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14 Cards in this Set
- Front
- Back
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what does the federal food and drug act do
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To protect the public from adulterated or mislabeled drugs.
To declare dangerous and possibly addicting drugs USP- United States Pharmacopeia NF – National Formulary |
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what did the harrison narcotic act do
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established the legal name of narcotic
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what did the federal food, drug, and cosmetic act do
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1938 Federal Food, Drug, and Cosmetic Act – Prohibited the marketing of new drugs before proper testing of their safety had been done.
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what did the durham-humphrey amendment to the FDC do
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Distinguished between drugs that could be sold with or without a prescription and identified those that could not be refilled. Term legend drugs identifies those that can be sold by prescription only thus” Caution – Federal law prohibits dispensing without a prescription.
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what did the kefauver-harris amendment do
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To prove both safety and efficacy of the drug.
Thalidomide babies - deformities |
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what did the controlled substances act do
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Enacted by Congress because of the misuse and abuse of drugs.
Also known as the Comprehensive Drug Abuse Prevention and Control Act. Promoted drug education and research into the prevention and treatment of drug dependence Designated schedules or categories for controlled substances. |
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what are the rules to make a new drug
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May take 12 years
Submit investigational new drug Informed consent Placebo controlled study- ½ received the drug, ½ do not In vitro studies |
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what is the first phase of drug studies
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involves a small number of healthy subjects to determine optimal dosage range and pharmcokinetics (absorption, distribution, metabolism, & excretion.
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what is the second phase in drug studies
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Small number of volunteers who have the disease, refinement of dosage
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what is the third phase in a drug study
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Large number of patients who are followed by medical research centers. Looking for adverse effects. Placebo studies used during this phase. The patient does not know if receiving the drug or not – called blinded investigational drug study. If the investigator does not know call double-blind, placebo-controlled study. Seek NDA (new drug applicatoin)
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what is the fourth phase in drug studies
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Postmarketing studies by the pharmaceutical companies.
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what are the classes of a voluntary recall
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Class I – Most serious
Class II – less severe Class III – no significant health problem |
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what is the ANA code of ethics
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Compassion
Commitment to the patient Protect the health, safety, and rights of the patient. Nurse is responsible and accountable Owes the same duty to self and others Participates in improving health care environments. Advance of the profession Collaborates with other health care professionals Articulation nursing values |
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what is polymorphism
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The effect of a patient’s age, gender, size, body composition and other variables associated with how an individual absorbs or metabolized specific drugs.
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