Clear Directions for Rx Drug Users : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

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.

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.