application for western herbal medicine to be regulated under the … · 2016-03-06 · to be...

Application for Western herbal medicine

to be regulated under the

Health Practitioners Competence Assurance Act 2003

May 2015

New Zealand Association of Medical Herbalists (1983) Inc.

2

Application for Western herbal medicine

to be regulated under the

Health Practitioners Competence Assurance Act 2003

1. Introduction

The New Zealand Association of Medical Herbalists (NZAMH) proposes that

Western herbal medicine (hereafter referred to as herbal medicine) be included as a

profession within the scope of the Health Practitioners Competence Assurance Act

2003 (HPCAA).

The NZAMH is the professional organisation that represents educated and trained

medical herbalists in New Zealand. Medical herbalists formulate and dispense

herbal medicines to clients. NZAMH is an independent self-governing body that sets

its own educational standards, has an established code of ethics, and issues annual

practising certificates to professional members.

The NZAMH strongly believes it is in the safety interests of both practitioners and

consumers of herbal medicine for the profession of herbal medicine to be statutorily

regulated. The profession was originally approved for inclusion under the HPCAA in

2007 by the then Minister of Health Pete Hodgson; however changes to regulation

criteria have necessitated this reapplication.

1.1 The Profession of Herbal Medicine

1.1.1 History

Herbal medicine is one of the oldest forms of medical treatment known. The

medicinal use of plants is common to all cultures and peoples of the world and

evidence of the use of plants as a source of medicine dates back to at least 60,000

BC1 . There is archaeological evidence of the utilisation of medicinal plants2 and

many ancient documents contain references to plant medicines including the

Chinese Nei Ching c. 2600 BC3 the Egyptian Ebers Papyrus c.1550 BC and the

Indian Atharva Veda c.1200 BC2.

Ongoing use of Western herbal medicines has been extensively documented and

includes works from authors such as Dioscorides, Avicenna, Gerard, Culpeper,

Withering, Grieve and others1. Such texts have provided a fundamental basis for

medical thought and consequently such knowledge has been included within both

contemporary orthodox and complementary medicine practices to varying degrees.

In recent times herbal medicines have provided the basis for many pharmaceutical

drugs in their traditional form or as isolated, active constituents4.


3

Western herbal medicine has its roots in the indigenous practices of the British Isles,

North America and European and Graeco-Roman traditions. It is practised today in

New Zealand and in many other Western countries including the United Kingdom,

United States, Canada and Australia5.

Western herbal medicine in New Zealand dates back to the first European settlers

who brought seeds of European plants with them for medicines6. Many of these

plants grew and flourished in New Zealand and remedies were prepared using water

or alcohol based preparations. When there was no ready access to European herbs

early herbalists through observation of Maori remedies substituted with New Zealand

native plants. A tincture of koromiko was included in Martindale’s Extra

Pharmacopeia4 for many years. Many great proponents of herbal medicine were

evident in early New Zealand history including Mother Aubert7 and Dr James Neil8.

1.1.2 Western Herbal Medicine

Members of NZAMH practice Western herbal medicine and as such this document

seeks to define and discuss only this discipline. Throughout this document the terms

‘medical herbalism’ and ‘herbal medicine’ are used as synonyms for ‘Western herbal

medicine’. These terms are distinctive and distinguishable from other forms of

traditional medicine that employ herbs, namely rongoā Maori, traditional Chinese

medicine, Ayurvedic medicine and traditional Tibetan herbal medicine.

Western herbal medicine is a traditional system of medicine based on the

fundamental principle of ‘Vis medicatrix naturae’, that is the “body’s inherent ability to

establish, maintain and restore health”9 . Western herbal medicine utilises plants for

healing and is based on observation and experience passed down over thousands of

years. Contemporary herbal medicine practice includes knowledge in medical

sciences (anatomy, physiology, biochemistry, pathophysiology, and pharmacology),

use of clinical information (derived from case taking, physical and laboratory

examination) and research in phytomedicine and phytopharmacology, as well as the

sciences of botany and nutrition.

Western herbal medicine is founded in a traditional philosophy of holistic practice. It

is characterised by a patient centred approach, so that the patient rather than the

disease or an isolated part of the body is the focus of the practitioner’s treatment.

The practitioner works at all times to create an environment of trust, shared

responsibility and decision-making within the therapeutic relationship. On

presentation to a practitioner the background to a patient’s condition is investigated

through a thorough case history that takes account of family, personal health history

and lifestyle choices. Physical examination and laboratory tests may be undertaken.

Assessment of the patient is made based on understanding the significance of the

patient’s presenting signs and symptoms, their age, vitality or constitution and any


4

other contributing physical and mental and lifestyle factors such as diet. The choice

of therapeutic herbal substances in any prescription is based on thorough

assessment and is directed at the individual contributing factors or causes of the

complaint, not merely the presenting symptoms or disease. As a result,

prescriptions may vary substantially between patients presenting with an apparently

similar condition.

New Zealand and Australian herbal medicine practice are similar. A national survey

of medical herbalists in Australia found that the predominant prescription by Western

herbal practitioners was individualised herbal formulae consisting of highly

concentrated fluid extracts in ratios of 1:1 or 1:2, rather than use of single herbs.

Traditional preparations of herbals such as teas and powders are used as are pre-

formulated tablets/capsules made by herbal manufacturers although individualised

liquid herbal formulas are most commonly dispensed10.

Herbal treatment is commonly reinforced with appropriate advice on healthy lifestyle

choices, particularly nutrition, stress management and exercise. Many practitioners

incorporate a naturopathic approach within their practices, often, but not always,

supplementing concomitant holistic methods such as nutritional medicine, body

therapies such as massage, and other techniques aimed at improving the overall

health and well-being of the patient. A 2011 survey of NZ medical herbalists found

76% practised multiple modalities11. Some naturopaths and other health

professionals also practice medical herbalism.

Western herbal medicine works within a traditional philosophical and therapeutic

framework that is increasingly supported by scientific research. The fundamental

purpose of treatment is to facilitate resolution of symptomatology and improve

outcomes in ill patients, as well as to enhance wellness and prevent ill health. This is

achieved primarily through recommendation and dispensing of herbal medicine

treatments individualised according to the patient’s situation. Such treatments also

support and activate the innate healing processes of the body itself and strengthen

mind, body and spirit. In this way treatment aims to have long-term efficacy.

1.1.3 Distinguishing Features of Herbal Medicine

Herbal medicine is a clearly identifiable health profession. An obvious and

fundamental point of difference is the form of medicines used. Medical herbalists

rely on the use of herbs, generally the crude or whole plant or plant part, rather than

pure, isolated chemicals refined from plants.

A “herbal remedy” is defined under the Medicines Act 198112 as being:

“a medicine (not being or containing a prescription medicine, or a restricted

medicine, or a pharmacy-only medicine) consisting of:


5

a) any substance produced by subjecting a plant to drying, crushing, or any

other similar process, or

b) a mixture comprising two or more such substances only, or

c) a mixture comprising one or more such substances with water or ethyl

alcohol or any inert substance.”

The MedSafe Consultation Paper (2004), Regulation of Herbal Substances in a Joint

Australia New Zealand Therapeutic Products Agency 13 suggests a different

definition, namely:

A herbal substance for the purpose of inclusion in a Class 1 medicine means:

a) a traditional preparation of crude herbal material:

i) obtained by the methods traditionally used to prepare that herb for

therapeutic application, for example: drying, crushing, comminuting, cooking

(charring, baking or frying), steeping in wine and frying in vinegar, honey, oil

or other herbal substances, traditional fermentation, or other processes

identified and justified by the sponsor as being used traditionally to prepare

crude herbal material; or

ii) obtained by a traditional extraction method such as infusion, decoction,

maceroexpression, percolation, expression or distillation.

b) a non-traditional preparation of crude herbal material:

i) not obtained using a chemical transformation process; and

ii) justified as phytochemically equivalent to a preparation of a crude herbal

material currently included as an active ingredient in a product listed in the

ARTG.

A further significant difference between orthodox medicine and traditional medicine

systems, such as herbal medicine, is philosophical. In traditional systems health and

disease are seen as a continuum15. A person can move from a state of health to ill-

health and/or to some extent from ill-health to health. The healing process can be

supported, facilitated and augmented by identifying and removing obstacles to health

and recovery and by supporting and nurturing the body’s innate self healing capacity

and external environment. Western herbal medicine can also be used to support

health maintenance and disease prevention; it can also be used in palliative care to

assist in relief of some symptoms and to provide comfort. The traditional therapeutic

framework that underpins Western herbal medicine practice provides a sophisticated

approach to treatment.

Medical herbalists promote health and well-being. They provide primary health care

based on Western herbal medicine, biomedical science and evidence-based

medicine and traditional therapeutic philosophy. They utilise diagnostic and

assessment techniques for the identification of dysfunction, disorder and disease,

and treatment techniques for the maintenance and restoration of health and the


6

prevention of disease14. Medical herbalists encourage the inherent self-healing

processes and homeostatic balance within each individual patient15,16.

The contemporary Western herbal medicine practitioner treats an individual patient

in a holistic manner17. Treatment predominantly takes the form of a blended mixture

of concentrated herbal extracts (commonly called ‘tinctures’) such that the medicine

is specific to the person being treated18.

Most patients who visit medical herbalists seek care for chronic conditions, some

acute health conditions as well as for maintaining health19. Most chronic conditions

have been medically diagnosed and patients generally continue to consult a general

practitioner23. More than half of all breast cancer patients and up to 90% of people

with chronic benign conditions such as arthritis use complementary and alternative

medicine (CAM)20. Many patients are taking herbal and pharmaceutical medicines

concurrently21.

Medical herbalists are educated in orthodox medical treatment of conditions

alongside herbal medicine components of their training. Particular attention is paid

to potential herb-drug interactions. Due to this educational focus most herbal

practitioners support a blend of both scientific and traditional values, thereby placing

them in a unique position within the healthcare sector.

1.2 Professional Organisations

The New Zealand Association of Medical Herbalists is the major professional

organisation representing medical herbalists in New Zealand. The NZAMH was

formed by a group of practising herbalists in the early 1900s and first applied for

statutory registration in 191022. In 1983 the NZAMH became an incorporated society

and in 2000 amalgamated with The Aotearoa Herbalists Inc (TAHI) to form a unified

national body. NZAMH is an independent body which is self-governing, sets its own

educational standards and competencies (Appendix 2), has a Constitution (Appendix

1), Code of Ethics (Appendix 3), Scope of Practice (Appendix 4) and Complaints and

disciplinary process (Appendix 1), and issues its own annual practicing certificates.

There are four classes of membership of the NZAMH: Professional Members,

Student Members, Associates, and Fellows. There are currently 235 professional

members of the NZAMH, although there are many more practitioners who don’t

currently belong to a professional body who choose to prescribe and dispense herbal

medicines.

Most NZAMH medical herbalists are also qualified naturopaths, and could be eligible

to join a naturopathic association. However, not all naturopaths are qualified as

medical herbalists. Some medical herbalists are trained nurses or general


7

practitioners. Other professional organisations to which medical herbalists may

belong include:

Naturopaths of New Zealand

New Zealand Society of Naturopaths

Natural Health Practitioners of New Zealand

Nursing Council of New Zealand

New Zealand Medical Association

Pharmaceutical Society of New Zealand

A medical herbalist is a health practitioner who prescribes, formulates, manufactures

and dispenses herbal medicine as a therapeutic agent to a patient for the purpose of

treatment. Therefore, for the safety and protection of individuals any person carrying

out this act should be deemed a medical herbalist and as such should be considered

within this application for registration.

1.3 Public Perceptions of Medical Herbalists

Herbal medicine has a long and rich history; it is not only cost effective but also

provides holistic care and is efficacious. However it is not exclusive of other healing

paradigms. The general public extensively choose to consult medical herbalists to

enhance their health and well-being23.

The choice to utilise herbal medicine occurs for various reasons. Motivations may

include the inadequacies or limitations of orthodox treatment, concern over drug

safety and costs and/or the desire for a more holistic approach to illness24. Many

patients view herbal medicine as a critical aspect of self-care25. Social forces,

consumer critique, economic factors, increased research validation and a paradigm

shift with regard to view of illness are all involved in the increased use of

complementary and alternative medicine (CAM) modalities by the general

public26,27,28,29,30.

Patients in New Zealand increasingly consult CAM practitioners. The 2006/7 NZ

Health Survey found 1 in 5 adults reported that they had consulted a CAM

practitioner in the past 12 months23. Of those who saw a CAM practitioner 6.5%

consulted a herbalist23 (up from 1 in 4 visits to CAM providers and 1.8% for

herbalists in the 2002 survey31). The public consult medical herbalists for many and

varied health concerns although chronic, complex and serious illnesses tend to

predominate within the clinical setting. Musculoskeletal, digestive, respiratory, skin

and non-specific illnesses are relatively commonplace as are psychological or

psychiatric conditions and cancer28,32,33,34,35. The marked growth in use of herbal

medicine is mirrored worldwide36,37,38.


8

A 2007 Australian survey39 on complementary medicine found 16.3% of Australians

had visited a Western herbal medicine practitioner in the past 12 months and 10.7%

a naturopathic practitioner (who also prescribe herbal medicine) compared with

16.1% who had visited a chiropractor, 4.6% visited an osteopath and 9.2% had

visited an acupuncturist. Currently chiropractors and osteopaths are statutorily

regulated professions in New Zealand.

A UK postal questionnaire undertaken by General practitioners of 400 consecutive

patients attending six Scottish medical practices found 36% of patients reported

concurrent use of complementary medicine remedies with 18% combining CAM

therapies40.

1.4 Primary Care Practice

Medical herbalists are used by the public as primary health care providers. It is

crucial to the health of the public that practitioners provide safe care. They must

have knowledge of, and the ability to respond to a medical emergency and know

when it is appropriate to refer a patient to a general practitioner or other healthcare

specialist. Medical herbalists fulfil this role. They are trained in comprehensive case

history taking, are competent in the clinical assessment of vital signs and symptoms,

understand pathology and diagnostic tests and have the ability to assess patient

health. A postal survey of 649 herbalists in Australia found that 99% indicated that

they referred patients to other health care professionals with 93% reporting that they

regularly referred patients to medical practitioners41.

As can be seen from the Practice Analysis (Appendix 5), patients may present with

complex health conditions, and could be taking several medications prescribed by

their general practitioner or medical/surgical specialist. Patients may also be using

self-prescribed nutritional supplements and herbs. Some of these supplements may

be either inappropriate and have a relatively low evidence basis for usefulness in

their situation, or provide an inappropriate dosage, or the product may be of

questionable quality. Medical herbalists are the experts in advising on such products

and are required to take details of all medications used by patients. They also have

up-to-date knowledge of phytopharmacology and potentially dangerous as well as

advantageous herb-drug or herb-nutrient interactions.

In current medical practice secondary referrals are also made to naturopaths and

medical herbalists by mainstream health care practitioners. A 2006 survey of NZ

GPs showed that the rate of referral from GPs to naturopaths was 12.3% and the

rate of referral from GPs to herbal medicine practitioners was 9.7%42.


9

HPCAA PRIMARY CRITERIA

2. Criterion A

Does the profession deliver a health service as defined by the Act?

Herbal medicine is a health service as defined by the Act: “a service provided for the

purpose of assessing, improving, protecting, or managing the physical or mental

health of individuals or groups of individuals”.

Herbal medicine is a clearly identifiable health profession providing primary health

care. Medical herbalists rely on the use of plant medicines, derived predominantly

from the whole crude plant rather than specific chemicals refined from plant material.

Patients consult medical herbalists on a wide range of health concerns within the

clinical setting, predominantly chronic and complex illnesses. The 2006/07 New

Zealand Health Survey found 25.8% of participants had visited a

naturopath/homoeopath and 6.5% had visited a herbalist at least once in the past 12

months23. Naturopaths and herbalists commonly prescribe herbal medicines.

2.1 International Recognition

Herbal medicine is recognised as a valid healthcare modality in many countries

around the world38. Furthermore, many studies suggest the level of usage of herbal

medicine by consumers in many countries is increasing markedly.

In Germany 70% of GPs favour herbal medicine use over pharmaceuticals43. Fifty

two countries including Argentina, Australia, Canada, France and the United States

of America have taken steps to regulate herbal medicines37,44. The World Health

Organisation (WHO) has acknowledged that over three quarters of the world’s

population rely on herbal medicine for their primary health care and they have

strongly encouraged regulation of these medicines to “protect and promote public

health”. The World Health Assembly (1991) resolutions resulted in the WHO

developing a Traditional Medicine (including Herbal and Complementary Medicine)

[T&CM] programme44 and then later a 10-year strategy for the period of 2014 to

202345 to promote its cohesive integration into national health care in all member

states. Within several Western countries there are now moves towards statutory

regulation of Western herbal medicine practitioners.

2.1.1 United Kingdom

Under long standing United Kingdom regulations, anyone could be a herbalist with

little or no training. Therefore new proposals were sought to limit the use of legally


10

protected titles to those practitioners on a statutory register. Such legally protected

titles would enable the public to determine who is a properly qualified practitioner

and enable practitioners contravening agreed codes of ethics or practice to be struck

off such a register, thereby losing use of the protected title.

In 2000 the ‘House of Lords’ Select Committee on Science and Technology’ report

on CAM was published46. This report recognised the growing use of complementary

medicine, including herbal medicine, and the risk posed by CAM practitioners with

inadequate training as well as from the supply of unregulated herbal medicines. It

also stated that herbal medicine had a well-organised professional base and that

research into its effectiveness had begun and was “likely to prove of benefit”.

The Government responded in 2001 to the Select Committee Report recommending

that herbal medicine practitioners should seek statutory regulation under the Health

Act 1999 to benefit both practitioners and patients47. This was then followed in 2002

by the Department of Health establishing an independent committee, the Herbal

Medicine Regulatory Working Group (HMRWG) to consider how statutory regulation

of herbal practitioners and their medicines could best be achieved.

The HMRWG rejected an independent Herbal Council as an option for the

registration of herbal practitioners. The HMRWG observed that while this might be

perceived as giving herbal medicine a clear identity, the need to work across

professional boundaries to deliver integrated healthcare was better achieved through

shared arrangements among CAM professions. In addition, the HMRWG noted, the

cost of a single Herbal Council was likely to be prohibitive to practitioners,

particularly for those practicing both acupuncture and herbal medicine. For these

reasons the HMRWG favoured the adoption of a shared council (to be called the

CAM Council), to include at this stage, both herbal medicine and acupuncture, with

the possibility of including other CAM disciplines at a later stage.

The consultation document proposed a number of significant changes to that part of

the 1968 Medicines Act that regulated one-to-one prescription of herbal medicines.

In particular, it proposed that the use of some herbal medicines should be limited to

herbal practitioners on the new Statutory Register. It also proposed that herbalists on

the Statutory Register have access to specific formulations manufactured to their

specification without the need for a full medicines license. This exemption from

licensing would also be granted for individual formulations made up by the herbalists

on their own premises. The consultation document also suggested that regulated

herbalists should use herbs on a broad list agreed upon by their regulating body in

consultation with the profession.

In March 2004, the U.K. Medicines and Healthcare Products Regulatory Agency

published a consultation document proposing significant changes to the U.K.

Medicines law in relation to the one-to-one prescription of herbal medicines48.

Consultation with interested organisations (including from both CAM and orthodox


11

medicine) and the public on the statutory regulation of both herbal medicine and

acupuncture proceeded in 2005. A positive response was received from 98.5% of

respondents.

Political delays meant that a steering group for regulation did not begin until 2006

and they reported in 2008 to the Minister of Health. Their main recommendations

were49:

statutory regulation proceed without delay for the public safety and to also

allow the public to make an informed choice

that supplies of herbal medicine by third parties should not change due to

regulation

that in accordance with section 12(1) of the 1968 Medicines Act only statutory

registered practitioners should be allowed to use herbal medicines without

marketing authorisation for individual patients

that regulation should be carried out by the Health Professions Council

The group also approved standards of education and ethics as provided to them and

encouraged research to verify the practice of herbal medicine.

In 2011 the UK government announced that they intended to statutorily regulate

medical herbalists and tasked the European Herbal and Traditional Medicine

Practitioners Association (EHTPA), an umbrella body of professional herbal medicine

associations from eastern and western traditions, with the interim responsibility for

accreditation of courses of herbal medicine. The intention was that in due course the

Health Professions Council would assume the task of both accreditation and

registration of practitioners.

The right of herbalists to prescribe unlicensed herbal medicines following one-to-one

consultations, granted in 1968 and called “herbalists’ exemption” was incorporated

into the 2012 Human Medicines Regulations.

Despite the above and that the statutory regulation of herbalists was supported by

two select committees50 this has not occurred possibly due to complexities within the

European Union. Instead there has been a focus on self-regulation and development

of national accredited registers for various practitioners. Each accredited register

sets and oversees education standards, continuing professional education and

complaints51.

Such regulation may be appropriate for low risk complementary therapies as

recommended in the NZ Ministerial Advisory Committee on Complementary and

Alternative Health (MACCAH) in 200452. However this approach does not address

all the safety concerns of high risk modalities (such as osteopathy, chiropractics,

herbal medicine, naturopathy, acupuncture, traditional Chinese medicine, Ayurvedic


12

medicine) that MACCAH recommended are regulated by the Health Practitioners

Competence Assurance Act 2003.

2.1.2 Ireland

Ireland had decided on the statutory regulation of complementary and alternative

health practitioners; however as in the UK the progression of herbalists to statutory

regulation has been stalled by moves from within the European Union. A survey of a

number of European countries by O’Sullivan described how these countries were

moving ‘very cautiously’ towards regulation53.

In May 2003 a working group was established by the Health Minister to look into and

recommend steps towards statutory regulation of complementary therapists54.

Their report published in December 2005 again cited that statutory regulation would

satisfy the need for the public to be able to make an informed choice. They

particularly recommended that herbalists be considered for statutory regulation

because of the issue of public safety surrounding the use of herbal medicines and

also the fact that herbalists are more likely to be a first port of call in primary health

care compared to other complementary therapies. They also suggested that

herbalists, due to their extensive training, be given continued access to herbal

medicines for making complex medicines on an individualised basis.

2.1.3 Australia

The Expert Committee on Complementary Medicines in the Health System

commissioned by the Federal Government has made significant recommendations

regarding the regulation of Western herbal medicine practitioners including that state

governments should move quickly to statutory regulation where appropriate55. As a

consequence both the New South Wales and Western Australia governments asked

for submissions on the registration of traditional Chinese medicine practitioners

although the expert committee did recommend that herbalists and naturopaths also

be regulated.

The National Herbalists Association of Australia (NHAA), the Australian equivalent of

NZAMH, was one of five CAM modality organisations to be granted $500 000 by the

Department of Health and Aged Care in 2002. This money was granted to assist in

working towards national registration systems and the retention of GST-free status.

The New South Wales Chief Health Officer released a discussion paper in October

2002 offering various models for regulation of CAM practitioners56.


13

In 2003 the Department of Human Services of the State of Victoria funded a major

review of the risks, benefits and regulation of naturopathic and Western herbal

medicine57.

In 2006 a single national register of all professional health practitioners was

proposed58 and it lead to the establishment of the Australian Health Practitioner

Regulation Authority (AHPRA), whose remit is to protect the public and set standards

with which all registered practitioners must comply. AHPRA’s operation is governed

by the Health Practitioner Regulation National Law in force throughout Australia

since 1 July 2010. The AHPRA initially covered 14 health professions that were

already regulated such as medical practitioners and pharmacists. In 2011 partially

registered professions were added to the register such as traditional Chinese

medicine practitioners. A third round was due to review the addition of unregulated

professions including Western medical herbalists but this has not yet transpired,

although it is still expected to happen in the next few years59. In the meantime the

independent Australian Register of Naturopaths and Herbalists (ARONAH) has been

established to protect the public. It functions according to the same criteria as

AHPRA and should enable the transfer of these professions to statutory regulation in

due course. This register became operational in July 201360.

Support for statutory registration of complementary medicine in Australia is

widespread and includes the Australian Medical Association61,62, the general

public63, some government reports63,64, and the professional organisation, the

National Herbalists Association of Australia58.

2.1.4 United States of America

Financial support by way of reimbursement for the use of herbal medicine in the

United States is determined by each state’s Health Maintenance Organisation

(HMO) and is at this stage limited65.

Herbalists are able to practice without a licence or under exemption laws. The United

States of America White House Commission on Complementary and Alternative

Medicine report recommended that the effects of different regulatory guidelines be

investigated in terms of consumer choice and consumer protection66. The

Commission’s extensive report recommended that the:

“States should consider whether a regulatory infrastructure for CAM practitioners is

necessary to promote quality of care and patient safety and to ensure practitioners'

accountability to the public. The Federal government should offer assistance to

states and professional organisations in developing and evaluating guidelines for

practitioner accountability and competence, including regulation of practice and

periodic review and assessment of the effects of regulations on consumer protection.


14

When appropriate, states should implement provisions for licensure, registration, and

exemption that are consistent with a practitioner's education, training, and scope of

practice.

Nationally recognised accrediting bodies should evaluate how health care

organisations are using CAM practices and develop strategies for the safe and

appropriate use of qualified CAM practitioners. In partnership with other public and

private organisations, they should evaluate the present use of CAM practitioners in

health care delivery settings and develop strategies for their appropriate use in ways

that will benefit the public. Current standards and guidelines should be reviewed to

ensure safe use of CAM practices and products in health care delivery

organisations.”

Numerous authors have investigated CAM modalities within the USA67,68,69,70, 71

including examination of regulatory policy72,73,74,75.

Consumer use of herbal medicine in the USA is high; a reported 20% of the adult

population had used herbal medicine according to a National Health Interview

Survey in 200276. In fact of all complementary therapies used in the USA, herbal

medicine is the most commonly used77. The only regulation at present is through the

American Herbalists Guild which is a peer-review self regulated organisation that

specifies training standards and maintains a register of herbalists who meet these

standards. Practitioners of herbal medicine are also found amongst physicians,

osteopaths and naturopaths78.

2.1.5 Canada

Although herbal medicine is widely used in Canada it is unregulated65. A survey by

the Fraser Institute in 1999 estimated herbal medicine use at 17% with insurance

payments covering less than 10% of cost of herbal medicine therapy79. Canadian

herbalists are currently self-regulated77.

The Health and Human Resource Strategies Division has examined CAM in the

Canadian health system since 1998. This division has produced the document

Perspectives on Complementary and Alternative Health Care: a collection of papers

prepared for Health Canada which discusses the regulation of CAM practitioners,

including herbalists80.

Health Canada’s Advisory Group on CAM have released a paper that discussed in

some depth the ethical issues surrounding regulation of CAM modalities and how

these impact on regulatory processes81.

http://www.hc-sc.gc.ca/hppb/healthcare/pubs/comp_alt/index.html

http://www.hc-sc.gc.ca/hppb/healthcare/pubs/comp_alt/index.html


15

Health regulation review, public support and protection have been identified as

drivers for regulation of complementary and alternative practitioners in the Canadian

context82,83. Better integration of CAM with conventional medicine and legitimacy of

these professions would be achieved by regulation and even though the health

regulators in the various provinces have shown an interest in CAM there has been

very slow progress in responding to the demands of CAM representatives for

regulation84.

As of 2005 four of the Canadian states had regulated naturopaths, who are providers

of herbal medicine65. However the professional associations of medical herbalists

are not required by law to be self regulated but have taken on the responsibility of

monitoring standards of training and practice65.

3. Criterion B

Do the health services concerned pose a risk of harm to the health and safety

of the public?

The risks of herbal medicine are sufficient to warrant regulation and are comparable

to those of regulated professions. Of 148 articles published about herbal or

complementary and alternative medicine in the Medical Journal of Australia

(Australia’s primary medical journal) from 1966 to 2008, 42% of articles referred to

adverse reactions or events and 30% referred to the risk of the

herbal/complementary and alternative medicine therapy or practitioner85.

The Western herbal medicine profession was originally approved for inclusion under

the HPCAA (2003) in 2007 by the then Minister of Health Pete Hodgson who

recognised there to be enough risk to the public to warrant regulation.

Herbal medicine practice poses a risk of harm to the health and safety of the public

through the prescription of herbal medicine itself as well as poor decision making

and actions of the practitioner. In addition, because herbal medicine practice sits

outside statutory regulation potentially risky referral practices are taking place. The

patient is the go between the medical practitioner and CAM practitioner, with

referrals done through word-of-mouth86. Such practice raises safety concerns and is

unsatisfactory in modern health care.

3.1 Clinical interventions with the potential for physical and mental harm

Physical risks specifically associated with the use of herbal medicines include:


16

risks associated with the potential toxicity of some herbal medicines, including

inappropriate use and overdose;

potential interactions between herbal medicines;

potential adverse interactions between herbal medicines and prescribed or

OTC pharmaceutical drugs;

potential for hypersensitivity or allergic reactions including anaphylaxis;

potential for inappropriate use due to physiological factors e.g. pregnancy;

risks associated with misidentification or substitution of plant species;

risks associated with use of incorrect plant part;

risks associated with poor product quality or product adulteration;

risks associated with self-prescription of inappropriate herbal medicine.

3.2 Clinical decision-making and its potential impacts for harm

Risks associated with poor clinical judgement of the herbal medicine practitioner

include:

misdiagnosis and poor patient management;

inappropriate, unnecessary or ineffective treatment;

aggravation or progression of a condition due to inappropriate treatment;

failure to refer to another practitioner when warranted;

inappropriate removal of allopathic medication;

failure to explain instructions, precautions, and contra-indications;

failure to identify adverse reactions and take appropriate remedial action;

practitioner impairment, professional misconduct and poor ethical decision-

making

unethical or misleading advertising

inappropriate internet prescribing

3.3 Establishing risk of harm

A risk assessment of the practice of herbal medicine needs to consider not only the

documented incidence of harm, but also the potential for harm inherent in both the

use of plants as therapeutic tools, and in the actions of practitioners inappropriately

educated and trained, and operating outside an apposite professional body. In New

Zealand the NZAMH are the only professional body specifically representing medical

herbalists, however there are an undetermined number of naturopaths, not

registered with the association, who also use herbal medicine as their primary tool of

trade.

3.3.1 The nature, frequency, severity and likelihood of harm to the consumer


17

Few adverse physical reactions to herbal medicines are reported. Whilst this

possibly reflects the reduced risks of taking herbal medicines in comparison to

pharmaceutical medicines, other factors may include the possibility that adverse

reactions to complementary therapies are not well recognised or that there exists a

lack of awareness by practitioners and the public that adverse reactions can be

reported to the Centre for Adverse Reactions Monitoring (CARM)87. Commenting on

a similar analysis of the situation in Australia, Wardle suggested that fear of having

therapeutic tools taken away and non-disclosure of use of complementary medicines

may also play a part in under-reporting89.

As part of the workforce survey in 2004 of naturopaths and herbal medicine

practitioners in Australia frequency of adverse events were reported14. In Australia

herbal medicine is an essential modality in both herbalist and naturopathic training

although in New Zealand a naturopath may qualify with little or no herbal medicine

education and yet practice herbal medicine.

The workforce survey analysed responses from 489 practitioners who identified

herbalism as one of their practice descriptors (62% of the total sample), and 604

practitioners who identified naturopathy as one of their practice descriptors (76% of

the total sample). The survey participants were asked questions related to adverse

events. Practitioners were asked to indicate the number of times each adverse event

had occurred during their practice lifetimes. The most common adverse events

reported in herbal medicine were mild gastrointestinal symptoms (n = 1952),

headaches (n = 870), menstrual irregularities (n = 322), significant skin reactions (n =

307) and severe gastrointestinal symptoms (n = 296).

Serious adverse events reported in herbal medicine included CNS effects (n = 17),

hepatotoxicity (n = 9) and significant respiratory disturbance (n = 9). Eighty-two

adverse event cases were significant enough to refer to a medical practitioner or

hospital, although no deaths were reported.

The most common adverse events reported in regard to use of nutritional medicines

were mild gastrointestinal symptoms (n = 1023), headache (n = 434) and severe

gastrointestinal symptoms (n = 150). Serious adverse events reported included CNS

effects (n = 1), significant respiratory disturbance (n = 8), renal toxicity (n = 1) and

one death. Fourteen adverse event cases were significant enough to refer to medical

practitioners or hospital.

Data suggested that practitioners will experience 2.3 adverse events for every 1000

consultations (excluding mild gastrointestinal events). The researchers estimated

that 1.9 million consultations were conducted annually in Australia and they

suggested that there was a need to re-examine whether statutory regulation of


18

herbal medicine practitioners was required to better protect the public14.

In June 2003, the Victorian Department of Human Services, Australia contracted with

the School of Public Health, La Trobe University, to coordinate research on the

benefits, risks, and regulatory requirements for the professions of naturopathy and

Western herbal medicine57. The aim of the project was to investigate and understand

the practice of naturopathy and Western herbal medicine in Australia, and to make

recommendations on the need, if any, for measures to protect the public.

The methodology adopted in the study included: (i) literature reviews (including

systematic reviews); (ii) reviews of documents and reports; (iii) reviews of

administrative data; and (iv) primary data collections through surveys and focus

groups.

This research examined the effectiveness of herbal and nutritional medicine and

showed a substantial increase in the publications devoted to examining efficacy of

these CAM therapies with 152,925 entries found between 1966 and 2003. There was

also evidence to support the use of herbal and nutritional medicine in the treatment

of all body systems.

Risks associated with CAM use were assessed to be due overall to one of two major

areas.

a) the clinical judgement of the practitioner including:

incorrect prescribing

lack of knowledge of contra-indications

inappropriate dosage

inappropriate duration of treatment

inadequate skills

failure to recognise the need to refer to other practitioners

b) inappropriate intake of herbal or nutritional medicines causing problems due to:

overdosing

interaction with pharmaceutical drugs

allergic reactions

idiosyncratic reactions

The researchers suggested that reporting of adverse reactions was likely to be

understated because of the method used to collect such data, but that there was

nonetheless a wide range of adverse events reported in the literature for both herbal

and nutritional medicine.


19

The research team’s review of coroners’ records, reports from professional

associations, data from the health services commissioner and media reports showed

that:

• there had been some deaths related to inappropriate clinical advice

• there were some common concerns about interaction between orthodox medicines

and herbal medicines.

General practitioners also reported high numbers of perceived adverse events,

estimated to be one for every 125 consultations. In order, chiropractic, herbal

medicine and naturopathy were responsible for the highest number of adverse

events of the CAM modalities surveyed. General practitioners attributed adverse

events to a number of causes, including ineffective treatment, wrong diagnosis,

allergic reaction, drug interaction, and profit-motive over-riding clinical judgement.

The study also indicated that 34% of those taking herbal medicine were taking

pharmaceuticals concurrently which in the light of increasing reports of such

interactions between the two was a cause for concern.

Data from the surveys and focus groups suggested that many people who used

complementary health care also used conventional medical services. There was also

a smaller number who did not wish to use conventional medicine unless necessary.

Patients have had to navigate two systems and this process has difficulties and

potential dangers when consumers do not feel they can inform all practitioners of

their use of particular services, or when they do not choose to inform all practitioners.

Poor communication between general practitioners and Western herbal medicine

practitioners was particularly concerning as a majority of patients were seeking care

for chronic conditions and were, therefore, frequent and routine users of both types

of medical care.

In summary, the evidence from this report suggested that the risks of Western herbal

medicine arise from both the primary care practice context as well as ‘tools of the

trade’.

More recently, the NHAA submission as part of the Review of the Australian

Government rebate on private health insurance for natural therapies, identified 1462

articles published on the PubMed database on the safety/toxicology of herbal

medicine and over half of these were published in the last 5 years (Table 1)89.


20

Table 1: The increasing publication of herbal medicine research (reprinted by

kind permission of NHAA89) Dates for

article publication

Any article n, (% of total)

Primary research n, (% of total)

RCT n, (% of total)

Systematic review n, (% of total)

Safety/ toxicology

n, (% of total)

Cost effectiveness

n, (% of total)

No date restriction

19766 2462 1262 728 1462 112

2007-2012 9856 (50%)

1118 (45%)

627 (50%)

438 (60%)

783 (54%)

67 (61%)

2001-2006 5975 (30%)

814 (33%)

427 (34%)

247 34%

418 (29%)

32 (28%)

1995-2000 2261 (12%)

357 (15%)

163 (13%)

43 (6%)

165 (11%)

8 (7%)

Pre 1995 1674 (8%)

173 (7%)

45 (3%)

0 (0%)

96 (6%)

5 (4%)

Similarly, an increasing amount of articles have recently been published concerning

the safety and toxicological status of nutritional/dietary supplements also prescribed

by many medical herbalists (Table 2).

Table 2. The increasing publication of nutritional/dietary supplement

research (reprinted by kind permission of NHAA89)

Dates

for

article

publicat

ions

Any

article

n, (% of

total)

Primary

research

n, (% of total)

RCT

n, (% of total)

Systematic

review

n, (% of total)

Safety/

toxicology

n, (% of

total)

Cost

effectiveness

n, (% of total)

No date

restricti

on

27633 8915 5632 1674 413 189

2007-

2012 13886

(50%)

4467

(50%)

3038

(54%)

1067

(64%)

207

(50%)

85

(45%)

2001-

2006 9485

(34%)

3138

(35%)

1949

(35%)

491

(30%)

164

(40%)

79

(42%)


21

1995-

2000 3082

(11%)

996

(11%)

557

(10%)

116

(7%)

32

(8%)

18

(9%)

Pre

1995 1180

(5%)

314

(4%)

88

(1%)

0

(0%)

10

(2%)

7

(4%)

Beyond the direct effects of herbal medicine and nutritional medicine products,

safety issues may also be associated with communication of this use with

conventional care providers”85,88,89

Research has highlighted that there is a public preference to use herbal medicine

compared to over-the-counter (OTC) or prescribed conventional medicine; the public

are more inclined to use a herbal medicine with a conventional medicine than with an

OTC and they believe that because herbal medicine is natural it is safer and can

therefore be used with less caution90.

This belief is clearly erroneous as herbal medicine combined with some medications

has the potential to either increase or decrease availability or utilisation of medicines.

In a 2011 survey of 305 university students, only 25% of herb users disclosed herb

use to a healthcare provider, and 13% had simultaneously used herbs (although

mostly self prescribed) and prescription medication in the last year91. Herb users who

inter-mixed herbs with prescription medications had higher depression and anxiety

scores.

New Zealand data reported by MedSafe for 2011 indicated adverse reports for CAM

were 0.4% of all those reported for that year, and were consistent with reports from

previous years. Of those for CAM 10% were considered to be of a serious nature87.

Based on the above information encouraging open referrals between the medical

profession and medical herbalists would not only increase the transparency of

patients’ use of both conventional and herbal medicine but it would make this

practice much safer.

Correspondence from the New Zealand Health and Disability Commissioner to the

Ministry of Health (2007) supported the regulation of herbal medicine under the

Health Practitioners Competence Assurance Act 2003 (HPCAA) as the HPCAA aims

to protect the health and safety of members of the public by providing mechanisms

to ensure that health practitioners are competent and fit to practice their

professions92 and in so doing encourages an open system of referral between health

providers.


22

Specific Risks

The principal physical risks specifically associated with the use of herbal medicines

include:

risks associated with the potential toxicity of some herbal medicines, including

inappropriate use and overdose;

potential interactions between herbal medicines and pharmaceutical drugs;

potential for hypersensitivity or allergic reactions;

risks associated with use of a herb when contraindicated e.g. during

pregnancy;

risks associated with misidentification or substitution of plant species;

risks associated with use of incorrect plant part;

risks associated with poor product quality, including adulteration;

risks associated with incorrect method of administration and self-prescription.

Adverse reactions due to inappropriate prescribing are rare for qualified practitioners

with good clinical practice. In the interest of public safety and confidence it is

essential that those medicinal herbs considered a risk to the public are prescribed,

administered, and monitored by suitably qualified practitioners of herbal medicine.

Potential Toxicity

Not all plants are safe to use as medicine. Restrictions vary throughout the world.

United Kingdom

Some plants have the potential to poison and are not permitted for use in herbal

therapy (e.g. Aconitum spp, Digitalis spp). Others, whilst potentially toxic, have their

availability restricted to suitably qualified herbal practitioners. This is the case for

herbs like Chelidonium majus (greater celandine), Ephedra sinica (ma huang),

Lobelia inflata (lobelia) and the tropane alkaloid-containing herbs like Datura

stramonium (thornapple)93,94.

Ireland and the European Union

Between 2004 and 2011 herbal medicines were able to be registered for use without

the need for community pharmaceutical marketing authorisation, by a simple

method, if they could demonstrate “well established use”. This meant that they had

detailed references in the scientific literature of efficacious and safe use spanning at

least 30 years and including 15 years of use in the European Union.

In 2007, the Committee for Herbal Medicinal Products (HMPC) was tasked by the

Herbal Directive, with scientifically assessing these traditional herbal substances,

preparations and combinations. They created monographs for registered herbal


23

medicines and their list included all those the EU considered safe with normal use.

The registered list is deemed to be acceptable in all member states95. Those herbal

medicines that were considered to have the potential for public harm are covered by

pharmaceutical legislation. This approach has been taken to allow public access to

herbal medicines without recourse to a qualified medical practitioner96.

In Ireland herbal practitioners are still allowed to prescribe herbal medicines under

Common Law of 1154 in England, Wales, Northern Ireland and Ireland.

Australia

In Australia restricted herbs may be prescribed by registered general practitioners

who not only have no knowledge of, or training in their use, but also have no interest

in using them88. In contrast trained herbal medicine practitioners are properly placed

to assess the potential for adverse reactions from a given herbal medicine based on

knowledge of the individual’s health status. The Expert Committee on

Complementary Medicine has suggested that practitioners with the relevant

education should be given access to some restricted herbs and that this may be

done by using a Schedule under the Standard for the Uniform Scheduling of Drugs

and Poisons and implemented nationally97. The list of scheduled herbs includes

those which are illegal to use such as Aconitum napellus and Schedules 2-4 which

contain restricted herbs for use by registered practitioners only. These herbs are

similar to those that have restricted-use status in the UK, but also include

Symphytum spp (comfrey), Tussilago farfara (coltsfoot) and Acorus calamus (sweet

flag)5, which can be used freely in the UK.

United States of America

Herbal medicine has been classified in the USA according to the Dietary Supplement

Health and Education Act of 1994, as a dietary supplement and as long as no

medicinal claims are made for it, or generic dosing given on the label, they are

accepted as safe until proof exists to the contrary (WHO Regulatory Situation)43,98.

This lack of ability to fully label products leaves the consumer with no guidance and

the American Herbalists Guild believes recognised herbal practitioners are therefore

even more necessary for the safe use of these medicines. Any medicinal claims

made for a herb, unless it is scientifically endorsed as effective and safe in support of

such claims, means it becomes classified as a drug and must fulfil the legal

requirements of premarket review and FDA approval99.

Some herbs e.g. Ephedra sinica cannot be sold in all states.

Canada

Herbal medicines are regulated as drugs in Canada and are subject to the labelling

requirements of the Food and Drugs Act and Regulations. Herbal medicines used


24

for minor self-limiting conditions receive a Drug Identification Number by way of

registration if there is sufficient pharmacologic and bibliographic evidence and

verified traditional use. Standardised drug monographs can also be used to support

the registration of herbal medicines.

At present only registered medical practitioners can prescribe restricted herbal

medicines although the naturopathic professionals are also pushing for prescribing

rights100.

New Zealand

Herbal medicines are currently treated as dietary supplements and subject to the law

under the Dietary Supplements Regulations 1985. This situation is considered

obsolete and “quite restrictive”101. It does not allow claims to be made for natural

health products even where evidence for therapeutic efficacy exists. It is seen as

necessary for public safety and assurance that some form of regulation be instituted.

However under the Medicines Act 1981, medical herbalists can prescribe herbal

medicines to an individual who has requested such a medicine102 and/or following a

consultation with an individual. They are not able to use herbal medicines that may

be classified as restricted e.g. Ephedra sinica (ma huang) or pharmacy-only

medicines e.g. Lobelia inflata (lobelia).

Cases of toxicity from overdose are usually attributable to selected plant products

that are well known in the materia medica for their toxic potential. There are a

number of documented cases of toxic overdose of herbal

products103,104,105,106,107,108,109,110,111,,112,113,114 . These reported incidences of adverse

events show the actual potential of plant substances to inflict harm when used

incorrectly.

A select few herbal medicines have a relatively narrow therapeutic index (i.e. are

potentially toxic at low dosages) and are required to be prescribed with care and

knowledge. These include some of those herbs with recorded toxic overdose such

as Datura stramonium113,114, Ephedra sinica115,116 and Phytolacca americana117. Use

of these herbal medicines requires a thorough understanding of their indications and

safety limits.

Herbal medicines with a narrow therapeutic index should be classed as ‘practitioner-

only’ medicines. With proper training in the use of these particular herbs, and the

physiological activity of their active constituents, their prescription should be limited

to registered medical herbalists. This control is only possible through statutory

regulation. At the present time, there are several medicinal herbs or phytochemicals

from medicinal herbs that are restricted in New Zealand and are available only by

doctor’s prescription or through licensed pharmacies; in both situations the

prescribing practitioner is unlikely to be suitably trained in clinical practice of herbal

medicine unless they have undertaken additional training.


25

The herb Piper methysticum (kava) is an effective treatment for mild anxiety

disorders and insomnia, and its safety profile in this regard is better than that of drug

treatments used for these conditions118. There have been concerns in recent years

about a possible association with the use of kava and liver toxicity, leading to its

restriction in many countries. The incidence of causally related case reports of liver

toxicity is very low, (around 14 cases accepted as “probably” related in 2003119), and

no cases have been reported in New Zealand to date. In Australia, the use of an

aqueous extract form of kava only has been allowed, although the evidence base for

practitioner-prescribed hydroethanolic liquid extracts of this herb posing a risk of liver

toxicity is unsubstantiated120. Indeed many clinical studies using kava have included

liver function tests with no increase in incidence of hepatoxicity121,122. There have

been a number of explanations put forward as to the cause of this cluster of kava-

linked liver problems123,124,125,126,127,128,129 but reviews have concluded that there is

not a single cause for all the events recorded123,128,130. New Zealand medical

herbalists are aware of the literature on possible adverse reactions to kava, and

continue to prescribe hydroethanolic liquid extracts of this valuable herb in a cautious

and safe manner. The United States has never restricted kava use131 and in

Germany, Kava is being prescribed again with limitations on dose and duration of

use118.

Herbal Medicine/Drug Interactions

A high number of patients receiving pharmaceutical medications may also take over-

the-counter (OTC) herbal medicines that are not prescribed by a qualified

practitioner132,133,134,135. As a result, adverse herb/drug interactions are of increasing

concern91,111,136,137,138,139,140.

Interactions can occur through a variety of mechanisms and may involve herbal

agents or foods that may either increase or reduce the effect of concurrent

prescribed drug medication91,119,141,142,143,144,145,146.

Pharmacokinetic mechanisms may affect the absorption, distribution, and/or

metabolism of administered drugs. Many of the studies conducted to date in this

area have centred on the induction or inhibition of cytochrome P450 metabolising

enzymes within hepatocytes by particular plant

products142,143,145,147,148,149,150,151,152,153. A range of other possible mechanisms is also

known to potentially cause drug/herb interactions154 - such as p-

glycoprotein146,155,156,157, a membrane transport protein, and anion-transporting

polypeptide-B158 that can be affected by one agent in uptake of another. Literature

on this subject is somewhat lacking, and while a number of documented interactions


26

are firmly based upon sound clinical evidence, others appear anecdotal or

theoretical.

Presently a number of herbs are under extensive study and there is the possibility

that more may be found to be interactive with pharmaceutical medications as time

progresses. Proper training and ongoing professional education ensures that

registered medical herbalists are kept up-to-date on new scientific findings and as

prescribers of herbal medicine they are likely to experience adverse reactions in

practice and are therefore ideally suited to monitor and avoid possible interactions

between herbs and pharmaceutical drugs.

Hypericum perforatum (St John's wort) is widely taken to assist with mild to

moderate depression. There have been reports of reduction in efficacy of

pharmaceutical medications due to cytochrome P450 and P-glycoprotein induction

as a result of Hypericum perforatum ingestion159,160,161,162,163,164,165,166,167,168,169,170.

Hypericum perforatum is therefore contraindicated where patients may be

concomitantly administered several narrow therapeutic index drugs, including

cyclosporine171,172,173 , tacrolimus165,174, amitriptyline175, digoxin176,177 , indinavir 178,179, warfarin140,166 , simvastatin167, atorvastatin168 and others119,154,180. Interaction

is also suspected but more contentious for oral contraceptives

(ethinylestradiol/desogestrel)181,182,183,184, loperamide185, and selective serotonin-

reuptake inhibitors140,186,187.

Concurrent use of drugs and phytomedicines with very similar pharmacological

actions may produce an additive or synergistic effect145,188,189. The efficacy of herbal

medicines may also be enhanced or inhibited by concurrent drug medication such as

antibiotics120.

Piper methysticum (kava) has achieved popularity through its action as a mild

sedative and its subsequent use as an anxiolytic. In 1993 in Germany, where it is

prescribed by doctors, 547,000 units of kava-containing preparations were sold190.

Four case reports have suggested that the herb could have an anti-dopaminergic

action, an action also suggested by in vitro studies190,191.


27

Hypersensitivity reactions

There have been reports of hypersensitivity reactions to several plants; the

frequency of reports is probably increasing due to the increased public consumption

of herbal medicines. Causal factors include alterations in metabolising

enzymes145,192,193,194,195,196,197, allergic reactions198,199,200,201,202,203,204,205,206,207,

adversity to ethanol present in the phytomedicine preparation208,209,210,211; and

idiopathic sensitivities212.

The Apiaceae (formerly Umbelliferae) and spice plants, including Cinnamomum spp

(cinnamon)213,214, have been the most often implicated with sensitivity reactions. So

too have herbs Matricaria recutita (chamomile)215,216 and Tanacetum parthenium

(feverfew)217,218 from Asteraceae (formerly Compositae) botanical family. It is likely

that reaction is due to idiosyncratic causes, rather than overt toxicity. Plants from the

Apiaceae family can, after ingestion with simultaneous exposure to sunlight,

potentially cause a phototoxic reaction due to their furanocoumarin content219,220.

This highlights the need for careful history taking in relation to allergies prior to

prescribing certain herbal medicines.

There have been reported cases of allergic type reactions to Echinacea purpurea/

angustifolia (echinacea)203,221. This is a classic example of an adverse reaction due

to an individualised sensitivity to the Asteraceae family. Such a reaction is rare and

appears to occur more often in atopic individuals. A careful clinical history performed

by a qualified herbalist can evaluate the possibility of such an adverse event

occurring.

Contraindications

A number of herbs can cause undesirable side effects in some instances. In general,

numerous clinical trials have shown these side effects to be either minor or

uncommon at correct therapeutic doses. Examples of these include:

i. Tannin-containing herbs which may inhibit absorption of some vitamins and/or

minerals222,223,224,225 e.g. Mentha piperita (peppermint) can inhibit iron

absorption 226.

ii. Saponins contained in some herbs can be gastric irritants227,228, e.g. Aesculus

hippocastanum (horsechestnut) and Gymnema sylvestre (gymnema).

iii. Glycyrrhiza glabra (licorice) can cause sodium and fluid retention and

potassium loss and is therefore contraindicated in people with high blood

pressure229,230.


28

iv. Panax ginseng (ginseng) can cause overstimulation - irritability, hypertension,

nervousness, diarrhoea, skin eruptions and insomnia if over-used231. This is

known as the “Ginseng Abuse Syndrome”.

v. Bitter herbs in high doses may cause some people to vomit232, e.g. Gentiana

lutea (gentian).

vi. Thujone containing herbs, e.g. Salvia officinalis (sage), Tanacetum vulgare

(tansy), Artemisia absinthium (wormwood), and Thuja occidentalis (arbour-

vitae), can cause central nervous system symptoms, in overdose, and should

be used with care in people with epilepsy. They can also cause

headaches233,234,235.

vii. Melissa officinalis (lemon balm) has the potential to inhibit thyroid function

and should be used with caution in persons with low thyroid function236,237.

viii. Echinacea spp and Zanthoxylum americanum (prickly ash) in some liquid

forms can cause tingling in the mouth and promote salivation which in high

doses can produce pharyngeal irritation and a choking sensation238,239.

ix. Fucus vesiculosis (kelp) is contraindicated in cases of hyperthyroidism due to

its enhancing effects on thyroid hormone production240,241.

x. Laxative herbs can cause griping and their abuse can lead to electrolyte loss

e.g. Cassia acutifolia (senna)228,242 and Rhamnus purshiana (cascara)228.

Chronic use of these anthraquinone containing stimulant laxatives such as

Cassia acutifolia can cause damage to the myenteric plexus resulting in

cathartic colon243.

Use of such herbs therefore needs to be monitored by a professional medical

herbalist.

Foetal and Infant Development

Plant products have been used to assist pregnancy and childbirth for centuries and

modern herbal medicine is sometimes used during the third trimester of pregnancy.

There are clear guidelines available in herbal materia medica for the use or

avoidance of herbal medicines during pregnancy and lactation. Articles cautioning

on the use of herbal medicines during pregnancy and breastfeeding have also been

published in a range of journals244,245,246,247,248,249,250,251,252,253,254,255.

In general, herbal medicines of concern in pregnancy have the potential to be either

abortifacient or teratogenic. There are a significant number of herbs that fall into one

or other of these categories including Mentha pulgeum (pennyroyal)228,256, Cytisus

scoparius (broom) due to its sparteine content228,257, Thuja occidentalis (thuja)235

and Anemone pulsatilla (pasque flower )258.


29

Risks due to specific physiology

Due to difference in body weights and compromised liver function, paediatric and

geriatric patients are more susceptible to adverse events (generally overdose) if

prescribed full adult dosages259,260. Dosage therefore needs to be determined and

monitored by a qualified medical herbalist.

Misidentification and substitution of species

There are multiple instances in the literature of herbal substitution such as Tussilago

farfara (coltsfoot)261,262,263 and Scutellaria lateriflora (skullcap)264,265 where adverse

events had been attributed to these particular herbs within a herbal product.

However when chemically analysed it was found that the herbs stated on the label

were not in fact present. Substitutions by entirely different plants, whether intentional

or not, were responsible for the observed effects. Reliable sourcing of herbal

extracts by a qualified medical herbalist for therapeutic use is fundamental to good

professional practice.

Incorrect plant part

Inadequate knowledge of the correct plant part/s to be used therapeutically can

result in ingestion of a plant part that is toxic, or a different physiological response to

that expected by use of the correct plant part. These types of adverse reactions are

rare, although some cases have been reported266,267,268,269,270. With adequate

training in herbal medicine and botanical examination and verification by supplier

companies, correct plant parts are able to be clearly identified, differentiated and

appropriately prescribed.

Incorrect administration and self-prescription

Some herbs have been deemed safe for external use, but not internal use (e.g.

Arnica montana (arnica), Aconitum napellus (aconite).

Symphytum officinalis (comfrey) is used externally to treat soft-tissue and bone

injuries and internally was traditionally indicated to treat stomach ulcers, hiatus

hernia, irritable bowel syndrome, ulcerative colitis, and a range of respiratory

conditions, including bronchitis and pleurisy17,271. Internal usage has been restricted

in some countries following several case reports of hepatic veno-occlusive

disease272, which has been linked, correctly or otherwise273, to the presence of

pyrrolizidine alkaloids (PAs). Some types of PAs are known to be hepatotoxic

although if they are present at all in Symphytum their levels have been found to be

low273,274. The rootstock has much higher levels of PAs than the leaf275, and until

clarity has been achieved most professional herbalists have opted not to use root

preparations internally.


30

Self-prescription of herbal medicines is common and the public has access to a wide

range of OTC products containing herbal medicines. Although the majority of herbs

are safe when used correctly they can be misused and result in harmful

consequences. There are examples of health problems resulting from overuse of

OTC products276. There were four cases reported in 1989 of women who were using

commercial herbal preparations, who went on to develop liver disease264. Two of the

cases were co-medicating with pharmaceuticals. Apart from the issues with suspect

OTC products a registered medical herbalist would have recognised early signs of

liver dysfunction and taken steps to investigate the cause(s).

Physical dependence on herbal medicines is not common but can potentially occur.

Medical herbalists are vigilant concerning potential physical dependence on some

herbal medicines, particularly those with psychoactive properties, e.g. Piper

methysticum (kava), Valeriana officinalis (valerian) and Panax ginseng (ginseng).

Use of psychoactive herbs without the supervision of a suitably qualified practitioner

is undesirable, not least because overdosing for some of them has been

reported231,277,278.

Risks associated with poor product quality

Factors that can contribute to poor quality herbal products include:

contamination – potentially toxic microorganisms such as E coli, Staph aureus

and Pseudomonas aeroginosa, and fungal metabolites such as aflatoxins and

ochratoxins in medicinal herbs279

potentially toxic and allergenic ginkgolic acids have been found in commercial

Ginkgo products 280,281 at levels higher than the maximum specified by

German Commission E282,283.

adulteration – at the height of popularity of kava for treating anxiety it appears

that kava root, which has a long growing time, was adulterated with plant

parts such as stem peelings, to meet demand. This may have led to the injury

associated with some of the kava products reported284. Many other instances

of adulteration of herbs with drugs or cheaper plant species have been

reported in the literature.

substitution - Teucrium spp. have been found in several commercial products

purporting to contain Scutellaria lateriflora (skullcap) the latter being

undetectable in the preparation264, 285. Teucrium spp. are associated with

hepatoxicity286.


31

sub-standard raw materials - an analysis of the quality of Matricaria recutita

(chamomile), a commonly used herbal tea, and widely sold commercially,

revealed variable quality of flowers. In one study half of the samples lacked

enough of the active essential oil to be effective287. To preserve the volatile oil

flowers need to be processed properly soon after harvesting. Growing

conditions and geographical location can also influence oil quality288,289.

poor manufacturing practice – failure of some manufacturers to follow Good

Manufacturing Practice principles can have serious patient safety

consequences. Extracts and therapeutic efficacy can vary with the solvent

system used290. Bio-availability of actives can also vary enormously

depending on manufacturing methods. Garlic preparations varied 3 - 94% in

the available active constituent, allicin, across 24 different brands291, 292.

mislabeling - Chinese herbal medicines sold in New Zealand were found to

contain pharmaceutical agents, sildenafil or tadalafil that were not disclosed

on the label293. Failure to state the correct botanical species or plant part

used is also relatively common.

Table 3: Potential factors affecting quality of CAM products (Reprinted by kind

permission of Wardle, 2008)Error! Bookmark not defined.

Factor affecting quality Example

Substitution

It is estimated that deliberate substitution of Namibian Devil’s Claw (Harpogophytum procumbens) with cheaper Angolan Harpogophytum zeyheri – a safe yet therapeutically far less effective substitute – may account for 50% of total imports of this herb

294,295.

Not all substitution may be intentional. In Canada Siberian Ginseng (Eleutherococcus senticosus) was initially classed as toxic after being accidently substituted in some products due to a combination of misinterpretation of its traditional name Wu-Jia-Pi and poor quality control by product manufacturers

296.

Ecology (Growing Area)

The essential oil of Basil (Ocimum basilicum) may exhibit different chemotypes depending on area grown. Basil essential oil grown in Madagascar, Comoros, Seychelles and areas of Thailand exhibits higher levels of methyl chavicol – a known skin irritant and carcinogenic agent

297.

Thyme (Thymus vulgaris) may exhibit any one of six major chemotypes with differing chemical constituents – all with very different therapeutic applications – depending on area


32

grown and growth stage at which it is harvested

298,299.

Tribulus terrestris, a herb often used in treatment of male infertility and menopause, demonstrates significantly different chemical profiles depending on geographic location the material is sourced from. Research suggests that many markers of quality – including levels of the active steroidal saponin protodioscin – occur in herbal product sourced from Eastern Europe and Western Asia, but not that sourced from India, China or Australia

300.

Part Used Evidence suggests that root parts are more effective and less allergenic than aerial (leaf) parts of Echinacea spp

301 yet most commercial

preparations sold in Australia continue to use the cheaper aerial parts or a combination of parts which leads to wide variations in markers of active compounds

302.

Only standardised Ginkgo leaf tip extract from a limited amount of suppliers is used clinically in Europe as imported crude leaf has been found to contain high quantities of therapeutically inactive leaf and stem material

303.

Variant used Glucosamine is sold in Australia in one of three major forms: glucosamine sulphate, glucosamine sulphate potassium and glucosamine hydrochloride

304. Only

glucosamine sulphate at doses of at least 1500mg daily has demonstrated efficacy in trials

305. More than half the supplements

available in Australia are of the cheaper, ineffective glucosamine hydrochloride variety

304.

Manufacturing process Inactive ingredients used in manufacturing process may render active constituents unabsorbable and therefore ineffective. An investigation of commercially available Coenzyme Q10 supplements in New Zealand found marked differences in bioavailability despite similar labelled doses due to variation in excipients used

306.

The proportion and type of solvents used in the extraction of herbs will determine amount of therapeutic agent extracted

307.


33

Contamination Some imported Ayurvedic and Chinese Medicines in Australia have been shown to have dangerous levels of heavy metal concentrations

308. It is currently left to the

discretion of the manufacturer to test for these according to GMP. CAM products may be contaminated with pharmaceutical drugs. An Australian herbal libido tonic was the subject of an urgent withdrawal in 2007 after it was found to contain sildenafil

309.

(Reprinted by kind permission of Wardle,

2008)Error! Bookmark not defined.

Poor quality herbal products have a high risk potential. Whilst we understand herbal

products will in the future be regulated under the Natural Health and Supplementary

Products Bill, numerous potential difficulties with the implementation of this bill could

be avoided through regulation of the practice of Western herbal medicine under the

HPCAA.

Consumer and patient safety would be more adequately protected through regulation

of Western herbal medicine by allowing the development of a clear definition of

‘practitioner only’ herbs, enabling more appropriate regulatory scheduling of these in

the future by providing an avenue for the establishment of a ‘practitioner only’

category of product. Such regulation would also help ameliorate potential regulatory

inconsistencies of the bill and improve consumer and professional acceptability of

the new legislation.

It is of concern, however, that just as with the current 1981 Medicines Act, no clear

definition of what constitutes a natural health practitioner, is contained in the current

wording of the draft Natural Health and Supplementary Products Bill. Without such a

definition or register of natural health practitioners being held by the Ministry of

Health, the current loophole contained in the 1981 Act that enables anyone even

without proper training to prescribe and dispense herbal medicines in the context of

a ‘one-to- one consultation’, is likely to continue.

Regulation would need to include the expertise of qualified medical herbalists as

they are familiar with the issues and are able to assess where products are

undesirable for OTC use. They will also be able to readily establish protocols for

assessing the quality of these OTC products.

Risks associated with practitioner performance

At the present time anyone in New Zealand, regardless of education or training, can


34

provide herbal medicine services to the public. Given all of the previously mentioned

factors, it is clear that there are substantial risks to public safety associated with this

situation.

Lack of/or inadequate education and training, and consequent deficiencies in herbal

medicine clinical practices may result in the following:

misdiagnosis and poor patient management;

unnecessary or ineffective treatment;

treatment causing adverse reactions;

failure to identify adverse reactions and to take appropriate remedial action;

aggravation or progression of a condition;

failure to identify conditions requiring referral;

adverse reactions from herb/drug interactions;

adverse reactions due to ignorance of contraindications

failure to ensure quality of herbal products prescribed

There are examples of poor practice on the part of complementary therapists

overseas. For instance, in Australia a Newcastle naturopath who attempted to treat a

child with a congenital heart abnormality, advising against medical surgery was

charged with manslaughter when the child died88.

In New Zealand the case of Ruth Nelson, who is not a qualified medical herbalist,

although she used herbs as part of her treatment, “misdiagnosed” a squamous cell

carcinoma leading to a long delay in appropriate treatment for the patient and

prolonging the course of the disease and its treatment and ultimate death of the

patient310. The doctors who reported this case have argued that self regulation of

CAM practitioners is “inadequate” and that statutory regulation should be considered.

3.3.2 Nature and severity of risk to the wider public

The most significant risks from Western herbal medicine to the wider public are:

self-prescription of over-the-counter products that are inappropriate for the

condition being treated

self-prescription of over-the-counter products combined with medications for a

chronic or acute condition

self-prescription of products obtained via the internet that may contain

pharmaceuticals or toxic substances

availability of herbal products of poor quality due to substandard

manufacturing practices and inadequate regulation


35

prescription of herbal medicines by health practitioners of other modalities

untrained in herbal medicine practice

A risk of harm to the wider public also exists when inadequately trained practitioners:

treat patients with serious infectious disease inappropriately, with the potential

outcome of disease transmission to family, friends, colleagues or the wider

community

fail to treat adequately, or refer, patients with serious illness, leading to

progression of illness and consequent negative impact on family and others,

and increased costs to public health

failure to match the patient’s clinical symptoms and diagnosis to appropriate

herbal prescriptions, thus compromising their effectiveness and/or safety.


36

4. Criterion C

Is it otherwise in the public interest that the health services be regulated

as a health profession under the Act?

4.1 Is it in the public interest?

It is in the public interest that herbal medicine be regulated as a profession under the

Act for the reasons stated above.

4.1.1 Consumer Protection

As with all health care professions, there is a strong presumption of public interest in

ensuring that those who present themselves as medical herbalists have appropriate

training and that consumers are able to identify the level of competency of a

practitioner. A large and increasing number of people utlilise the services of medical

herbalists, naturopaths and other health practitioners who prescribe herbal

medicine23 and it is therefore appropriate that they are registered and subject to the

competency assurance provisions provided under the HPCA Act. The public has a

clear right to know that their health care provider fulfils the expectations of

competency in their professional scope of practice and that of prescription of herbal

medicine. Regulation of medical herbalists can be seen as a reflection of a modern

healthcare system responding to public interest and public health requirements.

The majority of medical herbalists practise autonomously in individual sole-

practitioner situations. There is little scope for supervision or support for those that

choose not to be part of a professional body such as NZAMH.

Practitoners who choose to belong to NZAMH are bound by rules and ethical

guidelines. However, there are a significant number of practitioners (naturopaths,

other health professionals) who prescribe herbal medicine products, some with

inadequate training that are not members of NZAMH or other professional bodies.

These prescribers of herbal medicine may practise in health stores, chemists, sole

practice, under different titles and practice outside of the established NZAMH rules.

Without guidance of a strong professional code of conduct these practitioners are at

liberty to exploit vulnerable or isolated members of the public, financially or otherwise

and due to the autonomous nature of practice have the potential to cause harm as

described above.

Members of other health professions such as midwifery and chiropractic are also

known to utilise herbal medicine in their practices. These practitioners have very little

formal training in herbal medicine, if any, and as such are practicing outside their


37

scope of practice and putting consumer safety at risk. The public have a right to

know their primary health care practitioner is appropriately qualified to use their tools

of trade, which can only be guaranteed through statutory regulation and registration

of practitioners.

Herbal medicine and appropriately qualified and regulated herbal medicine

practitioners are of undoubted benefit in contributing to the treatment of illness and

the maintenance of health and vitality in the general community, but without

regulation there is very limited consumer protection.

4.1.2 Regulation of Herbal Medicines

At present, some useful herbal ingredients are scheduled as prescription medicines

because they are not considered safe when self-prescribed by consumers. Products

containing these ingredients need to be used under the supervision of an

appropriately trained health professional. At the present time the nonsensical

situation exists where these prescription rights apply only to general practitioners

and/or pharmacists, neither of whom receives any significant education in the

prescription of herbal medicine during their training.

In addition to the above scheduled herbal ingredients, there are several medicinal

herbs available for practitioner use in other countries (e.g. Britain) that are currently

unavailable to herbal medicine practitioners in New Zealand. A working group was

established with Medsafe in 2009 to identify herbal medicines that could usefully be

scheduled and thus available for prescription only by appropriately qualified medical

herbalists; however this process stalled when our profession was required to re-

apply for regulation.

The advent of the Natural Health and Supplementary Products Bill provides the

opportunity to establish a functional ‘practitioner-only’ category of herbal products,

but this will be practicable only if herbal medicine is a regulated profession. It is not

currently possible to allow medical herbalists to prescribe these substances because

they do not belong to a regulated profession to which 'prescribing rights' can be

granted. Regulation under the Act would allow for medical herbalists to prescribe

these products where there is a clear indication that their use would benefit patient

health.

Regulation of herbal medicines and medical herbalists would also allow the provision

of enforceable guidelines relating to conservation and biodiversity issues. There is

growing concern that the expanding herbal medicine market and its commercial

potential poses an environmental threat due to over-harvesting of raw materials311.


38

There are also issues around herbal medicine practitioners using endangered

medicinal herbs. Whilst this is discouraged by NZAMH and the educational

institutions through education regarding those plants under threat, without regulation

there exists no mechanism to encourage or enforce this across the board.

Panax ginseng (Korean ginseng) for example, is a herb in high demand that is used

traditionally to improve a wide range of health problems. (The name Panax derived

from the Greek word “panacea” reflects its traditional status as a cure-all.) It is the

root that is harvested for medicinal use and therefore the whole plant is destroyed

when it is taken from the wild. In addition, as increased demand raises the premium

paid for ginseng products the incentive to substitute it with other similar species

increases as does the associated risk of health problems311,312,313.

4.1.3 Integrated Health Care

Regulation of herbal medicine would substantially improve the methods of how

integration of herbal medicine is currently occurring in the New Zealand health care

system, improving safety and increasing consumer choice, outcomes, and consumer

satisfaction, and has the potential to reduce health costs and over-use of

medications.

A New Zealand survey of herbal and naturopathic practitioners86 reported that

medical herbalists and naturopaths receive referrals from a range of mainstream

health providers on a regular basis. These referrals primarily occur informally via the

patient and without formalised procedures. This word-of-mouth patient mediated

method of referral poses a potential risk for misinformation to be communicated by

the patient to either practitioner and compromises safety (particularly in drug-herb or

drug-nutrient interactions) and effectiveness due to lack of access to diagnosis and

treatment information between practitioners86.

In a regulated, integrated environment whole practice research could be undertaken

to effectively investigate outcomes of clinical practice as opposed to the efficacy of a

single herbal medicine under narrow parameters that does not reflect use of herbal

medicine in practice314.

Whole practice research (whole systems research) is the study of complex CAM

therapies at the systems level, as opposed to single-agent medicines; it moves

beyond randomised controlled trials (RCTs) to more adequately evaluate the whole

practice of a particular modality, and is more relevant to herbal and naturopathic

clinical practice315.

The National Herbalists Association of Australia (2013) submission to the Review of


39

the Australian Government rebate on private health insurance for Natural Therapies

cited 12 studies (pp.20-21) that examined health outcomes associated with

naturopathic care (which includes herbal medicine) using whole practice research316.

The predominant benefit of integration in terms of public health care and health

policy is perhaps best outlined in a 2001 article that featured in New Zealand

General Practitioner journal317.

In this article it was reported that Dr. Gerard Bodeker, senior clinical lecturer in public

health at Oxford University and Chair of the Commonwealth Working Group on

Traditional and Complementary Medicine, stated that the utilisation of

complementary health systems leads to cost savings via lowering the use of health

services alongside a decreased demand for insurance company payouts. He went

on to say that governments are looking to form relationships with Complementary

Medicine as part of health sector improvement and reform, but in a situation of

scarce resources political will is needed to integrate the Complementary Health

sector317.

The World Health Organisation has expressed the desire to integrate CAM

modalities into existing national health care systems and requested that increased

provision of CAM services be made available to the public318.The Health and

Independence Report (2008)319 and the 2011/12 Health Targets320 outline several

areas having priority for health improvement in New Zealand in which herbal

medicine can play a significant therapeutic role:

• reducing the harm caused by smoking

• improving nutrition, increasing physical activity and reducing obesity

• improving oral health

• improving mental health services

• reducing hospital admissions

• improving diabetes services

• improving cardiovascular services

More recently, the WHO Traditional Medicine Strategy 2014-2023321 for the next 10

years has been developed in order to foster appropriate integration, regulation and

supervision to promote the safe and effective use of traditional and complementary

medicine (T&CM) practices in expansion of health care.

In order to achieve this goal three strategic objectives are required:

1) building the knowledge base and formulating national policies;

2) strengthening safety, quality and effectiveness through regulation;

3) promoting universal health coverage by integrating T&CM services and self-health


40

care into national health systems.

4.1.4 Cost Effectiveness in Healthcare

Herbal medicine and other CAM modalities have the potential to save the health care

system a significant amount of money through reductions in direct health care costs.

Most current studies indicate that CAM patients have significantly lower costs and

are much less likely to require hospitalisation in their lifetimes88Error! Bookmark not

defined..

A 2005 Smallwood Report focused on the economic benefits of CAM322. It looked at

the benefits in three centres in the UK where GPs work with CAM practitioners under

the National Health Service (NHS). One of these centres, the Glastonbury Health

Centre, included herbal medicine as one of five therapies used. Other therapies

included: osteopathy, acupuncture, massage and homoeopathy.

Glastonbury Health Centre had offered free access to CAM therapies for patients in

a three-partner GP practice since 1992. Research undertaken since 1990 provided

good evidence that CAM contributed to health improvements including reduced

waiting lists and also significant cost savings. Sixty percent of those patients referred

for CAM therapy had musculoskeletal complaints; a third were referred because their

health problem wasn’t responding to conventional care and two-thirds had a severe

health problem.

Eighty-five percent of patients reported improvement in their condition and

practitioners reported that 50% showed marked improvements. In patients suffering

from short term, more severe musculoskeletal and psychosocial conditions, results

were particularly good; also CAM therapies were found to improve the health and

well being of patients with milder conditions and to encourage positive changes in

lifestyle.

Cost savings included a drop in visits to GPs by about a third and the largest

reduction was amongst those patients who were the most frequent users of GPs

prior to referral. Prescription use fell by about 50% and those who were the heaviest

users had the greatest reduction. There was also a reduction in secondary referrals

such as physiotherapy and X-rays. Estimates made by the Glastonbury Centre were

that CAM service could be expected to generate a sufficient reduction in

conventional care expenditure to cover its costs.

In summary, the Smallwood Report stated that CAM therapies were beneficial

because:


41

1) CAM therapies could be used to treat conditions, both physical and psychological,

that would otherwise not be satisfactorily treated within the standard NHS setting -

i.e. they fill the “effectiveness-gap”. These conditions related to pain both acute and

chronic and included:

joints (osteo- and rheumatoid arthritis)

headaches/migraines

anxiety stress and depression;

”ill-defined” chronic conditions

skin conditions, notably eczema.

2) They provided cost savings through less expensive treatment, saving 50% on

prescriptions and a third on the cost of GP visits. Visits to secondary care services

were markedly reduced. A costing was presented for St John’s wort comparing it to

the current conventional equivalent. Antidepressants in 2004 cost the UK £400

million annually, with each prescription costing £13.82. St John’s wort costed out at

82p a week at that time. These cost savings were refuted by Ernst (2006)323 however

the report on cost effectiveness of complementary medicines carried out by the

University of Western Sydney Australia, and published in 2010 compared favourably

with that of the Smallwood report in the UK. The Australian study found herbal

prescription in that country to be less expensive than the pharmaceutical equivalent.

The average cost per day of St John’s wort (at a dose of 900mg per day) in 2009

was 17 cents compared with estimated cost of 57 cents per day to the Australian

government for antidepressants dispensed in the same year. This cost did not

include prescription charges of $31.30 or $5.00 for those with a concession324.

Effective CAM treatments are likely to cost less than conventional ones, especially in

the case of herbal medicine. Where conventional and CAM therapies may be used

together the initial costs may be greater, but this would likely be offset by a reduction

in treatment time required and costs related to people having less time off work. This

cheaper form of healthcare that is out-of-pocket expenditure empowers individuals to

undertake self-care and healthy lifestyle choices and is likely to reduce

pharmaceutical expenditure and curtail rising health costs.

3) CAM therapies can make a significant contribution when used in low socio-

economic areas because these are the populations particularly affected by

psychosocial and chronic health problems and who also have less ability to access

these therapies.

The Smallwood Report318 also recommended increased funding into the research of

efficacy of CAM therapies, restricting the use of CAM therapies to those properly

trained and the early establishment of statutory regulation for several CAM therapies

including herbal medicine.


42

Secondary criteria 5. Criterion 1

Do existing regulatory or other mechanisms fail to address health and

safety issues arising from the practice of the profession?

5.1 Existing Regulatory mechanisms

5.1.1 The Health and Disability Commissioner Act 1994 and the Code of Health

and Disability Services Consumers’ Rights

The Health and Disability Commissioner Act (HDCA) 1994, and Code of

Health and Disability Services Consumers’ Rights (Code of Rights)

establishes the rights of consumers, and the obligations and duties of

providers of health and disability services.

The Code of Rights extends to any person or organisation providing, or

holding themselves out as providing, a health service to the public or to a

section of the public - whether that service is paid for or not.

The Code of Rights therefore covers both statutory registered and

unregistered health professionals and brings a level of accountability to all

those who may be considered outside the mainstream of medical practice,

e.g. medical herbalists, naturopaths, homoeopaths, or acupuncturists. The

difference between statutory registered and unregistered health practitioners

arises when the Health and Disability Commissioner upholds a complaint

against them.

A complaint against a registered health professional under the Health

Practitioner’s Competence Assurance Act can be referred to the appropriate

registration authority for review, or to the New Zealand Health Practitioners

Disciplinary Tribunal for disciplinary proceedings, however where the

complaint concerns a non-registered practitioner the principal avenue for

further action is through the Human Rights Tribunal.

Any person in New Zealand can call themselves a CAM practitioner or

medical herbalist irrespective of adequate education. In a case of

misdiagnosed squamous cell carcinoma treated for 16 months by an

unregistered CAM practitioner it has been argued that self-regulation of so-

called CAM practitioners is inadequate and that they require closer scrutiny

and that statutory regulation is an avenue for achieving this. The authors

argued that the HDCA is limited in its ability to prevent such cases occurring

and that there is no HPCAA-equivalent statute regulating CAM practitioners’

competency and fitness to practice and that this is a risk to the public310.


43

5.1.2 The Human Rights Review Tribunal

The Human Rights Review Tribunal is a statutory body that deals with cases

brought under the Human Rights Act 1993, the Privacy Act 1993, and the

Health and Disability Commissioner Act 1994.

The Human Rights Review Tribunal can award damages, and has the power

to make various other orders such as requiring a health care provider to

undergo remedial training. However, neither the Health and Disability

Commissioner, nor the Human Rights Review Tribunal, currently have the

power to prohibit a practitioner from practicing, even if found to be in serious

breach of the Health and Disability Commissioner Act.

This situation was highlighted in the Human Rights Review Tribunal of New

Zealand case NZHRRT 9, concerning a ‘natural therapies practitioner’ who

was found in three separate Health and Disability Commissioner cases

(06HDC09325, 06HDC07873 and 06HDC09882) to have breached several

standards of the Code of Rights and who was labelled a ‘sexual predator’. In

their decision, the Human Rights Tribunal stated:

“…since [the defendant] does not belong to any professional body or

association that might have an interest in his conduct, much less any

ability to oversee his activities, there is nothing that can be done by

way of a disciplinary process or otherwise to stop him from purporting

to provide health care services to the public in future”325

This is despite the opinion of the Deputy Health and Disabilities

Commissioner that the defendant:

“…should not now, or in the future, practise as a counsellor or a natural

therapies practitioner”326

This situation is patently unsatisfactory. A health professional providing

services to the public who practises in a way that harms a patient should be

subject to appropriate disciplinary action, including where warranted,

prohibition from future practice. The fact that a health profession such as

Western herbal medicine does pose a risk of harm to the health and safety of

the public, as illustrated earlier in this document, requires that there is

recourse by the public to appropriate means of complaint and protection.

5.1.3 New Zealand Medicines and Medical Devices Safety Authority (MedSafe)

and the Medicines Act 1981

MedSafe regulates herbal medicinal products (herbal remedies) under


44

Section 2(1) of the Medicines Act 327:

Herbal remedy means a medicine (not being or containing a prescription

medicine, or a restricted medicine, or a pharmacy-only medicine)

consisting of:

a) any substance produced by subjecting a plant to drying, crushing,

or any other similar process; or

b) a mixture comprising 2 or more such substances only; or

c) a mixture comprising 1 or more such substances with water or ethyl

alcohol or any inert substance

The Medicines Act Section 28 outlines special exemptions for natural health

practitioners from some of the requirements of the Act. These exemptions

relate to the provision of natural medicines classified as general sales

medicines to consumers.

These regulations within the Medicines Act are sufficient to cover false

advertising of efficacy of a herbal remedy and to some degree mitigate the

possibility of practitioners taking advantage of vulnerable consumers, however

there are significant regulatory limitations of the Act, as discussed earlier in

section 4.1.2.

5.1.4 Consumer Guarantees Act 1993 and Fair Trading Act 1986

The difference between the Fair Trading Act (FTA) and the Consumer

Guarantees Act (CGA) is, in general, the FTA covers claims about products

and services prior to sale and the CGA covers the quality of those products

and services after they have been bought.

The Consumer Guarantees Act protects consumers by specifying a series of

guarantees with respect to supply of goods and services for personal use.

Consumers have some recourse if goods and/or services are supplied that do

not meet reasonable expectations of quality. This act provides very limited

protection for consumers of herbal medicine products and services.

The Fair Trading Act prohibits what is called "misleading or deceptive

conduct, false representations and unfair practices". It also sets out when

information about certain products must be disclosed to consumers, and helps

ensure products are safe. This act provides some protection for consumers

with regards to false or misleading advertising, but is not concerned with

safety risk.


45

5.1.5 New Zealand Qualifications Authority

New Zealand Qualifications Authority (NZQA) ensures that New Zealand

qualifications are valued as credible and robust both nationally and

internationally.

NZQA awards the following qualifications which are currently considered to

provide sufficient training and education in the practice of herbal medicine to

qualify for professional membership of the New Zealand Association of

Medical Herbalists (NZAMH):

Diploma Herbal Medicine (level 6)

Diploma in Naturopathy and Herbal Medicine (level 7)

Bachelor of Naturopathy (level 7)

Bachelor of Naturopathic and Herbal Medicine (level 7)

Bachelor of Natural Medicine (level 7)

From 2020 only graduates and new members that hold a bachelor degree will

be accepted as professional members.

A NZ survey of medical herbalists in 2011 found that 57% of NZAMH

members at that time held a bachelor degree or higher qualification. In 2014,

68% of surveyed NZAMH members held a bachelor degree or higher with

some (24%) having undertaken a conversion programme from diploma to

bachelor degree offered through an Australian university. From 2013 onwards

the majority of graduates have held a NZ bachelor degree328.

One or more of the above qualifications are provided by three different

educational institutions. There has been one additional programme delivered

by a herbal college in New Zealand that has not wished to be accredited by

NZQA, yet graduates have been previously accepted as professional

members by NZAMH. This qualification no longer meets NZAMH education

standards and is currently in the process of being taught out. NZAMH will

continue to accept graduates of this Diploma in Herbal Medicine as

professional members until December 2015 when the last of the students are

expected to have completed.

Statutory regulation may necessitate practitioners having an NZQA

recognised qualification to qualify for registration. It is also the Association’s

wish to have some form of external assessment established that allows

practitioners from overseas and those without a NZQA qualification to prove

their competence and thus qualify for registration.


46

NZAMH considers that it is essential to maintain education standards and to

provide breadth and depth of herbal medicine education to ensure the health

and growth of the modality.

5.1.6 Criminal and Common Law

Criminal law is complaint-based and retrospective in effect. It usually offers

redress only in the most serious complaints, such as grievous bodily harm

and assault, and it is often difficult to gain a conviction. Criminal law and

litigation proceedings frequently pose further trauma to complainants and the

costs for private litigation are often prohibitive, making most complainants

unwilling to proceed.

This fails to address preventative health and safety issues. Indeed, even a

conviction does not restrict or prohibit a practitioner from continued practice.

5.1.7 ACC legislation

Current ACC legislation may restrict complainant’s rights to redress under

common law for medical misadventure. However without regulation medical

misadventure on the part of a medical herbalist falls outside the scope of

ACCs medical misadventure provisions’ leaving the injured party restricted in

their avenues for redress329.

5.1.8 Convention on the International Trade in Endangered Species of Wild

Fauna and Flora

New Zealand is a signatory to the Convention on the International Trade in

Endangered Species of Wild Fauna and Flora (CITES).

It is acknowledged by NZAMH that some plant species traditionally used in

herbal medicine practice are no longer acceptable for use in contemporary

healthcare due to the species being endangered or threatened in the wild.

International trade in species on CITES Appendix I is banned. There are no

plants on this list used in the practice of Western herbal medicine in New

Zealand.

International trade in species on CITES Appendix II is allowed, subject to the

relevant export and import permits and other authorisations being obtained.

CITES Appendix II species used in Western herbal medicine include, among

others, Hydrastis canadensis (golden seal), Panax quinqefolius (American

ginseng), Panax ginseng (Korean ginseng), Picrorrhiza kurroa (Picrorrhiza)

and Prunus africanum (pygeum)330.


47

There are however many plant species considered ‘at risk’ that are not subject

to any trade restrictions. These include the widely used medicinal herbs

Echinacea spp.(echinacea), Ulmus rubra (slippery elm) and Euphrasia spp.

(eyebright)331.

Using product derived from endangered and at risk species in healthcare

practice is against the broader public interest. Unscrupulous manufacturers

and practitioners are able to use at risk species without legal impediment and

as an unregulated profession, there is little scope for redress. Regulation

would provide the possibility of censure should there be a breach of the code

of ethics regarding endangered and at risk species.

Many of those plants under threat are now grown commercially for medicinal

purposes e.g. Hydrastis canadensis and Echinacea spp. Ethical

manufacturers and suppliers will do their utmost to ensure they are using

plants that do not put the endemic varieties at risk.

5.2 Product Regulation

As previously discussed in section 4.1.2, herbal medicine product regulation is

presently unsatisfactory and public safety is ineffectively safeguarded. New

Zealand is the only country in the developed world not requiring certification

under the code of Good Manufacturing Practice, for manufacturers of herbal

medicines. The Natural Health and Supplementary Products Bill has the

opportunity to rectify this situation, and to allow for different classes of product

including ‘practitioner only’. Whilst practitioner only products are currently

available in the marketplace, unlike Australia, this designation has no legal

standing. Just as many drugs are inappropriate for consumer or patient self-

selection, so are a small number of herbal medicines. Once Western herbal

medicine becomes a regulated profession, this situation will be easier to

address in an appropriate regulatory framework.

5.3 Supervision by Registered Practitioners

There are no statutorily regulated professions that have appropriate

knowledge of, or training in, the profession of Western herbal medicine. Thus

supervision by registered practitioners of another profession would be

inappropriate and maintain the potential to put consumers at risk.

5.4 Self-regulation

Self-regulation refers to the controlling of a process or activity by the people or

organisations that are involved in it rather than by an outside organisation

such as the government.


48

Currently the profession of Western herbal medicine is self-regulated.

NZAMH is the only professional association specifically for Western herbal

medicine practitioners, although many are naturopaths trained in herbal

medicine. The impact of self-regulation has been limited as there is no

statutory requirement for practitioners to join this or any other regulating body

hence many practice herbal medicine outside any professional framework.

Therefore due to the voluntary nature of practice and professional

membership, under the current self-regulation provisions the unregulated

practice of herbal medicine appears fairly widespread resulting in increased

consumer risk and potential for harm.

6. Criterion 2

Is regulation possible to implement for the profession in question?

Western herbal medicine is a well-defined profession, with a clear professional

identity. NZAMH have developed well defined standards, competencies and a robust

code of ethics. These can be carried over for use under the Act.

6.1 Definition of the profession

Western herbal medicine is a traditional system of medicine which uses plants

for healing and is based on observation and experience passed down over

thousands of years. It also utilises modern scientific information and research

in phytomedicine and phytopharmacology, combined with the medical

sciences of anatomy, physiology, biochemistry, pathophysiology,

pharmacology and clinical assessment as well as the sciences of botany and

nutrition.

Medical herbalists practice within a traditional holistic framework of restoring

and supporting the inherent self-healing processes within each individual

patient and by treating the whole person rather than just a disease or isolated

part of the body.

Western herbal medicine practice blends scientific and traditional values,

thereby placing it in a unique and discrete position within the healthcare

sector.

Naturopathic practitioners unlike Medical Herbalists may or may not include

use of herbal medicines as a therapeutic agent. Many naturopaths are also

medical herbalists but not all, just as some medical herbalists are not

naturopaths depending on training. However despite lack of training there is

nothing to stop a naturopath or any other health professional from prescribing


49

herbal medicine currently.

NZAMH envisages that application for registration of Medical herbalists under

the HPCA Act would mean all practitioners who formulate, prescribe,

manufacture and/or dispense herbal medicines for the therapeutic treatment

of an individual would be included under the HPCA Act. The act of

formulating, prescribing, manufacturing and/or dispensing a herbal medicine

for therapeutic purposes to another person makes that prescriber a Medical

Herbalist.

6.2 Teachable and testable body of knowledge underpinning practice

The fundamental theories of Western herbal medicine upon which health

assessment and treatment are based, are coherent, teachable and testable.

NZAMH has in place minimum educational requirements for practising

medical herbalists and have proposed education standards for courses in

herbal medicine [Appendix 2].

Whilst incorporating mainstream health sciences including research methods,

there is a strong endeavour to retain the traditional philosophy that underpins

practice, i.e. the individual, patient-centred, holistic approach of medical

herbalists.

6.2.1 Qualifications

The NZAMH currently recognises Herbal Medicine courses provided by the

following NZQA approved educational institutions:

Lotus Holistic Centre

South Pacific College of Natural Medicine

Wellpark College of Natural Therapies

Graduates of the above colleges that include herbal medicine courses in their

qualifications, qualify for professional membership of NZAMH without any

requirement to sit subsequent assessments outside of these colleges.

These institutions each offer one or more of the following qualifications:

Diploma in Herbal Medicine (level 6) [being phased out by 2020]

Diploma in Naturopathy and Herbal Medicine (level 7)

Bachelor of Naturopathy (level 7)


50

Bachelor of Naturopathic and Herbal Medicine (level 7)

Bachelor of Natural Medicine (level 7)

NZAMH has a policy in place that by 2020 all new graduates accepted into

NZAMH from accredited colleges will have a minimum level 7 bachelor

degree qualification. Those colleges that currently offer a bachelor degree

provide bridging programmes for past diploma-level graduates to up-skill to

bachelor degree level.

The NZAMH, as part of an ongoing commitment to supporting quality and

effective herbal medicine education monitors the teaching institutions it

accredits by requiring an annual list of tutors and their qualifications. All tutors

of herbal medicine at accredited colleges are required to be members of the

NZAMH.

It should be noted that, due to the currently unregulated nature of the

profession, there are a number of unrecognised providers delivering lower

level courses outside of the NZQA level structure which purport to provide

‘professional’ level training in herbal medicine.

As a result ‘practitioners’ who lack sufficient qualifications and training are

currently able to practice in New Zealand and in doing so pose a potential risk

to the public and the reputation of bona fide practitioners. Practitioners who do

not belong to the bona fide professional body NZAMH have no requirements

for continuing professional development.

NZAMH recognises the qualifications of those who have been accepted as

members of The National Institute of Herbal Medicine in UK (NIMH) and the

National Herbalists' Association of Australia (NHAA).

Applicants who have not graduated from an accredited NZAMH course or

recognised professional association have their qualifications considered on a

case-by-case basis using a formal assessment process involving matching of

learning outcomes for qualification content, submission of case studies and

practice observation.

6.2.2 Standards in relation to conduct, performance and ethics

Quality Assurance (QA) activities within the NZAMH focus on structure,

process and outcome. QA activities in relation to regulation of medical

herbalists cover the following:

Structure


51

NZAMH sets standards for education of medical herbalists

NZAMH establishes requirements and fitness for registration of

medical herbalists

NZAMH maintains requirements for ongoing continuing education and

professional development

NZAMH keeps a register of registered medical herbalists

NZAMH has appropriate complaints and disciplinary systems

Process

NZAMH sets standards for education of medical herbalists using

experts in the field of education and the guidelines of the New Zealand

Qualifications Authority

NZAMH evaluates programmes for the education of medical herbalists

in New Zealand

Registration for membership requires each applicant to demonstrate

that he or she meets the following criteria that will be added to the

constitution in the near future where currently not included:

o has the prescribed qualification

o is competent to practise

o is able to communicate effectively with clients

o does not have a condition which may mean he or she is not able

to perform the functions required

o has not been convicted of an offence punishable by three months

imprisonment or more that reflects adversely on his or her practise

o is not under investigation or the subject of disciplinary

proceedings in New Zealand or overseas that reflects adversely

on his or her practise

o has not had a disciplinary order made which reflects adversely on

his or her practise.


52

NZAMH requires registered medical herbalists to adhere to the

NZAMH Code of Ethics (Appendix 3) and to the Health and Disability

Commissioner Code of Consumer Rights

NZAMH receives and investigates complaints about professional

misconduct and disciplines where necessary

NZAMH receives notifications about medical herbalists who may pose

a risk of harm to the public by practising below the required standard of

competence and acts where appropriate to ensure competence is

improved

NZAMH requires registered medical herbalists to undertake regular

continuing professional education and to keep a record of these

activities

o Annual practising certificates are issued by the NZAMH for eligible

practitioners who have undertaken sufficient continuing

professional education, in areas which must relate to the clinical

practice of and/or professional development of herbal medicine.

o When renewing annual practising certificates, each member must

furnish proof of having completed their continuing education

requirement.

Outcomes

NZAMH accredits teaching institutions and their programmes for the

education of medical herbalists in New Zealand.

NZAMH registers medical herbalists.

NZAMH sets standards in relation to conduct, performance and ethics.

NZAMH issues annual practising certificates to medical herbalists.

The current practising certificate must be displayed in the practitioner’s

clinic.

6.2.3 Enforcement of standards

Discipline

The NZAMH constitution outlines disciplinary procedures should a complaint

be made regarding a professional member.


53

Continuing professional development

NZAMH requires registered medical herbalists to undertake regular continuing

professional education (CPE) and to keep a record of these activities.

A points system is used to record CPE, to allow weighting with regard to the

type of activity/education undertaken. Annual practising certificates are issued

by NZAMH for eligible practitioners who have achieved a minimum of 30

points from activities that must relate to the clinical practice, research and/or

professional development of herbal medicine.

Code of Ethics

Members are required to declare their commitment to the code of ethics each

year on re-registration.

6.2.4 Professional titles used

Herbalist

Medical Herbalist

Phytotherapist

Clinical Herbalist

Western Herbal Medicine Practitioner

7. Criterion 3

Is regulation practical to implement for the profession?

Current NZAMH membership levels (235 professional members) are marginal for

supporting professional regulation owing to the current unregulated status. This

membership, however, is greater than that in 2007 when our previous application for

statutory regulation under the HPCA was accepted by the then Minister of Health,

when NZAMH had 182 professional members. Furthermore, considerable numbers

of practitioners who prescribe Western herbal medicine remain outside of existing

voluntary regulation and supervision structures. There are also two naturopathic

professional bodies some of whose members prescribe Western herbal medicine.

Under statutory regulation naturopaths and other practitioners who formulate,

prescribe, manufacture and/or dispense herbal medicine would be required to

undertake registration increasing the number of registered practitioners and in so

doing increase the modalities capacity to support regulatory costs.


54

Western Herbal Medicine could combine with other complementary integrative

medicine [CIM] professions under one CIM regulating authority. A CIM authority

could be responsible for a number of professions as suggested by the Acting Health

and Disability Commissioner in 2007332.

A CIM authority could include a number of professions such as Western herbal

medicine, aromatic medicine, Ayurveda, yoga therapy, naturopathy, Traditional

Chinese Medicine, acupuncture, massage therapy and homoeopathy. Another

possibility could be for all CIM modalities to share the same regulatory authority as

osteopathy and chiropractics (Allied Health) which would be more cost effective

while supporting consumer safety.

As regards the implementation and mechanics of the regulatory environment,

NZAMH has over the past several years been implementing policies and procedures

in line with several currently regulated professions.

Therefore, as with other health modalities it is thought that Western medical

herbalism has the capacity, policies and procedural capacity to transition

successfully to statutory regulation.

7.1 Alternatives to statutory regulation

7.1.1 Self-regulation

Western herbal medicine in New Zealand is at present self-regulated.

This allows any person, qualified or not, to advertise and practise as a medical

herbalist. In light of the safety concerns outlined in section 3, this is considered an

untenable situation.

The major limitation of self-regulation is that it is voluntary and has minimal or no

influence on those practitioners who choose not to participate. As discussed

previously, whilst self-regulation has been successful to some extent in relation to

the conduct of those herbal medicine practitioners who have chosen to be members

of NZAMH, there are many Western herbal medicine practitioners who choose not to

belong and are thus free to conduct themselves how they wish, and in doing so pose

a greater potential risk to the public. Some excerpts from a 2011 Australian Health

Ministers Council paper on Regulatory Options for a Natural Medicines Register,

highlight such challenges:

“The voluntary nature of professional association membership is also the major

disadvantage of self-regulation.


55

… it can lead to duplication of co-regulatory arrangements.

Exacerbating this, within any modality… there may be many different professional

associations a practitioner can choose from, limiting the financial and other

resources available to each one and confusing the public334.

It is clear that existing regulatory measures for Western herbal medicine practice are

insufficient to ensure standards of education and practice are maintained across the

profession.

Self-regulation is thus inadequate to protect the safety of the public or provide

assurance of professional standards of care for referrals from other health

practitioners88Error! Bookmark not defined.. Self-regulation therefore is an inappropriate

means of regulation.

7.1.2 Negative licensing

To improve the accountability of unregistered practitioners, the New South Wales

government developed a statutory Code of Conduct for unregistered practitioners.

The purpose was to remove individual health practitioners found guilty of gross

negligence or unscrupulous behaviour from practising and causing serious risk to

public health and safety333.

As applied in New South Wales Australia334, negative licensing may be a possibility

in the regulation of Western medical herbalists.

Negative licensing particularly targets334:

Practitioners who present a serious risk of harm to consumers because of

incompetence or impairment and

People who are unfit to practice because they repeatedly engage in unethical

or illegal practices.

“Disadvantages of the model are that while the existence of the code should of

itself have an educative and preventive impact, it also means individuals can set

up as practitioners with no necessary probity checks or qualifications. Action is

generally taken after harm has already occurred and generally relies on

complaints being made. This means there is strong reliance on public awareness

of the scheme and individual preparedness to make a complaint. The model also

relies on government for the adequacy of the resources it has to take action”334

Negative licensing is a reactive model that can only prosecute once harm has

occurred rather than a proactive model which may protect the public from sustaining


56

harm through development and enforcement of high practice training and

standards333.

Further the implementation of negative licensing would require the establishment of

a statutorily enforceable ‘code of conduct’ and in so doing, negative licensing simply

forms a variation in statutory regulation.

Currently negative licensing does not form part of the regulatory landscape for health

practitioners within New Zealand and would therefore require considerable legislative

and structural development in order to implement. Therefore development,

implementation and operation costs would significantly exceed possible benefits,

whilst outcomes would be less effective than existing statutory regulation structures

within the HPCAA.

7.1.3 Statutory regulation

Statutory regulation under the HPCAA is the established model for the regulation of

healthcare professions within New Zealand. As well as being applied to ‘main

stream’ health professions it has also been applied to a number of other

complementary and allied health professions for example chiropractics and

osteopathy.

Given that the practice of Western herbal medicine poses a similar risk to the public

as other regulated health professions statutory regulation is the appropriate tool for

the regulation of the profession.

Further, as with other health professions and in the interests of public safety, there is

a need to acknowledge the requirement for specialist skill sets and appropriate levels

of training in order to practice Western herbal medicine safely and effectively.

As a well-established model, statutory regulation has frameworks and operational

models/structures that can be, as with other professions, applied to Western herbal

medicine.

Statutory regulation could therefore represent the lowest implementation cost both in

terms of legislation and practical terms. Whilst it falls short of extending regulation

from the (current) regulation of title, to (the preferred) regulation of both title and core

practices, it provides the best model for increasing public safety given the limited

efficacy evident in the current self-regulatory model. The regulation of core practices,

that is formulation, prescription, manufacturing and/or dispensing of herbal medicine

based on Western herbal medicine philosophy could, and in fact should, be

legislated through the Medicines Act or future Natural Health and Supplementary

Products Act, which in its current wording, provides no clear definition of a Natural

Health Practitioner, a major inadequacy of the current Medicines Act.


57

In 2007, during the consultation process on the regulation of the profession of Herbal

Medicine under the Health Practitioners Competence Assurance Act 2003

(‘HPCAA’), the then Acting Health and Disability Commissioner agreed that it would

be in the public interest for Herbal Medicine to be regulated as a health profession

under the HPCAA, as it would provide tools to ensure the competence of

practitioners and the safety of consumers, although they questioned how Medical

herbalists could be distinguished from other health providers such as naturopaths

and traditional Chinese Medical Herbalists332.

Naturopaths who formulate, prescribe, manufacture and/or dispense herbal

medicines to all intents and purposes are Medical Herbalists as in NZ not all

naturopathic institutions have included herbal medicine as a dominant focus in

education.

Traditional Chinese Medicine (TCM) is a practice that often includes acupuncture as

well as indigenous Chinese herbs, animal parts and other substances. TCM is

furthermore based on a completely different conception and philosophy of biological

processes, diagnoses and treatment approaches to that of western herbal medicine

practice. Traditional Chinese medicines are mostly used in different dosage forms

from that of western herbal medicine. The two disciplines are therefore very different

from each other and would require separate regulation.

Within the current non-statutorily regulated environment there are no legally

enforceable means of ensuring public safety or the proper training and practice of

herbal medicine. This has resulted in inappropriately qualified and/or inappropriately

supervised practitioners of the modality with direct and potentially serious

implications for public risk and loss of confidence by both public and other health

professionals.

New Zealand Association of Medical Herbalists considers the current self-regulatory

framework to be insufficient to ensure public safety and that statutory regulation is

necessary.


58

Appendix 1

THE NZAMH CONSTITUTION [2010]

1. NAME

The name shall be the New Zealand Association of Medical Herbalists (1983)

Incorporated.

2. INTERPRETATION

In this Constitution except where a contrary indication appears:

‘Practise’ shall mean the provision of advice regarding treatment with Western herbal

medicine.

‘A.G.M’ shall mean ‘Annual General Meeting’ of the Association.

‘Association’ shall mean ‘New Zealand Association of Medical Herbalists (1983)

Incorporated’.

‘Committee’ shall mean ‘governing body of the Association’ as defined in Rule 12.

‘N.Z.A.M.H.’ shall mean New Zealand Association of Medical Herbalists (1983)

Incorporated.

‘President’, ‘Secretary’, etc. shall mean ‘President of the Association’, ‘Secretary of

the Association’, etc.

‘Year’ shall mean ‘financial year of the Association, as defined in Rule 23.

3. OBJECTS AND PURPOSE

(a) To maintain a Register of Medical Herbalists.

(b) To ensure that every person registered and given professional membership meets the following standards:

(i) They practise according to the Ethical Standards of the Association;

(ii) They have a proper understanding and knowledge of Herbal Materia Medica;

(iii) They have been adequately trained in the essential medical sciences and have had suitable clinical training and experience.

(c) To monitor the standard and quality of the teaching of Herbal Medicine (see

Schedule 4).

(d) To promote Herbal Medicine to the public and other health professionals.


59

(e) To represent members of the Association (and the cause of Herbal Medicine) in

respect of any legislation concerning Herbal Medicine, and make submissions to

the appropriate authorities on their behalf.

(f) To encourage/ provide ongoing professional education for members of the

Association.

(g) To publish and circulate a newsletter and any other material of interest to

members.

4. TRAINING STANDARDS

(a) The Committee shall monitor the standard and quality of the teaching of Herbal

Medicine theory and practice as carried out by the Educational Institutions that

teach Herbal Medicine, and are accredited by the Association.

(b) The Committee shall at its own discretion formally recognise the qualification

conferred by those Educational Institutions, which teach the theory and practice

of Herbal Medicine to a level which meets the Association’s standards.

(c) If the standard and quality of the teaching carried out by any Educational

Institution does not meet the Association’s standards then the Association shall

at its own discretion not recognise the qualifications conferred by any such

Educational Institution.

5. AFFILIATIONS

(a) In keeping with the objects and purpose of the Association, N.Z.A.M.H. may

affiliate with any other body or bodies that the membership sees fit.

(b) Branches of the N.Z.A.M.H. may be formed. The N.Z.A.M.H will represent these

branches.

6. MEMBERSHIP

Members of the Association shall be divided into 4 classes:

(a) Professional members - members practicing herbal medicine, including:

(i) Full or part time practitioners giving advice to clients, whether the client is

paying or not

(ii) Those involved in the formulation or manufacture of medicinal herbal

products for public consumption.

(iii) Those involved in the training or supervision of students in the practice of

herbal medicine.


60

(b) Associate Members – members who do not practise but have an interest in

herbal medicine, including:

(i) Educational Institutions.

(ii) Owners and/or employees of business retailing or wholesaling herbal

medicine, who do not provide herbal advice or recommend medicinal

herbal product to customers.

(iii) Other Individuals

(c) Student members – members who are studying toward a herbal medicine

qualification at an NZAMH recognized college.

(d) Fellow members – members of long-term standing who have distinguished

themselves in any branch of the profession OR rendered any conspicuous

service to the Association OR retired from professional practice after long

service to the profession

A Professional Member shall:

(a) Do nothing to bring Herbal medicine, or the Association, into disrepute.

(b) Shall have complied with a curriculum of training and passed examinations that

the Committee accept or prescribes;

OR

Fulfilled the education standards as set by the Committee

(c ) When renewing accreditation / practice certificates each year, each member

must:

(i) furnish proof of having completed professional education relating to the

clinical practice and professional development of herbal medicine, as

specified by the current Continuing Professional Education standards;

(ii) have paid the current annual subscription;

(iii) provide evidence of a current first aid certificate (in case of disability,

provide evidence of current training to instruct others in first aid) from an

NZQA provider.

An Associate Member:

(a) Must do nothing to bring Herbal Medicine, or the Association in disrepute.

(b) Must not practice herbal medicine.


61

A Student Member:

(a) Must do nothing to bring Herbal Medicine, or the Association, into disrepute.

(b) Will be in the process of completing a course at an NZAMH recognised

institution.

A Fellow Member:

(a) Must do nothing to bring Herbal Medicine, or the Association, into disrepute.

(b) The Association may elect as Fellow members of the Association anyone who

has distinguished themselves in any branch of the profession OR rendered any

conspicuous service to the Association OR retired from professional practice

after long service to the profession.

(c) If practicing herbal medicine, when renewing accreditation/practice certificates

each year must –

(i) Provide evidence of a current first aid certificate (in case of disability,

provide evidence of current training to instruct others in first aid) from an

NZQA provider.

7. REGISTRATION PROCEDURES FOR MEMBERS

Candidates for Professional Membership must:

(a) enclose the annual membership fee and a one-time only application fee with a

completed application form.

(b) attach photocopies of diplomas/ degrees in Herbal Medicine from their College of

Herbal Training and photocopies of other relevant qualifications. The said

photocopies must be certified as true copies of the original documents by a

Justice of the Peace, Public Notary or Barrister or Solicitor of the High Court of

New Zealand.

(c) If the application is declined the Committee may give an explanation as to why it

has been declined and the Committee will give an explanation as to the reasons

for declining an application if the applicant requests an explanation. The

committee may suggest further training or other appropriate action.

(d) If the Application is successful the applicant’s name is then put on the

Association’s Official Register. A properly signed and sealed certificate is

issued and may be displayed as evidence of Registration with the Association.

(e) The decision of the Committee is final and there is no right of appeal.


62

Candidates for Associate and Student Membership must:

(a) enclose both the annual membership fee and a one-time only application fee with a completed application form.

8. ASSOCIATION REGULATIONS

(a) No member other than a Professional Member shall utilise the name, goodwill or

facilities of the Association for monetary gain, to enhance personal reputation, to

solicit patients, or to obtain personal benefits.

(b) Only those on the ‘PROFESSIONAL’ Register may use the title ‘Registered

Medical Herbalist’ and ‘Registered with the New Zealand Association of Medical

Herbalists’. Approved abbreviation is MNZAMH.

(c) Members not on the ‘PROFESSIONAL’ Register may not use their membership

nor the name ‘Member of the New Zealand Association of Medical Herbalists’ or

any other variations of it for any purpose.

9. SUBSCRIPTIONS

(a) The annual subscription for individual members shall be fixed at the AGM.

(b) Any member whose membership subscriptions are in arrears for more then 3

months will have their names removed from the membership roll and may by

required to make a new application for membership should they wish to rejoin.

(c) If a member wishes to suspend membership they may apply for an exemption for

up to 3 years. They will not be issued with a practising certificate during this time.

(d) To enable membership to be maintained (including receiving the NZAMH

journal) the subscription for a Professional Member granted an exemption shall

be the same as that set for an Associate member.

10. COMPLAINTS, DISPUTES, DISCIPLINE

(a) If any member shall willfully refuse or neglect to comply with the provisions of the

Constitution/Code of Ethics or shall be guilty of any conduct which in the opinion

of the committee is unbecoming of a member or prejudicial to the interest of the

Association, the committee shall have the power by resolution to censure,

suspend or expel the member from the Association.

(b) The Association’s Committee will establish a complaints committee and if

necessary a disciplinary committee to carry out these procedures. (See

Appendix - Code of Ethics).


63

11. RESIGNATION

Any member may resign from membership by giving to the Secretary of the

Association notice in writing to that effect.

12. OFFICERS/COMMITTEE OF THE ASSOCIATION

(a) The Officers of the Association shall be the President, Vice President,

Membership Secretary, Correspondence/Minutes Secretary, Treasurer, Student

Representative and up to six others.

(b) The Officers of the Association shall be appointed at the AGM of the Association

each year. In the event of resignation of an officers(s), an acting officer(s) to fill

the position(s) until the AGM, shall be appointed by vote at a general meeting of

the Association.

(c) The entire management of the Association and its property shall be deputed to

the Committee. The Committee must inform all members of the Association

regarding proposed changes to its management of the Association and its

property in order that proper discussion and if necessary voting can be held

regarding important decisions.

(d) The Editor of the newsletter may be an ex officio member of the Committee if

she/he so desires.

(e) The Immediate Past-President may be an ex officio member of the Committee.

(f) Members of the Association may be nominated, seconded and elected to the

Committee at a General meeting of the Association, should a quorum of

members be present and voting, if deemed necessary.

(g) The Committee has the right to co-opt additional members of the Association to

attend its meetings or help in its functions, should the need arise. Such

appointments should however be on a temporary basis, and only after a majority

of Committee members deem it necessary to do so.

(h) Members may resign from membership of the Committee by giving to the

Secretary of the Association notice in writing to that effect at least fourteen days

prior to the date the resignation is to become effective.

(i) Members may be expelled from membership of the Committee by resolution

passed at a General Meeting of the Association excepting that this resolution

must have been specified in the meeting agenda and reasonable effort must

have been made at least twenty one days before the meeting to notify the

member or members to be expelled.


64

13. ELECTION OF COMMITTEE

(a) Nominations shall be called from all financial members within all branches of the

Association.

(b) Nominations may be only for Professional members excepting for the Student

Representative.

(c) Exceptions can be made when there is no professional member available for the

position and a student/ associate member, who may have special skills and who

is competent enough to undertake a particular duty, is available.

(d) Nomination for Executive positions and Committee members must be received in

writing at least forty eight days before the AGM. Nominations must include the

name of the nominator as well as a seconder and should be accompanied by a

profile of the nominee. Except in case of 12(f).

(e) Ballot papers will be sent no less than 30 days prior to the AGM. These will

include a brief profile of each proposed nominee.

(f) Voting will be finalised at the AGM after a final and definitive count of all votes.

(g) The Student Representative on Committee shall have been elected by the

student members.

(h) Appointment of the Committee shall be made at the AGM. Members may be

elected to vacant positions on the Committee at any General Meeting of the

Association.

(i) If there is no more than one nomination for each position on the Committee there

is no need to hold a postal ballot.

14. COMMITTEE MEETINGS

(a) A Committee Meeting may be called at any time by an Officer of the Association.

(b) Notice of any Committee meeting shall be given to every member of the Committee at least 48 hours before the meeting.

(c) At each meeting five (5) shall constitute a quorum.

15. COMMITTEE VACANCY

The position of a member of the committee shall become vacant if the member:

(a) Becomes of unsound mind or person whose person or estate is liable to be dealt

with in any way under the law relating to mental health.

(b) Resigns the office by notice of writing to the Association.


65

(c) For more than six months is absent without permission of the Association from

meetings of the Association held during that period.

(d) Ceases to be a member of the Association.

16. PERSONAL LIABILITY OF OFFICERS OF THE ASSOCIATION AND OF COMMITTEE MEMBERS

(a) No Officer of the Association shall be personally liable for any act or omission

(including negligence). The liability of such Officer of the Association shall be

limited to the assets of the Association.

(b) No member of the Committee shall be personally liable for any act or omission

(including negligence) concerning the management of the association. The

liability of such Officer of the Association shall be limited to the assets of the

Association.

(c) The preceding clauses shall not absolve any officer of the Association or member

of the Committee form taking proper care in paying full attention to their duties in

acting responsibly and with due diligence and where necessary obtaining proper

knowledge in seeking competent advice pursuant to the carrying out of their

respective office.

17. PROFESSIONAL INDEMNITY INSURANCE

The Committee may effect professional indemnity cover in such amount as the

Committee in its discretion deems appropriate for the Association and for all of the

members of the Committee against any liability (including statutory liability) which

may arise out of any act or omission in the course of the Committee’s conduct of the

business of the Association.

18. GENERAL MEETINGS OF THE ASSOCIATION

(a) General Meetings of the Association shall be called by the Committee:

(i) upon its own initiative; or

(ii) within sixty (60) days of receiving a request to do so, in writing

signed by 50% or more of the members of the Association.

(b) Items to be included on the agenda shall be given to the Secretary of the

Association not less than seven (7) days before the meeting.

(c) The Secretary of the Association, not less than seven (7) days before any

General Meeting of the Association, shall notify or make reasonable effort to

notify all members of the time, place, and date of the meeting. An agenda shall

also be available seven (7) days before the meeting.


66

(d) The quorum at any General Meeting of the Association shall be seven (7)

members.

(e) The chairperson at any general meeting of the Association shall be the President

or if he/she is not present the Vice President, followed by the Secretary, followed

by a nominated member of the Committee or if none are present some financial

member chosen by the meeting.

(f) Only Professional and Fellow members have the right to vote. If any issue

arises, directly pertaining to students, a motion may be formed at a General

Meeting to enable students to vote on this issue.

(g) Every Professional and Fellow member shall have one vote, and in the case of

equality of votes, the chairperson shall have a second or deciding vote. Voting

will be by ballot. Two or more persons shall be appointed as scrutineers. The

scrutineers shall not have a vote and should preferably be non-members.

19. ANNUAL GENERAL MEETING OF THE ASSOCIATION

(a) The A.G.M shall be held within the first 60 days following the end of the financial year (31st March) on a date determined by the Committee.

(b) A statement of Accounts and Balance Sheet shall be prepared and a copy shall be given to each member of the Association at or prior to the A.G.M.

20. BANK ACCOUNTS

The Funds of the Association shall be lodged with a Trading Bank or Savings Bank.

The bank books, cheque books, together with the Association’s Books of Accounts

shall be produced by the treasurer at each Committee Meeting.

21. INVESTMENTS

If the Committee so determines, any part of the funds of the Association may be

invested in the manner provided by the Trustee Act 1908 or any Act amending or

replacing the same.

22. CONTROL OF FUNDS

(a) The Association’s bank account shall be operated upon the signature of any two

Officers of the Association.

(b) All accounts shall be passed for payment by the Committee, payments under

$1,000 to be approved by two members of the committee, payments over $1,000

to be approved to two members plus the President.


67

(c) The Committee shall have power to borrow such amounts and on such terms as

it thinks fit, and to give security therefore and interests thereon such security as

the Committee may determine (in accordance with Rule 12(c).

23. FINANCIAL YEAR

The financial year of the Association shall end on the 31st March each year, to which

date the accounts shall be balanced.

24. ALTERATION OF THE CONSTITUTION

These rules may be rescinded, altered or added to by an ordinary resolution passed

at a General Meeting of the Association, excepting that the proposed repeal,

alteration or addition must have been specified in the agenda and that all financial

voting members have been notified twenty one (21) days prior to the meeting.

25. WINDING UP

(a) The Association shall be wound up in accordance with the Incorporated Societies

Act 1908 or any Act amending or replacing the same.

(b) Upon winding up, any Association assets remaining after payment of all

Association liabilities shall be disposed of in such a manner as passed by

resolution at the General Meeting convened for the purpose of winding up the

Association.

SIGNED BY THREE OFFICERS OF THE NEW ZEALAND ASSOCIATION OF MEDICAL HERBALISTS (1983) INC.

1. PRESIDENT:

Name Date:

Occupation

Address


68

2. OFFICE HOLDER Position:

Name Date:

Occupation

Address

3. OFFICE HOLDER Position:

Name Date:

Occupation

Address


69

Appendix 2

NZAMH Education Standards Standard One – The educational institute 1.1 The educational institute should preferably be recognised by the NZQA.

1.2 The relevant educational course must be approved by the NZAMH to the

minimum standard of a NZQA level 6 three year diploma, or equivalent, with the

goal of working toward a NZQA level 7 degree. In 2020 all graduate and new

membership requires a minimum of level 7 Bachelor degree.

1.3 The management of the teaching institution supplies such information to the

NZAMH for approval.

Standard Two – Curriculum 2.1 The curriculum is reviewed every 2 years or as advised by the NZAMH.

2.2 The curriculum should be written and reviewed in consultation with lecturers,

practitioners and other stakeholders within the community.

2.3 The NZAMH should be advised of any major curriculum change.

2.4 The curriculum has an identifiable and integrated focus consistent with the

philosophy of Western herbal medicine.

2.5 The curriculum identifies expected outcomes.

2.6 The curriculum allows for appropriate clinical experience that encourages

students to integrate knowledge.

2.7 The curriculum is consistent with the scope of practice of medical herbalists.

Standard Three – Curriculum Content The scope and content of the curriculum includes theory and related clinical

experience to enable students to achieve the expected outcomes of the programme.

3.1 The content includes:

Core knowledge

Anatomy and physiology


70

Biochemistry

Nutrition

Pathophysiology

Botany

Plant identification

Herbal horticulture

Sustainability

Herbal materia medica*

Pharmacology (herbal and common medications)

Herbal therapeutics

Introduction to Rongoa Maori

Health promotion

Models of health and wellbeing

History and philosophy of Western Herbal Medicine

Politics of natural health in New Zealand

Cultural awareness

Professionalism and ethics

Safe practices

Relevant New Zealand legislation

First aid clinical practice

Basic research skills

Common biomedical diagnostic procedures and biomedical treatments

Naturopathic diagnostic procedures and treatments

Practice and business management

*The herbal materia medica content should include

- a minimum of 150 herbs including New Zealand natives

- a knowledge of herbs with a narrow therapeutic margin

Students should develop the skills necessary to build upon this knowledge once in

practice.

Professional Practice Skills

The ability to gather, analyse, critically assess and record a client’s holistic

(mental, emotional and physical) health history

The ability to perform basic clinical skills appropriate for the assessment of

client’s health

The ability to interpret and integrate the history and physical examination

findings to arrive at an appropriate treatment

The ability to formulate a safe and comprehensive healthcare management

plan with the client, integrating theoretical and clinical knowledge

The ability to communicate sensitively and effectively to clients, their families


71

and other health professionals

The ability to recognise when to refer to other health professionals

The ability to use information technology resources appropriately

Cultural competence

knowledge of the Treaty of Waitangi and its implications

psychological, cultural and spiritual well-being of clients and their families

3.2 The programme provides supervised clinical practice for a minimum of 200

clinical hours for all students, including a minimum of 50 client contact hours.

3.3 The clinical programme experiences have well-formulated learning outcomes

which relate to the competencies for the scope of practice of Western medical

herbalists.

3.4 Where an educational institute uses external student clinical hours and clinical

placements these should be rigorously documented and monitored.

Standard Four – Teaching staff The curriculum is implemented by lecturers who are qualified for their roles, or who

are assisted to obtain these qualifications.

4.1 Lecturers/supervisors involved in the clinical programme should have at least five

years clinical experience and should have a current client base.

4.2 Lecturers involved in the herbal programme should have at least three years

experience in herbal medicine practice.

4.3 Lecturers/supervisors should have current NZAMH practicing certificates.

4.4 Lecturers must maintain and update knowledge and skills relevant to the area in

which they are teaching.

Standard Five – Teaching and Learning The environment supports the teaching-learning process and there is documentation

to demonstrate this.

5.1 Teaching and learning resources are appropriate to achieve programme

outcomes and purposes.


72

5.2 Student performance is assessed against learning outcomes relevant to practice.

5.3 There is a process for ensuring relevant and appropriate student assessment.

5.4 Students undertake a variety of assessments to test application of knowledge

and clinical skills.

5.5 There is a process of moderation in place for all courses.

NZAMH Competencies Medical herbalists assess health needs and support and enable individuals, families,

groups and communities to restore, maintain or improve their health. They apply

their knowledge competently and appropriately and always have regard for safe

practice. They practise independently and in collaboration with other health

professionals. Medical herbalists may also use their expertise to educate, research

and promote health and well-being. Medical herbalists have an in-depth knowledge

of herbs as medicines including herbal horticulture, plant identification, manufacture

and prescribing according to individual needs.

There are five domains of competence for medical herbalists.

Core knowledge

Medical herbalists should have a knowledge and understanding of:

Anatomy and physiology, biochemistry, nutrition, pathophysiology, botany and

plant identification, herbal materia medica, pharmacology (herbal and

common medications), herbal therapeutics, history and philosophy of

Western Herbal Medicine, first aid, clinical practice and basic research skills.

The aetiology, pathophysiology, symptoms and signs, progression, and

prognosis of common mental and physical ailments at all life stages.

Common biomedical or naturopathic diagnostic procedures and biomedical

treatments.

The psychological, cultural and spiritual well-being of clients and their families,

and the interactions between people and their social and physical

environment.

Professional Practice Skills

Medical herbalists should demonstrate:


73

The ability to gather, analyse, and critically assess record a client’s holistic

(mental, emotional and physical) health history.

The ability to perform basic clinical skills appropriate for the assessment of

client’s health.

The ability to interpret and integrate the history and physical examination

findings to arrive at an appropriate diagnosis or differential diagnosis.

The ability to formulate a safe and comprehensive healthcare management

plan with the client, integrating theoretical and clinical knowledge.

The ability to recognise when to refer to other health professionals.

The ability to use information technology resources appropriately.

Cultural Competence

Cultural Competence refers to the acquisition of skills to better understand members

of other cultures in order to achieve the best health outcome (Mason Durie, 2001).

It is important to recognise that culture includes but is not restricted to age, gender,

sexual orientation, occupation, socio-economic status, ethnic origin or migrant

experience, religious or spiritual belief, disability.

Medical herbalists will

Understand the relevance of the Treaty of Waitangi to the health of Maori in

Aotearoa/New Zealand.

Demonstrate cultural safety and practice in a manner which follows culturally

appropriate assessment.

Show an understanding and respect for clients’ cultural beliefs, values,

practices and individual differences.

Have an understanding of their own cultural beliefs, values and practices.

Communication


Use effective communication at all times including being able to listen and

respond sensitively and effectively, to clients and their families, other health

professionals, and the general public.

Be aware of barriers that impact on communication and act appropriately.

Professional responsibility



74

Practise lawfully in regard to all relevant legislation.

Abide by the NZAMH Code of Ethics.

Work within the Scope of Practice.

Visibly display the current annual practising certificate issued by the NZAMH

and the NZAMH Code of Ethics.

Visibly display all relevant information on consumer rights, under the Health

and Disability Commissioner Act and Health and Disability information.

Recognise that their primary professional responsibilities are the health

interests of the client and the community.

Demonstrate a commitment to ongoing learning and professional

development, and an appreciation of the responsibility to maintain standards

of natural health practice at the highest possible level throughout a

professional career.

Demonstrate an appreciation that they must act with integrity when they

supply clients with product.


75

List of herbs for Materia Medica

Education establishments are required to teach 150 herbs made up of 75 Mandatory

herbs and a further 75 of their own choosing including medicinal NZ plants.

Mandatory herbs:

Achillea millefolium Yarrow

Aesculus hippocastanum Horse Chestnut

Allium sativum Garlic

Aloe spp. Aloe vera

Althaea officinalis Marshmallow

Andrographis paniculata Andrographis

Arctium lappa Burdock

Arctostaphylos uva-ursi Bearberry

Astragalus membranaceus Astragalus

Avena sativa Oats straw/ seed

Bacopa monnieri Bacopa

Berberis vulgaris Barberry

Boswellia serrata Boswellia

Bupleurum falcatum Bupleurum

Calendula officinalis Pot Marigold, Calendula

Capsicum minimum Capsicum, cayenne

Centella asiatica Gotu kola

Cinnamomum zeylanicum/ C. cassia Cinnamon

Crataegus oxycantha/C. monogyna Hawthorn

Curcuma longa Turmeric

Echinacea angustifolia/E. purpurea/E. pallida Echinacea

Eleutherococcus senticosus Siberian ginseng

Equisetum arvense Horsetail

Euphrasia officinalis Eyebright


76

Filipendula ulmaria Meadowsweet

Foeniculum vulgare Fennel

Fucus vesiculosis Bladderwrack

Galium aparine Clivers

Gentiana lutea Gentian

Ginkgo biloba Ginkgo

Glycyrrhiza glabra Licorice

Gymnema sylvestre Gymnema

Hamamelis virginiana Witch hazel

Harpagophytum procumbens Devil’s claw

Humulus lupulus Hops

Hydrastis canadensis Golden Seal

Hypericum perforatum St John’s wort

Inula helenium Elecampane

Lavandula officinalis Lavender

Leonurus cardiaca Motherwort

Matricaria recutita Chamomile

Melissa officinalis Lemon balm

Mentha x piperita Peppermint

Paeonia lactiflora Peony

Panax ginseng Panax, Korean ginseng

Passiflora incarnata Passionflower

Phytolacca decandra/P. americana Poke root

Piper methysticum Kava

Rehmannia glutinosa Rehmannia

Rhodiola rosa Rhodiola

Rosmarinus officinalis Rosemary

Rumex crispus Yellow dock


77

Salix alba White willow

Salvia officinalis Sage

Sambucus nigra Elder

Schisandra chinensis Schisandra

Scutellaria baicalensis Baical scullcap

Scutellaria lateriflora Skullcap

Serenoa serrulata/S. repens Saw Palmetto

Silybum marianum St Mary’s Thistle

Taraxacum officinale (folia and radix) Dandelion (leaf and root)

Thuja occidentalis Thuja

Thymus vulgaris Thyme

Trigonella foenum-graecum Fenugreek

Turnera diffusa Damiana

Urtica dioica/U. urens Nettle

Vaccinium myrtillus Bilberry

Valeriana officinalis Valerian

Verbascum thapsus Mullein

Verbena officinalis Vervain

Vitex agnus-castus Chaste tree

Withania somnifera Withania

Zea mays Corn silk

Zingiber officinale Ginger

Zizyphus spinosa/ Z. jujube Zizyphus

New Zealand Native Plants

Coprosma robusta Karamu

Dodonoaea viscosa Akeake

Hebe salicifolia Koromiko

Hoheria populnea Hoheria


78

Leptospermum scoparium Manuka

Macropiper excelsum Kawakawa

Myrsine australis Red Matipou/Mapau

Pomaderris kumerahou Kumerahou

Solanum aviculare Poroporo

Phormium tenax Harakeke

Kunzea ericoides Kanuka

Phyllocladus trichomanoides Tanekaha

Podocarpus dacrydiodes Kahikatea

Podocarpus totara Totara

Porphyra columbina Karengo

Gnaphalium luteo-album Pukatea

Pseudowintera axillaris Horopito

Dysoxylum spectabile Kohekohe


79

Appendix 3

CODE OF ETHICS

(CODE OF CONDUCT, COMPLAINTS AND DISCIPLINE)

Preamble

Medical Herbalism involves a relationship between practitioners and patients

that is based on principles of integrity, trust and beneficence. Medical

Herbalism supports and enables individuals, families, groups and

communities to restore, maintain or improve their health.

This code of ethics has been developed for Medical Herbalism within the New

Zealand context, and shares many aspects with the ethical practice of Medical

Herbalism in the western world.

This code of ethics is a set of principles that serves to guide good professional

conduct for Medical Herbalism. These principles delineate the nature of a

contractual basis, which is made between a Medical Herbalist and patients,

colleagues, professional acquaintances and the public at large. It does not

serve as a statute but may be used as a benchmark for professional conduct

within the profession of Medical Herbalism.

This code cannot resolve all ethical issues but does provide a framework for

addressing ethical and Medical Herbalism practice-related issues.

This code of ethics expresses the general principles applicable to all Medical

Herbalists and then identifies the specific areas of ethical practice along with

annotations. The general principles are addressed and blended within the

sum of these specific areas.

Due to the changing nature of Medical Herbalism practise; alongside the ever-

changing face of health care, this code of ethics will be reviewed every three

years or, if deemed necessary, at short notice.

General Principles

The general principles of the code of ethics are as follows:

Respect for Autonomy

Non-malfeasance

Beneficence

Justice


80

Specific Areas of Ethical Practice

The specific areas of ethical practice of the code of ethics are as follows:

1: Compliance with the Code of Ethics

2: Relations with Patients

3: Relations with Colleagues

4: Relations with the Public

5: Competence

6: Practice Management

7: Infringement of the Code of Ethics

8: Complaints Procedures

9: Disciplinary Procedures

1: Compliance with the Code of Ethics

1.1: Members and practitioners of NZAMH shall at all times comply with the

code of ethics.

1.2: Compliance to the code of ethics will be considered when a complaint

is made against a member or practitioner of NZAMH. Practitioners

failing to meet the requirements of the code of ethics may be subject to

disciplinary measure on the grounds of unacceptable professional

conduct (see section 7).

1.3: Members and practitioners are reminded that this code of ethics is no

substitute for either medical or civil law.

1.4: Members, particularly practitioners, are encouraged to be covered by

professional and public liability insurance.

2: Relations with Patients

2.1: Practitioners shall recognize an obligation towards the patient at all

times, and shall practise their profession to the best of their ability for

the benefit of the patient. The patient’s comfort, welfare and future

health must always have priority.

2.2: No discrimination will be made against patients on any grounds

including age, race, colour, gender, religion, education, sexual


81

orientation, social class, political belief, philosophical persuasion or

disability.

2.3: All actions and treatment applied to a patient must be carried out with

the informed consent of that patient or the caregiver of that patient. A

person from whom informed consent for examination or treatment is

sought must possess the necessary intellectual and legal capacity to

give consent. A patient will have the intellectual capacity if able to

understand in simple language what the examination or treatment is, its

purpose and why it is being proposed, to understand its principle

benefits, risk and alternatives, and to retain the information long

enough to make an effective decision with free choice.

2.4: Written or spoken consent must be obtained from the parent or

caregiver of patients under the age of sixteen (16) years who seek

treatment. Physical examination of a child under the age of sixteen (16)

years requires the presence of a third party, usually the parent or

caregiver.

2.5: Examination or treatment of any intimate area of any patient regardless

of age or gender requires the presence of a third party unless explicitly

agreed to by the patient. Consent for examination or treatment without

the presence of a third party should be recorded in writing.

2.6: In an emergency situation where the patient, or the patient’s caregiver,

is unable to give consent, treatment may be given if it is deemed to be

in the patient’s best health interests.

2.7: The confidence of the patient, and diagnostic findings acquired during

consultation, or in the course of treatment, shall not be divulged to

anyone without the patient’s consent except where required to by law

or where failure to take action would constitute a menace or danger to

the patient or another member of the community.

2.8: Practitioners shall not give guarantees regarding the results of any

treatment nor exploit a patient for financial gain through inferences or

misrepresentations of any sort.

2.9: Practitioners must act with consideration with regard to fees and the

justification for any treatment.

2.10: Practitioners shall not use their professional position to instigate nor

pursue an improper relationship with a patient, personal companion or

relative of that patient. This includes personal, professional, political,

financial or sexual gain.

2.11: Where deemed necessary the practitioner should refer patients

promptly to another competent health professional.


82

2.12 Practitioners shall provide, to the satisfaction of the patient, details of

the herbal medicines prescribed, if requested by the patient to do so.

3: Relations with Colleagues

3.1: Members and practitioners must at all times conduct themselves in an

honourable manner towards other health care professionals

3.2: Members and practitioners should be respectful towards the treatment

philosophy of other health care providers.

3.3: Members and practitioners must not speak publicly in a derogatory

fashion of other health care providers.

3.4: Practitioners having patients referred to them by another practitioner

shall return such patients to the original practitioner when the specified

treatment is completed.

3.5: Members and practitioners shall not denigrate another practitioner's

treatment plan.

3.6: A practitioner shall not knowingly interfere with any ongoing treatment

instigated by another practitioner whilst the patient is under that other

practitioner's care.

3.7: Practitioners concerned with regard to a patient's treatment in any way

whatsoever must proceed to address these issues in a discreet and

professional manner through the appropriate channels.

3.8: When patients request a health care service outside the scope of

practice of the Medical Herbalist it is the responsibility of the

practitioner to assist with that request.

3.9: Practitioners shall respect the intellectual property of other practitioners and use it only with explicit consent.

4: Relations with the Public

4.1: Members and practitioners must at all times conduct themselves in an

honourable manner towards the public, irrespective of the medium

used (direct communication, newspaper, television, radio, internet, any

media avenue)

4.2: Members and practitioners will never make misleading claims

regarding the ability to treat or cure illness, nor imply abilities beyond

their competence.

4.3: Advertising must be in compliance with legal requirements.


83

4.4: Advertising must be compatible and congruent with the standards of

the profession of Medical Herbalism and must not contravene any of

the points of the code of ethics.

4.5: Members and practitioners are permitted to lecture to the public on the

topic of Medical Herbalism where the purpose is to promote and further

the understanding of Medical Herbalism.

4.6: Practitioners shall not use titles or descriptions that give the impression

of medical or other qualifications to which they are not entitled.

5: Competence

5.1: Individuals are entitled to be members of NZAMH on the completion of

adequate training, as approved by the committee.

5.2: Members are responsible for undertaking continuing professional

development.

5.3: Practitioners must be aware of the current information regarding the

healing techniques they practise.

5.4: Practitioners shall not claim competence that they do not possess.

5.5: Practitioners shall diligently monitor their fitness to practise with respect

to their physical, mental, emotional and spiritual health.

6: Practice Management

6.1: Practitioners shall share the responsibility of upholding the integrity of

the profession of Medical Herbalism.

6.2: Practitioners shall act with honesty and integrity.

6.3: Practitioners are obliged to manage their practices with due diligence.

6.4: All external notices and name plates advertising any professional

practice should conform to legal and professional requirements.

6.5: Any persons employed within a clinical practice are required to be

suitably trained for their position.

6.6: The practitioner is responsible for any actions undertaken by an

employee or assistant working within their practice who is not

registered as a member of NZAMH.

6.7: Practitioners must provide a practice complaints procedure within their practice that is clearly visible to patients in accordance with the NZ Health & Disability Consumer Code of Rights. A standard complaints


84

procedure notice for practitioners to display is available from the NZAMH.

6.8: Practitioners shall display current practicing certificates and this code

of ethics in a prominent position in their premises within easy viewing

of the patient.

6.9: Practitioners premises must be maintained in a safe and hygienic

condition.

6.10: Practitioner's are responsible for the safe and effective disposal of

items deemed unsafe.

6.11: Telephone email and internet (including web cam) consultations with unknown persons are to be strongly discouraged. Where in exceptional circumstances a face-to-face consultation is not practical, the practitioner:

a) must ensure that the patient is assessed by an appropriately qualified practitioner before any course of treatment is recommended;

b) has the responsibility to sight any relevant reports generated from a consultation conducted by another appropriately qualified practitioner;

c) should conduct a face-to-face follow-up consultation at least once every twelve (12) months if treatment of the patient is ongoing.

6.12: Patient confidentiality is a legitimate expectation of patients and must

be adhered to at all times. Practice personnel must maintain this same

level of confidentiality

6.13: Patient records are the responsibility of the practitioner.

6.14: Patient records must be kept in a safe and secure place for no less

than seven (7) years from the date of last appointment.

6.15: The transfer of patient records is to be carried out only with the consent

of the patient.

6.16: Patients or registered caregivers are allowed access to patient records

at all times.

6.17: Patient records can be disclosed without patient or caregiver consent in

situations of legal requirement or where failure to disclose would

constitute a menace or danger to the patient or another member of the

community.

6.18: Patient records and the information contained therein may be used in

instances of clinical trial, clinical audit, case-history reporting,

qualitative research or any other method of research only with the

informed consent of the patient or caregiver concerned. This must be

accompanied by an assurance of maintenance of confidentiality


85

6.19: Whenever acting as locum tenens practitioners shall not attempt to

secure the future care of any patients.

6.20: Practitioners in private practice are expected to prescribe herbal

medicines in combinations that are individualised to the needs of the

patient that they are treating at that time.

6.21: Practitioners should not use herbal medicines derived from any wild

species that are known to be threatened or endangered in their natural

habitat. Practitioners have a responsibility to ensure that they are

aware of the population status of herbal medicines. Practitioners

should be aware of and respect any treaties and national laws relating

to medicinal plant conservation, especially the 1993 Convention on

International Trade in Endangered Species of Wild Fauna and Flora

(CITES). Information is available from the NZAMH.

6.22: Practitioners should respect Article 24 of the 2007 United Nations

Declaration on the Rights of Indigenous Peoples, namely that

"Indigenous peoples have the right to their traditional medicines and to

maintain their health practices, including the conservation of their vital

medicinal plants... ".

6.23: NZAMH is opposed to genetic engineering and/or modification of

medicinal plants as being contrary to and not conforming with

traditional usage. Members therefore have a duty not to prescribe or

recommend plant medicines or foods derived from this technology.

6.23: Practitioners shall continue to develop their professional knowledge

and share this knowledge with colleagues, other relevant health

professionals and the public.

7: Infringement of the Code of Ethics

7.1: Infringement of this code of ethics may render members liable to

disciplinary action with subsequent loss of privileges and benefits of

registration with NZAMH.

7.2: Any complaint against any member can only be upheld if there is

shown to be a breach of the code of ethics.

7.3: The interpretation of infringement of the code of ethics cannot be

exhaustive and is intended as guidance only.


86

8: Complaints Procedures

8.1: A Convenor of the Complaints Committee will be appointed at the first

Committee Meeting of the Association in each financial year.

8.2: At least two other members will be recommended as potential

Complaints Committee members at this same committee meeting.

They will then be available if called on.

8.3: A complaint may be presented to the President of the Association if it is

believed that any member has wilfully refused or neglected to comply

with the provisions of the Constitution/Code of Ethics, or is guilty of any

conduct unbecoming to that member, or prejudicial to the interest of the

Association.

8.4: The complaint shall be in writing.

8.5: Any written complaint received by the President of the Association

must be passed to the Convenor of the Complaints Committee

immediately.

8.6: The Convenor of the Complaints Committee must begin action within

fourteen (14) working days of the complaint being received by the

President of the Association.

8.7: Said Convenor will then appoint at least two other members to the

Complaints Committee to deal with this specific complaint, one of

whom may be a non-member of the Association. At least one person

on this committee must have knowledge and experience of the area

under consideration. None of the Complaints Committee members

should be involved already in this particular case. It is recommended

that both genders be represented on this committee. This committee

has the power to co -opt, and, if deemed necessary, to consult a

lawyer.

8.8: Any complaint received will be processed in a fair, open and

transparent manner with prompt information disseminated to the

parties involved. Full details of the complaint will be sent to the

defendant by the Convenor of the Complaints Committee within

fourteen (14) working days of the receipt of the complaint.

8.9: If the Complaints Committee decides that the complaint is not one with which it is empowered to deal with, a report will be made to the Committee of the Association and the complainant will then be informed of this in writing by an officer representing the Association Committee.

8.10: The first objective of the Complaints Committee is a resolution of the dispute.


87

8.11: It is recommended that a meeting with both parties be held as soon as possible. It may be that the Complaints Committee deems it appropriate to meet with each of the parties separately first.

8.12: A mediation process is to be considered a priority.

8.13: If the defendant is shown to be not in breach of the Code of Ethics/Constitution and is deemed not guilty of conduct unbecoming of a member or prejudicial to the interests of the Association, then it is to be recommended to the Committee of the Association that the complaint be dismissed.

8.14: If the defendant is deemed in breach of the above, then a full report is to be made to the Committee of the Association, with recommendations of the disciplinary action to be taken.

8.15: If the involved parties are dissatisfied with any part of the complaints

process the matter can be referred to the Health and Disability

Commissioner.

9: Disciplinary Procedures

9.1: If the Complaints Committee recommends disciplinary action, either the

President of the Association or a member appointed as Convenor of

the Disciplinary Committee shall appoint at least two more members to

the Disciplinary Committee.

9.2: It is recommended that these include one person of each gender. The

two appointed members can, but do not need to be members of the

Association.

9.3: Disciplinary action may take the form of censure, suspension from the

Association, expulsion from the Association, a fine of up to $1,000 or a

recovery of costs to the Association from one or both parties. There

could be a combination of some of these actions.

9.4: It could be recommended that the matter be referred to the Health and

Disability Commissioner.

9.5: The Convenor of the Disciplinary Committee shall inform the

complainant, the defendant and the NZAMH Committee of the

disciplinary action to be taken within fourteen (14) working days of the

decision being made.

9.6: The defendant shall also be given the date of the next scheduled

committee meeting of the Association.

9.7: The defendant may then give notice that she/he will be appealing this

disciplinary action at this committee meeting. The defendant may at this


88

committee meeting give orally or in writing any defence that she/he

sees fit. The full committee will then decide whether to uphold or to

change the disciplinary action.

9.8: No member, except for the purpose of pleading her/his case, shall take

part in the determination of any dispute in which she he is personally

involved.

9.9: If a member is fined, or expected to pay costs, and has not paid, that

member is not entitled to voting rights, receipt of the Association

magazine or meeting attendance. The Association retains the right to

follow standard debt recovery procedures if necessary.

9.10: No member, who has been suspended or expelled or chosen to resign

as a result of a complaints process, is entitled to any refund of

subscription or other sum.

9.11: Readmission to NZAMH once struck off is entirely at the discretion of

the Officers of the Association.


89

Appendix 4

Scope of Practice - Medical Herbalist General Scope of Practice Medical Herbalists provide primary health care based on nutrition, Western Herbal

Medicine, biomedical science and traditional philosophy of practice.

Medical Herbalists principally use herbal medicine a traditional system of medicine

and nutrition to promote well-being and healing. Western Herbal Medicine is based

on observation and experience passed down over thousands of years and includes

modern scientific information and research into phytomedicine, phytopharmacology

and nutritional science. These are combined with the medical sciences of anatomy,

physiology, biochemistry, pathophysiology, pharmacology and clinical diagnosis as

well as the science of botany. Medical Herbalists practice within a traditional holistic

framework of restoring and supporting the inherent self-healing processes within

each individual patient and by treating the whole person rather than just a disease or

isolated part of the body.

Medical Herbalists promote health and well-being and provide primary health care

through assessment, advice, education and treatment to clients. Medical Herbalists

practice independently in a variety of settings including clinical, education, research

and an advisory capacity, commonly in shared care with other primary health

practitioners.

In the clinical setting, a medical herbalist utilises diagnostic and assessment

techniques for the identification of disease, disorder and dysfunction. They perform

comprehensive health assessments through case history and physical examination,

identifying differential diagnoses, and ordering and interpreting diagnostic tests.

Medical Herbalists provide appropriate herbal and nutritional therapy and practical

lifestyle advice for health improvement.

Medical Herbalists working in education, research and advisory roles utilise their

professional education and practice experience to provide education and advice to

individuals, groups and communities on health promotion and prevention of ill health.

Medical Herbalists include but are not limited to the use of nutrition and herbal

preparations as their primary therapeutic tool. Medical herbalists may prescribe and

formulate herbal prescriptions for therapeutic application which can be dispensed or

extemporaneously compounded for that client.


90

Medical Herbalists work in collaboration with other health professionals wherever

possible to ensure clients receive the best possible health care including risk

management and referrals.

Transitional arrangements

Medical Herbalists who are full members of “NZAMH” and who meet Annual

Practising Certificate requirements are granted full registration as Medical Herbalists

within the scope of practice.

Qualifications

New Zealand Graduates

Level 6 Diploma in Herbal Medicine or Naturopathy [that meets NZAMH herbal

education standards] or their equivalent.

From 2020, NZAMH will require a bachelor degree in Herbal Medicine and/or

Naturopathy [that meets NZAMH herbal education standards] or their equivalent.

Medical Herbalists from Overseas

a. Qualification in herbal medicine accepted by:

- National Herbalists’ of Australia Association (NHAA)

- European Herbal and Traditional Medicine Practitioners’ Association

(EHTPA)

- National Institute of Medical Herbalists in the United Kingdom (NIMH)

- Australian Register of Naturopaths and Herbalists (ARONAH)

b. Overseas qualifications and experience are assessed on case by case basis

for eligibility for full practitioner membership. This process requires details of

the course completed including proof of at least 200 hours of clinical practice

(if recently qualified) and details of the applicant’s recent practice/experience.

c. The applicant may be requested to submit case studies for review by the

education sub-committee if their suitability is unclear, at which point limited

registration would be granted.

d. Limited registration may be granted to those deemed to require additional

training or clinical supervision to achieve eligibility for professional registration.

Practising Certificates

Medical Herbalists who are professional members of “NZAMH” are required to apply

for an Annual Practising Certificate. Annual Practising Certificates are only awarded

if Continuing Education requirements are met and verified.


91

Reserved Titles for Registered Medical Herbalists

Medical Herbalist.

Phytotherapist.

Clinical Herbalist.

Practitioner of Western Herbal Medicine.

Herbalist


92

Appendix 5

Practice Profile Practice profile of an independent Medical Herbalist, 1

st April 2004 – 31

st March 2005

Hart Road Herbal Medicine Clinic

Client gender Female Male

74% 26%

Age of clients 1 – 29 30 – 49 50 – 69 70+

10% 34% 38% 18%

Major diagnoses of clients (Most clients had multiple medical conditions)

Skin conditions Anxiety or depression CVD/Hypertension Menstrual/Female GU Digestive problems Endocrine conditions Musculoskeletal Hypercholesterolaemia Respiratory disease Obesity/Weight management Male GU Cancer Migraine Chronic Fatigue Syndrome

35% 28% 23% 22% 20% 16% 14% 11% 10% 10% 6% 6% 4% 4%

Clients referred by Medical Herbalist for laboratory test

32%

Major medications already prescribed by General Practitioner

Cardiac/BP meds Antidepressants Hormonal therapy Lipid lowering drugs Steroids Anti-inflammatories Prescribed analgesics Pr/pump/H2 inhibitors Bronchodilators Sleeping pills Oral contraceptives Antihistamines

33% 21% 18% 18% 15% 12% 15% 12% 9% 8% 6% 6%

Self prescribed supplements client was taking on first consultation

Vitamins Minerals OTC herbs Essential fatty acids OTC analgesics

28% 23% 13% 11% 8%

Clinic treatments purchased by client after consultation, assessment and discussion of treatment options

Diet/lifestyle advice Herbal products (practitioner) Minerals/vitamins/amino acids Essential fatty acids Individualised herbal tinctures Herbal creams Probiotics

100% 87% 77% 50% 47% 13% 6%

Follow up visits Nil One Two Three Four Five of more

12% 28% 15% 7% 10% 28%

Client outcomes No improvement Small improvement Moderate improvement Significant improvement Unknown

5% 32% 33% 21% 9%


93

References

1 Griggs B. New Green Pharmacy. The Story of Western Herbal Medicine. London: Random House Ltd. 1997.

2 Lyons A, Petrucelli J. Medicine: An Illustrated History. Melbourne: Macmillan. 1979

3 Hurtak J. Historical Origins of Classical Chinese Medical Texts and Herbal Usage. J Altern Complement Med.

2003;9(1):20 4 Martindale W, Reynolds JEF. The Extra Pharmacopoeia. 31st ed. London: Pharmaceutical Press. 1996

5 Lin V, McCabe P. Evolution of the practice of naturopathy and Western herbal medicine. Bundoora: La Trobe

University. 2006 6 Pollock K. Alternative health therapies - Homeopathy and naturopathy. Wellington: Te Ara - the Encyclopedia

of New Zealand; 2011. http://www.TeAra.govt.nz/en/alternative-health-therapies/3 7 Mother Aubert's medicines. Wellington: Museum of New Zealand, Te Papa Tongawera; 2012 [4th July 2012];

Available from: http://collections.tepapa.govt.nz/theme.aspx?irn=2077. 8 Neil, J. The New Zealand Family Herb Doctor. Dunedin: Mills, Dick & Co.; 1889.

9 Bone K, Mills S. Principles and practice of phytotherapy 2nd ed. Edinburgh: Churchill Livingstone, Elsevier,

p15. 2013 10

Casey MG, Adams J, Sibbritt D. An examination of the prescription and dispensing of medicines by Western herbal therapists: A national survey in Australia. Complemen Ther Med. 2007; 15: 13-20. 11

Dunn J. Challenges in herbal medicine clinic research: Key issues in curriculum, contemporary herbal medicine clinical practice & professional development. NHAA Conference March, 2015. 12

Medicines Act 1981, (1981). http://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html#DLM56046 13

MedSafe. Regulation of Herbal Substances in a Joint Australia New Zealand Therapeutic Products Agency. Wellington: Ministry of Health. 2004 14

Bensoussan A et al. Naturopathic and Western herbal medicine practice in Australia—a workforce survey. Complement Ther Med. 2004;12(1):17-27. 15

Pal SK. Complementary and alternative medicine: An overview. Curr Sci. 2002;82(5):518-24. 16

Fulder S. The Basic Concepts of Alternative Medicine and Their Impact on Our Views of Health. J Altern Complement Med. 1998;4(2):147-58. 17

Hoffman D. Medical Herbalism: The Science Principles and Practices of Herbal Medicine. Rochester, Vermont: Healing Arts Press; 2003. 18

Casey MG, Adams J, Sibbritt D. An examination of the prescription and dispensing of medicines by Western herbal therapists: A national survey in Australia. Complement Ther Med. 2007; 15(1): 13-20. 19

Eardley S et al. A systematic literature review of complementary and alternative medicine prevalence in EU. Fors Komplement. 2012; 19(suppl 2): 18-28. 20

Mansky PJ, Wallerstedt DB. Complementary medicine in palliative care and cancer symptom management. Cancer J 2006; 12:425-431 21

Aςikgöz SK et al. Effect of herbal medicine use on medication adherence of cardiology patients. Comp Ther Med.2014;22:648-654. 22

Otago Daily Times, Issue 14915, 18 August 1910, p8. http://paperspast.natlib.govt.nz/cgi-bin/paperspast?a=d&cl=search&d=ODT19100818.2.96&srpos=9&e=-------10--1----0medical+herbalists-- 23

A Portrait of Health: Key results of the 2006/07 New Zealand Health Survey. Published on-line 2008 June. http://www.health.govt.nz/publication/portrait-health-key-results-2006-07-new-zealand-health-survey 24

Jonas WB. Advising patients on the use of complementary and alternative medicine. Appl Psychophysiol Biofeedback. 2001 Sep;26(3):205-214. 25

Thorne S. Complementary/Alternative medicine in chronic illness as informed self-care decision making. Int J Nurs Stud. 2002 Sep;39(7):671-683. 26

Cassidy CM. Unravelling the ball of string: Reality, paradigms, and the study of alternative medicine J Mind/Body Health. 1994 Winter; 10(1). 27

Wootton JC, Sparber A. Surveys of complementary and Alternative Medicine: part I. General trends and demographic groups. J Altern Complement Med. 2001; Apr;7(2):195-208. 28

Thorne et al. Ethical Dimensions in the Borderland Between Conventional and Complementary/Alternative Medicine. J Altern Complement Med. 2002; 8(6):907-915


94

29

Salmond G. Paradigm shifts, making connections and managing change: A personal perspective Health Workforce Advisory Committee Summit, Wellington. 2003, March 26-27. 30

Taylor M. Patients’ and general practitioners’ attitudes towards complementary medicine in Wanganui, New Zealand. NZ Fam Practice. 2003; 30:102-107 31

Complementary and alternative health care in New Zealand: advice to the Minister of Health. Ministerial Advisory Committee on Complementary and Alternative Health. 2004. 32

Bullock et al. Characteristics and complaints of patients seeking therapy at a hospital-based alternative medicine clinic J Altern Complement Med. 1997 Fall;3(3):212 33

Sparber A, Wootton J. Surveys of Complementary and Alternative Medicine Part 2. Use of complementary and alternative cancer therapies. J Altern Complement Med. 2001; 7(3):281-287 34

Wotton J, Sparber A. Surveys of Complementary and Alternative Medicine: Part 4. Use of complementary and alternative therapies for Rheumatologic and Other Diseases. J Altern Complement Med. 2001; 7(6):715-721 35

Barrett B et al. Themes of Holism, Empowerment, Access and Legitimacy define Complementary, Alternative and Integrative medicine in relation to Conventional Biomedicine. J Altern Complement Med. 2003; 9(6) 937-947. 36

Guide lines for the Appropriate Use of Herbal Medicines. 1998 http://apps.who.int/medicinedocs/en/d/Jh2945e/2.3.html#Jh2945e.2.3 37 Calixto, JB. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines

(phytotherapeutic agents). Braz J Med Biol Res. 2000; Feb 33(2): 179-189. 38

Frass M et al. Use and Acceptance of Complementary and Alternative Medicine Among the General Population and Medical Personnel: A Systematic Review. Ochsner J. 2012 Spring; 12(1): 45–56. 39

Xue C, Zhang A, Lin V, Da Costa C, Story D. Complementary and Alternative Medicine Use in Australia: A

National Population-Based Survey. Journal of Alternative and Complementary Medicine 2007; 13: 643-650. 40

Harris P, Rees R. The prevalence of complementary and alternative medicine use among the general population: a systematic review of the literature. Complemen Ther Med. 2000;8(2):88-96. 41

Casey M, Adams J, Sibbritt D. An examination of the clinical practices and perceptions of professional herbalists providing patient care concurrently with conventional medical practice in Australia. Comp Ther Med. 2008; 16: 228-232. 42 Poynton L et al. General practitioners' attitudes toward (and use of) complementary and alternative

medicine: a New Zealand nationwide survey. NZMJ. 2005;119(1247):U2361. 43

The regulatory status of Complementary and Alternative Medicine for medical doctors in Europe. http://www.camdoc.eu/Pdf/CAMDOCRegulatoryStatus8_10.pdf 44

Regulatory Situation of Herbal Medicines - A Worldwide Review. (1998). http://apps.who.int/medicinedocs/en/d/Jwhozip57e/ 45

WHO Traditional Medicine Strategy 2014-2023. World Health Organization 2013. http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090_eng.pdf 46

House of Lords Select Committee on Science and Technology (2000). Complementary and Alternative Medicine. London: The Stationery Office 47

Department of Health [London]. Government Response to the House of Lords’ Select Committee on Science and Technology’s Report on Complementary and Alternative Medicine. Presented to Parliament by the Secretary of State for Health by command of Her Majesty. 2001 48

Department of Health. Regulation of Herbal Medicine and Acupuncture: Proposals for statutory regulation. London: Department of Health. 2004 49

Steering Group Report. http://www.ehtpa.eu/pdf/steeringgroup/Introduction_steering_group_report_16june08.pdf 50

Statutory Regulation of Herbal Medicine and Acupuncture. Report on the consultation. Department of Health Feb 2005. http://ehtpa.eu/pdf/DH_report_on_consultation_of_hm_and_acu.pdf 51

Professional Standards Authority. 2015 March. http://www.professionalstandards.org.uk/library/document-detail?id=98755a9e-2ce2-6f4b-9ceb-ff0000b2236b 52

Complementary and Alternative Health Care in New Zealand. MACCAH.2004 June.

http://www.moh.govt.nz/notebook/nbbooks.nsf/0/c64721a66307cad4cc256ef200701547/$FILE/Complement


95

ary%20and%20alternative%20health%20care%20in%20New%20Zealand%20-

%20advise%20to%20the%20Minister%20of%20Health.pdf 53

O’Sullivan, T. Report on the Regulation of Practitioners of Complementary and Alternative Medicine in Ireland. Health Services Department Unit, Institute of Public Administration. 2002. 54

Report of the National Working Group on the Regulation of Complementary Therapists to the Minister for Health and Children. 2005 December. http://ehtpa.eu/pdf/NWG_report_dec05.pdf 55

Expert Committee on Complementary Medicines in the Health System. Report to the Parliamentary Secretary to the Minister for Health and Ageing. Commonwealth of Australia,Canberra. 2003. 56

New South Wales Health. Regulation of Complementary Health Practitioner. Ministry of Health, Sydney.2002 57

RRRCH. Benefits, Risk and Regulatory options for the Professions of Naturopathy and Western Herbal Medicine (WHM): A Progress Report. Risks and Regulatory Requirements for Complementary Healthcare Reference Group, La Trobe University, Melbourne. 2003 58

Braun LA et al. Naturopaths and Western herbalists’ attitudes to evidence, regulation, information sources and knowledge about popular complementary medicines. Complement Ther Med. 2013;21:58-64 59

Regulation of Herbalists and Naturopaths in Australia. National Herbalists Association of Australia website. http://www.nhaa.org.au/mediareleases/be-informed/regulation-of-practitioners. 60

Australian Register of Naturopaths and Herbalists. http://www.aronah.org/about-aronah/ 61

Lin V et al. The practice and regulatory requirements of naturopathy and western herbal medicine. Melbourne: Department of Human Services, 2005. 62

Australian Medical Association. AMA Position Statement: Complementary Medicine. Canberra: Australian Medical Association, 2002. 63

The Practice and Regulatory Requirements of Naturopathy and Western Herbal Medicine. La Trobe University School of Public Health. 2005 Nov. http://www.aronah.org/wp-content/uploads/naturopathy-final1106.pdf 64 Inquiry into Bogus, Unregistered and Deregistered Health Practitioners. 2009 report by the Parliament of

South Australian’s Social Development Committee. Thirtieth report of the social development committee. 65

Dixon A. Regulating complementary medical practitioners Case studies. March 2008. http://www.kingsfund.org.uk/sites/files/kf/regulating-complementary-medical-practitioners-case-studies-anna-dixon-mar08.pdf 66

White House Commission on Complementary and Alternative Medicine (2002). Final Report.Washington DC: WHCCAMP 67

Martin J. Historical and professional perspectives of complementary and alternative medicine with a particular emphasis on rediscovering and embracing complementary and alternative medicine in contemporary western society. J Altern Complement Med. 2001; 7(S1):S11-S18 68

Freshley C, Carlson LK. Complementary and alternative medicine: an opportunity for reform. Front Health Serv Manage. 2000 Winter;17(2):3-14. 69

Eisenberg et al. Credentialing complementary and alternative medical providers. Ann Intern Med. 2002 Dec 17;137(12):965-973. 70

Giordano et al. Blending the boundaries: steps towards an integration of complementary and alternative medicine in mainstream practice. J Altern Complement Med. 2002 Dec;8(6):897-906. 71

Yarnell et al. Credentialing of practitioners of botanical medicine. Am J Med Qual. 2002 Jan-Feb;17(1):15-20. 72

Bodeker G, Kronenberg F. A public health agenda for traditional, complementary and alternative medicine. Am J Public Health. 2002 Oct;92(10):1582-1591 73

Hess DJ. Complementary or alternative? Stronger vs weaker integration policies. Am J Public Health 2002 Oct;92(10):1579-1581. 74

Moura VL, Warber SL, James SA. CAM providers’ messages to conventional medicine: a qualitative study. Am J Med Qual. 2002 Jan-Feb;17(1):10-14. 75

Cohen M. Complementary and Integrative medical therapies, the FDA and the NIH: definitions and regulation Dermatol Ther Jun. 2003;16(2):77-84. 76

Barnes PM et al. Complementary and alternative medicine use among adults: United States, 2002. Adv Data. 2004;343:1–19 77

Bodeker G et al. World Health Organisation. WHO Global Atlas of Traditional, Complementary and

Alternative Medicine. Kobe: World Health Organisation.2005

https://www.google.co.nz/search?q=Bodeker+G+et+al.+WHO+Global+Atlas+of+Traditional,+Complementary+


96

and+Alternative+Medicine.+Kobe:+World+Health+Organisation.+2005+&rls=com.microsoft:en-nz&ie=UTF-

8&oe=UTF-8&startIndex=&startPage=1&gws_rd=cr&ei=mmDXUpOCA86UkgW99IGYBg 78

Vickers A, Zollman and Lee R. Herbal Medicine. West J Med. 2001 August; 175(2): 125–128 79

Ramsey C, Walker M, Alexander J. Alternative Medicine in Canada: Use and public attitudes. Public Policy Sources No 21. 1999 Vancouver: Fraser Institute. 80

Health Canada. Complementary and Alternative Health Care. 2003. www.hcsc.gc.ca/hppb/healthcare/pubs/comp_alt/regs.html 81

Thorne et al. Ethical Dimensions in the Borderland Between Conventional and Complementary/Alternative Medicine. J Altern Complement Med. 2002; 8(6):907-915. 82

Boon H. Regulation of complementary/alternative practitioners: a Canadian perspective. Complement Ther Med. 2002 Mar;10(1):14-19. 83

Saunders PR. Complementary and alternative medicine in Canada: What is the future? HealthcPap 2003;3(5):43-49; 72-77. 84

Kelner M et al. The role of the state in the social inclusion of complementary and alternative medical occupations. Complementary Therapies in Medicine. 2004;12(2–3):79-89. 85

Lewis M. Risk and efficacy in biomedical media representations of herbal medicine and complementary and alternative medicine (CAM). J Evid-Based Complement Altern Med. 2011; 16 (3): 210-217. 86

Cottingham P et al. The characteristics, experiences and perceptions of naturopathic and herbal medicine practitioners: Results from a national survey in New Zealand. BMC Complement Altern Med. 2015 [In Press] 87

MedSafe Prescriber Update. Adverse Reaction Reporting in New Zealand in 2011. March 2012;33(1):7 ISSN 1172-5648 88

Wardle J. Regulation of complementary medicines: A brief report on the regulation and potential role of

complementary medicine in Australia. The Naturopathy Foundation, NorphCAM. Aug 2008. 89

http://www.health.gov.au/internet/main/publishing.nsf/Content/phi-natural-therapies-submissions-

containerpage/$file/NHAA%20Submission.pdf. 90

Lynch N, Berry D. Differences in perceived risks and benefits of herbal, over-the-counter conventional, and prescribed conventional, medicines, and the implications of this for the safe and effective use of herbal products. Complementary Therapies in Medicine June 2007;15(2):84-91 91

McCrea CE, Pritchard ME. Concurrent herb-prescription medication use and healthcare provider disclosure amongst university students. Complemen Ther Med. 2011; 19: 32-36. 92

Thomas T. (Consultation on the regulation of the profession of Herbal Medicine under the Health Practitioners Competence Assurance Act 2003. 2007). http://www.hdc.org.nz/media/3584/MOH%20-%20Proposal%20to%20regulate%20Herbal%20Medicine%20under%20HPCAA.pdf 93

Mills S, Bone K. Poke Root. Principles and Practice of Phytotherapy Churchill Livingstone. 2000;515-518. 94

MHRA Regulating Medicine and Medical Devices http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/Prohibitedorrestrictedherbalingredients/index.htm 95

European Commission Medicinal Products for Human Use: Herbal Medicinal Products. 2004March. http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm 96

Draft communication from the commission to the council and the European Parliament. Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products. 2007.http://ec.europa.eu/health/files/pharmacos/docs/doc2007/2007_05/herbals_draft_report_2007_05_29_en.pdf 97

Complementary Medicines in the Australian Health System. Expert Committee on Complementary Medicines in the Health System. September 2003. http://www.tga.gov.au/pdf/archive/committees-eccmhs-report-031031.pdf 98

World Health Organisation. Regulatory Situation of Herbal medicines a Worldwide Review. 1998 http://apps.who.int/medicinedocs/en/d/Jwhozip57e/4.2.8.html#Jwhozip57e.4.2.8 99

US Food and Drug Administration. Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration. Guidance for Industry - Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration. http://www.fda.gov/regulatoryinformation/guidances/ucm144657.htm#iii


97

100

Health Canada. Natural Health Product Directorate (NHPD) stakeholder bilateral meeting program - Meeting with the Canadian Association of Naturopathic Doctors (CAND). http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_12-03-12-eng.php. 2012 Dec 3. 101

Ministry of Health NZ. March 2010. Public consultation on natural health products. http://www.health.govt.nz/news-media/media-releases/public-consultation-natural-health-products 102

New Zealand Legislation. Medicines Act 1981. http://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html?search=sw_096be8ed80bee4b7_herb_25_se&p=1#DLM55417 103

Lin SH, Lin MS. A survey on drug-related hospitalization in a community teaching hospital. Int J Clin Pharmacol Ther Toxicol. 1993;Feb 31(2):66-69. London. 104

Larrey D. Liver involvement in the course of phytotherapy. Presse Med. 1994; Apr 16;23(15): 691-693. 105

Mateo MP et al. Erythema-multiforme-like eruption following allergic contact dermatitis from sesquiterpene lactones in herbal medicine. Contact Dermatitis. 1995; Dec 33(6): 449-450. 106

Drew AK, Myers SP. Safety issues in herbal medicine: implications for the health professions. Med J Aust. 1997;May 19.166(10):538-541. 107

Kamiyama T et al. Autoimmune hepatitis triggered by administration of an herbal medicine. Am J Gastroenterol. 1997 Apr;92(4):703-704. 108

Bagheri H et al. Fulminate hepatic failure after herbal medicine ingestion in children. Therapie. 1998 Jan-Feb; 53(1):82-3. 109

Vanherweghem LJ. Misuse of herbal remedies: the case of an outbreak of terminal renal failure in Belgium (Chinese herbs nephropathy). J Altern Complement Med. 1998 Spring; 4(1):9-13. 110

Pinn G. Adverse effects associated with herbal medicine. Aust Fam Physician. 2001 Nov;30(11):1070- 1075. 111

Ernst E. Harmless herbs? A review of the recent literature. Am J Med. 1998 Feb;104(2):170-178. 112

Caksen H et al. Deadly nightshade (Atropa belladonna) intoxication: an analysis of 49 children. Hum Exp Toxicol. 2003 Dec;22(12):665-8 113

Spina SP, Taddei A. Teenagers with Jimson weed (Datura stramonium) poisoning. CJEM. 2007 Nov;9(6):467-8 114

Montcriol A et al. Intentional Datura stramonium intoxication: an unknown etiology of mydriasis. Ann Fr Anesth Reanim. 2007 Sep;26(9):810-3 115

Wiener I, Tilkian AG, Palazzolo M. Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion. Cathet Cardiovasc Diagn. 1990;20(1):51–53. 116

Bruno A, Nolte KB, Chapin J. Stroke associated with ephedrine use. Neurology. 1993;43(7):1313–1316. 117

Lewis WH, Smith PR. Poke root herbal tea poisoning. JAMA. 1979 Dec 21;242(25):2759-60. 118

Ernst E. Kava: a European perspective. NZ Med J, 2004 November 5; 117(1205):U1143. 119

Fisher C. Materia Medica of Western Herbs. 2009 Vitex Medica, Nelson, New Zealand. 120

Rasmussen PL. Submission to the Medicines Classification Committee concerning a proposal to reschedule Kava, NZ Association of Medical Herbalists, 2005 June . 121

Gastpar M, Klimm HD. Treatment of anxiety, tension and restlessness states with Kava special extract WS 1490 in general practice: a randomized placebo-controlled double-blind multicenter trial. Phytomedicine. 2003 Nov;10(8):631-9 122

Stevinson C et al. A systematic review of the safety of kava extract in the treatment of anxiety. Drug Saf. 2002;25(4):251-61 123

Teschke R et al. Kava extracts: safety and risks including rare hepatotoxicity. Phytomedicine. 2003;10(5):440-6 124

Anke J, Ramzan I. Kava Hepatotoxicity: Are we any closer to the truth? Planta Med. 2004 Mar;70(3):193-6 125

Clouatre DL. Kava kava: examining new reports of toxicity. Toxicol Lett. 2004 Apr 15;150(1):85-96 126

Richardson WN, Henderson L. The safety of kava: a regulatory perspective. Br J Clin Pharmacol. 2007 Oct;64(4):418-20 127

Brown AC et al. Traditional kava beverage consumption and liver function tests in a predominantly Tongan population in Hawaii. Clin Toxicol (Phila). 2007 Jun-Aug;45(5):549-56 128

Denham A et al. Kava--the unfolding story: report on a work-in-progress. J Altern Complement Med. 2002 Jun;8(3):237-63

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_12-03-12-eng.php


98

129

Teschke R et al. Kava, the anxiolytic herb: back to basics to prevent liver injury? Br J Clin Pharmacol. 2011 March; 71(3): 445–448. 130

Mills SY, Steinhoff B. Kava-kava: a lesson for the phytomedicine community. Phytomedicine. 2003 Mar;10(2-3):261-2 131 Global Response to Kava Reintroduction Proposal. HerbalEGram: 2011 April; 8(4) 132

MacLennan A, Myers S, Taylor A. The continuing use of complementary and alternative medicine in South Australia: costs and beliefs in 2004. Medical Journal of Australia 2006; 184: 27-31. 133

Sidora-Arcoleo K et al. Don't ask, don't tell: parental nondisclosure of complementary and alternative medicine and over-the-counter medication use in children's asthma management. J Pediatr Health Care. 2008 Jul-Aug;22(4):221-9. 134

Warriner, S et al. Women's attitude towards the use of complementary and alternative medicines (CAM) in pregnancy. Midwifery. 2014 Jan;30(1):138-43. 135

Robinson A, McGrail MR. Disclosure of CAM use to medical practitioners: a review of qualitative and quantitative studies. Complement Ther Med. 2004 Jun-Sep;12(2-3):90-8. 136

Miller LG. Herbal medicinals: selected clinical considerations focusing on known or potential drug-herb interactions. Arch Intern Med. 1998 Nov 9;158(20):2200-2211. 137

Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-138. 138

Windrum P, Hull DR, Morris TC. Herb-drug interactions. Lancet. 2000 Mar 18;355(9208):1019-1020. 139

Braun L. Herb-drug interaction guide. Aust Fam Physician.2001 Jun;30(6):581-582. 140

Izzo AA, Ernst E. Interactions between herbal medicines and prescribed drugs: a systematic review. Drugs.2001; 61(15):2163-2175. 141

Rasmussen, PL. Herb-Drug Interactions. Seminar notes, Phytomed Medicinal Herbs Ltd, Auckland. Sept 2001. 142

Shader RI, Greenblatt DJ. J Phenelzine and the dream machine-ramblings and reflections. Clin Psychopharmacol. 1985 Feb;5(2):65 143

Jones BD, Runikis AM. Interaction of ginseng with phenelzine. J Clin Psychopharmacol. 1987 Jun;7(3):201-2 144

Rengelshausen J et al. Opposite effects of short-term and long-term St John's wort intake on voriconazole pharmacokinetics. Clin Pharmacol Ther. 2005 Jul;78(1):25-33 145

Aruna D, Naidu MU. Pharmacodynamic interaction studies of Ginkgo biloba with cilostazol and clopidogrel in healthy human subjects. Br J Clin Pharmacol. 2007 Mar;63(3):333-8 146

Wang X et al. Liquorice, a unique "guide drug" of traditional Chinese medicine: A review of its role in drug interactions J Ethnopharmacol. 2013 Dec 12;150(3):781-90. 147

Zhou S et al. Herbal bioactivation: the good, the bad and the ugly.Life Sci. 2004 Jan 9;74(8):935-68 148

Wenk M et al. Effect of St John's wort on the activities of CYP1A2, CYP3A4, CYP2D6, N-acetyltransferase 2, and xanthine oxidase in healthy males and females. Br J Clin Pharmacol. 2004 Apr;57(4):495-9 149

Unger M, Frank A. Simultaneous determination of the inhibitory potency of herbal extracts on the activity of six major cytochrome P450 enzymes using liquid chromatography/mass spectrometry and automated online extraction. Rapid Commun Mass Spectrom. 2004;18(19):2273-81 150

Hellum BH et al. The induction of CYP1A2, CYP2D6 and CYP3A4 by six trade herbal products in cultured primary human hepatocytes. Basic Clin Pharmacol Toxicol. 2007 Jan;100(1):23-30 151

Foster BC et al. In vitro inhibition of human cytochrome P450-mediated metabolism of marker substrates by natural products. Phytomedicine. 2003 May;10(4):334-42 152

Patel J et al. In vitro interaction of the HIV protease inhibitor ritonavir with herbal constituents: changes in P-gp and CYP3A4 activity.Am J Ther. 2004 Jul-Aug;11(4):262-77 153

Etheridge AS et al. An in vitro evaluation of cytochrome P450 inhibition and P-glycoprotein interaction with goldenseal, Ginkgo biloba, grape seed, milk thistle, and ginseng extracts and their constituents. Planta Med. 2007 Jul;73(8):731-41 154

Rasmussen PL. Herb-Drug Interactions. Seminar notes, Phytomed Medicinal Herbs Ltd, Auckland. Christchurch and Nelson,2005 July 23-24. 155

Weber CC et al. Modulation of P-glycoprotein function by St John's wort extract and its major constituents.Pharmacopsychiatry. 2004 Nov;37(6):292-8 156

Perloff MD et al. Rapid assessment of P-glycoprotein inhibition and induction in vitro. Pharm Res. 2003 Aug;20(8):1177-83


99

157

Nabekura T et al. Effects of dietary chemopreventive phytochemicals on P-glycoprotein function. Biochem Biophys Res Commun. 2005 Feb 18;327(3):866-70 158

Fuchikami H et al. Effects of herbal extracts on the function of human organic anion-transporting polypeptide OATP-B. Drug Metab Dispos. 2006 Apr;34(4):577-82 159

Ratz AE, von Moos M, Drewe J. St. John's wort: a pharmaceutical with potentially dangerous interactions. Schweiz Rundsch Med Prax. 2001 May 10;90(19): 843-849. 160

Wang Z et al. The effects of St John's wort (Hypericum perforatum) on human cytochrome P450 activity. Clin Pharmacol Ther. 2001 Oct;70(4):317-326. 161

Rengelshausen J et al. Opposite effects of short-term and long-term St John's wort intake on voriconazole pharmacokinetics.Clin Pharmacol Ther. 2005 Jul;78(1):25-33 162

Frye RF et al. Effect of St John's wort on imatinib mesylate pharmacokinetics. Clin Pharmacol Ther. 2004 Oct;76(4):323-9 163

Wang LS et al. St John's wort induces both cytochrome P450 3A4-catalyzed sulfoxidation and 2C19-dependent hydroxylation of omeprazole. Clin Pharmacol Ther. 2004 Mar;75(3):191-7 164

Schwarz UI et al. Unwanted pregnancy on self-medication with St John’s wort despite hormonal contraception. Br J Clin Pharmacol. 2003 Jan;55(1):112-3 165

Hebert MF et al. Effects of St. John's Wort (Hypericum perforatum) on Tacrolimus Pharmacokinetics in Healthy Volunteers . J Clin Pharmacol. 2004 Jan;44(1):89-94 166

Jiang X et al. Effect of St John’s wort and ginseng on the pharmacokinetics and pharmacodynamics of warfarin in healthy subjects. Br J Clin Pharmacol. 2004 May;57(5):592-9 167

Sugimoto K et al. Different effects of St John’s wort on the pharmacokinetics of simvastatin and pravastatin. Clin Pharmacol Ther. 2001 Dec;70(6):518-24 168

Andrén L, Andreasson A, Eggertsen R. Interaction between a commercially available St. John’s wort product (Movina) and atorvastatin in patients with hypercholesterolemia. Eur J Clin Pharmacol. 2007;63:913–916. 169

Wang XD et al. Impact of the haplotypes of the human pregnane X receptor gene on the basal and St John’s wort-induced activity of cytochrome P450 3A4 enzyme. Br J Clin Pharmacol. 2009;67:255–261 170

Tannergren C et al. St John’s wort decreases the bioavailability of R- and S-verapamil through induction of the first-pass metabolism. Clin Pharmacol Ther. 2004;75:298–309. 171

Moschella C, Jaber BL. Interaction between cyclosporine and Hypericum perforatum (St. John's wort) after organ transplantation. Am J Kidney Dis. 2001 Nov;38(5):1105-1107. 172

Alscher DM, Klotz U. Drug interaction of herbal tea containing St. John’s wort with cyclosporine. Transpl Int. 2003;16:543–544 173

Dresser GK et al. Coordinate induction of both cytochrome P4503A and MDR1 by St John’s wort in healthy subjects. Clin Pharmacol Ther. 2003;73:41–50 174

Mai I et al. Impact of St John’s wort treatment on the pharmacokinetics of tacrolimus and mycophenolic acid in renal transplant patients. Nephrol Dial Transplant. 2003;18:819–822 175

Johne A et al. Decreased Plasma Levels of Amitriptyline and Its Metabolites on Comedication With an Extract From St. John's Wort (Hypericum perforatum). J Clin Psychopharmacol. 2002 Feb;22(1):46-54. 176

Cheng TO. St John's wort interaction with digoxin. Arch Intern Med. 2000 Sep 11;160(16):2548. 177

Mueller SC et al. Effect of St John’s wort dose and preparations on the pharmacokinetics of digoxin. Clin Pharmacol Ther. 2004;75:546–557 178

Piscitelli SC et al. Indinavir concentrations and St John's wort. Lancet. 2000 Feb 12;355(9203):547-548. 179

Hu Z et al. Herb–drug interactions: a literature review. Drugs. 2005;65:1239–1282 180

Borrelli F, Izzo AA. Herb–Drug Interactions with St John’s Wort (Hypericum perforatum): an Update on Clinical Observations. AAPS J. 2009 Dec;11(4):710-27. 181

Will-Shahab L et al. St John’s wort extract (Ze 117) does not alter the pharmacokinetics of a low-dose oral contraceptive. Eur J Clin Pharmacol. 2009;65:287–294 182

Hall SD et al. The interaction between St John’s wort and an oral contraceptive. Clin Pharmacol Ther. 2003;74:525–535 183

Pfrunder A et al. Interaction of St John’s wort with low-dose oral contraceptive therapy: a randomized controlled trial. Br J Clin Pharmacol. 2003;56:683–690 184

Murphy PA et al. Interaction of St. John’s wort with oral contraceptives: effects on the pharmacokinetics of norethindrone and ethinyl estradiol, ovarian activity and breakthrough bleeding. Contraception. 2005;71:402–408.


100

185

Khawaja IS, Marotta RF, Lippmann S. Herbal medicines as a factor in delirium. Psychiatr Serv. 1999;50:969–970 186

Markowitz JS et al. Effect of St. John's wort (Hypericum perforatum) on cytochrome P-450 2D6 and 3A4 activity in healthy volunteers. Life Sci. 2000 Jan;21:66(9):PL133-9 187

Lantz MS et al. St. John's wort and antidepressant drug interactions in the elderly. J Geriatr Psychiatry Neurol. 1999 Spring;12(1):7-10 188

Dergal JM et al. Potential interactions between herbal medicines and conventional drug therapies used by older adults attending a memory clinic. Drugs Aging. 2002;19(11):879-86 189

Meisel C et al. Fatal intracerebral mass bleeding associated with Ginkgo biloba and ibuprofen. Atherosclerosis. 2003 Apr;167(2):367 190

Schelosky L et al. Kava and dopamine antagonism. J Neurol Neurosurg Psychiatry. 1995 191

Dinh LD et al. Interaction of various Piper methysticum cultivars with CNS receptors in vitro, Planta Med. 2001 Jun;67(4):306-11. 192

Durr D et al. St John's Wort induces intestinal P-glycoprotein/MDR1 and intestinal and hepatic CYP3A4. Clin Pharmacol Ther 2000 Dec;68(6):598-604. 193

Guo LQ, Yamazoe Y. Inhibition of cytochrome P450 by furanocoumarins in grapefruit juice and herbal medicines. Acta Pharmacol Sin. 2004 Feb;25(2):129-36. 194

Foster BC et al. An in vitro evaluation of human cytochrome P450 3A4 and P-glycoprotein inhibition by garlic. J Pharm Pharm Sci. 2001 May -Aug;4(2): 176-184. 195

Guo LQ et al. Inhibitory potential of herbal medicines on human cytochrome P450-mediated oxidation: properties of umbelliferous or citrus crude drugs and their relative prescriptions. Jpn J Pharmacol. 2001 Apr;85(4):399-408. 196

Mannel M. Drug interactions with St John's wort: mechanisms and clinical implications. Drug Saf. 2004;27(11):773-97. 197

Yoshioka M et al. Studies on interactions between functional foods or dietary supplements and medicines. IV. Effects of ginkgo biloba leaf extract on the pharmacokinetics and pharmacodynamics of nifedipine in healthy volunteers. Biol Pharm Bull. 2004 Dec;27(12):2006-9 198

Soderberg U et al. Time-course studies of immediate and delayed immune reactivity in patients with atopic dermatitis treated with herbal drugs. Allergy. 1990 Nov;45(8) 559-565. 199

Mateo MP et al (1995). Erythema-multiforme-like eruption following allergic contact dermatitis from sesquiterpene lactones in herbal medicine. Contact Dermatitis. Dec;33(6): 449-450. 200

Al-Suwaidan SN et al. Allergic contact dermatitis from myrrh, a topical herbal medicine used to promote healing. Contact Dermatitis. 1998 Sep;39(3):137. 201

Frieri M. Herbal therapies: what allergist-immunologists should know regarding patient use of complementary and alternative medicine. Allergy Asthma Proc. 2001 Jul-Aug;22(4):209-215. 202

Kim SH et al. IgE-mediated occupational asthma induced by herbal medicine, Banha (Pinellia ternata). Clin Exp Allergy. 2001 May;31(5):779-781. 203

Mullins RJ & Heddle R. Adverse reactions associated with echinacea: the Australian experience. Ann Allergy Asthma Immunol. 2002 Jan;88(1):42-51. 204

Gazquez Garcia V et al. Aniseed-induced nocturnal tongue angioedema. J Investig Allergol Clin Immunol. 2007;17(6):406-8 205

Cadot P et al. Int Arch Allergy Immunol. Oral allergy syndrome to chicory associated with birch pollen allergy. 2003 May;131(1):19-24 206

Franck P et al. Int Arch Allergy Immunol. Anaphylactic reaction to inulin: first identification of specific IgEs to an inulin protein compound. 2005 Feb;136(2):155-8 207

Cosmes PM et al. Allergol Immunopathol (Madr). Sensitization to Castanea sativa pollen and pollinosis in northern Extremadura (Spain).2005 May-Jun;33(3):145-50 208

McCaul ME et al. Familial density of alcoholism: effects on psychophysiological responses to ethanol. Alcohol. 1991 May-Jun;8(3): 219-222. 209

Kishimoto R et al. Combined effects of ethanol and garlic on hepatic ethanol metabolism in mice. J Nutr Sci Vitaminol (Tokyo).1999 Jun;45(3):275-286. 210

Lieber CS. The discovery of the microsomal ethanol oxidizing system and its physiologic and pathologic role. Drug Metab Rev. 2004 Oct;36(3-4):511-29.


101

211

Quinn PD, Fromme K. Subjective response to alcohol challenge: a quantitative review. Alcohol Clin Exp Res. 2011; 35: 1759-1770 212

Kar HK et al. Occurrence of plant sensitivity among patients of photodermatoses: a control-matched study of 156 cases from New Delhi. Indian J Dermatol Venereol Leprol. 2009 Sep-Oct;75(5):483-7. 213

Endo H, Rees TD. Clinical features of cinnamon-induced contact stomatitis. Compend Contin Educ Dent. 2006 Jul;27(7):403-9 214

Hoskyn J, Guin JD. Contact allergy to cinnamal in a patient with oral lichen planus. Contact Dermatitis. 2005 Mar;52(3):160-1 215

Reider N et al. Anaphylaxis to camomile: clinical features and allergen cross-reactivity. Clin Exp Allergy. 2000 Oct; 30(10):1436-43 216

McKay DL, Blumberg JB. A review of the bioactivity and potential health benefits of chamomile tea (Matricaria recutita L.). Phytother Res. 2006 Jul;20(7):519-30.. 217

Lamminpaa A et al. Occupational allergic contact dermatitis caused by decorative plants. Contact Dermatitis. 1996 May;34(5):330-5 218

Paulsen E et al. Patch test reactivity to feverfew-containing creams in feverfew-allergic patients. Contact Dermatitis. 2010 Sep;63(3):146-50. 219

Schlatter J et al. Dietary intake and risk assessment of phototoxic furocoumarins in humans. Food Chem Toxicol. 1991 Aug;29(8):523-30. 220

Lenković M et al. Phytophotodermatitis in Rijeka region, Croatia. Coll Antropol. 2008 Oct;32 Suppl 2:203-5. 221

Huntley AL, Thompson Coon J, Ernst E. The safety of herbal medicinal products derived from Echinacea species: a systematic review. Drug Saf. 2005;28(5):387-400. 222

Brune M, Rossander L, Hallberg L. Iron absorption and phenolic compounds: importance of different phenolic structures Eur J Clin Nutr. 1989 Aug;43(8):547-57.. 223

Nelson M, Poulter J. Impact of tea drinking on iron status in the UK: a review. J Hum Nutr Diet. 2004 Feb;17(1):43-54. 224

Brune M, Rossander L, Hallberg L. Iron absorption and phenolic compounds: importance of different phenolic structures. Eur J Clin Nutr 1989;43:547–58. 225

Rungruangsak K et al. Chemical interactions between thiamin and tannic acid. I. Kinetics, oxygen dependence and inhibition by ascorbic acid. Am J Clin Nutr. 1977 Oct;30(10):1680-5. 226

Huntley AL et al. Inhibition of non-haem iron absorption in man by polyphenolic-containing beverages. Drug Saf. 2005;28(5):387-400 227

Poisonous Substances. North Carolina State University. (accessed Jan 2014) http://www.cals.ncsu.edu/plantbiology/ncsc/Poisonplants/Poisonous_substances.htm. 228

Martindale, The Extra Pharmacopoeia 26th Ed. Pharmaceutical Press London March 1973 229

Sigurjonsdottir HA et al. Liquorice-induced rise in blood pressure: a linear dose-response relationship. J Hum Hypertens. 2001 Aug;15(8):549-52 230

Sigurjonsdottir HA et al. Subjects with essential hypertension are more sensitive to the inhibition of 11 beta-HSD by liquorice. J Hum Hypertens. 2003 Feb;17(2):125-31 231

Siegel RK. Ginseng abuse syndrome. Problems with the panacea. JAMA. 1979;241:1614-15 232

Shariff A et al. Entrapment of andrographolide in cross-linked alginate pellets: I. Formulation and evaluation of associated release kinetics. Pak J Pharm Sci. 2007 Jan;20(1):1-9. 233

Padosch SA et al. Absinthism: a fictitious 19th century syndrome with present impact. Subst Abuse Treat Prev Policy. 2006 May 10;1(1):14 234

WHO Monographs on Selected Medicinal Plants - Vol. 2. WHO Geneva 2004;317-328 235 Naser B et al. Thuja occidentalis (Arbor vitae): A Review of its Pharmaceutical, Pharmacological and Clinical

Properties. Evid Based Complement Altern Med. 2005 Mar;2(1):69-78. 236

Santini F et al. In vitro assay of thyroid disruptors affecting TSH-stimulated adenylate cyclase activity. J Endocrinol Invest. 2003 Oct;26(10):950-5 237

Auf’mkolk M et al. Extracts and auto-oxidized constituents of certain plants inhibit the receptor-binding and the biological activity of Graves' immunoglobulins. Endocrinology. 1985 May;116(5):1687-93 238

Greger H. Alkamides: structural relationships, distribution and biological activity. Planta Med. 1984 Oct;50(5):366-75. 239

Bauer R, Khan IA, Wagner H. TLC and HPLC analysis of Echinacea pallida and E. angustifolia roots. Planta Med. 1988 Oct;54(5):426-30

http://www.cals.ncsu.edu/plantbiology/ncsc/Poisonplants/Poisonous_substances.htm


102

240

Moro CO, Basile G. Obesity and medicinal plants. Fitoterapia. 2000 Aug;71 Suppl 1:S73-82 241

Arbaizar B, Llorca J. Fucus vesiculosus induced hyperthyroidism in a patient undergoing concomitant treatment with lithium. Actas Esp Psiquiatr. 2011 Nov-Dec;39(6):401-3 242

WHO Monographs on Selected Medicinal Plants - Vol 1. WHO Geneva 1999:241-58 243

Sweeney M-A. Constipation: Diagnosis and treatment. Home Care Provider. 1997; (2) 5:250-255. 244

Anderson IB et al. Pennyroyal toxicity: measurement of toxic metabolite levels in two cases and review of the literature. Ann Intern Med 1996 Apr 15;124(8): 726-734. 245

Belew C. Herbs and the childbearing woman. Guidelines for midwives. J Nurse Midwifery. 1999 May-Jun;44(3):231-252. 246

Bone K. Safe and Effective Use of Herbal Treatments during Pregnancy Avena. The Magazine of the New Zealand Association of Medical Herbalists 2003 Summer 13-20 247

Bone, K. Safe Use of Herbs in Pregnancy. Modern Phytotherapist. 1999; 4(3)12-18. 248

McFarlin BL et al. A national survey of herbal preparation use by nurse-midwives for labor stimulation. Review of the literature and recommendations for practice. Midwifery. 1999 44:205-216. 249

Burgess, I. Abortifacient Herb Use. Avena - The Magazine of the New Zealand Association of Medical Herbalists. 2001 Jan: 5-7. 250

Westfall RE. Herbal medicine in pregnancy and childbirth. Adv Ther. 2001 Jan-Feb;18(1):47-55. 251

Klier CM et al. St. John's Wort (Hypericum Perforatum) - Is it Safe during Breastfeeding? Pharmacopsychiatry. 2002 Jan;35(1):29-30. 252

Koeman M. Herbal Treatment in Pregnancy. Avena. The Magazine of the New Zealand Association of Medical Herbalists. 2003 Summer :22-25. 253

Gardiner P et al. Herb use, vitamin use, and diet in low-income, postpartum women. J Midwifery Womens Health. 2013 Mar-Apr;58(2):150-7. 254

Budzynska K et al. Systematic review of breastfeeding and herbs. Breastfeed Med. 2012 Dec;7(6):489-503. 255

Low Dog T. The use of botanicals during pregnancy and lactation. Altern Ther Health Med. 2009 Jan-Feb;15(1):54-8. 256

Ciganda C, Laborde A Herbal infusions used for induced abortion. J Toxicol Clin Toxicol. 2003;41(3):235-9. 257

British Herbal Pharmacopoeia. British Herbal Medicine Association, 1983. 258

British Herbal Compendium. British Herbal Medicine Association, 1992. 259

Ernst E. Herbal medications for common ailments in the elderly. Drugs Aging 1999 Dec;15(6):423-428. 260

Tomassoni AJ, Simone K. Herbal medicines for children: an illusion of safety? Curr Opin Pediatr. 2001 Apr;13(2):162-169 261

Sperl W et al. Reversible hepatic veno-occlusive disease in an infant after consumption of pyrrolizidine-containing herbal tea. Eur J Pediatr. 1995 Feb;154(2):112-6 262

Roulet M et al. Hepatic veno-occlusive disease in newborn infant of a woman drinking herbal tea. J Pediatr. 1988 Mar;112(3):433-6 263

Spang R. Toxicity of tea containing pyrrolizidine alkaloids. J Pediatr. 1988;115:1025 264

MacGregor FB et al. Hepatotoxicity of herbal remedies. BMJ. 1989 Nov 4;299(6708):1156-7 265

Gafner S et al. Analysis of Scutellaria lateriflora and its adulterants Teucrium canadense and Teucrium chamaedrys by LC-UV/MS, TLC, and digital photomicroscopy. J AOAC Int. 2003 May-Jun;86(3):453-60 266

Furmanowa M, Guzewska J, Beldowska B. Mutagenic effects of aqueous extracts of `Symphytum officinale L. and of its alkaloidal fractions. J Appl Toxicol. 1983 Jun;3(3):127-130. 267

Larrey D. Liver involvement in the course of phytotherapy Presse Med. 1994 Apr 16;23(15): 691-693. 268

Stickel F, Seitz HK. The efficacy and safety of comfrey. Public Health Nutr. 2000 Dec;3(4A):501- 508. 269

Hasegawa S et al. Ginkgo nut intoxication in a 2-year-old male. Pediatr Neurol. 2006 Oct;35(4):275-6. 270

Barceloux DG. Rhubarb and oxalosis (Rheum species). Dis Mon. 2009 Jun;55(6):403-11. 271

Chevallier, A. The Encyclopedia of Medicinal Plants. New York: DK Publishing.1996 272

Ridker PM, McDermott WV. Comfrey herb tea and hepatic veno-occlusive disease. Lancet. 1989 Mar 25;333(8639):657-8 273

Rode D. Comfrey toxicity revisited.Trends Pharmacol Sci. 2002 Nov;23(11):497-99 274

Schanenberg BT et al. Evaporative light scattering detection of pyrrolizidine alkaloids. Phytochem Anal. 2004 Jan-Feb;15(1):36-9 275

Roder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. Pharmazie. 1995;50:83-98


103

276

Nisly NL et al. Dietary supplement polypharmacy: an unrecognized public health problem? Evid Based Complement Alternat Med. 2010 Mar;7(1):107-13. 277

Garner LF, Klinger JD. Some visual effects caused by the beverage kava. J Ethnopharmacol. 1985 Jul;13(3):307-11 278

Perez J, Holmes JF. Altered mental status and ataxia secondary to acute Kava ingestion. J Emerg Med. 2005 Jan;28(1):49-51 279

Tassaneeyakul W et al. Contamination of Aflatoxins in Herbal Medicinal Products in Thailand. Mycopatholo. 2004 Sep; 158(2):239-244. 280

Liu C, Mandal R, Li XF. Detection of fortification of ginkgo products using nanoelectrospray ionization mass spectrometry. Analyst. 2005 Mar;130(3):325-9. 281

Lawrence GA, Scott PM. Improved extraction of ginkgotoxin (4'-O-methylpyridoxine) from Ginkgo biloba products. J AOAC Int. 2005 Jan-Feb;88(1):26-9. 282

Fuzzati N, Pace R, Villa F. A simple HPLC-UV method for the assay of ginkgolic acids in Ginkgo biloba extracts. Fitoterapia. 2003 Apr;74(3):247-56. 283

Ndjoko K et al. Determination of trace amounts of ginkgolic acids in Ginkgo biloba L. leaf extracts and phytopharmaceuticals by liquid chromatography-electrospray mass spectrometry. J Chromatogr B Biomed Sci Appl. 2000 Jul 21;744(2):249-55. 284

Richardson WN, Henderson L. The safety of kava – a regulatory perspective. Br J Clin Pharmacol. 2007 Oct;64(4):418-20 285

Gafner S et al. Analysis of Scutellaria lateriflora and its adulterants Teucrium canadense and Teucrium chamaedrys by LC-UV/MS, TLC, and digital photomicroscopy JAOAC Int. 2003 May-Jun;86(3):453-60.. 286

Kouzi SA, McMurtry RJ, Nelson SD. Hepatotoxicity of germander (Teucrium chamaedrys L.) and one of its constituent neoclerodane diterpenes teucrin A in the mouse. Chem Res Toxicol. 1994 Nov-Dec;7(6):850-6. 287

Brandao MG et al. Surveillance of phytotherapeutic drugs in the state of Minas Gerais. Quality assessment of commercial samples of chamomile. Cad Saude Publica. 1998 Jul-Sep;14(3):613-6 288

Wang Y et al. Metabolomic strategy for the classification and quality control of phytomedicine: a case study of chamomile flower (Matricaria recutita L.). Planta Med. 2004 Mar;70(3):250-5. 289

Singh O et al. Chamomile (Matricaria chamomilla L.): An overview. Pharmacogn Rev. 2011 Jan-Jun; 5(9): 82–95. 290

Meier B. The extraction strength of ethanol/water mixtures commonly used for the processing of herbal drugs. Planta Medica 1991; 57: 26 291

Lawson LD, Gardner CD. Composition, Stability, and Bioavailability of Garlic Products Being Used in a Clinical Trial. J Agric Food Chem. 2005 Aug 10;53(16):6254-61 292

Lawson LD et al. Allicin release under simulated gastrointestinal conditions from garlic powder tablets employed in clinical trials on serum cholesterol. Planta Med. 2001 Feb;67(1):13-8 293

MedSafe publication. Oct 2004. http://www.medsafe.govt.nz/hot/alerts/HerbalRemedies/HerbalRemedies.asp 294

Schmidt M et al. Anbau der Teufelskralle. Ein Projekt in Namibia zur Sicherung der pharmazeutischen Qualität. Deutsch Apotheker-Zeitung 1998; 138: 4540-4549. 295

Peltz K, Penman K, Lehmann R. Devil's claw authentication by HPLC. Herbal Medicine: Practice and Science International

Convention. Brisbane, 1999. 296

Awang D. Siberian ginseng toxicity may be case of mistaken identity. Can Med Assoc J. 1996; 155: 1237. 297

Grayer R et al. Infraspecific taxonomy and essential oil chemotypes in sweet basil, Ocimum basilicum. Phytochem. 1996; 43: 1033-1039. 298

Hudaib M et al. V. GC/MS evaluation of thyme (Thymus vulgaris L.) oil composition and variations during the vegetative cycle. J Pharm Biomed Anal. 2002; 29: 691-700. 299

Stahl-Biskup E. Essential oil chemistry of the genus Thymus-a global view. In: Stahl-Biskup E, Sáez F, (eds.) Thyme, the genus Thymus. London: Taylor and Francis, 2002; 75-124. 300

Dinchev D et al. Distribution of steroidal saponins in Tribulus terrestris from different geographical regions. Phytochem. 2008; 69: 176-186. 301

Linde K et al. Echinacea for preventing and treating the common cold. Cochrane Database Systematic Review 2006 302

Wills R, Stuart D. Levels of active constituents in manufactured Echinacea products. Chemistry in Australia 1998; 9: 17-19. 303

Bilia A. Ginkgo biloba L.: A workshop report. Fitoterapia 2002; 73: 276-279.


104

304

Australian Consumer's Association. Spotlight on glucosamine: it's a popular alternative treatment for osteoarthritis, but does glucosamine really work? New research findings make the evidence look shaky. Choice, 2008; 16-20. 305

Vlad S et al. Glucosamine for pain in osteoarthritis: why do trial results differ? Arth Rheum 2007; 56: 2267-2277. 306

Molyneux S, Florkowski C, Lever M, George P. The bioavailability of coenzyme Q10 supplements available in New Zealand differs markedly. NZMJ. 2004; 117: 1-6. 307

Meier B. The extraction strength of ethanol/water mixtures commonly used for the processing of herbal drugs. Planta Med. 1991; 57: 26. 308

Adverse Drug Reactions Advisory Committee. Traditional Indian (Ayurvedic) and Chinese medicines associated with heavy metal poisoning. Australian Adverse Drug Reactions Bulletin 2007; 26: 1. 309

Stafford A. Herbal sex drive capsules tainted by dose of Viagra. The Age. Melbourne, 2007. 310

Mistry,R et al. A case of misdiagnosed squamous cell carcinoma due to alternative medical misadventure—time for tightening regulation? NZMJ. 2010, Apr 09;123(1312) 311

Medicinal plants – guidelines to promote patient safety and plant conservation for a US$ 60 billion industry. http://www.who.int/mediacentre/news/notes/2004/np3/en/ 312

Cui J et al. What do commercial ginseng preparations contain? Lancet. 1994 Jul 9;344(8915):134. 313

Yap KY et al. Overview on the analytical tools for quality control of natural product-based supplements: a case study of ginseng. Assay Drug Dev Technol. 2005 Dec;3(6):683-99. 314

Dodds S et al. When a Whole Practice Model Is the Intervention. Evid Based Complement Alternat Med. 2013;2013(652047):1-11. 315

Ritenbaugh C et al. Whole systems research: a discipline for studying complementary and alternative medicine. Altern Ther Health Med. [Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S. Review]. 2003 Jul-Aug;9(4):32-6 316

Review of the Australian Government rebate on private health insurance for Natural Therapies. National Herbalists Association of Australia - August 2012 http://www.health.gov.au/internet/main/publishing.nsf/Content/phi-natural-therapies-submissions-containerpage/$file/NHAA%20Submission.pdf 317

Budd S. Complementary Health. A consumer led trend. NZGP. 2001; 12 Dec:16. ISSN:1174-4960 318

World Health Organisation. WHO Traditional Medicine Strategy 2002-2005. World Health Organisation Publication. 2002. 319

Health and Independence Report 2008. http://www.health.govt.nz/publication/health-and-independence-report-2008 320

Health targets – 2011/12 quarter four – results summary. http://www.health.govt.nz/new-zealand-health-system/health-targets/how-my-dhb-performing/how-my-dhb-performing-2011-12/health-targets-2011-12-quarter-four-results-summary 321

WHO Traditional Medicine Strategy 2014-2023. WHO 2013. ISBN 978 92 4 150609 0

http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090_eng.pdf?ua=1. 322

Smallwood C. The Role of Complementary and Alternative Medicine in the NHS: An Investigation Into the Potential Contribution of Mainstream Complementary Therapies to Healthcare in the UK. London: FreshMinds, 2005. 323

Ernst E. The Smallwood report – Method or madness? BJ Gen Prac, 2006 Jan;56(522): 64-65 324

http://nicm.edu.au/__data/assets/pdf_file/0006/537657/Cost_effectiveness_of_CM_2010.pdf 325

Hindle RDC, Clapshaw DA, Hall AA. Human Rights Review Tribunal of New Zealand. New Zealand Legal Information Institute.2008 May.http://www.nzlii.org/cgi-bin/sinodisp/nz/cases/NZHRRT/2008/9.html?query=mogridge 326

Deputy Health and Disability Commissioner. Decision 06HDC09325. Health and Disability Commissioner. 2006. http://www.hdc.org.nz/decisions--case-notes/commissioner's-decisions/2006/06hdc09325 327

New Zealand Legislation. Medicines Act 1981. http://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html?search=sw_096be8ed80bee4b7_herb_25_se&p=1#DLM55417 328

Dunn J. Challenges in herbal medicine clinic research: Key issues in curriculum, contemporary herbal medicine clinical practice & professional development. NHAA Conference March, 2015.

http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090_eng.pdf?ua=1


105

329

Medical Misadventure. Accident Compensation Corporation. http://www.acc.co.nz/about-acc/glossary-of-acc-terms/PRD_CTRB103877 330

CITES.http://www.cites.org/eng/app/appendices.php

331 United Plant Savers. Species at Risk. 2013. www.unitedplantsavers.org/

332 http://www.hdc.org.nz/media/3584/MOH%20-

%20Proposal%20to%20regulate%20Herbal%20Medicine%20under%20HPCAA.pdf 333

Wardle J et al. Regulatory and legislative protections for consumers in complementary medicine: Lessons from Australian policy and legal developments. Eur J Integr Med. 2014; 6:423-433. 334

Natural Medicine Register Regulatory Options Paper November 2013 prepared by Meredith Carter & Associates.http://www.nmr.org.au/Documents/docs/Regulatory_Options_Paper_NMR_2013.pdf