Guidelines for safe practice of Chinese herbal medicine

Codes and Guidelines

This FAQ relates to the Guidelines for safe practice of Chinese herbal medicine.

Labels, nomenclature & packaging

Is pin yin accepted as the standard form of writing herb names?

Yes. You need to use the authorised pin yin as found in the Herbal Nomenclature Compendium of commonly used Chinese herbs, commissioned by the Board and published here.

Do I have to use the botanical / scientific name of herbs when writing prescriptions or labels?

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No, except when the scientific name is required to clarify potential ambiguity, or if you prefer to use these names in addition to the pin yin. Examples are given in Appendix Two of the Guidelines for safe practice of Chinese herbal medicine.

Can I use Chinese characters alone to list the herb names in a prescription or on a label?

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No, it must be accompanied by the pin yin name, examples of which are given in Appendix One of the Guidelines for safe practice of Chinese herbal medicine. Other members of the healthcare team, or the patient or caregiver, who may not understand Chinese characters, may need to know what herbs the patient is using.

Can I add Chinese characters to the pin yin when writing herb names on prescriptions and labels?

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Yes, so long as the pin yin name is clearly stated.

Do written instructions about the preparation and administration of herbs and any decoction methods have to be provided to the patient every time a formula is dispensed?

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Yes.

Can cooking preparation instructions be given in a language other than English when this benefits the patient because it is their first language?

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Instructions for preparing or cooking Chinese herbal medicine ingredients should be provided in English and, if desirable, in the patient’s language.

Can a pre-packaged, manufactured medicine (often referred to as ‘patent medicine’ or ‘cheng yao, 成药，成藥’) be repackaged either in the same quantity or smaller quantities?

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In most instances, the Board strongly discourages repackaging of listed or registered medicines into smaller quantities. Occasionally there may be a valid reason to dispense a smaller quantity of a manufactured medicine for a specific patient or for a specific reason (see section 4.3 of the guidelines).

If unexpected symptoms occur which the practitioner believes are probably not caused by the herbs or other treatment, should an ‘adverse event’ notification be submitted?

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Although the event may or may not be related to the medicine or treatment, it is the professional responsibility of all Chinese medicine practitioners to report suspected adverse events to the Therapeutic Goods Administration (TGA). (See section 7 and Appendix 7 of the guidelines for further details).

Is a practitioner in trouble on the basis of an ‘adverse event’ or ‘adverse reaction’ report?

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No. Reporting adverse events is designed to improve quality assurance in healthcare. It is a public health safety system designed to identify unusual but important side effects. It is not used to penalise people who report it.

Dispensers and assistants

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Can a dispenser who is not a registered Chinese herbal medicine practitioner make decisions about the suitability of a formula for the patient?

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No. If the dispenser has questions they should consult the prescriber.

If a herbal formula is unusual in any respect (e.g. it includes potentially toxic herbs, or herbs in a unusually high dosage, or unusually prolonged administration) should the dispenser discuss this with the patient?

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No. If the dispenser has questions, they should consult the prescriber. If the patient has questions, they too should consult the prescriber.

Does a dispenser or dispensing assistant who is not a registered Chinese herbal medicine practitioner have to provide the patient with written instructions for preparation and administration?

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Yes. The instructions must be as the same as the instructions written by the prescriber.

If written instructions for preparation and administration are given is it necessary also to explain verbally?

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Yes. The dispenser has a duty and responsibility to ensure that the patient understands the preparation and administration instructions clearly. The dispenser must also be prepared to answer questions and to consider the needs of any patients with impairments or disabilities to ensure that the patient can understand how to use their medicine safely.

Who has ultimate responsibility for the supervision and training of dispensing assistants to ensure that the guidelines are followed?

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The registered Chinese herbal medicine practitioner or the registered Chinese herbal medicine dispenser who employs them.

Individualised (also known as ‘customised’) formulae which are dispensed on the spot for a particular patient at a particular time (extemporaneously), are exempt from Good Manufacturing Practice regulations. Are formulae prepared in advance before a patient or patients present with a particular condition also exempt?

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No. See https://www.tga.gov.au/resources/resource/guidance/overview-regulation-listed-medicines-and-registered-complementary-medicines

Other

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Do the Safe Chinese Herbal Medicine Practice Guidelines apply to the use of injectable Chinese herbal medicines?

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No, this is not a standard form of Chinese medicine practice in Australia and is not taught in accredited Australian Chinese medicine programs.