On November 16, 2015 the Chinese Medicine Board Australia has released the final guidelines for safe herbal dispensing. The aim of the guidelines is to provide recommendations to the most suitable nomenclature to be used on labels, greater consistency across the profession and the protection of the general public.
Pin Yin and Herbal Compendium for Cross-Referencing
The public consultation process of the draft guidelines released by the National Board between May and July 2014 created a massive response from the profession. The area that was most criticized was the use of botanical names on labels. At the time, we carefully prepared a submission as we were unable to understand why the board would make such a suggestion. Since Chinese medicine modalities have become a part of Western cultures, herbs have always been named in Pin yin.
Thankfully, with the assistance of a high profile expert committee (TAG = Technical Advisory Group) the board has come to the conclusion that their recommendation is Pin yin. In addition, the board commissioned The National Institute of Complementary Medicine to develop a nomenclature compendium of commonly used Chinese herbal medicines for cross-referencing. This compendium is downloadable from the Board’s webpage as an excel file.
With this extract, we have attempted to capture the essence of the document.
Who Does Have to Know About the Guidelines?
- Chinese medicine practitioners, Chinese medicine students (who perform supervised clinical treatments) and dispensary assistants (who are supervised by registered Chinese medicine practitioners).
What Type of Medicines Do They Apply To?
- Any medicines that you are going to prescribe/dispense or compound for a patient that you have had a consultation with (extemporaneously compounded exemptions).
- It also includes any topical formulas.
- Please consider CITES and SUSMP restricted herbs.
- Use the free compendium provided by the board (downloadable in Excel). Any alterations made to this compendium after downloading will invalidate it. Feedback on the compendium is welcome. To provide feedback on the compendium please email email@example.com”.
- The medicines prescribed/dispensed and/or compounded (internal and external) have to be noted in the patient records.
- Provide proper instructions to your patient in English language or the language of the patient.
- Attach a label with relevant and accurate information to your prescribed/dispensed/compounded product.
- The nomenclature for herbs is Pin yin, in case where there is potential for confusion, another names such as the botanical (scientific) or pharmaceutical name should be used (-> Appendix 2 of guidelines: 1) Da Ji 大蓟, 2) Da Ji (Circium japonicum), 3) Da Ji (Cirsii Japonica Herb).
- If you write a prescription for the patients to take away, it has to be written in English and contain information outlined -> Appendix 3. The information in Appendix 3 is also required to be dispensed with manufactured herbal medicines.
- Pre-packaged herbal medicines (manufactured herbal medicines) has to be manufactured under GMP (Good Manufacturing Practice) principles. They need to be registered with the firstname.lastname@example.org(Australian Register of Therapeutic Goods) and should not be re-packed by a Chinese medicine practitioner/dispenser -> Appendix 6.
Compounding & Dispensing
- Make sure that you dispense accurately and exactly what’s on the prescription.
- It’s required by the dispenser to scrutinize the prescription before dispensing for obvious errors (dosage, instructions, restricted herbs)
- Provide the patient with clearly written instructions in English language (or the patient’s language) on how to prepare, ingest and/or apply the medicines topically. Point out if there are precautions about other medicines, herbs, food.
- If using an independent dispenser, provide information on how many repeats are to be filled (if applicable).
- Provide or observe the expiry date of the prescription.
- Be aware and manage potential conflicts of interest (e.g. Dispensing/compounding what’s on your shelf rather than what the patient needs).
- Use sensible judgment for patients who self-medicate (and you are supplying/selling patent medicines).
- If you are using an independent dispenser, you must provide the patient with a written prescription.
Adverse Effect Reporting
- If any adverse effects occur or are suspected with a patient on herbal medicines, it’s the profession’s responsibility to report them to the TGA (Therapeutic Goods Administration) -> Appendix 7 of the guidelines clearly explains how it should be done.
As this guidelines will be enforced by the board, practitioners have two years to transition from their current systems to meet the requirements. The board uses the guidelines as evidence as what it considers professional conduct. Also, the board aims at reviewing the guidelines every 3 years.
We welcome the publishing of this long awaited guidelines. It will assist our profession to reach a higher standard in herbal dispensing practices.