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Legal, Ethical, and Cultural Considerations in Pharmacology Lilley, Chapter 4 Mosby items and derived items © 2006 by Mosby, Inc. Slide 1 Notable Landmarks in Drug Approval History 1938: Food, Drug, and Cosmetic Act— empowered the FDA to oversee regulating and monitoring. Subsequent amendments differentiated between OTC and Rx and mandated labeling for adverse reactions and required drug companies to establish effectiveness before marketing. 1970: Controlled Substances Act—to control drug abuse by promoting drug education, drug rehab, and scheduling of drugs (Tables 4-3, 4-4 p. 53) Copyright © 2006, 2001 by Mosby, Inc. Slide 2 History cont’d 1983: Orphan Drug Act—allows manufacturing of drugs that are effective for rare disorders, but are not profitable for mass production. See www.rarediseases.org 1997: FDA Modernization Act—promoted new drugs, allowed trials on children, etc. 2003: HIPAA—limited access to pharmacy info and private area for consultation 2003: MMA (a.k.a. Medicare Part D)— Medicare prescription plans for seniors Copyright © 2006, 2001 by Mosby, Inc. Slide 3 New Drug Development Long and costly process from lab research to the consumer. Manufacturers have to meet certain standards to ensure each drug has the same: potency quality purity strength reliability Copyright © 2006, 2001 by Mosby, Inc. Slide 4 FDA Approval Process— Preclinical Phase Animal studies are done first to determine toxicity, therapeutic index, and how the body processes the drug. Investigators have to then submit an IND application for a new drug, or for a new indication for a drug already approved Results of animal studies and investigators’ qualifications are also submitted Informed consent obtained from Phase I volunteers Copyright © 2006, 2001 by Mosby, Inc. Slide 5 FDA Drug Testing Sequence Investigators must get approval for each phase before going to next Human studies: Phase I: Initial pharmacologic evaluation Phase II: Limited controlled evaluation Phase III: Extended clinical evaluation Phase IV: Post-marketing studies voluntarily done by pharm companies Copyright © 2006, 2001 by Mosby, Inc. Slide 6 Human Studies—Clinical Trials Phase 1—small # of healthy volunteers take drug and are closely monitored for its effects. Phase 2—small #s of individuals with targeted disease are gradually given increasing doses until effectiveness is achieved (determining therapeutic range). Side effects are monitored. Double-blinds may be done. Phase 3—larger groups tested at various sites to determine effectiveness, safety, and dosage range. Double-blinds may be done. Copyright © 2006, 2001 by Mosby, Inc. Slide 7 FDA Approval Process cont’d After Phase 3, all data is submitted via a NDA If approved, drug is marketed to the public. Phase IV begins and lasts 2 yrs. Med Watch created by FDA to encourage reporting of adverse effects in this phase by health professionals who are treating clients. If serious adverse effects occur, drug is recalled. Back to the drawing board! Copyright © 2006, 2001 by Mosby, Inc. Slide 8 Unlabeled Use of Drugs HCPs may give drugs for an indication other than what was approved by the FDA. While drug is in approval process, the HCPs may give it anyway. These decisions are based on successful clinical trials published in professional journals and have been “blessed” by the physician’s professional organization. Technically could be sued and prosecuted if something went wrong. Copyright © 2006, 2001 by Mosby, Inc. Slide 9 Legal Issues for Nurses Medication order must be valid/safe Prescriber and nurse must be licensed Nurses cannot dispense—only pharmacists Nurse must know purpose, actions, effects, and major side effects and toxic effects of drug and the teaching required to enable client or caregiver to safely and accurately self-administer drug Nurses must keep up with continuing education R/T meds and skills Copyright © 2006, 2001 by Mosby, Inc. Slide 10 Legal Responsibilities of Nurses Monitor for SEs and report them Correctly calculate drug dosages Never pre-pour, pre-chart, give others meds, or falsify Question prescriber if necessary Follow policies regarding verbal and phone orders Be familiar with practice guidelines by NCBON, federal regulations, and employer Abide by drug control laws—inside/outside of work Be responsible for those people you supervise Copyright © 2006, 2001 by Mosby, Inc. Slide 11 Follow Standards of Care Institute of Safe Medicine Practices Joint Commission on Accreditation of Health Care Organizations National Patient Safety Goals Copyright © 2006, 2001 by Mosby, Inc. Slide 12 Legal Must: Interdisciplinary Communication Prescriber Pharmacist Nurse to nurse Student to nurse Chain of command For nurse For student Copyright © 2006, 2001 by Mosby, Inc. Slide 13 Legal Must: Documentation Verbal MD orders MAR Narcotics Nurse’s notes Admission hx D/C instructions Variance reports Copyright © 2006, 2001 by Mosby, Inc. Slide 14 Document Defensively Record promptly—especially prns, stats, onetimes Record effectiveness of prns Record refusals and reason and reporting of the refusal Record adverse responses and the reporting of them Record fluid intake taken if pt is on I&O Copyright © 2006, 2001 by Mosby, Inc. Slide 15 Ethical Guidelines Do no harm (non-malfeasance) Do good (beneficence) Let patients decide for themselves after giving full information (autonomy) Be truthful (veracity) Treat all the same (justice) Be faithful to practice and patients (fidelity) Possess integrity and accountability Copyright © 2006, 2001 by Mosby, Inc. Slide 16 Legal/Ethical Considerations in the Drug Approval Process Informed consent for clinical trials—subject must be competent, consent must be voluntary, without coercion, and be fully informed of procedure, benefits, risks. Must be written in subject’s language, signed, dated and witnessed. History of informed consent : Nuremburg Code of 1947 Declaration of Helsinki of 1964 FDA Modernization Act of 1997 Copyright © 2006, 2001 by Mosby, Inc. Slide 17 Legal/Ethical Considerations for Nurses Fine line sometimes between violating own principles and providing nonjudgmental nursing care. Forcing meds—only children and legally certified mentally incompetent. Forcing on competent adults is assault and battery. Use of placebos Chemical restraints Threatening to withhold medications to get patient to comply with other things Unlabeled use of drugs Copyright © 2006, 2001 by Mosby, Inc. Slide 18 Cultural Considerations Ethnopharmacology—Broad field of study which involves looking at the genetic influence on pharmacokinetics and drug response that may occur from inherited metabolic defects or deficiencies. May be used to customize drug therapy for each ethnic group. Copyright © 2006, 2001 by Mosby, Inc. Slide 19 Possible Reasons for Genetic Variations in Drug Response Changes in receptor configuration, receptor quantity, or intracellular proteins that interact with the receptors Unique variations in drug absorption and distribution Unique variations in drug metabolism by cytochrome P450 isoenzymes. Amount of these isoenzymes is genetically determined. This causes differences in therapeutic responses and side effects Copyright © 2006, 2001 by Mosby, Inc. Slide 20 Common Drug Groups With Unique Pharmacogenetic Responses Analgesics—narcotic and non-narcotic Cardiovascular medications Central nervous system agents— sedative/hypnotics, anxiolytics, antidepressants, ETOH, tranquilizers Copyright © 2006, 2001 by Mosby, Inc. Slide 21 Examples of Genetic Differences African Americans—ACEIs and B-blockers may be less effective in lowering blood pressure Chinese—poor metabolizers of Codeine; more sensitive to antidepressants and tranquilizers Hispanics—more sensitive to antidepressants Native Americans—less tolerant to ETOH Caucasians—more sensitive to tranquilizers and more SEs to ETOH Copyright © 2006, 2001 by Mosby, Inc. Slide 22 Cultural Influences on Medication Therapy Biocultural response to meds Nutrition and dietary habits Religious beliefs Sick role Pain responses Attitudes about illness & treatment Attitude toward HCPs Copyright © 2006, 2001 by Mosby, Inc. Slide 23 Cultural Influences cont’d Cultural diversity affects compliance Most cultures self-treat or seek alternative methods before seeking Western medicine so ask what person has tried before To gain some insight, ask, “How do you keep well?”, “What do you believe made you sick?”, or “Do you have any concerns about medication that could affect your care while in the hospital?” Copyright © 2006, 2001 by Mosby, Inc. Slide 24 Specific Cultures: Hispanics Origins in Cuba, Mexico, Puerto Rico, Central and South America, and Spain Sense of fatalism and that health is good luck, reward, or blessing Strong belief in prayer, magic, hot and cold balance, and wearing religious objects Folk healer is called “curandero” who practices cleansing and healing rituals, prescribes herbal teas based on dreams, prescribes hot and cold therapy, and performs massage Copyright © 2006, 2001 by Mosby, Inc. Slide 25 Hispanics cont’d Believe causes of illness include: Imbalance in four aspects of body—blood, phlegm, yellow bile, and black bile Supernatural forces—malevolent spirits, bad luck, witchcraft, ”mal ojo” Strong emotional states—”susto”, embarrassment, envy, anger, fear, excessive worry Family turmoil, immoral or unethical behavior Bad air, bad food, germs, getting too hot or cold, poverty Copyright © 2006, 2001 by Mosby, Inc. Slide 26 Asian Americans and Pacific Islanders Origins include China, Japan, Korea, Vietnam, Hawaii, Phillipines See body as gift from ancestors and must take care of it—illness prevention is a major focus Believe in balance which is maintained by the supernatural forces of Yin and Yang Traditional methods of Chinese healing: holistic medicine, acupuncture, moxibustion, meditation, and herbal remedies Copyright © 2006, 2001 by Mosby, Inc. Slide 27 Asians cont’d Believe illness and disasters are caused by imbalance of Yin and Yang. Yin is female and negative and represents darkness, coldness and emptiness. Also represents solid organs and forces inside body Yang is male and + and represents light, warmth, and fullness. Represents the hollow organs and forces outside body Copyright © 2006, 2001 by Mosby, Inc. Slide 28 Asians cont’d Dx is by appearance, history, smell of person, appearance of tongue, and palpation of superficial and deep pulses. Balance must be restored with herbs, and accupuncture or moxibustion along yin and yang points (meridians). Copyright © 2006, 2001 by Mosby, Inc. Slide 29 Native Americans Illness is imbalance between body and universe because of ill spirits, not following traditional beliefs, or a disruption in nature. Need to trace back cause of illness to an action or lack of action by client, which may be known or unknown. Recovery is based on diagnosing problem and reestablishing harmony or balance with nature Prevention is practiced thru wearing charms, dancing rituals, sweat bath purification, and protection from temperature extremes. Each tribe (more than 200) has specific ideas and practices related to health and illness Copyright © 2006, 2001 by Mosby, Inc. Slide 30 Native Americans cont’d Medicine man decides tx after conferring with family Dx is made by using divination with chanting rituals, medicinal herbs, or stargazing and asking star spirit for guidance. Color of star determines dx and px Tx includes rituals, heat, exercise, massage, dietary changes, and herbs. Herbs are colorcoded and odors and shapes are important. Plants exposed to eastern sunlight are best. Copyright © 2006, 2001 by Mosby, Inc. Slide 31 African Americans Origins in Africa and West Indies Health means that body, mind, and spirit are in harmony Illness is disharmony, either from natural causes or divine punishment, or as a result of the activity of demons and evil spirits Survival is to restore harmony and balance by removing evil spirits Healing is considered a divine gift Western medicine sometimes perceived as degrading, humiliating, and racist Copyright © 2006, 2001 by Mosby, Inc. Slide 32 African Americans cont’d Healer or “root man” can prescribe a regimen of herbs or rituals and practices to be done by sick person. Should be done before seeing a physician Healer must be stronger than person who sent the “hex” Home remedies include herbs, prayer, laying on of hands, wearing charms or amulets that protect against evil spirits, herbal teas, hot baths, and hot compresses. Copyright © 2006, 2001 by Mosby, Inc. Slide 33 European Americans and Caucasians Most ascribe to biomedical theory. 1st self tx by home remedies or OTC meds then MD Religious rituals or ceremonies may be carried out in addition to Western medicine, such as Hail Marys, rosaries, laying on of hands, prayer, wearing crosses or other symbols, or use of herbs Examples of home remedies include salt water gargles, honey and whiskey for coughs, Vicks for congestion, chicken soup, baking soda, wet tobacco for stings, raw potatoes for warts, and alcohol, mercurochrome, or merthiolate for cuts. Copyright © 2006, 2001 by Mosby, Inc. Slide 34 CAM Therapy Complementary medicine is used together with conventional medicine Alternative medicine is used in place of conventional medicine CAM is abbreviation for complementaryalternative medicine A wide variety of herbs, flowers, leaves, teas, poultices, powders, prayers, chants, procedures, and even animal parts are used by different cultures to treat “illness.” Copyright © 2006, 2001 by Mosby, Inc. Slide 35 Commonly Used Herbs Aloe: burns Black Cohosh, Dong quai: menopause Chamomile, peppermint, ginger: GI problems Cranberry: UTI Echinacea and Goldenseal: immunity Garlic: hypercholesteremia Ginkgo: memory enhancement, circulation Ginseng: energy Copyright © 2006, 2001 by Mosby, Inc. Slide 36 Commonly Used Herbs cont’d Glucosamine/condroitin: osteoarthritis Green tea: antioxidant Feverfew: migraines Hawthorn: HTN Milk thistle—liver and GB problems Saw palmetto: prostate health St. John’s Wort: depression Valerian and Kava: insomnia Copyright © 2006, 2001 by Mosby, Inc. Slide 37 Client Education Efficacy from one dose to another cannot be guaranteed. Many interfere with blood clotting and insulin activity. Should not be used by pregnant or breastfeeding or on children w/o MD advice. Lifestyle changes may be equally effective as “a pill can fix everything” mentality Copyright © 2006, 2001 by Mosby, Inc. Slide 38 Education cont’d Use single-agent products for better evaluation. Read package labels and warnings Takes longer to work Treat herbs like other meds—do not exceed recommended dosage Don’t stop regular med w/o MD advice Keep in original container and store in cool, dry, dark place Copyright © 2006, 2001 by Mosby, Inc. Slide 39