Week 1: Introduction to Clinical Therapeutics Flashcards
What is the role of the TGA?
The Therapeutic Goods Administration is the Aus regulatory authority for therapeutic goods. Its role is to regulate the supply, import, export and manufacturing/advertising of therapeutic goods
What is classified as a therapeutic good?
Anything that claims to aid in you health, prescribed medicine, general medicine, complementary medicine, medical devices, diagnostic devices, vaccines, blood products, biologicals
What is AUST-L
AUST-L is listed medication of lower risk
Safety and quality assessed but no evidence provided
e.g. vitamins, herbal supplements
AUST-R
AUST-R is registered medications of higher risk
Tested for safety, quality, efficacy and have had evidence provided
e.g. painkillers, prescription medications
What is ASE-C-POP
Appropriate - DRP relevant to appropriateness of the treatment
Safe - DRP relevant to safety of treatment
Effective - DRP relevant to effectiveness of treatment
Comprehensive review - compliance/adherence issues, conditions and comorbidity, complementary/alternative therapy
Problem List - create for patient
Options - for each problem create a range of possible treatment options
Plan - implement treatment plan and monitor outcomes
What is an active ingredient?
The name of the chemical in the medicine that makes it work
What is the brand name?
Name drug is sold under
What is meant by the original brand
First patented brand of medicine
What is meant by the generic brand
After a period of time alternate companies develop their own versions of the original drug
Same active ingredient but may have different fillers and binders
What is bio-equivalence?
Two different brands of a drug of the same dose will have same amount of active ingredient and be absorbed in same time period into body and exit body within same amount of time
