Preliminary findings from project Twenty21 Australia: An observational study of patients prescribed medicinal Cannabis for chronic pain, anxiety, posttraumatic stress disorder and multiple sclerosis

O’Brien, Kylie; Beilby, Justin; Frans, Michelle; Lynskey, Michael; Barnes, Michael P.; Jayasuriya, Mihindu; Athanasiou-Fragkouli, Alkyoni; Blair, Philip; Nutt, David

doi:10.1177/20503245231164718

Cited by 3 publications

(1 citation statement)

References 40 publications

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“…In addition, at the three month follow-up visits, they also complete a questionnaire that measures global impression of change, a Cannabis-Based Medicines Questionnaire (CBMQ) and a symptom questionnaire. The detailed methodology has been described elsewhere (O'Brien et al 2023). This paper describes, briefly, the methodology in relation to chronic pain participants, and some preliminary data at the three-month follow-up mark.…”

Section: Introductionmentioning

confidence: 99%

Medicinal cannabis for pain: Real-world data on three-month changes in symptoms and quality of life

O’Brien

Beilby

Frans

et al. 2023

Drug Science, Policy and Law

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Background Internationally, one of the most common conditions for which people seek medicinal cannabis (MC) is chronic pain. However, relatively little is known about the effectiveness of cannabis for reducing pain in Australia. Medicinal cannabis was made legally available in Australia in 2016. Project Twenty21 Australia is an observational study that follows patients prescribed MC for chronic pain, anxiety, PTSD and multiple sclerosis for up to 12 months. It commenced recruitment in February 2022. This paper describes some preliminary findings for a cohort of patients with chronic pain. Method Participants seeking treatment for chronic pain are prescribed MC from within a Project Formulary, and complete questionnaires at baseline then three monthly for up to 12 months. Pain severity and interference are assessed using the Brief Pain Index while standardised measures of quality of life, mood and sleep quality are also applied. Results By 30 November 2022, 55 participants with chronic pain had completed the first three-month follow-up. Patients reported a low quality of life and high levels of co-morbidity. Three-month data indicate that MC use was associated with significant reductions in self-reported pain intensity and pain interference (Effect sizes = 0.66 [95% CI = 0.34–0.98] and 0.56 [0.24–0.88], respectively). Additionally, there were significant improvements in quality of life, general health, mood/depression and sleep (Effect sizes = 0.53–0.63). One adverse reaction was reported which was mild in nature. Conclusions Preliminary evidence suggests that MC may be effective in reducing both pain severity and pain interference while also improving quality of life, general health, mood and sleep in patients with chronic pain. Increasing uptake of MC coupled with growing evidence of both the effectiveness and safety of these medications indicate a need both to make MC more widely available and to reduce financial costs associated with its use.

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Section: Introductionmentioning

confidence: 99%

Medicinal cannabis for pain: Real-world data on three-month changes in symptoms and quality of life

O’Brien

Beilby

Frans

et al. 2023

Drug Science, Policy and Law

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An overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: A scoping review using a systematic approach

Wang,

Bonomo,

Hallinan

2024

Preprint

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The use of cannabis-based medicines (CBM) as a therapeutic has grown exponentially over the last 5 years in Australia. Prior to this increase, there was significant legislative resistance to the use of CBM for clinical trials, hence pre-clinical data is limited. Safety monitoring systems for CBM are not structured and do not fit easily into the workflow of busy health professionals. Hence, post-marketing surveillance of CBM is patchy. CBM are available in many countries globally and face similar issues in relation to pharmacovigilance. The objective of this review is to answer the following question: What are the systems in place internationally to monitor side effects and adverse events of cannabis use as a medicine? We used the PICO framework to develop keyword elements, which guided two search queries. Each query contained a different combination of keywords to increase sensitivity and specificity of the search. Both queries were entered into Embase and Scopus for retrieval of quality relevant peer-reviewed literature. Only the second search query, was used for the grey literature. Fifty-four full text articles were included in the review, thirty-nine were from the peer-reviewed search, eight were from the grey literature search, and seven were from citations of relevant texts. Our search yielded two main forms of monitoring systems: databases and registries, with databases often created by regulatory authorities. There was great variability within these systems, differing in methods of causality assessment, level of detail collected, terminology, and affiliations. Only one monitoring system captured in our search obligated reporting from patients. VigiBase remains the largest form of centralised monitoring, receiving case reports internationally. Regardless of the scope of VigiBase, there remains heterogeneity of data within the system. As such, our study reaffirms a greater need for a centralised, consistent, and accessible system for the post-marketing surveillance of side effects and adverse events associated with usage of CBM.

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Overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: a scoping review using a systematic approach

Wang,

Bonomo,

Hallinan

2024

BMJ Open

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ObjectivesThe use of cannabis-based medicine (CBM) as a therapeutic has surged in Australia over the past 5 years. Historically, the United Nations Single Convention on Narcotic Drugs (1961) prohibited cannabis use in Europe, the USA, the UK and Australia, leading to legislative resistance and limited preclinical data on CBM. Existing safety monitoring systems for CBM are poorly structured and do not integrate well into the workflows of busy health professionals. As a result, postmarketing surveillance is inconsistent. This review aims to evaluate international systems for monitoring CBM side effects and adverse events.DesignTo undertake a scoping review with a systematic approach, we used the Population, Intervention, Comparison, Outcome (PICO) framework to develop keyword elements, and two search queries to maximise search sensitivity and specificity.Data sourcesSearch queries were entered into Embase and Scopus for peer-reviewed literature, and additional searches for grey literature were conducted on 23 June 2023.Eligibility criteriaWe included 54 full-text articles in the review: 39 from peer-reviewed searches, 8 from grey literature and 7 from citations of relevant texts.Data extraction and synthesisOur search yielded two main forms of monitoring systems: databases and registries. Out of the 24 monitoring systems identified, there were 10 databases and 14 registries, with databases often created by regulatory authorities. Systems differed in methods of causality assessment, level of detail collected, terminology and affiliations.ResultsWithin the monitoring systems with enough published data for analysis, all except one remain active at the time of this review. VigiBase is the largest centralised monitoring system, receiving international case reports, however data heterogeneity persists.ConclusionsOur study emphasises the need for a centralised, consistent and accessible system for the postmarketing surveillance of side effects and adverse events associated with medicinal cannabis use.

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Preliminary findings from project Twenty21 Australia: An observational study of patients prescribed medicinal Cannabis for chronic pain, anxiety, posttraumatic stress disorder and multiple sclerosis

Cited by 3 publications

References 40 publications

Medicinal cannabis for pain: Real-world data on three-month changes in symptoms and quality of life

Medicinal cannabis for pain: Real-world data on three-month changes in symptoms and quality of life

An overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: A scoping review using a systematic approach

Overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: a scoping review using a systematic approach

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