Optimising Medical Cannabis Policy Panel an Australian Labor Party member of the New South Wales Legislative Council since May The Lambert Initiative is advancing medicinal cannabis research for Our aim is to optimise safe and effective cannabinoid therapeutics into mainstream medicine in Australia and beyond to deliver We acknowledge the tradition of custodianship and law of the Country on which the University of Sydney campuses stand. Medicinal Cannabis and the Tyranny of Distance: Policy Reform Required for Optimizing Patient and Health System Net Benefit in Australia Appl Health Econ barnesreview.info# page1.
(Video) Cannabis in Medicinal Australia Optimizing Policy
From a healthcare perspective, medicinal use of cannabis would refer to use based on a prescription or recommendation by a registered physician, for a known medical condition, that has evidence demonstrating its indication and efficacy [ 3 ].
For many years, cannabis has been viewed as an illicit substance and this negative repute has hindered efforts to conduct research into its therapeutic benefits. A plethora of literature exists investigating the abuse, misuse and side effect profile of cannabis, in the realms of addiction, mental cognition and schizophrenia.
More recently however, there has been a gradual increase of research into the therapeutic benefits associated with the medicinal use of cannabis. The expanding body of research into the medicinal application of cannabis has initiated the development of marketable forms of cannabis internationally, as well as rapid policy making by governing bodies worldwide.
A systematic and meta-analysis into the therapeutic applications of cannabis provided moderate-quality evidence to support the use of cannabinoids for the treatment of chronic pain and spasticity. For conditions other than pain and spasticity such as nausea and vomiting, weight loss in HIV infection, sleep disorders and Tourette syndrome , minor improvements were noted [ 4 ] and more evidence is emerging as more stringent investigations are being undertaken.
Globally, the type and intent of legislation governing cannabis use is complex and varied with focus on both general and medicinal use. In the case of medicinal cannabis, countries including the UK, Denmark, Czech Republic, Austria, Sweden, Germany, and Spain [ 3 ] have all formally approved use of cannabis based products of one form or another Table 1 , [ 5 ] thus decriminalising its therapeutic use.
In the United State US to date, 18 states and Washington DC have legalised recreational cannabis use, and 23 states in total have legalised the medicinal use of cannabis [ 6 ].
The US Foods and Drugs Administration FDA has yet to approve the marketing of products containing or derived from botanical marijuana extract—despite its legislative status. There are, however, approved synthetic cannabis derivatives formulated such as dronabino l, the marketed deltatetrahydrocannabinol THC analogue registered as Marinol, for the therapeutic treatment of anorexia in AIDS patients. Also, Cesamet containing the synthetic THC analogue nabilone , which is approved as a last line antiemetic.
It has also registered the nabiximol Sativex [ 9 ], a combination of cannabidiol and THC, for the indicated treatment of spasticity in multiple sclerosis and nabilone [ 10 ] for the treatment of amyotrophic lateral sclerosis. However as of 24 th February , The Australian parliament passed new national laws and amendments to the Narcotics Drug Act to allow for the controlled cultivation of cannabis for medical and scientific purposes in Australia [ 11 ].
These legislations are designed to allow access for those in need while limiting abuse and diversion potential. Worldwide, the growing development of cannabis-based medicines has led to greater discussion among patients, prescribers and policy makers. However, in such countries ethical principles in medicine mandate a degree of separation between prescribing a drug and its supply; thus necessitating the need for independent channels of distribution.
In most instances this is the role of the pharmacy profession. Thus—should medicinal cannabis be legalised—pharmacists would be responsible for the stocking, handling, ethical supply, counselling and overseeing the safe use of medicinal cannabis.
This makes their professional support, opinion and perspective a fundamental aspect to be explored in order to ensure medicinal cannabis is implemented successfully.
The pharmacy profession itself has championed many public health services across several OECD nations in order to better the community. A key example in the UK and Australia is the implementation of fundamental harm-minimisation programmes such as the needle exchange program, which aims to reduce the transmission of blood borne viruses among intravenous drug users [ 19 ].
The opioid substitution therapy OST is another program aimed at reducing risk behaviours and illicit drug use in individuals [ 20 ]. The provision of flu vaccinations by pharmacists across Europe, Canada, the UK and Australia is an expanded public health prevention service and helps to reduce the burden of disease costs on healthcare systems.
In addition to these services pharmacists have been central in the supply of the emergency contraception, aiming to reduce the risk of unwanted pregnancies, especially in young adults [ 21 ]. Given the ongoing debate and controversy surrounding medicinal cannabis, the viewpoint of the pharmacy profession is just as important for the successful implementation and delivery of medicinal cannabis to patients worldwide. All participants were required to sign a formal standardized Consent Form before starting the interview and audio-recording, as per University of Sydney HREC requirements.
Signed Consent forms, constituting evidence of informed consent, from every participant were collected and retained. These were stored in hard copies in a dedicated locked cabinet in the supervising researcher's office. The sampling strategy involved a convenience sampling of Australian pharmacists.
To enable the sampling of a wide variety of views, the inclusion criteria were that the interviewees were currently registered with the Australian Health Practitioner Regulation Agency as pharmacists, and willing to express their views on the legalisation of medicinal cannabis. It also employed a purposive sampling of a subset of Leading Representatives of Professional Organisations LRPO and was followed by passive snowballing as a result of individual requests to participate.
Their contact details were found in the public domain from various Internet websites and professional journals. Recruitment was initiated via email, phone and face-to-face invitation circulation, along with advertisements placed on professional society newsletters and social media sites of professional organisations.
A broad range of locations were targeted in order to capture a variety of perspectives based on location, practice environment and experience. We sought the perspective of community pharmacists and key stakeholders of the profession. An interview protocol Table 2 was developed based on research literature on medicinal cannabis 4, 16—18 and practice experience of the researching team.
The semi-structured interviews incorporated open-ended questions to enable the exploration of new ideas with prompts to allow deeper probing and expansion of key issues relating to medicinal cannabis. For participants who required greater knowledge or awareness about medicinal cannabis, clinical research papers including a meta-analysis was provided to them for greater familiarity with the topic, before re-commencing the interview at a later scheduled time.
For uniformity, the interviews were conducted by one interviewer SI and were between 10—30 minutes in length each. They were audio-recorded following participant consent, transcribed ad verbatim and de-identified. For quality control and to ensure reasonably objective analyses, the research team independently read and coded transcripts into themes to create a coding scheme for thematic analysis [ 22 ].
Constant comparison of interviews helped extract key perspectives and ensured a level of consistency and reliability of analysis. These key themes were then used to generate a driver diagram as seen in Fig 1.
A total of 34 respondents met inclusion criteria and participated in the study. The gender distribution was equivalent, and their level of practice experience varied Table 3. Registered pharmacists from across Australia were interviewed, but a greater proportion were pharmacists practicing in the state of New South Wales.
In regards to primary roles between practicing pharmacists, academics and LRPOs, the majority of participants were solely practicing pharmacists. Although concordant with other representative data, the views, strength of conviction and proactive ideas of LRPO participants emanated more resoundingly when compared to other participants. This was determined via linguistic analysis of the recorded interviews and interpretation of verbal cues. Interestingly, there were varying levels of knowledge across the differing demographics.
Different patterns of awareness were observed, as pharmacists in academia had greater pharmacological and pharmacotherapeutic knowledge while LRPOs appeared to have a greater sense of clinical and regulatory awareness than those in other roles.
It was also acknowledged by LRPO participants that professional organisations in pharmacy—like theirs—should take responsibility for the ongoing training and support of members of the profession when it comes to the legalisation of medicinal cannabis. Overall, the majority of participants expressed support and encouragement for the legalisation of medicinal cannabis with a sense of duty of care to their patients.
There is finally going to be a treatment option for those that up until now had no hope and no treatment. The results are presented under the five following emergent themes: Each theme was deduced from the data of quotes extracted from the interview transcripts.
The majority of participants expressed agreement that pharmacists would play an essential role in providing legitimate access to medicinal cannabis. As drug specialists, participating pharmacists identified their role as central to the drugs supply, use and safekeeping.
You know we are the ones to most likely dispense and supply it. They also acknowledged, successful implementation of medicinal cannabis programs require input from the profession in this contemporary debate and discussions amongst all involved.
The majority of the participants expressed the view that medicinal cannabis would be best introduced as a controlled substance, which under Australian regulation is categorised as a dangerous drug or schedule 8 S8 as opposed to prescription only medicines or schedule 4 S4 drugs [ 23 ].
Participants felt that this controlled scheduling would be best suited for medicinal cannabis due to its perceived propensity to be misused. Also based on past experiences with the OST and misuse of other medicines such as pseudoephedrine for illicit purposes, pharmacists expressed a desire for stringent guidelines as a means of legislative support.
S8 gives the pharmacist some comfort about the level of legislation behind it; checking the medication and making sure doctors write the prescriptions properly. On the other hand some participants who had a greater knowledge on the cannabinoid constituents and their pharmacological effects conveyed a lesser focus on controlled scheduling, rather a greater focus on its accessibility as a prescription drug. I see it more as a schedule 4.
In addition to the legislation, some participants suggested the development of comprehensive recording systems e. Parallels were drawn with current systems for recording of supplied medications including: Some participants stated that the success of implementation of legal medicinal cannabis supply would depend on a nationalised framework.
Participants with a broad knowledge of all the multiple constituents of cannabis stressed a need to have stringent quality assurance protocols. They expressed the need for a standard homogenous stable formulation of a high pharmaceutical grade, regardless of manufacturer.
Conversely, a portion of those interviewed revealed a confidence in existing regulatory bodies to govern the standardisation of medicinal cannabis and its key components. Majority of participants even those who worked in pharmacies that identified as compounding pharmacies felt strongly about the initiation of medicinal cannabis as a standardised pharmaceutical product in order to preserve the medications quality control and minimise any risk of harm to the patient associated with compounded forms of cannabis.
I see it as being a medicinally used product… I guess much along the lines that digitalis was standardised and used. Several avenues for access to medicinal cannabis were proposed. The majority of participants felt that the most suitable setting would be via a community pharmacy setting due to the importance of accessibility for chronic and palliative patients. I think that all palliative care should be… in terms of accessibility, within the community is best.
This was followed by the suggestion of staged implementation, with supply initiating at clinics or hospitals before being introduced to a community setting. Some participants preferred cannabis to be supplied in a hospital environment with the key reason cited being a more specialised team monitoring its use.
A few participants making this suggestion, also proposed a clinic setting like that used for methadone initiation would minimise the potential for cannabis abuse. A number of participants were indifferent to the location of supply, suggesting that it could be successfully supplied in a multiple number of settings in order to make it accessible to all patients in various locations and with various needs. A few participants suggested a specialised cannabis supplier model similar to those existing overseas as means of cannabis supply.
A number of participants were concerned about potential long-term effects of medicinal cannabis with risks associated with cognitive impairment and psychosis. However, most participants mentioned that all medicines have risks involved and it is a matter of weighing up those risks with the benefits for each individual undergoing treatment. There is no doubt about that. A few participants perceived the gaps in current regulations and recording systems as an opportunity for abuse and misuse of controlled substances.
They emphasised the need to either have more stringent safe keeping protocols or even have special formulations to avoid these perceived risks. The mainstream outlook on medicinal cannabis is that such a formulation for medicinal use makes the risk of abuse or diversion potential almost insignificant.
Many held the firm view that the profession was one of primary care and prevention and was well equipped to manage and assist those who need it most.
A level of concern was raised by LRPOs, in regards to safety and security issues for pharmacies. That would be a security issue that would need to be looked into. As a result, despite the advocacy and encouragement, there was an acknowledgment of the ethical principle of professional autonomy and of the right of the pharmacist to conscientious objection, as long as a level of professional duty of care is preserved.
I just think we should encourage all pharmacists to be part of it and participate in it as they have a responsibility here to dispense these particular products. All participants identified the presence of public stigma associated with medicinal cannabis. Further to that, many proposed that the current illicit status of medicinal cannabis has led to this. Many participants identified the lack of public awareness, influence of cultural upbringing, age and inability to distinguish between medicinal and recreational cannabis as key factors contributing to public stigma.
It was apparent that most participants drew upon their previous experiences with patients on OST and opioid medicines, and would only be resolved with ongoing public health campaigns and further discussion. Participants discussed how the media had played a predominant role in creating the awareness about medicinal cannabis whether negative or positive. Some suggested that the power of the media be harnessed for creating informed awareness on the therapeutic evidence behind medicinal cannabis and to dissolve negative stigma and rebuild the image of cannabis in a healthcare setting.
Participants cited recent media attention advocating the medical use of cannabis, as a shift away from conventional views. I think there's more like a push for it to be available. I've seen a lot of stories where it's been beneficial. While pharmacists acknowledged a lack of extensive understanding about medicinal cannabis, it was deemed no different to any other new drug that enters the market.
The majority of participants suggested the need for development of new training courses and learning opportunities, in order to ensure a greater understanding of the effects of medicinal cannabis. Many participants suggested the development of a collaborative team of healthcare professionals to discuss the implications of legalising medicinal cannabis in order to ensure multidisciplinary care. They need to raise issues that are going to affect them or their profession and considerations need to be made so I think that is very key.
Given the global discussion about medicinal cannabis currently, there is a clear need to ensure that the views of all stakeholders involved are explored; particularly that of pharmacists, who have the role of medicine supply. Our study gathered the opinions of a reasonably heterogeneous sample of pharmacists, including professional leaders, and results indicated that a majority supported the legislation and decriminalisation of medicinal cannabis in order to provide a suitable treatment option to those with refractory and chronic medical conditions.
Participating pharmacists described the need for suitable legislative and forensic frameworks that would allow legitimate supply under their scrutiny and recommended several models of supply. Pharmacists the world over, have demonstrated willingness and capacity for delivering harm minimisation services such as needle exchange programs and OST. Medicinal cannabis may be viewed in the same vein, where legal formulations dispensed with the purview of a trained and knowledgeable professional may be far safer than other means of procurement frustrated patients resort to.
Pragmatic models offered by the participants and previous experience with pharmacy-delivered harm minimisation programs should drive future implementation programs for therapeutic cannabis provision. The perspective of pharmacists should also be probed in health systems considering legalising medicinal cannabis.
In contrast to our participants, the expressed opinions of prescribers worldwide have been relatively more sceptical with negative attitudes towards the use of cannabis medicinally. Our participants did share these common concerns for patient safety but expressed that these are universal for all medicines, and for medicinal cannabis the benefits outweigh the risks primarily when needed to optimise quality of life in conditions recalcitrant to other treatments. As illustrated in our study results, participants acknowledged the importance of continued training and learning in regards to information on medicinal cannabis.
Similar needs for training preceding new program implementation have been expressed by pharmacists for other programs, such as the methadone program offered by pharmacies in many countries. In a survey conducted by Fleming et al. Pharmacists may not be unique in desiring training prior to supply program implementation.
Training is an essential element in implementing novel treatment. In a trial comprising pharmacists and opioid dependent consumers in Victoria, Australia, health policy researchers used seven key pillars to bridge the know-do gap in using buprenorphine for OST [ 27 ].
These pillars included skilled and experienced practitioners, government and policy support, incentives to prescribe the new treatment, specialist support services, clinical guidelines, training programs and patient involvement and information. Authors propose that this multi-faceted approach propelled the uptake of buprenorphine as maintenance therapy for opioid dependent patients in Victoria [ 27 ]. Our study also identified the need for greater collaboration to enhance transparency and involvement of all stakeholders, including pharmacists.
This, along with maintaining open lines of communication may help mitigate errors and ensure improved patient outcomes following the facilitation of medicinal cannabis [ 29 , 30 ]. Successful specialised treatment programs, for example buprenorphine provision, have often utilised inter-professional training for pharmacists and specialist physicians [ 31 , 32 ].
Similar methods need to be applied in the case of medicinal cannabis as well. A major issue emergent from our study was the need for nationalised legislation to maintain uniform regulatory policies.
This view is reflective of international literature that documents the long-running battle between federal and state law. For reasons of safety and reproducibility, introducing standardized forms of synthetic or extracted cannabinoids supply, although more expensive, rather than extractions of phytocannabinoids in the cannabis sativa plant, would be ideal.
However, there are no globally recognised standardized forms or formulations of medicinal cannabis available yet, due to vast variability in constituents from plant to plant. Suggestions also included pharmacovigilance to monitor patient safety, addressing risk of abuse and creating support to reduce prescribing under duress as well as establishing robust support for pharmacy safety.
Such suggestions were drawn from past experiences with OST and the supply of dangerous drugs of addiction. A survey study by Winstock et al. And for pharmacies to supply medicinal cannabis this needs to be specifically addressed. Stigma was identified as a major barrier that needed to be mitigated in order for medicinal cannabis to be successfully rolled out. The influence of negative stigma on the actual adoption of such medicines and health programs is revealed in various studies.
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