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Rationale Consideration by the US Drug Enforcement Administration and Food and Drug Administration of placing kratom into Schedule I of the Controlled Substances Act (CSA) requires its evaluation of abuse potential in the context of public health. Objective The objective of the study is to provide a review of kratom abuse potential and its evaluation according to the 8 factors of the CSA. Results Kratom leaves and extracts have been used for centuries in Southeast Asia and elsewhere to manage pain and other disorders and, by mid-twentieth century, to manage opioid withdrawal. Kratom has some opioid effects but low respiratory depression and abuse potential compared to opioids of abuse. This appears due to its non-opioid-derived and resembling molecular structure recently referred to as biased agonists. By the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems. Conclusions Although kratom appears to have pharmacological properties that support some level of scheduling, if it was an approved drug, placing it into Schedule I, thus banning it, risks creating public health problems that do not presently exist. Furthermore, appropriate regulation by FDA is vital to ensure appropriate and safe use.

Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse.

Pregabalin is commonly used for treating pain but is also recognized for its misuse potential. In response to rising abuse, Egyptian health authorities reclassified pregabalin as a controlled substance in August 2019, aiming to curb misuse and regulate its distribution. This study evaluated the impact of the 2019 policy on gabapentinoid (pregabalin and gabapentin) and opioid sales in Egypt. An interrupted time-series analysis using Autoregressive Integrated Moving Average (ARIMA) models was conducted on IQVIA MIDAS® quarterly volume sales data obtained under license from IQVIA for the period 2012-2023. Copyright IQVIA. All rights reserved. Drug volume sales were standardized per 1,000 individuals based on population estimates. ARIMA modelling was used to capture immediate and delayed effects of the August 2019 policy change. Percent changes for 3-, 6- and 12-months were also calculated. Overall gabapentinoid sales increased steadily until the second quarter of 2019. Following reclassification, a significant decline in total gabapentinoid sales (-67%) was observed, driven by a 99% drop in pregabalin sales, while gabapentin sales surged by 198%. ARIMA analyses of gabapentinoid sales showed a significant short-term effect (pulse: p < 0.001) and a notable gradual long-term change (ramp: p = 0.008). In contrast, opioids exhibited a significant short-term sustained increase (step: p = 0.010) but a non-significant gradual long-term change (ramp: p = 0.256), with sales rising by up to 49.5% at one year post-policy. Reclassifying pregabalin effectively reduced its utilization but prompted a shift to gabapentin use. Our findings highlight the complexity of drug policy interventions, underscoring the need for continuous monitoring to mitigate unintended substitution effects and better understand policy impacts of the treatment of pain.

Policies and practices have proliferated to optimize prescribers' use of their states' prescription drug monitoring programs, which are statewide databases of controlled substances dispensed at retail pharmacies. Our study assessed the effectiveness of three such policies: comprehensive legislative mandates to use the program, laws that allow prescribers to delegate its use to office staff, and state participation in interstate data sharing. Our analysis of information from a large commercial insurance database indicated that comprehensive use mandates implemented during 2011-15 were associated with a 6-9 percent reduction in opioid prescriptions with high risk for misuse and overdose. We also found delegate laws to be associated with reductions of a similar magnitude for selected outcomes. In general, the effects of all three policies strengthened over time, especially beginning in the second year after implementation. Our findings support comprehensive use mandates and delegate laws to optimize prescribers' use of drug monitoring programs, but the results will need updates in the context of evolving state opioid policies-including the increasing integration of drug monitoring data with electronic health records.

On December 6 and 7, 2017, the US Department of Health and Human Services (HHS) hosted its first Code-a-Thon event aimed at leveraging technology and data-driven solutions to help combat the opioid epidemic. The authors—an interdisciplinary team from academia, the private sector, and the US Centers for Disease Control and Prevention—participated in the Code-a-Thon as part of the prevention track. The aim of this study was to develop and deploy a methodology using machine learning to accurately detect the marketing and sale of opioids by illicit online sellers via Twitter as part of participation at the HHS Opioid Code-a-Thon event. Tweets were collected from the Twitter public application programming interface stream filtered for common prescription opioid keywords in conjunction with participation in the Code-a-Thon from November 15, 2017 to December 5, 2017. An unsupervised machine learning–based approach was developed and used during the Code-a-Thon competition (24 hours) to obtain a summary of the content of the tweets to isolate those clusters associated with illegal online marketing and sale using a biterm topic model (BTM). After isolating relevant tweets, hyperlinks associated with these tweets were reviewed to assess the characteristics of illegal online sellers. We collected and analyzed 213,041 tweets over the course of the Code-a-Thon containing keywords codeine, percocet, vicodin, oxycontin, oxycodone, fentanyl, and hydrocodone. Using BTM, 0.32% (692/213,041) tweets were identified as being associated with illegal online marketing and sale of prescription opioids. After removing duplicates and dead links, we identified 34 unique “live” tweets, with 44% (15/34) directing consumers to illicit online pharmacies, 32% (11/34) linked to individual drug sellers, and 21% (7/34) used by marketing affiliates. In addition to offering the “no prescription” sale of opioids, many of these vendors also sold other controlled substances and illicit drugs. The results of this study are in line with prior studies that have identified social media platforms, including Twitter, as a potential conduit for supply and sale of illicit opioids. To translate these results into action, authors also developed a prototype wireframe for the purposes of detecting, classifying, and reporting illicit online pharmacy tweets selling controlled substances illegally to the US Food and Drug Administration and the US Drug Enforcement Agency. Further development of solutions based on these methods has the potential to proactively alert regulators and law enforcement agencies of illegal opioid sales, while also making the online environment safer for the public.

Rationale Lemborexant (LEM) is a dual orexin receptor antagonist (DORA) approved in multiple countries including the USA, Japan, Canada, Australia, and several Asian countries for the treatment of insomnia in adults. As a compound with central nervous system activity, it is important to understand the abuse potential of LEM with respect to public health. Objectives This review discusses data for LEM relevant to each of the 8 factors of the United States Controlled Substances Act. Results LEM did not demonstrate abuse potential in nonclinical testing and was associated with a low incidence of abuse-related adverse events in clinical study participants with insomnia disorder. Similar to other DORAs that have been evaluated (eg., almorexant, suvorexant (SUV), and daridorexant), LEM and the positive controls (zolpidem and SUV) also showed drug liking in a phase 1 abuse potential study that enrolled subjects who used sedatives recreationally. However, internet surveillance of SUV and the FDA Adverse Events Reporting System suggests that drugs in the DORA class display very low abuse-related risks in the community. Additionally, as described in FDA-approved labeling, it does not carry physical dependence and withdrawal risks. Conclusions LEM, similar to most other prescription insomnia medications, was placed into Schedule IV. However, LEM and other drugs in the DORA class may have a lower potential for abuse as suggested by real-world postmarketing data from federal surveys and internet surveillance, and thus may have lower risks to public health than Schedule IV benzodiazepines and nonbenzodiazepine hypnotics that potentiate GABA signaling.

Some pharmacies were choosing to serve long-standing patients over newer ones to prevent breaching the cap on orders, Lemrey Carter (executive director of the National Association of Boards of Pharmacy, Mount Prospect, IL, USA, a non-profit that works with state pharmacy boards on public health) told The Lancet Oncology. The regulations affecting pharmacies were brought in only because of “a few bad actors, while the vast majority simply want to serve their patients,” Kurt Proctor (senior vice president of strategic initiatives at the National Community Pharmacists Association, Alexandria, VA, USA that represents independent pharmacies) told The Lancet Oncology. To resolve the regulatory blocks, federal officials needed to declare there was a health risk of concern and the legal settlement made with the drug distributors should be adjusted, Stefan Kertesz, Professor of Medicine at the University of Alabama at Birmingham (Birmingham, AL, USA), told The Lancet Oncology.

Background As the misuse and abuse of medical narcotics are increasing in South Korea, an information system for the integrated information management of medical narcotic drugs across the nation is needed. This paper presents the development process of the Narcotics Information Management System (NIMS) for the monitoring of medical narcotics usage and the results of its implementation. Methods As the NIMS enforces that all narcotics handlers digitally report all information on handling medical narcotic drugs, the functional requirements of the NIMS have been identified in accordance with the Narcotics Control Act. In addition to the functional requirements, the non-functional requirements of the NIMS have been elicited by major narcotics handlers and their associations. The non-functional requirements include privacy, availability, connectivity, interoperability, and data integrity. The system design with entity-relationship diagrams and its implementation processes have been presented. Results The NIMS encompasses all narcotic handlers, which comprise exporting, importing, and pharmaceutical companies; wholesalers; hospitals and clinics; and pharmacies, collecting over 120 million cases annually. It enables transparent monitoring throughout the life cycle, from manufacturing, sales, purchase, and disposal of narcotics. As a result, the number of prescriptions for medical narcotics has been reduced by 9.2%. Conclusions To the best of our knowledge, the NIMS is the world's first system to manage all information on the total life cycle of medical narcotics, including imports, production, distribution, use, and disposal of drugs. This system has enabled the safety management and monitoring of medical narcotic drugs. Additionally, it provides consistent and transparent information to physicians and patients, leading to the autonomous safety management of narcotics. The successful development of the NIMS can provide guidelines for implementing a narcotics management system in other countries.

Background and rationaleCathinones are amphetamine analogues that produce stimulant effects with rewarding properties. For many decades, synthetic cathinones have been used in the United States (USA) for abuse purposes, leading to concern about public safety by the federal government. Under the Controlled Substances Act (CSA), the federal government may place drugs with high abuse potential but no currently accepted medical use into Schedule I of the CSA. The process of scheduling an abusable drug involves both the Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), and the Department of Justice, through the Drug Enforcement Administration (DEA).ResultsThis paper details how numerous synthetic cathinones were placed under CSA control between 1973 and 2018, with an emphasis on 10 cathinones that were placed into Schedule I in 2017 (butylone, naphyrone, pentylone, pentedrone, 3-fluoro-N-methylcathinone (FMC), 4-FMC, 4-methyl-N-ethylcathinone, 4-methyl-pyrrolidinopropiophenone, alpha-pyrrolidinobutiophenone, and α-pyrrolidinopentiophenone). A summary is provided of the scientific and medical analysis performed by HHS, in the form of an Eight-Factor Analysis (8FA), as prescribed by the CSA. This 8FA was then evaluated and signed by the Assistant Secretary for Health at HHS and transmitted to DEA, which permanently placed the 10 cathinones into Schedule I after public notices were published into the Federal Register.Discussion and conclusionsUnderstanding the scientific data, analysis, and complex process utilized by the US federal government in the CSA scheduling of cathinones with abuse potential and no accepted medical use is important for transparency in governmental decision-making.

Intrathecal drug delivery systems (IDDS) are effective tools for the management of chronic non-cancer pain, cancer-associated pain, and spasticity. Given the overall risks of opioid medications, it is imperative that IDDS opioid-infusion patients receive education regarding the risks versus benefits of their intrathecal opioid medications and that controlled substance agreements (CSAs) are utilized to both educate patients and hold them accountable for keeping IDDS programming visits, refill appointments, or other IDDS maintenance appointments. A retrospective electronic medical record (EMR) review study was conducted at an interventional pain management practice, quantifying the number of non-cancer chronic pain IDDS opioid therapy patients with signed CSAs. An educational intervention was conducted to increase staff awareness regarding compliance with CSAs and the location of proper CSA documentation within the EMR. Follow-up EMR review and provider knowledge assessment surveys were deployed to assess the success of the intervention. Staff knowledge of CSAs increased from 14.3% (3/21) to 45.5% (10/22) following CSA education while their ability to locate CSAs within the EMR also increased from 38.1% (8/21) to 40.9% (9/22). Post-education intervention, rates of CSA documentation improved from 4.5% to 74.5%. Lastly, there was a 39.5% reduction in rescheduled IDDS appointments within the patient population studied. The results of this study suggest potentially profound impacts that a simple education intervention can have on staff knowledge and compliance with CSA documentation for patients receiving IDDS opioid therapy for chronic non-cancer pain. Furthermore, implementation of CSAs for this patient population may be associated with a decrease in the number of missed, no-show, or rescheduled IDDS maintenance appointments, which have important patient safety implications. Further research is warranted to investigate the impact of CSA compliance on adverse patient outcomes and the potential cost-savings practices with required CSAs.