Controlled Substances

Prescription, or Legend, Drugs

The FDA has decided that many drugs are dangerous and their use must be carefully controlled. Access to these drugs is provided by a few health care professionals (physicians, dentists, and nurse practitioners). This control is through a written prescription or order that must be written before the drug may be given. Prescription drugs make up most of the medications the nurse gives to patients in a hospital. Prescription drugs are carefully tested before they are put on the market. The drugs have been shown to be safe and effective. However, even though much may be known about a particular medication, each patient is different and may have a somewhat different reaction to the drug. Pediatric patients, older adult patients, and critically ill patients may be weak and more likely to have problems taking a drug. The nurse must be alert and watch for signs that the drug is working the way it should, as well as for adverse reactions that may develop. Because the patient often gets several drugs at the same time, the interaction among the drugs may make it hard to tell how each drug affects the patient. Although a lot of research about drugs has been done, many drugs are not FDA approved as safe and effective for children or pregnant women. Geriatric patients are at high risk for problems with prescriptions drugs, because they may not take the drug properly because of poor eyesight, memory, or coordination; they may take many drugs that interact with each other; or they may have chronic diseases that interfere with how the drug works.

The Omnibus Budget Reconciliation Acts of 1989, 1990, and 1991 placed further controls on drugs for Medicare or older patients. More and more, insurance or government groups who pay for drugs limit the types and numbers of drugs that may be ordered to those on a preferred drug list. The preferred drug list may require the use of cheaper generic drugs to control costs because new or brand-name drugs usually cost more.

Over-the-Counter Medications

The FDA has also found that many drugs are quite safe and do not need a prescription. These drugs may easily be purchased at a drugstore or pharmacy. These drugs often come in a low dosage, and they have low risk for abuse. Warning labels and special information supplied with these drugs make them safe for the average buyer. They are used to treat many common human illnesses: colds, allergies, headaches, burns, constipation, upset stomach, and so on. These drugs are often the first thing patients try before they go to the doctor. Although OTC medications are widely available, they are not without risk. Like all drugs, some may produce adverse effects in some patients. They may also have “hidden” chemicals such as caffeine or stimulants that may produce problems if taken with other drugs. Confusion by parents over the correct dosage of common cold preparations led to many accidental overdoses in children, so these drugs have been removed from the market. Other cold products that contain dextromethorphan and might be abused are now stored behind the pharmacy counter. Talking to patients about the use of OTC medications is very important for patients who are already taking many prescription drugs. New federal laws for labeling of these products will make more information available about the drug and make it easier for the patient to understand.

OTC drugs are also given in the hospital for minor problems patients may have. Although these medications do not require a prescription for purchase, a physician’s order is required before they may be given in the hospital. In fact, without an order, hospitalized patients cannot take even their own OTC medicines brought along to the hospital. This policy is necessary for safety reasons. If patients could take their own medicines in addition to those medicines given by hospital staff, it could result in an overdose of medicine.

In recent years, many people have become interested in herbal products. Research shows that most people will try an herbal product at some time in their lives. Health food stores, grocery stores, and pharmacies all carry some of these products. Some people take these herbal products instead of their prescription drugs, and some use them along with their prescription drugs. Although research may someday find that these products are safe and effective, at present these herbal products are not regulated, standardized, or tested for safety and effectiveness. Because the federal government considers herbal products to be nutritional supplements rather than drugs, there are no regulations to control how they are made. There is no way to know if one leaf that is ground up and made into a pill will work the same as another leaf that is ground up. Also, the nurse cannot easily tell how much of the herbal product is in each pill, or even if each pill in a bottle contains the same amount of the product. Because research on these products is only beginning, little is known about side effects, and it is hard to tell if some of them actually have the intended effect. Finally, adverse effects may occur when a patient takes herbal products and prescription drugs at the same time.

Because of the high cost of drugs in the United States, some patients try to buy drugs from other countries where they both cost less and are easier to buy—usually in Mexico or Canada. Although low-cost drugs can be good for patients, in some cases there is a risk the drugs may not be pure, may not be the drugs patients believe they are buying, or may even be dangerous. Drugs that originate in China or India often look like real drugs but may be fake. It is hard to know if the drugs sold in other countries or over the Internet are real. At this time, buying drugs in other countries and bringing them into the United States is not legal. The FDA is opposed to patients being able to get drugs that cannot be proven to meet high U.S. standards.

Because U.S. drug companies often sell their drugs to other countries at a cheaper rate than in the United States, there is growing interest by many groups in buying some of these drugs, particularly from Canada. Many nurses and patients in Canada or along the U.S.-Canadian border must deal with Canadian drug regulations and classifications that are different from those in the United States; some specific information is provided in the next section.