Chapter 1 Flashcards
Drug (Dorland)
chemical compound used on or administered to humans/animals as an aid in diagnosis/treatment/prevention of a disease/abnormal condition for relief of pain or suffering OR to control or improve any physiologic or pathologic condition
Drug (others)
chemical substance that affects biologic systems
Minerals, herbs, vitamins and amino acids
have pharmacologic effects on the body, by law they are not classified as drugs
Food and Drug Administration
FDA
Pharmacologist
studies and develops drugs
Hives
an example of an allergic response to drugs
allergy
an allergic response to a drug
side effects
predictable responses to drugs that act on nontarget organs
life-long learning
appropriate reference sources should be available and consulted
foundation knowledge
body of information relied upon for decisions that surround performing the competency
knowledge of pharmacology to perform:
obtaining a health history; administering drugs in the office; handling emergency situations; planning appointments; nonprescription medications; nutritional or herbal supplements; discussing drugs
proprietary names
aka trade names
nonsteroidal antiinflammatory drug
drug group that relieves pain and reduces inflammation; not corticosteroids
generic drug
nonproprietary name (not trade name)
therapeutic indexes
LD50/ED50; used to compare safety of drugs
pharmacokinetic
movement of a drug within the body
contraindications
an aspect of a patient’s condition that makes the use of a certain drug or therapy an unwise or dangerous decision
barbiturates
group of sedative-hypnotic drugs that reduce activity in the brain; are habit-forming and possibly fatal when taken with alcohol
LO: #1 history and relationship to oral health care provider
Humans noticed that ingesting certain plants altered body functions or awareness; first pharmacologist was a person who became more astute in observing and remembering which plant products produced predictable results; agents-useful-prescribed and dispensed-dentistry-dentists (for dental problems)
LO: #2 drugs, named and significance
chemical name- determined by its chemical structure; code name - combination of letters and numbers, much easier to speak and write; trade name (capitalized) - usually chosen so that it can be easily remembered and promoted commercially, registered as a trademark; brand name - technically name of company marketing the product; generic name - “official” name of the drug (only one generic name; not capitalized); naming multiple-entity drugs is difficult because of several ingredients
LO: #3 acts and agencies to regulate drugs
Harrison Narcotic Act of 1914 - regulates use of opium, opiates, and cocaine and marijuana added in 1937; FDA grants approval so that drugs can be marketed in the US; Federal Trade Commission regulates trade practices of drug companies and prohibits false advertising of foods, nonprescription drugs and cosmetics; Drug Enforcement Administration regulates substances that have a potential for abuse, including opioids, stimulants and sedatives; Omnibus Budget Reconciliation Act mandates that pharmacists must provide patient counseling and prospective drug utilization review for Medicaid patients (some do ALL patients)
LO: #4 four phases
PHASES of human studies: 1. small and then increasing doses to limited number of healthy humans to determine safety - biologic effects, metabolism, safe dose range, toxic effects. 2. larger groups and any adverse reactions are reported - to test effectiveness. 3. large number of patients who have the condition for which drug is indicated - both safety and efficacy must be demonstrate and dosage is determined. 4. postmarketing surveillance - toxicity of drug occurring in patients taking the drug after it is release is recorded - removed from market if phase 4 shows serious toxicity
LO: #4 five schedules
I -- Highest abuse potential II -- High abuse potential III -- Moderate abuse potential IV -- Less abuse potential V -- Least abuse potential
LO: #5 Elements of drug prescription
Heading - name, address, and telephone # of prescriber (printed) and name, address, age, and telephone # of patient (written) and date of prescription;
Body - The Rx symbol, name and dose size or concentration of the drug, amount to be dispensed, and directions to the patient;
Closing - prescriber’s signature, DEA number if required, and refill instructions
Dentist can legally write prescription if:
person for whom prescription is written is a patient of record and has the dental condition for which it is being prescribed
Chemically equivalent
two formulations of a drug meet chemical and physical standards established by regulatory agencies
biologically equivalent
two formulations produce similar concentrations of drug in the blood and tissues
therapeutically equivalent
prove to have an equal therapeutic effect in a clinical trial
Each drug has only ___ generic name but may have ______ Trade names
Each drug has only one generic name but may have several Trade names
After 17 years, the patent companies can market the same compound under a generic name.
VS
The trade name is protected by the Federal Patent Law for 20 years from the earliest claimed filing date, plus patent term extensions.