Publications

Published: 1 June 2017

Prescribing Cannabis-based Products

Prescriber Update 38(2): 21-23
June 2017

The use of cannabis-based products for medicinal purposes is attracting considerable public interest in New Zealand and internationally. In New Zealand, over the past few years, there has been increasing public pressure on prescribers, the Ministry of Health and Government to enable greater access to products derived from the cannabis plant. Cannabinoid products can also be manufactured synthetically and have been available in the United States and some other countries for several years. However, most advocates of the medical benefits of cannabis believe that products derived from plant material are more effective.

The Government prefers to refer to ‘cannabis-based products’ rather than ‘medicinal cannabis’ because the majority of the products available do not meet the criteria normally associated with a medicine. That is, the products are not manufactured to international good manufacturing practice (GMP) standards for pharmaceutical-grade products. Evidence of the composition of these products, the reproducibility of the composition from batch to batch and the stability of the products in use is not available. Evidence of the safety and efficacy of most of the individual products from clinical trials is lacking. Nonetheless, an evidence base for the use of cannabis for medicinal purposes is developing.

Evidence

There are now a large number of clinical trials of cannabis-based medicines reported and several systematic reviews1–3. The majority of trials have used synthetically produced medicines. Evidence of the efficacy of cannabis-based medicines in certain conditions is now emerging and there is good agreement across the systematic reviews as to the benefits of cannabis-based products and also the potential harms.

The most recent and comprehensive review is The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research1.

Information for Healthcare Professionals

Health Canada has a comprehensive publication Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids (www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php). It was published in February 2013 and an update is due later in 2017.

This publication provides comprehensive information on pharmacology and potential therapeutic uses. Please note that in Canada, cannabis is available for smoking from federally licensed producers and since the publication of this document patients have again been allowed to grow their own cannabis pursuant to a medical document.

The Therapeutic Goods Administration (TGA) in Australia is undertaking a systematic review with the aim to develop clinical guidelines to educate and assist prescribing choices. They aim to complete this review in 2017. In the interim, the Queensland Department of Health has developed the first clinical guidelines for Australia (www.health.qld.gov.au/__data/assets/pdf_file/0023/634163/med-cannabis-clinical-guide.pdf).

The Queensland Department of Health notes that this guide will be replaced by the national document when completed. The information is mostly transferable to the New Zealand situation. One principal difference is that Sativex is available in New Zealand, whereas it is imported on an individual patient approval basis in Australia.

Products

At the time of writing, Sativex is the only cannabis-based medicine with consent (approval) for distribution in New Zealand. Sativex is indicated as add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. Sativex for other indications is unapproved.

All other cannabis-based products are unapproved in New Zealand. Prescribers need to be clear on their responsibilities under the Code of Health and Disability Services Consumers’ Rights to ensure that the patient is fully informed and that written consent is obtained. Please see the Medsafe Guidelines for Use of Unapproved Medicines (www.medsafe.govt.nz/profs/RIss/unapp.asp).

Other products that the Ministry of Health believes are of pharmaceutical grade or are GMP certified for at least part of the manufacturing process are Tilray and Bedrocan.

Tilray products are manufactured by a Canadian company. Tilray has oil and capsule products that have been produced to GMP standards for the cultivation and extraction of the active ingredients, but the Ministry of Health does not consider that the products are pharmaceutical grade.

Bedrocan products are obtained from certified sites in the Netherlands. Bedrocan has a range of standardised plant (cannabis flowers, often called flos, and granulated plant material) products with different standardised concentrations of THC and CBD. The recommended method of administration for Bedrocan is via a medical vaporisation device.

Other cannabinoid-based medications include Marinol containing dronabinol (a synthetic THC), Cesamet containing nabilone (a synthetic analogue of THC) and Syndros, a liquid formulation of dronabinol. These are medicines based on cannabinoids but have been manufactured synthetically rather than derived from cannabis plant material. They are all pharmaceutical grade, FDA approved and can legally be exported from the United States.

All other available cannabis-based products produced in the United States that the Ministry of Health is aware of are not pharmaceutical grade. Cannabis-based products derived from plant material are also classified as Schedule 1 substances, which means that they cannot be legally exported from the United States.

To date, the Ministry of Health has only received applications to prescribe and import one particular Tilray product. The Ministry of Health has not tested the availability of the other products listed above.

Application Process

Cannabis-based products are Class B1 or C1 controlled drugs and Ministerial approval is required before these can be prescribed, supplied or administered, in accordance with Regulation 22 of the Misuse of Drugs Regulations 1977. Ministerial approval is now delegated to the Ministry of Health for all types of cannabis-based products.

To prescribe cannabis-based products:

  1. an application to the Ministry of Health is required in most cases. The exception is when prescribing Sativex for the consented condition of multiple sclerosis. In this case, a general ministerial approval has been gazetted to allow medical practitioners with a vocational scope of practice of Internal Medicine (specialising in neurology), or a general practitioner on the recommendation of a neurologist, to prescribe Sativex for multiple sclerosis without an application to the Ministry.
  2. a specialist needs to be involved in the application process in all instances, and needs to make the application to the Ministry of Health, except for applications for off-label uses of Sativex when a GP can apply following the recommendation of a specialist.

Further information and application forms can be found on the Ministry of Health website (www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/prescribing-cannabis-based-products).

If you have any questions relating to an application, or potential application, for a cannabis-based product please email medicinescontrol@moh.govt.nz.

References
  1. The National Academy of Sciences, Engineering and Medicine. 2017. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press. doi: 10.17226/24625 (accessed 20 April 2017).
  2. Barnes MP, Barnes JC. 2016. Cannabis: The Evidence for Medical Use. London: All-Party Parliamentary Group for Drug Policy Reform. URL: drugsandalcohol.ie/26086/ (accessed 20 April 2017).
  3. Whiting PF, Wolff RF, Deshpande S, et al. 2015. Cannabinoids for Medical Use, A Systematic Review and Meta-analysis. JAMA 313(24): 2456–73. doi:10.1001/jama.2015.6358 (accessed 20 April 2017).