HSC 235 Exam 1

Exceptions: Special Drug-Marketing Laws

"Fast-track" rule Applied to testing of certain drugs, such as ones for rare cancers and AIDS Orphan Drug Law Tax advantages for development of drugs to treat "rare diseases" since this can be otherwise unprofitable Prescription Drug User Fee Act of 1992 Increase reviewers and decrease review time

Drug use contains three major simultaneous changes in the user

1. The social and psychological rewards from the effects of the drug "high" results in the illusion of temporary satisfaction and postponement of social pressures and anxieties leading to a superficial belief that problems and/or concerns are nonproblematic. 2. Pharmacologically, the nonmedical use of most drugs alters body chemistry largely by interfering with (affecting) its proper (homeostatic) functioning. Drugs enhance, slow down, speed-up, or distort the reception and transmission of reality. 3. Using a particular drug may satisfy an inborn or genetically programmed need or desire.

What age group has the highest concentration of drug users and experimenters?

18-25

National Household Survey on Drug Abuse, 2011

82.2% (211.7 million) Americans used alcohol during their lifetime 62.8 (161.7 million) Americans used cigarettes 47% (117 million) Americans used any illicit drug(s) Most commonly used illicit drugs (Lifetime Use): 107.8 million (41.9%) used marijuana/hashish 51.3 million (19.9%) used nonmedical use of any psychotherapeutics, such as pain relievers, tranquilizers, stimulants, or sedatives (does not include OTC drugs) 36.3 million (14.3%) used cocaine 36.3 million (14.4) used hallucinogens 34.2 million (13.3%) used pain relievers

The Federal Food, Drug, and Cosmetic Act was passed in response to which of the following events?

A pharmaceutical company marketed an antibiotic dissolved in the toxic solvent, diethylene glycol.

Suggestions for Reducing Demand

A top priority of prevention is to reduce demand by youth. Education must be carefully designed for the target population. Attitudes toward drug abuse must be changed. Replacement therapy can be useful.

Three Principle Biological Theories

Abused Drugs are Positive Reinforcers Most drugs with abuse potential enhance pleasure centers by causing the release of specific brain neurotransmitters such as dopamine Drug Abuse and Psychiatric Disorders Biological explanations are thought to be responsible for the substantial overlap that exists between drug addiction and mental illness Genetic Explanations Inherited traits can predispose some individuals to drug addiction.

The Sherley Amendment in 1912

Accuracy of manufacturers' therapeutic claims was not controlled by the Pure Food and Drug Act. The Sherley Amendment in 1912 was passed to strengthen existing laws and required that labels should not contain "any statement ... regarding the curative or therapeutic effect ... which is false and fraudulent."

Drug Interaction

Additive effects Summation of effects of drugs taken concurrently Antagonistic (inhibitory) effects One drug cancels or blocks effects of another Potentiative (synergistic) effects Effect of a drug is enhanced by another drug or substance

Secure and Responsible Drug Disposal Act

Addresses the problem that patients were not allowed to return drugs to DEA registrants

Pharmacokinetic FactorsThat Influence Drug Effects

Administration Absorption Distribution Inactivation Biotransformation and elimination

Physiological Variables That Modify Drug Effects

Age Gender Pregnancy

Drug Use: Additional Findings

Age Patterns: 18-20 age category report the most illicit drug use Racial and Ethnic Differences: (rates of use, past month, 2002-2011) Two or more races 13.5% American Indian/Alaska Natives 13.4% Black/African American: 10% Whites: 8.7%  Hispanic or Latino: 8.4% Asians: 3.8% Gender Males were more likely than females among persons age 12 or older to be current illicit drug users (11.1% vs. 6.5%). The rate of past-month marijuana use for males was about twice as high for males as the rate for females (9.3% vs. 4.9%). Pregnant Women Pregnant women are less likely to use drugs than similar age women who are not pregnant.

Major Types of Commonly Abused Drugs

Alcohol (ethanol) Nicotine (all forms of tobacco) Prescription drugs (many drugs that are prescribed by a physician) Stimulants Major stimulants: amphetamines, cocaine, and crack Minor stimulants: nicotine, caffeine, tea, and chocolate Hallucinogens/psychedelics: LSD, mescaline, peyote, and psilocybin ("magic mushrooms") Bath salts (a designer drug) Depressants: barbiturates, benzodiazepines, valium, and alcohol Cannabis: marijuana and hashish Anabolic steroids: a synthetic form of the male hormone testosterone Inhalants/organic solvents: inhalants like gasoline, model glue, paint thinner, certain foods, herbs, and vitamins Narcotics/opiates: opium, morphine, codeine, and heroin

Major Risk Factors for Addiction

Alcohol and/or other drugs used alone Alcohol and/or other drugs used in order to reduce stress and/or anxiety Availability of drugs Abusive and/or neglectful parents; other dysfunctional family patterns Misperception of peer norms regarding the extent of alcohol and/or drug use (belief that many other people are using drugs) Alienation factors, like isolation and emptiness

Introduction to Nervous Systems

All nervous systems consist of specialized nerve cells called neurons and glia (supporting cells). Neurons are responsible for conducting the homeostatic functions of the brain and other parts of the nervous system by receiving and sending information. Sending and receiving information is an electrochemical process.

The principal forms of drug administration include which of the following?

All of the above

The Abuse of Hormones:Anabolic Steroids

Androgens Produce growth of muscle mass Increase body weight Anabolic steroids Are structurally related to the male hormone testosterone Sometimes abused by athletes and body builders to improve strength and appearances Controlled as Schedule III substances

Costs of Addiction

As a major social problem, the public's view of drug abuse and addiction has been debatable over the past 20 years while the social costs of addiction have not. The total criminal justice, health insurance, and other costs in the United States are roughly estimated at $90 to $185 billion annually.

The History of CNS Depressants

Attempts to find CNS depressants other than alcohol began in the 1800s. Bromides were introduced to treat nervousness and anxiety in the 1800s. Very popular but toxic In the early 1900s, bromides were replaced by barbiturates. Initially heralded as safe and effective Apparent problems with tolerance, dependence, and safety In the 1950s the first benzodiazepines were marketed as substitutes for barbiturates. Relatively safe when used for short periods Long-term use can cause dependence and withdrawal problems Benzodiazepines were routinely prescribed for stress, anxiety, or apprehension. In 1973, 100 million prescriptions were written for benzodiazepines. Twice as many women as men taking them. As medical community became aware of the problem, use of depressants declined, but benzodiazepines remained still very popular. Classified as Schedule V drugs

Types of CNS Depressants

Benzodiazepines: Valium-Type Drugs Prescribed for anxiety, relaxation and sleep Medical uses Relief from anxiety, treatment of neurosis, relaxation of muscles, alleviation of lower-back pain, treatment of convulsive disorders, induction of sleep, relief from withdrawal symptoms, induction of amnesia Mechanisms of action for benzodiazepine Affect neurons that have receptors for the neurotransmitter GABA GABA: most common inhibitory transmitter in brain regions Limbic system (alter mood) RAS (cause drowsiness) Motor cortex (relax muscles) Types of benzodiazepines Many benzodiazepine compounds available in the United States Distinguished primarily by their duration of action: short-acting (hypnotics), long-acting (sedatives) Side effects include drowsiness to paradoxical effects (e.g. increased restlessness), tolerance, dependence, withdrawal, and abuse Barbiturates played an important historical role as sedative-hypnotic agents. However, due to their narrow margin of safety and their abuse liability, they were replaced by benzodiazepines. Caused many negative side effects, from nausea to death, from respiratory or cardiovascular depression

Four Principle Factors That Affect Drug Use

Biological, Genetic, and Pharmacological Factors: Substance abuse and addiction involve biological and genetic factors. The pharmacology of drug use focuses on how the ingredients of a particular drug affect the body and the nervous system, and in turn, a person's experience with a particular drug. Cultural Factors: How do societal views, determined by custom and tradition, affect our initial approach to and use of a drug? Social Factors: What are the specific reasons why a drug is taken (e.g., curing an illness, self-medicating, escape from reality, peer pressure, family upbringing, membership in drug-abusing subcultures)? Contextual Factors: How do physical surroundings (music concerts, bars, nightclubs, or fraternity and sorority parties) affect the amount of drug use?

Biological Explanations for the Use and Abuse of Drugs

Biological: Genetic and biophysiological theories Addiction is based on genes, brain dysfunction, and biochemical patterns Biological explanations emphasize the effects of drugs on the central nervous system (CNS) Reward centers in some people are more sensitive to drugs, resulting in more pleasure and greater rewarding experiences from the use of drugs - Drugs interfere with functioning neurotransmitters (neurotransmitters are chemical messengers used for communication between brain regions)

Biotransformation

Biotransformation: The process of changing the chemical or pharmacological properties of a drug by metabolism. The liver is the major organ that metabolizes drugs in the body. The kidney is the next most important organ for drug elimination.

Major Factors Affecting Alcohol and Drug Use

Body size: smaller or thinner persons experience the effects of drugs more intensely Gender: physical make-up of women have reduced tolerance to drugs in comparison to men Other drugs (poly drug use): taking multiple drugs can dramatically increase drug impairment Fatigue or illness: increases drug effects Empty stomach: increases drug effects Strength (alcohol proof) and how the amount of the drug affects one's reaction Mindset: uncontrollable or impulse drinking and/or use of drugs dramatically increases drug effects

Drug Dependence

Both physical and psychological factors precipitate drug dependence: Physical dependence refers to the need to continue taking the drug to avoid withdrawal symptoms, which often include feelings of discomfort and illness. Psychological dependence refers to the need that a user may mentally feel about continuing the use of a drug to experience its effects and/or relieve withdrawal symptoms.

The Effects of CNS Depressants

CNS depressants reduce CNS activity and diminish the brain's level of awareness. Depressant drugs include: Benzodiazepines Barbiturate-like drugs Alcohol Antihistamines Opioid narcotics like heroin Depressants are usually classified according to the degree of their medical effects on the body. For example: Sedatives cause mild depression and relaxation Anxiolytic—drugs that relieve anxiety Hypnotics induce drowsiness and encourage sleep Amnesiac effects can cause the loss of memory The same drug can cause different effects depending on dose. Low dose (sedatives—relieve anxiety and promote relaxation) Higher doses (hypnotics—can cause drowsiness and promote sleep) Even higher doses (anesthetics can cause anesthesia and are used for patient management during surgery)

Central Nervous System

CNS includes the brain and the spinal cord CNS receives information from PNS, evaluates the information, then regulates muscle and organ activity via PNS Reticular activating system Receives input from all the sensory systems and cerebral cortex Controls the brain's state of arousal (sleep vs. awake) Reticular activating system Basal ganglia Controls motor activity Establishes and maintains behaviors Limbic system Regulates emotional activities, memory, reward, and endocrine activity Includes the nucleus accumbens, the brain's reward center Dopamine The cerebral cortex Helps interpret, process, and respond to information; selects appropriate behavior and suppresses inappropriate behavior The hypothalamus Controls endocrine and basic body functions

Genetic Explanations for Contribution to Drug Abuse Vulnerability

Character traits, such as insecurity and vulnerability, which is often found in many drug users/abusers may be genetically determined. Factors that determine how difficult it will be to break a drug addiction may be genetically determined.

Peripheral Nervous System

Consists of input and output nerves Input to brain and spinal cord Conveys sensory info (pain, pressure, temperature) Output: Two types Somatic (control of voluntary muscles) Autonomic (control of unconscious functions)

The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) (APA 2013)

DSM-5 combines substance abuse and substance dependence into a single condition called substance use disorder. The diagnosis of substance use disorder includes the following: Pharmacological - taking the substance in larger doses Excessive time spent obtaining the substance Craving the drug Social impairment: failure to meet goals and obligations Risky use of the substance: despite physical and/or psychological problems encountered Tolerance: The individual needs increased amounts to achieve the diminishing effects of the drug Withdrawal: Symptoms that can often leading to renewed substance dependence

Neurons

Dendrites are the receiving regions of a neuron's cell body. Each neuron in the central nervous system is in close proximity with other neurons. Although they are close, neurons never actually touch. Synapse is the point of communication between one neuron and another. Synaptic cleft is the gap between neurons at the synapse.

Drug Courts

Designed to deal with nonviolent, drug-abusing offenders Integrate mandatory drug testing, substance abuse treatment, sanctions, and incentives in a judicially supervised setting

Danger Signals of Drug Abuse

Do those close to you often ask about your drug use? Have they noticed changes in your moods or behavior? Are you defensive if a friend or relative mentions your drug or alcohol use? Are you sometimes embarrassed or frightened by your behavior under the influence of drugs or alcohol? Have you ever gone to see a new doctor because your regular physician would not prescribe the drug you wanted? When you are under pressure or feel anxious, do you automatically take a depressant, stimulant, or drink? Do you take drugs more often or for purposes other than those recommended by your doctor? Do you mix other types of drugs with alcohol? Do you drink or take drugs regularly to help you sleep? Do you have to take drugs to relieve boredom or get through the day? Do you personally think you may have a drug problem? Do you avoid people who do not use drugs? Do you believe you cannot have fun without alcohol or other drugs?

Dimensions of Drug Abuse

Drug abuse is also known as chemical or substance abuse and is the willful misuse of either licit or illicit drugs for the purpose of recreation, perceived necessity, or convenience. Drug abuse refers to a more intense misuse of drugs—often to the point of addiction. Also known as chemical or substance abuse.

DRUG MISUSE

Drug misuse is the unintentional or inappropriate use of prescribed or over-the-counter (OTC) types of drugs.

Drug use

Drug users are found in all occupations and professions, at all income and social class levels, and in all age groups. No one is immune to drug use, (that often leads to drug dependence). Drug use is an equal-opportunity affliction.

Other Types of CNS Depressants

Drugs with barbiturate-like properties: Chloral hydrate Glutethimide Methyprylon Methaqualone Antihistamines Propofol (abused general anesthetic) GHB (gamma hydroxybutyrate)

Media Influence on Drug Use

Each year, the alcohol industry spends more than $1 billion on advertising (television, radio, print, and outdoor ads) (FTC 2007). Drug companies spent $1.6 billion a year on televised commercials for Viagra, Claritin, Allegra, and other drugs. The advertising budget for Budweiser beer exceeds the entire budget for research on alcoholism and alcohol abusers. Alcohol companies spent $4.9 billion on television advertising between 2001 and 2005. Teens viewing photos of inebriated friends posted on social media, such as MySpace for example, are four times more likely to have used marijuana and three times more likely to have used alcohol and tobacco.

Drug Use: Additional Findings (continued)

Education: College graduates (5.4%) had the lowest rate of current illicit drug use, while those who did not complete high school (11.1%) had the highest use of illicit drugs. Past-month alcohol use increased with higher levels of completed education (35.1% with less than high school vs. 68.2% of college graduates.Employment: Unemployed persons (17.2%) have a greater tendency to use more illicit-types of drugs than people gainfully employed (8% full-time and 11.6% part-time workers). Geography: The rate of past-month illicit drug use was 9.2% in large metropolitan counties, 8.7% in small metropolitan counties, and 5.7% in nonmetropolitan counties. Criminal Justice: 33% of state prisoners and 25% of federal prisoners reported that they had committed their offenses while under the influence of drugs. In 2008, an estimated 333,000 prisoners were arrested for drug law violations—20% of state and 52% of federal inmates (Sabol and Cooper 2009).

Synapses

Excitatory synapse initiates an impulse in the receiving neuron when stimulated, causing release of neurotransmitters or increasing activity in target cell. Inhibitory synapse diminishes likelihood of an impulse in the receiving neuron or reduces the activity in other target cells. A receiving neuron or target cell may have many synapses. Final cellular activity is a summation of these many excitatory and inhibitory synaptic signals.

Career Pattern of Addiction

Experimentation or initiation of drug use Escalation: increasing use Maintenance: optimistic belief that the drug fits in well with day-to-day goals and activities Dysfunction: problems with use interfering with day-to-day goals Recovery: getting out of drug use/abuse Ex-addict: successfully quitting

Three Types of Drug Users

Experimenters: Begin using drugs largely because of peer pressure and curiosity, and they confine their use to recreational settings Compulsive users: Devote considerable time and energy into getting high, talk incessantly (sometimes exclusively) about drug use, and become connoisseurs of street drugs Floaters or "chippers": Focus more on using other people's drugs without maintaining as much of a personal supply

Cultural factors account for how drug use behavior develops from the physical surroundings in which the drug is taken.

False

Long-term effects that occur after multiple drug doses are classified as acute.

False

Most drugs do not pass from the mother into the fetal circulation.

False

Preferring to drink alone is not a factor that contributes to drug addiction.

False

Selective legalization is an approach that would legalize those drugs of abuse that are the most likely to cause addiction.

False

The effects of acute and chronic use with the same drug are always the same.

False

Trend data show that between the years 2010 through 2011, illicit drug use has been steadily decreasing.

False

Why Do People Use Drugs?

From 1960 to the present, drug use has become a widespread phenomenon. Drugs are much more potent than they were years ago. Drug use remains extremely popular. Drugs sales are a multibillion-dollar-a-year business, with major influence on many national economies. More so today than years ago, both licit and illicit drugs are experimented with by youths at an increasingly younger age. These drugs are often supplied by older siblings, friends, and acquaintances. Through the media (such as television, radio, magazine, and newspaper advertising), people in today's society are more directly exposed to drug advertising. Greater availability and wider dissemination of drug information through emails, drug websites for purchasing prescription drugs without prescriptions, chat rooms, and methods and instructions on how to make drugs. Crack as well as crystal methamphetamine and other manufactured "newer" drugs offer potent effects at a low cost. Drug use endangers the future of a society by harming its youth and potentially destroying the lives of many young men and women. Drug use and especially drug dealing are becoming major factors in the growth of crime rates among the young. Seven in ten drug users work full-time and this increases the possibility of serious accidents in the workplace.

Barbiturates likely cause their depressant effects by enhancing which transmitter?

GABA

Gateway Drugs

Gateway drugs are types of commonly used drugs that are believed to lead to the use of other more powerful mind-altering and addictive drugs, such as hallucinogens, cocaine, crack, and heroin. Alcohol, tobacco, and marijuana are the most commonly used gateway drugs.

Holistic Self-Awareness Approach

Holistic philosophy that advocates that the mind, body, and spirit work best when they are drug-free.

Theories Based on Learning

Humans acquire drug use behavior by the close association or pairing of one significant reinforcing stimulus (like friendship and intimacy) with another less significant or neutral stimulus (e.g., initial use of alcohol, marijuana, ecstasy, cocaine). In learning to use drugs the following occurs: Conditioning: The close association of significant reinforcing stimulus with another less significant or neutral stimulus Habituation: Repeating certain patterns of behavior until they become established or habitual "Addiction to pleasure" theory: Assumes it is biologically normal to continue a pleasure stimulus when once begun

Principal Issues Influencing Laws Regarding Substance Abuse

If a person abuses a drug, should he or she be treated as a criminal or as a sick person inflicted with a disease? How is the user (supposedly the victim) distinguished from the pusher (supposedly the criminal) of an illicit drug, and who should be more harshly punished? Are the laws and associated penalties effective deterrents against drug use or abuse, and how is effectiveness determined?

Social Psychological Learning Theories

If the effects of drug use become personally rewarding, "or become reinforcing through conditioning, the chances of continuing to use are greater than stopping" (Akers 1992, p. 86). Primary conditions determining drug use are: Amount of exposure to drug-using peers Extent of drug use in a given neighborhood Age of first use (exposure to drugs at younger ages results in greater difficulty in stopping drug use) Frequency of drug use among peers

New Drug Application (NDA)

If there is sufficient data to demonstrate that a drug is safe and effective, the company submits an NDA as a formal request that the FDA approve it for marketing.

Costs of Drug Use to Society

Illnesses Shortened lifespans Marital and family strife Fetal alcohol syndrome Criminalistic behavior Drugs in the workplace/disruption of careers and professions Cost of assistance programs (e.g., Employee Assistance Programs [EAPs])

The Regulation ofNonprescription Drugs

In 1972, the FDA initiated a program to evaluate the effectiveness and safety of nonprescription drugs. The FDA evaluated each active ingredient in OTC medications and placed ingredients into three categories: I. Generally recognized as safe and effective II. Not safe and effective or unacceptable indications III. Insufficient data to permit final classification

Drug Testing

In response to the demand by society to stop the spread of drug abuse and its adverse consequences, drug testing has been implemented in some situations to detect drug users. Breathalyzers Urine, blood, and hair specimens

Drugs in the Workplace

In the U.S., alcohol and drug use and their related problems costs employers and tax payers billions of dollars per year. The National Household surveys found significant drug use in the workplace with 64.3% of full-time workers reported alcohol use (7% to 9% drinking while working) and 6.4% reported marijuana use within the past month (SAMHSA 2012). Among the 19 major industry categories, the highest rates of past month illicit drug use among full-time workers aged 18 to 64 were found in accommodations and food services (16.9%), construction (13.7%), and arts, entertainment, and recreation (11.6%); (see Figure 1.10). The industry categories with the lowest rates of past month illicit drug use were utilities (3.8%), educational services (4%), and public administration (4.1%).

Psychological Factors AffectingDrug Effect

Individual's mental set Placebo effects

Intended and Unintended Effects of Drugs

Intended responses: Reason for using the drug Unintended responses: Side effects The main distinction between intended responses and side effects depends on the therapeutic objective.

Erich Goode's Four Types of Drug Use

Legal instrumental use: Taking prescribed drugs or OTC drugs to relieve or treat mental or physical symptoms Legal recreational use: Using licit drugs like tobacco, alcohol, and caffeine to achieve a certain mental state Illegal instrumental use: Taking nonprescribed drugs to achieve a task or goal Illegal recreational use: Taking illicit drugs for fun or pleasure

Major Risk Factors for Adults

Loss of meaningful role or occupational identity due to pending retirement Loss, grief, or isolation due to divorce, loss of parents, or departure of children ("empty nest syndrome") Loss of positive body image Dealing with a newly diagnosed illness (e.g., diabetes, heart problems, arthritis, cancer) Disappointment when life's expectations are clearly not met

Low-Risk and High-Risk Drug Choices

Low-risk drug choices refer to values and attitudes that lead to controlling the use of alcohol or drugs—self-monitoring your drug use, behavior, and abstinence. High-risk drug choices refer to developing values and attitudes that lead to using drugs both habitually and addictively, such as constantly searching for drinking and drug parties and hanging with drug abusers.

Durham-Humphrey Amendment

Made formal distinction between prescription and nonprescription drugs Established drug classification categories: Drug is habit-forming Drug is not safe for self-medication Drug is a new drug and not shown to be completely safe

Neurotransmitters

Many drugs affect the activity of neuro-transmitters by altering their synthesis, storage, release, or deactivation. Neurotransmitters frequently altered by drugs of abuse: Acetylcholine Catecholamines Serotonin GABA Endorphins Anandamide

Dose-Response

Many factors can affect the way an individual responds to a drug, including the following: Dose Tolerance Potency Additional factors Pharmacokinetic properties: Rate of absorption Manner distributed throughout the body Rate metabolized and eliminated Form of the drug Manner in which the drug is administered

The Harrison Act of 1914

Marked the first legitimate effort by the federal government to regulate and control the production and importation of addicting substances

Major Models of Addiction

Moral Model: Poor morals and lifestyle; a choice Disease Model: A belief that addiction is both chronic and progressive, and that the drug user does not have control over the use and abuse of the drug Characterological or Personality Predisposition Model: Personality disorder, problems with the personality of the addicted (needs, motives, attitudes of the individual, and impulse control disorders)

Distribution

Most drugs are distributed throughout the body in the blood. It takes approximately 1 minute for a drug to circulate throughout the body after it enters the bloodstream. Drugs have different patterns of distribution depending on their chemical properties.

Direct-to-Consumer (DTC) Advertising

Most physicians surveyed agreed that because their patient saw a DTC advertisement, he/she asked thoughtful questions during the visit. Approximately the same percentage of physicians thought the advertisements made their patients more aware of possible treatments. The physicians surveyed indicated that the advertisements did not convey information about risks and benefits equally well. Approximately 75% of physicians surveyed indicated that DTC ads cause patients to think that the drug works better than it does, and many physicians felt some pressure to prescribe something when patients mentioned DTC ads. The physicians surveyed reported that patients understand that they need to consult a health care provider concerning appropriate treatments.

Common Side Effects of Drugs

Nausea or vomiting Changes in mental alertness Dependence Withdrawal Allergic reactions Changes in cardiovascular activity

Neurons and Neurotransmitters

Neurons can send discrete excitatory or inhibitory messages to their target cells. Neurons are distinguished by the type of neurotransmitter they release. Neurotransmitters represent a wide variety of chemical substances and functions. Example: Dopamine activates the pleasure center.

Forms and Methods of Taking Drugs

Oral ingestion Inhalation Injection Topical application

Kefauver-Harris Amendments

Passed, in part, as a consequence of the thalidomide tragedy Drug manufacturers had to demonstrate the efficacy and safety of drugs The FDA was empowered to withdraw approval of a drug that was already being marketed The FDA was permitted to regulate and evaluate drug testing by pharmaceutical companies

Why Are People Attracted to Drugs?

People use drugs as a means to temporarily: Experience pleasure or heighten good feelings Relieve stress, tension, or anxiety Forget one's problems and avoid or postpone worries Relax after a tension-filled day of work Fit in with peers or as a rite of passage Enhance religious or mystical experiences Relieve pain and some symptoms of illness

Who Is at Risk?

People who are at a high risk for drug use and addiction are often known as drug sensation-seeking individuals or simply, sensation-seekers. Sensation-seekers continually search for new or novel thrills in their experiences, and are known to have a relentless desire to pursue physical and psychological stimulation often involving dangerous behavior. Sensation-seekers attracted to drug are more likely to maintain a constant preoccupation with altering their consciousness (getting high).

Drug Dependence

Physical Dependence (e.g.,withdrawal and rebound) Psychological Dependence (e.g., craving)

Addiction Includes Physical and Psychological Dependence

Physical dependence refers to the body's need to constantly have the drug or drugs. Psychological dependence refers to the mental inability to stop using the drug or drugs.

Major Risk Factors for Adolescents

Physical or sexual abuse (past and/or present) Peer norms favoring drug use Misperception and/or power of age group peer norms Conflicts, such as dependence versus independence, adult maturational tasks versus fear, and low self-esteem. Teenage risk-taking and view of being omnipotent and invulnerable to drug effects Drug use viewed as a rite of passage into adulthood Drug use perceived as glamorous, fun, facilitating, and intimate Electronic social media influences like photos of drinking posted on MySpace

Potency vs. Toxicity

Potency: The amount of drug necessary to cause an effect Toxicity: The capacity of a drug to do damage or cause adverse effects in the body

Drug Advertising

Promotional efforts by pharmaceutical companies have a large impact on the drug-purchasing habits of the general public and health professionals. As a general rule, the FDA oversees most issues related to advertising of prescription products. The FTC regulates OTC advertising.

Genetic Factors Contribute to Drug Abuse Vulnerability

Psychiatric disorders may be relieved by taking drugs of abuse, thus encouraging their use. Drug users may have reward centers in the brain that may be especially sensitive to addictive drugs. Addiction is a medical condition in the brain of addicts. Addiction is genetically determined, and people with this predisposition are less likely to abandon their drug of abuse.

Psychoactive Drugs

Psychoactive drugs are classified as either: Licit (Legal): Examples may include coffee, tea, alcohol, tobacco, and over-the-counter drugs. Illicit (Illegal): Examples may include marijuana, cocaine, and LSD.

Psychological Explanations for Drug Use/Abuse

Psychological theories regarding drug use and addiction mostly focus on mental or emotional states of drug users, the possible existence of unconscious motivations that are within all of us, and social and environmental factors. The American Psychiatric Association classifies severe drug dependence as a form of psychiatric disorder. Drugs that are abused can cause mental conditions that mimic major psychiatric illness. Psychological factors of addiction include: Escape from reality Boredom Inability to cope with anxiety Destructive self-indulgence (constantly desiring intoxicants) Blind compliance with drug-abusing peers Self-destructiveness Blindly using drugs without wanting to understand the harmful effects of drug use Self medicating (need the drug to feel better)

Drug Quiz

Q: How many Americans, age 12 and up, have used alcohol in the past month? A: 125 million Q: How many Americans in the past month have smoked tobacco? A: 61.5 million Q: How many Americans use or have used marijuana/hashish in their lifetime? A: 107,842 million (41.9%) Q: How many drugs can be found in the average household? A: 50 drugs (40% prescriptions, 60% OTC)

The Dimensions of Drug Abuse

Q: What is a drug? A: Any substance that modifies (enhances, inhibits, or distorts) mind and/or body functioning. Q: What are psychoactive drugs? A: Drug compounds (substances) that affect the central nervous system and/or alter consciousness and/or perceptions.

Drugs, Crime, and Violence

Regarding the connection between drug use and crime, the following findings can be summarized: Drug users in comparison to non-drug users are more likely to commit crimes. A high percentage of arrestees are often under the influence of a drug while committing crimes. A high percentage of drug users arrested for drug use and violence are more likely to be under the influence of alcohol and/or stimulant-types of drugs such as cocaine, crack, and methamphetamines.

Stages of Drug Dependence

Relief: Satisfaction from negative feelings in using the drug Increased Use: Involves taking greater quantities of the drug Preoccupation: Consists of a constant concern with the substance Dependency: A synonym for addiction, is when more of the drug is sought despite the presence of physical symptoms Withdrawal: The physical and/or psychological effects from not using the drug

The 1906 Pure Food and Drug Act

Required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each product Did not prohibit distribution of dangerous preparations

Tolerance

Reverse tolerance (sensitization): Enhanced response to a given drug dose; opposite of tolerance Cross-tolerance: Development of tolerance to one drug causes tolerance to related drugs

"Scheduling"

Schedule I substances have high-abuse potential and no currently approved medicinal uses. Schedule II substances have high-abuse potential but are approved for medical uses and can be prescribed. Schedule II-V substances reflect the likelihood of abuse and clinical usefulness.

__________ drugs have high abuse potential but are approved for medical purposes.

Schedule II

Basic Reasons People Take Drugs

Searching for pleasure Relieve pain, stress, tension, or depression Peer pressure Enhance religious or mystical experiences Enhance social experiences Enhance work performance, (i.e. amphetamine-types of drugs and cocaine) Drugs (primarily performance-enhancing drugs) can be used to improve athletic performance Relieve pain or symptoms of illness

Drug Use: Statistics and Trends

Social Drugs $90 billion for alcohol $51.9 billion for cigarettes $2 billion for cigars, chewing tobacco, pipe tobacco, roll-your-own tobacco, and snuff $5.7 billion for coffee, teas, and cocoa Prescription Drugs $950 billion worldwide in 2012. $237.5 billion in the United States OTC Drugs $23.5 billion Nonmedical Use of Prescription Drugs In 2008, 51.9 million Americans age 12 or older had used prescription-type drugs nonmedically at least once in their lifetime. Miscellaneous Drugs Examples include inhalants, nutmeg, and morning glory seeds Extent of use cannot be verified

Sociological Explanations

Social Influence Theories: Focus on microscopic explanations that concentrate on the roles played by significant others and their impact on the individual. Structural Influence Theories: Focus on macroscopic explanations of drug use and the assumption that the organizational structure of society has a major impact on individual drug use.

Social Influence Theories

Social learning theory explains drug use as a form of learned behavior. Social influence and the role of significant others says the use of drugs is learned during intimate interaction with others who, while using the drug, serve as a primary group. Labeling theory says people whose opinions we value have a determining influence over our self-image. Key factors in labeling theory include: Primary deviance Secondary deviance Master status Retrospective interpretation - Can you define these four key factors used in labeling theory? Subculture theory explains that peer pressure is a determining cause of drug experimentation, use, and/or abuse.

Guidelines for Controlling Drug Development and Marketing

Society has the right to protect itself from the damaging impact of drug use. Society has the right to demand safe and effective drugs.

Regulatory Steps for New Prescription Drugs

Step 1: Preclinical research and development Step 2: Clinical research and development Initial clinical stage Clinical pharmacological evaluation stage Extended clinical evaluation Step 3: Permission to market Postmarketing surveillance

Structural Influence Theories

Structural Influence Theories: Focus on how the organization of a society, group, or subculture is largely responsible for drug abuse by its members Social Disorganization and Social Strain Theories: Drug use is caused by rapid and disruptive social change in society Control Theories: Belief that if people are left without attachments (bonds) to other groups (family, peers, social institutions), they have a tendency to deviate from expected cultural values, norms, and attitudes and use drugs Socialization: Internal and external controls

Designer Drugs/Synthetic Drugs or Synthetic Opioids

Structural analogs are drugs that result from altered chemical structures of current illicit drugs. It involves modifying the basic molecular skeleton of a compound to form a new molecular species. Designer Drugs /Synthetic Drugs or Synthetic Opioids New categories of hybrid drugs like Ecstasy and Demerol. These relatively recent types of drugs are created as structural analogs of substances already classified under the Controlled Substances Act.

Strategies for Preventing Drug Abuse

Supply Reduction - Attempts to curtail the supply of illegal drugs or their precursors and exert greater control over other, more therapeutic drugs - Includes interdiction, the policy of cutting off or destroying supplies of illicit drugs - Limited success Inoculation - Aims to protect drug users by teaching them responsibility and explaining the effects of drugs on bodily and mental functioning Demand Reduction - Aims to reduce the actual demand for drugs

Autonomic Nervous System

Sympathetic and parasympathetic system These systems work in an antagonistic fashion to control unconscious, visceral functions such as breathing and cardiovascular activity Sympathetic system Norepinephrine Parasympathetic system Acetylcholine

Six Examples of Drug Misuse

Taking more drugs than prescribed Using OTC or psychoactive drugs in excess without medical supervision Mixing drugs with alcohol or other types of drugs Using old medicines to self-treat new symptoms of an illness Discontinuing prescribed drugs at will and/or against physician's orders Administering prescribed drugs to a family member without medical consultation and supervision

Patterns of Abuse with CNS Depressants

The American Psychiatric Association considers dependence on CNS depressants a psychiatric disorder. People most likely to abuse CNS depressants include individuals who: Use drugs to relieve continual stress Paradoxically feel euphoria and stimulation from depressants Use depressants to counteract the unpleasant effects of other drugs of abuse Combine depressants with alcohol and heroin to potentiate the effects Detoxification: The elimination of a toxic substance, such as a drug, and its effects With CNS depressants, this is achieved by substituting a longer-acting barbiturate for the offending CNS depressant and gradually reducing the dose to avoid unpleasant withdrawal effects. Withdrawal from CNS depressants, if not managed properly, can be very dangerous, or even fatal.

Another Definition of Addiction

The National Institute on Drug Abuse (NIDA) defines addiction as ". . . a chronic, relapsing brain disease that is characterized by compulsive drug-seeking and use, despite harmful consequences. It is considered a brain disease because drugs change the brain—they change its structure and how it works. These brain changes can be long lasting and can lead to the harmful behaviors seen in people who abuse drugs" (NIDA 2008a, p. 5).

Costs of Drug Use to Society: Statistics

The National Institute on Drug Abuse (NIDA) estimates that the typical narcotic habit costs $100/day. A heroin addict must steal three to five times the actual cost of the drugs to maintain a habit—about $100,000 per year. Three out of four prostitutes in major cities have a serious drug dependency.

Factors Determining Scheduling

The actual or relative potential for abuse of the drug. Scientific evidence of the pharmacological effects of the drug. The state of current scientific knowledge regarding the substance. Its history and current pattern of abuse. What, if any, risk there is to the public health. The psychological or physiological dependence liability of the drug. The scope, duration, and significance of abuse. Whether the substance is an immediate precursor of a substance already controlled.

Regulating New Drug Development

The amended Food, Drug, and Cosmetic Act requires that all new drugs be registered with and approved by the FDA. The FDA is mandated by Congress to: Ensure the rights and safety of human subjects during clinical testing Evaluate the safety and efficacy of new treatments Compare benefits and risks of new drugs and determine if approval for marketing is appropriate

When Does Use Lead to Abuse?

The amount of drug taken does not necessarily determine abuse. The motive for taking the drug is the most important factor in determining presence of abuse. Initial drug abuse symptoms include: Excessive use Constant preoccupation about the availability and supply of the drug Refusal to admit excessive use Reliance on the drug

Drug Receptors

The chemical messengers from glands and neurons exert their effects by interacting with special protein regions in membranes called receptors. Receptors only interact with molecules that have specific configurations. Agonists: Substances or drugs that activate receptors Antagonists: Substances or drugs that attach to receptors and prevent them from being activated

Time-Response Factors

The closer a drug is placed to the target area, the faster the onset of action. Acute drug response: Immediate or short-term effects after a single drug dose Chronic drug response: Long-term effects after a single dose

Switching Policy

The drug must have been used by prescription for 3 years. Use must have been relatively high during the time it was used by prescription. Adverse drug reactions must not be alarming, and the frequency of side effects must not have increased during the time the drug was available to the public.

Introduction to the Endocrine System

The endocrine system consists of secreting glands (e.g., adrenal, thyroid, pituitary) These glands produce substances called hormones (e.g., adrenaline, steroids, insulin, sex hormones) These substances are information transferring molecules Hormones are secreted into the bloodstream and carried by the blood to all the organs and tissues of the body. Hormones affect selected tissues that are designed to receive the information. Hormones may be highly selective or very general with regard to the cells or organs they influence.

Pragmatic Drug Policies

The government must develop programs that are consistent with the desires of the majority of the population. Programs must consider de-emphasizing interdiction and stress programs that reduce demand. Government and society must better understand how laws, used properly and selectively, can reinforce and communicate expected social behavior and values. Programs, such as anti-smoking campaigns, should be implemented that employ "public consensus" more effectively.

Margin of Safety

The range in dose between the amount of drug necessary to cause a therapeutic effect and a toxic effect.

Transfer of Messages by Neurons

The receiving region of the neuron is affected by a chemical message that either excites or inhibits it. Neuronal message: Impulse moves from the receiving region of the neuron down the axon to the sending region (terminal). Chemical messengers (neurotransmitters) are released. Neurotransmitters travel and attach to receiving proteins called receptors on target cells. Activation of receptors causes a change in the activity of the target cell; the target cells can be other neurons or cells that make up organs, muscles, or glands.

Food, Drug, and Cosmetic Act

The sale and use of Elixir Sulfanilamide led to a tragic accident that killed over 100 people. Companies required to file applications with the government showing that new drugs were safe. Required safe tolerances be set for unavoidable poisonous substances. Authorized establishment of identity and quality for foods.

Defining Addiction

The term addiction is derived from the Latin verb addicere, which refers to the process of binding to things. Today, the word largely refers to a chronic adherence (attachment) to drugs. Originally, the World Health Organization (WHO) defined it as "a state of periodic or chronic intoxication detrimental to the individual and society, which is characterized by an overwhelming desire to continue taking the drug and to obtain it by any means" (1964, pp. 9-10). Addiction is a complex disease.

Patent Medicines

The term patent medicines signified that the ingredients were secret, not patented. The patent medicines of the late 1800s and early 1900s demonstrated the problems of insufficient regulation of the drug industry.

Addiction and Abuse

The use of the term addiction is sometimes confusing. It is often used interchangeably with dependence, either physiological or psychological in nature; other times, it is used synonymously with the term drug abuse. A more accurate definition is the compulsive drug use despite negative consequences. Factors affecting variability in dependence/addiction: Hereditary factors (genetic variants); responsible for 40-60% vulnerability Drug craving Other factors contributing to drug use patterns: Positive versus negative effects of drug Peer pressure Home, school, and work environment Mental state

The Comprehensive Drug Abuse Prevention and Control Act

This 1970 act divided substances with abuse potential into categories based on the degree of their abuse potential and clinical usefulness. Schedules I, II, III, IV, and V

Abused Drugs as Positive Reinforcers

This explanation believes that most drugs with abuse potential enhance the pleasure centers by causing the release of dopamine, which is a specific brain neurotransmitter.

Required Doses for Effects

Threshold dose: The minimum amount of a drug necessary to have an effect Plateau effect: The maximum effect a drug can have regardless of the dose Cumulative effect: The buildup of drug concentration in the body due to multiple doses taken within short intervals

Adaptive Processes

Tolerance: Changes causing decreased response to a set dose of a drug Dependence: The physiological and psychological changes or adaptations that occur in response to the frequent administration of a drug Withdrawal

Drug testing is frequently mandatory for participants in sports at all levels.

True

Holistic self-awareness approach emphasizes a healthy balance among mind, body, and spirit.

True

In 2011, the rate of current illicit drug use was higher among males aged 12 to 17 than females aged 12 to 17.

True

Personality patterns are partially responsible for how an individual responds to drug use; likewise, it is very difficult to explain individual motivations as a group-wide basis.

True

The Drug Addiction Treatment Act allowed qualified physicians to prescribe specially approved Schedule III narcotics for the treatment of opioid addiction in medical treatment settings.

True

The autonomic nervous system is divided into two functional components, the sympathetic and the parasympathetic nervous systems.

True

The effects of the CNS depressants tend to be dose dependent; therefore, a high dose of a sedative has a hypnotic effect.

True

The limbic system in the brain helps to regulate emotional activities and memory.

True

The nonbarbiturate CNS depressants are classified as Schedule II, Schedule III, and Schedule IV according to their relative potential for physical and psychological dependence and their perceived clinical usefulness.

True

Women's reactions to barbiturates may differ from men because of their higher body-fat ratio.

True

Major Divisions of the Nervous System

Two major components of the nervous system Central nervous system (CNS) Peripheral nervous system (PNS)

Drug Testing

Used to identify those who may be using drugs Urine, blood screening, or hair analysis Duration of Detection /"Cut-Offs" for Urine Analysis: Amphetamines: 24-72 hours Cocaine/metabolite: 24-72 hours Opiates: 24-72 hours PCP: 24-96 hours THC/metabolite: 24 hours-3 weeks (depends on frequency of use) Note: Hair analysis 1 to 3 months for all drugs listed above Approximately 70% of large companies,50% of medium companies, and 22% of small companies drug test. Over 90% use urine analysis, less than 20% use blood analysis, and less than 3% use hair analysis. Most drug-using youth do not cease drug use when they begin working.

Drug Legalization Debate

Violence and crime would decrease/increase? Profits associated with illegal trade would decrease/increase? Law enforcement costs would decrease/increase? Addiction would decrease/increase? Societal/health costs would decrease/increase? Consumption would increase/decrease?

Why are CNS depressants problematic?

Why are CNS depressants problematic? Usually prescribed under physician's direction Second most frequently abused prescription drug and sometimes contributes to death due to accidental overdoses Can cause very alarming and dangerous behavior if not closely monitored Most problems associated with these drugs due to inadequate professional supervision Seemingly unrelated drug groups can cause CNS depression Combination use can cause dangerous drug interactions Can cause disruptive personality changes

Nicotinic receptors are activated by which of the following transmitters?

acetylcholine (Ach)

The prevailing concept or model of addiction in the United States is the __________.

disease model

Which of the following neurotransmitters is metabolized by the enzyme monoamine oxidase (MAO)?

dopamine

Drugs administered using which of the following methods can enter the blood almost as quickly as intravenous injection?

inhalation

Which structure has been found to be important in maintaining nicotine dependence?

insula

Freud established early psychological theories that linked addiction to __________ habits.

masturbatory

Which of the following usually causes death resulting from a barbiturate overdose?

respiratory or cardiovascular depression

The view that alcoholism is a __________ dates back to 200 years ago.

sickness