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What is not included in the definition of a drug product?
What is a substance used in the diagnosis, prevention, or treatment of a disease or medical condition?
What information is essential to know for safe administration of a drug?
- route of administration
- side effects, ADEs
- techniques in an emergency
a published source of drug information based on drugs in a given geographic area
by best guess or statistical probabilities
drug that must be secured with a prescription
those products that produce similar concentrations of the drug in the blood and tissues
How is a legend drug obtained?
by prescription only
What is the original source for drugs?
All drugs have an official name called the ___________
The proprietary name for a drug is the ________
Biologic equivalence is equal to ___________
What is the time period of patent protection for the manufacture and marketing of a drug?
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
Which agency oversees nonprescription drug products?
Federal Trade Commission FTC
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
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
What is the purpose of postmarket surveillance?
It is used to determine the true risk-benefit profile of a new drug
The CSA is administered by what U.S. government agency?
Drug Enforcement Administration (DEA)
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
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
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
Define the acronym FDA
Food and Drug Administration
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
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
When preparing a drug card, which 4 items of info should be included?
- drug name (generic, brand)
- 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
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