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1938: Food Drug and cosmetic Act |
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Definition
monitor and regulate the manufactures and marketing of drugs |
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1952: Durham- Humphrey Amendment to the 1938 Act |
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Definition
distinguished between drugs that can be sold with or without prescription and those that should not be refilled with out a new prescription |
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1962: Kefauver-Harris Amendment to the 1938 act |
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tightened controls on drug safety, especially experimental drugs, and required that the adverse reactions and contradictions must be labeled and included in the literature |
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1970: the controlled substances act |
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Definition
designed to remedy the escalatiing problem of drug abuse |
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1978: Drug Regulation Reform Act |
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this reform act shortened the time in which new drugs could be developed and marketed |
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Definition
the regulations were changed to increase the approval rate of drugs used to treat acquired immunodeficiency syndromes (AIDS)and cancer |
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1997: The Food and Drug Administration Modernization Act |
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Definition
1. review and use of new drugs is accelerated. 2. drugs can be tested in children before marketing 3. clinical trail and data are necessary for experimental drug use for serious of life threatening health conditions 4. drug companies are required to give information on "off-label" drugs 5. drug companies that plan to discontinue drugs must inform healthy professionals and clients at least 6 months before stopping drug production |
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2003: Health Insurance Portability and Accountability Act (HIPPA) |
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Definition
sets the standards for the privacy of individually identifiable health information as of 2003 |
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2003: Pediatric Research Equality Act |
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Definition
The FDA is authorized to require testing by drug manufactures of drugs and biological products for their safety and effectiveness in children |
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2003: Medicare Prescription Drug Improvement and Modernization Act(MMA) |
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Definition
serves to provide financial assistance to seniors to purchase needed prescription medications |
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Definition
Negligence; giving the wrong drug or drug dose that results in the client's death |
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Omission; omitting a drug dose that results in the client's death |
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giving the correct drug but by the wrong route the results in the clients death |
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the official or nonproprietary name of the drug |
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Definition
also known as the proprietary name, is chosen by the drug company and is usually registered trademark owned by that specific maufacture |
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Definition
is the study of the effects of chemical substances on living tissues. Early drugs were derived from plants, animals and minerals |
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18th Century Breakthrough drugs were introduced |
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Definition
Vaccine for smallpox, digitalis and vitamin C |
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Definition
asprin, phenobarbital insulin and sulfonamides weredeveloped |
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antibiotics, antihistamines cortisone were developed |
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Definition
antipsychotic drugs, antihypertensives, oral contraceptives, and the polio vaccine |
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Schedule 1 of controlled substances.. C1 |
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Definition
Drugs with high abuse potential. No accepted medical use.
EX: heroin hallucinogenics |
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Term
Schedule 2 of controlled substances...C2 |
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Definition
High potentian for drug abuse Accepted medical use can lead to strong physical and psychological dependency.
EX: Demerol, morphine, oxycodone |
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Schedule 3 controlled substances...C3 |
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Definition
Medically accepted drugs. Potential abuse is less than that for schedule 1 and 2. May cause dependence.
EX: codeine preparations, paregoric, nonnarcotic drugs |
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Term
Schedule 4 Controlled substances..C4 |
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Definition
Medically accepted drugs may cause dependence
EX: phenobarbital, benzodiazepines |
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Schedule 5 controlled substances...C5 |
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Definition
Medically accepted drugs. Very limited potential for dependence
EX: opiod-controlled substances |
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Definition
Controlled Drug and Substance Act National Association of pharmacy regulatory authority Nonprescription drugs |
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~FDA and Consumer groups ~Tighter oversight of distributors ~Rapid alert system ~better informed consumers ~verified internet pharmacy practice site (VIPPS) |
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No risk to fetus. Studies have not shown evidence of fetal harm |
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Definition
No risk in animal studies and well-controlled studies in pregnant women are not available.It is assumed there is little to no risk in pregnant women |
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Definition
Animal studies indicate a risk to the fetus. Controlled studies on pregnant women are not available. Risk versus benefit of the drug must be determined |
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Definition
A risk to the human fetus has been proved. Risk versus benefit of the drug must be determined. It could be used in life-threatening conditions |
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Definition
A risk to the human fetus has been proved. Risk outweighs the benefits and drug shouls be avoided during pregnancy. |
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Definition
combination of ethnic and cultural variables. |
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Term
The Purnell Model for Cultural Competence |
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Definition
is a circle with an outlying rim that represents global society, a second rim that represents community, a third rim that that represents family and an inner rim that represents the person |
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includes concepts related to orgins, topography, economics, and education |
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defined as the physical proximity between people conversing, varies between and among cultural groups |
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or the perspective of time , determines whether the client stresses a past, present, or future orientation,and needs to be considered when the cares for clients from diverse cultures |
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includes concepts related to biologic variations, heredity, genetics, endemics, and drug metabolism |
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Definition
includes the use of tobacco, alcohol, sex practices, and recreational drugs |
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Definition
includes concepts related to common foods, eating rituals, limitations in obtaining nutritious foods, enzyme deficiencies, and how foods are used for health promotion and wellness. |
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includes concepts related to religious preference, meaning of life, and individual sources of strength |
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Definition
the primary reason most people see health professional-is expressed differently among ethnocultural groups. |
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Definition
is a culture bound phenomenon. |
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Definition
an altered or modified action or effect of a drug as a result of interaction with one or more drugs |
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Term
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Definition
chemical or physical reaction between two or more drugs. reaction occurs within a syringe, IV bag or any other artificial environment outside of body |
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Term
3 ways one drug can block, decrease, or increase the absorption rate of another drug |
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Definition
~BY decreasing/increasing gastric emptying time ~By changing the gastric pH ~By forming drug complexes |
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Factors that influence displacement of drugs are... |
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Definition
1) the drug concentration in the blood. 2)protien-binding power of the drugs 3) volume distribution (vd) |
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Definition
Drugs that promote induction of enzymes |
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Definition
drugs can increase or decrease renal excretion and |
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Definition
Drugs can increase or decrease renal excretion and have an effect on the excretion of other drugs |
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Definition
when two drugs with similar action are administered, the drug interaction |
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is when the clinical effect is substantially greater than the combined effect of the two |
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Definition
is when each drug cancels the effect of the other |
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Definition
Food can bind drugs, causing less or slower drug absorption |
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Definition
is a skin reaction that is caused by exposure to sunlight |
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Definition
occurs when a drug undergoes activation in the skinby ultraviolet light to a compound that is more allergenic than the parent compound |
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Definition
drugs judged to be both safe and effective |
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drugs judged to be either unsafe or ineffective; these drugs should not be included in nonprescription products |
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Drugs for which there are insufficien data to judge safety of efficacy |
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Definition
avoidance of substance use |
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Definition
A compulsive, uncontrollabe craving for and dependence on a substance to such a degree that cessation cause severe emotional, mental, and physiological reactions. |
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Definition
a term used by health care professionals to describe behaviors related to the effects of drugs or substances on performance. |
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Subjective need for a substance, usually experienced after decreased use or abstinence. |
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is stimulated in the presence of situations previously associated with drug taking |
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Reliance on a substance that has reached the level that its absence will cause on impairment in function |
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Compulsive need to experience pleasurable response from the substance |
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Definition
Altered physiological state from prolonged substance use, regular use is necessary to prevent withdrawal syndrome |
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Definition
overindulgence in and dependence on a substance that has a negative impact on psychologic, physiologic, and social functioning of an individual, synonymous with chemical dependence |
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Definition
Indiscriminate use of a drug for purpose other than those for which it is intended. |
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Definition
return to substance use during abstinence |
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Definition
drug, chemical, or biological entity |
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Definition
Decreased effect of a substance that results from repeated exposure. It is possible to develop cross-tolerance to other substances in same category |
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Definition
COnstellation of physiologic and psychologic responses that occur when there is abrupt cessation or reduced intake of a substance oh which an individual is dependent or when the effect is counteracted by a specific antagonist |
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Definition
is a state of being poisoned by a drug or other toxic substance |
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Definition
involves treating an intoxicated client to diminish or remove drugs or their effects from the body |
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Definition
Increased arousal and alertness; performance enhancement; increased heart rate, cardiac output, and blood pressure; cutaneous vasoconstriction; fine tremor, decreased appetite; antidiuretic effect; increased gastric motility |
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Term
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Definition
Euphoria, grandiosity, mood swings, hyperactivity, hyperalertness, restlessness, anorexia, insomnia, hypertension, tachycardia, marked vasconstriction, tremor, dysrhythmias, seizures, sexual arousal, dilated pupils, diaphoresis |
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Definition
Mood elevation, increased alertness, nervousness, jitteriness, irritability, insomnia, increased respirations, increased heart rate and force of myocardial contraction, relaxation of smooth muscle, diuresis |
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Term
Depressants: Alcohol, Sedative-hypnotics,Benzodiazepines, Nonbarbituates/nonbenzodiazepines |
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Definition
initial relaxation, emotional lability, decreased inhibitions, drowsiness, lack of coordination, imparied judgment, slurred speech, hypotension, bradycardia, bradypnea, constricted pupils |
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Definition
Analgesia, euphoria, drowsiness, detachment from environment, relaxation, constricted of pupils, constipation, nausea, decreased respiratory rate, slurred speech, imparied judgment, decreased sexual and aggressive drives |
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Term
Cannabis:Marijuana Hashish |
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Definition
Relaxation, euphoria, amotivation, slowed time sensation, sexual arousal, abrupt mood changes, impaired memory and attention, impaired judgment, reddened eyes, dry mouth, lack of cordination, tachycardia, increased appetite |
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Psychedelics: lsd, mushrooms, pcp |
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Definition
perceptual distortions, hallucinations, delusions (pcp), depersonalization, heightened sensory perception, euphoria, mood swings, suspiciousness, panic, impaired judgment, increased body temperature, hypertension, flushed face, tremor, dilated pupils, constricted pupils (pcp), nystagmus (pcp), violence (pcp) |
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Definition
euphoria, decreased inhibitions, giddiness, slurred speech, illusions, drowsiness, clouded sensorium, tinnitus, nystagmus, dysrhythmias, cough, nausea, vomitting, diarrhea, irritation to eyes, nose, mouth |
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