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This reprint from FDA Consumer magazine is based on the
"FDA's Rx for Better Medication Information" (which appeared in the November 1995 issue)
and contains revisions made in December 1997.
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:
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.
Children and Medicine
Protect Against Tampering
Dixie Farley is a staff writer for FDA Consumer.
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.
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."
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."
Publication No. (FDA) 96-3221
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