Chapter 3: Cultural, Legal, and Ethical Considerations

The nurse is assessing an Asian patient who has back pain. Which questions will the nurse ask while performing the cultural assessment? Select all that apply. "Can you tell me about your usual diet?" "Do you perform exercises on a regular basis?" "What measures do you usually take to control pain?" "How frequently do you use over-the-counter drugs?" "Do other people in the workplace have similar complaints?"

"Can you tell me about your usual diet?" "What measures do you usually take to control pain?" "How frequently do you use over-the-counter drugs?" (While performing the cultural assessment of a patient, the nurse would ask about the patient's usual diet. Diet varies from culture to culture and plays a major role in determining the health of an individual. It is also known to affect drug action. Different cultures may use different treatment methods to cure pain. Therefore the nurse would ask about the use of traditional methods to treat pain. The usage of over-the-counter medications also varies among different cultures. People belonging to Western cultures rely more on these drugs compared to people belonging to Eastern cultures. Performing regular exercise is an individual preference and does not vary significantly among different cultures. The nurse would ask about other people in the patient's workplace who have similar complaints while taking the occupational history.)

Which statement by a patient supports the nurse's conclusion that the patient follows Asian cultural practices? "I prefer to eat hot soup when I have the flu." "I have faith in spiritual people as therapists." "I believe that a disease is caused by doing bad deeds." "I believe that disharmony with nature and evil spirits cause disease."

"I prefer to eat hot soup when I have the flu" (Many Asians believe in traditional medicine and therefore prefer hot soups, tea, and herbs to cure ailments. The patient's preference for hot soup indicates that the patient follows Asian cultural practices. Many Africans use spiritualists as healers or therapists. Many people who belong to a Hispanic culture believe that good deeds bring health and that bad deeds bring illness. Many Native Americans believe that evil spirits and disharmony with nature cause disease.)

New drugs must go through extensive research and testing before approval for use in humans. What is the average length of time a medication is researched before being prescribed for humans? 2 to 4 years 6 to 8 years 10 to 12 years 14 to 16 years

10 to 12 years (The average length of time it takes for a drug to move from the application and research process to being prescribed for a patient is 10 to 12 years.)

Once a drug is on the market, how much time does the company have to recoup the cost of research? 1 to 2 years 5 to 7 years 10 to 12 years 16 to 17 years

5 to 7 years (Once a new drug reaches the market, the manufacturer has 5 to 7 years to recoup the research costs because at that point, the drug's patent expires. Once the patent expires, it becomes a generic drug and is free to be manufactured by other companies. One to 2 years is a very short time period in which to recoup the costs incurred. Ten to 12 years is the time period required for complete drug research. The drug discovery process, from the discovery of the molecule until the patent expires, is about 16 to 17 years.)

Which is an "orphan drug?" A drug that is used to treat cancers A drug that is used to treat rare illnesses A drug that provides only symptomatic relief A drug that is used to treat common mental illnesses

A drug that is used to treat rare illnesses (The Orphan Drug Act (1983) enabled the US Food and Drug Administration to promote research and marketing of "orphan drugs." These drugs are used for treating rare diseases. An orphan drug is not used for treating cancers. In addition, orphan drugs are not drugs that provide only symptomatic relief. These drugs also are not used to treat common mental illnesses.)

What are the nursing implications of the Health Insurance Portability and Accountability Act (HIPAA) legislation? A nurse should share patient information with family members. A nurse should ask the parents to make the patient's health care decisions. A nurse should not inform the primary health care provider about confidential patient information. A nurse should share confidential information only with the direct care staff and those that the patient consents to inform.

A nurse should share confidential information only with the direct care staff and those that the patient consents to inform. (HIPAA protects patients' privacy and emphasizes careful handling of electronic medical records. It helps to protect confidential patient information. Under this Act, a patient's information should not be shared with family members or with staff members because it can lead to infringement of HIPAA. This act does not allow the parents of a patient to make health care decisions for the patient unless the patient is a minor. The information can be shared with the primary health care provider if it affects treatment.)

Which regulation was prompted by the HIV/AIDS epidemic? Orphan Drug Act Kefauver-Harris Amendments Accelerated Drug Review Regulations Federal Food, Drug, and Cosmetic Act

Accelerated Drug Review Regulations (The Accelerated Drug Review Regulations (1991) enabled faster approval by the US Food and Drug Administration of drugs to treat life-threatening illnesses. This law was prompted by the HIV/AIDS epidemic. The Orphan Drug Act was prompted because of limited knowledge of and research on the treatment of rare illnesses. The Kefauver-Harris Amendments were prompted by the thalidomide tragedy in the United Kingdom. The Federal Food, Drug, and Cosmetic Act was prompted by the diethylene glycol-contaminated sulfanilamide elixir tragedy in the United States.)

The nurse learns about the regulatory approvals for drugs by the US Food and Drug Administration (FDA). Drugs for which condition may receive expedited approval by the FDA? Hypertension Diabetes mellitus Rheumatoid arthritis Acquired immunodeficiency syndrome (AIDS)

Acquired immunodeficiency syndrome (AIDS) (The FDA provides expedited approvals to drugs used to treat life-threatening conditions or the complications arising from those conditions. AIDS is one such condition. This helps to shorten the approval process and allows primary health care providers to prescribe medications that showed promise during early phase I and phase II trials. Hypertension, diabetes mellitus, and rheumatoid arthritis are not life-threatening conditions.)

The nurse is working in a phase III trial. Which would be the objectives of the trial? Select all that apply. Ascertain the drug's safety for use Obtain further proof of adverse action Obtain further proof of therapeutic action Establish the drug's clinical effectiveness Determine the dosage range for best action

Ascertain the drug's safety for use Establish the drug's clinical effectiveness Determine the dosage range for best action (Clinical trials are performed in four phases. Phase III trials are aimed at ascertaining a drug's safety for use, establishing a drug's clinical effectiveness, and determining the dosage range. The trials help to launch the drug in the market without the risk of serious health effects. Phase IV trials are aimed at determining the adverse effects of the new drug and at obtaining further proof of the drug's therapeutic action.)

After teaching about the purpose, procedure, and risks involved in magnetic resonance imaging (MRI) with dye, the nurse asks a patient whether the patient wishes to go ahead with the MRI procedure. Which ethical principle is the nurse following? Justice Autonomy Beneficence Confidentiality

Autonomy (According to the ethical principle of autonomy, the nurse would ensure that the patient is the most important decision maker related to the health care provided. Therefore the nurse would keep the patient informed about all health care procedures and would also receive consent before beginning any procedure. Justice is the ethical principle of being fair or equal in one's actions while caring for patients. Beneficence is the ethical principle of actively promoting good for all patients. Confidentiality is the ethical principle according to which privileged information about a patient is respected by the nurse. The nurse would disclose information only if the patient agrees to it.)

Which ethical principle is referred to by promoting decision-making by patients and supporting informed consent? Justice Autonomy Beneficence Confidentiality

Autonomy (Ethical principles are integral to nursing practice. Autonomy refers to promoting patient independence and helping patients make the right decision. Justice refers to giving fair treatment to all patients irrespective of any bias. Beneficence refers to performing actions that are beneficial to patients. Confidentiality refers to the duty of the nurse to respect privileged information about a patient.)

The nurse is referring to systematic reviews and meta analyses to find the best possible nursing interventions for effectively removing secretions in a patient with obstructive pulmonary disease. Which ethical principle is the nurse following? Veracity Beneficence Confidentiality Nonmaleficence

Beneficence (Beneficence is the ethical principle of doing or actively promoting good for the health of a patient. The nurse would use evidence to find the interventions that are most beneficial to a patient. Veracity is the ethical principle that ensures that nurses are always truthful while giving information to patients. Confidentiality is the ethical principle according to which privileged information on a patient is respected by the nurse. The patient's personal and health-related information should be disclosed only if the patient agrees to it. Nonmaleficence is the ethical principle according to which nurses would take adequate measures to do no harm to patients.)

Which is the preferred drug for the treatment of hypertension in African-American patients? Diuretics Beta blockers Calcium channel blockers Angiotensin converting enzyme (ACE) inhibitors

Calcium channel blockers (African-American patients respond best to calcium channel blockers. Although diuretics are a preferred choice over ACE inhibitors, they are not as good as calcium channel blockers for the treatment of hypertension. Beta blockers and ACE inhibitors are less effective for treating hypertension in African-American patients.)

The nurse learns that the postmarketing studies of an investigational drug have found that the drug is unsafe to use and may cause serious health effects. What would be the recall class for this drug? Class I Class II Class III Class IV

Class I (Class I drugs have the most serious side effects and are the most unsafe for use. Class II drug recalls are less severe, and the drugs may cause reversible effects on health. Class III drug recalls are the least severe, and the drugs do not cause significant health problems. There is no class IV drug recall classification.)

The nurse ensures that the patient's medical files are not accessed by other nurses in the hospital. Which ethical principle is demonstrated here? Autonomy Beneficence Confidentiality Nonmaleficence

Confidentiality (The nurse's actions indicate that the nurse is trying to prevent the patient's health information from being leaked to other people. According to the principle of confidentiality, the nurse would respect privileged information about a patient. According to the principle of autonomy, the nurse would ensure that the patient makes his or her own health care decisions. According to the principle of beneficence, the nurse would always try to achieve the best health-related outcomes in a patient. According to the principle of nonmaleficence, nurses would take adequate measures to do no harm to patients.)

After finishing a stressful day at work the nurse logs on to a social media website and discusses the day, including the patients at the clinic. Which legal or ethical principle does this violate? Veracity Autonomy Confidentiality Nonmaleficence

Confidentiality (The principle of confidentiality protects patients' personal information. The nurse is violating the confidentiality of the patients by discussing their information using social media. The principle of veracity promotes telling the truth to a patient without giving false reassurance. Autonomy is helping a patient to make his own decisions and providing support when patients give informed consent. Nonmaleficence is the duty of the nurse not to harm a patient while the patient is in his or her care.)

Which is an environmental factor that affects drug polymorphism? Age Diet Culture Gender

Diet (The factors that affect drug polymorphism are divided into environmental factors, cultural factors, and genetic factors. Environmental factors include diet and nutritional status. Age and gender are not environmental factors. Culture is a cultural factor.)

The caption "Caution—federal law prohibits dispensing without a prescription" on all prescription medications was mandated by which legislative act? Federal Food and Drugs Act Kefauver-Harris Amendments Durham-Humphrey Amendment Federal Food, Drug, and Cosmetic Act

Durham-Humphrey Amendment (According to the Durham-Humphrey Amendment, drug labels must carry the legend "Caution—federal law prohibits dispensing without a prescription." According to the Federal Food and Drugs Act, drug manufacturers are required to list on the drug product label the presence of dangerous and possibly addicting substances. According to the Kefauver-Harris Amendment, drug manufacturers are required to demonstrate both the therapeutic efficacy and safety of a new drug. According to the Federal Food, Drug, and Cosmetic Act, drug manufacturers are required to provide data proving drug safety before receiving US Food and Drug Administration approval.)

The nurse wishes to research how a specific prescription drug affects people from various cultures. Which study is this concept named? Pharmacokinetics Pharmacogenetics Ethnopharmacology Pharmacodynamics

Ethnopharmacology (Ethnopharmacology helps to explain the specific impact of cultural factors on patients' responses to drugs. Pharmacokinetics deals with the absorption, distribution, metabolism, and excretion of a drug. Pharmacogenetics is the study of genetic factors that can alter response to a drug. Pharmacodynamics is the study of therapeutic effects of a drug in patients.)

Subjects are being recruited for the trial of a drug that has benefits as well as potential side effects. Which action would the nurse researcher perform when receiving informed consent from the subjects? Explain about the benefits of the drug Explain about the potential side effects Explain about the metabolism of the drug Explain about the benefits and side effects

Explain about the benefits and side effects (When providing informed consent, the subjects should be informed clearly and in detail about the actions of the drug. This includes the benefits as well as the side effects. It helps the subjects to make an informed decision. The nurse would explain not only the side effects but also the benefits so that the subjects are motivated to join the trial. The metabolism of the drug may not be well understood by the subjects. Therefore the metabolism of the drug need not be explained.)

Which is the most dangerous effect of thalidomide drugs? Death Renal failure Fetal abnormalities Severe hepatotoxicity

Fetal abnormalities (The thalidomide tragedy occurred in Europe between the 1940s and 1960s. This disaster caused pregnant women to give birth to infants with serious deformities. The sulfanilamide tragedy caused the death of many patients. Renal failure and hepatotoxicity are not known to be associated with thalidomide.)

Which legislation, passed in 1996, ensures that the privacy of patient information is protected? Durham-Humphrey Amendment Federal Food, Drug, and Cosmetic Act Health Insurance Portability and Accountability Act Medicare Prescription Drug, Improvement, and Modernization Act

Health Insurance Portability and Accountability Act (The Health Insurance Portability and Accountability Act (HIPAA) officially required all health-related organizations as well as schools to maintain the privacy of protected health information. The Durham-Humphrey Amendment to the FFDCA established legend drugs or prescription drugs. The Federal Food, Drug, and Cosmetic Act (FFDCA) required drug manufacturers to provide data proving drug safety with US Food and Drug Administration (FDA) review and established the investigational new drug application process. The Medicare Prescription Drug, Improvement, and Modernization Act provided seniors and disabled persons with an insurance benefit program for prescription drugs.)

During a case presentation, the nurse mistakenly mentions the name, age, and diagnosis of a patient. Which specific law has the nurse violated? Common law American Nurses Association (ANA) code of ethics International Council of Nurses (ICN) code of ethics Health Insurance Portability and Accountability Act (HIPAA)

Health Insurance Portability and Accountability Act (HIPAA) (HIPAA is legislation that protects patients' right to privacy. The law emphasizes protecting patients' confidential information from becoming public. The information may include the patient's diagnosis, financial condition, family issues, or other information that could disclose the identity of the patient. Common law is a law common to everybody and is not specific to nursing practice. The ANA code of ethics and the ICN code of ethics are ethical guidelines provided for nurses to increase the standard of nursing practice.)

The nurse is assessing a patient who is having intermittent episodes of back pain. The nurse asks the patient what he normally uses to relieve pain. The patient states that he uses a heating pad. Which cultural group does the patient most likely belong? Asian African Hispanic Native American

Hispanics (Hispanics may use heat to treat illnesses. The explanation that the application of heat relieves back pain may indicate that the patient is from a Hispanic background. Asians may incorporate hot and cold foods as remedies for illnesses. Africans may use herbs, oils, and roots for treatment. Native Americans may refer to their traditional healer to treat illnesses.)

Which drug is classified in the C-II category? Hydrocodone Meprobamate Phenobarbital Chloral hydrate

Hydrocodone (Hydrocodone is a category C-II drug. Phenobarbital, chloral hydrate, and meprobamate are class C-IV drugs.)

The nurse is studying the medical reports of a Japanese patient with a history of tuberculosis. The nurse finds that the dosage of isoniazid is higher than the usual dose prescribed in the United States. Which is the probable reason for this finding? Japanese patients are known to be slow acetylators. Japanese patients are known to be rapid acetylators. Japanese patients are known to have a low rate of drug absorption. Japanese patients are known to have a high rate of drug absorption.

Japanese patients are known to be rapid acetylators. (People of Japanese descent are known to be rapid acetylators, which means that their bodies attach acetyl groups to the drug molecules at a faster rate compared to other races. Therefore the drug concentration levels are lower. Thus a higher dose of isoniazid is required to achieve the desired effects. Some people belonging to African and European races are known to be slow acetylators. This means that their bodies attach acetyl groups to the drug molecules at a slower rate. They have a high drug concentration for a prolonged duration if they are given the same dose of the drug as a Japanese person. Thus they require a comparatively lower dose of the drug to achieve the desired effects. A difference in drug absorption in the Japanese and people belonging to other races has not been cited. Therefore the nurse cannot say that the rate of drug absorption varies between the Japanese and the other races.)

Which is the nurse's role in the development of new and investigational drugs? Selecting patients to participate in Phase I studies Identifying patients who are receiving placebo drugs during Phase III studies Monitoring for and reporting any adverse effects noted during Phase IV studies Informing patients of the specific drug they are receiving within a blinded investigational study during Phase III

Monitoring for and reporting any adverse effects noted during Phase IV studies (Phase IV studies rely on health care professionals to report adverse effects that may not have been apparent in previous phases. Nurses do not participate in the selection process for Phase I studies. In most studies, neither the health care providers nor the patients know which patients are being given the real drug versus the placebo.)

The nurse is working in a clinical trial for which healthy volunteers are being recruited. Which phase of the clinical trial is the nurse participating? Phase I Phase II Phase III Phase IV

Phase I (Clinical trials are performed in four phases. In a phase I clinical trial, healthy volunteers are used to determine the optimal dosage range and the pharmacokinetics of the drug. The phase II trial involves small numbers of volunteers who have the disease for which the drug is designed. The phase III trial involves many patients suffering from the disease that the drug intends to treat. The phase IV studies are postmarketing studies.)

The drug manufacturer has prepared an investigational new drug application. After which phase will the manufacturer submit the application to the US Food and Drug administration (FDA) for approval? Phase I Phase II Phase III Phase IV

Phase III (The drug can be marketed after phase III is completed if an investigational new drug application submitted by the manufacturer is approved by the FDA. Thus the investigational new drug application is submitted at the end of the third phase of the drug trial. The research evidence gained during phase I and phase II of the clinical drug trial is insufficient for the drug to be introduced to the market. In phase IV, the drug is already on the market. The research carried out in this phase usually compares the effect of the drug with the effects of the other drugs on the market that are within the same therapeutic category.)

The nurse wishes to find an alternative drug to aspirin that is better for reducing pain in patients with rheumatoid arthritis. Which type of drug trial will the nurse review to obtain this information? Phase I Phase II Phase III Phase IV

Phase IV (Phase IV clinical drug trials are the trials that compare the safety and efficacy of a new drug with those of another drug within the same therapeutic category. Referring to such research would give information about better drugs with desired effects and fewer risks involved. In phase I studies, the pharmacokinetics of a drug are determined. In phase II studies, the adverse effects associated with a drug are determined. Phase III trials establish the drug's clinical effectiveness, safety, and dosage range.)

A pharmaceutical company is voluntarily conducting a postmarketing study to obtain further proof of the therapeutic effects of a new drug. Which phase of drug study is this considered? Phase I Phase II Phase III Phase IV

Phase IV (Phase IV studies are conducted by pharmaceutical companies after the drug is on the market to obtain further data and information on the drug. Phase I studies determine the optimal dosage range and the pharmokinetics of the drug on healthy individuals to determine if more testing is needed. Phase II studies involve small numbers of volunteers with the disease that the medicine is intended to treat; the purpose of this stage is to determine the drug's effectiveness and identify any adverse effects. Phase III studies involve large numbers of participants in order to establish the drug's clinical effectiveness, safety, and dosage range. These three phases occur prior to release to the public.)

The nurse is assessing a patient's culture and race on admission to the hospital. Which concept is important for the nurse to understand regarding drug therapy as it relates to different races of individuals? Polypharmacy Polymorphism Pharmacokinetics Pharmacodynamics

Polymorphism (Drug polymorphism refers to the effect of a patient's age, gender, size, body composition, and other characteristics on the pharmacokinetics of specific drugs. The race of an individual may influence drug therapy decisions for the individual. Polypharmacy is the use of many different drugs concurrently in treating a patient who often has several health problems. Pharmacokinetics is the study of what happens to a drug from the time it is put into the body until the parent drug and all metabolites have left the body. Pharmacodynamics is the study of what the drug does to the body.)

The nurse is looking for new serious adverse effects of a drug that have been seen in few people after the drug was marketed. Which information would the nurse refer to? The black box warning Ethnopharmacologic studies The phase I trials of the drug The phase II trials of the drug

The black box warning (If severe reactions related to a newly marketed drug are seen in some people, the US Food and Drug Administration requests that the drug manufacturer issue a black box warning. The black box warning indicates the serious adverse effects of the drug that have been reported. Therefore the nurse would refer to the black box warning to find the new, serious adverse effects of the drug that have been seen in few people after the drug was marketed. Ethnopharmacologic studies provide information on the effects of a drug across various ethnicities. These studies do not report new drug reactions. Phase I studies determine the optimal dosage range and the pharmacokinetics of a drug. They do not find the adverse effects related to the drug. Phase II trials report the adverse effects of the drug, but the drug is not marketed during this phase.)

The nurse is responsible for dispensing medications and notes that diazepam is a C-IV drug. Which information can the nurse interpret from this? Select all that apply. The drug container must have a warning label. The prescription can be refilled for only a year. The drug is dispensed via an approved protocol. The drug is dispensed by written or oral prescription. The drug is considered to be a controlled substance.

The drug container must have a warning label. The drug is dispensed by written or oral prescription. The drug is considered to be a controlled substance. (Controlled drugs are classified into five categories. A C-IV drug must have a warning label to educate the dispenser and the patient and to prevent abuse. The drug is dispensed only by written or oral prescription to prevent abuse. A C-IV drug is a controlled substance whose use is limited. The prescription of a C-IV drug is valid for only 6 months, with a maximum of five refills during that period. This helps to prevent drug abuse. C-I drugs need to be dispensed via an approved protocol because they have a high potential for causing dependency.)

The nurse learns in a news bulletin that a drug is in a class III drug recall. Which information can the nurse infer? The drug is safe for use and is not recalled. The drug is likely to cause serious health effects. The drug is likely to cause temporary health effects. The drug is not likely to cause significant health problems.

The drug is not likely to cause significant health problems. (Per the US Food and Drug Administration (FDA), drug recalls are one of three classes. A class III drug recall indicates that the drug is relatively safe and is unlikely to cause any significant health problems. If a drug is safe for use, then the drug is not recalled by the FDA. Class I recall drugs are unsafe and likely to cause serious health problems. Drugs that may cause temporary health effects are class II recalls.)

Which finding is correct for a drug classified as C-II? The drug is unacceptable for medical use. The drug may have moderate potential for abuse. The drug may cause limited physical dependency. The drug may cause severe psychological dependency.

The drug may cause severe psychological dependency. (Some drugs are classified as controlled substances because of their potential for abuse and for causing dependency. These categories are C-I, C-II, C-III, C-IV, and C-V. A C-II drug has the potential to cause severe psychological dependency, and its use should be controlled. The drug is acceptable for medical use and causes severe physical dependency. The drug also has high potential for abuse because it causes severe physical dependency.)

Which factors are defined by the Nurse Practice Acts? Select all that apply. The educational requirements for nurses The rights of patients receiving health care The expanded nursing roles for patient care The behaviors of nurses while treating patients The differences between nursing and medical practice

The educational requirements for nurses The expanded nursing roles for patient care The differences between nursing and medical practice (The Nurse Practice Acts are the laws that define the boundaries of the nursing practice. These define educational requirements for nurses, expanded nursing roles, and the differences between nursing and medical practice. The rights of patients and the behaviors of nurses while treating patients are not included in the Nurse Practice Acts.)

An investigational drug completes a phase III trial; however, the drug cannot enter the market. Which could be the possible reason for this? The drug needs some more data to confirm its safety. The investigational drug is not in demand in the market. The manufacturers do not have enough financing to bring the drug to the market. The investigational new drug application is not approved by the US Food and Drug Administration (FDA).

The investigational new drug application is not approved by the US Food and Drug Administration (FDA). (Once a drug completes the phase III trial, an investigational new drug application is submitted to the FDA. The drug goes to the market only if the FDA approves the drug and confirms its safety for prescription. If the drug needs more confirmation of safety, additional trials are advised. Manufacturing drugs that are not in demand will not be profitable for the manufacturer. Financial constraint is unlikely because drug research requires substantial investment. Drugs that are not in demand may not be investigated during clinical trials.)

The nurse is performing the initial assessment of a Hispanic patient. Which behavior of the nurse is considered appropriate? Select all that apply. The nurse speaks in a normal tone of voice to the patient. The nurse avoids freely expressing emotions to the patient. The nurse maintains eye contact while speaking to the patient. The nurse shakes hands with the patient during the initial introduction. The nurse stands at a distance of 1 ft (0.30 m) while speaking to the patient.

The nurse speaks in a normal tone of voice to the patient. The nurse avoids freely expressing emotions to the patient. The nurse shakes hands with the patient during the initial introduction. (While speaking to a Hispanic patient, the nurse must speak in a normal tone of voice and shake hands with the patient as a sign of greeting. The nurse would try not to express personal feelings while speaking to the patient, as the patient may consider it disrespectful. When the nurse avoids eye contact while speaking with the patient, it is considered a show of respect by the nurse and indicates attentiveness. The nurse would maintain a distance of at least 4 ft (1.22 m) while speaking to the patient. The patient may feel threatened if the nurse stands very close to the patient, within a distance of 1 ft (0.30 m).)

The nurse is preparing healthy research subjects for the first phase of a new drug trial. Which information will be obtained upon the completion of phase I of the trial? The adverse drug effects The risks associated with the drug The optimal dosage range of the drug Comparative efficacy with other similar drugs

The optimal dosage range of the drug (The purpose of phase I of a clinical drug trial is to find the optimal dosage range and the pharmacokinetics of the drug. The purpose of phase II drug study is to find the adverse effects associated with the drug. The purpose of phase III studies is to find the risks associated with the drug. The purpose of phase IV drug study is to find the efficacy of the drug with respect to other drugs on the market belonging to the same therapeutic category.)

The health care provider prescribes haloperidol to an Asian patient who has a psychotic illness. Which information will the nurse expect to find in the patient's prescription? The patient's drug intake is at less frequent intervals than usual. The patient's drug intake is at more frequent intervals than usual. The patient has been prescribed a lower than usual dose of the drug. The patient has been prescribed a higher than usual dose of the drug.

The patient has been prescribed a lower than usual dose of the drug. (Asian patients require a lower dose of drugs such as haloperidol to achieve the desired effects. These patients have a slower elimination rate of drugs and therefore require lower doses. An increase or decrease in the frequency of drug administration will not prevent the patient from developing adverse effects if the total dose prescribed is usual. If the patient is prescribed a higher than usual or usual dose of the drug, the patient will be susceptible to developing adverse reactions to the higher concentration.)

A Hispanic patient tells the nurse that he wishes to go to a curandero. Which cultural practice does the nurse interpret from this? The patient wishes to use heat therapy to treat illness. The patient wishes to use herbal remedies to treat illness. The patient wishes to have spiritual healing to treat illness. The patient wishes to use dietary modifications to treat illness.

The patient wishes to have spiritual healing to treat illness. (Hispanics generally prefer to go to a curandero to receive spiritual healing. They perform rituals to cure illnesses. Curanderos do not perform heat therapy or prescribe herbal remedies. They also do not give advice regarding dietary modifications.)

The patient with a lung mass is scheduled for a lung biopsy followed by chemotherapy and radiation if cancerous. The patient asks the nurse if there are any risks from the procedures or medications. Keeping the principle of veracity in mind, which answer would be the nurse provide? There is no risk involved in the procedure. The procedure has some risk but is important. The procedure is painless, safe, and necessary. The procedure is highly risky; it's better to avoid it.

The procedure has some risk but is important. (The principle of veracity promotes telling the truth to patients and avoiding false reassurance. This helps to build trust in the nurse-patient relationship. Therefore the nurse would explain to the patient that the procedure has risks associated with it, but that it is important for diagnosing and treating the disease. The nurse would not provide false reassurance by telling the patient that the procedure has no risk or is painless and safe. The nurse also would not scare the patient by saying that the procedure is too risky.)

The nurse is preparing the informed consent for a specific drug trial. Which information does the nurse include in the consent form? Select all that apply. The purpose of the drug trial The procedure(s) of the drug trial The criteria of selection of subjects The risks involved in participating in the trial The general health assessment of the subject

The purpose of the drug trial The procedure(s) of the drug trial The risks involved in participating in the trial (An informed consent is a written document that informs the research subjects about the purpose and procedures of a drug trial and the risks involved in participation. The research subjects need to have this information before they voluntarily agree to participate. The research subjects need not be informed about the criteria of selection of subjects. The nurse has to assess the patient to determine whether the patient fulfills all of the criteria of the drug research. The consent contains information about the drug research and not about the patient's health. The nurse need not document the patient's general health assessment in the consent because it is information about the patient and not about the research.)

A group of nurses conducts a single-blind investigational drug study. Which points will the group consider while conducting the study? Select all that apply. The subject is aware of which group (drug or placebo) it belongs to. The subject is not aware of which group (drug or placebo) it belongs to. The researcher knows that the subject belongs to either the drug or the placebo group. The researcher does not know whether the subject belongs to the drug or the placebo group. The researcher and subject are not aware of which group (drug or placebo) the subject belongs to.

The subject is not aware of which group (drug or placebo) it belongs to. The researcher knows that the subject belongs to either the drug or the placebo group. (In a single-blind investigational drug study, the researcher knows whether the subject belongs to the drug or the placebo group, but the subject does not know which group he belongs to. In a double-blind investigational drug study, both the subject and the researcher do not know whether the subject belongs to the drug or the placebo group. If the subject is aware of which group (drug or placebo) he belongs to, the trial is not a blind investigational trial.)

What is the chief purpose of the MedWatch program, which is an initiative of the US Food and Drug Administration (FDA)? To find the new adverse effects of newly approved drugs To find the pharmacokinetic properties of a newly approved drug To find the dosages of drug required to treat different illnesses To find the differences in drug response across various cultures

To find the new adverse effects of newly approved drugs (MedWatch is a voluntary program initiated by the FDA in which health care professionals are encouraged to report any adverse events seen with newly approved drugs. The primary health care providers cannot report the pharmacokinetic properties of the newly approved drugs. These properties are identified by proper drug trials. The drug dosages required to treat various illnesses are determined in phase I and phase III drug trials. The MedWatch program does not deal with understanding the dosages of the drug for various illnesses. The primary health care providers do not report the differences in drug response across various cultures in the MedWatch program. Ethnopharmacologic studies and surveys are performed to find the differences in drug responses across cultures.)

A nurse is documenting the history of a patient and the patient states that she does not take any medications, but the nurse notes a bottle of capsules in the patient's purse. Which information will the nurse collect next? Vital signs Insurance information Primary care provider name Use of herbs or over-the-counter medications

Use of herbs or over-the-counter medications (The nurse will ask the patient if she takes any herbs or other nonprescription medications. The patient may use herbal remedies that she does not consider medications. The other choices are not part of the history.)

The nurse researcher is reviewing the written informed consent form for a drug trial to ensure that none of the information provided is untrue. Which ethical principle is demonstrated in this situation? Veracity Autonomy Beneficence Nonmaleficence

Veracity (According to the principle of veracity, the nurse would provide only truthful information to patients. By reviewing the information in the written informed consent form, the nurse ensures that the information provided to the patients is true. According to the principle of autonomy, the nurse would ensure that patients make their own health care decisions. Beneficence is the ethical principle of actively promoting good for all patients. According to the principle of nonmaleficence, nurses would take adequate measures to do no harm to patients.)