How many subjects are generally included in premarketing drug trial groups?
3,000 to 4,000
from a statistical perspective, a population of 30,000 would have to be exposed to the drug to have a ___% chance of detecting an ADE with an incidence of 1 in 10,000 subjects; which means, ADEs that occur at low frequencies what?
can easily be missed
study groups for drug trials often exclude _______, _________, and _________, making ADEs in this population unlikely to be identified in data supplied to the FDA for drug approval
the efficacy of a drug is evaluated only for a ________ set of indications and may not include the actual evolving use of a drug
premarketing clinical trials are designed to detect only the most common ADEs, including thos occurring more frequently than ___ in ______; these are listed in the product's official labeling at the time of approval
1 in 1,000
What was the first federal law (1914) intended to reduce drug addiction or substance abuse?
Harrison Narcotics Act (HNA)
What act is usually referred to as the controlled substance act (CSA), and replaced the HNA and other legilsation related to narcotic drug prescription; designed to prevent drug abuse and dependence and to include recommendations for treatment and rehab of drug-dependant persons.
Comprehensive Drug abuse prevention and control act of 1970
What act identifies drugs that have the potential to cause dependence or abuse and classifies them according to their abuse potential; also identifies drugs within each of 5 schedules and sets requirements for writing prescriptions for these scheduled drugs?
Comprehensive drug abuse prevention and control act of 1970 (CSA)
What regulatory agency enforces the food, drug, and cosmetic act, which gives the agency the authority to regulate labeling and packaging of drug products, and to establish standards for purity and strength?
true or false. another purpose of pharmacology in dentl hygiene practice is to guide the practitioner toward using reliable sources of drug information for drug investigation
detailed and complete drug information can be found in a variety of publications including what 3 sources?
dental drug references
drug interaction publications
true or false. Dental hygienists may be asked by clients to recommend OTC products for postoperative pain control, antiviral or antifungal treatments, or any other number of reasons
Drugs entered in the treatment record should should include what 3 things?
route of administration
true or false. any drug recommended or given as a sample to a client should be recorded in the treatment record, with the client's instructions
why is it so important for the dental hygienist to understand the pertinent pharmacological properties of those drugs used as adjuncts to dental hygiene procedures?
so they can identify specific drugs to use in a specific procedure
the proper dose to use
the method of application or administration
precautions or contraindications in using any given product
Why do dental hygienists have an obligation to understand the pharmacologic effects of agents reported on the health history?
so they can investigate all drugs, supplements, and herbal products reported by clients on during the health history review
All pharmacologic products should be investigated in a medical or dental drug reference with attention given to what?
the action of the product and potential ADEs, or side effects
Who is responsible for prescribing the indicated antibiotic? And who plays a role as part of the pretreatment evaluation to ensure that the client takes the proper dose and knows when it should be taken?
Why is the information of antibiotics prescribed to the pt recorded in the client's treatment record?
to verify that this follow-up procedure is done
What information needs to be included on the drug card? (5)
drug name (generic and brand name)
indication (why drug was taken)
side effects relevant to DH care
clinical implications for each drug effect experienced by the pt; ADE's and indications considered
oral health information topecs, warnings, or condition for which the drug was indicated