Complementary and Alternative Medicines Flashcards
Define complementary and alternative medicines.
• Complementary and alternative medicine was
defined by Ernst et al (1995) as:
– “diagnosis, treatment and/or prevention which
complements mainstream medicine by contributing to
a common whole, by satisfying a demand not met by
orthodoxy or by diversifying the conceptual
frameworks of medicine.”
• More recently, Ernst and Singh (2008):
– “any therapy that is not accepted by the majority of
mainstream doctors”
List common CAMs based on substances.
– based on substances, e.g. • herbal medicines, dietary supplements • traditional Chinese medicines • homeopathy • aromatherapy
List CAMs based on body systems or mind-body relationship.
– based on actions/mind-body relationships, e.g. • acupuncture • chiropractic • hypnotherapy • meditations
What severe adverse effect can all of these CAMs – Kava Kava – Pennyroyal – Germander – Chaparral – Comfrey have
• Hepatotoxicity – Kava Kava – Pennyroyal – Germander – Chaparral – Comfrey
What CAM can cause nephrotoxicity
• Nephrotoxicity - Aristolochic acid
Stroke is a severe adverse effect of what CAM?
• Strokes - ma huang, guarana, yohimbine
• Other: echinacea sample tested by TGA had E
Coli, due to presence of rat feces
What two levels of regulators are involved in regulating herbal medicines?
• Regulation occurs at two levels – Therapeutic Goods administration (TGA) – Guilds and Associations of Complementary and Alternative Medical (CAM) practitioners‘ • Australian Natural Therapists Association http://www.anta.com.au/ • Chinese Medicine Board of Australia http://www.chinesemedicineboard.gov.au/
What is the first step in regulation of an OTC medication such as ibuprofen?
• Regulated by the TGA/FDA etc. • Pre-marketing approval required. 1000s of pages of documentation. • Manufacturing and marketing also regulated • Company must prove that a product is “safe” and “effective”
What are four features that are involved in a company proving that their drug is safe and effective?
– Preclinical pharmacology and toxicology
– Extensive clinical trials
– Double blind placebo controlled trials
– Adverse drug reaction reporting mandatory
What are three conditions that a medication must fulfill to be TGA listed?
• Has to fulfill 3 conditions:
– only contain certain low risk ingredients in acceptable
amounts that are permitted for use in listed medicines by TGA
– must be manufactured by Good Manufacturing Practice (GMP)
– only make indications (for therapeutic use) for health
maintenance and health enhancement or certain indications for non-serious, self-limiting conditions
• Evidence for claims not evaluated by TGA but sponsor
has to hold evidence to support claim.
Are TGA listed items considered low or high risk?
low risk
Are TGA registered items considered low or high risk?
high risk
Why would a medication be TGA registered?
Considered to be higher risk based on indications
or ingredients.
