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Australian complementary medicines – clearing the confusion and presenting clarity

13 May 2022 11:29 AM | Anonymous member (Administrator)

In a recent article, Assistant Director of Pharmacy at Bond University Treasure McGuire wrote in The Conversation, "Taking vitamins and supplements to help recover from COVID-19? An expert advises if it works (10 May 2022)." Treasure McGuire made several statements about complementary medicines. Here we question the validity and present clarity in her arguments.



1. "There is little evidence supplementation in a healthy person prevents respiratory infections such as COVID."

CMA says: However, in Australia, the advertising of products to consumers for the treatment of COVID-19 is prohibited without prior TGA authorisation, which is issued only in limited circumstances and where efficacy can be established.

 

Complementary medicines on the ARTG are not marketed for Covid, and TGA has no infringements have been issued for these ARTG products advertising.


2. "Ready access to supplements without a prescription from a myriad of online and shopfront sources and the uncontrolled spread of claims that supplements can prevent or treat COVID symptoms, has created an "infodemic".

CMA says: This is not the case in Australia. Australian complementary medicines are subject to rigorous guidelines for claims both on the label and on websites.

 

The strictly controlled environment in Australia means that legitimate complementary medicines manufacturers in Australia do not recommend any supplement to prevent or treat COVID symptoms.


It is precisely the regulations that Australian manufacturers are bound by that mean that Australians can be confident about claims on an Australian complementary health product.


When taken correctly, these products are lower risk substances that can only make lower risk claims which means they are suitable for consumer self-selection and do not require a prescription.


3. "These claims are fuelled by supplement manufacturers being able to "list" their products on the Australian Register of Therapeutic Goods, with limited evidence of safety or effectiveness."

CMA says: Australian manufacturers would argue that being listed on the ARTG is precisely what holds their exacting standards far above those of products produced overseas.


Australia's risk-based approach has a two-tiered system for the regulation of all medicines, with three avenues for entry on the Australian Register of Therapeutic Goods (ARTG) for complementary medicines being:


Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG),  which ensures they are manufactured in tightly quality controlled facilities subject to TGA inspections. Quantities of substances or health claims known to be unsafe are not permitted to be included in these medicines. The inclusion of the ARTG under these strict conditions protects consumers.


Listed assessed medicines can be listed on the ARTG when the TGA has conducted a pre-market assessment for evidence of higher therapeutic claims.


Higher risk medicines must be registered on the ARTG.


This tight regulation means that consumers can be confident about Australian complementary medicines; this cannot be said for products bought overseas. Thus, it may be that the author is quoting overseas products?


4. "Supplements can cause harm in adverse effects, drug interactions and expense. They also add to a patient's medication burden, may delay more effective therapy, or give false hope to the vulnerable."

CMA says: Generally speaking, vitamins and minerals are much safer than conventional drugs.


However, complementary medicines are medicines, and they should be taken according to the instructions on the label or after guidance from a health practitioner such as a suitably trained pharmacist. Complementary medicines can be used as an adjunct to conventional medicine and, in some cases, as a standalone medicine. Again, sound advice from a suitably trained health professional is advised. And as far as giving false hope to the vulnerable, to repeat, the label and surrounding guidance around dosage and stated indications provide an accurate overview of therapeutic and safe use.


5. "Despite the large variety of complementary medicines marketed, most clinical trials to date have studied the impact of vitamin D, vitamin C or zinc to reduce the risk of contracting COVID, improve rates of hospitalisation or death."

CMA says: Complementary medicines on the ARTG are not marketed for Covid, and TGA has issued no infringements for these ARTG products advertising. Clinical trials exist to educate regarding therapeutic potential. 


Some research has found that people with a vitamin D deficiency are more likely to develop a severe or critical COVID-19 response than those with sufficient blood levels. Research regarding nutrients and Covid severity is in its early stages. However, the link between low vitamin C and zinc levels and viral infections such as colds is very well documented.


Australia's complementary medicines industry is committed to high-quality research to underpin ingredients some people have used for thousands of years. Our industry supports high-level research to support the growing evidence base for complementary medicines and their benefits to Australians. However, any therapeutic claim referring to Covid must be pre-approved by the TGA before marketing; therefore, no inappropriate marketing can legally occur without TGA approval, even if any trials are successful.


6. "However, supplements may be beneficial when individuals cannot achieve a balanced and varied diet."

The vast majority of Australians – around 97 per cent – don't achieve a balanced and varied diet.


The complementary medicines industry in Australia has always strongly advocated for people to consume a healthy balanced diet, exercise regularly and avoid high-risk behaviours. Numerous studies have shown – and continue to show – that most people do not. For example, over 90 per cent of Australians do not consume enough vitamin and mineral-rich vegetables and fruits.


7. "High doses or chronic use of COVID supplements have also been linked with adverse effects: vitamin D with muscle pain and loss of bone mass; vitamin A with elevated liver function tests and blurred vision; vitamin E with bleeding risk; plant extracts, magnesium with gastrointestinal effects; and selenium with hair loss and brittle nails."

CMA says: Adhering to the advice on the label prevents overdosing on every medicine – including natural medicines.

 

Australia regulates complementary health products to the highest standards – standards considered to be a global benchmark. The Department of Health's Therapeutic Goods Administration (TGA) stringently enforces these strict safety and quality regulations. Labels clearly state indications and dosage. Consumers are urged to read and adhere to labels created with both safety and quality in mind.


The TGA, like other regulatory agencies around the world, monitors the safety of medicines marketed in Australia to contribute to a better understanding of their possible adverse effects; this is known as pharmacovigilance and is routine for all medicines, including prescription, OTC and complementary medicines.

 

The TGA monitors the safety of medicines marketed in Australia using:

  • reports of adverse events;
  • sharing of information with other regulatory agencies;
  • sharing of information with Australian state and territory health authorities;
  • Risk Management Plans (RMPs) and Periodic Safety Update Reports
  • (PSURs); and
  • reviews of literature.


Generally speaking, vitamins and minerals are lower risk than conventional medicines. However, they are natural medicines and should be taken according to the instructions on the label or guidance from a health practitioner.


Despite increasing consumption, side effects remain rare. Thanks to a small but vocal group of anti-complementary medicines detractors, negative headlines make the news intermittently as they take the opportunity to place their views on the agenda; this can be very confusing, and their inaccuracies do a disservice to the community. Australian complementary medicines are manufactured to the highest standards globally, increasingly chosen by Australians and discerning customers overseas. Over 70% of Australians choose one or more complementary medicines to complement their health, and this figure is increasing.


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