FDA's Tips for Taking Medicines

How to Get the Most Benefits with the Fewest Risks

by Dixie Farley

Whether prescription or over-the-counter (OTC), no medicine is without risk. Besides benefits, medicines may cause side effects, allergic reactions, and interactions with foods, drinks, or other drugs.

For prescription drugs, a patient's first step to safe and effective treatment is to ask the doctor questions with each new prescription. For example:

• What is the medicine's name, and what is it supposed to do?
• How and when do I take it, and for how long?
• While taking this medicine, should I avoid:
  • certain foods or dietary supplements?
  • caffeine, alcohol, or other beverages?
  • other medicines, prescription and OTC?
  • certain activities, such as driving or smoking?
• Will this new medicine work safely with prescription and OTC medicines I'm already taking?
• Are there side effects, and what do I do if they occur?
• Will the medicine affect my sleep or activity level?
• What should I do if I miss a dose?
• Is there written information available about the medicine? (At the very least, ask the doctor or pharmacist to write out complicated directions and medicine names.)

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

Some patients need to overcome being nervous about asking these questions, says FDA's Ellen Tabak, Ph.D., of the Food and Drug Administration's division of drug marketing, advertising and communications. "There is a feeling among some patients that it will be a bother." But 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."

And, "to prevent mix-ups, patients ought to insist that the medicine's purpose be put on the label," Cohen adds.

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

General Advice

• Keep a record of all your current medicines, including their names and regimens (dose, time, and other instructions for taking). Write down any problems you have with the medicine so you can discuss them with your doctor or pharmacist.
• Using adequate light, read labels carefully before taking doses.
• Ask the doctor's or pharmacist's advice before crushing or splitting tablets; some should only be swallowed whole.
• Contact the doctor or pharmacist if new or unexpected symptoms or other problems appear.
• Never stop taking 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 the stability of your medicine.
• 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.

Dixie Farley is a staff writer for FDA Consumer.

Containers That Count, Bottles That Beep,
and Other Helpful Gizmos

A medicine container that beeps when it's time for a dose, a computerized drug organizer-dispenser, and a special cap that counts openings of a prescription vial to tell if the day's doses have been taken are among the aids available for consumers who feel they need some extra help to take their medicines correctly.

These and other aids are listed in a catalog from the National Council on Patient Information and Education, Washington, D.C., from which pharmacists can order.

Pharmacies commonly carry simple compliance aids such as drug containers with compartments labeled for meals and bedtime (some with Braille markings) and spoons and syringes clearly marked with doses for liquid medications.

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 the stability of your medicine.

Even with one day's poor storage, tablets containing certain medicines could break down. 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.

Medicine storage "can be a significant problem when you carry medicine around in a poorly sealed container under high humidity, as occurs along the Gulf Coast," says L. Timothy Grady, Ph.D., vice president and director of standard development at the U.S. Pharmacopeia, an independent standards-setting organization. "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.

--D.F.

Preventing Medicine Misuse

Up to half of the people who use medicines don't use them as prescribed.

That's a lot of medicine misuse, considering that pharmacists dispensed some 2.4 billion prescriptions in 1996, according to the National Prescription Audit by IMS America Ltd., of Plymouth Meeting, Pa.

And the results of misuse can be tragic. Missed doses of glaucoma medicine, for example, can lead to optic nerve damage or blindness. Missed doses of heart medicine can lead to cardiac arrest.

Better Written Information

To help prevent medicine misuse, health professionals now voluntarily distribute leaflets that give patients more and better information about their prescription drugs. The leaflets were prompted by the "Action Plan for the Provision of Useful Medicine Information." Health professionals and consumer, government and industry representatives helped develop the plan.

Information in the leaflets must include the medicine's uses approved by FDA, directions for correct use, and possible side effects. It must be scientifically accurate, unbiased, specific, complete, understandable, up-to-date, and useful.

"But the criteria aren't set in stone," says pharmacist Thomas McGinnis, FDA's associate director of pharmacy affairs. For example, the format may be adjusted for older people, who may need larger type because of failing eyesight. And doctors or pharmacists may add information about a use not approved by FDA (or "off-label" use) when necessary for an individual patient. With computer software on medicine information widely available, McGinnis says pharmacists can easily generate the leaflets.

This information must reach at least 75 percent of patients by the year 2000, and at least 95 percent of patients by 2006. FDA will survey consumers nationwide in those years to determine whether the goals have been met, and will sample the patient labeling to evaluate whether it provides the required information in simple language. If the goals aren't met, the agency may require the information by regulation.

The Right to Counseling

In addition, the Health Care Financing Administration (HCFA) requires pharmacists or their assistants to offer prescription medicine counseling to Medicaid patients and review their medicine usage. Mail-order pharmacies must provide toll-free telephone service.

HCFA health insurance specialist Christina Lyon says the offer to counsel 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 have extended HCFA's rules to give all patients a legal right to counseling on their medicines, says Carmen Catizone, executive director of the National Association of Boards of Pharmacy.

"Patients shoudl 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."

--D.F.

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.

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 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."

--D.F.

Publication No. (FDA) 96-3221

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