Low-or-no THC cannabinoids scheduled S4, more education for health professionals, PBS subsidy and national consistency can break down medicinal cannabis access barriers, say pharmacy groups
In November 2019, the Senate referred an inquiry into the current barriers to patient access to medicinal cannabis in Australia to the Senate Community Affairs References Committee.
Submissions were originally due by 17 January, but an extension until 26 February 2020 has been granted.
Here’s what three key pharmacy groups had to say in their submissions.
The Society of Hospital Pharmacists of Australia:
The SHPA’s submission notes that its members are “progressive advocates for clinical excellence and are committed to evidence-based practice and passionate about patient care”.
It says that, “Currently, the greatest barrier to the access and wide-spread utilisation of medicinal cannabis in Australia is largely due to the limited scientific evidence available to support its use”.
While SHPA notes that hospital pharmacists are accustomed to dealing with high-cost and experimental medicines, and have a strong role in supporting prescribers and patients in their safe use, the “lack of scientific evidence and therefore quality clinical guidelines, on the use of medicinal cannabis has created a culture of uncertainty amongst health professionals”.
It notes the TGA guidance for use of medicinal cannabis indicates that the medicine only be considered when registered medicines have been tried and proven unsuccessful in managing the symptoms or condition; further, the guidance includes caveats that state the information is for an unapproved medicine in the context of limited evidence of efficacy.
SHPA says it has received member feedback suggesting that medicinal cannabis manufacturers have been “reluctant” to fund clinical trials and provide their product free to candidates.
“There is a concern that candidates who pay a significant amount of money to be involved in the current medicinal cannabis clinical trials, bias them,” it warns.
SHPA consulted members of relevant speciality practice groups and found that these SHPA members were concerned that given the ack of evidence of this unlicensed product there is “remarkably” a lack of safety barriers to access of medicinal cannabis in Australia.
“With government bodies bending to political pressure, the majority of Special Access Scheme applications are being approved, even those considered potentially unsafe,” it says.
“Members have also noted that prices of backyard grown medicinal cannabis products have skyrocketed and desperate patients/carers are purchasing them without any certainty of the quality and/or safety of these unregulated products.
“Members report extra costs attributed to certain medical practices who charge exorbitant amounts for what would typically be considered regular healthcare. That is, in addition to the price of the product, certain medicinal cannabis clinics are charging patients unreasonable prices for initial consultations, the filling out of SAS applications, follow up phone consultations etc.”
Ultimately the SHPA is calling for a larger focus on the gathering of evidence to support the clinical use of medicinal cannabis and the development of clear clinical guidelines for health practitioners.
Combined with health professional education, this would help reduce barriers to access, it says.
The Pharmaceutical Society of Australia:
The PSA’s submission states that the organisation supports a “rigorous but flexible” national regulatory framework for the medicinal use of cannabis.
This framework would be able to accommodate changes or enhancements in a timely manner as more information on the evidence of efficacy of cannabis and cannabinoids becomes available, PSA says.
PSA says it supports uniformity regarding access to medicinal cannabis products, and that where possible, this should involve national consistency to reduce confusion for everyone involve.
Despite work by the TGA and Office of Drug Control to improve access mechanisms and processes, PSA says pharmacists feel that “the available information is still onerous and not streamlined as well as it could be”.
“Despite the efforts to broaden access to medicinal cannabis, some pharmacists were aware that, in some situations, the burdensome processes were so significant that they impacted negatively on patients who, with high acuity needs, end up accessing cannabis from ‘illicit’ pathways or the black market,” PSA observes.
“Pharmacists have observed that patients can become trapped in a cycle of illicit use. Some people have reportedly commenced illicit use of cannabis, often as a last resort, and found that it helped to manage their condition better and improved their overall quality of life.
“As they would prefer to access cannabis legally for medicinal use, the patients try to locate doctors who will consider prescribing medicinal cannabis.
“However, patients feel frustrated when they cannot find a medical practitioner who is either willing to prescribe or write a referral to another doctor who will consider medicinal cannabis for their therapy.
“Pharmacists who have spoken to patients and medical practitioners also discovered that many doctors voiced concerns including, ‘I don’t believe medicinal cannabis works’ and ‘I don’t want anything to do with unregistered medications’, or that their clinic or practice preferred to not be associated with patients who could be regarded as exhibiting drug-seeking behaviour.”
PSA also says that as the evidence base grows, appropriate consideration can be given to the most appropriate scheduling.
However it says cannabinoids with low or no amounts of delta-9-tetrahydrocannabinol (THC) and therefore minimal or no psychoactive properties should be considered proactively for inclusion in Schedule 4.
Pharmacists have also complained that procurement of medicinal cannabis products is difficult, involving a limited supply channel, cumbersome paperwork, delays in the arrival of orders and significant costs to pharmacies and patients.
“As with all therapeutic products, pharmacist have an important and integral role in supporting patients and carers in the supply, use and management of cannabis products for medicinal purposes,” says the PSA.
“From the perspective of pharmacists, challenges have been experienced by patients, carers and health professionals in accessing medicinal cannabis products.
“While acknowledging the current limited experience in therapeutic use and evidence base of medicinal cannabis products, PSA believes it is in the long term interests of Australian patients that governments continue to invest in research and trials and work with health professionals and patients to improve access arrangements.”
The Pharmacy Guild of Australia:
The Guild says in its submission that it feels that the TGA is the appropriate regulatory body to deal with medicinal cannabis regulation, as with other medicines; and that the PBS is the appropriate mechanism to subsidise them.
The Guild also notes that all health professionals would benefit from ongoing training and education on the subject, as well as the Australian regulatory system.
“The Guild supports the medicinal use of cannabis preparations, following appropriate consideration by Australia’s regulatory bodies as with other therapeutic goods,” it says.
“We believe the current regulatory regime through the Therapeutic Goods Administration (TGA) Special Access Scheme, Authorised Prescriber Scheme and clinical trials is appropriate.
“The Guild did not support the creation of a new regulator for licensing the production, manufacture, supply, use and import and export of medicinal cannabis.”
This was for several reasons, including that such a new body would fragment regulation.
As for PBS subsidy, the Guild notes that “Under the PBS, the government subsidises the cost of medicine for most medical conditions”.
“Most of the listed medicines are dispensed by pharmacists for use by patients at home. We believe that it is entirely appropriate for the PBS to be used for subsidising patient access to medicinal cannabis products and that it would be unnecessary and wasteful to develop another subsidy scheme along with all the attendant bureaucracy and additional costs of evaluation, listing and claiming processes etc for medicinal cannabis products.”
The Guild also calls for the States and Territories to work together to harmonise variations in their Poisons legislation, including for medicinal cannabis.
It expresses concern that patients may be relying on unregulated supplies of cannabis, “as they will not have been assessed for quality safety and efficacy”.
“Community pharmacies are the most easily accessed primary health care facility in Australia and the vast majority of pharmacies are open after-hours, including weekends.
“Given the high accessibility, community pharmacies should be involved in the delivery of these products to consumers.”
Hear pharmacy opinion leaders discuss the evidence for and against the use of medicinal cannabis by patients, the TGA’s approach to approval, and how pharmacists can discuss the topic both professionally and with patients. Access the AJP podcast here.