This issue of the Newsletter mainly reports on the work of the Chinese Medicine Practitioners Board (PB) in the past four months, which includes the Chinese Medicine Practitioners Licensing Examination, renewal of practising certificates for registered Chinese Medicine Practitioners (CMPs), results of the review of the mechanism for Continuing Education in Chinese Medicine (CME), findings of disciplinary inquiries, and reminders for CMPs from the PB.
With a view to enabling elderly registered CMPs to enhance their professional knowledge and skills by participating in various CME activities, the PB has decided to adjust the upper limits of CME points acquired by registered CMPs aged 75 or above through participation in different accredited CME activities in each CME cycle on a pro rata basis. With respect to the effective date, this revision shall be applicable to CME cycles that commence on or after 1 January 2016. For details, please refer to the content.
Furthermore, it is also reiterated in this Newsletter that all registered CMPs must comply with the requirements on continuing education prescribed by the PB in order to have their practising certificates renewed. This is to ensure that their professional knowledge and skills are continuously improved through CME. Except under very special circumstances, the PB will reject applications for renewal of practising certificate from registered CMPs if they fail to acquire the required CME points unless and until they make up the unearned points.
With regard to disciplinary inquiries, the PB specifically reminds all CMPs to note and observe the regulations on professional responsibilities and ethics, make medical referrals when necessary, include all requisite information in the prescriptions, and report offences committed to the PB, as stipulated in the Chinese Medicine Ordinance (CMO) and the Codes of Conduct (the Codes1) in their practice lest they should violate the laws inadvertently or perform acts which might constitute professional misconduct.
Also featured in this Newsletter are the standards of prescribing Chinese herbal medicines (Chm) which contain aconitum alkaloids, arrangements for submitting product specification documents and general stability test reports for application of transitional registration of proprietary Chinese medicine (pCm), as well as information on the use of pCms in clinical research. Please refer to the content for details.
I hereby wish you all good health and happiness.
Mr WONG Kit
Chairman of the Chinese Medicine Practitioners Board
1The Codes refer to the Code of Professional Conduct for Registered Chinese Medicine Practitioners in Hong Kong and the Code of Conduct for Listed Chinese Medicine Practitioners.
Paper 1 and Paper 2 of Part I Written Examination of the 2015 Chinese Medicine Practitioners Licensing Examination were conducted on 9 June and 11 June respectively. The Clinical Examination (Part II) was conducted from 3 August to mid August. A total of 396 candidates sat for the Written Examination, 14 candidates were absent from the examination and 292 candidates (73.7% of candidates) passed the examination.
The PB will publish the Candidates' Handbook for the 2016 CMPs Licensing Examination in September 2015 and disseminate the details of taking the 2016 examination. Please take notice of the announcements on the homepage of the Chinese Medicine Council of Hong Kong (CMCHK) (http://www.cmchk.org.hk).
As at the end of July 2015, there were 6,896 registered CMPs, 65 CMPs with limited registration and 2,690 listed CMPs.
Pursuant to section 76 of the CMO, registered CMPs must obtain valid practising certificates before they are allowed to practise Chinese medicine in Hong Kong. The usual validity period of a practising certificate is three years. Registered CMPs should fulfill the CME requirements prescribed by the PB before they can renew their practising certificates.
From April 2015 to July 2015, 1,234 registered CMPs renewed their practising certificates. All registered CMPs who have their practising certificates renewed should report promptly to their CME Administrators their new CME cycles, required CME points, and the validity period of their practising certificates.
The CMO also stipulates that if registered CMPs practise Chinese medicine without obtaining valid practising certificates for a period exceeding six months since the expiry of their practising certificates, the PB may order removal from the Register the name of those registered CMPs in accordance with section 56(1)(d) of the CMO.
Apart from the CMO, the Codes also stipulate that registered CMPs should be holders of valid practising certificate to practise Chinese medicine. The PB will process violation cases seriously in accordance with the procedures stipulated under the CMO.
As stipulated in section 76(2) of the CMO, when a registered CMP applies for renewal of a practising certificate, his/her application shall be accompanied by a prescribed fee and a declaration as to whether he/she has been convicted of any offence punishable with imprisonment or whether he/she has been found guilty of misconduct in a professional respect. Besides, he/she is also required to submit a copy of the certificate of fulfillment of CME requirements issued by the CME Administrator.
Having considered that the CME system has been launched since February 2005, but there are still some registered CMPs who failed to acquire the required CME points, the PB has revised the arrangement from 1 July 2013 onwards that, if registered CMPs fail again to acquire the required CME points (i.e. they have been warned for their former failure), the PB will, except for very special circumstances, reject their application for renewal of practicing certificate until they make up the unearned points in the CME cycle. The PB has informed the CMP associations and all registered CMPs of the revised arrangement in February 2013 and further promulgated the arrangement vide the PB newsletter (Issue No. 33/April 2013). Attention of all registered CMPs is hereby drawn again to the above revised arrangement.
The CME system has been implemented since 28 February 2005. Five CME reviews were conducted in end 2005 and 2006, early 2009, 2012 and 2015 respectively. The report period of the fifth review was from 1 January 2012 to 31 December 2014 (36 months in total). The PB has completed the fifth review and review results are enclosed in Appendix.
With a view to enabling elderly registered CMPs to enhance their professional knowledge and skills by participating in various CME activities, the PB has decided to adjust the upper limits of CME points acquired by registered CMPs aged 75 or above through participation in different accredited CME activities in each CME cycle on a pro rata basis. To put it simple, the revised upper limits will be equivalent to half of those set for registered CMPs aged under 75. The above revision will apply to CME cycles which commence on or after 1 January 2016. The revisions are summarised as follows:
The PB held disciplinary inquiries from April to July 2015 on three registered CMPs and two listed CMPs who were convicted of an offence punishable with imprisonment and/or alleged breaching the Codes. Two registered CMPs and one listed CMP were found guilty after the inquiries. The PB warned and removed the name of a registered CMP for 18 months with a suspension of 24 months; reprimanded one registered CMP and put the decision for one listed CMP on record for future reference.
Summing up the above cases, the PB reminds all CMPs to take note of the following issues:
According to the provisions of section 2 of Part III of the Code, CMPs have a professional responsibility to patients. They should patiently explain to patients their medical conditions, methods of treatment and the precautions in taking drugs. They should diligently improve their professional knowledge and skills, so as to maintain high professional standards in providing medical service to patients. If the PB considers that a CMP, in the course of conduct of his profession, has conducted himself in a way which has fallen short of the reasonable standards of conduct expected among his professional colleagues, the CMP may have committed the above-mentioned provisions of the Code.
Appropriate Referral of Patients
According to section 2(5) of Part III of the Code, CMPs should make medical referrals when necessary, and the registered medical professionals to whom a patient is referred should be able to provide the required treatment according to the diagnosis. The PB reminds all CMPs to make appropriate referral of patients when necessary and choose the medicines or apparatus that best serve the medical interest of patients according to his independent professional judgment.
Information that must be included in prescriptions
The PB has noticed that there are CMPs who did not list out all information that must be included in their prescriptions, such as the names and dosages of all Chms medicines involved, methods of preparation and administration, the number of times for re-dispensing, the name, address, contact telephone number and signature of CMP, as well as the issuing date of the prescription. When prescribing pCms, CMPs should also clearly list out the ingredients and dosages of the Chms, so that patients would know the respective ingredients and dosages of the prescribed pCms. In addition, the names of all Chms should be based on the names in the Schedules of the CMO. Names of Chms not listed in the Schedules should be based on the names in the "Pharmacopoeia of the People's Republic of China" (《中華人民共和國藥典》), the "Chinese Materia Medica", (written by XU Guojun, etc.) (《中國藥材學》(徐國鈞等著)), the "Dictionary of Chinese Herbal Medicines" (《中藥大辭典》) or the "Chinese Herbal Medicines" (《中華本草》). Regarding the information that must be included in the issued prescriptions, CMPs could take reference from the Codes.
All CMPs are reminded again that patients have the right to know clearly the details of the Chinese medicines being prescribed. In case of any medical incident, medical professionals can make use of the prescription to initiate investigation and take immediate follow up actions for the best benefit of patients.
Reporting Court Convictions to the PB
According to the Codes, if a CMP has been convicted of an offence punishable with imprisonment in Hong Kong or elsewhere (irrespective of whether a prison term is imposed or not), he/she must report to the PB within 28 days, specifying the case number, date of conviction, venue, offence and sentence. If the CMP concerned fails to do so, the PB will take disciplinary actions in accordance with the Codes.
Chm containing aconitum alkaloids are mainly used to treat wind-dampness and relieve pain by warming the meridians. Aconitum alkaloids, being the active ingredients of these Chm, have their toxicity. Hence, use of these Chm may lead to poisoning incidents if due consideration is not taken in the quality of processing, dosages, decoction time, combination and source of Chm. When prescribing these Chm, CMPs should make reference to relevant usage recommendations, such as that of the "Pharmacopoeia of the People's Republic of China" (《中華人民共和國藥典》), and should exercise caution on the following issues:
Chm containing aconitim alkaloids such as unprocessed Radix Aconiti, unprocessed Radix Aconiti Kusnezoffii and unprocessed Radix Aconiti Lateralis are listed in Schedule 1 of the CMO, while processed forms such as processed Radix Aconiti, processed Radix Aconiti Kusnezoffii and processed Radix Aconiti Lateralis are listed in Schedule 2 of the CMO. Be cautious when considering prescribing unprocessed form for oral use and processed form should be used in general. If intended to be decocted for oral consumption, they should be decocted sufficiently by pre-decoction and prolonged decoction, in order to reduce its toxicity.
The prescribed dosages of these Chm should be tailored carefully according to patients’ clinical status. When prescribing a combination of Chm containing aconitum alkaloids, the dosages should be reduced suitably to prevent the patient from poisoning due to overdose of aconitum alkaloids.
To safeguard public health and safety, the CMO was enacted in 1999, the same year when the CMCHK, underpinned by the Chinese Medicine Practitioners Board and Chinese Medicines Board (Medicines Board), was established to formulate and implement regulatory measures relating to Chinese medicine. The registration system for pCms was put into practice by the Medicines Board in December 2003. Applicants should submit their applications to the Medicines Board in accordance with the relevant registration arrangements and requirements. The Medicines Board will then decide whether the applications should be approved taking into consideration the safety, quality and efficacy of the products, while the Department of Health (DH) provides professional and administrative support to the Medicines Board.
In view of the history and current situation of pCm sales in Hong Kong, and pursuant to section 128 of the CMO, local manufacturers or distributors (for products manufactured overseas) of all pCms manufactured, sold or supplied for sale in Hong Kong as at 1 March 1999 can apply for transitional registration for their products within the period specified by the Medicines Board (i.e. from 19 December 2003 to 30 June 2004). Applicants should provide objective evidences that their products meet the registration requirements. Having been fully assessed by the Medicines Board, the products will be issued with a "Notice of confirmation of transitional registration of pCm" (HKP).
Holders of HKP are required to submit documents in respect of the safety, quality and efficacy of the products to the Medicines Board to facilitate the processing of transitional registration to formal registration. A “Certificate of registration of pCm” (HKC) will be issued to products which have been assessed by the Medicines Board as meeting the registration requirements.
As promulgated by the Medicines Board on 26 June 2013, all holders of HKP must submit the product specification documents and general stability test report of the first batch of products on or before 30 June 2015.
Arrangements after the deadline for submission of product specification documents and general stability test reports for HKP products
The majority of the pCm registration holders have already submitted the reports before the deadline. On 7 July 2015, the Medicines Board issued reminder letters to holders who had not submitted any product specification documents or general stability test reports. The holders must submit in full the documents and reports within 3 months from the date of the reminder letters (i.e. on or before 6 October 2015). If they cannot do so, they should provide sufficient justifications (e.g. evidence issued by a testing centre that testing is being conducted) for consideration of the Medicines Board. Otherwise, the Medicines Board may consider rejecting the applications concerned.
The Medicines Board and DH have held seminars on the arrangements for the submission of product specification documents and general stability test reports for application of transitional registration of pCms, the content of which has been uploaded to the CMCHK website (http://www.cmchk.org.hk) for CMPs' perusal.
Implications of the situation on CMPs
When procuring pCms for patients’ use, CMPs must take heed of whether the products have been approved for sale on the market. For the list of the relevant pCms, please refer to the CMCHK website (http://www.cmchk.org.hk).
Pursuant to section 119 of the CMO, no person shall sell, import or possess any pCm unless the pCm is registered with the Medicines Board, otherwise that person shall be guilty of an offence and is liable to a maximum fine at level 6 and imprisonment for 2 years.
Furthermore, section 158(6) of the CMO and section 37 of the Chinese Medicines Regulation respectively expounded on the exemptions for registered CMPs and listed CMPs on administering or supplying pCms to patients, as well as entrusting licensed pCm manufacturers with the manufacture of the pCms. Please visit the website of the Bilingual Laws Information System of the Department of Justice (http://www.legislation.gov.hk) for the detailed provisions.
Pursuant to section 129 of the CMO, for the purpose of facilitating the conduct of a clinical trial or medicinal test of any pCm, the Medicines Board may, upon application, issue a certificate for clinical trial and medicinal test (the certificate). Upon receiving the documents, information, samples and other materials required, and payment of the prescribed fee, the Medicines Board may issue a certificate, and impose such conditions as the Medicines Board thinks fit.
The Medicines Board has also developed the 'Good Clinical Practice for Proprietary Chinese Medicines' (GCP) as the guiding principles of clinical trials for pCms in order to ensure the trial process is standardized, the results obtained are scientific and reliable and the rights and safety of the trial subjects are protected. The GCP can be downloaded from the following link (http://www.cmchk.org.hk/pcm/pdf/gcp_e.pdf).
Clinical Trial is defined in the GCP as any systematic investigation in human bodies (patients or healthy volunteers) intended to verify and discover the effects, adverse reactions and/or absorption, distribution, metabolism, and excretion of an investigational product with the objective of ascertaining its efficacy and safety.
In order to facilitate the stakeholders in applying for the certificate, the Medicines Board has formulated the Guidance Notes on the ‘Application for Certificate for Clinical Trial and Medicinal Test (Reference for Industry)’ and ‘Guidance Notes on the Application for Certificate for Clinical Trial and Medicinal Test’ as reference documents. The aforesaid documents can be downloaded from the CMCHK website (http://www.cmchk.org.hk/pcm/pdf/CT_Cert_GL.pdf).
Please note that according to section 119 of the CMO, no pCm shall be sold, imported or possessed unless it has been registered. A pCm shall not be taken as registered under section 121 unless its particulars are identical with the registered particulars of the registered pCm. The provisions under section 119 of the CMO (pCms to be registered) are not applicable to the pCms imported by holders of the certificate to be used in the clinical trial relating to the certificate. Pursuant to section 158(1) of the CMO, the Medicines Board may exempt, with or without conditions or restrictions, a person or institution concerned with education or scientific research from the application of section 119 (pCms to be registered) if the pCms in question are required for the purposes of education or scientific research.
As such, in order to use unregistered pCms in clinical trials, the sponsor/ investigator must apply for a certificate, whereas for locally-manufactured pCms used as investigational products, exemptions pursuant to section 158(1) of the CMO should be separately applied for. The application forms for the certificate and exemptions pursuant to section 158(1) of the CMO can be downloaded from the CMCHK website (http://www.cmchk.org.hk/pcm/eng/#main_down02.htm#CT_Cert)
In accordance with section 56(2) of the CMO, the PB may order the removal from the Register the name of any registered CMP who fails to acknowledge within 4 months after the date of despatch the receipt of a registered letter addressed to him at his address as recorded in the Register. Pursuant to section 57 of the CMO, the PB will serve a notice on the registered CMP in question, stating its intention to make the order of removal under section 56(2) of the CMO, and inviting him to give a written representation to the PB.
The PB appeals to the following registered CMP for contacting the Secretariat of the CMCHK as soon as possible. If other CMPs have contact with him, please notify him of the above.
All CMPs are requested to notify the Secretariat as soon as possible if there are changes in their registered address, correspondence address, practising address, telephone number, fax number and other personal data which have been previously reported to the PB. The form of Change of Personal Particulars of CMPs can be obtained from the Secretariat or downloaded from the CMCHK homepage (http://www.cmchk.org.hk).
Should you have any opinions regarding the content of the Newsletter, please send them to the Secretariat by post, fax or email, indicating "Newsletter of the Chinese Medicine Practitioners Board". All published Newsletters are uploaded to the CMCHK homepage (http://www.cmchk.org.hk). CMPs are cordially invited to visit the above website.
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