Adverse effects and Drug Interactions Associated with Inhaled Recreational and Medical Marijuana

Objectives: To provide an overview of the addiction potential; adverse effects (e.g., cardiovascular, immune dysfunction, respiratory system, mental health disorders); drug interactions; effects of accidental exposure; crime statistics; and pharmacist’s considerations for the use of inhaled medical marijuana. Methods: A PubMed search was conducted from 1966 to March 2016 to identify articles in which the safety of inhaled medical marijuana was assessed. Key MeSH search terms included medical marijuana with a subheading for adverse effect. Only articles in adult patients were considered. In addition, medical marijuana or cannabis plus one of the following search terms were searched: drug interactions, herb-drug interactions, drug-related side effects and adverse drug reactions, substance-related disorders, addiction, and abuse. A free-text search was also conducted to identify articles not included in the MeSH term search. A bibliographic search was also conducted. Articles were included if they addressed adverse effects of medical marijuana for the treatment of a condition. Meta-analyses, randomized controlled clinical trials, and case reports were included in the review if the primary focus of the article related to the adverse effect profile of inhaled medical marijuana. Medical marijuana efficacy studies were not assessed. In the absence of this information, case reports or reports of inhaled recreational marijuana use was used. Studies were excluded if published in languages other than English. In addition, studies highlighting mechanisms of action, studies of pharmacodynamics or pharmacokinetic effects were excluded, unless these effects were due to drug-drug interactions. Prescription products containing marijuana or derivatives were excluded from evaluation. An Internet search was conducted to locate the most up-to-date information on the laws concerning medical marijuana. Key findings: A PubMed search revealed 58 articles and 28 of those studies were included in this review. Several studies were located that evaluated the safety of medical marijuana; however, much of the review focused on inhaled, recreational marijuana use due to the paucity of information on inhaled medical marijuana. Since marijuana is a Schedule1 product, few clinical studies have been conducted to determine the adverse event profile of the product. As a result, several articles that characterized recreational inhaled marijuana were included. Recreational inhaled marijuana use may be associated with an increase in cardiovascular (CV)/ cerebrovascular effects (CVA); however, conflicting information exists in the literature. Recreational marijuana use may also increase risky behaviors that increase the transmission of infectious diseases and respiratory diseases. Many of the studies were retrospective in nature; therefore, it was difficult to determine a cause and effect relationship between inhaled marijuana use and the development of adverse reactions or drug-drug interactions. Conclusions: There is a paucity of information related to the use of inhaled medical marijuana. Recreational marijuana use is associated with several adverse events including CV/CVA, respiratory, and transmission of infectious diseases. Theoretical literature indicates that medical marijuana may be associated with significant drug-drug interactions and adverse drug reactions. Legalization of medical marijuana may be associated with an increase in abuse/dependence and accidental exposures in children. Pharmacists need to be educated regarding the appropriate use of medical marijuana to avoid adverse reactions and potential drug-drug interactions between medical marijuana and other products.   Type: Original Researc

Immuno-Oncology Medicines: Policy Implications and Economic Considerations

Significant progress has taken place in the field of cancer immunotherapy in recent years. Cancer immunotherapy, particularly immune checkpoint inhibitors, have shown rather dramatic results and are believed to have completely transformed the field of oncology. However, these transformational therapies are more expensive than previous cancer therapies. As more cancer immunotherapy agents are being developed, with some already being marketed, it is important to consider how economic constraints will shape health policy and value assessment related to these agents. A number of strategies have been suggested to alleviate the price burden and the ensuing concerns about the sustainability of publicly funded healthcare systems. Among these strategies, value-based pricing (VBP) for innovative drugs dominates the headlines in the field of oncology. The specifics of how VBP may be implemented in the United States is still unclear. Nonetheless, policy reform and economic considerations will have to be incorporated into the planning of VBP. The objective of this paper is multifold: (i) to identify the factors affecting the impact of cancer immunotherapy on healthcare cost; (ii) to critically appraise current approaches used to assess the value of novel cancer therapies; (iii) to assess the methodological challenges associated with the economic evaluation of cancer immunotherapy. As the health care system in the U.S transitions toward a value-based model, the need for a formal value assessment framework is warranted in cancer immunotherapy.   Article Type: Revie

Geographic Distribution of Antipsychotic Use in Medicare Part D Patients

Purpose: To determine if there is a geographic variation in antipsychotic prescribing in Medicare recipients in 10 US divisions. Methods: Data was collected in the Microsoft Excel format from the Medicare Provider Utilization and Payment Data: Part D Prescriber Public Use File for 2013 CMS data. Antipsychotics were sorted and downloaded into separate excel formats. The states were separated into the 10 geographic according to the US Census Bureau to identify prescribing trends. The primary endpoint was to determine the difference in the rates of CMS Medicare Part D utilizers who had antipsychotic prescriptions in each of the 10 geographic divisions. The rate of antipsychotic prescribing was calculated by determining the number of prescription claims for each antipsychotic for the division and dividing by the number of people utilizing Medicare Part D in each division. Data was converted to SPSS (version19, Armonk, NY) for further analysis. ANOVA was used to compare the differences. Results: Approximately 35 million claims were included in the data set. Antipsychotics comprised 4.75% of the total spending on medications for Medicare Part D. New England was found to have the highest rate of claims at 0.83. No statistically significant differences in the rate of antipsychotic prescribing across geographic regions was observed; however, a statistically significant difference was observed for total claims (P<0.001) and total antipsychotic costs (P<0.017) across regions. Conclusion: Additional studies need to be conducted to determine if there is a difference in antipsychotic prescribing in the United States. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Student Projec

A Systematic Review of the Effectiveness of Text Message Reminders on Asthma Medication Adherence

Objective: Cell phone text messaging reminders offers the promise of an efficient technology for the management of chronic diseases, such as asthma. This review aims to evaluate the effectiveness of text message reminders in improving medication adherence for asthma compared to usual care. Methods: Randomized controlled trials assessing the effect of text message reminders on adherence to asthma medication were identified from PubMed, Medline, Web of Knowledge EBSCOhost, OvidSP, PsycINFO, and Cochrane Central Register of Controlled Trials and Cochran Health Technology Assessment databases. Literature searches were restricted to the English language, and no restrictions were imposed on the year and country of publication. Results:  Five studies that were deemed relevant to the systematic review were identified from the literature search. Findings on whether text message reminders improve medication adherence were mixed. However, the review indicates that text-messaging interventions were effective as a means of addressing forgetfulness by reminding patients to take their medications. Conclusion: This review adds to the body of literature reviewing the effectiveness of emerging technologies in the management of diseases. Despite the fact there is limited evidence across the population of studies to support the effectiveness of text message reminders, such technology represents an important tool to achieve optimal medication adherence among asthmatics.   Article Type: Student Projec

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC). The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9%) of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%). The three most frequently reported labeling changes were warnings (68.7%), precautions (58.6%), and patient package insert/medication guide (23.2%). Case reports resulted in the greatest number of documented literature types (n = 791), followed by randomized controlled trials (n = 76), and case control/cohort studies (n = 74). Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%), compared to LOE A (17.1%), and LOE C (14.1%) (p = 0.007). Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Researc

Geographic Distribution of Antipsychotic Use in Medicare Part D Patients

Purpose: To determine if there is a geographic variation in antipsychotic prescribing in Medicare recipients in 10 US divisions. Methods: Data was collected in the Microsoft Excel format from the Medicare Provider Utilization and Payment Data: Part D Prescriber Public Use File for 2013 CMS data. Antipsychotics were sorted and downloaded into separate excel formats. The states were separated into the 10 geographic according to the US Census Bureau to identify prescribing trends. The primary endpoint was to determine the difference in the rates of CMS Medicare Part D utilizers who had antipsychotic prescriptions in each of the 10 geographic divisions. The rate of antipsychotic prescribing was calculated by determining the number of prescription claims for each antipsychotic for the division and dividing by the number of people utilizing Medicare Part D in each division. Data was converted to SPSS (version19, Armonk, NY) for further analysis. ANOVA was used to compare the differences. Results: Approximately 35 million claims were included in the data set. Antipsychotics comprised 4.75% of the total spending on medications for Medicare Part D. New England was found to have the highest rate of claims at 0.83. No statistically significant differences in the rate of antipsychotic prescribing across geographic regions was observed; however, a statistically significant difference was observed for total claims (P<0.001) and total antipsychotic costs (P<0.017) across regions. Conclusion: Additional studies need to be conducted to determine if there is a difference in antipsychotic prescribing in the United States. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Student Projec