Barriers to the wider adoption of medicinal<i>Cannabis</i>

Alexander, Stephen P.H.

doi:10.1177/2049463720922884

Cited by 16 publications

(14 citation statements)

References 81 publications

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“…Evidence around efficacy of cannabis in certain health conditions continues to evolve, with rapidly increasing global numbers of randomized controlled trials (RCTs) and preclinical research ( Schlag et al, 2021 ). However, there remain many conditions for which clinical evidence is minimal or ambiguous, with systematic reviews often highlighting a paucity of high quality randomized RCTs to support current prescribing ( Alexander, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Medicinal Cannabis Prescribing in Australia: An Analysis of Trends Over the First Five Years

et al. 2022

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A regulatory framework allowing legal access to medicinal cannabis (MC) products has operated in Australia since November 2016. MC prescribing by healthcare practitioners (HCPs) is primarily conducted through the Special Access Scheme - Category B (SAS-B) pathway, through which prescribers apply to the Therapeutic Goods Administration (TGA–the federal regulator) for approval to prescribe a category of product to an individual patient suffering from a specific indication. The dataset collected by the TGA provides a unique opportunity to examine MC prescribing trends over time in the Australian population. Here we analysed this TGA SAS-B dataset since inception with respect to age, gender, product type (e.g., oil, flower, etc.), CBD content, indication treated, and prescriber location. Results are presented descriptively as well as being analysed using non-linear regression models. Relationship between variables were explored via correspondence analyses. Indications were classified with reference to the International Statistical Classification of Diseases and Related Health Problems (10th Revision). As of 31 August 2021, a total of 159,665 SAS-B approvals had been issued for MC products, 82.4% of were since January 2020. Leading indications for approvals were for pain, anxiety, and sleep disorders. Oil products were the most popular product type, while CBD-dominant products (≥98% CBD) accounted for 25.1% of total approvals. Approvals for flower products increased markedly during 2020–2021, as did approvals involving younger age groups (18–31 years old), male patients, and non-CBD dominant products. A disproportionate number of SAS-B MC applications (around 50%) came from HCPs in the state of Queensland. Associations between patient gender and age and/or indication with product type were found. For example, approvals for oil products were commonly associated with approvals for pain. While, overall prescribing increased dramatically over the last 2 years of analysis, stabilization of approval numbers is evident for some indications, such as pain. Current prescribing practices do not always reflect provided TGA guidance documents for MC prescribing. While acknowledging some limitations around the SAS-B dataset, it provides a unique and valuable resource with which to better understand current prescribing practices and utilisation of MC products within Australia.

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Section: Introductionmentioning

confidence: 99%

Medicinal Cannabis Prescribing in Australia: An Analysis of Trends Over the First Five Years

et al. 2022

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“…Cannabis-based medicinal products (CBMPs) are a collective term to describe a preparation or other product that contains cannabis or its derivatives for medicinal use in humans [ 1 ]. There are significant barriers to the integration of CBMPs within treatment pathways including ongoing stigma, cost, education, complex pharmacology and a paucity of evidence to inform international and national guidelines [ 2 , 3 ]. Limited evidence, does, however, support the role of CBMPs in conditions such as chronic pain, neurological disorders, and psychiatric disease [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Real World Evidence in Medical Cannabis Research

Banerjee

Erridge

Salazar

et al. 2021

Ther Innov Regul Sci

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Background Whilst access to cannabis-based medicinal products (CBMPs) has increased globally subject to relaxation of scheduling laws globally, one of the main barriers to appropriate patient access remains a paucity of high-quality evidence surrounding their clinical effects. Discussion Whilst randomised controlled trials (RCTs) remain the gold-standard for clinical evaluation, there are notable barriers to their implementation. Development of CBMPs requires novel approaches of evidence collection to address these challenges. Real world evidence (RWE) presents a solution to not only both provide immediate impact on clinical care, but also inform well-conducted RCTs. RWE is defined as evidence derived from health data sourced from non-interventional studies, registries, electronic health records and insurance data. Currently it is used mostly to monitor post-approval safety requirements allowing for long-term pharmacovigilance. However, RWE has the potential to be used in conjunction or as an extension to RCTs to both broaden and streamline the process of evidence generation. Conclusion Novel approaches of data collection and analysis will be integral to improving clinical evidence on CBMPs. RWE can be used in conjunction or as an extension to RCTs to increase the speed of evidence generation, as well as reduce costs. Currently, there is an abundance of potential data however, whilst a number of platforms now exist to capture real world data it is important the right tools and analysis are utilised to unlock potential insights from these.

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“…RCT necessitates a stable, standardized, and characterized product to test against another product in a characterized sample of patients. However, standardization/characterization is a problem when dealing with plant material ( 32 ). Second, given the variability of cannabis materials, the external validity of RCT results would be highly questionable.…”

Section: Cannabis a Square Peg In The Round Hole Of Evidence-based Me...mentioning

confidence: 99%