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42 Cards in this Set
- Front
- Back
(study of) variances within the pharmacokinetic processes mainly related to culture, in this specific context we are discussing patients’ response to medications. |
Ethnopharmacology |
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the study of the genetic basis for differences we see in patients’ responses to the meds we administer (aka pharmacogenomics) |
pharmacogenetics |
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Variation in response to a drug because of a patient's age, gender, size, body composition |
drug polymorphism |
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Another name for prescription drugs |
legend drugs "Caution- federal law prohibits dispensing without a prescription" |
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Any drugs listed on one of the "schedules" of the Controlled Substance Act |
controlled substance |
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Drug used to treat patients with rare diseases |
orphan drug |
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Congress passed this act which requires manufacturers of products to ensure their safety, and prohibits them from making any unsubstantiated claims on the label (Label has to say "for depression" not ""known to cure depression" |
Dietary Supplemental Health and Education Act |
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The drug approval process is complex and prolonged. It begins with preclinical testing phases which include in vitro studies and animal studies in vitro: |
using tissue samples and cell cultures |
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_______ studies follow preclinical phase |
Clinical (human) |
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the drug is put on the market after phase III is completed if an investigational new drug application is submitted |
An application that must be submitted to the FDA before a drug can be studied in humans |
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Involves careful explanation to the human test patient of the purpose of the study etc. |
informed consent |
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Which phase of clinical study? Small number of volunteers who have the disease that the drug is designed to diagnose or treat. Closely monitored to determine drug's effectiveness and any adverse effects |
Phase II |
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Which phase of clinical study? Small number of healthy subjects rather than those who the drug is intended to treat. This phase determines dosage range, pharmacokinetics of the drug |
Phase I |
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Which phase of clinical study? Large number of patients who are followed by medical research centers. Provides info about infrequent or rare adverse effects that may have not been yet observed. Placebos, Blind, double blind, |
Phase III |
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Which phase of clinical study? Post marketing studies that are voluntarily conducted by pharmaceutical company to obtain further proof of therapeutic and adverse affects. FDA may request Black box warning |
Phase IV |
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FDA may recall drug any time 3 classes of recall: |
Class 1: Most serious, drug has probability of serious adverse effects or death Class 2: Less severe, drug may cause temporarily or medically reversable health effects Class 3: Least severe, drug is not likely to cause any significant health problems |
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The ethical principle of doing or actively promoting good |
Beneficence |
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The duty to do no harm to a patient |
Nonmaleficence |
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The duty to tell the truth |
Veracity |
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State laws that are instrumental in defining the scope of nursing practice |
Nurse Practice Acts |
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the characteristics we obtain genetically from our parents and relatives before them |
heredity |
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a unit of heredity that is transferred from a parent to offspring and is held to determine some characteristic of the offspring. |
Genes |
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all things that mostly cannot be controlled- ex. gender, age, ethnicity |
intrinsic |
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stress levels, activity levels, diet, trust in health care system |
extrinsic |
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Sanitation worker of our cells. Job is to remove toxins from our cells |
P-glycoprotein |
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Over the decades that drug trials have been going on, not really using culturally diverse sample of clients. How are we changing that? |
expanding drug trials through diversity |
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Phase 1 of metabolism Phase 2 of metabolism |
CYP 450 Acetylation |
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Half life will be shortened in rapid _______ |
acetylator |
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Liver tries to make ___ soluble less ___ soluble. Kidneys only like to excrete _____ soluble stuff |
fat fat water |
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reason we have drug doses: |
acetylation |
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when the liver is preparing the medication for the kidneys to excrete. Trying to make fat soluble medications a little less fat soluble |
acetlyation |
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Planning care is taylor made which means testing for drug metabolizing _______ are available in our generation |
enzymes |
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laughing in the face of scientists who said cannot be changed Tells us that genes cannot be altered but their function can be changed. We can try to stop bad through environmental factors- ex. Predisposition to cancer |
Epigenetics |
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DispensingRegulations I II III IV V |
I – noprescriptions except in the case of approved protocols and studies II –written Rx and NO refills (codeine, morphine, demerol,methadone, pentobarbital, anabolic steroids III –written Rx with 5 or less refills in a 6month period (codeine in combination, vicodin) IV – writtenRx with 5 or less refills in 6 month period (ativan,valium, chloral hydrate) V – writtenRx or OTC availability (state specific/coughremedies s/a Phenergan, and antidiarrhealss/a Lomotil) |
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If there is a narcotic ______ no one can leave until it is resolved |
discrepancy |
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given an order where you need to split the pill, legally the other half is not to be retained Has to be witnessed by __ to RN or ____ to RN |
wasting RN LPN |
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Two types of dependence: |
addiction habituation |
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individual develops physical symptoms if the drug is stopped |
physical dependence |
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individual is emotionally attached to the drug and no physical symptoms* manifest upon cessation of the drug. Symptoms are behaviorally based. |
Psychological dependence |
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body becomes accustomed to a drug over time and larger doses are needed to elicit same effect |
tolerance |
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body develops tolerance to drugs within the same classification or pharmacological class |
cross tolerance |
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Controlled substance schedule categories: I II III IV V |
I–Highest potential for severe dependence (no med use) II –High potential for severe dependence III –Moderate to low potential IV –Limited/low potential V –Limited/low potential |