FDA Proposes Program to Give Patients
Better Medication Information

More patients would receive more and better medication information with their prescriptions under a patient education program recently proposed by the Food and Drug Administration.

"This program will increase patient participation in decisions about their health, and encourage adherence to medical regimens," says FDA Commissioner David A. Kessler, M.D.

Under the new program, by the turn of the century, at least 75 percent of patients getting new prescriptions filled would receive adequate, useful, and easily understood written information that meets quality standards. After reaching this goal, the agency would seek to ensure that by 2006, such information is provided to at least 95 percent of patients receiving new prescriptions.

If these goals are not met, FDA would either institute a mandatory comprehensive program of patient information or seek public comment on the issue.

FDA welcomes comments from the public on the proposed program. (See accompanying article, "You Can Comment.")

Lack of information is one of the main reasons why 30 to 50 percent of patients do not use medicines as prescribed. And that's a lot of medicine misuse, considering that U.S. pharmacists dispensed more than 2 billion prescriptions in 1994, according to the annual National Prescription Audit by IMS America Ltd., of Plymouth Meeting, Pa.

The Costs

Medical costs due to prescription medicine misuse and adverse reactions total more than $20 billion a year. When consequences such as lost productivity are included, annual costs are as high as $100 billion, reports the National Pharmaceutical Council, Inc. (NPC), of Reston, Va.

Most common misuses are:

• taking incorrect doses
• taking doses at wrong times
• forgetting to take doses
• stopping medicine too soon.

A factor increasing the risk for misuse is chronic illness causing no symptoms or erratic ones, according to NPC. Such illnesses include mental disorders, heart and blood vessel diseases, asthma, glaucoma, and osteoporosis.

Another factor is old age. Older people tend to have serious illnesses and take several medicines. They often have vision so poor it interferes with reading labels. One in four prescriptions is for a person 65 or older, NPC states.

The American Association of Retired Persons says people have an increased risk of medicine misuse if they:

• are depressed
• are going thorough a life change such as death of a loved one, retirement, moving, divorce, or remarriage
• frequently drink alcohol
• live alone and don't get out much
• suffer from pain
• can't easily talk to the doctor because they have language or hearing difficulty or feel uncomfortable asking questions.

With each new prescription, a patient's first step to safe and effective treatment is to ask the doctor questions.

Some patients need to overcome a certain barrier, says FDA's Ellen Tabak, Ph.D., of the agency's division of drug marketing, advertising and communications. "There is a feeling among some patients that it will be a bother if they ask a question." In Tabak's research before coming to FDA, patients who asked questions were more satisfied with their medical visits.

Pharmacist Michael Cohen, president of the Institute for Safe Medication Practices, Warminster, Pa., adds, "If you can't ask questions comfortably, get someone to do it for you. There are patient advocates in the hospital, and relatives or friends on the outside."

It's vital to ask for written information about side effects and interactions with other prescription or over-the-counter (OTC) medicines, tobacco, alcohol, or food, including dietary supplements, and ways to prevent or counteract them.

Patients should ask if a medicine will affect sleep or activity level, Cohen says, and how to handle a missed dose. "To prevent mix-ups, patients ought to insist that the medicine's purpose be put on the label."

Following Regimens

For whatever reasons, intentional or not, some people may never fully comply with their prescribed medicine regimens. Others manage this responsibility easily. Still others want to comply, but have difficulty.

When help is needed, there's a medicine expert nearby--the pharmacist.

Also, various compliance aids are available. Women taking birth control tablets already know one: the calendar blister pack. Each tablet is encased on a card in a plastic "blister" marked for each day of the month. There's no mistaking whether a day's dose is taken.

Aids listed in the catalog of the National Council on Patient Information and Education, Washington, D.C., from which pharmacists can order, include a container that beeps when it's time for a dose, a computerized organizer-dispenser, and a cap fitting over the prescription vial cap that counts openings, indicating whether the day's doses were taken.

Pharmacies commonly carry simple compliance aids such as convenience containers (some with compartments labeled for meals and bedtime, some with braille markings) and spoons and syringes clearly marked with dosages for liquids.

While convenience containers aid compliance by helping to organize medicines in advance, it's a good idea to ask the pharmacist whether the container you're planning to use will affect your medicines' stability.

Even with one day's poor storage, tablets containing certain medicines could break down, says FDA chemistry reviewer Jeanne Taborsky. "It depends on where the medicine is stored and how sensitive it is to moisture, light or oxygen. Pharmacists consider a medicine's particular sensitivities when selecting its prescription container."

States and the U.S. Pharmacopoeia (USP) have set standards for testing prescription medicine containers, and drug firms use these standards to meet FDA's good manufacturing practices (GMPs) for proper packaging. GMPs do not generally apply to OTC convenience containers, Taborsky says, but manufacturers may use the same procedures to test them. Whether any OTC convenience containers in fact meet the standards is unknown at this time, she says.

At its convention last March, USP voted to look into the problem of medicine storage.

"It can be a significant problem," says L. Timothy Grady, Ph.D., USP vice president and director of standard development, "when you carry medicine around in a poorly sealed container under high humidity, as occurs along the Gulf Coast. Carrying medicine in a pocket next to the body can raise the temperature." As some medicines break down, Grady says, they may no longer dissolve properly, and the body therefore can't use them. But this is hard to document, he says. "Someone who doesn't get blood pressure control for a few days may not notice it. Scientifically, you know it could happen, but there's no immediate data."

USP plans to identify drugs whose deterioration could be critical, Grady says, and then advise pharmacists to attach time-temperature strips to the vials. The strips would alert patients by a color change if the environment will likely cause deterioration.

Informing Patients of Proper Use

Federal law requires labeling on OTC medicines to include adequate directions for proper use and warnings against misuse, because consumers take these medicines pretty much on their own. FDA and others have long worked to better inform patients about prescription medicines, too.

A Health Care Financing Administration (HCFA) rule, effective January 1993, requires pharmacists or assistants to offer medicine counseling to Medicaid patients. Mail-order pharmacies must provide toll-free telephone service.

"States must set counseling standards," says HCFA health insurance specialist Christina Lyon, "on such issues as whether to extend the offer to counsel to refills."

Lyon says the offer to counsel (patients may refuse) must include all important aspects of the medicine, such as its description, dosage form, length of treatment, special directions, common severe side effects, interactions and their avoidance or remedy, storage, the way to handle a missed dose, and techniques for self-monitoring treatment, such as blood testing by diabetics.

The vast majority of states require a face-to-face offer for counseling for all patients, according to the National Association of Boards of Pharmacy, Park Ridge, Ill.

However, a July 1994 survey sponsored by the association found only 38 percent of patients receiving a verbal offer for counseling. And preliminary results of an FDA survey last winter show only 55 percent receiving written information beyond the label and warning stickers on the container.

In proposing its new program to provide useful, written patient information on prescription medicines, FDA urges patients to ask their health-care professionals questions about their medicines and urges professionals to counsel patients verbally and reinforce the verbal counseling with written information, says Thomas McGinnis, R.Ph., FDA associate director for pharmacy affairs.

Practically every pharmacy has a computer and printer, and patient information software is widely available, McGinnis says. "Yet only just over half the pharmacies generate computer information for patients. We would like that number to increase substantially."

FDA also would like better quality information.

"Too many brochures and leaflets give too much information about benefits and not enough about risks, such as adverse reactions and warnings," McGinnis says. "Some people think risk information will scare patients, and they won't take their medicines properly. That isn't true. Studies show patients can handle it and, in fact, want the information."

McGinnis says FDA wants pharmacists to dispense more comprehensive information about the medicine. Many handouts he and colleagues studied had only a few bullets of information or a simple paragraph.

The agency also wants to explore a standard format, he says, "as we did with food labeling, so that, for instance, if you wanted adverse reaction information, you'd always look at the lower right side of the sheet. And if you wanted dosing information, you'd always look at the lower left."

Profiles and Reviews

In addition to generating patient information, pharmacists can use computers to maintain profiles on their patients.

Profiles are required by all states except Alaska, Arizona, Colorado, Maryland, and Missouri; neither are they required by the District of Columbia or Puerto Rico, says Carmen Catizone, executive director of the National Association of Boards of Pharmacy. Profiles may include patient information such as chronic conditions, medicines dispensed, allergies, and adverse reactions.

Pharmacists use profiles to meet another HCFA requirement: to review their Medicaid patients' medicine usage.

A recent Texas law requires doctors to include in all prescriptions the medicine's intended use. This law helps pharmacists better perform drug regimen reviews, says Steve Morse, R.Ph., assistant director of compliance with the Texas State Board of Pharmacy, in Austin. (An exception exists if the prescriber decides that providing the intended use isn't in the patient's best interest. Texas also strengthened its confidentiality requirements.)

"Having some idea of what the physician intends the drug to do," Morse says, "is a key ingredient to finding and identifying problems, working with the doctor to resolve those problems before they harm the patient, and then counseling the patient to get maximum benefit from the medication."

An additional benefit from a container label's stating the intended use, Morse says, is "patients are less confused about which of their medications treats which health condition."

Texas requires that patient counseling be reinforced with written information.

Except for Colorado, Connecticut, Hawaii, Maryland, Minnesota, South Carolina, Wyoming, the District of Columbia, and Puerto Rico, state laws have extended HCFA's rules to give all patients a legal right to counseling on their medicines, says Catizone.

"Patients should exercise that right," he says, "to make sure they've received the correct medicine and that they completely understand how to take that medicine and what side effects there may be."

Dixie Farley is a staff writer for FDA Consumer.

You Can Comment

Comments on the proposal, published in the Aug. 24, 1995, Federal Register (carried in some libraries), may be sent to: FDA Dockets Management Branch (HFA-305), Rockville, MD 20857.

Working closely with health professional and consumer groups, FDA would establish broad standards for the information's content and format and its distribution. Pharmacists and other health professionals would select and distribute the information.

Medicines posing serious and significant health concerns would have to be accompanied by a Medication Guide leaflet providing information reviewed and approved by FDA.

Among other proposed standards, the information would:

be in a form that is permanent, easily accessed, and convenient to carry--most likely, in leaflets, brochures, or computer-generated printouts, but possibly in audiotapes, computer disks, or videotapes if they meet the proposed standards.

The agency intends to hold a public meeting after the comment period to further discuss the proposed program.

--D.F.

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Tips for Taking Your Medicine

Whether prescription or over-the-counter (OTC), no medicine is without risk. Besides benefits, medicines may cause side effects, allergic reactions, and interactions with other medicines, alcohol, tobacco, and even foods, including dietary supplements.

The National Council on Patient Information and Education, Washington, D.C., recommends asking the doctor these questions:

• What is the medicine's name, 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 side effects, and what do I do if they occur?
• Will this new prescription work safely with other prescription and OTC medicines I'm taking?
• Is there written information available about the medicine?

It's wise to write down the answers to these questions immediately, to make sure you'll remember all the details.

Here are more tips for helping your medicines work as safely and effectively as possible.

General Advice

• Keep a record of names, doses and regimens of current medicines; record medicine problems and the reasons for the problems.
• Ask the doctor or pharmacist to write out complicated directions and medicine names.
• Using adequate light, read labels carefully before taking doses.
• Ask the doctor's or pharmacist's advice before crushing or splitting tablets; some should be swallowed whole.
• Contact the doctor or pharmacist if new or unexpected symptoms appear.
• Never stop medicine the doctor has told you to finish just because symptoms disappear.
• Ask the doctor periodically to reevaluate long-term treatments.
• If you have questions, talk to your pharmacist or doctor before using an OTC medicine the first time, especially if you use other medicine.
• Carefully read OTC medicine labels for ingredients, proper uses, directions, warnings, precautions, and expiration dates.
• Discard outdated medicine.
• Store medicine in the original container, where the label identifies it and gives directions. If, however, you choose to use an OTC convenience container, ask the pharmacist whether the container will affect your medicines' stability.
• Never store medicine in the bathroom. Unless instructed otherwise, keep it away from heat, light and moisture.
• Never store medicine near a dangerous substance, which could be taken by mistake.
• Never take someone else's medicine.
• Tell your health professional if you:
  • are breast-feeding or are, or may be, pregnant
  • are allergic to drugs or foods
  • have diabetes or kidney or liver disease
  • take other prescription or OTC medicines regularly
  • follow a special diet or take dietary supplements
  • use alcohol or tobacco.

Children and Medicine

• Keep all medicine out of children's reach. Some medicines, such as iron supplements, are very toxic to children.
• Use child-resistant caps, and never leave containers uncapped.
• Examine dose cups carefully. Cups may be marked with various measurement units and may not use standard abbreviations. Follow label directions. Never substitute a cup from another product.
• When using a dosing syringe with a cap, discard the cap before use.
• Never guess when converting measuring units--from teaspoons or tablespoons to ounces, for example. Consult a reliable source, such as the pharmacist.
• Never try to remember the dose used during previous illnesses; read the label each time.
• Check with the doctor or pharmacist before giving a child more than one medicine at a time.
• Never give medicine to children unless it is recommended for them on the label or by a doctor.
• Never use medicine for purposes not mentioned on the label, unless so directed by a doctor.
• Check with the doctor before giving a child aspirin products. Never give aspirin to a child or teenager who has or is recovering from chickenpox, flu symptoms (nausea, vomiting or fever), or flu. Aspirin may be associated in such patients with an increased risk of Reye syndrome, a rare but serious illness.

Protect Against Tampering

• Read the label about the product's tamper-evident features.
• Look at the package for tampering signs such as broken seals, puncture holes, or open or damaged wrappings.
• Look at the medicine. Never take medicine that is discolored, has an unusual odor, or seems suspicious in some other way.
• Return suspicious medicine to the store manager or pharmacist.
• Look again when you take a dose. Never take medicine if you're not alert or can't see clearly.

--D.F.

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Facing a Hospital Stay?

For people in the hospital, the Institute for Safe Medication Practices, Warminster, Pa., offers this advice:

• Before taking medicine, to prevent mix-ups, make sure the medicine is the same size, shape, color, and dosage form as before. If not, ask why; the reason may be proper replacement with a generic.
• Before taking a new medicine, ask the name, dose, possible side effects, and reason for use.
• Have whoever gives you medicine check your ID bracelet or armband.
• Ask whether scheduled tests require drugs or dyes. If you've had a bad reaction to such substances before, tell the staff.

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FDA Consumer magazine (November 1995)