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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 a medical condition?
what information is essential to know for safe administration of a drug? (7)
appropriate dose to use
rout of administration
indication or reason for using the drug
significant side effects and potential adverse reactions
relevant drug interactions
contraindications for using the drug on a pt
appropriate monitoring techniques and interventions in case of medical emergency
collection of published drug information in a specific geographic area
use of experience or statistical probabilities for making drug choices
drug secured by a prescription
ability of a generic drug to reach blood levels equivalent to those reached by a brand name drug
how is a legend drug obtained?
with a prescription
what is the original source for drugs
all drugs have an official name called the ______ name
the proprietary name for a drug is the ______ name
trade or brand name
biologic equivalence is equal to ______ equivalence
what is the time period of patent protection for the manufacture and marketing of a drug?
what are the functions of the FDA?
safety, labeling, manufacturing standards, regulates prescription vs OTC sales
approve drugs that have been shown to be safe and effective
tests food products to make sure they are safe to consume
enforces the food drug and cosmetic act
which agency oversees no prescription drug products?
federal trade commission FTC
describe the difference between drug trail phases
: new drug tested in animals to prove its safety
phase I clinical trials
: low doses tested on 20-80 healthy volunteers to study safety and pharmacokinetic characteristics
phase II clinical trials
: controlled studies involving 100 to 300 volunteers assessing drug effectiveness
phase III clinical trials
: controlled studies involving 1000 to 3000 volunteers to confirm the drugs safety and efficacy and identify ADEs
: determine the true risk benefit profile of new drug
what is the chance that all ADEs are identified when all the trial phases are complete?
unlikely most are missed 30000 people would have to be exposed to the drug to have 95% chance of detecting an ADE with an incidence of 1 in 10000 subjects
what groups are often excluded in drug trials?
children women and elderly
what is the purpose of postmarket surveillance?
determine the true risk benefit profile of the new drug
the CSA is administered by which Us governmental agency?
drug enforcement administration DEA
which act identifies rules for writing prescriptions for narcotics in the US?
harrison narcotics act HNA
identify sources for dentally related drug information that provide fast retrieval of drug relevant to dental hygiene practice
detailed and complete drug information publications
dental drug references
drug interaction publication
food and drug adminstration
describe three ways the RDH applies knowledge of pharmacology
drugs used during the course of an appt
drugs recommended to the pt
drug or herbal supplements in HHX of the pt that have side effects or require modification to TX
which three types of information should be placed in the TX record
route of administration
when preparing a drug card which five items of information should be included
side effects relevant to DH
oral health information
list four to six ADEs that can modify the dental hygiene treatment plan
effect on blood pressure or pulse
immune response changes
increased bleeding risk
central nervous system effects
what information should be considered when investigating drugs reported on the medical history?
side effects (ADEs) requiring modificaiton to dental treatment, any contraindications to dental treatment or dental drugs
ch 1 self study review