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What is not included in the definition of a drug product?
food
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What is a substance used in the diagnosis, prevention, or treatment of a disease or medical condition?
drugs
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What information is essential to know for safe administration of a drug?
- dose
- route of administration
- indication
- side effects, ADEs
- contraindications
- techniques in an emergency
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a published source of drug information based on drugs in a given geographic area
pharmacopeia
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by best guess or statistical probabilities
empirical
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drug that must be secured with a prescription
legend
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those products that produce similar concentrations of the drug in the blood and tissues
biologically equivalent
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How is a legend drug obtained?
by prescription only
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What is the original source for drugs?
plants
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All drugs have an official name called the ___________
generic name
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The proprietary name for a drug is the ________
brand name
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Biologic equivalence is equal to ___________
therapeutic equivalence
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What is the time period of patent protection for the manufacture and marketing of a drug?
17 years
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What are the functions of the FDA?
- approve drugs that have been shown to be safe and effective
- tests foods to ensure they are safe to consume
- enforces the drug and cosmetic act which gives authority to regulate labeling and packaging of drug products and establishes standards for purity and strength
- takes pharmacologic productrs off the market when standards are not met
- decides which drugs are sold prescription or OTC
- regulates claims and ads of labels
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Which agency oversees nonprescription drug products?
Federal Trade Commission FTC
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Describe the differences between drug trial phases. What is the chance that all ADEs are identified when all the phases are completed?
- preclinical trials - lab and animal studies to prove safety
- Phase I - 20-80 healthy volunteers to determine dose range and safety profile
- Phase II - 100-300 volunteers w/specific disease to determine drugs effectiveness
- Phase III - 1,000-3,000 volunteers to confirm safety and efficacy and determine ADEs
- Postmarketing - determine true risk/benefit
- Only includes ADEs that occur more than 1 in 1,000 cases - does not usually include children or elderly
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Briefly describe the steps required for a drug to get FDA approval. What groups are often excluded in drug trials?
- has to be tested on animals
- tested on healthy volunteers
- tested on people with specific disease
- tested on 1,000-3,000 volunteers for safety and efficacy and ADEs
- women, children, and elderly are often excluded in drug trials
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What is the purpose of postmarket surveillance?
It is used to determine the true risk-benefit profile of a new drug
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The CSA is administered by what U.S. government agency?
Drug Enforcement Administration (DEA)
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Which act identifies rules for writing prescriptions for narcotics in the U.S? Which government enforces this act?
- Comprehensive Drug Abuse Prevention and Control Act, or Controlled Substance Act (CSA) which used to be Harrison Narcotics Act (HNA)
- Federal government
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Identify sources for drug information that provide fast retrieval of drug information relevant to dental hygiene practice.
- Publications such as:
- facts and comparisons
- physicians drug reference (PDR)
- the US pharmacopeia drug information
- american hospital formulary service drug information
- mosby's dental drug reference
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Identify sources for dentally related drug information that provide fast retrieval of drug information relevant to dental hygiene practice.
- dental drug reference with clinical implications
- dental drug reference
- drug information handbook for dentistry
- drug interaction facts
- handbook of Adverse drug interactions
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Define the acronym FDA
Food and Drug Administration
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Describe 3 ways the RDH applies knowledge of pharmacology.
- administering of local anesthetics
- recommend OTC products
- determine drug effects that may warrant treatment plan modifications
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Which three types of information should be placed in the treatment record?
- drugs used including drug, dose, and route of administration
- drugs recommended or given as a sample with client instructions
- investigation of ADEs and modifications to tx of drugs listed in pts health history
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When preparing a drug card, which 4 items of info should be included?
- drug name (generic, brand)
- indication
- side effects relevant to DH care
- clinical considerations and treatment implications for indication of drug
- oral health info topics related to drug effects, and drug warnings, or condition for which it was taken
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What information should be considered when investigating drugs reported on the medical history?
- why are they taking it
- didi they take it today
- have they noticed side effects
- evaluate vital signs
- examine oral cavity for evidence of drug effects
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