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.

Patient Charts

The patient’s chart, whether it is paper or electronic, is a legal record. It is the major source of information about the patient and the care received while in the hospital. It provides a central place where members of the health care team record information about the patient and all treatment. The physician or other health care provider describes the patient’s condition on admission, determines the diagnosis, and provides orders to identify or resolve the patient’s problems. The nurse records the assessment of the patient’s condition, the implementation of basic nursing procedures, the patient’s response, and the progress in completing the diagnostic and therapeutic plans. While the patient might request a copy of the chart, the chart belongs to the hospital. It is not the property of the patient, the nurse, or the physician. It is the legal record of the patient’s stay in the hospital. It is kept after the patient has been discharged, and it is often used for billing, insurance, and auditing activities; in medical or nursing research; and to provide information if the patient should be admitted again. In cases of court action or lawsuits, the chart may be used by lawyers as evidence. It is especially important that nurses write meaningful and accurate information in a complete and readable manner. Using electronic medical records and data entry systems helps nurses do this.

Kardex

Drug Distribution Systems

Narcotics Control Systems

Both federal and state laws, as well as agency policies, are very clear about how controlled substances are handled in the hospital. These procedures are nearly identical from hospital to hospital. The primary goal of all regulations and policies is to verify and account for all controlled substances. When controlled substances, particularly narcotics, are ordered from the pharmacy, they come in single-dose unit or prefilled syringes and are attached to a special inventory sheet. The nurse receiving the order from the pharmacy must inspect the medication and return to the pharmacy a signed record stating that all the medication ordered was received and that it was in acceptable condition. As each medication is used, it must be accounted for on the inventory sheet by the nurse giving the medication.

The use of narcotics is carefully monitored on the hospital unit. Medication is stored in a special locked cabinet. The key to this cabinet is carried by the head nurse or by a medication nurse. This individual has the legal responsibility for the use and recording of all the narcotics during that shift, whether or not they personally give the medications to the patients. There are automated medication dispensing systems. They include narcotics plus also stock medicines that nurses withdraw by password or fingerprint instead of a key system.

When controlled substances are ordered for a patient, the nurse responsible for giving the medication first checks the order and verifies the dosage and the last time the medication was given before obtaining the key to the cabinet. The nurse must sign out all medications administered during the shift. The inventory report form is completed before the drug is removed from the cabinet. This report may be written or a patient barcode inserted and should state the patient’s name, date, drug, dosage, and the signature of the nurse giving the medication. The medication given should be noted in the patient’s chart, and there should also be a follow-up note about the patient’s response to the medication. If a dose is ordered that is smaller than that provided (so that some medication must be discarded), or if the medication is accidentally dropped, contaminated, spilled, or otherwise made unusable and unreturnable, two nurses must sign the inventory report and describe the situation. Institutional policy may require additional actions.

At the end of each shift, the responsibility for all narcotic controlled substances and the key to the controlled substances cabinet is transferred to another nurse from the new shift. The contents of the locked cabinet are counted together by one nurse from each shift. The numbers of each ampule, tablet, and prefilled syringe in the cabinet must match the numbers listed on the inventory report form. Sealed packages are kept sealed. Opened packages of medications must each be inspected and counted. Prefilled syringes must be examined to make sure they all have the same color, the same fluid levels, and the same amounts of air within them. Both nurses must sign the inventory report, officially stating that the records and inventory are accurate at that time.

Occasionally, the inventory and the written report do not agree. Any errors in the number of remaining doses and the number listed in the inventory report must be explained. All nurses having access to the key must be asked about medication they have given. Steps must be retraced to see if someone forgot to record any medication. Patient charts might also be checked to see if medication was given that was not signed for on the inventory report. If errors in the report cannot be found, both the pharmacy and the nursing service office must be notified. If the error is large, the hospital administrator and security police are usually contacted.

You can see that the nurse with the key has a lot of responsibility in watching over the controlled drugs on the nursing unit. This nurse is usually a very mature person, often the head nurse or a nurse who has been with the hospital for some time and has proven he or she can be trusted. It is the duty of this nurse to give the key only to other nurses authorized to administer controlled substances. Keys are never given to physicians or any other health care worker. (Sometimes a physician will want to give the medication, but the nurse should get the medication and sign the inventory report.) The nurse in charge of narcotic controlled substances should be able to monitor all activity with the controlled drugs on a daily basis so that if a pattern develops, changes are easily seen. On a hospital unit that has many patients coming from surgery, use of narcotics for these patients will be high soon after surgery but should taper off within 2 to 3 days. If a patient continues to need large or frequent doses or needs narcotics for longer than other patients with the same condition, the nurse in charge of these drugs should be suspicious. Any activity that causes concern relating to controlled substances should be noted by the head nurse.

The Drug Order

Both state law and agency policy require that all medications given in hospitals must be ordered by licensed health care providers acting within their areas of professional training. This generally restricts prescriptive authority (the authority to write an order or prescription for medication) to physicians, dentists, and, in some states, nurse practitioners, nurse midwives, nurse anesthetists, and physician assistants who work for the hospital or clinic. Prescriptions for a hospitalized patient are written on the order form in the patient’s chart or recorded in the electronic record, which may be seen by the pharmacy. Sometimes the order can be faxed, sent electronically, or is on a tear-off sheet sent directly to the pharmacy to get the medication. Other times the order must be transcribed, or rewritten, by the nurse or unit secretary onto a special pharmacy order form.