scholarly journals Evaluation of Patient Reported Safety and Efficacy of Cannabis From a Survey of Medical Cannabis Patients in Canada

2021 ◽  
Vol 9 ◽  
Author(s):  
Shaina P. Cahill ◽  
Stephanie E. Lunn ◽  
Patrick Diaz ◽  
Jonathan E. Page
Keyword(s):  
Sleep Disorders ◽  
Real World ◽  
Medical Condition ◽  
Scientific Data ◽  
Medical Conditions ◽  
Recurrent Pain ◽  
Medical Cannabis ◽  
Post Traumatic Stress ◽  
Real World Evidence ◽  
Patient Reported

With the medical use of cannabis permitted in Canada since 2001, patients seek to use this botanical drug to treat a range of medical conditions. However, many healthcare practitioners express the need for further scientific evidence around the use of medical cannabis. This real-world evidence study aimed to address the paucity of scientific data by surveying newly registered medical cannabis patients, before beginning medical cannabis treatment, and at one follow up 6 weeks after beginning medical cannabis treatment. The goal was to collect data on efficacy, safety and cannabis product type information to capture the potential impact medical cannabis had on patient-reported quality of life (QOL) and several medical conditions over a 6-week period using validated questionnaires. The 214 participants were mainly male (58%) and 57% of the population was older than 50. The most frequently reported medical conditions were recurrent pain, post-traumatic stress disorder (PTSD), anxiety, sleep disorders [including restless leg syndrome (RLS)], and arthritis and other rheumatic disorders. Here we report that over 60% of our medical cannabis cohort self-reported improvements in their medical conditions. With the use of validated surveys, we found significant improvements in recurrent pain, PTSD, and sleep disorders after 6 weeks of medical cannabis treatment. Our findings from patients who reported arthritis and other rheumatic disorders are complex, showing improvements in pain and global activity sub-scores, but not overall changes in validated survey scores. We also report that patients who stated anxiety as their main medical condition did not experience significant changes in their anxiety after 6 weeks of cannabis treatment, though there were QOL improvements. While these results show that patients find cannabis treatment effective for a broad range of medical conditions, cannabis was not a remedy for all the conditions investigated. Thus, there is a need for future clinical research to support the findings we have reported. Additionally, while real-world evidence has not historically been utilized by regulatory bodies, we suggest changes in public policy surrounding cannabis should occur to reflect patient reported efficacy of cannabis from real-world studies due to the uniqueness of medical cannabis's path to legalization.

scholarly journals Longitudinal analysis of safety and medication adherence of patients in the Fingolimod patient support program: a real-world observational study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Aline Bourdin ◽  
Marie Paule Schneider ◽  
Isabella Locatelli ◽  
Myriam Schluep ◽  
Olivier Bugnon ◽  
...  
Keyword(s):  
Patient Safety ◽  
Medication Adherence ◽  
Real World ◽  
Safety Data ◽  
Support Program ◽  
Patient Support ◽  
Patient Support Program ◽  
Dose Monitoring ◽  
Real World Evidence ◽  
Patient Reported

AbstractThe Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. This study aims to evaluate the safety and medication adherence of patients who joined the F-PSP between 2013 and 2016. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. Sixty-seven patients joined the F-PSP. Patients reported a high frequency of symptoms. Due to AEs, 7 patients discontinued fingolimod, 3 took therapeutic breaks, and 1 reduced the regimen temporarily. Three patients repeated the first-dose monitoring. Patients had a high medication adherence over the 18-month analysis period: implementation decreased from 98.8 to 93.7%, and fingolimod persistence was 83.2% at 18 months. The patients’ level of education, professional situation, and living with child(ren) influenced implementation. Patients reported more facilitators of medication adherence than barriers. The F-PSP seems valuable for supporting individual patients (ensuring responsible use of fingolimod and inviting patients for shared-decision making) and public health (indirectly gathering real-world evidence).

scholarly journals Online survey into developing a model for a legal cannabis market in the United Kingdom

2021 ◽  
Vol 7 ◽  
pp. 205032452110349
Author(s):  
Edward James ◽  
Thomas L Robertshaw ◽  
Michael J Pascoe ◽  
Fiona M Chapman ◽  
Andrew D Westwell ◽  
...  
Keyword(s):  
United Kingdom ◽  
Online Survey ◽  
Medical Condition ◽  
Population Sample ◽  
Regulatory System ◽  
Supporting Evidence ◽  
Medical Conditions ◽  
Medical Cannabis ◽  
Individual Liberty ◽  
The United Kingdom

Background Despite rescheduling of cannabis to Schedule 2 and amendments to the law permitting legal availability of cannabis for the treatment of medical conditions, access to cannabis for medical use remains challenging for patients in the United Kingdom (UK). Recreational use is widespread despite laws stating users can be sentenced to prison for up to 5 years for possession. Objective The aim of the study was to develop a model for a legal cannabis market in the UK building upon the results of a preceding study in which a UK population sample determined that pharmacies are the most suitable primary legal vendor of cannabis as opposed to regulated shops or the black market. Methods An online survey was developed using Qualtrics software and advertised via the Multidisciplinary Association for Psychedelic Studies’ Facebook, Twitter and Instagram social media accounts and monthly newsletter. Results Three hundred and ninety seven individuals, a majority having used cannabis at least once, consented to participate in the study. The participants concluded that there is enough evidence for cannabis to be prescribed to treat a range of medical conditions. In addition to pharmacies providing cannabis to patients with a prescription, a majority of participants supported cannabis being sold in pharmacies for harm reduction purposes and allowing access to medicinal cannabis in cases where supporting evidence is insufficient to merit a prescription. Participants supported greater integration between dispensing pharmacies and mental health services. Overall, the participants did not oppose a consultation or screening for potential cannabis users prior to obtaining access from licensed vendors. UK participants were supportive of the concept of a cannabis card, which users can present to licensed vendors such as pharmacies, with specific recommendations (such as strains relevant to a patient’s medical condition) being coded into the card. A majority of participants supported the existence of shisha-type bars for the purchase and onsite consumption of cannabis and determined that such vendors should not be part of a pharmacy chain of stores or regulated by pharmacy regulators. The participants generally preferred that laws regarding public consumption are in line with existing smoking legislation. Participants determined that it should be legally permitted to grow cannabis at home for personal medical and non-medical purposes but not to sell for profit. Conclusion The results are suggestive of a regulatory system that medical and non-medical cannabis users can use which aims to maximise therapeutic applications, minimise harms and respect individual liberty.

scholarly journals Medical cannabis use in the United States: a retrospective database study

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
V. Kishan Mahabir ◽  
Jamil J. Merchant ◽  
Christopher Smith ◽  
Alisha Garibaldi
Keyword(s):  
United States ◽  
Medical Condition ◽  
Statistical Tests ◽  
The United States ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Medical Conditions ◽  
Comorbid Conditions ◽  
Medical Cannabis ◽  
Number Of Patients

Abstract Introduction Growing interest in the medicinal properties of cannabis has led to an increase in its use to treat medical conditions, and the establishment of state-specific medical cannabis programs. Despite medical cannabis being legal in 33 states and the District of Colombia, there remains a paucity of data characterizing the patients accessing medical cannabis programs. Methods We retrospectively reviewed a registry with data from 33 medical cannabis evaluation clinics in the United States, owned and operated by CB2 Insights. Data were collected primarily by face-to-face interviews for patients seeking medical cannabis certification between November 18, 2018 and March 18, 2020. Patients were removed from the analysis if they did not have a valid date of birth, were less than 18, or did not have a primary medical condition reported; a total of 61,379 patients were included in the analysis. Data were summarized using descriptive statistics expressed as a mean (standard deviation (SD)) or median (interquartile range (IQR)) as appropriate for continuous variables, and number (percent) for categorical variables. Statistical tests performed across groups included t-tests, chi-squared tests and regression. Results The average age of patients was 45.5, 54.8% were male and the majority were Caucasian (87.5%). Female patients were significantly older than males (47.0 compared to 44.6). Most patients reported cannabis experience prior to seeking medical certification (66.9%). The top three mutually exclusive primary medical conditions reported were unspecified chronic pain (38.8%), anxiety (13.5%) and post-traumatic stress disorder (PTSD) (8.4%). The average number of comorbid conditions reported was 2.7, of which anxiety was the most common (28.3%). Females reported significantly more comorbid conditions than males (3.1 compared to 2.3). Conclusion This retrospective study highlighted the range and number of conditions for which patients in the US seek medical cannabis. Rigorous clinical trials investigating the use of medical cannabis to treat pain conditions, anxiety, insomnia, depression and PTSD would benefit a large number of patients, many of whom use medical cannabis to treat multiple conditions.

Unveiling the real-world outcomes of breast cancer (BC) patients with taxanes-induced neuropathy using a digital patient-powered network (PPN).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18248-e18248
Author(s):  
Raanan Berger ◽  
Lior Hasid ◽  
Irad Deutsch ◽  
Eliran Malki ◽  
Maytal Bivas-Benita
Keyword(s):  
Cancer Patients ◽  
Real World ◽  
Healthcare Costs ◽  
Patient Reported Outcomes ◽  
Early Stage ◽  
Treatment Decisions ◽  
Real World Evidence ◽  
Patient Reported ◽  
The Us ◽  
Disease Stages

e18248 Background: Taxanes-induced neuropathy is common in BC patients receiving taxanes, forcing dose reductions and treatment delays and posing serious challenges for the long-term patient QoL. Discovering neuropathy predictors in patients could guide better treatment decisions, improved QoL and reduce healthcare costs. Belong digital PPN is a social network for cancer patients and caregivers that supports disease management. In this study we used our artificial intelligence (AI) engine to classify the prevalence, characteristics and taxanes-induced neuropathy status of BC patients. Methods: We analyzed real-world patient-reported outcomes provided voluntarily and anonymously from users on the Belong PPN. Data from BC patients reporting treatment with taxanes was extracted and additional analysis segmented the data to those who experienced neuropathy and those who did not. Further validation of the data was performed by our research team to assure accuracy. Results: We evaluated 169 BC cancer patients from the US treated with taxanes. In the cohort 72% were Paclitaxel-treated and 28% Docetaxel-treated at various disease stages: 68% at early stage BC (0-2) and 32% at the advanced/metastatic stages (3-4). 83% of Paclitaxel-treated patients and 67% of Docetaxel-treated patients reported experiencing neuropathy in the Belong platform. These real-world reports indicated significantly higher incidence of taxane-induced neuropathy in comparison to literature summarizing data from clinical trials, suggesting neuropathy incidence of 27% for paclitaxel and 16% for docetaxel (grades 2-4). Conclusions: Real-world patient-reported outcomes from the Belong PPN captured the prevalence of taxanes-induced neuropathy in BC patients and correlated it to the specific drug in use. Evidence for higher incidence of taxanes-induced neuropathy may lead to lower patient QoL and higher healthcare costs and should stimulate better treatment decisions. Further exploration of the gap between controlled clinical studies and real-world evidence is urgently needed to understand the true patient outcomes and optimize healthcare accordingly.

A randomized trial of medical cannabis (MC) in patients with advanced cancer (AC) to assess impact on opioid use and cancer-related symptoms.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 109-109
Author(s):  
Dylan M. Zylla ◽  
Justin Eklund ◽  
Grace Gilmore ◽  
Alissa Gavenda ◽  
Gabriela Vazquez-Benitez ◽  
...  
Keyword(s):  
Pain Control ◽  
Negative Impact ◽  
Stage Iv ◽  
Scientific Data ◽  
Medical Cannabis ◽  
Opioid Use ◽  
Negative Effects ◽  
Opioid Dose ◽  
Patient Reported ◽  
Oncology Care

109 Background: Higher pain and greater long-term opioid requirements have been associated with shorter survival and decreased quality of life (QOL) in patients with AC. Routine use of MC is limited by a lack of rigorous scientific data and concerns about side effects, legal ramifications, and cost. Methods: 30 patients with stage IV cancer requiring opioids were randomized 1:1 to early cannabis (EC, n=15) vs. delayed cannabis (DC, n=15). The EC group was provided with 3 months (3M) of MC at no charge, while the DC group received standard oncology care without MC for the first 3M. Patients met with licensed pharmacists at one of two MC manufacturers to determine optimal MC dosing, formulation, and route. Patients completed monthly pain logs, opioid/MC logs, and validated Patient-Reported Symptom Monitoring surveys. Results: A higher proportion of EC patients achieved a reduction in opioid use and improved pain control. On average over a 3M window, EC patients did not require opioid dose escalation, had lower mean pain, and had similar QOL compared to DC patients. Estimated mean daily THC and CBD dose at 3M was 76 mg (range 5-186 mg) and 36 mg (range <1-516 mg), respectively. Mean perceived benefit of MC was 5.1 and mean perceived negative impact was 2.7 (1 = no benefit/negative effects, 7 = a great deal of benefit/negative effects). 33% of patients died during the anticipated 6-month study period and patient compliance with study logs limited analysis. Conclusions: Randomized studies of MC in the oncology setting are feasible, but rigorous data collection is challenging. The addition of MC to standard oncology care in patients with AC was well-tolerated and may lead to improved pain control and lower opioid requirements. [Table: see text]

Opinion Mining and Multi-Label Classification of Patient-Generated Long-Term Anti-Obesity Medication Reviews (Preprint)

2021 ◽  
Author(s):  
Kyrian Ezendu ◽  
Askal Ali
Keyword(s):  
Blood Pressure ◽  
Adverse Effect ◽  
Weight Loss ◽  
Real World ◽  
Classification Model ◽  
Frequency Of Occurrence ◽  
Real World Evidence ◽  
Patient Reported ◽  
Sentiment Score

BACKGROUND With the explosion of web 2.0 technology, patients have taken to the internet to share experiences about their health conditions and treatments. Online drug review portals currently allow patients to their experiences with drugs they used in managing their conditions. These data sources could be harnessed for patient-reported real-world evidence to understand the impact of drugs on the users. OBJECTIVE To understand patients’ opinions about long-term AOMs (phentermine-topiramate, orlistat, naltrexone-bupropion, lorcaserin, and liraglutide) through online patient-posted user reviews. To determine the frequency of occurrence of key obesity treatment outcomes and build a multi-label classification model for detecting key obesity outcome topics. METHODS We crawled drug.com, askaapatient.com, webmd.com, druglib.com, and extracted reviews posted by the users of long-term AOMs about their experience with the drugs. Next, we carried out a generic lexicon-based document-level sentiment analysis by matching the words in the reviews of each AOM with their polarity classes in the sentiment dictionary. We then calculated the scaled sentiment score to measure how averagely positive the patient’s opinion is towards the drugs. The frequencies of occurrence of weight, adverse effect, glycemic, blood pressure, lipidemic outcome topics in the posted reviews were analyzed. A Multi-label classification model for classifying obesity outcome related topics was built and tested. RESULTS Patients expressed the most positive opinion for lorcaserin with a scaled sentiment score of 0.139, followed by phentermine-topiramate with scaled sentiment score of 0.04. Orlistat and naltrexone-bupropion had scaled-sentiment scores of -0.008 and -0.02 respectively. Having a scaled sentiment score -0.036, liraglutide was the most negatively appraised long-term AOM by patients’ reviews. Comparing the frequency of occurrence of weight and cardiometabolic topic in the reviews, weight loss outcome was the dominant topic, occurring in 1585 reviews, adverse effect topic occurred in 1273 reviews, glycemic outcome topic occurred in 92 reviews, blood pressure outcome topic occurred in 72 reviews, lipidemic outcome topic occurred in 48 reviews and topic on pulse outcome occurred in 31 reviews. The Multi-label classification model trained with the patient-posted AOM reviews has F1 score of 0.98, 0.55, 0.67, 0.80, and 0.67 in predicting AOM-related weight loss, adverse effect, , glycemic, blood pressure, lipidemic and pulse topics respectively in free text form. CONCLUSIONS Sentiment analysis of patient-posted long-term AOM reviews could be useful in understanding patient‘s experience with long-term AOMs. Despite having being withdrawn for the market, lorcaserin was the most positively appraised long-term AOM followed by phentermine-topiramate, orlistat, naltrexone-bupropion, and liraglutide. The users of AOMs commented most on the weight and safety (adverse effects) outcomes of AOMs than cardio-metabolic outcomes of their treatments. Classification model trained with patient posted AOM reviews had a good performance in detecting efficacy and safety signals occurring in text documents. sentiments/opinions formed by obese and overweight patients from their experience with long-term AOMs could be used in demonstrating the values of the medications, as part of patient-reported real-world evidence.

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