Chapter 1: The Foundation of Pharmacology: Quality and Safety PrepU
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."
a. "DEA numbers are given to physicians and pharmacists when they register with the DEA to prescribe and dispense controlled substances." 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.
The client is prescribed a medication that was just approved by the FDA. The client tells the nurse, "This medication is too expensive. Could the doctor order a generic form of this medication?" What is the nurse's best response? a. "New medications are patented by the manufacturers. A generic is not available." b. "You can request the generic form but the binder used may make the drug less effective for this medication." c. "The generic form of the medication would not be any less expensive because this is a relatively new medication." d. "Generic medications are lower-quality drugs, and that would mean you would not be getting the best treatment available."
a. "New medications are patented by the manufacturers. A generic is not available." When a new drug enters the market, it is given a time-limited patent; generic forms of the medication cannot be produced until the patent expires. Because no generic version of this drug will exist because it is so new, it is impossible to predict what binder will be used or what the cost would be.
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. "OTC drugs are serious medications and carry serious risks if not taken as directed." b. "Taking medications like that is careless and you could cause yourself serious harm if you keep doing it." c. "Sometimes you need to take more than the package directs to treat the symptoms. It's important not to do this frequently." d. "Did you notify your health care provider of the increased dosage you were taking?"
a. "OTC drugs are serious medications and carry serious risks if not taken as directed." 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.
The nurse explains the Drug Enforcement Agency's (DEA's) schedule of controlled substances to the nursing assistant who asks, "Do you ever get a prescription for schedule I medications?" What is the nurse's best response? a. "Schedule I medications have no medical use so they are not prescribed." b. "Schedule I medications have the lowest risk for abuse and do not require a prescription." c, "Schedule I medications are only prescribed in monitored units for client safety." d. "Schedule I medications are found in antitussives and antidiarrheals sold over the counter."
a. "Schedule I medications have no medical use so they are not prescribed." Schedule I medications have no medical use and are never prescribed. Schedule II have high abuse potential with severe dependence liability. Schedule III have less abuse potential than schedule II drugs and moderate dependence liability. Schedule IV have less abuse potential than schedule III and limited dependence liability. Schedule V medications have the lowest risk for abuse and are found mostly in antitussives and antidiarrheals, but they are not sold over the counter.
The nurse is assisting with a phase I drug study. What potential participant would be most appropriate? a. 22-year-old male with an unremarkable health history b. 24-year-old female who takes oral contraceptives c. 49-year-old female who has completed menopause d. 17-year-old male who is in good health
a. 22-year-old male with an unremarkable health history Phase I drug trials usually involve healthy male volunteers because chemicals may exert an unknown and harmful effect on ova in women, which could result in fetal damage when the woman becomes pregnant. Drugs are tested on both men and women, but women must be fully informed of risks and sign a consent stating they understand the potential for birth defects. A 17-year-old would normally be too young to participate.
Which statement best defines how a chemical becomes a drug? a. A chemical must have a proven therapeutic value or efficacy without severe toxicity or damaging properties to become a drug. b. A chemical becomes a drug when it is introduced into the body to cause a change. c. A chemical is considered a drug when the FDA approves its release to be marketed. d. A chemical must have demonstrated therapeutic value to become a drug.
a. A chemical must have a proven therapeutic value or efficacy without severe toxicity or damaging properties to become a drug. A chemical must undergo a series of tests to determine its therapeutic value and efficacy without severe toxicity or damaging properties before it is termed a drug. Test results are reported to the FDA, which may or may not give approval.
While preparing an in-service presentation for nursing staff, a nurse reviews Joint Commission performance measures related to safety in drug administration. The nurse's presentation will correctly identify which drug type as being subject to these performance measures? a. Anticoagulants b. Analgesics c. Anesthetics d. Antipsychotics
a. Anticoagulants According to the Joint Commission, health care institutions that provide anticoagulant therapy must establish a defined process that has a positive impact on client safety with this class of medications. This is not necessarily true when considering the other options.
The nurse is preparing to move to another state. The nurse should complete which action? a. Become familiar with the nurse practice act of the new state. b. Obtain local providers' Drug Enforcement Agency (DEA) number for prescribing controlled substances. c. Become familiar with pregnancy drug categorization system used in the new state. d. Learn about the particular OTC drugs that are for sale in the new state.
a. Become familiar with the nurse practice act of the new state. The nurse needs to learn the rules and regulations in the Nurse Practice Act of the new state she is moving to because regulating of the nurses practice is done by state and they are not all the same. Some are more rigorous than others. Nurses do not memorize a provider's DEA numbers. The DEA is a federal agency that monitors controlled substances in all states. Pregnancy drug categories are standardized nationwide and there is minimal variation on the availability of OTC drugs.
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-III c. C-IV d. C-V
a. C-II Morphine is a schedule II (C-II) controlled substance.
Which of the following are ways that drugs are classified? Select all that apply. a. Effects on body systems b. Therapeutic uses c. Chemical characteristics d. Method of manufacture e. Dosage
a. Effects on body systems b. Therapeutic uses c. Chemical characteristics Drugs are classified according to their effects on particular body systems, their therapeutic uses, and their chemical characteristics.
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. Food and Drug Administration (FDA) b. Drug Enforcement Agency (DEA) c. Centers for Disease Control and Prevention (CDC) d. Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
a. Food and Drug Administration (FDA) 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.
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. Gathering data from clients taking the drug after it has been released to market. b. Recruiting a small number of healthy volunteers to take the drug. c. Administering the drug to clients who have a diagnosis of cancer. d. Publicizing the therapeutic benefits of the drug to cancer support groups.
a. 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.
Which statement is true regarding generic and trade names of drugs? a. Generic names are independent of the manufacturer. b. Trade names are designated by the Food and Drug Administration (FDA). c. Generic names indicate a drug group. d. Trade names are presented in lowercase letters.
a. Generic names are independent of the manufacturer. The generic name is related to the chemical or official name and it is independent of the manufacturer. The generic name often indicates the drug group. The brand or trade name is designated and patented by the manufacturer. In drug literature, trade names are capitalized and generic names are presented in lowercase unless in a list or at the beginning of a sentence.
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.
a. Health care providers report adverse effects to FDA. 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.
Which of the following drugs is considered the prototype of opioid analgesics? a. Morphine b. Codeine c. Aspirin d. Methadone
a. Morphine Morphine is the prototype of opioid analgesics.
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? a. Phase 0 involves testing the medication's effect on animals b. Phase I results of animal testing are forwarded to the Food and Drug Administration (FDA) c. Animal dosing is studied in detail in Phase 2 d. Phase III involves the evaluation of the medication on a variety of different animals including humans
a. 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.
In determining why a medication error occurred, what is an effective strategy for nurses to implement? a. Root cause analysis b. Double-blind study c. Experimental study d. Literature review
a. Root cause analysis Root cause analysis looks at processes as well as end results. In the case of a medication error, the process of administration--from ordering, dispensing, and documenting to administering--needs to be evaluated. All aspects of the unit-based care should be examined.
Which of the following are examples of drugs with local effects? Select all that apply. a. Sunscreen b. Cold sore medicine c. Antihypertensive d. Oral diabetes drugs e. Wart medicine
a. Sunscreen b. Cold sore medicine e. Wart medicine 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.
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 with animals b. Test the drugs on volunteers with the disease c. Test the drugs with placebos d. Test the drugs on healthy volunteers
a. Test the drugs with animals 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.
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 National Institutes of Health (NIH) Revitalization Act b. The Federal Food, Drug, and Cosmetic Act c. The Controlled Drugs and Substance Act d. The Food and Drugs Act
a. The National Institutes of Health (NIH) Revitalization Act 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.
A drug was introduced to the market, where it was well received, and the nurse has learned that generic equivalents will soon be released. The nurse should understand what implication of this fact? a. The manufacturer's patent on the drug has recently expired. b. The drug has recently completed phase 3 testing. c. The drug was previously an orphan drug, with limited supply. d. The drug is facing increased competition from OTC drugs.
a. The manufacturer's patent on the drug has recently expired. Once a brand name drug's patent expires, generic equivalents can be released. This drug would have completed full FDA testing. An orphan drug is not available on the market, usually because it is not financially feasible. The release of generic equivalents is unrelated to competition from OTC drugs.
What behavior demonstrates that a nurse is using knowledge for safe patient care under Quality and Safety Education for Nurses (QSEN) competencies when administering medications? a. The nurse keeps the computer printout of medications to refer to when pulling out medications that are due. b. Consults with the pharmacist about possible adverse reactions to a newly approved drug c. Makes suggestion for feature to be included on a new drug dispensing system d. Searches drug databases for effective patient education materials
a. The nurse keeps the computer printout of medications to refer to when pulling out medications that are due. QSEN delineates safe practices. The nurse should not rely on memory to administer medications, and should have strategies to reduce reliance on memory. The nurse engages in teamwork and collaboration when consulting the pharmacist. Appropriate use of technology is demonstrated when researching information and making suggestions relates to quality improvement.
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. chemical name b. generic name c. trade name d. metabolic name e. off brand name
a. chemical name b. generic name c. trade name 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.
A new drug has been created by altering DNA. What process has been utilized to create this drug? a. genetic engineering b. pharmacodynamics c. organic chemistry d. pharmacotherapeutics
a. genetic engineering 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.
The Controlled Substances Act of 1970 regulates what actions in regards to drugs classified as controlled substances? (Select all that apply.) a. manufacturing b. elimination c. distribution d. formulation e. dispensing
a. manufacturing c. distribution e. dispensing The Controlled Substances Act of 1970 regulates the manufacture, distribution, and dispensing of drugs classified as controlled substances.
What is the branch of pharmacology that uses drugs to treat, prevent, and diagnose disease? a. pharmacotherapeutics b. pharmacology c. pharmacodynamics d. chemistry
a. pharmacotherapeutics Pharmacotherapeutics is a branch of pharmacology specifically focused on the use of drugs as therapy, to treat, prevent, and diagnose disease. Pharmacology is the all-encompassing term for the study of the biological effects of chemicals. Pharmacodynamics is one topic discussed in pharmacotherapeutics that addresses what the drug does to the body, while pharmacokinetics addresses what the body does to the drug. The drugs being used to treat, diagnose, and prevent disease are chemicals, but the study of chemistry includes far more than just therapeutic chemicals.
A drug has been tested on laboratory animals and is now ready for the next phase. What is the next step? a. phase I study b. phase III study c. phase II study d. preclinical trial
a. phase I study A phase I study uses human volunteers for testing. This phase occurs after preclinical trials, which involve animal testing. A phase III study involves the use of the drug in a vast clinical market. This phase follows phase II, which involves trying the drug out in clients with the disease that the drug is designed to treat. A phase II study allows investigators to try out the drug in clients who have the disease that the drug is designed to treat. This phase follows testing on human volunteers. A preclinical trial is the first step in drug testing and involves drug testing on laboratory animals.
A drug has been approved by the Food and Drug Administration. What study phase would occur next? a. phase IV study b. phase III study c. phase II study d. phase I study
a. 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.
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? a. prescription drugs b. nonprescription drugs c. herbalism d. vitamin supplements
a. 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 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
a. right drug b. right route c. right client d. right time 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).
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)
a. schedule II (C-II) 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? a. the effect of the drug on the client's body b. the way that the client's body processes hormones c. the processes of absorption and elimination d. safe and effective methods for drug administration
a. 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.
A nurse demonstrates an understanding of the impact the National Institutes of Health (NIH) Revitalization Act has had on the policies currently guiding drug trials, when making which statement? a. "Every drug research study must include the gathering of data on the medication's effect on men." b. "There is such a important information now available since both women and minorities are included in drug research studies." c. "The safety of the participants has improved since animal testing must be completed prior to human drug testing." d. "The inclusion of a double-blind testing format adds credibility to the findings of human drug testing."
b. "There is such a important information now available since both women and minorities are included in drug research studies." Historically, drug research was done mainly with young, white males as subjects. In 1993, Congress passed the National Institutes of Health (NIH) Revitalization Act, which formalized a policy of the NIH that women and minorities must be included in human subject research studies funded by the NIH and in clinical drug trials.
What information does the nurse acquire by knowing the therapeutic classification of the drug being administered? a. Factors that will affect the drug's effectiveness b. Conditions for which the medication is used c. Possible adverse reactions to the medications d. Possible generic names for the medication
b. Conditions for which the medication is used Drugs are classified according to their effects on particular body systems, their therapeutic uses, and their chemical characteristics. The names of therapeutic classifications usually reflect the conditions for which the drugs are used (e.g., antidepressants, antihypertensives). The information provided by the therapeutic classification is not associated with effectiveness, adverse reactions, or generic name.
What is the manufacturer's responsibility during phase IV of a drug trial? a. Find healthy volunteers to test for adverse effects. b. Continue to monitor the drug's effects while the drug is in general use. c. Match clients with similar characteristics to test drug effectiveness. d. Determine if the drug is too toxic for human use.
b. 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)? a. Loss of bowel and bladder control b. Difficulty breathing and maintaining an airway c. Feelings of chest tightness and heaviness d. Decrease in appetite and food consumption
b. 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? a. U.S. Department of Justice b. Drug Enforcement Agency c. Department of Health and Human Services d. Food and Drug Administration
b. 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.
While reviewing a package insert for a drug, what would the nurse identify as the drug's generic name? a. L-thyroxine b. Levothyroxine sodium c. Levothroid d. Synthroid
b. Levothyroxine sodium Levothyroxine sodium is the generic name. L-thyroxine would be the chemical name; Levothroid or Synthroid would be the brand names.
The nurse is preparing a client for discharge knowing the client will be self-administering medication at home. What is the nurse's most appropriate action? a. Provide the client with the nurse's contact information for when the client has questions. b. Provide thorough medication teaching about drugs and the drug regimen. c. Advise the use of over-the-counter medication to treat potential adverse effects. d. Provide a 2-day supply of medication to take home until prescription is filled.
b. Provide thorough medication teaching about drugs and the drug regimen. The nurse is responsible for providing thorough medication teaching about drugs and the drug regimen to ensure the client knows how to take the medication and when to notify the provider. The nurse never provides personal contact information to a client. If adverse effects arise, the client is taught to call the healthcare provider and should not self-medicate with over-the-counter drugs, which could mask serious symptoms. The nurse never dispenses medication because it must be properly labeled for home use; this is done by the pharmacy.
Which are true of nonprescription drugs? (Select all that apply.) a. They require a prescription to obtain. b. They are referred to as over-the-counter drugs. c. They can be taken without risk to the client. d. They have certain labeling requirements. e. They should be taken only as directed on the label.
b. They are referred to as over-the-counter drugs. d. They have certain labeling requirements. e. They should be taken only as directed on the label. Nonprescription drugs are often referred to as over-the-counter (OTC) drugs. They do not require a prescription but do not come without risk to the client. The federal government has imposed labeling requirements of OTC drugs and should only be taken as directed on the label unless under the supervision of a health care provider.
A nurse is unfamiliar with a drug that a client in the community has recently been prescribed. What resource should the nurse consult to assess relevant nursing related information? a. Drug Facts and Comparisons b. a nurse's drug guide c. www.drugs.com d. The Physicians' Drug Reference
b. a nurse's drug guide A nurse's drug guide provides nursing implications and client teaching points that are most useful to nurses in addiction to need-to-know drug information in a very user-friendly organizational style. Lippincott's Nursing Drug Guide (LNDG) has drug monographs organized alphabetically and includes nursing implications and client teaching points. Numerous other drug handbooks are also on the market and readily available for nurses to use. Although other drug reference books such as Drug Facts and Comparisons and PDR can all provide essential drug information, they will not contain nursing information and teaching points. They can also be more difficult to use than nurse's drug guides. A reputable drug guide is a better source than a consumer website.
What is included in FDA approval of a drug for OTC availability? a. analysis of the cost of the drug to the consumer b. evaluation of evidence that the consumer can use the drug safely, using information on the product label c. studies involving the safe use of the medication by the consumer d. analysis of the diagnoses for which the medication may be used by the consumer
b. evaluation of evidence that the consumer can use the drug safely, using information on the product label 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.
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? a. brand name b. generic c. orphan drug d. controlled drug
b. 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.
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
b. generic 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.
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. pharmacoeconomics b. pharmacotherapeutics c. pharmacodynamics d. pharmacokinetics
b. pharmacotherapeutics 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.
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."
c. "Drugs in the preclinical phase of testing are tested on animals and have not received approval from the FDA to be prescribed yet." 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.
The client asks the nurse why generic drugs would be used and voices concerns that only the brand-name product will be safe. What is the nurse's best response? a. "Generic drugs are absolutely identical to brand-name drugs, and less expensive." b. "Some significant quality control problems have been found with generic drugs, but they're much cheaper." c. "Most generic drugs are very safe, are cost-effective, and have only subtle differences." d. "Although initial cost is higher for a brand name it may cost less in the long run."
c. "Most generic drugs are very safe, are cost-effective, and have only subtle differences." Most generic medications are less expensive than brand name versions, but this does not address the client's concern about safety. There may be subtle differences between generic drugs and brand name drugs. Although some quality control issues have occurred in the past, this does not address the client's concerns regarding safety or explain why generic drugs are prescribed and used. It is true that some providers believe that brand name drugs have a higher initial cost but will cost less over time; however, this response does not address the client's concerns.
For which patient will the nurse need to consult the Beers Criteria prior to administering medications? a. A toddler who has just been prescribed an antibiotic for an infection b. A newborn who has just been prescribed a medication for reflux c. An elderly patient who has been prescribed new medications for pain control d. A teenage patient newly diagnosed with type 1 diabetes mellitus
c. An elderly patient who has been prescribed new medications for pain control The Beers Criteria is a list of medications generally considered inappropriate when given to the elderly. The nurse should consult this list prior to administering new medications to an elderly patient. Newborns, toddlers, and teenage patients would not be covered by this list of medications.
Prescription practices of primary health care providers for controlled substances are monitored by which agency? a. U.S. Pharmacopeia (USP) b. Food and Drug Agency (FDA) c. Drug Enforcement Agency (DEA) d. World Health Organization (WHO)
c. Drug Enforcement Agency (DEA) 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.
What is a major disadvantage of using over-the-counter (OTC) medications? a. Cause increased visits to the health care practitioner. b. Consumers resist the effort to learn more about their condition. c. People may choose an OTC that interacts with another medication. d. There is a lack of autonomy.
c. 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.
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
c. adverse effects 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.
A nurse is teaching the client about the use of over-the-counter (OTC) drugs. Which statement best informs the client about their safe use? a. "OTC drugs are products that are available without prescription for self-treatment of minor health issues." b. "OTC drugs are considered medications and should be reported on a drug history." c. "OTC drugs were approved as prescription drugs but later were found to be safe without the need of a prescription." d. "OTC drugs need to be taken with caution; they can mask the signs and symptoms of an underlying disease and interfere with prescription drug therapy."
d. "OTC drugs need to be taken with caution; they can mask the signs and symptoms of an underlying disease and interfere with prescription drug therapy." OTC drugs are considered medications and should be reported. OTC drugs are available without a prescription although some were first approved as prescription drugs. The most important teaching should relate to their safe use and that OTC drugs can mask symptoms of disease and interfere with prescribed drugs.
When asked by a client about the generic name of a drug, what is the nurse's best response? a. "The generic name describes the molecular structure of the drug." b. "The generic name is the drug name registered by the manufacturer." c. "The generic name is written in capital letters on the drug container." d. "The generic name is the official name given by the U.S. Food and Drug Administration."
d. "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.
What statement describes a required characteristic of all generic drugs? a. Generic drugs are required to be protected by a current American patent. b. Generic drugs are designated and patented exclusively by the manufacturer. c. Generic drugs are categorized according to overall usefulness and potential for abuse. d. Generic drugs must be therapeutically equivalent to brand name drugs.
d. Generic drugs must be therapeutically equivalent to brand name drugs. 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.
Which legislative act allowed the FDA to tighten control over the quality of drugs and required that safety and efficacy standards be established? a. Pure Food and Drug Act of 1906 b. Federal Food, Drug, and Cosmetic Act of 1938 c. Durham-Humphrey Amendment of 1951 d. Kefauver-Harris Act of 1962
d. Kefauver-Harris Act of 1962 The Kefauver-Harris Act was the result of the use of the 1960s drug, thalidomide (Thalomid). The public concern led to the legislation that gave the FDA regulatory control over testing and evaluating of drugs and allowed them to set standards for efficacy and safety. The Pure Food and Drug Act required labeling to eliminate false claims. The Federal Food, Drug, and Cosmetic Act gave the FDA power to enforce standards for testing drug toxicity and monitoring labeling. The Durham-Humphrey amendment enforced prescriptions for distribution.
The nurse is working in a community outreach clinic. What should the nurse teach a client about over-the-counter medications? a. The only risks of OTC medications are associated with overdoses and drug interactions. b. They are best used to enhance the effects of prescription medications. c. They are always more cost effective than prescription medications. d. OTC medications are not risk free.
d. OTC medications are not risk free. Over-the-counter, or OTC, medications are those that can be purchased without a prescription. Because the individual can purchase these drugs without the guidance of a provider, it is important to read and follow the directions carefully to avoid self-harm. They pose numerous potential risks and can be costly.
The nurse is reviewing a client's medication regimen. What medication would the nurse recognize as being a schedule V (C-V) medication? a. oral morphine b. ibuprofen c. a "daytime" allergy medication d. cough syrup that contains a small amount of codeine
d. 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.
Which drug may be derived from an animal source? a. digitalis b. opium c. morphine d. insulin
d. insulin 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 coli bacteria. Digitalis, opium, and morphine are derived from plant sources.
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
d. 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.
During a phase II study, a drug may be removed from testing because of: a. greater than anticipated effectiveness. b. low risk of toxicity. c. high benefit-to-risk ratio. d. unacceptable adverse effects.
d. unacceptable adverse effects. 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.
