Chapter 01: Introduction to Drugs (prep-u)

The nurse treating a client for the past week notes no improvement in the client's condition. Another nurse mentions a new drug that might help the client. The first nurse has never heard of this newly introduced drug. What is the most likely reason that Sally has not heard about this new drug?

The nurse was not aware of or did not have access to reliable resources for new drug information. It is most likely that Sally has not had access to reliable and up-to-date drug reference information. Awareness of reliable resources and the specific type of information provided in those resources ensures that a nurse is efficiently and completely informed about safe drug administration and new therapeutic developments. It is unlikely that the cause could be Sally's lack of initiative or level of interest in the ailment.

Male volunteers are usually selected for drug testing during a phase I study for which reason?

The risk for damaging or destroying women's ova is too great. Women are not good candidates for phase I studies because the chemicals may exert unknown and harmful effects on a woman's ova, and too much risk is involved in taking a drug that might destroy or alter the ova. Women do not make new ova after birth. Men produce sperm daily, so there is less potential for complete destruction or alteration of the sperm. Women are not more unreliable, and men are not more consistent in body build or less likely to develop toxic effects.

The nurse received an order for furosemide (Lasix). Why should the nurse write the generic name on the order sent to the pharmacy?

There is less chance of the wrong drug being given, because trade names can be similar. The generic name of a drug is also known as its nonproprietary name. Each drug has only one generic name, which identifies the drug's active ingredient. As a general rule, generic names are less complicated than the chemical names from which they are derived, but they are more complicated than trade names. Generic names are easily recognizable because the first letter of the name is typically not capitalized.

One of the phases of drug development is the post-marketing surveillance phase. Which activity is carried out during this phase?

Health care providers report adverse effects to FDA.

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.

While reviewing a package insert for a drug, what would the nurse identify as the drug's generic name?

Levothyroxine sodium Levothyroxine sodium is the generic name L-thyroxine would be the chemical name; Levothroid or Synthroid would be the brand names.

A nurse is preparing to administer morphine. The nurse understands that this drug is categorized as which schedule of a controlled substance? C-II C-III C-IV C-V

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

Which schedule drugs have high abuse potential and no accepted medical use? Schedule I Schedule II Schedule III Schedule IV

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.

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.

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

A client has asked the nurse to research a drug that the client read about online. The nurse's research reveals that it is an orphan drug. What should the nurse teach the client about this drug? "This drug used to be commonly used, but the FDA has withdrawn its approval." "There are benefits to this drug, but it requires you to stop taking all other drugs while you're taking it." "It could be very difficult to access this drug because it's not readily available on the market." "This drug is temporarily withheld from the market because its patent is in dispute."

"It could be very difficult to access this drug because it's not readily available on the market." Orphan drugs are drugs that have been discovered but are not financially viable and therefore have not been "adopted" by any drug company. For this reason, access is largely nonexistent. This is unrelated to patent issues, the need to forego other medications, or withdrawal of FDA approval.

A client diagnosed with diabetes mellitus has been started on insulin therapy to control glucose levels. The client does not want to take any medications that come from an animal source. What is the best response by the nurse? "If you do not take the animal-based insulin, you will not be able to control your glucose levels." "Many forms of insulin, such as genetically engineered, do not use animal products." "No insulin products come from animals any longer." "It is necessary that you take the form of insulin that the physician prescribes."

"Many forms of insulin, such as genetically engineered, do not use animal products." Traditionally, drugs from animal sources include agents such as insulin. Today, genetically engineered hormones, including insulin, are rapidly replacing animal-based drugs. The advantage of genetically engineered drugs is their purity.

The nurse is administering Tylenol to a client with a fever. The client expresses usually taking acetaminophen for fever and pain. What should the nurse explain to the client about the name of the drug? "The name 'Tylenol' is a generic name and is the same as acetaminophen." "The name 'Tylenol' is the trade name for acetaminophen." "The name 'Tylenol' is the chemical name for acetaminophen." "Tylenol and acetaminophen are not the same medication."

"The name 'Tylenol' is the trade name for acetaminophen." The trade name is also known as a brand or proprietary name, such as Tylenol, and is given to a drug by its manufacturer. Trade names are usually easy to say and remember and are protected by trademark.

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."

The nurse understands that medications are not just manufactured and dispensed. How many phases of clinical trials must a drug go through in order to meet approval standards? 1 2 3 4

4 The approval process for a new drug is lengthy and expensive. It involves four phases of clinical trials.

Which statement correctly defines a drug? A drug is any chemical that can affect living processes. A drug is a genetic composition of molecular compounds. A drug is a biological composition that can affect living processes. A drug is a narcotic composition.

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.

A physician has ordered subcutaneous injections of morphine, a narcotic, every 4 hours as needed for pain for a motor vehicle accident victim. The nurse is aware that there is a high abuse potential for this drug and that it is categorized as a:

C-II drug. Schedule I (C-I): High abuse potential and no accepted medical use (heroin, marijuana, LSD) Schedule II (C-II): High abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates) Schedule III (C-III): Less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics) Schedule IV (C-IV): Less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, and nonnarcotic analgesics) Schedule V (C-V): Limited abuse potential. Primarily small amounts of narcotics (codeine) used as antitussives or antidiarrheals. Under federal law, limited quantities of certain schedule V drugs may be purchased without a prescription directly from a pharmacist. The purchaser must be at least 18 years of age and must furnish suitable identification. All such transactions must be recorded by the dispensing pharmacist.

A nurse has administered drugs to a client per the physician's orders. Which activity should the nurse perform after administering a drug to the client?

Check for adverse drug reactions.

What is the manufacturer's responsibility during phase IV of a drug trial? Find healthy volunteers to test for adverse effects. Continue to monitor the drug's effects while the drug is in general use. Match clients with similar characteristics to test drug effectiveness. Determine if the drug is too toxic for human use.

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.

A nurse is responsible for maintaining an accurate count and record of the controlled substances on the nursing division. This nursing action is regulated by which law or agency? Food, Drug, and Cosmetic Act of 1938 Public Health Service Drug Enforcement Administration Sherley Amendment

Drug Enforcement Administration The Drug Enforcement Administration enforces the Controlled Substances Act. Under this enforcement, nurses are responsible for storing controlled substances in locked containers, administering them only to the people for whom they are prescribed, recording each dose given, and maintaining an accurate inventory. The Food, Drug, and Cosmetic Act of 1938 revised and broadened FDA powers and responsibilities, giving the FDA control over drug safety. The Public Health Service is regulated by the state to maintain the health of individual citizens of the state. The Sherley Amendment of 1912 prohibited fraudulent claims of drug effectiveness.

Which agency is responsible for the enforcement of controlled substances?

Drug Enforcement Agency

A 22-year-old man has been accepted as a participant in a drug trial while his female friend of the same age was rejected. What is the most likely rationale for this decision? Drugs pose a risk to the woman's ova. Risks of toxicity are slightly higher for females. Men as a group typically have homogeneous body builds and tissue mass. Men are less likely to experience adverse effects of the drug.

Drugs pose a risk to the woman's ova. Women are not good candidates for phase I studies because the chemicals may exert unknown and harmful effects on a woman's ova, involving too much risk. Women do not make new ova, so once damaged, the ova will not be replaced, while men make new sperm daily, so there is less potential for damage. Men's bodies are just as varied as women's bodies. Men are not less likely to experience any adverse effects of the drug. Risks of toxicity are not higher among women.

Federal legislation dictates a lengthy and rigorous process of testing for new drugs. What is the primary purpose of this testing process?

Ensure the safety of the public.

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

Escherichia coli

Most drugs that have been developed from inorganic compounds were discovered based on strict studies to demonstrate efficacy.

False Drugs developed from inorganic compounds were discovered accidentally when a cause-effect relationship was observed.

Which agency evaluates drugs that have completed phase III?

Food and Drug Administration (FDA)

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.

The nurse is transcribing physician orders for a client with pneumonia who has been admitted to the hospital. Why should the physician order the medications using the generic name instead of a brand name?

Numerous brand names may exist for the same drug, sothe generic drug should be ordered.

What is a major disadvantage of using over-the-counter (OTC) medications? Cause increased visits to the health care practitioner. Consumers resist the effort to learn more about their condition. People may choose an OTC that interacts with another medication. There is a lack of autonomy.

People may choose an OTC that interacts with another medication. Disadvantages of using an OTC include inaccurate self-diagnoses and potential risks of choosing a wrong or contraindicated drug, delayed treatment by a health care professional, and development of adverse drug reactions and interactions. Advances include greater autonomy, faster and more convenient access to effective treatment, possibly earlier resumption of usual activities of daily living, fewer visits to a health care provider, and possibly increased efforts by consumers to learn about their symptoms/conditions and recommended treatments.

A patient, scheduled to be involved in a drug trial, asks about the involvement of animals in the process. What information should the nurse provide to the patient? During which stage of drug development is the drug tested on laboratory animals?

Phase 0 involves testing the medication's effect on animals During Phase 0, drugs are tested on laboratory animals. 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.

Generic drugs are required to be:

bioequivalent and less expensive than trade-name drugs. Other pharmaceutical companies can market newer drugs, but they must be bioequivalent to the brand name drug and are usually less expensive because the drugs are not patented.

What information does a drug label contain? (Select all that apply.) client's social security number brand name of the drug generic name of the drug expiration date of the medication special drug warnings

brand name of the drug generic name of the drug expiration date of the medication special drug warnings A drug label identifies the brand and generic names of the drug, drug dosage, expiration date, and special drug warnings. It does not contain the client's social security number.

How may drugs be prescribed and dispensed?

by generic or trade name

A nurse reviews the pregnancy risk categories for several drugs. The nurse would identify a drug belonging to which category as being safest to administer to a pregnant woman?

category A A drug identified as category A would be safest because studies of such a drug have not demonstrated a risk to the fetus in the first trimester of pregnancy and no evidence of risk in later trimesters. A category X drug is one in which studies have demonstrated fetal abnormalities or adverse reactions with reported evidence of fetal risks. A category B drug is one in which animal studies have not demonstrated a risk to the fetus but there are no adequate studies in pregnant women, or animal studies have shown an adverse effect but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy and there is no evidence of risk in later trimesters. A category C drug is one in which animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans.

A nurse is to administer medications to a pregnant woman. What class of drug would the nurse interpret as being shown to have adverse effects on animal fetuses but no human studies have been done?

category C Category C: Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans; the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks, or there are no animal reproduction studies and no adequate studies in humans.

A nurse is to administer several drugs. A drug belonging to which class would the nurse interpret as being contraindicated for a pregnant woman? category X category A category B category C

category X A category X drug is one in which studies have demonstrated fetal abnormalities or adverse reactions with reported evidence of fetal risks. A drug in this category would be contraindicated for use in a pregnant woman. A drug identified as category A would be safest because studies of such a drug have not demonstrated a risk to the fetus in the first trimester of pregnancy, and no evidence of risk in later trimesters. A category B drug is one in which animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women, or animal studies have shown an adverse effect, but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy and there is no evidence of risk in later trimesters. Benefit would need to outweigh the risk. A category C drug is one in which animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans. Benefit would need to outweigh the risk.

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.

What drug category indicates fetal risk where the risk outweighs any potential benefit? category A category B category D category X

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.

FDA approval of a drug for OTC availability includes:

evaluation of evidence that the consumer can use the drug safely, using information on the product label.

The nurse instructs the client that some drugs are no longer covered under patent and may be less expensive. What type of drug is the nurse describing? brand name generic orphan drug controlled drug

generic Generic medications are those that are no longer covered by a patent, thereby allowing other companies to make the medication and charge less for the product. Brand name means the name of the drug given by the company that originally manufactured the drug, which may or may not still be under patent. Orphan medications are pharmaceuticals that have been developed to treat a rare disease or carry a high risk of harm and the pharmaceutical company is given an incentive to continue producing the drug. Controlled drugs are those with risk for abuse and dependence. Controlled drugs might be available in generic form, or they may still be under patent if they are drugs that were recently developed.

The nurse dispensing medications to clients knows that medications have various names. What is the medication name most physicians use to prescribe drugs?

generic name The generic name is assigned by the medication's first manufacturer. If more than one company makes the same medication, it will have the same generic name, but different trade names. For this reason, many physicians order medications using only the generic name. The chemical name describes the medication's chemical composition. The official name is the name identified in the USP or NF or in Canada's Health Canada's publications. The trade name or brand name is the copyrighted name assigned by the company manufacturing the medication and is usually followed by the symbol ®.

Drugs related to the chemical or official name and independent of the manufacturer are:

generic name drugs.

A new drug has been created by altering DNA. What process has been utilized to create this drug?

genetic engineering

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.

Administration of a drug is primarily the responsibility of which health care provider?

nurse

Which drug type has been discovered but not manufactured by any drug company?

orphan

A client with a rare genetic disorder is prescribed a medication specific to this disorder. What is the name given to drugs manufactured by companies that receive tax benefits to invest in these drugs? rare drugs practice drugs orphan drugs ghost drugs

orphan drugs The 1982 Orphan Drug Act provides certain tax benefits to companies that invest in drugs useful in the diagnosis, treatment, or prevention of rare diseases, termed orphan drugs.

What is the branch of pharmacology that uses drugs to treat, prevent, and diagnose disease?

pharmacotherapeutics

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

Which duty related to drug therapy is inconsistent with the role of the registered nurse (RN)?

prescribing drugs

A nurse is preparing to administer morphine and recognizes morphine as belonging to what classification of controlled substance?

schedule II (C-II) Schedule II (C-II): High abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates) Morphine is a schedule II (C-II) controlled substance with a severe risk of abuse and dependence. Schedule III drugs have a lower abuse potential and generally contain nonbarbiturate sedatives, nonamphetamine stimulants, and limited amounts of certain narcotics. Schedule IV drugs are those with less abuse potential than schedule III and limited dependence liability, including some sedatives, antianxiety agents, and nonnarcotic analgesics. Schedule V medications have limited abuse potential and are often found in small amounts in antitussives or antidiarrheals. Federal law allows purchase without a prescription directly from a pharmacist if the purchaser is over age 18 and furnishes suitable identification.

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

A nurse who provides care in a long-term care facility is documenting a new resident's medication regimen on the resident's intake admission. The nurse is documenting the generic, rather than proprietary or trade, names of the resident's current drugs because:

there is a potential for confusion and miscommunication if proprietary names are used. The use of generic instead of proprietary (trade) names mitigates some of the potential for confusion that exists due to similar trade names between different drugs. Trade names do not vary from state to state and use of these names in documentation is not legally restricted. There are not typically differences in the use of drugs that are based solely on generic or proprietary name.

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 digitalis opium morphine

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.

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 likelihood of prohibitive cost patent violation lack of participants for clinical trials

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.

The nurse is caring for a group of clients involved in phase 3 of a drug study. Which tasks is the nurse supposed to perform in clinical testing? (Select all that apply.)

•Note the pharmacologic and biologic effects of the drug carefully. •Address how clients feel about the clinical trial.

The nurse is unfamiliar with a medication. What would be considered reliable sources for guidance in administration of this new medication? (Select all that apply.)

•medication package insert •health care facility pharmacist •drug information on the Internet

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.)

•official •nonproprietary