February 2018

Issue 15

• Chair’s message
• Chinese Medicine Board vacancy – express your interest
• Upcoming forums: invitation for Chinese medicine practitioners, students and stakeholders 
• Self-assessment tool launched to help health practitioners and advertisers
• Who does what in healthcare regulation?
• What you need to know: changes to the Public Health Act 2005 Queensland
• Reminder: obtain information from patients about medications and maintain medication knowledge
• Reporting adverse events
• Non-practising registration for Chinese medicine practitioners
• Engaging with rural, remote and regional practitioners
• Potential project for access to restricted herbs
• National Scheme news 
  • AHPRA's 2016/17 annual report reveals increased engagement with the profession by the Chinese Medicine Board
  • South Australia adopts legislative amendments
  • National regulation of paramedicine moves a step closer
  • Co-Chairs announced to help lead the way for the first ever National Scheme Aboriginal and Torres Strait Islander Health Strategy
  • National Boards approve policy for removing reprimands from the national register
  • COAG Health Council meeting communiqué 
  • Update on the Independent Accreditation Systems Review: AHPRA and National Boards’ responses
• Keep in touch with the Board 

Chair’s message

Welcome to the 15th edition of the Chinese Medicine Board of Australia (the Board) newsletter.

In this newsletter we cover a number of important announcements, including Board member appointments (the third term of National Board appointments since 2011), another of our forums in Perth, more on advertising and various reminders relevant to your registration and safe practice of Chinese medicine. This is a bumper newsletter as a lot has happened since we published our last newsletter in July 2017.

As a new term begins for Board members we say farewell with deep gratitude to Professor Craig Zimitat, who has served on the Board as a Community member since 1 July 2014. Craig chaired the Board’s Registration and Notifications Committee (RNC) during the grandparenting period, which was extremely challenging. He was also the Deputy Chair of the Board as well as the Chair of the Multi-profession Immediate Action Committee. Now located in Western Australia (WA), he is serving as a member of the WA Immediate Action Committee and the RNC for the Dental Board of Australia.

We are pleased to also welcome our new Board members. We wish David Brereton, our new community member located in Tasmania, the best in his new role. David is a retired member of the Australian Public Service with a career spanning 34 years, the last 20 at senior management and executive levels. He is also a community member of the Tasmanian Board of the Medical Board of Australia.

To kick off the year of regulatory work ahead, the Board is holding a planning day in early February 2018 to review our work to date and to plan our regulatory priorities for the next three years.

We wish everyone a safe and healthy new year. 

Professor Charlie Xue
Chair, Chinese Medicine Board of Australia

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Chinese Medicine Board vacancy – express your interest

A scheduled vacancy has arisen on the Chinese Medicine Board for a practitioner member from the Australian Capital Territory, the Northern Territory or Tasmania.

The National Scheme has a commitment to increasing Aboriginal and Torres Strait Islander Peoples’ leadership and voices. Aboriginal and Torres Strait Islander people are strongly encouraged to apply, as are people from rural or regional areas in Australia.

All National Board appointments are made by the Australian Health Workforce Ministerial Council. If you are interested, please visit the Australian Health Practitioner Regulation Agency’s (AHPRA) National Boards recruitment page to download the information guide and application form. More information is provided about eligibility requirements specific to these advertised vacancies, National Board member roles, and the application process.

For enquiries, please contact statutoryappointments@ahpra.gov.au. The closing date is Monday 19 February 2018 5pm AEST.

Upcoming forums: invitation for Chinese medicine practitioners, students and stakeholders

The Board is inviting Chinese medicine practitioners, students and stakeholders to attend information forums being held around Australia. The next forum is being held in WA, see details below. 

There will be a Board presentation and time for questions and discussion, then networking and light refreshments. Participation in the forum provides 1.5 continuing professional development (CPD) hours.

Anyone interested in attending is asked to put this date in their diary.

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Self-assessment tool launched to help health practitioners and advertisers

AHPRA and the National Boards have launched a self-assessment tool to help health practitioners, including Chinese medicine practitioners and other advertisers, check and correct their advertising.

All registered Chinese medicine practitioners need to make sure they meet their professional and legal obligations when advertising Chinese medicine services. The tool was developed in consultation with National Boards and with feedback from AHPRA’s Professions Reference Group.

The tool is easy to use and asks users to consider a number of questions about their advertising which can help them understand if it is in breach of the Guidelines for advertising regulated health services, and in turn the National Law¹.

The self-assessment tool is the latest of a series of advertising resources for practitioners, healthcare providers and other advertisers of regulated health services to use to help them stay in line with the law.

This work is part of a broader strategy ‒ the Advertising compliance and enforcement strategy for the National Scheme ‒ which started last year. The strategy has met a number of its targets since its launch including clear, concise and helpful correspondence for when AHPRA receives a complaint about advertising and new resources such as:

• a summary of advertising obligations
• frequently asked questions
• tips on words to be wary about
• all-professions examples of compliant and non-compliant advertising, and
• specific examples for Chinese medicine practitioners.

The self-assessment tool is now available to use on the check, correct and comply section of the AHPRA website.

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Who does what in healthcare regulation?

The following table summarises the roles of the various healthcare regulators in Australia of particular interest to Chinese medicine practitioners.

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What you need to know: changes to the Public Health Act 2005 Queensland

From 1 September 2017 important changes were made to the Public Health Act 2005 (Queensland) (the Act) that affect some healthcare service providers, including Chinese medicine practitioners, practising in Queensland.

These changes are necessary to help prevent potential infection control breaches. The amendments provide for a broader range of compliance and enforcement actions.

The Queensland Government strengthened its existing regulatory framework by improving Queensland Health’s ability to respond to unsatisfactory and unsafe infection control practices. Corrective action may now be required of, and penalties for serious breaches applied to, relevant healthcare professionals.

Note, there are no changes to the existing obligation to minimise risks of infection or the Infection Control Management Plan (ICMP) provisions.

Chapter 4 of the Act requires people that perform declared health services, as defined under the Act, to take reasonable precautions and care to minimise the risk of infection to other people. A declared health service is a service intended to maintain, improve or restore a patient’s health, that involves the insertion of an instrument, appliance or other object into human tissue, organs, body cavities or body orifices or activity that otherwise exposes the practitioner or another person to blood or another bodily fluid.

The Act places a further onus on the owners/operators of healthcare facilities to have an ICMP for the facility. The ICMP must identify the infection risks at the facility and detail the measures to be taken to prevent or minimise the risks.

All facilities that perform declared health services as defined under the Act must have an existing ICMP and review and update it before offering new declared health services. New facilities must have an ICMP before providing declared health services.

These provisions apply to practitioners providing acupuncture services in Queensland. Further information is available on the Queensland Government website.

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Reminder: obtain information from patients about medications and maintain medication knowledge

Successful communication with patients has long been understood as a fundamental competency for practitioners. Successful practitioner communication includes:

• developing a rapport with the patient
• gathering information from the patient
• providing information to the patient and responding to their queries and emotions
• checking that they understand the information, and
• making decisions while involving the patient in the process.

This is all part of gaining informed consent from patients.

Gaining full medication history is important as it prevents prescribing errors and consequent risks to patients. Apart from preventing prescribing errors, accurate medication histories are also useful in detecting medicine-related pathology and/or changes in clinical signs that may be the result of medications.

A good medication history should cover all currently and recently prescribed medicines, previous adverse reactions including hypersensitivity reactions and any over-the-counter medications, such as complementary medicines.

In addition, Chinese medicine practitioners’ own knowledge needs to be kept up to date through their annual CPD plan.
So remember, obtain and maintain to help keep the public safe!

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Reporting adverse events

Under the Code of conduct and the Guidelines for safe herbal medicine practice, registered Chinese medicine practitioners are expected to report adverse events.

In the case of a complaint about the conduct, performance or health of a registered practitioner and/or a health service such as acupuncture, it should be reported to AHPRA. In the case of an adverse event related to a medicine or medical device it should be reported to the TGA.

The Board will provide more information on this matter to practitioners. In the meantime practitioners should understand and comply with the following overview which is mainly related to adverse events associated with herbal medicines reported to the TGA.

Any untoward medical occurrence in a patient arising from a medicine, even if it does not necessarily have a causal relationship with this medicine, is described as an adverse event (AE). This includes any unfavourable and unintended sign (for example, an abnormal laboratory finding), symptom and/ or disease.⁴

The practice of Chinese herbal medicine (CHM) can have predictable and/or unpredictable reactions from patients. Predictable reactions can include toxicity either directly or by overdose, interactions between herbs and/or pharmaceuticals. Unpredictable reactions include allergy/anaphylaxis and idiosyncratic reactions.

According to literature, CHM AEs include but are not limited to:

• allergic reactions
• nausea and vomiting
• sore mouth
• diarrhea
• direct toxic reactions including hepatotoxicity⁵,⁶, and
• interactions with other prescribed medicines.⁷

This may happen in response to:

• the variability of the quality of medicinal products (including failure of good handling and manufacture which includes misidentification, lack of standardisation, contamination substitution and/or adulteration of herbs)
• confusion between herbal species related to the complexity of herbal naming systems⁸
• poor clinical judgement of practitioners such as misdiagnosis⁹
• idiosyncratic reactions, and/or
• inappropriate usage, for example ginseng claims to ‘prolong life’ and ‘improve hearing and vision’ but excessive usage may cause nervous system and digestive system AEs or death.¹⁰

Typical data collection for an AE includes:

• the type of AEs
• serious and non-serious
• common or rare
• severity
• frequency
• duration of events, and/or
• possible interactions between herbs and other prescribed medication.

Therefore patients need to disclose, and practitioners need to record, all ingestible medicines including vitamins, pharmaceutical and herbal preparations in patient records.

The Database of Adverse Event Notification (DAEN) for therapeutic goods maintained by the TGA identifies 111 reports (cases) of AEs associated with medicines classified as Chinese herbal medicines between 1 January 1971 and 15 March 2017. There were 66 single CHMs which were attributed to 80 cases with the balance being a combination of products. There were two cases where death was reported as an outcome (hypoglycaemic encephalopathy and cerebral infarction). The products suspected were an accidental overdose of glibenclamide from the ingestion of Luquan capsules and Ma Huang (Ephedra) respectively.

The following table shows the number of AE cases by reaction, the number of cases where a single suspected medicine was considered responsible and the percentage which this reaction represents in the 111 notifications. Only cases where three or more incidents have been reported over the last 46 years are listed.

Please note that the total number of cases in the medicine summary is usually less than the sum of the number of MedDRA reaction terms because multiple adverse events have been reported for some patients.

Considering that there have been 111 reports associated with CHM over 46 years, it is very likely that it has previously not been the practice to report AEs.

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Non-practising registration for Chinese medicine practitioners

Non-practising registration is an option for practitioners to take up if they are not practising as a Chinese medicine practitioner for a period of time and during which they may not wish to maintain professional indemnity insurance (PII) or complete the Board’s continuing professional development (CPD) requirements. However, if a practitioner continues to hold general registration during this period then they have to comply with the PII and CPD registration standards.

Practitioners who wish to request non-practising registration can only do this by applying to AHPRA.
Some practitioners have mistakenly believed they apply by notifying their practitioner association and then, when audited by AHPRA, have found themselves to be non-compliant with the PII and/or CPD standards – which is a very serious issue.

The Board is asking practitioners considering non-practising registration to use the relevant form which is available on the Board's website.

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Engaging with rural, remote and regional practitioners

The Board is very conscious of its responsibility to help all registered practitioners understand the regulatory National Scheme for Chinese medicine practitioners.

The Board uses a number of mechanisms to do this including providing information including its website www.chinesemedicineboard.gov.au, regular newsletters and communiqués. It also facilitates direct contact and interactive discussion with practitioners through forums held across Australia. These forums are very useful as issues and concerns for Chinese medicine practitioners are able to be discussed in detail.

However, the Board is also aware that it is very difficult for some practitioners to attend such events for practical reasons such as distance and cost. As part of its outreach to these practitioners, the Board recently directly contacted 126 practitioners whose principal place of practice is identified as either being remote or in an outer regional area.

On 8 November 2017 the Board Executive Officer addressed a group of practitioners in Cairns and on 18 December 2017 the Board conducted a teleconference with 12 practitioners from Cairns and surrounds. The feedback was very positive and such events will continue.

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Potential project for access to restricted herbs

The Board has met with various Chinese medicine professional associations to discuss this issue, which is of importance to the profession. After meeting with them in September 2017 the Board received a joint submission reflecting such issues and congratulates the involved organisations on forming a unified position.

The Board has now referred the matter to its Policy, Planning and Communications Committee (PPCC) for detailed consideration and to make recommendation to the Board on the appropriate next step. The Board is also scoping a prospective related project on access to restricted herbs.

The Board will then consider whether it is feasible to work towards making a submission to the Ministerial Council about endorsing suitably trained practitioners to have access to specific scheduled herbs. An ‘Access to scheduled herbs project’ would be both a long and very challenging process – likely to take many years. In addition, it will ultimately be a Ministerial Council decision, not a decision of the Board.

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National Scheme news

AHPRA's 2016/17 annual report reveals increased engagement with the profession by the Chinese Medicine Board

The annual report for AHPRA and the 14 National Boards for the year to 30 June 2017 is now available to view online.

The Chinese medicine health workforce grew by 2.1% over the past year, to 4,860 total registrants, according to data released in the 2016/17 annual report. The annual report is a comprehensive record of the National Scheme for the 12 months to 30 June 2017.

While Chinese medicine practitioners constitute a relatively small proportion of the 678,983 registrants currently in the National Scheme, the profession continues to grow year on year.

In order to protect the public, the Board took a proactive approach to engaging with the profession this year.

‘A major focus for the Board during the year was to ensure practitioners are aware of their professional obligations under the National Law,’ said Professor Charlie Xue, Chair of the Board. ‘To that end, the Board published a series of quick reference guides, which provide concise, clear information for practitioners about safe Chinese herbal medicine practice.’

Minor amendments were also made to the key resource, the Nomenclature compendium of commonly used Chinese herbal medicines, and, following wide consultation, the Board published new guidelines for creating and maintaining health records. It also released a Position statement on endangered species and Chinese medicine in Australia.

Registered practitioners were also reminded during the year to check, correct and comply with their professional and legal advertising obligations. The Boards, along with other National Boards and AHPRA published a strategy for the National Scheme to help keep health service consumers safe from misleading advertising – the Advertising compliance and enforcement strategy for the National Scheme. The strategy explains how National Boards and AHPRA will manage advertising complaints and compliance, including the regulatory powers available to deal with breaches of the National Law.

Another highlight included the Board sending a delegation to China for the first time, and the establishment of the Chinese Medicine Reference Group (CMRG).

‘The CMRG is made up of individual practitioner members, community members, and representatives of professional associations and education institutions,’ Professor Xue said.

‘The purpose of the group is to promote a common understanding of the National Scheme, and to have members of both the community and profession share thoughts and give advice on policy and other matters.’

More highlights are published on the Board's website.

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National Law update: South Australia adopts legislative amendments

AHPRA and National Boards Board welcome further progress in the adoption of amendments to the National Law in South Australia. The legislative reforms include the establishment of the Paramedicine Board of Australia and additional measures to protect the public.

Previously, on 6 September 2017, the Queensland Parliament passed a bill containing amendments to the National Law that applied in all states and territories, with the exception of Western Australia (WA) and South Australia (SA). In WA there is a corresponding amendment bill (the Health Practitioner Regulation National Law (WA) Amendment Bill 2017) which is currently before their Legislative Council.

Amendments to the Health Practitioner Regulation National Law as it applies in SA must be made by regulation.

The South Australian Governor has made the Health Practitioner Regulation National Law (South Australia) (Amendment of Law) Regulations 2017 which were published in the SA Government Gazette on 19 December 2017. These regulations cover those amendments that came into effect on the assent to the Queensland Act and also those that came into effect 28 days after assent.

AHPRA will work with the Board, other National Boards and state and territory Boards and/or committees, governments, health departments, professions and consumer representatives to support the implementation of these changes into our day to day work in the coming months.

Further amendments to the National Law are likely to be rolled out through a staggered process during 2018.

The Health Practitioner Regulation and National Law and Other Legislation Amendment Act 2017 as passed by the Queensland Parliament can be accessed on the Queensland Parliament website.

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National regulation of paramedicine moves a step closer

The national regulation of paramedicine moves a step closer with the appointment of the first Paramedicine Board of Australia.

The Health Ministers made the announcement of the nine-person board at the Council of Australian Governments (COAG) Health Council meeting held on 19 October 2017. Paramedicine will be the first profession to be regulated under the National Registration and Accreditation Scheme (National Scheme) since 2012.

Registration of paramedicine is due to start from late 2018. Paramedics will be able to register once and practise anywhere in Australia. The title ‘paramedic’ will also become a ‘protected title’ – only people registered with the Board will be able to call themselves a paramedic.

More information, including news about the implementation of the regulation of paramedics and the newly appointed Board members, is available on the Paramedicine Board of Australia’s website.

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Co-Chairs announced to help lead the way for the first ever National Scheme Aboriginal and Torres Strait Islander Health Strategy

The National Scheme is pleased to announce the appointment of co-Chairs for the Aboriginal and Torres Strait Islander Health Strategy Group.

Associate Professor Gregory Phillips, CEO of ABSTARR Consulting, and Dr Joanna Flynn AM, Chair of the Medical Board of Australia, have been appointed as co-Chairs of the group.

The strategy group has been brought together to develop the National Scheme’s first ever Aboriginal and Torres Strait Islander health strategy.

AHPRA, the 14 National Boards responsible for regulating the health professions, accreditation authorities and Aboriginal and Torres Strait Islander health sector leaders and organisations have committed to an Aboriginal and Torres Strait Islander health strategy with this vision: ‘Patient safety for Aboriginal and Torres Strait Islander peoples in Australia’s health system is the norm, as defined by Aboriginal and Torres Strait Islander peoples.’

Associate Professor Gregory Phillips was nominated by Aboriginal and Torres Strait Islander health sector leaders and organisations to be co-Chair. Gregory Phillips is from the Waanyi and Jaru peoples, and comes from Cloncurry and Mount Isa in North-West Queensland. Dr Joanna Flynn was nominated by leaders of the National Scheme to be co-Chair.

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National Boards approve policy for removing reprimands from the national register

A policy to ensure consistent removal of reprimands from the national register of practitioners has been approved by all National Boards.

Reprimands on a practitioner’s registration can be imposed under the National Law by a performance or professional standards panel, professional standards committee (NSW) and a relevant tribunal or court.

A reprimand imposed under the National Law will be removed from the national register of practitioners on the publication end date set by the relevant panel, committee, court or tribunal. Where a panel or tribunal has not set a publication end date, or where the reprimand was imposed under previous legislation, the reprimand will be removed no earlier than five years from the date of initial publication.

This is subject to:

• the practitioner making an application for removal of the reprimand
• no relevant event having occurred in the five-year period of publication of the reprimand, and
• legal advice confirming the power to remove a reprimand imposed under previous legislation.

A relevant event is any health, performance or conduct notification, action taken against the practitioner in relation to an adverse disclosure on renewal of registration, new information returned on a criminal history check or a confirmed breach of restrictions. It also includes when action has been taken against a practitioner about their conduct, health or performance. New notifications, irrespective of whether action was taken, will also be taken into account if an application for removal of a reprimand is received after the five-year period of publication.

The policy took effect on 2 October 2017 and will be reviewed annually. An application form for removal of a reprimand from the national register is published under Common forms on the AHPRA website.

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COAG Health Council meeting communiqué

The federal and state and territory health ministers met in Brisbane on 4 August 2017 at the COAG Health Council to discuss a range of national health issues. The meeting was chaired by the Victorian Minister for Health, the Hon. Jill Hennessy. AHPRA CEO Martin Fletcher attended the Australian Health Workforce Ministerial Council (the Ministerial Council) meeting which brings together all health ministers throughout Australia to provide oversight for the work of the National Scheme. AHPRA and the National Boards provide a regular update to the Ministerial Council on our work.

The meeting included an agreement by health ministers to proceed with amendments to the National Law to strengthen penalties for offences committed by people who hold themselves out to be a registered health practitioner, including those who use reserved professional titles or carry out restricted practices when not registered. Ministers also agreed to proceed with an amendment to introduce a custodial sentence with a maximum term of up to three years for these offences. These important reforms will be fast tracked to strengthen public protection under the National Law. Preparation will now begin on a draft amendment bill, with a view to being introduced to the Queensland Parliament in 2018.

Ministers also discussed mandatory reporting provisions for treating health practitioners, agreeing that protecting the public from harm is of paramount importance as is supporting practitioners to seek help and treatment for their health concerns, including for their mental health and wellbeing. They agreed practitioners should be able to confidentially seek treatment for health issues while preserving the requirement for patient safety. It was agreed that the Australian Health Ministers’ Advisory Council will recommend a nationally consistent approach to mandatory reporting following a consultation process with consumer and practitioner groups.

The Council produces a communiqué from its meeting which can be accessed on AHPRA’s website.

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Update on the Independent Accreditation Systems Review

In October 2016 Australia’s health ministers commissioned Professor Michael Woods, former Productivity Commissioner, to carry out the Independent Accreditation Systems Review (the Review). Following public consultations Professor Woods has prepared draft recommendations for ministers. Many of the reforms in his draft report would, in their current form, require significant changes to our legislation and how we manage the accreditation of courses leading to registration as well as assessment of internationally qualified practitioners.

In response to the draft recommendations, AHPRA and National Boards have published a joint submission to the Review on the AHPRA website. In summary we propose that a more effective and efficient approach would be to make changes to roles of AHRPA, National Boards and Accreditation Councils, rather than create new regulatory bodies with the likely cost and complexity this could create. We believe that this would deliver the changes required to support the professional health workforce required by Australia.

The joint submission includes additional responses from four participating National Boards ‒ Chiropractic, Medical, Optometry and Psychology. The Pharmacy Board made a separate submission and has published this on its website.

AHPRA and National Boards look forward to the Review’s final report and health ministers’ response in due course. A news item including a high-level summary of key aspects of the joint submission has been published on the AHPRA website.

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Keep in touch with the Board

• Visit the Chinese Medicine Board website for news about the profession, information on the National Scheme and for registration standards, codes, guidelines, policies and fact sheets.
• Read the National Board Communiqué each month on the website: these publications inform everyone of the decisions made at the Board’s monthly meeting.
• Lodge an online enquiry form.
• For registration enquiries call 1300 419 495 (from within Australia) or +61 3 9275 9009 (for overseas callers).
• Address mail correspondence to: Prof. Charlie Xue, Chair, Chinese Medicine Board of Australia, GPO Box 9958, Melbourne VIC 3001.

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¹ Health Practitioner Regulation National Law, as in force in each state and territory (the National Law).
² Health Practitioner Regulation National Law, as in force in each state and territory (the National Law).
³ Statutory offences are managed nationally by AHPRA and include someone claiming to be a registered health practitioner and/or unlawful advertising. For all other concerns there are co-regulatory arrangements in Qld and NSW:
in NSW, complaints can be made to the Health Professional Councils Authority or Health Care Complaints Commission. In Qld it is the Office of the Health Ombudsman (OHO).
⁴ A. Reporting side effects and other problems with medicines, vaccines and medical devices: Information for consumers. At: https://www.tga.gov.au/node/4581 Accessed 8 July 2018.
⁵ Shaw D. Toxicological risks of Chinese herbs. Planta Med. [Review]. 2010 Dec;76(17):2012-8.
⁶ De Smet PAGM. Health risks of herbal remedies: An update. Clin Pharmacol Ther. 2004;76(1):1-17.
⁷ Williamson EM, Lorenc A, Booker A, Robinson N. The rise of traditional Chinese medicine and its materia medica: a comparison of the frequency and safety of materials and species used in Europe and China. Journal of Ethnopharmacology. [Comparative Study Research Support, Non-U.S. Gov't]. 2013 Sep 16;149(2):453-62.
⁸ Wu KM, Farrelly JG, Upton R, Chen J. Complexities of the herbal nomenclature system in traditional Chinese medicine (TCM): Lessons learned from the misuse of Aristolochia-related species and the importance of the pharmaceutical name during botanical drug product development. Phytomedicine. 2007;14(4):273-9.
⁹ Shaw D. Toxicological risks of Chinese herbs. Planta Med. [Review]. 2010 Dec;76(17):2012-8.
¹⁰ Zeng Z-P, Jiang J-G. Analysis of the adverse reactions induced by natural product-derived drugs. British Journal of Pharmacology. [Article]. 2010;159(7):1374-91.