Over the counter low-dose cannabidiol: A viewpoint from the ACRE Capacity Building Group

Bonomo

2022

IJERPH

Self Cite

Medicinal cannabis was legalised in Australia in November 2016. By August 2022, there were 5284 specialist physician and general practitioner (GP) prescribers who submitted Special Access Scheme (SAS) applications to the Therapeutic Goods Administration (TGA) for the provision of medicinal cannabis prescriptions their patients. In this article we examine the impact of the delivery of publicly available clinical guidance documents, provision of education to prescribers, establishment of the TGA online portal, and launching of cannabis clinics on the number of applications approved by the TGA over time. We considered these findings in the context of the need to align the interventions facilitating the prescribing of medicinal cannabis with the establishment of processes to enable the systematic monitoring of patient outcomes. The cumulative number of medicinal cannabis Special Access Scheme-B (SAS-B) prescription approvals from January 2017 to June 2022 was 258,926. SAS-B approvals increased at an average rate of 208.55% p < 0.000, (95% CI 187.25–229.85) per month. Conclusion: There has been a rapid growth in prescribing since the legalisation of medicinal cannabis in Australia and this expansion has not been accompanied by parallel processes for the monitoring of medicinal cannabis. The capture of more highly granulated data, as found in the electronic medical record (EMR), patient smartphone applications, and social media provide an opportunity to monitor medicinal cannabis effectiveness and safety across multiple prescribing indications.

Section: Background and Contextmentioning

confidence: 99%

The Rise and Rise of Medicinal Cannabis, What Now? Medicinal Cannabis Prescribing in Australia 2017–2022

Bonomo

2022

IJERPH

Self Cite

“…In light of this, concerns regarding patient safety is warranted especially when marketing for some cannabinoid products is associated with inadequate labelling and/or inappropriate dosage recommendations [26]. These concerns are compounded by the downscheduling of over-the-counter cannabis products which do not require a prescription [27] and the illicit drug market [28]. Given this dynamic interplay between marketing, product innovation, regulation, and consumer demand, innovative methods are required to augment existing established approaches to the surveillance and monitoring of emerging and unapproved drugs.…”

Section: Introductionmentioning

confidence: 99%

Social media discourse and internet search queries on cannabis as a medicine: A systematic scoping review

Habibabadi²,

Conway³

et al. 2023

PLoS ONE

The use of cannabis for medicinal purposes has increased globally over the past decade since patient access to medicinal cannabis has been legislated across jurisdictions in Europe, the United Kingdom, the United States, Canada, and Australia. Yet, evidence relating to the effect of medical cannabis on the management of symptoms for a suite of conditions is only just emerging. Although there is considerable engagement from many stakeholders to add to the evidence base through randomized controlled trials, many gaps in the literature remain. Data from real-world and patient reported sources can provide opportunities to address this evidence deficit. This real-world data can be captured from a variety of sources such as found in routinely collected health care and health services records that include but are not limited to patient generated data from medical, administrative and claims data, patient reported data from surveys, wearable trackers, patient registries, and social media. In this systematic scoping review, we seek to understand the utility of online user generated text into the use of cannabis as a medicine. In this scoping review, we aimed to systematically search published literature to examine the extent, range, and nature of research that utilises user-generated content to examine to cannabis as a medicine. The objective of this methodological review is to synthesise primary research that uses social media discourse and internet search engine queries to answer the following questions: (i) In what way, is online user-generated text used as a data source in the investigation of cannabis as a medicine? (ii) What are the aims, data sources, methods, and research themes of studies using online user-generated text to discuss the medicinal use of cannabis. We conducted a manual search of primary research studies which used online user-generated text as a data source using the MEDLINE, Embase, Web of Science, and Scopus databases in October 2022. Editorials, letters, commentaries, surveys, protocols, and book chapters were excluded from the review. Forty-two studies were included in this review, twenty-two studies used manually labelled data, four studies used existing meta-data (Google trends/geo-location data), two studies used data that was manually coded using crowdsourcing services, and two used automated coding supplied by a social media analytics company, fifteen used computational methods for annotating data. Our review reflects a growing interest in the use of user-generated content for public health surveillance. It also demonstrates the need for the development of a systematic approach for evaluating the quality of social media studies and highlights the utility of automatic processing and computational methods (machine learning technologies) for large social media datasets. This systematic scoping review has shown that user-generated content as a data source for studying cannabis as a medicine provides another means to understand how cannabis is perceived and used in the community. As such, it provides another potential ‘tool’ with which to engage in pharmacovigilance of, not only cannabis as a medicine, but also other novel therapeutics as they enter the market.

“…However, with changes to legislation enacted in February 2021, where low-dose formulations of CBD (<150 mg daily dose) were reclassified to a Schedule 3 (pharmacist only) over-the-counter product, the use of CBD in Australia is likely to increase (TGA 2020). Although CBD is considered to have an acceptable safety and tolerability profile at lower doses, there are known risks associated with drug-to-drug interactions, especially when CBD is used concomitantly with other commonly prescribed drugs metabolised via CYP450 pathways (Hallinan et al 2022a). These interaction concerns are additional to the risks associated with all other cannabinoid products, as evidence for the safe and optimal use of medicinal cannabis is still emerging.…”

Section: Introductionmentioning

confidence: 99%

Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible?

Gunn

Bonomo

2022

Aust. J. Prim. Health

Self Cite

Background. General practitioners are well positioned to contribute to the pharmacovigilance of medical cannabis via the general practice electronic medical record (EMR). The aim of this research is to interrogate de-identified patient data from the Patron primary care data repository for reports of medicinal cannabis to ascertain the feasibility of using EMRs to monitor medicinal cannabis prescribing in Australia. Methods. EMR rule-based digital phenotyping of 1 164 846 active patients from 109 practices was undertaken to investigate reports of medicinal cannabis use from September 2017 to September 2020. Results. Eighty patients with 170 prescriptions of medicinal cannabis were identified in the Patron repository. Reasons for prescription included anxiety, multiple sclerosis, cancer, nausea, and Crohn's disease. Nine patients showed symptoms of a possible adverse event, including depression, motor vehicle accident, gastrointestinal symptoms, and anxiety. Conclusions. The recording of medicinal cannabis effects in the patient EMR provides potential for medicinal cannabis monitoring in the community. This is especially feasible if monitoring were to be embedded into general practitioner workflow.