19. Complimentary Medicines Flashcards
For a product to become available in Australia what criteria must it meet?
What framework does the TGA operate on?
Product Availability
- Any product for which therapeutic claims are made must be either Listed or Registered on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia (some exemptions)
- The therapeutic framework within which the Therapeutic Goods Administration (TGA) operates is based on a risk management approach
What is the difference between a Registered and Listed Medicine in Australia?
What are they each assessed for?
Risk Management Approach
Registered Medicines
- include all prescription medicines and most pharmacy OTC medications
- assessed for quality, safety and efficacy
Listed Medicines
- include most complementary medicines e.g. herbal, mineral and vitamin products
- assessed for quality and safety but not efficacy
Are Registered or Listed Medicines considered lower risk?
Listed Medicines
- Listed medicines are considered to be of lower risk than Registered medicines
- Listed medicines are assessed by the TGA for quality and safety, but not efficacy
- This means that the TGA has not directly assessed any Listed medicine to see if it works
How does the TGA assess the quality of Listed Medicines?
Listed Medicines - How does the TGA assess quality?
Assessment includes:
- Product is manufactured in TGA approved facilities
- Product is manufactured according to good manufacturing practice (GMP)
How does the TGA assess safety of Listed Medicines?
Listed Medicines - How does the TGA assess safety?
- No direct toxicity testing by the TGA
- There is a reliance on lack of reported or documented toxicity
- Historical use over time with no apparent toxicity e.g. Naturopathy, Traditional Chinese Medicine (TCM), Ayurvedic Medicine etc
- Historical use over the centuries, however, has been in communities which have had high mortality rates and lower life expectancy
What are the issues with how the TGA assesses safety of Listed Medicines?
Listed Medicines - Testing for Safety
Issues with this:
- How effective was the collection, assessment and documentation of data?
- Acute versus chronic use/toxicity?
- Use in different age groups e.g. child/elderly?
- How reliant is historical data?
What must all sponsors of a Listed medice hold information about?
How does the TGA monitor this?
Listed Medicines
- It is a requirement under the Therapeutic Goods Act that the sponsors of a Listed medicine hold information to substantiate all of their product’s claims
- Targeted and random assessments by the TGA of the efficacy data and claims made for Listed medicines
- Listed medicines must display an “AUSTL” number on the label as proof of listing
What are Complementary Medicines?
Examples?
Complementary Medicines
- Complementary medicines (also known as ‘traditional’ or ‘alternative’ medicines) include vitamin, mineral, herbal etc products
- The vast majority of complementary medicines are listed medicines, and as such have not been assessed by the TGA for efficacy
- A small number have been assessed by the TGA for efficacy and are registered medicines e.g. ferrous sulphate for the treatment of iron deficient anaemia, folic acid for the prevention of spina bifida, calcium for the treatment of osteoporosis
How many Complimentary Medicines are on the market in Australia?
What is the industry worth?
How many Australians have used at least 1 CM in the last 12 months?
What is the highest user group of complimentary medicines?
Complementary Medicines
- There are over 10,000 complementary medicines available on the Australian market
- In 2018 the Australian complementary medicines industry achieved sales of $5.2 billion
- 68% of the Australian population have used at least one complementary medicine in the last 12 months
- Some consumers are passionate, committed, true believers
- Highest user group - younger to middle aged females with higher income and education levels
What’s the problem with the argument that products must be good for you because they are “natural”?
“Natural” Products
- However, it makes no sense to say that “natural” products will always be good for you, and that they will never have any side effects
- Some of the most toxic and poisonous substances on the planet are naturally occurring
- Arsenic
- Strychnine
- Cocaine
- Cyanide
- Nicotine
- Plutonium
- Saying that something is “non-chemical” or “chemical-free” is a complete nonsense
- Everything that exists on this planet is made of chemicals, including complementary medicines
- Complementary medicines (e.g. natural, herbal, vitamin, antioxidant and mineral products) are all made of chemicals, and as such can cause side effects and toxicity (like any medicine can)
Why must doctors always ask their patients about complimentary medicines?
What are 3 reasons why patients might not disclose this?
Complimentary Medicines
- Complementary medicines may produce significant drug interactions with prescribed and OTC medications
- Healthcare professionals should always ask about complementary medicines as many patients will often not volunteer that they are taking them:
- fear of negative response
- desire to control their own health and wellbeing
- do not think of them as medicines
What are some natural/complimentary medicines that have potential Warfarin interactions?
Potential Warfarin Interactions
- Gingko biloba
- St John’s wort
- Ginger
- Co-enzyme Q10
- Celery
- Horse chestnut
- Ginseng
- Cranberry Juice
- Feverfew
- Garlic
- Alfalfa
- Aniseed
- Fenugreek
- Red clover
- Green tea
- Glucosamine
What are 3 reasons why patients may take Complimentary Medicines?
Complementary Medicines
Patients take complementary medicines for a number of reasons
- To treat a current condition e.g. glucosamine
- To protect against future illnesses e.g. gingko biloba, vitamins, antioxidants etc
- To control their own health and wellbeing, to help maintain “wellness” e.g. vitamins, minerals, antioxidants etc
What are 3 possible outcomes when using complementary medicines (or any medicine for that matter)?
Complementary Medicines - Possible Outcomes
There are three possible outcomes when using complementary medicines (or any medicine for that matter)
- Beneficial effect
- Neutral effect
- Harmful effect
What led to the marketing and promotion of vitamin, mineral etc preparations?
Healthy Diet
- Epidemiological studies suggest that diets high in fruit and vegetables reduce the risk of some diseases e.g. cancer and cardiovascular disease
- Fruit and vegetables contain many compounds including antioxidants, carotenoids, minerals, vitamins and other essential nutrients
- This has led to the marketing and promotion of complementary medicines containing many of these compounds e.g. vitamin preparations
What TGA category do most oral vitamin preparations in Australia fall under?
Listed Medicines - Vitamins
- The majority of oral vitamin preparations available in Australia are Listed medicines
- They have an AUSTL number and contain vitamins approved for use by the TGA
What is one major issue with how vitamins are regulated in Australia?
Listed Medicines - Vitamins - Dose
- At present, when approving many vitamins for use, the TGA does not always stipulate a dosage range, or an upper dose limit (some do have upper limit)
- There seems to be an assumption by the TGA that many vitamins are safe, irrespective of the amount taken
- This means that manufacturers can, if they choose to do so, market some vitamin preparations with recommended doses far in excess of the recommended daily intake (RDI) of the vitamin
- This can result in the use of marketing and promotional terms such as Mega Dose, Mega Potency, High Potency, Double Strength, Super Strength etc
What is the Recommended Daily Intake (RDI) of Vitamin E?
Vitamin E - RDI
- The RDI of vitamin E for adults is 22.4IU per day
- Some vitamin E products on the ARTG have a recommended daily dose of 1000IU per day (45 times the RDI)
- Claims made for vitamin E products include antioxidant activity and assistance in maintaining a healthy heart and circulation
- However, what evidence is there to support the use of a dose of 1000IU per day in preference to a dose of 400, 200, 50 or even 22.4 IU per day?
What has longer term use of high dose vitamin E (400IU or higher per day) has been reported to increase? (5)
Vitamin E - Adverse Effects of high dose
Longer term use of high dose vitamin E (400IU or higher per day) has been reported to increase:
- the incidence of heart failure
- the incidence of haemorrhagic stroke
- the incidence of lung cancer, particularly in smokers
- the risk of prostate cancer
- all cause mortality
What are some of the adverse effects of long term high dose Beta Carotene use?
Beta Carotene - High Dose Adverse Effects
- High dose beta carotene (20-30mg per day) has been reported to increase the incidence of lung cancer in smokers
- Average Western dietary intake of beta carotene is 2-4mg per day
- The bioavailability of beta carotene obtained from carotenoid containing foods is only 20% of that obtained from supplements
- Subjects taking 30mg beta carotene daily had a mean blood level of 2100ng/ml, while the placebo controls had 170ng/ml
What does the TGA require to be on the label of vitamin preparations?
Vitamins - Warnings on Labels
The TGA requires one of the following warning statements to be on the label of vitamin preparations:
- ‘vitamins can only be of assistance if the dietary vitamin intake is inadequate’
- ‘vitamin supplements should not replace a balanced diet’
Why should we obtain vitamins from our diet but not from supplements?
Vitamins - Diet vs. Supplements
- The amounts of vitamins contained in our food are generally much less than the amounts in high dose supplements
- Food contains many chemicals, nutrients and trace elements which may act as cofactors to influence and regulate the activity of vitamins
- These substances are clearly not present in single entity supplements
- No evidence that vitamins in food are harmful
- High dose vitamin supplements contain vitamin levels often far in excess of those found in food
- High dose vitamin supplements do not contain the co-factors and regulatory factors found in food
- In high doses, instead of acting as antioxidants, vitamins supplements may exert pro-oxidant activity which can lead to cellular dysfunction and pro-carcinogenic effects
- Need for some reactive oxygen species for normal cellular function
What are 2 reasons why patients may take longterm high dose vitamin products?
Vitamins - Long Term High Dose Reasons
Some patients take on a longterm basis high dose vitamin products to
- Help maintain “wellness”
- Try and stop the development of a condition which in fact they may never get
How should we discuss vitamin supplements with patients?
When are they appropriate vs. not?
Vitamin Supplements
- Are appropriate if the patient has a documented deficiency e.g. vitamin D
- If there is no documented deficiency discuss with the patient if there is any real need to take a vitamin supplement
- If a patient wants to take a vitamin supplement recommend a product with doses close to the RDIs
- With multivitamin supplements note the individual components e.g. vitamin K may interact with warfarin
- Don’t even think about using high dose supplements
- lack of evidence for efficacy
- potential for serious &/or life-threatening adverse effects
Why is the data around Listed Medicines harm not complete?
Listed Medicines
- Death certificates, autopsy reports, coroner’s reports etc very seldom, if ever, document the complementary medicines the deceased was taking
- Who ever asks, or even thinks to ask if the deceased had been taking a complementary medicine?
- If a person dies of a haemorrhagic stroke who asks, or even thinks to ask about high dose vitamin E use?
