Ch 1: The Foundation of Pharmacology: Quality and Safety

c) Continue to monitor the drug's effects while the drug is in general use Pg. 7 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.

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

c) Unacceptable adverse effects Pg. 7 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.

1. 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? a) Likelihood of prohibitive cost b) Patent violation c) Unacceptable adverse effects d) Lack of participants for clinical trials

c) "Drugs in the preclinical phase of testing are tested on animals and have not received approval from the FDA to be prescribed yet" Pg. 7 During the preclinical phase (phase 0) of testing, drugs are tested on animals and are not available to clients. In phase I, the drug is tested on healthy volunteers. It is only in phase III studies that the drug is made available to prescribers who agree to closely monitor clients getting the medication.

10. The client tells the nurse about a new drug being tested to treat the disease he or she was diagnosed with and asks the nurse whether the doctor can prescribe a medication still in the preclinical phase of testing. What is the nurse's best response? a) "The doctor would have to complete a great deal of paperwork to get approval to prescribe that drug" b) "Sometimes pharmaceutical companies are looking for volunteers to test a new drug, and the doctor could give them your name" c) "Drugs in the preclinical phase of testing are tested on animals and have not received approval from the FDA to be prescribed yet" d) "Drugs in the preclinical phase of testing are given only to healthy young men and so would not be available to you"

a) Right drug b) Right route c) Right client d) Right time Pg. 8 The traditional rights of medication administration (right drug, right dose, right client, right route, right time, right reason, and right documentation) now include additional rights that should also be considered (right education, right evaluation, and right to refuse the medication).

11. A nurse is preparing to give a client's scheduled medication and is reviewing the rights of medication administration. What will be included in these rights? Select all that apply. a) Right drug b) Right route c) Right client d) Right time e) Right setting

d) Difficulty breathing and maintaining an airway Pg. 7 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.

12. Which is an example of a black box warning by the Food and Drug Administration (FDA)? a) Loss of bowel and bladder control b) Feelings of chest tightness and heaviness c) Decrease in appetite and food consumption d) Difficulty breathing and maintaining an airway

b) Genetic engineering Pg. 3 Genetic engineering is the process of altering DNA in order to produce a chemical that is therapeutic and effective. Most often, the DNA is altered in a bacterium to create the new drug. Pharmacodynamics is one topic discussed in pharmacotherapeutics that addresses what the drug does to the body, but it does not specifically address the process of altering DNA. The drugs being used to treat, diagnose, and prevent disease are chemicals, but the study of chemistry includes far more than just those formed by altering DNA. Pharmacotherapeutics is a branch of pharmacology specifically focused on the use of drugs as therapy, to treat, prevent, and diagnose disease. DNA modification may be used on some drugs discussed by this branch of pharmacology, but there is a specific term for modifying DNA.

13. A new drug has been created by altering DNA. What process has been utilized to create this drug? a) Pharmacotherapeutics b) Genetic engineering c) Organic chemistry d) Pharmacodynamics

c) Adverse effects Pg. 11 Negative or unexpected effects are known as adverse or side effects. Teratogenic effects are adverse effects on the fetus and not a likely concern for an older adult. Toxic effects occur when medication is taken in larger than recommended dosages caused by an increase in serum drug levels. Paradoxical effects are drug effects that are the opposite of what is intended.

14. The nurse is caring for an older adult who needs to know that drugs, even when taken correctly, can produce negative or unexpected effects. The nurse should address what topic during health education? a) Teratogenic effects b) Toxic effects c) Adverse effects d) Paradoxical effects

b) Insulin Pg. 3 Insulin for treating diabetes was obtained exclusively from the pancreas of cows and pigs, but now genetic engineering has allowed scientists to produce human insulin by altering Escherichia colibacteria. Digitalis, opium, and morphine are derived from plant sources.

15. Which drug may be derived from an animal source? a) Opium b) Insulin c) Digitalis d) Morphine

d) The effect of the drug on the client's body Pg. 3 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.

16. 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? a) The processes of absorption and elimination b) The way that the client's body processes hormones c) Safe and effective methods for drug administration d) The effect of the drug on the client's body

c) Evaluation of evidence that the consumer can use the drug safely, using information on the product label Pg. 7 FDA approval of a drug for OTC availability involves evaluation of evidence that the consumer can use the drug safely, using information on the product label, and shifts primary responsibility for safe and effective drug therapy from health care professionals to consumers. With prescription drugs, a health care professional diagnoses the condition, often with the help of laboratory and other diagnostic tests, and determines a need for the drug.

18. What is included in FDA approval of a drug for OTC availability? a) Studies involving the safe use of the medication by the consumer b) Analysis of the cost of the drug to the consumer c) Evaluation of evidence that the consumer can use the drug safely, using information on the product label d) Analysis of the diagnoses for which the medication may be used by the consumer

b) Morphine Pg. 6 Morphine is the prototype of opioid analgesics.

19. Which of the following drugs is considered the prototype of opioid analgesics? a) Codeine b) Morphine c) Aspirin d) Methadone

b) People may choose an OTC that interacts with another medication Pg. 7 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.

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

a) Health care providers report adverse effects to FDA Pg. 7 The post-marketing surveillance phase of drug development encourages health care professionals to report adverse effects of drugs to the FDA using MedWatch. Phase I of clinical testing involves 20 to 100 healthy volunteers. In vitro testing of the drug on human or animal cells is done in the pre-FDA phase. In phase II of clinical testing, the drug is given to clients with the disease for which the drug is manufactured.

20. One of the phases of drug development is the post-marketing surveillance phase. Which activity is carried out during this phase? a) Health care providers report adverse effects to FDA b) Healthy volunteers are involved in the test c) In vitro tests are performed using human cells d) The drug is given to clients with the disease

b) "OTC drugs are safe and do not cause adverse effects if taken properly" c) "OTC drugs have been around for years and have not been cleared by the Food and Drug Administration (FDA)" d) "OTC drugs are different from any drugs available by prescription and cost less" e) "OTC drugs can often be used as a cost-effective substitute for prescribed drugs" Pg. 7 It is important to follow package directions because OTCs are medications that can cause serious harm if not taken properly. OTCs are drugs that have been determined to be safe when taken as directed; however, all drugs can produce adverse effects even when taken properly. They may have originally been prescription drugs that were cleared by the FDA or they may have been grandfathered in when the FDA laws changed. OTC education should always be included as a part of the hospital discharge instructions. Clients should not view OTC drugs as being substitutes for prescribed drugs.

21. Discharge planning for clients leaving the hospital should include instructions on the use of over-the-counter (OTC) drugs. Which comments by the client should prompt the nurse to provide health education? Select all that apply. a) "OTC drugs could cause serious harm if not taken according to directions" b) "OTC drugs are safe and do not cause adverse effects if taken properly" c) "OTC drugs have been around for years and have not been cleared by the Food and Drug Administration (FDA)" d) "OTC drugs are different from any drugs available by prescription and cost less" e) "OTC drugs can often be used as a cost-effective substitute for prescribed drugs"

a) Generic drugs must be therapeutically equivalent to brand name drugs Pg. 4 Generic drugs must be therapeutically equivalent to the brand name drug and are usually less expensive. Generic drugs are categorized in the same fashion as are brand name drugs. The remaining statements are descriptive of brand name drugs.

22. What statement describes a required characteristic of all generic drugs? a) Generic drugs must be therapeutically equivalent to brand name drugs b) Generic drugs are required to be protected by a current American patent c) Generic drugs are designated and patented exclusively by the manufacturer d) Generic drugs are categorized according to overall usefulness and potential for abuse

d) The National Institutes of Health (NIH) Revitalization Act Pg. 7 In 1993, Congress passed the National Institutes of Health Revitalization Act, which formalized a policy that women and minorities be included in human research studies. None of the other options are associated with assuring drugs provide gender-related effectiveness.

23. Newly developed drugs must include gender-related effectiveness and safety information in the initial Food and Drug Administration (FDA) application based upon which legislative act? a) The Controlled Drugs and Substance Act b) The Federal Food, Drug, and Cosmetic Act c) The Food and Drugs Act d) The National Institutes of Health (NIH) Revitalization Act

a) Schedule II Pg. 6 Opioids with a high abuse potential are classified as schedule II drugs because of severe dependence liability. Schedule I drugs have high abuse potential and no accepted medical use. Schedule III drugs have a lesser abuse potential than schedule II drugs and an accepted medical use. Schedule IV drugs have low abuse potential and limited dependence liability.

24. The care provider has prescribed intravenous hydromorphone for a client using a client-controlled analgesia (PCA) pump. The nurse is aware that this drug has a high abuse potential. Under what category would hydromorphone be classified? a) Schedule II b) Schedule IV c) Schedule III d) Schedule I

d) Morphine Pg. 6 Individual drugs, often the first drugs of a particular group to be developed, are usually the standard with which newer, similar drugs are compared. While all the options are opioids analgesics, morphine is the prototype for opioids. Understanding morphine makes learning about other opioid analgesics easier because they are compared with morphine.

25. What drug would the nurse discuss when educating a client about the prototype of opioid analgesics? a) Hydrocodone b) Meperidine c) Methadone d) Morphine

d) "OTC drugs are serious medications and carry serious risks if not taken as directed" Pg. 7 OTC drugs are no less a medication than prescription drugs and carry the same types of risks for overdose and toxicity if directions are not followed. Although increasing the dosage is careless and dangerous, it is important to use the information as a teaching opportunity rather than scolding the client. Agreeing with the client or asking the client if they talked to the health care provider misses the teaching opportunity, which could be harmful for the client.

26. While collecting a medication history, the client admits to doubling the recommended dosage of acetaminophen, saying "It's harmless or they would require a prescription." What is the nurse's best response? a) "Did you notify your health care provider of the increased dosage you were taking?" b) "Sometimes you need to take more than the package directs to treat the symptoms. It's important not to do this frequently" c) "Taking medications like that is careless and you could cause yourself serious harm if you keep doing it" d) "OTC drugs are serious medications and carry serious risks if not taken as directed"

b) Unacceptable adverse effects Pg. 7 A drug may be removed from further testing during a phase II study if it produces unacceptable adverse effects, is less effective than anticipated, is too toxic when used with clients, and has a low benefit-to-risk ratio.

27. During a phase II study, a drug may be removed from testing because of: a) High benefit-to-risk ratio b) Unacceptable adverse effects c) Low risk of toxicity d) Greater than anticipated effectiveness

a) C-II Pg. 6 Morphine is a schedule II (C-II) controlled substance.

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

b) Pharmacotherapeutics Pg. 3 Pharmacology is the study of the biological effects of chemicals. Nurses are involved with clinical pharmacology or pharmacotherapeutics, which is a branch of pharmacology that deals with the uses of drugs to treat, prevent, and diagnose disease. The nurse working in radiology is administering a drug to help diagnose a disease. The nurse working in an oncology unit is administering a drug to help treat a disease. Pharmacoeconomics includes any costs involved in drug therapy. Pharmacodynamics involves how a drug affects the body and pharmacokinetics is how the body acts on the drug.

29. A nurse working in radiology administers iodine to a client who is having a CAT scan. The nurse working on the oncology unit administers chemotherapy to clients who have cancer. At the Public Health Department, a nurse administers an MMR to a 14-month-old child as a routine immunization. Which branch of pharmacology describes the actions of all three nurses? a) Pharmacokinetics b) Pharmacotherapeutics c) Pharmacoeconomics d) Pharmacodynamics

b) Sunscreen c) Cold sore medicine e) Wart medicine Pg. 3 Medications may be given for local or systemic effects. Drugs with local effects act mainly at the site of application. Those with systemic effects are taken into the body, circulated through the bloodstream to their sites of action in various body tissues, and eventually eliminated from the body.

3. Which of the following are examples of drugs with local effects? Select all that apply. a) Antihypertensive b) Sunscreen c) Cold sore medicine d) Oral diabetes drug e) Wart medicine

b) Prescription c) Nonprescription e) Controlled substance Pg. 7 Once drugs are approved for use, the FDA assigns the drug to one of the following categories: prescription, nonprescription, or controlled substance.

30. The Food and Drug Administration assigns newly approved drugs to which categories? (Select all that apply.) a) Noncontrolled substance b) Prescription c) Nonprescription d) Nutraceuticals e) Controlled substance

d) Therapeutic classification Pg. 3 Referring to a medication by the condition for which it is used is identifying its therapeutic classification. The trade name and brand name are created by the company manufacturing the medication. The chemical name is developed during the creation of the drug.

31. A nurse is teaching a patient about medications referred to as "antihypertensives." To what is the term "antihypertensive" referring? a) Chemical name b) Brand name c) Generic name d) Therapeutic classification

a) "DEA numbers are given to physicians and pharmacists when they register with the DEA to prescribe and dispense controlled substances" Pg. 6 All pharmacists and physicians must register with the DEA. They are given numbers that are required before they can dispense or prescribe controlled substances. DEA numbers are only needed when prescribing controlled substances. A DEA number is neither a case number nor a drug code.

32. A client asks the nurse, "What is a Drug Enforcement Agency (DEA) number?" What is the nurse's best response? a) "DEA numbers are given to physicians and pharmacists when they register with the DEA to prescribe and dispense controlled substances" b) "Physicians must have a DEA number in order to prescribe any type of medication for clients" c) "DEA numbers are case numbers given when someone breaks the law involving a controlled substance" d) "DEA numbers standardized codes for each drug that is on the market in the United States"

b) Test the drugs with animals Pg. 7 Since 1962, newly developed drugs have been extensively tested before being marketed for general use using a five phase process. In Phase 0, the drug testing occurs in animals and small groups of humans. In Phase 1, a few doses are given to a certain number of healthy volunteers. In Phase 2, a few doses are given to a certain number of subjects with the disease or symptom for which the drug is being studied. In Phase 3, the drug is given to different populations and different dosages and by using the drug in combination with other drugs. in double-blind, placebo-controlled design, half of the subjects receive the new drug and half receive a placebo. 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.

33. Since 1962, newly developed medications have been extensively tested before being marketed for general use. Which step must the pharmaceutical companies prioritize when beginning the testing? a) Test the drugs on volunteers with the disease b) Test the drugs with animals c) Test the drugs with placebos d) Test the drugs on healthy volunteers

c) Drug Enforcement Agency (DEA) Pg. 6 The Drug Enforcement Agency is responsible for monitoring prescription practices for controlled substances of the primary health care provider. The FDA monitors all drug development. The USP organization sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. The World Health Organizations represents the entire world and does not monitor controlled substances of primary health care providers.

34. Prescription practices of primary health care providers for controlled substances are monitored by which agency? a) World Health Organization (WHO) b) U.S. Pharmacopeia (USP) c) Drug Enforcement Agency (DEA) d) Food and Drug Agency (FDA)

a) Generic name c) Chemical name d) Trade name Pg. 3 Medications have several names assigned to them: a chemical name, a generic (nonproprietary, official) name, and a trade (or brand) name. Off-brand names or metabolic names are not used to classify medications.

35. A nurse determines that medications are known by different names. What are the different classifications of names assigned to medications? Select all that apply. a) Generic name b) Metabolic name c) Chemical name d) Trade name e) Off brand name

c) Gathering data from clients taking the drug after it has been released to market Pg. 7 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.

36. 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? a) Publicizing the therapeutic benefits of the drug to cancer support groups b) Administering the drug to clients who have a diagnosis of cancer c) Gathering data from clients taking the drug after it has been released to market d) Recruiting a small number of healthy volunteers to take the drug

d) Phase IV study Pg. 7 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.

4. Which phase of drug development is associated with continual evaluation of the drug? a) Phase I study b) Phase II study c) Phase III study d) Phase IV study

a) Schedule II (C-II) Pg. 6 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.

5. A nurse is preparing to administer morphine and recognizes morphine as belonging to what classification of controlled substance? a) Schedule II (C-II) b) Schedule III (C-III) c) Schedule IV (C-IV) d) Schedule V (C-V)

c) Food and Drug Administration (FDA) Pg. 4 The FDA is responsible for controlling and regulating the development and sale of drugs in the United States, allowing new drugs to enter the market only after being subjected to rigorous scientific testing. The DEA regulates and controls the use of controlled substances. The CDC monitors and responds to infectious diseases. The JCAHO is an accrediting body that inspects acute care facilities to ensure minimum standards are met.

6. In response to the client's question about whether drugs are safe, the nurse explains that all medications in the United States undergo rigorous testing controlled by what organization? a) Drug Enforcement Agency (DEA) b) Centers for Disease Control and Prevention (CDC) c) Food and Drug Administration (FDA) d) Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

b) Generic Pg. 3 Individual drugs are known by the trade (brand) or generic names. Those designated and patented by manufacturers are trade (brand) name drugs. Generic drugs are independent of the manufacturer's trade or brand name. Prototype is the term used to identify the first drug of a particular drug class to be developed.

7. What term is used to describe drugs identified by their chemical or official name in order to be independent of any manufacturer's assigned name? a) Brand b) Generic c) Prototype d) Trade

a) Solubility c) Protein binding e) Blood flow Pg. 19 Distribution of an absorbed drug in the body depends on protein binding, solubility, and blood flow. Metabolites may undergo further metabolism or may be excreted from the body unchanged. Half-life refers to the time required for the body to eliminate 50% of the drug.

8. Which would the nurse identify as a factor in the distribution of a drug? Select all that apply. a) Solubility b) Metabolite formation c) Protein binding d) Half-life e) Blood flow

a) Drug Enforcement Agency (DEA) Pg. 6 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.

9. Which agency is responsible for the enforcement of controlled substances? a) Drug Enforcement Agency (DEA) b) U.S. Department of Justice c) Department of Health and Human Services d) Food and Drug Administration (FDA)