‘Medicinal Cannabis Must Become a Core Pharmacy Offering’
Speak to any senior pharmacy industry executive in the USA or Canada and they will tell you that the pharmacy profession missed the boat on medicinal cannabis. Their emphatic message to Australia is to ensure the pharmacy profession engages early, and to ensure the wider community pharmacy network facilitates the dispensing of medicinal cannabis. That is the best option for the continuity of care for the patient and it is the best option for the business of pharmacy. This is exactly what the Medicinal Cannabis Medicines Portal (MCMP) will achieve, but before explaining the new Portal, here is some key background information.
Medicinal Cannabis – Not First-Line Therapy
Medicinal Cannabis will be prescribed as an adjunct to therapy, but not prescribed as first-line therapy. When prescribed, patients will be advised to continue taking their current medicines. That approach will help assess if the medicinal cannabis has had the desired therapeutic effect. It would be a mistake therefore to leave medicinal cannabis to be dispensed at specialist pharmacies via mail order, or purpose build pharmacies because eventually they will also dispense the patient’s other medicines.
To date, doctors in Australia have been slow to embrace medicinal cannabis because they seek prescribing guidelines, dose titration information and want a guarantee from their professional indemnity organisations that they will be covered legally for prescribing the product. Those issues will soon be addressed.
Governance and Guidance regarding Medicinal Cannabis
The Australian Advisory Council on the Medicinal Use of Cannabis is the peak body in Australia which provides advice to the Minister for Health on issues relating to the medicinal use of cannabis and the implementation of the regulatory scheme under the Narcotic Drugs Act 1967. In addition to receiving briefings on the regulatory scheme for the cultivation, production and manufacture of medicinal cannabis in Australia, Council members discuss three main areas of interest:
- the current state of evidence for the use of medicinal cannabis
- patient access and medical practitioner education
- aligning State, Territory and Commonwealth schemes.
In October 2016, the National Drug and Alcohol Research Centre (NDARC) was contracted by the TGA to review evidence regarding Medicinal Cannabis in key medical conditions. By the end of the year, and from this review, the TGA will develop five clinical guidance documents aimed at assisting doctors in prescribing medicinal cannabis products and identifying suitable products. These documents will be a guide only and thus are not legally binding. I personally expect to see significantly more prescriptions when these documents are in place. The five therapy areas where ‘Guidance’ will be provided will be:
- Palliative Care
- Multiple Sclerosis
- Nausea and vomiting, including chemotherapy-induced and in HIV/AIDS
Access to Medicinal Cannabis
On 1 November 2016, the TGA down-scheduled medicinal cannabis from a S9 to S8 Controlled Drug. As there is no local production of medicinal cannabis, the TGA created an access pathway to allow for imported, unapproved medicinal cannabis via Special Access Scheme Type B (SAS B) and Authorised Prescriber (AP).
In my opinion, the SAS B bulk import method is the only efficient method for pharmacies to implement supply. Under this process, an importer may seek import approval of medicinal cannabis products before SAS B approvals and Approved Prescriber requests, which will allow for supplies of medicinal cannabis products to be available in a timelier fashion. This does not change the requirements for approval through SAS B or AP, but reduces the time taken from approval to supply. Supply of medicinal cannabis products will remain a controlled process and there are several strict conditions that will be placed on importers and suppliers around what types of medicinal cannabis products may be imported and supplied, and how. The Portal aims to streamline this process for prescribers and dispensers.
Overlaying this, States and Territories have their own requirements so the administrative burden has impacted access to the product. Doctors must submit and obtain necessary Federal and State approvals. The Pharmacy must have necessary approvals to dispense the product and order the product from a licenced bulk sponsor.
Medicinal Cannabis Medicines Portal (MCMP)
Sinapse/ PharmaPrograms has launched the Medicinal Cannabis Medicines Portal (MCMP) (mcmp.com.au). The MCMP is a collaborative approach between Prescribers, Pharmacists and Sponsors to help patients get timely access to appropriate medicinal cannabis treatment in line with all applicable National and State/Territory based laws and requirements. Sinapse, a health consultancy, has developed an IT-based system to bring transparency to the process, and product and price certainty for the prescribing and dispensing of medicinal cannabis in Australia. If your pharmacy has not already done so, they should register and begin using the MCMP to help their patients get legal access to medicinal cannabis. The patient live launch of the MCMP will occur in October 2017.
Pharmacy Preparatory Work
In some States and Territories there are prerequisites that need to be in place before a pharmacy can dispense a prescription for Medicinal Cannabis. By way of example, in Queensland, a pharmacy must have a Medicinal Cannabis Management Plan in place and this plan needs to be submitted to Qld Health via a specific notification form before a prescription can be dispensed. All State/Territory requirements are detailed on the MCMP which will be kept up to date as legislation changes.
The Guild has developed the Medicinal Cannabis Readiness Module and I recommend this be completed — it is worth the small fee. The course takes approximately 3 hours and is divided into three modules:
- Module 1 – Background/Introduction to MC
- Module 2 – Legislation and Dispensing requirements of MC
- Module 3 – Therapeutics of MC
What does participation in the MCMP involve?
The overall aim of the MCMP is to support patients to ensure better compliance to these medicines. This means:
- Network Pharmacies must agree to dispense the specific Medicinal Cannabis at no more than the listed price. The prices will be available on the MCMP, and the patient will be made aware of the maximum price for their Medicinal Cannabis product when it is prescribed by their doctor.
- Consent must be gained from the patient to be registered in the MCMP if the prescriber has not already done so.
- Network Pharmacies will order the specific Medicinal Cannabis item once they have sighted the prescription and SAS B Approval form, and the patient has paid for the medicine. The patient will have been provided a tailored form (available via the MCMP) by their doctor explaining the process, which they should bring with them when paying for and collecting their medicine.
- All Commonwealth and State/Territory prerequisites for dispensing Medicinal Cannabis must be met, and Network Pharmacies also need to ensure they have opened accounts with the preferred wholesaler of the specific Medicinal Cannabis manufacturer.
- Pharmacy staff must notify patients, or their carers when the stock arrives at the pharmacy.
- Network Pharmacies will create a tailored Patient Information Leaflet (available via the MCMP) to explain some key Quality Use of Medicines (QUM) elements. A printed copy is to be provided to the patient each time they collect their medication.
- Some sponsor manufacturers will remunerate pharmacies for additional pharmacist led patient support programs which are separate to the standard PharmaPrograms professional service fee.
Resources for the Program
Once your pharmacy is registered, you will receive an email at the nominated address with your Pharmacy ID details for the MCMP. Store those details in a safe location and share with appropriate pharmacy staff. Print the Implementation Checklist and Quick Reference Guide to ensure your team is ready for the first patient request. Review the Staff Q&A to help answer any questions you may have about the Portal and arrange a staff meeting, utilising the Staff Meeting Agenda. PharmaPrograms are facilitating the MCMP and are available to answer any questions relating to the logistics and workings of the portal via 1300 364 231 (9 am to 5 pm AEST, Monday–Friday) or by email at firstname.lastname@example.org.
Medicinal cannabis must be seen as a core pharmacy offering in the eyes of the Australian consumer. For that to occur, it needs to become a national pharmacy offer. A national pharmacy offer is defined as one that is offered by at least 50% of the community pharmacy network. Almost every patient that will be prescribed medicinal cannabis will also be taking many chronic therapy medicines. It is in your interest to support and assist these patients and facilitate their access to medicinal cannabis.
Kos Sclavos, Senior Health Strategist, Sinapse