NUR104A Contemporary Issues in Pharmacology PDF

NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES...

NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 Traditional Healers play a role in health practices worldwide and can include priests, shamans, bone setters, herbalists, THE DRUG APPROVAL PROCESS curanderos, and midwives Once a promising new candidate is identified, it is tested in preclinical studies (in vitro systems and experimental Dietary supplement health and education act of 1984 animals). Defined dietary supplements as the following: Drugs that still look promising after these preclinical studies’ - intended to supplement diet application of investigational new drugs (IND) are filed with - contains one or more dietary ingredients (including the DRA for testing in clinical trials first in healthy people vitamins, minerals and herbs) or their constituents. (Phase 0 and I) and then in people with the target disease - is intended to be taken by mouth , in forms such as (Phases II and III). In phase 0, a very low dose of the drug is tablet, capsule, powder, soft gel, gelcap or liquid. tested for the first time on human subjects (10 to 15 subjects). Labels are required to have the following five components Based on the pharmacogenetic or pharmacodynamic A. Name of the supplement properties, a decision on whether to start phase 1 or not is B. Amount of the supplement (net quantity) taken. These clinical trials assess safety and effectiveness in C. Nutrition labeling human beings. D. Ingredient list If the drug appears promising through three phases of clinical E. Name and place of the manufacturer trials, the manufacturer files an application for approval of NDA from DRA to market the drug. It is important that the Manufacturers of dietary supplements are allowed to make manufacturer and the DRA continue post-marketing three types of claims: surveillance of new drugs (Phase IV) in real-life patients A. Health claims under diverse conditions for early detection of risk of toxicity B. Structure and function claims that occurs rarely enough which escapes detection in the C. Nutrient content claims clinical trials setting. ○ The physiologic effects of the product can be noted, but Preclinical and clinical phases of drug evaluation: The drug no claims can be made about preventing or curing development path and objectives of various phases of the specific conditions. clinical trials, the number of patients enrolled at each stage. Patent protection and generic drugs: A company usually patents novel/new chemical entities early in the drug COMMONLY USED HERBAL REMEDIES discovery process. Astragalus (A. membranaceus and A. mangholicus) - adjunct to boost the immune system, such as for hepatitis and cancer, and to limit the effects of cold and flu symptoms. Chamomile (Matricoria recutita) - is used primarily to treat sleeplessness, anxiety, and stomach, or intestinal ailments Cinnamon (cinnamomum zeylanicum) -long history of use as treatment for bronchitis, gastrointestinal(GI) problems,anorexia, and diabetes. Echinacea (Echinacea purpurea) - is commonly used for colds, flu and infections.It has also been used for skin problems, such as acne. Garlic (Allium Sativum) - It is reported to lower cholesterol, decrease blood pressure, and reduce heart disease. Ginger (Zinger officinale) - It has been used to treat postoperative , pregnancy related, and chemotherapy related nausea as well as motion sickness and diarrhea. St John’s Wort (Hypericum perforatum) - It has been used extensively throughout history to treat mental disorders and nerve pain. TRANSCULTURAL AND GENETIC CONSIDERATION CULTURAL CONSIDERATION PEDIATRIC CONSIDERATION Ethnomedicine, sometimes referred to as folk medicine or A number of anatomical and physiological factors traditional medicine, is a focus within medical anthropology determine the pharmacokinetic profile of a drug. Differences that examines the ways in which people in different cultures in physiology in pediatric populations compared with adults conceptualize health and illness. can influence the concentration of drugs within the plasma or These cultural constructs dictate healing practices. In many tissue. non-Western cultures, there is the belief that illness is Healthcare professionals need to be aware of anatomical spiritually based rather than biologically based. In some and physiological changes that affect pharmacokinetic cultures, illness is thought to be caused by spirit possession profiles of drugs to understand consequences of dose or by a loss of balance within the body. Healing techniques adjustments in infants and children. may be based on astrology, magic, rituals, and indigenous medicinal compounds. 1 NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 Pharmacokinetic clinical trials in children are complicated owing to the limitations on blood sample volumes and CULTURAL CONSIDERATION perception of pain in children resulting from blood sampling. Ethnopharmacology is a subdivision of ethnomedicine and focuses on the use of herbs, powders, teas, and animal Absorption products as healing remedies. ○ Liberation of drug from a formulation can differ in children These traditional health practices can have neutral, beneficial, since gut transit time and intestinal fluid composition or deleterious effects on a patient’s health. (including pH) can significantly affect drug dissolution. The emergence of ethnopharmacology highlights the need for ○ Intestinal transit time has been reported to be shorter in nurses to use research from the social sciences, as well as young children which may reduce the amount of drug the biological and physical sciences, to provide holistic absorbed, particularly for poorly soluble drugs or nursing care within a culturally competent context. sustained release products (e.g. theophylline) Culture is based on learned beliefs and behaviors that are Distribution shared by a group of people. Symbols, artifacts, institutions, ○ Drug distribution is affected by factors such as body fluid values, mores, and rules are the products of culture. Culture composition,body tissue composition, protein–binding , is not biologically inherited. There are certain universals that and effectiveness of various barriers to drug transport. are biologically driven, such as the need to eat, but what is ○ In neonates and infants, the body is about 75% water, eaten and how it is eaten is culturally driven. compared with 60% in adults ○ until about the age 2 years, the pediatric patient requires higher doses of water-soluble drugs to achieve therapeutic levels. TRANSCULTURAL NURSING Metabolism The concept of transcultural nursing was formalized by ○ Infants have reduced hepatic blood flow and drug Madeleine Leininger, a nurse anthropologist who founded metabolizing enzymes. the Transcultural Nursing Society in 1974. ○ however, by the time they reach 1 year of age, hepatic To provide culturally competent care, it is imperative that blood flow has reached that of an adult.Whereas, drug nurses be sensitive to the beliefs and practices of immigrant metabolizing enzymes reach an adult level at round 11 and indigenous groups concerning health and illness. years of age , it is important to understand that the As part of the health history, it is important to determine all the isoenzymes involved in the cytochrome P450 system, pharmacotherapeutic agents the patient is using. CYP1, CYP2 and CYP3 develop at different rates and demonstrate individual variation. The Giger and Davidhizar Transcultural Assessment Excretion Model ○ The glomerular filtration rate (GFR) in term neonates is ○ The Transcultural Assessment model, developed by roughly 30% that of adults. During infancy, the GFR rises Giger and Davidhizar in 1998, depicts the six cultural and by 12 months, it reaches adult levels phenomena of (1) communication, (2) space, (3) social organization, (4) time, (5) environmental control, and (6) biologic variation. DRUG THERAPY IN OLDER ADULTS Physiologic Changes ○ a reduction in total body water and lean body mass, resulting in increased body fat, which alters the volume of distribution of drugs ○ a reduction in kidney mass and lower kidney blood flow, leading to a reduced glomerular filtration rate (GFR) and reduced clearance of drugs excreted by the kidneys ○ a reduction in liver size and blood flow, resulting in reduced hepatic clearance of drugs. Drug Classes that require Dosage Adjustment in Chronic Kidney Disease ○ Beta blockers – ( Acebutolol, atenolol) ○ ACEl’s ○ NSAIDS, Opioids ○ Diuretics COMMUNICATION ○ Diabetic medications ○ Communication occurs verbally and nonverbally. Nurses ○ Cholesterol medications must be alert to different types of communication styles ○ Anti-microbials among patients to provide culturally competent care. ○ Miscellaneous (Allopurinol, colchicine) ○ When the patient and the health care provider speak ○ Psychotropics (Lithium, gabapentin) different languages, professional translators should be used whenever possible to safeguard a patient’s confidentiality. ○ If a professional translator is not available, it is important that the nurse select an alternative person carefully. 2 NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 ○ Vernacular English and Standard English SELECTED CULTURAL GROUPS AND COMPONENTS OF THE ○ Greetings and Communication Styles GIGER AND DAVIDHIZAR TRANSCULTURAL ASSESSMENT MODEL SPACE ○ The amount of space around a person’s body is an important psychological consideration. ○ Americans often desire a great deal of personal space and value privacy. In other cultures, population density dictates limited personal space. Patients who are used to dense living quarters may feel insecure in a hospital room. It is important that the nurse have frequent contact with these patients and allow significant members of the social group to remain with the patient as much as possible. SOCIAL ORGANIZATION ○ Families are basic social units. The definition of family and the criteria for inclusion vary among individuals and among cultures. ○ Nurses are in a position to advocate for inclusion of the family in health care settings. Limiting the amount of time a patient can visit with members of the social group is a long-standing practice in American health care settings, but in some other countries, such as the Philippines, it is expected that family members will stay by the patient’s bedside and participate in his or her care. This table is limited in scope and does not necessarily reflect an individual's beliefs, behaviors, or biological functioning. TIME ○ Nurses and patients are likely to have different PHARMACOGENETICS perceptions of time. Time moves slowly for a patient who ○ Refers to the study of all the different genes that is anxious or in pain but moves quickly for a nurse who determine drug behavior within the human body. has a demanding workload. Culturally competent care integrates pharmacogenetics ○ The use of vague terms to denote time may also cause a with the social and cultural attributes of the patient, which disparity between nurses’ and patients’ perceptions of helps to predict variations in drug responses time. Words like soon, about, or later may have vastly ○ Mapping of the human genome has instilled hope for different nuances among individuals and groups. improving diagnosis and treatment of disease, predicting disease potential based on genetic predisposition, and ENVIRONMENTAL CONTROL personalizing medicine based on genetic profiles. ○ A major aspect of some cultures is the desire to enlist the However, as with drugs not being “one size fits all,” use assistance of nature to facilitate the needs of human of pharmacogenetics is not appropriate for all patients. beings. The concept of “nature” may include otherworldly forces or beings, such as deities and spirits. ○ Healers and spiritual advisors can be beneficial in health care settings; examples include the practice of clergy (e.g., ministers, priests, rabbis) visiting ill members of a congregation or the inclusion of a traditional healer in the plan of care. BIOLOGIC VARIATIONS ○ The Genographic Project was conducted by National Geographic scientists and performed DNA testing on populations all over the world. Findings reveal that human beings are 99.9% genetically identical. ○ To illustrate the significance of these findings in patient care settings, it is necessary to review additional terms used in the field of pharmacogenetics. ○ Genomes are a complete set of chromosomes and make up a cell’s DNA. ○ Polymorphisms are DNA variants that occur within a specific population at a frequency greater than 1%. A substrate is a substance that binds to and is metabolized by one or more enzymes. 39 “ 3 NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 INDIVIDUAL VARIATION IN METABOLISM OF SELECT DRUG INTERACTIONS DRUGS What are Drug Interactions? - Anytime you take more than Mercaptopurine one medication, or even mix it with certain foods, beverages, ○ The FDA recommends genetic testing before the or over-the-counter medicines, you are at risk of drug administration of mercaptopurine to patients with acute interaction. Most drug interactions are not serious, but lymphoblastic leukemia. Genetic variation in thiopurine because a few are, it is important to understand the possible S-methyltransferase (TPMT) can interfere with the outcome before you take your medications. metabolism of the drug, leading to an increased severity is defined as an altered or modified action or effect of a in side effects and increased risk of infection. drug as a result of interaction with one or multiple drugs. Warfarin It should not be confused with drug incompatibility or an ○ This drug is a vitamin K antagonist used for prophylaxis adverse drug reaction, an undesirable drug effect that ranges and treatment of venous thromboembolism and for from mild untoward effects to severe toxic effects that include persons with atrial fibrillation or heart valve replacement, hypersensitivity reaction and anaphylaxis. among other uses. It has a narrow therapeutic range. Drug incompatibility is a chemical or physical reaction that Clopidogrel occurs among two or more drugs in vitro. In other words, the ○ Persons with genetic variation in the CYP2C19 enzyme, reaction occurs between two or more drugs within a syringe, which is necessary to convert the prodrug clopidogrel, an IV bag, or other artificial environment outside of the body inhibitor of platelet aggregation, to the active metabolite, Drug interactions can be divided into two categories may be at risk for clot formation due to failure to convert ○ Pharmacokinetic Interactions the prodrug to active drug. ○ Pharmacodynamic interactions Opioids ○ Codeine and tramadol are prodrugs that do not exhibit analgesic properties until converted to active drug by the CYP2D6 138 enzyme in the liver. PHARMACOKINETIC INTERACTIONS Mental Health Drugs are changes that occur in the absorption, distribution, ○ Many drugs used to treat depression (e.g., tricyclic metabolism, and excretion of one or more drugs. antidepressants and selective serotonin reuptake Absorption: inhibitors) and other psychiatric disorders (i.e., ○ Some drugs can alter the absorption of another drug into aripiprazole for use in bipolar disorder and schizophrenia, your bloodstream. and atomoxetine for use in ADHD) are metabolized by ○ For example, calcium can bind with some medications the CYP2D6 enzyme and block absorption. The HIV treatment dolutegravir Carbamazepine (Tivicay) should not be taken at the same time as calcium ○ Persons with the human leukocyte antigen (HLA) B∗1502 carbonate (Tums, Maalox, others), because it can lower variant should avoid using carbamazepine due to the amount of dolutegravir absorbed into the increased risk of developing StevensJohnson syndrome bloodstream and reduce its effectiveness in treating or toxic epidermal necrolysis. Persons of Asian descent HIV infection. Dolutegravir should be taken 2 hours are most likely to carry this genetic variant before or 6 hours after medications that contain calcium or other minerals to help prevent this interaction. ○ In the same manner, many drugs cannot be taken with milk or dairy products because they will bind with the calcium. Drugs that affect stomach or intestine motility, pH, or natural flora can also lead to drug interactions. Distribution: ○ Protein-binding interactions can occur when two or more highly protein-bound drugs compete for a limited number of binding sites on plasma proteins. One example of an interaction is between fenofibric acid (Trilipix), used to lower cholesterol and triglycerides in the blood, and warfarin, a common blood thinner to help prevent clots. ○ Fenofibric acid can increase the effects of warfarin and cause you to bleed more easily Metabolism: ○ Drugs are usually eliminated from the body as either the unchanged (parent) drug or as a metabolite that has been changed in some way. Enzymes in the liver, usually the CYP450 enzymes, are often responsible for breaking down drugs for elimination from the body. However, enzyme levels may go up or down and affect how drugs are broken down. ○ For example, using diltiazem (a blood pressure medication) with simvastatin (a medicine to lower cholesterol) may elevate the blood levels and side effects of simvastatin. Diltiazem can inhibit (block) the CYP450 4 NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 3A4 enzymes needed for the breakdown (metabolism) of simvastatin. High blood levels of simvastatin can lead to INTERACTIONS serious liver and muscle side effects Drug-drug Interaction Excretion: ○ These are the most common types of drug interaction. ○ Some nonsteroidal anti-inflammatory drugs (NSAIDs), The more medications you take, the greater the chance like indomethacin, may lower kidney function and affect for your drug interacting with another medicine. the excretion of lithium, a drug used for bipolar disorder. ○ Drug-drug interactions can decrease how well your You may need a dose adjustment or more frequent medications work, may increase minor or serious monitoring by your doctor to safely use both medications unexpected side effects, or even increase the blood level together. and possible toxicity of a certain drug. ○ For example, if you take a pain medication, like Vicodin, and a sedating antihistamine, such as Benadryl, at the PHARMACODYNAMIC INTERACTIONS same time you will have an additive amount of drowsiness as both medications cause this side effect. occurs when two drugs given together act at the same or Drug-food/beverage Interactions similar receptor site and lead to a greater (additive or ○ You have probably seen the stickers on your prescription synergistic) effect or a decreased (antagonist) effect. bottle to “avoid grapefruit juice” at one time or another. For example, when chlorpromazine, sometimes used to help This may seem odd, but certain medications can interact prevent nausea and vomiting, and haloperidol, an with foods or beverages. For example, grapefruit juice antipsychotic medication for schizophrenia, are given together can lower the levels of enzymes in your liver responsible there may be a greater risk for causing a serious, possibly for breaking down medications. Blood levels of an fatal irregular heart rhythm. interacting drug may rise, leading to toxicity. Additive Drug Effects, When two drugs are administered in ○ This interaction can occur with the commonly used combination, and the response is increased beyond what statins to lower cholesterol, like atorvastatin, lovastatin, either could produce alone, the drug interaction is called an or simvastatin. The result can be muscle pain, or even additive effect; it is the sum of the effects of the two drugs. severe muscle injury known as rhabdomyolysis. Additive effects can be desirable or undesirable Drug-disease interactions ○ For example, a desirable additive drug effect occurs ○ Drug interactions don't always occur with just other drugs when a diuretic and a beta blocker are administered for or foods. Your existing medical condition can affect the the treatment of hypertension. In combination, these two way a drug works, too. drugs use different mechanisms to have a more ○ For example, over-the-counter oral decongestants like pronounced blood pressure–lowering effect. As another pseudoephedrine (Sudafed) or phenylephrine (Sudafed example, aspirin and codeine are two analgesics that PE) may increase blood pressure and can be dangerous work by different mechanisms but can be given together if you have high blood pressure. for increased pain relief. Synergistic Drug Effects and Potentiation When two or more drugs are given together, one drug can have a synergistic effect on another. In other words, the clinical OVER-THE-COUNTER DRUGS effect of the two drugs given together is substantially OTC - are products that are available without prescription for greater than that of either drug alone self treatment of a variety of complaints. ○ An example of this is the use of two cytotoxic drugs to OTC drugs are medications that are safe and effective for use reduce individual drug dosing, thereby decreasing side by the general public without seeking treatment by a health effects. An example of an undesirable effect occurs when professional. alcohol and a sedative-hypnotic drug such as diazepam In 2002, the FDA standardized OTC labeling to provide are combined. The resultant effect of this example is consumers with better information and to describe the increased CNS depression. benefits and risks associated with taking OTC drugs. Antagonistic Drug Effects, When drugs with antagonistic It is an important nursing responsibility to ensure that patients effects are administered together, one drug reduces or blocks are able to read and understand OTC labels. the effect of the other. In some situations, antagonistic effects All OTC drugs must have labels that provide the following are desirable. In morphine sulfate overdose, naloxone is given information in this specific order. as an antagonist to block the narcotic effects of morphine ○ The product’s active ingredients, including the amount in sulfate. each dosage unit This is a beneficial drug interaction of an antagonist. Likewise, ○ The purpose of the product in the case of heparin overdose, protamine sulfate is ○ The uses (indications) for the product administered to block the effects of heparin. ○ Specific warnings, including when the product should not The most common symptoms of drug-drug interactions be used under any circumstances, substances or include nausea, heartburn, headache, and lightheadedness. activities to avoid, side effects that could occur, and when it is appropriate to consult with a doctor or pharmacist ○ Dosage instructions that include when, how, and how often to take the product ○ The product’s inactive ingredients and important information to help ○ consumers avoid ingredients that may cause an allergic reaction. 5 NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 much or not enough to be effective. This is very true of medicines such as acetaminophen (Tylenol) or ibuprofen (Advil), in which repeated overdoses may lead to poisoning of the child, liver destruction, or coma. ○ If the label says to take 2 teaspoons and the dosing cup is marked with ounces only, get another measuring device. Don't try to guess about how much should be given. ○ Always follow the age limits listed. If the label says the product should not be given to a child younger than 2 years, do not give it. ○ Always use the child-resistant cap, and relock the cap after use. ○ Throw away old, discolored, or expired medicine or medicine that has lost its label instructions. ○ Do not give medicine containing alcohol to children DRUG OF ABUSE Substance Use Disorder ○ occurs “when the recurrent use of alcohol and/or drugs causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home.” ○ street drugs — nonprescription drugs with no known therapeutic use—to enhance their moods and increase pleasure. Social risk factors: Nursing Considerations Related to Over-the-Counter Drugs ○ Deviant peer relationships (i.e., the adolescent Nurses should advise patients of the following when associates with abusers and uses drugs to feel accepted) over-the-counter (OTC) drugs are considered: ○ Peer pressure ○ Always read the instructions on the label. ○ Popularity ○ Do not take OTC medicines in higher dosages or for a ○ Bullying longer time than the label states. ○ Gang affiliation is associated with higher drug use and ○ If you do not get well, stop treating yourself and talk with delinquent behavior. a healthcare professional. Individual risk factors: ○ Side effects from OTCs are relatively uncommon, but it is ○ Deviant Individuals with attention-deficit/hyperactivity your job to know what side effects might result from the disorder (ADHD) are three times as likely as the general medicines you are taking. population to use drugs such as nicotine, alcohol, and ○ Because every person is different, your response to the drugs other than Cannabis medicine may be different than another person's ○ depression is associated with alcohol use, particularly response. among young men. ○ OTC medicines often interact with other medicines, and ○ It should be noted that positive family relationships are a with food or alcohol, or they might have an effect on protective factor that has been related to a decrease in other health problems you may have. drug use among adolescents. ○ If you do not understand the label, check with the pharmacist. ○ Do not take medicine if the package does not have a label on it. ○ Throw away medicines that have expired (are older than the date on the package). ○ Do not use medicine that belongs to a friend. ○ Buy products that treat only the symptoms you have. Types of Substance Use Disorders ○ If cost is an issue, generic OTC products may be ○ Alcohol Use Disorder (AUD) cheaper than brand name items. ○ Cannabis Use Disorder ○ Avoid buying these products online, outside of ○ Opioid Use Disorder well-known Internet insurance company sites, because ○ Tobacco Use Disorder many OTC preparations sold through the Internet are ○ Cough and Cold Products counterfeit products. These may not be what you ordered ○ Anabolic-Androgenic Steroids and may be dangerous. Alcohol Use Disorder (AUD) Parents should know the following special information ○ Alcohol use disorder (AUD) is a medical condition about using OTCs for children: characterized by an impaired ability to stop or control ○ Parents should never guess about the amount of medicine to give a child. Half an adult dose may be too 6 NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 alcohol use despite adverse social, occupational, or steroids are also associated with major mood disorders health consequences. such as mania, hypomania,87 and major depression. ○ Alcohol intoxication causes behavior problems and ○ The misuse of anabolic steroids can cause long-term mental changes. These may include inappropriate side effects. These can include cardiovascular behavior, unstable moods, poor judgment, slurred complications, liver disease, reproductive organ damage speech, problems with attention or memory, and poor and severe mood swings. Support is available for coordination. You can also have periods called anabolic steroid users who want to change their "blackouts," where you don't remember events. dependence on these drugs. ○ According to the 2021 National Survey on Drug Use and Frequently Abused Street Drugs and Their Potential Health, 28.6 million adults ages 18 and older (11.3% in Health Consequences this age group) had AUD in 2021.1,2 Among youth, an estimated 894,000 adolescents ages 12 to 17 (3.4% of this age group) had AUD during this time frame.1,2 Cannabis use disorder (CUD) ○ Cannabis use disorder (CUD) is a diagnosis given for problematic marijuana use. This condition was introduced in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition or DSM-5. The previous DSM edition separated problematic use into two different disorders: cannabis abuse and cannabis dependence. ○ Signs and Symptoms of Cannabis Use Disorder A. Continuing to use cannabis despite physical or psychological problems B. Continuing to use cannabis despite social or relationship problems C. Craving cannabis D. Difficulty controlling or cutting down cannabis use E. Giving up or reducing other activities in favor of cannabis use F. Spending a lot of time on cannabis use G. Taking Cannabis in high-risk situations H. Taking more cannabis than was intended I. Tolerance to cannabis J. Withdrawal when discontinuing cannabis Opioid use disorder ○ A person with an opioid use disorder is unable to control the use of opioids, and behaviors associated with getting and using opioids increasingly interfere with daily life. Cravings: These are overwhelming physical and emotional urges to take the drug, despite an understanding of potential consequences to well-being. ○ Craving, or a strong desire or urge to use opioids. Recurrent opioid use resulting in a failure to fulfill major role obligations at work, school, or home. Continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids. Tobacco use disorder ○ Tobacco use disorder means you are addicted to NURSE IN DRUG RESEARCH tobacco. With tobacco use disorder, you have trouble stopping using tobacco. Tobacco contains the drug Clinical research nicotine. Nicotine is addictive because it gives a quick ○ Clinical research is a systematic investigation of human boost to your mood. biology, health, or illness, involving human beings.The Cold and Cough medication abuse goal of clinical research is to develop or contribute to ○ Commonly abused cold and cough medication generalizable knowledge about human health and illness ○ Two commonly abused cough and cold medIcines are: and to test methods that might improve our ability to Dextromethorphan (DXM), a cough suppressant and prevent, diagnose, and treat illness and provide care for expectorant found in many OTC cold medicines. It may patients. produce euphoria and dissociative effects or even Types of clinical trials hallucinations when taken in quantities greater than the ○ Treatment trials test experimental treatments, new recommended therapeutic dose. combinations of drugs, or new approaches to surgery or Anabolic steroid user abuse radiation therapy. ○ Anabolic steroid users are more likely than nonusers to ○ Prevention trials look for better ways to prevent disease report anxiety. Moderate to high doses of anabolic in people who have never had the disease or to prevent 7 NUR104A CONTEMPORARY ISSUES IN PHARMACOLOGY KENNETH JOE R. CORALES 10/22/24 a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. ○ Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. ○ Screening trials test the best way to detect certain diseases or health conditions. ○ Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness. Nurses involved in research, whether as a principal investigator, a study coordinator, clinical trials nurse, or as a staff nurse caring for patients who are research subjects have a responsibility to promote the ethical conduct of clinical research. Fulfilling this responsibility requires understanding what clinical research is and knowing what makes clinical research ethical. Only then can a nurse determine when to take action for what she or he believes is right. Alice is a 42-year-old woman with an aggressive cancer that has not responded to previous therapy. She is offered participation in a phase one clinical trial with a promising new investigational agent. Alice’s nurse knows that the purpose of the trial is to evaluate the safety of the drug and that the possibility that Alice might benefit in terms of tumor shrinkage or an increase in the length or quality of her life is very small. The nurse is concerned that the principal investigator (PI) has not made this clear enough to Alice, and is concerned that Alice is not well informed about what alternatives are available to her. Respecting Alice’s right to make her own decision about study participation, the nurse feels strongly that Alice’s informed consent may be compromised.. When the nurse raises these concerns, the PI expresses apprehension about confusing Alice. The nurse suggests that a multidisciplinary discussion of the options available for Alice and a plan for assuring she understands the options would be helpful for everyone. The PI agrees. The nurse organizes a patient care conference to include the PI, medical fellow, relevant nursing staff, social worker, spiritual counselor, and bioethicist. All agree that it would be helpful if the nurse spent additional time reviewing information about the study with Alice. After a lengthy and engaging discussion with Alice about the study and her options, the nurse asks Alice to explain in her own words what the study is about, what is likely to happen during the study, and what other choices she has besides participation. Much more confident that Alice has a better understanding of the study and is making an informed choice about participation, the nurse offers continued discussion with Alice throughout the study In order to both promote valuable clinical research and protect the rights and interests of people like Alice, it is important to be familiar with ways in which clinical research differs from clinical practice. Without an understanding of the purpose of a phase one trial or the importance of informed consent to research, the nurse might not have taken any steps to help Alice make an informed decision. 8