Introduction to Drugs Chapter 1

A nurse is preparing to administer morphine. The nurse understands that this drug is categorized as which schedule of a controlled substance?

C-II Morphine is a schedule II (C-II) controlled substance.

Which schedule drugs have high abuse potential and no accepted medical use?

Schedule I Schedule I drugs have a high abuse potential and no accepted medical use. Schedule II drugs have high abuse potential with severe dependence liability. Schedule III medications have less abuse potential than schedule II drugs and moderate dependence liability. Schedule IV drugs have less abuse potential that schedule III and limited dependence liability. Schedule V drugs have limited abuse potential.

Which effects may occur with the ingestion of large amounts of licorice?

hypOkalemia The body converts natural licorice to a false aldosterone, resulting in fluid retention and hypokalemia (low serum potassium levels) if large amounts of licorice are eaten.

There are many sources of drug formulation. What is the advantage of a synthetic drug over a natural drug?

increased stability of the drug Natural drugs are affected by pharmacodynamic changes including potency and stability. Synthetic drugs have fewer side effects than natural drugs. Natural drugs are not tolerated any better than synthetic drugs.

A drug being tested is removed from testing during a phase II study. What would be the most likely reason for the drug being removed from testing?

unacceptable adverse effects A drug is removed from testing if it produces unacceptable adverse effects. Financial concerns, logistics of performing human trials, and patent issues are rarely the cause of the cessation of testing.

A newly pregnant client has been taking a category A drug for several years. What should the nurse instruct the client about this drug?

"Discuss this with your care provider, but you'll likely be able to keep taking it." For drugs in category A, there are adequate studies in pregnant women that have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters. For drugs in categories B, C, and D, the benefits of taking the drug need to be assessed against the potential level of risk. For drugs in category X the risk to the futus outweighs the benefits of the meication.

Which statement made by a nurse would suggest that he/she is involved in a Phase III clinical drug study associated with a new antidepressant?

"Evidence is strong that the medication's benefits certainly outweigh any risks that have been noted." Phase 3 studies help determine whether the potential benefits of the drug outweigh the risks. Testing may be stopped during any of the early phases if inadequate effectiveness or excessive toxicity becomes evident. In Phase 1, a few doses are given to a certain number of healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity. In Phase 4, the FDA allows the drug to be marketed and requires manufacturers to continue post-marketing monitoring and electronic report submission of the drug's safety and effectiveness.

Which question asked by the nurse demonstrates an understanding of a key concern related to pharmacology?

"How has the drug affected your feelings of depression?" Pharmacology addresses the drug's effects on the body and the body's response to the drug. Pharmacogenomics (also known as pharmacogenetics) is the study of how a person's genetic heritage lead to variable responses to drugs. Pharmacoeconomics involves the costs of drug therapy, including the consumer's costs of purchasing the drug. Pharmacotherapy is the use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes

When asked by a client about the generic name of a drug, what is the nurse's best response?

"The generic name is the official name given by the U.S. Food and Drug Administration." The generic name of a drug is the official name given by the U.S. Food and Drug Administration. This name will be used by anyone who markets the drug and is not owned by any agency. The name is written in lowercase letters. The chemical name of the drug describes the molecular structure of the drug. The trade name, not the generic name, is the name registered by the manufacturer.

A nurse is preparing to administer digitalis to a client with congestive heart failure. The client asks the nurse, "Tell me something about this drug. Where does it come from?" What is the best response by the nurse?

"This drug comes from a plant called the purple foxglove." Drug sources from the plant world date back to primitive times. A common drug from plants is digitalis, which is derived from the purple foxglove.

Which statement correctly defines a drug?

A drug is any chemical that can affect living processes. A drug is any chemical that can affect living processes. Virtually all chemicals can be considered drugs because, when given in large enough amounts, all chemicals will have some effect on life. Drugs can be manufactured from plant sources as well as synthetically. Narcotic composition does not define what a drug is. Not all drugs are narcotics.

What drug category indicates fetal risk where the potential benefit might be acceptable despite the risk?

Category D Category X drugs carry the risk of fetal abnormalities. The risk of use in pregnant women clearly outweighs any possible benefit. With Category A drugs, adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters. With Category B drugs, animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women. With Category D drugs, there is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite these potential risks.

What is the manufacturer's responsibility during phase IV of a drug trial?

Continue to monitor the drug's effects while the drug is in general use. During phase IV of a drug trial, it is the manufacturer's responsibility to continue to monitor the drug's effects while the drug has been placed in general use. During phase I, healthy volunteers are found to test the drug. In phase II, clients with a disease are divided into two groups, and one receives the new drug and the other receives a placebo. During phase III, it is determined if the drug's benefits outweigh the adverse effects.

Which is an example of a black box warning by the Food and Drug Administration (FDA)?

Difficulty breathing and maintaining an airway Over the past 25 years, the FDA has issued black box warnings about drugs that can cause serious adverse effects. Difficulty breathing and maintain an airway is a serious adverse effect. The others are mild adverse effects.

Which agency is responsible for the enforcement of controlled substances?

Drug Enforcement Agency The Drug Enforcement Agency, a part of the U.S. Department of Justice, is the agency responsible for enforcing the control of substances with abuse potential. The FDA, an agency in the U.S. Department of Health and Human Services, is responsible for studying drugs and determining their abuse potential.

Genetic engineering allows scientists to produce human insulin by altering which type of bacteria?

Escherichia coli Genetic engineering permits scientists to produce human insulin by altering Escherichia coli bacteria, making insulin a better product without some of the impurities that accompany animal products.

The nurse is currently participating in phase IV of a clinical study of a chemotherapeutic drug. What action would the nurse be expected to perform during this phase of testing?

Gathering data from clients taking the drug after it has been released to market. Phase IV study involves continuous evaluation of a drug after it has been released for marketing. Publicity is not a component of the approval process. Healthy volunteers are needed in phase I, and the clients who actually have the disease in question are involved in phase II.

A nurse is preparing to call a prescriber about a client who would like to sleep through the night. The nurse is clarifying with the client the need of a medication to fall asleep which would be hypnotic or a medication to relax them like a sedative. What are the differences between sedatives and hypnotics? Select all that apply.

Hypnotic drugs induce drowsiness or sleep. Sedative drugs aid in the healing process by assistance with sleep. Sedative drugs assist with keeping a client sleeping. A hypnotic is a drug that induces drowsiness or sleep, allowing the client to fall asleep and stay asleep. Hypnotics are given at night or bedtime. Sedative drugs produces a relaxing, calming effect and are usually given during daytime hours. Sedative drugs do not produce sleep. Sleep deprivation may interfere with the healing process, therefore a hypnotic may be given. Sedative drugs are given prior to surgery to relax the client.

The birth defects associated with thalidomide (Thalomid) resulted in legislation known as the:

Kefauver-Harris Act of 1962. The Kefauver-Harris Act of 1962 gave the Food and Drug Administration (FDA) regulatory control over testing and evaluating drugs and set standards for efficacy and safety. The Controlled Substances Act defined drug abuse and classified drugs according to their potential for abuse. The Pure Food and Drug Act prevented the marketing of adulterated drugs. The Durham-Humphrey Amendment tightened control of certain drugs.

Since 1962, newly developed drugs have been extensively tested before being marketed for general use. What do drug companies do to test drugs initially?

Test the drugs with animals. Since 1962, newly developed drugs have been extensively tested before being marketed for general use. Initially, drugs are tested in animals, and the FDA reviews the test results. Next, clinical trials in humans are done, usually with a randomized, controlled experimental design that involves selection of subjects according to established criteria, random assignment of subjects to experimental groups, and administration of the test drug to one group and a control substance to another group.

The nurse is reviewing a prescription for a medication with a client. On the prescription, the nurse read "DAW." What should the nurse teach the client?

The brand name of the drug must be dispensed. DAW means "dispense as written." That is, the brand name of the product must be used to fill the prescription. A generic form of the drug could not be substituted. Another drug with a similar chemical name could not be substituted. DAW does not denote a particular patent status. Reference:

A client diagnosed with an autoimmune disorder has just been prescribed a synthetic drug. Which characteristic is a noted advantage of synthetic drugs?

The client is at a lesser risk for an allergic reaction. Synthetic drugs are more standardized in their chemical characteristics, more consistent in their effects, and less likely to produce allergic reactions. They do not necessarily require less frequent dosing and may or may not be available OTC. They are not noted to be available in a wider variety of administration routes than naturally occurring substances.

What statement should the nurse include in a discussion to a community group about patent drugs?

The patent prevents other drug manufacturers from making or selling that drug A new drug is protected by patent for several years, during which time only the pharmaceutical manufacturer that developed it can market it. Other pharmaceutical companies cannot manufacture and market the drug until the patent expires. However, for new drugs that are popular and widely used, other companies often produce similar drugs, with different generic and trade names.

In phase 1 clinical trials, the potential uses and effects of a new drug are determined by which method?

administering doses to healthy volunteers Phase 1 studies allow for the administration of the medication to healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity. In Phase 2 studies, a few doses are given to a certain number of subjects with the disease or symptom for which the drug is being studied and responses are compared with those of healthy subjects. Placebo-controlled designs are used in Phase 3 studies, in which half of the subjects receive the new drug and half receive the placebo. Calculating the risk-to-benefit ratio is used in Phase 2 studies to determine whether the potential benefits of the drug outweigh the risks.

The nurse is educating a client on over-the-counter (OTC) medications. What information is required to be placed on the label of the medication? (Select all that apply.)

adverse reactions dosage of the medication contraindications to the medication

After reviewing class material about the natural sources of drugs, the students demonstrate understanding of the material when they identify which as an example of a drug that is derived from inorganic compounds?

aluminum hydroxide Aluminum hydroxide, an antacid, is an example of a drug from an inorganic compound. Codeine is derived from a plant source. Penicillin is derived from organic sources. Insulin is a drug originally derived from an animal source, but more recently has been created synthetically via genetic engineering.

Which medications are capable of CNS depression, hypnosis, deep coma, respiratory depression, and prescribed infrequently?

barbiturates All barbiturates are capable of producing central nervous system (CNS) depression and mood alterations ranging from mild excitation to mild sedation, hypnosis (sleep), and deep coma. These drugs also are respiratory depressants; the degree of depression usually depends on the dose taken. Barbiturates have a long half-life, which prolongs a sleep or drowsy feeling and that is the reason they are used infrequently, if at all. Benzodiazepines are used for a variety of reasons including anxiety. They do not produce hypnosis or deep coma. Opioids are used for pain. Opioids are CNS depressants, can have respiratory depression but prescribed frequently for pain. Nonbenzodiazepines do not elicit the CNS depression.

How may drugs be prescribed and dispensed?

by generic or trade name Drugs may be prescribed and dispensed by generic name or by trade name.

Which Food and Drug Administration (FDA) pregnancy category indicates that animal studies on the drug have shown adverse fetal effects, but there are no adequate studies in humans?

category C Category C drugs are those in which animal studies have shown adverse fetal effects, but there are no adequate studies in humans. With category A drugs, adequate studies in pregnant women have not demonstrated risks to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters. With category B drugs, animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women. With category D drugs, there is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

What drug category indicates fetal risk where the risk outweighs any potential benefit?

category X Category X drugs carry the risk of fetal abnormalities. The risk of use in pregnant women clearly outweighs any possible benefit. With category A drugs, adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters. With category B drugs, animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women. With category D drugs, there is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite these potential risks.

The nurse is administering a medication to a client who reports pain in the knees from arthritis. The nurse observes the name of the drug as p-isobutylhydratropic and recognizes that this refers to a:

chemical name. The chemical name of a drug precisely describes the drug's atomic and molecular structure, using exact chemical nomenclature (language) and terminology. The chemical name, which is usually long and complex, is not practical for everyday use but is useful to chemists and biochemists.

The nurse is reviewing a client's medication regimen. What medication would the nurse recognize as being a schedule V (C-V) medication?

cough syrup that contains a small amount of codeine Schedule V (C-V) medications have limited abuse potential, primarily including small amounts of narcotics (codeine) used as antitussives or antidiarrheals. Morphine is a schedule 2 medication. Ibuprofen and allergy medications are not controlled substances.

The nurse is educating a client on over-the-counter (OTC) medications. What information is required to be placed on the label of the medication? (Select all that apply.)

dosage of the medication adverse reactions contraindications to the medication Over-the-counter medication labels are required to include the name of the drug, dosage, contraindications, precautions, and adverse effects. They are not required to place a picture of the medication, or to place the cost of the medication, on the label.

What serves to protect the public by ensuring the purity of a drug and its contents?

federal legislation Federal legislation serves to protect the public from drugs that are impure, toxic, ineffective, or improperly tested prior to marketing. The primary purpose of federal legislation is to ensure safety. The United States Adopted Names Council was established to ensure uniform drug nomenclature. The official name of each drug is published in the United States Pharmacopeia and the National Formulary. The American Pharmaceutical Association does not ensure the safety and purity of drug content but is a professional organization for pharmacists.

A nurse is involved in a phase II study. The nurse should perform what action?

giving the drug to clients with the disease that drug is designed to treat In a phase II study, clinical investigators try out the drug in clients who have the disease that the drug is designed to treat. Preclinical trials involve the use of animal testing of a drug. A phase I study involves the use of human volunteers, usually healthy young men, to test a drug. A phase III study involves the use of the drug in a vast clinical market.

A client who reports joint pain is being seen in the rheumatology clinic. The nurse understands that which element is used to treat rheumatoid arthritis?

gold Gold has a therapeutic use in the treatment of rheumatoid arthritis. Aluminum has been used to treat gastric acidity and prevent the formation of phosphate urinary stones. Iron is effective in the treatment of iron-deficiency anemia. Fluorine (fluoride) is used to prevent dental cavities.

A drug has been approved by the Food and Drug Administration. What study phase would occur next?

phase IV study Once a drug is approved, a phase IV study occurs. This is a phase of continual evaluation in which prescribers are obligated to report to the Food and Drug Administration any untoward or unexpected adverse effects associated with the drugs being used. A phase III study involves the use of the drug in a vast clinical market. FDA approval occurs with completion of this phase. A phase II study allows investigators to try out the drug in clients who have the disease that the drug is designed to treat. A phase I study uses human volunteers for testing. This step follows preclinical trials, which involves drug testing on laboratory animals.

Which phase of drug development is associated with continual evaluation of the drug?

phase IV study Phase IV study is a phase of continual evaluation in which prescribers are obligated to report to the Food and Drug Administration (FDA) any untoward or unexpected adverse effects associated with the drugs being used. A phase I study uses human volunteers for testing. A phase II study allows investigators to try out the drug in clients who have the disease that the drug is designed to treat. A phase III study involves the use of the drug in a vast clinical market.

Plants and plant parts have been used as medicines since prehistoric times. Morphine (roxanol) is derived from which plant?

poppy Morphine (Roxanol) is derived from the poppy plant (Papaver somniferum). Foxglove is associated with digitalis preparations. Aloe vera is used to treat burns. Eucalyptus oil is used in over-the-counter cough and cold medicines.

The Food and Drug Administration assigns newly approved drugs to which categories? (Select all that apply.)

prescription nonprescription controlled substance Once drugs are approved for use, the FDA assigns the drug to one of the following categories: prescription, nonprescription, or controlled substance.

After teaching a group of nursing students about drug classes and categories, the instructor determines that the teaching was successful when the students identify legend drugs as referred to as which medication?

prescription drugs Prescription drugs are also called legend drugs. Nonprescription drugs are also known as over-the-counter (OTC) drugs designated by the U.S. Food and Drug Administration (FDA) to be safe (if taken as directed) and obtainable without a prescription which includes vitamin supplements. Herbalism is the practice of using complementary/alternative therapy that uses plants or herbs to treat various disorders.

A nurse is administering a large number of medications to a diverse group of clients. What types of drugs will be excluded from these medications?

schedule I Schedule I medications have no accepted medical use and are not prescribed. Schedule II drugs are often prescribed and include medications such as narcotic analgesics. Schedule III drugs are often prescribed and include nonbarbiturate sedatives, nonamphetamines, stimulants, and non-narcotic analgesics. Schedule IV drugs are often prescribed and include sedatives, antianxiety agents, and non-narcotic analgesics.

When reviewing the Drug Enforcement Agency schedules of controlled substances, the nurse would understand that the schedule with limited abuse potential is:

schedule V. Schedule V controlled substances have limited abuse potential. Schedule II drugs have high abuse potential with severe dependence liability. Schedule III drugs have less abuse potential than schedule II drugs and moderate dependence liability. Schedule IV drugs have less abuse potential than schedule III drugs and limited dependence liability.

The nurse reviews various legislation related to drug therapy, including the Kefauver-Harris Act. What aspect of drug therapy is most directly affected by this legislation?

the drug testing process overseen by the FDA Thalidomide resulted in the birth of many babies with limb deformities. Public outcry resulted in the Kefauver-Harris Act of 1962, which underlies the FDA approval process. This specific act does not address controlled substances, DEA numbers or patenting.

A nurse is teaching a client about the pharmacotherapeutics of the hormone replacement therapy that the client has been prescribed. What topic should the nurse address?

the effect of the drug on the client's body Pharmacotherapeutics addresses the drug's effect on the body and the body's response to the drug. Metabolism, absorption and elimination are a focus of pharmacokinetics.

Drugs are classified according to what features?

therapeutic uses Drugs are classified according to their effects on particular body systems, their therapeutic uses, and their chemical characteristics.

After teaching a group of students about the sources of drugs, the instructor determines that the students need additional teaching when they identify what as an example of a drug from a plant source?

thyroid hormone Thyroid hormone is derived from an animal source, but now may be created synthetically. Digitalis is derived from a plant source. Opium is derived from a plant source. Morphine is derived from a plant source.