ASMI addresses 4 Corners concerns about advertising claims for complementary medicines
15 February, 2017 –
The Australian Self Medication Industry (ASMI) today addressed concerns raised in a 4 Corners report on complementary medicines that the huge growth of the complementary medicines markets and its move into the mainstream has resulted in some companies overreaching in their marketing claims.
ASMI advocates for minimum effective regulation that will maintain consumer confidence as well as responsible access to medicines.
ASMI supports measures that build evidence for complementary medicines and help increase compliance to regulations. Therefore, ASMI welcomes and support the regulatory reforms proposed in the recent Medicines and Medical Devices Review (MMDR).
As complementary medicines move further into the mainstream and the range of brands and products proliferates, ASMI acknowledges that the TGA has had to raise the bar on compliance measures.
However, one recommendation calls for the abolition of the pre-approval of advertising of non-prescription medicines to consumers.
ASMI CEO Deon Schoombie, says:
“The MMDR review recommends alternative measures to advertising pre-approvals to improve compliance, but ASMI believes it would be sensible to see how effective these measures are in practice before abolishing the current system, which we believe is an important compliance measure.”
The important role of complementary medicines for the health of Australians
14 February, 2017 –
The Australian Self Medication Industry (ASMI) reminds consumers that complementary medicines approved for supply in Australia are highly regulated by the Therapeutic Goods Administration (TGA), a recognised world class regulatory authority. These medicines remain an important part of a self care approach for millions of Australians.
Complementary medicines, such as fish oil, vitamins and mineral supplements, are all regulated as medicines and must be manufactured to medicinal standards in TGA-approved sites.
They must contain the ingredients listed on the label and no other active ingredients, and they must only be produced using ingredients approved as low risk by the TGA.
“Labelling of complementary medicines is highly regulated to ensure labels contain the right information to help consumers select and use these products appropriately,” says Steve Scarff, ASMI Director of Regulatory and Scientific Affairs.
“Unlike in some overseas markets, companies marketing complementary medicines in Australia can only make limited claims regarding their effectiveness and are required to hold evidence supporting those claims.”
ASMI encourages further investment in the evidence surrounding complementary medicines and supports reforms that enable consumers to make informed decisions.At least two out of three Australian adults use some form of complementary medicine.(1)
Vitamin and mineral supplements can also play an important role for the 52% of Australian adults who do not eat the recommended intake of fruit or the 92% who do not eat the recommended intake of vegetables each day.(2)
Additionally, the 2011–13 Australian Health Survey identified that:
* calcium intake across the population is largely inadequate, with 73% of females and 51% of males consuming less than the estimated average requirements (EAR)
* females are more likely to have inadequate iron intake than males (23% of females don’t achieve the EAR compared with 3% of males)
* 2% of males and 8% of females do not meet their iodine requirements.
Several specific dietary supplements with excellent safety and efficacy profiles also have also been identified as being able to reduce the relative risk of experiencing a medical event associated with common conditions. (3)
* magnesium and calcium/Vitamin D combinations for osteoporosis
* folic acid/B6 /B12 and Omega-3 (e.g. fish or krill oils) for cardiovascular disease
* lutein & zeaxanthin for age-related macular degeneration
* St John’s Wort for major depression
* folic acid supplements for women who are pregnant or considering pregnancy sometime in their future. (4)
In 2016, the Australian Consumer Association report in CHOICE also listed 10 ‘useful’ supplements for use with targeted conditions, which included St John’s Wort, cranberry and lactase.(5)
As with any medicine, ASMI urges consumers to consider whether a product is appropriate for you to use, and only take the recommended amount.
The product label and your health professional can provide helpful information on the correct usage of medicines.
It is also important for consumers and health professionals, such as doctors and pharmacists, to have an open discussion about any medications and supplements to ensure that the risk of adverse drug interactions is reduced .
This is especially important for those taking prescription medications, women who are breastfeeding or pregnant/trying to become pregnant, and anyone with serious kidney, liver or stomach issues.
Purchasing complementary medicines from a pharmacy provides a good opportunity for consumers to discuss any products they are considering with the pharmacist, who can provide professional advice.
Any adverse reaction should be immediately reported to a healthcare professional, who are then require to report this to the TGA.
The TGA has a rigorous system for recording, monitoring and responding to adverse events for all medicines, including complementary medicines.
“Consumers are reminded to only purchase regulated complementary medicines in Australia and not online from overseas, to follow label instructions and warning statements, to report any adverse reactions, and to consult with a healthcare professional about possible interactions with other medicines,” says Steve Scarff.
1. National Consumer Survey 2006, National Prescribing Service.
2. Australian Health Survey: Usual Nutrient Intakes, 2011–12, ABS cat. no. 4364.0.55.008. Canberra: Australian Bureau of Statistics.
3. Targeted Use of Complementary Medicines: Potential Health Care Outcomes & Cost Savings in Australia – Frost & Sullivan, 2014.
4. Folic Acid Supplementation for the Prevention of Neural Tube Defects – US Preventive Services Task Force Recommendation Statement, Jan. 10, 2017. 5. Bray, K., Complementary Medicines and Supplements – are they safe?, CHOICE, 1 Mar. 2016
S3 Advertising – A Win for All New research reveals S3 advertising enhances role of pharmacists and results in better healthcare outcomes for consumers
8 February 2017 –
Laws that prohibit consumer advertising of Schedule 3 (S3) medicines are out of step with international practice and deliver no public health benefit, according to the peak non-prescription medicines body, the Australian Self Medication Industry (ASMI). This follows research findings launched today on the potential health benefits of consumer advertising of S3 medicines, a class of products that are available through pharmacists, but largely invisible to the wider public.
Unlike other non-prescription medicines, S3 products cannot be advertised under Therapeutic Goods Regulations, except through an exemption (Appendix H exemption).
ASMI has proposed an alternative model for S3 medicines advertising.
The proposed model comprises of three core elements which require equal prominence – education on the condition/disease, branded product information and the role of the pharmacists in determining whether the medication is appropriate for the consumer.
Furthermore, the proposed model advocates for the distribution of clinical protocols and product information to all pharmacy prior to the commencement of consumer advertising.
ASMI will propose this alternate model for advertising S3 medicines to an upcoming government review of medicines scheduling slated for next month.
ASMI commissioned the Centre for Health Economics Research and Evaluation (CHERE) at the University of Technology Sydney (UTS) to conduct research to determine the impact of the proposed consumer communication model for S3 medicines on the Quality Use of Medicines (QUM), a central plank of the national medicines policy.
Professor Rosalie Viney, Professor of Health Economics and Director of CHERE said there appeared to be no public health benefit from the current restriction on S3 advertising and that the evidence suggested ASMI’s alternative model could have a positive impact on the Quality Use of Medicines.
“Unfortunately, there is limited consumer awareness of S3 medicines, so many people don’t think to go to a pharmacist for a minor ailment that could be treated fairly easily, without the need for a GP visit.
“Our research showed that the proposed advertising significantly increased the likelihood of consumers engaging in conversations with pharmacists about their health conditions and treatment options,” Professor Viney said.
“Importantly, the pharmacists and pharmacy assistants involved in the study were not influenced by the consumer advertising, and regularly chose the most appropriate treatment for the consumer,” she said.
The UTS CHERE research involved almost 1300 consumers, 500 pharmacists and 500 pharmacy assistants in a randomised study to assess the impact of a ‘mock S3 product TV advertisement’ (which followed the proposed ASMI infomercial model format).
The researchers selected an existing non-advertisable S3 category (S3 cold sore antivirals), and used a ‘test and control’ environment with choice modelling to isolate the impact of the advertising model on consumers, pharmacists and pharmacy assistants.
Advancing consumer health through responsible self care “The pharmacists’ responses indicated that they were not likely to recommend an antiviral tablet to someone whose condition indicated that they should see a GP – their quantitative responses showed that they were quite comfortable referring people [to GPs].”
The findings dispelled myths that recommendations from pharmacists and their staff are influenced by consumer advertising, and that pharmacists and pharmacy assistants buckle under the pressure of customers demanding branded products after seeing them advertised.
ASMI Chief Executive Officer Dr Deon Schoombie said the study highlighted the potential health benefits of relaxing advertising restrictions for S3 medicines.
“Importantly, the advertisement created more awareness about health conditions and encouraged consumers to open up a conversation with their pharmacist. This has the potential to free up GPs’ time for treatment of more serious conditions while reducing costs to the healthcare system”.
“The current S3 advertising restrictions discourage innovation in the medicines sector because they are an obstacle to down-scheduling (‘switching’) of medicines from prescription to non-prescription, and they leave Australia out of step with countries such as New Zealand,” he said.
Dr Schoombie said ASMI’s proposed advertising model included a clearly defined “non-advertisable” list for S3 products which have a history of misuse, abuse or diversion for illegal use.
The default advertising position would become one which allows advertising for all S3 products, with the exception of those which featured on this “non-advertisable” exemption list.
See the UTS CHERE report, ‘Estimating the impact of schedule 3 consumer advertising’.
See the ASMI mock advertisement designed for S3 advertising.
See more CHERE research