Cultural, Legal, and Ethical Considerations



Cultural, Legal, and Ethical Considerations


Objectives


When you reach the end of this chapter, you will be able to do the following:



Discuss the various cultural factors that may influence an individual’s response to medications.


Identify various cultural phenomena affecting health care and use of medications.


List the drugs that are more commonly associated with variations in response due to cultural and racial/ethnic factors.


Briefly discuss the important components of drug legislation at the state and federal levels.


Provide examples of how drug legislation impacts drug therapy, professional nursing practice, and the nursing process.


Discuss the various categories of controlled substances, and give specific drug examples in each category.


Identify the process involved in the development of new drugs, including the investigational new drug application, the phases of investigational drug studies, and the process for obtaining informed consent.


Discuss the nurse’s role in the development of new and investigational drugs and the informed consent process.


Discuss the ethical principles and how they apply to pharmacology and the nursing process.


10 Identify the ethical principles involved in making an ethical decision.


11 Develop a nursing care plan that addresses the cultural, legal, and ethical care of patients with a specific focus on drug therapy and the nursing process.


Key Terms


Bias Any systematic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs (see later). (p. 57)


Black box warning A type of warning that appears in a drug’s prescribing information and is required by the U.S. Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug. (p. 57)


Blinded investigational drug study A research design in which the subjects are purposely unaware of whether the substance they are administered is the drug under study or a placebo. This method serves to minimize bias on the part of research subjects in reporting their body’s responses to investigational drugs. (p. 57)


Controlled substances Any drugs listed on one of the “schedules” of the Controlled Substance Act (also called scheduled drugs). (p. 55)


Culture The customary beliefs, social forms, and material traits of a racial, religious, or social group. (p. 51)


Double-blind investigational drug study A research design in which both the investigator(s) and the subjects are purposely unaware of whether the substance administered to a given subject is the drug under study or a placebo. This method minimizes bias on the part of both the investigator and the subject. (p. 57)


Drug polymorphism Variation in response to a drug because of a patient’s age, gender, size, and/or body composition. (p. 52)


Ethics The rules of conduct recognized in respect to a particular class of human actions or a particular group. (p. 59)


Ethnicity Relating to or characteristics of a human group having racial, religious, language, and other traits in common. (p. 51)


Ethnopharmacology The study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution, and excretion (i.e., pharmacokinetics; see Chapter 2) as well as the study of genetic variations to drugs (i.e., pharmacogenetics). (p. 51)


Expedited drug approval Acceleration of the usual investigational new drug approval process by the FDA and pharmaceutical companies, usually for drugs used to treat life-threatening diseases. (p. 55)


Health Insurance Portability and Accountability Act (HIPAA) An act that protects health insurance coverage for workers and their families when they change jobs. It also protects patient information. If confidentiality of a patient is breached, severe fines may be imposed. (p. 54)


Informed consent Written permission obtained from a patient consenting to a specific procedure (e.g., receiving an investigational drug), after the patient has been given information regarding the procedure deemed necessary for him or her to make a sound or “informed” decision. (p. 56)


Investigational new drug (IND) A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy. (p. 56)


Investigational new drug application An application that must be submitted to the FDA before a drug can be studied in humans. (p. 56)


Legend drugs Another name for prescription drugs. (p. 55)


Malpractice A special type of negligence or the failure of a professional and/or individual with specialized education and training to act in a reasonable and prudent way. (p. 58)


Narcotic A legal term established under the Harrison Narcotic Act of 1914. It originally applied to drugs that produced insensibility or stupor, especially the opioids (e.g., morphine, heroin). The term is currently used in clinical settings to refer to any medically administered controlled substance and in legal settings to refer to any illicit or “street” drug. (p. 55)


Negligence The failure to act in a reasonable and prudent manner or failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render or use under similar circumstances. (p. 58)


Orphan drugs A special category of drugs that have been identified to help treat patients with rare diseases. (p. 55)


Over-the-counter drugs Drugs available to consumers without a prescription. Also called nonprescription drugs. (p. 53)


Placebo An inactive (inert) substance (e.g., saline, distilled water, starch, sugar) that is not a drug but is formulated to resemble a drug for research purposes. (p. 57)


Race Descendants of a common ancestor; a tribe, family, or people believed to belong to the same lineage. (p. 51)


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http://evolve.elsevier.com/Lilley



Cultural Considerations


The United States is a very culturally diverse nation as evidenced by its constantly and rapidly changing demographics. Minority groups, being approximately one third of the U.S. population, are expected to become the majority by 2042 and will represent 54% of the nation’s population by 2050. That is, the combined population of all groups except non-Hispanic, single-race whites is projected to be approximately 235 million out of a total U.S. population of 439 million in 2050. The non-Hispanic, single-race white population is projected to be only slightly larger in 2050 (at about 203 million) than in 2010. It is predicted that nearly one in three U.S. residents will be Hispanic by 2050. The African-American population is projected to increase from 41 million (about 14%) to about 66 million (or 15%) by 2050. The Asian population is projected to increase from 15 million to about 40 million, rising from a current 5.1% to 9.2% of the total. Of the remaining racial groups, Native Americans and Alaska Natives are projected to increase in number from 4.9 million to 8.6 million (or from 1.6% to 2% of the total population). The population of Native Hawaiians and other Pacific Islanders is expected to more than double, from 1.1 million to 2.6 million. The number of people who identify themselves as being of two or more races is projected to more than triple, from about 5 million to 16 million.


The field of ethnopharmacology provides an expanding body of knowledge for understanding the specific impact of cultural factors on patient drug response. It is hampered, however, by the lack of clarity in terms such as race, ethnicity, and culture. For example, although some researchers have used the term Hispanic to encompass geographic groups as diverse as Puerto Ricans, Mexicans, and Peruvians, other researchers have used it to denote a specific racial group. It is impossible to know a patient’s genotype by either physical appearance or health care history.


It is essential to be up to date in your knowledge of the nursing process and understanding of the art and science of professional nursing practice. Cultural assessment needs to be part of the assessment phase of the nursing process. Acknowledgment and acceptance of the influences of a patient’s cultural beliefs, values, and customs is necessary to promote optimal health and wellness. Some relevant practices are discussed in the Patient-Centered Care: Cultural Implications box on p. 52.


Influence of Ethnicity and Genetics on Drug Response


The concept of polymorphism is critical to an understanding of how the same drug may result in very different responses in different individuals. For example, why does a Chinese patient




image PATIENT-CENTERED CARE: CULTURAL IMPLICATIONS


A Brief Review of Common Practices among Selected Cultural Groups




































CULTURAL GROUP COMMON HEALTH BELIEFS AND ALTERNATIVE HEALERS VERBAL AND NONVERBAL COMMUNICATION; TOUCH/TIME FAMILY BIOLOGIC VARIATIONS
African Practice folk medicine; employ “root doctors” as healers; spiritualist
Use herbs, oils, and roots
Asking personal questions of someone met for the first time seen as intrusive and not proper
Direct eye contact seen as rude
Present oriented
Have close extended family ties
Women play important key role in making health care decisions
Keloid formation, sickle cell anemia, lactose intolerance, skin color
Asian Believe in traditional medicine; hot and cold foods; herbs/teas/soups; use of acupuncturist, acupressurist, and herbalist High respect of others, especially of individuals in positions of authority
Not usually comfortable with custom of shaking hands with those of opposite sex
Present oriented
Have close extended family ties; family needs more important than individual needs Many drug interactions, lactose intolerance, skin color, thalassemia
Hispanic View health as a result of good luck and living right; see illness as a result of doing a bad deed
Heat, cold, and herbs used as remedies
Use curandero, spiritualist
Expressing negative feelings seen as impolite
Avoiding eye contact seen as respectful and attentive
Touching acceptable between two persons in conversation
Have close extended family ties; all family members involved in health care decisions Lactose intolerance, skin color
Native American Believe in harmony with nature and ill spirits causing disease
Use medicine man
Speak in low tone of voice
Light touch of a person’s hand is preferred versus a firm handshake as a greeting
Present oriented
Have close extended family ties; emphasis on family Lactose intolerance, skin
color, cleft uvula
problems


Image


Data from Bhui K, Dinos S: Health beliefs and culture: Essential considerations for outcome measurement, Dis Manag Health Out 16(6):411-419, 2008; Giger JN, Davidhizar RE: Transcultural nursing: assessment and intervention, ed 4, St Louis, 2004, Mosby.


require lower dosages of an antianxiety drug than a white patient? Why does an African-American patient respond differently to antihypertensives than a white patient? Drug polymorphism refers to the effect of a patient’s age, gender, size, body composition, and other characteristics on the pharmacokinetics of specific drugs. Factors contributing to drug polymorphism may be categorized into environmental factors (e.g., diet and nutritional status), cultural factors, and genetic (inherited) factors.


Medication response depends greatly on the level of the patient’s compliance with the therapy regimen. Yet compliance may vary depending on the patient’s cultural beliefs, experiences with medications, personal expectations, family expectations and influence, and level of education. Compliance is not the only issue, however. Prescribers must also be aware that some patients use alternative therapies, such as herbal and homeopathic remedies, that can inhibit or accelerate drug metabolism and therefore alter a drug’s response.


Environmental and economic factors (e.g., diet) can contribute to drug response. For example, a diet high in fat has been documented to increase the absorption of the drug griseofulvin (an antifungal drug). Malnutrition with deficiencies in protein, vitamins, and minerals may modify the functioning of metabolic enzymes, which may alter the body’s ability to absorb or eliminate a medication.


Historically, most clinical drug trials were conducted using white men, often college students, as research subjects. However, there are data that demonstrate the impact of genetic factors on drug pharmacokinetics and drug pharmacodynamics or drug response (see Chapter 8). Some individuals of European and African descent are known to be slow acetylators. This means that their bodies attach acetyl groups to drug molecules at a relatively slow rate, which results in elevated drug concentrations. This situation may warrant lower drug dosages. A classic example of a drug whose metabolism is affected by this characteristic is the antituberculosis drug isoniazid. In contrast, some patients of Japanese and Inuit descent are more rapid acetylators and metabolize drugs more quickly, which predisposes the patient to subtherapeutic drug concentrations and may require higher drug dosages.


Levels of the cytochrome P-450 enzymes (see Chapter 2) are also known to vary between ethnic groups. This has effects on the ability to metabolize many drugs. Most psychotropic drugs (see Chapter 16) are metabolized in the liver in a two-phase process. Cytochrome P-450 enzymes often control phase I of the hepatic metabolism of both antidepressants and antipsychotic drugs. This can affect plasma drug levels, and therefore the intensity of drug response, at different doses. Groups of Asian patients have been shown to be “poor metabolizers” of these drugs and often require lower dosages to achieve desired therapeutic effects. In contrast, white patients are more likely to be classified as “ultrarapid metabolizers” and may require higher drug dosages.


Variations are also reported between ethnic groups in the occurrence of adverse effects. For example, African American patients taking lithium may need to be monitored more closely for symptoms of drug toxicity, because serum drug levels may be higher than in white patients given the same dosage. Likewise, Japanese and Taiwanese patients may require lower dosages of lithium. For the treatment of hypertension, thiazide diuretics appear to be more effective in African Americans than in whites. Several additional examples of racial and ethnic differences in drug response are outlined in the Patient-Centered Care: Cultural Implications box below.



Individuals throughout the world share common views and beliefs regarding health practices and medication use. However, specific cultural influences, beliefs, and practices do exist. Awareness of cultural differences is critical for the care of patients because of the constantly changing U.S. demographics. As a result of these changes, attending to each patient’s cultural background helps to ensure safe and quality nursing care, including medication administration.


For example, some African Americans have health beliefs and practices that include an emphasis on proper diet and rest; the use of herbal teas, laxatives, protective bracelets; and the use of folk medicine, prayer, and the “laying on of hands.” Reliance on various home remedies can also be an important component of their health practices. Some Asian-American patients, especially the Chinese, believe in the concepts of yin and yang. Yin and yang are opposing forces that lead to illness or health, depending on which force is dominant in the individual and whether the forces are balanced. Balance produces healthy states. Other common health practices of Asian Americans include use of acupuncture, herbal remedies, and heat. All such beliefs and practices need to be considered—especially when the patient values their use more highly than the use of medications. Many of these beliefs are strongly grounded in religion. The Asian and Pacific Islander racial/ethnic group also includes Thais, Vietnamese, Filipinos, Koreans, and Japanese, among others.


Some Native Americans believe in preserving harmony with nature or keeping a balance between the body and mind and the environment to maintain health. Ill spirits are seen as the cause of disease. The traditional healer for this culture is the medicine man, and treatments vary from massage and application of heat to acts of purification. Some individuals of Hispanic descent view health as a result of good luck and living right and illness as a result of bad luck or committing a bad deed. To restore health, these individuals seek a balance between the body and mind through the use of cold remedies or foods for “hot” illnesses (of blood or yellow bile) and hot remedies for “cold” illnesses (of phlegm or black bile). Hispanics may use a variety of religious rituals for healing (e.g., lighting of candles), which may also be practiced by adherents of other religions and/or belief systems. It is very important to remember that these beliefs vary from patient to patient; therefore, consult with the patient rather than assume that the patient holds certain beliefs because he or she belongs to a certain ethnic group.


Barriers to adequate health care for the culturally diverse U.S. patient population include language, poverty, access, pride, and beliefs regarding medical practices. Medications may have a different meaning to different cultures, as would any form of medical treatment. Therefore, before any medication is administered, complete a thorough cultural assessment. This assessment includes questions regarding the following:



Cultural Nursing Considerations and Drug Therapy


It is important to be knowledgeable about drugs that may elicit varied responses in culturally diverse patients or those from different racial/ethnic groups. Varied responses may include differences in therapeutic dosages and adverse effects, so that some patients may have therapeutic responses at lower dosages than are typically recommended. For example, in Hispanic individuals taking traditional antipsychotics, symptoms may be managed effectively at lower dosages than the usual recommended dosage range.


Another aspect of cultural care as it relates to drug therapy is the recognition that patterns of communication may differ based on a patient’s race or ethnicity. Communication also includes the use of language, tone, volume, as well as spatial distancing, touch, eye contact, greetings, and naming format. It is important to assess (see Box 4-3) and apply these aspects of cultural and racial/ethnic variations to patient care and to drug therapy and the nursing process. One specific example of cultural diversity is the use of verb tense; some languages, such as the Chinese language, do not have numerous verb tenses as compared to the English language. Therefore, very precise instructions must be included in patient education about medication(s) and how to best and safely take them. Avoiding the use of contractions such as can’t, won’t, and don’t is important with patients from other countries to prevent confusion. Instead, use of cannot, will not, and do not is recommended to improve understanding.


Legal Considerations


Prescription drug use is vital to treating and preventing illness. However, due to safety reasons, its use is regulated by several different agencies, including the Food and Drug Administration (FDA), The Drug Enforcement Agency (DEA), and individual state laws. Traditionally, only medical doctors (M.D.) and doctors of osteopathy (D.O.) had the privilege of prescribing medications. Dentists and podiatrists are also allowed to prescribe medications so long as it is within the scope of their practice. In some states, other health care professionals may also prescribe, including licensed physician’s assistants (P.A.s) and advanced practice registered nurses (APRNs).


As the number and complexity of prescriptions continue to increase and technology continually changes, so do the laws regarding their use. With the ever-changing role of the professional nurse and other members of the health care team and with the increasing pace of technologic advances, each role becomes more complex. Even more autonomy has been gained by the professional nurse over his or her nursing practice. With this increasing autonomy comes greater liability and legal accountability; therefore, the professional nurse must be aware and duly consider this responsibility as he or she practices. Specific laws and regulations are discussed later and in the nursing process section of this chapter.


U.S. Drug and Related Legislation


Until the beginning of the twentieth century there were no federal rules and regulations in the United States to protect consumers from the dangers of medications. The various legislative interventions that have occurred have often been prompted by large-scale serious adverse drug reactions. One example is the sulfanilamide tragedy of 1937. Over 100 deaths occurred in the United States when people ingested a diethylene glycol solution of sulfanilamide that had been marketed as a therapeutic drug. Diethylene glycol is a component of automobile antifreeze solution, and the drug containing it was never tested for its toxicity. Another prominent example is the thalidomide tragedy that occurred in Europe between the 1940s and 1960s. Many pregnant women who took this sedative-hypnotic drug gave birth to seriously deformed infants.


A recent and significant piece of legislation is the Health Insurance Portability and Accountability Act (HIPAA) of 1996. HIPAA requires all health care providers, health insurance and life insurance companies, public health authorities, employers, and schools to maintain patient privacy regarding protected health information. Protected health information includes any individually identifying information such as patients’ health conditions, account numbers, prescription numbers, medications, and payment information. Such information can be oral and/or recorded in any paper or electronic form. The primary purpose of federal legislation is to ensure the safety and efficacy of new drugs and, in the case of HIPAA, to protect patient confidentiality. Table 4-1 provides a timeline summary of major U.S. drug legislation.



TABLE 4-1


SUMMARY OF MAJOR U.S. DRUG AND RELATED LEGISLATION








































NAME OF LEGISLATION (YEAR) PROVISIONS/COMMENTS
Federal Food and Drugs Act (FFDA, 1906) Required drug manufacturers to list on the drug product label the presence of dangerous and possibly addicting substances; recognized the U.S. Pharmacopeia and National Formulary as printed references standards for drugs
Sherley Amendment (1912) to FFDA Prohibited fraudulent claims for drug products
Harrison Narcotic Act (1914) Established the legal term narcotic and regulated the manufacture and sale of habit-forming drugs
Federal Food, Drug, and Cosmetic Act (FFDCA,1938; amendment to FFDA) Required drug manufacturers to provide data proving drug safety with FDA review; established the investigational new drug application process (prompted by sulfanilamide elixir tragedy)
Durham-Humphrey Amendment (1951) to FFDCA Established legend drugs or prescription drugs; drug labels must carry the legend, “Caution—Federal law prohibits dispensing without a prescription”
Kefauver-Harris Amendments (1962) to FFDCA Required manufacturers to demonstrate both therapeutic efficacy and safety of new drugs (prompted by thalidomide tragedy)
Controlled Substance Act (1970) Established “schedules” for controlled substances (Tables 4-2 and 4-3); promoted drug addiction education, research, and treatment
Orphan Drug Act (1983) Enabled the FDA to promote research and marketing of orphan drugs used to treat rare diseases
Accelerated Drug Review Regulations (1991) Enabled faster approval by the FDA of drugs to treat life-threatening illnesses (prompted by HIV/AIDS epidemic)
Health Insurance Portability and Accountability Act (1996) More commonly known by its acronym, HIPAA; officially required all health-related organizations as well as schools to maintain privacy of protected health information
Medicare Prescription Drug Improvement and Modernization Act (2003) More commonly known as Medicare Part D; provides seniors and disabled persons with an insurance benefit program for prescription drugs; the cost of medications is shared by the patient and the federal government

AIDS, Acquired immunodeficiency syndrome; FDA, Food and Drug Administration; HIV, human immunodeficiency virus.

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May 9, 2017 | Posted by in NURSING | Comments Off on Cultural, Legal, and Ethical Considerations

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