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59 Cards in this Set
- Front
- Back
(def)
the study of the effects of chemical substances on living tissue |
Pharmacology
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Chemical substances classified as drugs can be derived from what 3 sources?
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- plants
- animals - inorganic compounds |
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What drug is extracted from the foxglove plant?
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digoxin (Lanoxin)
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Natural conjugated estrogen (Premarin) is derived from what source?
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the urine of pregnant mares
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What drug can be obtained from the pancreas of pigs?
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insulin
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Is iron derived from plants, animals or inorganic compounds?
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inorganic compounds
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What drug type can be produced by the genetic engineering of the DNA of E. Coli?
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Insulin
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(def)
the application of pharmacology to prevent disease |
Pharmacotherapeutics (clinical pharmacology)
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In 1906, the "Federal Food and Drug Act" was passed to protect the public by controlling the sale of drugs which were _______, ________, and _______ ________.
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altered, dangerous, and falsely labeled
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Although the "Federal Food and Drug Act" was the first step taken to make drugs safer, it did little to ensure what?
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effectiveness
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What original publication was designated as the official publication of drug standards?
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"United States Pharmacopeia"
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What original publication was designated as the official listing of all drugs available in the US?
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"National Formulary"
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The "United States Pharmacopeia" and the "National Formulary" are now combined and updated how often?
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Every 5 years
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What is the purpose of the "Food and Drug Administration Drug Bulletin" that is published quarterly?
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to impart new information to health practitioners involved in prescribing or dispensing drugs
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How does the term "formulary" apply to Health Insurance companies or Pharmacies?
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Health Ins. companies may use a formulary, or list of drugs that they will pay for, as a guideline for payment. Pharmacies may have their own formulary for what drugs they will or will not carry.
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What was the purpose for the 1912 "Federal Food and Drug Act - Sherley Amendment"?
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to prohibit drug companies from making false claims about their products
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What was the purpose of the 1914 Harrison Narcotic Act?
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It defined the legal term "narcotic" and regulated the importation, manufacturing, and sale of opium, cocaine, and their derivatives.
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What was the purpose of the renaming of the "Federal Food and Drug Act" to the "Federal Food, Drug, and Cosmetic Act" in 1938.
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- It mandated pharmaceutical companies to submit an investigational new drug (IND) application to the FDA and conduct toxicity testing in lab animals before marking new drugs (and cosmetics).
- FDA was empowered to approve and recall drugs |
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What was the purpose of the 1951 "Federal Food, Drug, and Cosmetic Act - Durham-Humphrey Amendment"?
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- prescription (legend) and OTC drugs had to be distinguished. Legend drugs had to beard the inscription "Caution - Federal Law prohibits dispensing without a prescription"
- specified that controlled substances could not be refilled without a new prescription - Restricted the dispensing of drugs to licensed pharmacists |
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What was the purpose of the 1962 "Federal Food, Drug, and Cosmetic Act - Kefauver-Harris Amendment"?
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- required drugs be effective as well as safe
-revisited the issue of drug companies making false claims - pregnancy safety categories were introduced |
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What was the purpose of the 1970 "Comprehensive Drug Abuse Prevention and Control Act"?
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- categorized addictive drugs into 5 schedules according to abuse potential
- DEA controlled legislation re: controlled substances - Gov. Programs to prevent and treat drug abuse were established |
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Which schedule of drugs is considered to be the most addictive?
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Schedule 1
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What effect did the "Comprehensive Drug Abuse Prevention and Control Act" have on nursing?
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Double-lock system
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What was the purpose and result of the 1982 "Tamper Proof Packaging Requirement" act?
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Purpose - to prevent tampering
Result - OTC drugs had to be packaged in such a way that it was obvious if it had been tampered with |
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What was the purpose of the 1983 "Orphan Drug Act"?
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Offered substantial tax credits to pharmaceutical companies to develop drugs to treat rare diseases or which have a limited market.
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What was the purpose of the 1984 "Generic Drug Law"?
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enabled pharmaceutical companies to manufacture and market a drug under the generic name and to apply their own trade name once the patent held by the original manufacturer expired.
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A generic drug is considered a bioequivalent if the peak serum concentration and the plasma-concentration curve fall within ____ - _____ % of the original brand-name drug.
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80-125%
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What is the primary reason that generic drugs are less expensive than that of the original manufacturer?
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studies do not have to be duplicated
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What was the purpose of the 1992 "Drug Relations Act"?
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Allowed the review process to be accelerated if the drugs would be used to treat HIV, AIDS, or cancer. (fast-tracked)
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What was the purpose of the 2003 "Pediatric Research Equality Act"?
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required testing of certain drugs for safety and effectiveness in children
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What was the purpose of the 2003 "Medicare Prescription Drug and Modernization Act"?
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provides financial assistance to senior citizens to purchase prescription drugs
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Who controls drug testing in the US?
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Food and Drug Administration
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True/False:
Drugs marketed as dietary supplements (vitamins, minerals, and herbs) do not have to be monitored by the FDA. |
False- effective 2007 the FDA began monitoring these agents (there is a 3 year phase in for smaller companies)
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What is granted by the FDA if the laboratory studies (pre-clinical) studies are satisfactory?
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"Investigational New Drug Exemption" which will permit testing on humans
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How many phases are clinical trials on humans?
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4
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During which phase of clinical trials is the drug given to a small # of healthy volunteers?
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Phase 1
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What group of people are generally excluded from clinical trials?
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Women of child-bearing age
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During which phase of clinical trials is the drug given to a small number of volunteers who have the disorder that the drug is intended to treat?
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phase II
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During which phase of clinical trials is the drug given to a large # of patients who have the disorder?
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Phase III
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During which phase of clinical trials are double-blind studies often uses?
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Phase III
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At what point can a pharmaceutical company apply to the FDA for a "new drug application" (NDA)?
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Phase III
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Which phase of clinical trails is referred to as post-marketing surveillance?
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Phase IV
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What is considered a flaw in the system of reporting adverse drug reactions?
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reporting is voluntary
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Who do you contact to report adverse drug reactions?
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FDA's "Medwatch" program
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Approximately how long does the FDA grant a patent to assist a pharmaceutical company in recouping the cost of development?
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13-17 years
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What are the 3 names drugs are given?
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1- chemical
2- generic 3- trade, brand or propriety |
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Which drug name is related to the chemical structure of the drug?
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chemical
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Which drug name is assigned to the drug when the pharmaceutical company applies for the approval process?
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generic
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What drug name is used to facilitate marketing?
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trade, brand or propriety
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What change to a drug's name is made to indicate some alteration to the drug (ex. SR for sustained release)?
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a suffix is added
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Drugs are administered according to the "five rights". What are they?
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- right patient
- right drug - right dose - right route - right time |
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Who wrote the code of ethics for nurses which delineates our responsibilities to our profession, our clients and the general public?
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American Nurses Association
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What is the purpose of the nurse practice act?
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to protect the residents of the state by maintaining minimum safe standards for nursing
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What test is given to demonstrate that the nurse possesses the expected competencies to practice nursing safely?
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NCLEX-RN
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To be valid, a medication order must be written by the appropriate licensed professional and contain what information?
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- patient's name
- time and date the order is written - the name of the drug (generic is preferred) - the dose of the drug - route the drug is to be administered - time interval the drug is to be administered - the signature of the person writing the order |
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True/False:
Orders written by medical students are not valid unless co-signed by a licensed physician. |
True
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How long does a practitioner have to cosign verbal orders in an acute care setting?
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24 hours
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What is the best method a nurse can use to ensure that she/he understands the verbal orders that were given?
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repeat them back to the person giving the orders
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Who is legally responsible for knowing the purpose, therapeutic effects, and possible adverse effects of drugs administered?
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the nurse
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