Medicinal Cannabis Guidance and Resources for Health Professionals to Inform Clinical Decision Making.

PURPOSE: Interest in the use of cannabis as a medicine has markedly increased during the last decade, with an unprecedented number of patients now seeking advice or prescriptions for medicinal cannabis. Unlike other medicines prescribed by physicians, many medicinal cannabis products have not undergone standard clinical trial development required by regulatory authorities. Different formulations with varying strengths and ratios of tetrahydrocannabinol and cannabidiol are available, and this diversity of medicinal cannabis products available for a myriad of therapeutic indications adds to the complexity. Physicians face challenges and barriers in their clinical decision making with medicinal cannabis because of current evidence limitations. Research efforts to address evidence limitations are ongoing; in the interim, educational resources and clinical guidance are being developed to address the gap in clinical information and support the needs of health professionals. METHODS: This article provides an overview of various resources that health professionals may use when seeking information about medicinal cannabis in the absence of high-quality evidence and clinical guidelines. It also identifies examples of international evidence-based resources that support clinical decision making with medicinal cannabis. FINDINGS: Similarities and differences between international examples of guidance and guideline documents are identified and summarized. IMPLICATIONS: Guidance can help guide physicians in the individualized choice and dose of medicinal cannabis. Before quality clinical trials and regulator-approved products with risk management programs, safety data require clinical and academic collaborative pharmacovigilance.

Evaluation of the Prescribing Skills Assessment implementation, performance and medical student experience in Australia and New Zealand.

AIMS: The UK Prescribing Safety Assessment was modified for use in Australia and New Zealand (ANZ) as the Prescribing Skills Assessment (PSA). We investigated the implementation, student performance and acceptability of the ANZ PSA for final-year medical students. METHODS: This study used a mixed-method approach involving student data (n = 6440) for 2017-2019 (PSA overall score and 8 domain subscores). Data were also aggregated by medical school and included student evaluation survey results. Quantitative data were analysed using descriptive and multivariate analyses. The pass rate was established by a modified Angoff method. Thematic analyses of open-ended survey comments were conducted. RESULTS: The average pass rate was slightly higher in 2017 (89%) which used a different examination to 2018 (85%) and 2019 (86%). Little difference was identified between schools for the PSA overall performance or domain subscores. There was low intercorrelation between subscores. Most students provided positive feedback about the PSA regarding the interface and clarity of questions, but an average of 35% reported insufficient time for completion. Further, 70% on average felt unprepared by their school curricula for the PSA, which is in part explained by the low prescribing experience; 69% reported completing ≤10 prescriptions during training. CONCLUSION: The ANZ PSA was associated with high pass rates and acceptability, although student preparedness was highlighted as a concern for further investigation. We demonstrate how a collaboration of medical schools can adapt a medical education assessment resource (UK PSA) as a means for fulfilling an unmet need.

Cannabidiol drug interaction considerations for prescribers and pharmacists.

INTRODUCTION: In light of the widespread use of non-prescribed and prescribed cannabidiol, the use of cannabidiol with other medications is likely, and this may result in drug interactions. AREAS COVERED: We aimed to ascertain if clinical guidance could be provided on the dose range at which cannabidiol drug interactions are likely to occur with concurrently prescribed medicines. Literature searches were conducted in Embase, MEDLINE, and PubMed from database inception to January 2022 using Emtree and MeSH terms. Reference list screening yielded further studies. Using currently available data, likely drug interactions of which prescribers of cannabidiol need to be aware, at the doses likely to cause clinically significant interactions, and drug dosing changes that may be needed are highlighted. EXPERT OPINION: We have provided an overview of evidence-based pharmacokinetic predictions and general guidance about the dose range at which clinically relevant cannabidiol drug interactions are likely. For an individual patient, there are inherent limitations in providing clinical guidance due to gaps in specific drug dose-response data and knowledge of individual pharmacokinetic profiles, including different co-morbidities, and concurrent medicines. Clinician awareness of cannabinoid pharmacology, along with clinical and therapeutic drug monitoring, are current best practice approaches to manage cannabinoid drug interactions.

NSW Cannabis Medicines Advisory Service preliminary survey results: enquirer perceptions and patient outcomes.

BACKGROUND: In 2018, an innovative, State government-funded cannabis medicines drug information service was established for health professionals in New South Wales (NSW). The NSW Cannabis Medicines Advisory Service (CMAS) provides expert clinical guidance and support to medical practitioners considering prescribing a cannabis medicine to their patient(s). AIMS: This research examines quality assurance and patient outcomes related to enquirers' experience with NSW CMAS. METHODS: Data collection involved an online, anonymous survey with two components. Following a health professional enquiry, quality assurance data were collected about the enquirers' experience with NSW CMAS. The second survey focussed on patient outcomes and provides real-world observational data about cannabis medicines safety and effectiveness across a wide range of indications. RESULTS: Data collection occurred between January 2020 and June 2021. Preliminary analyses were based on 68 quality assurance and 50 patient outcomes survey responses. General practitioners represented the highest proportion of survey responses (n = 33; 49%). The most common enquiry involved 'patient-specific advice' (n = 50; 74%). Patient-specific information provided by the service was mainly used for prescribing decision support (n = 45; 90%). CONCLUSIONS: Preliminary findings highlight the impact of an innovative cannabis medicines drug information service in supporting health professional clinical practice in an area of rapid knowledge translation. Quality assurance data indicate that the service is perceived well by the majority of enquirers. Patient outcomes data across a wide range of indications suggest some effectiveness and a reasonable safety profile for prescribed cannabis medicines for most patients.

Translational hurdles with cannabis medicines.

PURPOSE: Internationally, there has been widespread medical use of cannabis medicines before rigorous evaluations in randomised controlled trials (RCTs). Some advocates of medicinal use of cannabis argue that real-world evidence (RWE) can be a substitute for or at least supplement evidence from RCTs. We explore the utility, limitations and impact of RWE in the translation of cannabis medicines research into clinical practice using the established literature. METHODS: A literature search was performed via Embase and Medline using a diverse range of cannabinoid and RWE search terms. The review provides a snapshot of cannabis medicine RWE initiatives from around the world. RESULTS: Diverse and novel sources of real-world data and RWE include international cannabis registries, surveys, post-marketing data collection and use of electronic or digital health records. The strengths and limitations of using RWE in translational research are highlighted, along with the identification of barriers to RCTs involving cannabis medicines. CONCLUSIONS: RWE promises to play a significant role in the evaluation of cannabis medicines around the world. When used appropriately RWE may complement RCT data by providing valuable insights into cannabis medicine safety and effectiveness. TAKE HOME MESSAGES: It is important that real-world evidence (RWE) is used to complement rather than replace randomised controlled trial (RCT) evidence on cannabis medicines. Technological advances have created the opportunity to explore diverse and novel sources of cannabis medicine RWE. Although RWE may be more reflective of real-world clinical practice, it cannot provide conclusive evidence of the safety and efficacy of cannabis medicines. While acknowledging its limitations, RWE may nonetheless provide some guidance on safety and adverse events of cannabis medicines. RWE has already had a significant impact on the regulation of cannabis medicines.

Vancomycin therapeutic drug monitoring in paediatrics.

AIM: Vancomycin guidelines for therapeutic drug monitoring (TDM) aim to maximise efficacy while minimising toxicity and resistance. Vancomycin is effective against Staphylococcus aureus when it achieves area under the concentration-time curve (AUC)/minimum inhibitory concentration (MIC) > 400. Studies in children have shown that target trough concentrations poorly correlate to AUC/MIC > 400; however, they are used in practice for clinical convenience. This review in paediatric inpatients aims to audit performance against TDM guidelines and consider what changes are needed to optimise vancomycin monitoring. METHODS: Vancomycin prescriptions in patients younger than 18 years old were collected over a 15-month period. Primary outcome measures were vancomycin initial dose (mg/kg/day) and the timing and result of first trough concentration (mg/L). Secondary outcome measures were the numbers achieving recommended targets and whether appropriate dose adjustments were made in response to TDM. RESULTS: A total of 133 courses reached the time when TDM should occur. Average patient age was 6.5 years, and the average initial dose was 52.55 mg/kg/day (range 19.05-86.54 mg/kg). Only 25% of courses (n = 34) had a trough concentration measured at the recommended time. The mean trough concentration was 11.6 mg/L (range < 2.0-39.7). Of 40 patients with a low trough concentration, 50% continued without dose adjustment. CONCLUSION: As shown in the literature, there is a poor correlation between the vancomycin dose given and the trough concentration achieved. Given that recommendations for trough concentration monitoring are designed to simplify the process yet are poorly adhered to, a strategic plan to address these issues is needed.

Nutrition information in pregnancy: Where do women seek advice and has this changed over time?

AIM: Nutrition during pregnancy is fundamental to both the health of the mother and her baby. Sources of nutrition-related information are available via many sources but their accuracy is unknown. The present study aimed to (a) identify where women source their nutrition information during pregnancy and (2) assess the accuracy of nutrition information for pregnancy that is available on the internet. METHODS: A survey instrument that identified the main sources of nutrition information was administered to 68 pregnant women recruited online. Data from this survey were compared to previous similar surveys conducted with pregnant mothers across years 2008, 2011 and 2014. A content analysis of websites was simultaneously conducted to assess the accuracy of available information. RESULTS: The main source of nutrition information for a variety of topics was verbal communication from health professionals (% responses affirmative for that source ranged from 6.6% to 69% across survey years). There was an increasing trend in internet sourced information for most nutrition topics, but this source remained low for iodine across all years (range: 7.3%-15.9%). The internet was the main source of information for listeria/food safety (15.3%-32.4%) and healthy eating (25%-42%). Of the n = 165 websites identified by the content analysis, 82.4% (n = 136) were rated as accurate, with government (96.9%) and business/company (100%) sites having the highest accuracy. CONCLUSION: Verbal communication from health professionals remains the most important source of nutrition information for pregnancy. The high credibility of websites indicates this to be an additional resource. Further study into health literacy levels among women visiting these sites is needed to assess impact on dietary behaviour.

Developing professional education for primary healthcare providers about nutrition.

Nutrition care is an important component of primary health care as a way to promote positive lifestyle behaviours and reduce risks of chronic disease. Despite this, it appears that primary healthcare settings, including antenatal care, miss opportunities to deliver nutrition care. Time constraints, lack of nutrition knowledge and lack of confidence have been identified as barriers for primary healthcare providers in delivering nutrition care. Nutrition training to upskill primary healthcare providers to deliver nutrition care in a timely manner therefore appears warranted. This forum article discusses models and methods of continuing professional development (CPD) and the effectiveness of nutrition CPD for primary healthcare professionals. It includes a case study as an example of developing nutrition CPD for midwives using adult learning theory and concludes with implications for developing nutrition education resources for primary healthcare providers.

Optimising low-dose methotrexate for rheumatoid arthritis-A review.

Methotrexate at low doses (5-25 mg/week) is first-line therapy for rheumatoid arthritis. However, there is inter- and intrapatient variability in response, with contribution of variability in concentrations of active polyglutamate metabolites, associated with clinical efficacy and toxicity. Prescribing remains heterogeneous across population groups, disease states and regimens. This review examines current knowledge of dose-response of oral methotrexate in the setting of rheumatoid arthritis, and how this could help inform dosage regimens.

Feasibility of face-to-face and online learning methods to provide nutrition education to midwives, general practice nurses and student nurses.

Midwives and general practice nurses are ideally positioned to provide nutrition education to pregnant women. However, it appears that they do not receive sufficient nutrition training to enable them to fulfil this role. This study aimed to develop, implement and evaluate a suite of learning resources developed specifically for midwives, general practice nurses and student nurses. A four-module suite of learning resources was developed based on recommendations in the Australian Antenatal Care Clinical Guidelines as well as formative evaluation with stakeholders. The feasibility of these modules was tested using a pre-test and post-test quasi-experimental design with three arms using convenient sampling (face-to-face with midwives; online with student nurses; and online with midwives, nurses and practice nurses). Completion rates across the three study arms were poor (n=40 participants in total). For the combined data, there was a significant increase in knowledge scores across all modules from the pretest score (median (IQR): 3.46 (2.09-4.13)) to the post-test score (5.66 (4.66-6.00)) (p<0.001). Studies of high quality are required to determine if changing the nutrition knowledge and confidence in delivering nutrition care of health professionals results in sustainable changes to their clinical practice.