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abuse deterrent

M M Dynes, E Twentyman, L Kelly, G Maro, A A Msuya, S Dominico, P Chaote, R Rusibamayila, F Serbanescu
BACKGROUND: Lack of respectful maternity care (RMC) is increasingly recognized as a human rights issue and a key deterrent to women seeking facility-based deliveries. Ensuring facility-based RMC is essential for improving maternal and neonatal health, especially in sub-Saharan African countries where mortality and non-skilled delivery care remain high. Few studies have attempted to quantitatively identify patient and delivery factors associated with RMC, and none has modeled the influence of provider characteristics on RMC...
March 5, 2018: Reproductive Health
Vijay Kata, Matthew B Novitch, Mark R Jones, Best O Anyama, Erik M Helander, Alan D Kaye
PURPOSE OF REVIEW: The primary cause of overdose death in the United States is related to pharmaceutical opioids. A few particular populations that struggle with adverse outcomes related to opioid abuse are those in palliative care, those with chronic pain, and those receiving pain treatments secondary to cancer or chemotherapy. RECENT FINDINGS: There have been massive efforts to decrease the use of opioid abuse in patient care in a gestalt manner, but palliative care provides unique challenges in applying these reduction tactics used by other specialties...
February 19, 2018: Current Opinion in Supportive and Palliative Care
Joseph V Pergolizzi, Robert Taylor, Jo Ann LeQuang, Robert B Raffa
Proper management of severe pain represents one of the most challenging clinical dilemmas. Two equally important goals must be attained: the humanitarian/medical goal to relieve suffering and the societal/legal goal to not contribute to the drug abuse problem. This is an age-old problem, and the prevailing emphasis placed on one or the other goal has resulted in pendulum swings that have resulted in either undertreatment of pain or the current epidemic of misuse and abuse. In an effort to provide efficacious strong pain relievers (opioids) that are more difficult to abuse by the most dangerous routes of administration, pharmaceutical companies are developing products in which the opioid is manufactured in a formulation that is designed to be tamper resistant...
2018: Journal of Pain Research
Joshua P Cohen, Mario Mendoza, Carl Roland
PURPOSE: This commentary examines the development, regulatory, and reimbursement challenges facing abuse-deterrent formulation (ADF) products. METHODS: In January 2017, the Tufts Center for the Study of Drug Development convened a roundtable to explore clinical development, regulatory, and reimbursement challenges with respect to ADFs of opioid analgesics. Roundtable participants, who included a range of pharmaceutical industry and other experts, discussed multiple challenges...
February 2018: Clinical Therapeutics
Lynn R Webster, Eugene R Viscusi, Colville Brown, Jeffrey M Dayno
BACKGROUND: The development and use of abuse-deterrent (AD) opioids is part of a multifaceted strategy to reduce misuse, abuse, and diversion, while maintaining access for patients with severe pain who may benefit from their analgesic efficacy. Morphine AD, extended-release (ER), injection-molded tablets (morphine-ADER-IMT; ARYMO® ER; Egalet US Inc, Wayne, PA) is approved by the FDA as an AD opioid. As part of the characterization of AD opioids, assessments of their human abuse potential (HAP) are required...
January 25, 2018: Current Medical Research and Opinion
Briony Larance, Timothy Dobbins, Amy Peacock, Robert Ali, Raimondo Bruno, Nicholas Lintzeris, Michael Farrell, Louisa Degenhardt
BACKGROUND: Escalation of pharmaceutical opioid use and harm in North America is well-documented, with similar issues emerging in Australia. One response is the development of tamper-resistant formulations of opioids. A potentially tamper-resistant formulation of controlled-release oxycodone was introduced in Australia in April, 2014, rapidly replacing the non-tamper-resistant formulation. Our study is the most systematic and comprehensive examination of the impact of a new opioid formulation to date, assessing the effect of tamper-resistant formulation of controlled-release oxycodone on population-level opioid use and opioid-related harm (ie, overdose, help-seeking, and treatment-seeking); and opioid use, tampering, and preference for the tamper-resistant formulation of controlled-release oxycodone compared with other drugs or formulations among sentinel populations likely to tamper with pharmaceutical opioids...
January 10, 2018: Lancet Psychiatry
Emily Peca, John Sandberg
BACKGROUND: Despite global gains, women in hard-to-reach areas are at a relatively higher risk of death and disability related to childbirth. Traditional methods of measuring satisfaction may mask negative experiences (such as disrespect and abuse) that can drive down demand for institutional care. Better measurement of women's perceptions of care quality, especially among marginalized populations with historically low utilization of institutional care, are needed to inform how to improve services and foster greater utilization of (potentially life-saving) clinical care...
January 11, 2018: Reproductive Health
Anteneh Asefa, Delayehu Bekele, Alison Morgan, Michelle Kermode
BACKGROUND: Disrespect and abuse (D&A) of women during childbirth by the attending staff in health facilities has been widely reported in many countries. Although D&A in labor rooms is recognized as a deterrent to maternal health service utilization, approaches to defining, classifying, and measuring D&A are still at an early stage of development. This study aims to enhance understanding of service providers' experiences of D&A during facility based childbirth in health facilities in Addis Ababa...
January 5, 2018: Reproductive Health
Gregory D Curfman, Leo Beletsky, Ameet Sarpatwari
No abstract text is available yet for this article.
January 1, 2018: JAMA Internal Medicine
Suzanne K Vosburg, S Geoffrey Severtson, Richard C Dart, Theodore J Cicero, Steven P Kurtz, Mark W Parrino, Jody L Green
Tapentadol, a Schedule II opioid with a combination of µ-opioid activity and norepinephrine reuptake inhibition, is used for the management of moderate to severe acute and chronic pain. Its dual-mechanism of action is thought to reduce opioid-related side effects that can complicate pain management. Since approval, tapentadol has been tracked across multiple outcomes suggesting abuse liability, and a pattern of relatively low, although not absent, abuse liability has been found. This retrospective cohort study further details the abuse liability of tapentadol as an Active Pharmaceutical Ingredient (API) when both immediate-release and extended-release formulations were on the market together (4Q2011 to 2Q2016)...
December 7, 2017: Journal of Pain: Official Journal of the American Pain Society
Mihran Ara Yenikomshian, Alan G White, Michael E Carson, Louis P Garrison, Gary M Oderda, Joseph E Biskupiak, Patrick R Hlavacek, Carl L Roland
OBJECTIVES: To estimate healthcare resource utilization, associated costs, and number needed to harm (NNH) from a physician's decision to prescribe extended-release (ER) non-abuse-deterrent opioids (non-ADO) as compared to ER ADOs in a chronic pain population. DESIGN: A 12-month probabilistic simulation model was developed to estimate the reduction of misuse and/or abuse from a physician's prescribing decisions for 10,000 patients. Model inputs included probabilities for opioid misuse and/or abuse-related events, opioid discontinuation, and switching from ADO to non-ADO...
September 2017: Journal of Opioid Management
Ya-Han Lee, Daniel L Brown, Hsiang-Yin Chen
BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations...
November 2017: Pain Physician
Arnold J Weil, Elizabeth T Masters, Alexandra I Barsdorf, Almasa Bass, Glenn Pixton, Jacquelyn G Wilson, Gernot Wolfram
BACKGROUND: The efficacy of ALO-02, an abuse-deterrent formulation containing extended-release oxycodone and sequestered naltrexone, in the treatment of chronic low back pain (CLBP) was studied in a 12-week randomized controlled trial. Primary efficacy endpoint results have been published previously (Rauck et al., 2015). The current paper focuses on patient-reported outcomes for health-related quality of life (HRQL), work productivity, and activity impairment that were assessed during this study...
October 17, 2017: Health and Quality of Life Outcomes
Sven M Guenther, Travis C Mickle, Andrew C Barrett, Kathryn Ann Roupe, Jing Zhou, Vincent Lam
Objectives: Benzhydrocodone is a hydrocodone prodrug that has been combined with acetaminophen (APAP) in a novel immediate-release analgesic. This study evaluated the relative bioavailability, intranasal abuse potential, and safety of benzhydrocodone/APAP compared with commercially available hydrocodone bitartrate (HB)/APAP. Design: Single-center, randomized, double-blind, double-dummy, two-part study comprising a Dose Selection (Part A) phase and a Main Study (Part B) phase...
August 25, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Abigail Brooks, Courtney Kominek
No abstract text is available yet for this article.
September 7, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Briony Larance, Louisa Degenhardt, Amy Peacock, Natasa Gisev, Richard Mattick, Samantha Colledge, Gabrielle Campbell
There are parallels between the North American experience of escalating pharmaceutical opioid utilisation and harm and the trends being observed in Australia. In Australia, opioid utilisation has increased dramatically over the past two decades. There have been significant shifts away from the predominant prescribing of 'weak' and short-acting opioids, to 'strong' and long-acting opioids, for an increasing range of chronic pain indications. In concordance with escalating use, Australia is experiencing increases in opioid-related hospital admissions and overdose, as well as opioid dependence and treatment seeking...
October 12, 2017: Drug and Alcohol Review
Stephen F Butler, Ryan A Black, Alison B Fleming
Objective: Some crush-resistant tablet formulations (CRTs) reduce prescription opioid abuse by nonoral routes of administration (ROAs), especially insufflation and injection, while oral abuse increases. Oral abuse involving product manipulation vs swallowing whole for CRTs and comparators was examined. Methods: Abuse by oral modes of administration (e.g., swallowing whole, chewing, dissolving in the mouth), was examined using the ASI-MV, a computerized, clinical interview for adults in substance abuse treatment from January 2009 to March 2015...
July 8, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Mary Bond, Kerri A Schoedel, Laura Rabinovich-Guilatt, Maciej Gasior, William Tracewell, Richard Malamut, Yuju Ma, Lynn R Webster
Objective: To assess the intranasal abuse potential of hydrocodone extended-release (ER) tablets developed with CIMA Abuse-Deterrence Technology compared with hydrocodone powder and hydrocodone bitartrate ER capsules (Zohydro ER, original formulation [HYD-OF]). Design: Single-dose, randomized, double-blind, quadruple-dummy, active- and placebo-controlled, crossover study. Setting: One US site. Subjects: Healthy, adult, nondependent, recreational opioid users...
June 14, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Phil Skolnick
The widespread abuse of prescription opioids and a dramatic increase in the availability of illicit opioids have created what is commonly referred to as the opioid epidemic. The magnitude of this epidemic is startling: About 4% of the adult US population misuses prescription opioids, and in 2015, more than 33,000 deaths were attributable to overdose with licit and illicit opioids. Increasing the availability of medication-assisted treatments (such as buprenorphine and naltrexone), the use of abuse-deterrent formulations, and the adoption of US Centers for Disease Control and Prevention prescribing guidelines all constitute short-term approaches to quell this epidemic...
October 2, 2017: Annual Review of Pharmacology and Toxicology
Mary Bond, Laura Rabinovich-Guilatt, Sally Selim, Mona Darwish, William Tracewell, Philmore Robertson, Ronghua Yang, Richard Malamut, Philippe Colucci, Murray P Ducharme, Ofer Spiegelstein
BACKGROUND AND OBJECTIVES: Food intake can alter the pharmacokinetics of certain medications, including changes in their oral bioavailability, which is of particular concern for extended-release (ER) opioids because of the high drug loads. Two randomized, open-label studies assessed the effect of food on the pharmacokinetics of single and multiple doses of hydrocodone ER formulated with CIMA(®) Abuse-Deterrence Technology. METHODS: Healthy subjects in fed and fasted states received single 90-mg doses of hydrocodone ER (Studies 1 and 2) or multiple doses of hydrocodone ER (45 mg twice daily on days 2-3, 60 mg twice daily on days 4-5, 90 mg twice daily on days 6-10, and 90 mg once in the morning on day 11) (Study 2)...
December 2017: Clinical Drug Investigation
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