What is a therapeutic good
Examples of therapeutic goods
• Medicines o OTC complementary medicines vitamins sunscreens • Medical devices o Pacemakers x ray bandages • Biologicals o Derives from human or animal cells • Blood and and blood components • Some disfectants and tampons
Herbal medicines
Traditional medicines
Homeopathic medicines
• Capable of producing in a healthy persons symptoms similar to those which it is administered to alleviate
o Onion used to treat hay fever
o Let like cure like
• Prepared via serial dilution of a mother tincture in water aqueous ethanol
• Mainly derived from plants
• Highly diluted rendered non toxic
• Manufactured to different strengths /potencies
Vitamins and minerals
Nutritional substances
• Some regulated as foods others as TG
o Fish oil krill oil shark cartilage
Essential oils
* Regulated by national industrial chemical notification and assessment scheme
Regulation of commentary medicines
• Registered medicines
o are considered to be of higher risk and evaluated for safety quality and efficacy
• Listed medicines are lower risk and are evaluated for safety and quality only not efficacy
o AUST L
Listed meds
• Lower risk
• Assessed for quality and safety not efficacy
• Product manufactured in TGA approved facilitis
o Lincesed manufacturer
• TGA does not perform direct toxcitiy testing
• Lack of reported or documented toxcitiy
o Published literature
o History of use
• Dossier of safety data evaulted
• Evidence from scientific literature and based on history of use
• Provide evidence to TGA if requested
Post marketing surveillance of CM
What did COIVD19 do
• Handsantisr hand wash PPE • Consumer drop in demand for cold and flu • Consumer increase in demand for immunity and well being o Pre and probiotic Echminame o Vit c and d o Vitamins • Online purchasing
The following may interact with warfarin
Patients often do not inform their doctor that they are taking CM
Why do people use CM
St johns wort
• Relieve nervousness • Healthy mood balance • Mood support • Relief of sleeplessness • How it is advertised • Cannot cure or prevent • Efficacy in depression o Superior to placebo in patients with major depression o Similarly effective as standard antidepressants o Less side effects than standard antidepressant • Hypericin • Pseudihypercin • Hyperforin • Aldyherperforin
• Uptake inhibition of serotonin, NA etc with hyperforin
st johns wort risk
Risks • Induces CYP3A4 • Induces p-glycoprotein • Serotonin syndrome/toxicity • Can affect absorption and elimination
COQ10
• Vital component for energy production within the cell o Ubiquitous o Supports ATP production in the mitochondria • Use with statins • HF • Angina • Hypertension • Migraine • Improve circulation • Better aborded orally when o Taken with fatty meal o Mixed with oil in capsule o Bioequliance? • Generally, well tolerated
CoQ10 and statins
Taking CoQ10 supplements can help increase your CoQ10 levels and may reduce statin side effects.
• Muscle symptoms • Eg pain • Important that any muscle symptoms are investigated o Muscle damage • Measure CK levels • Benign statin induces myalgia treatment o Reduce dose o Switch to another statin o Switch alternative therapy
CoQ10 and warfarin
Coq10 and HF
Ginkgo biloba
• Extract prepared from leaves of ginkgo tree • Claimed action o Inhibit platelet aggregation o Vasodilation o Anti-oxidant free radical scavenger o Anti-inflammatory o Enhance cognitive function o Improve and enhance memory dementia o Fatigue o Learning • Listed • Well tolerance • Might see o Gi disturbance o Headache o Dizziness o May increase bleeding – interaction with warfarin