instructions
  • general information, including a statement encouraging discussion with a health-care professional and a statement that the drug should not be given to others.
  • a statement that the patient labeling does not contain all possible information about the medicine and that the health-care professional has more information.
To Get a Copy of the Action Plan
Visit the Keystone Center Home Page at
http://www.nyam.org/keystone/
(202) 783-0248

For Even More Information About the Action Plan
Kimberly Edgerly
FDA Office of Consumer Affairs (HFE-88)
5600 Fishers Lane
Rockville, MD 20857
(1-800) 532-4440
(10 a.m. to 4 p.m. Eastern time, Monday through Friday)


FDA / FDA Consumer