1 Flashcards
USAN
United States Adopted names councils designated non-proprietary names for drugs
Ethics
Study of standards and moral judgement influenced by society, religion, philosophy or profession
Food and Drug administration
Leading enforcement agency at the federal for regulations concerning drug products
DEA
Drug enforcement administration
Agency that controls the distribution of drugs that may be easily abused
Food and drug act of 1906
Create to regulate and classify drugs so you know what you are putting in your system
Food and drug and cosmetic act of 1938
Create to ensure that all drugs are pure and safe before entering the market
Durham-Humphrey Amendment 1951
Determines which drug requires a prescription and the “federal law prohibits. Dispensing without a prescription” label
Kefauver -Harris amendments 1962
Provide proof of both safety and effectiveness before entering the market
Poison prevention packaging act
Childproof packaging on all controlled substances
Controlled substances act
Classifies drugs that may be easily abused and restricts their distribution
1990 omnibus budget reconciliation act
Pharmacist offer counseling to patients
HIPAA
Health insurance portability and accountability act 1996
Law that provides regulations to protect patients privacy
Placebo
Substances used to test the effectiveness of drugs used in clinical trials
Clinical trials
Test in humans , to test safety and effectiveness of certain drugs
Double blind
Clinical trial in which neither the patient nor the physician know who is getting investigational drug
Generics
Copies of branded drugs released by competing companies after the original patent protection expires
Prescription drug label
Name, address of dispenser, serial number, date filled, prescriber name, patient name , directions for use and cautions
NDC
National drug code
Unique number assigned to a medication that shows the manifacturer, dosage , packaging
Controlled Substances
Any drug that has potential to be abused
DEA number
Unique number with 2 letters and 7 numbers for prescribers of controlled drug prescriptions
Risk of approved drug
There is always the potential for adverse effects
Class 1 recall
Products will cause serious adverse reactions or death
Class 2 recall
Temporary but reversible adverse effects
Class 3 recall
Where a product is not likely to cause adverse effects
Medwatch
FDA program for healtcare proffessionals to report adverse effects from the use of a drug
Criminal
Laws pertaining to a wrong to society
Civil
Laws pertaining to a wrong to an individual
Liability
You can be prosecuted for misconduct
Negligence
Failing to do something that should or must be done
Schedule 1
Drug with high potential for abuse ( illegal in the USA)
Schedule 2
High potential for abuse and may lead to physical or psychological dependence but is accepted in the us
Schedule 3
Moderate potential for abuse , moderate to low physical dependence or high psychological dependence
Orange book
List of all fda approved prescriptions published annually
Beneficence
Actions of any health are provider should always be in the best interest of the patient
Adverse effect
Unintended negative action of a medication which is in some way injurious to the patient
Legend drug
Medication valid with a prescription and requires the label rx only
Autonomy
Right of a patient to choose their own treatment
PHI
Protected health information
Any info that could identify and individual or their medical history
NDC
National drug code
Number on manufacturer’s label indicating the manufacturer and product information
OTC
Over the counter
Drug without prescriptions
Room temperature
20-25 degrees C or 68-77 degrees f
Non controlled drugs
Medications that require a prescription
Phase 1
Testing of a drug on health volunteers to check safety
Phase 2
Test of a drug to check efficacy and side effects
Phase 3
Testing of a drug on a large number of patient to check safety, effectiveness