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https://www.readbyqxmd.com/read/28833803/important-statistical-considerations-in-the-evaluation-of-post-market-studies-to-assess-whether-opioids-with-abuse-deterrent-properties-result-in-reduced-abuse-in-the-community
#1
Kunthel By, Jana K McAninch, Stephine L Keeton, Alex Secora, Cynthia J Kornegay, Catherine S Hwang, Thomas Ly, Mark S Levenson
PURPOSE: Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community...
August 23, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28830383/midwives-and-patients-perspectives-on-disrespect-and-abuse-during-labor-and-delivery-care-in-ethiopia-a-qualitative-study
#2
Sahai Burrowes, Sarah Jane Holcombe, Dube Jara, Danielle Carter, Katheryn Smith
BACKGROUND: It is increasingly recognized that disrespect and abuse of women during labor and delivery is a violation of a woman's rights and a deterrent to the use of life-saving, facility-based labor and delivery services. In Ethiopia, rates of skilled birth attendance are still only 28% despite a recent dramatic national scale up in the numbers of trained providers and facilities. Concerns have been raised that womens' perceptions of poor quality of care and fear of mistreatment might contribute to this low utilization...
August 22, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28829526/clinical-relevance-of-the-pharmacokinetic-characteristics-of-an-abuse-deterrent-extended-release-injection-molded-morphine-tablet
#3
Jeffrey M Dayno, Gwendolyn Niebler, John Lawler, Torben Elhauge, Karsten Lindhardt
OBJECTIVE: To characterize the pharmacokinetics (PK) and in vitro alcohol dissolution characteristics of extended-release (ER), injection-molded (IM) morphine tablets with abuse-deterrent (AD) features (morphine-ADER-IMT). DESIGN: In vivo, in vitro, and in silico studies were conducted. A randomized, two-cohort study evaluated the bioequivalence of morphine-ADER-IMT (60 mg) to morphine ER (60 mg; MS Contin®; Purdue Pharma LP, Stamford, CT) and characterized the effect of food on the PK profile of morphine-ADER-IMT...
March 2017: Journal of Opioid Management
https://www.readbyqxmd.com/read/28794653/real-world-utilization-of-once-daily-extended-release-abuse-deterrent-formulation-of-hydrocodone-a-comparison-with-the-pre-approval-randomized-clinical-trials
#4
Louise Taber, T Christopher Bond, Xuezhe Wang, Aditi Kadakia, Tracy J Mayne
BACKGROUND AND OBJECTIVE: Hydrocodone bitartrate extended release (Hysingla(®) ER, HYD) was previously studied in a 12-week randomized, double-blind, placebo-controlled trial and a 52-week open-label safety study. Both of these preapproval studies allowed dose titration to efficacy. The purpose of the present analysis was to compare dosing and utilization patterns in these previous clinical trials with real-world data (RWD) usage in a retrospective claim analysis performed 12-14 months post approval in the US...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/28772173/heroin-use-onset-among-nonmedical-prescription-opioid-users-in-the-club-scene
#5
Hilary L Surratt, Steven P Kurtz, Mance Buttram, Maria A Levi-Minzi, Maria E Pagano, Theodore J Cicero
BACKGROUND: Nonmedical prescription opioid use (NMPOU) is well documented among participants in the club scene, yet prior studies have not examined transition to heroin use. We prospectively examined heroin initiation among a sample of young adults with drug involvement associated with participation in the club scene, to understand factors that influence transition from NMPOU to heroin and to identify opportunities for intervention. METHODS: Data were drawn from a randomized trial that enrolled 750 Miami-based club and prescription drug users through respondent driven sampling, and tested the efficacy of assessment interventions in reducing risk...
October 1, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28771942/patterns-of-abuse-and-routes-of-administration-for-immediate-release-hydrocodone-combination-products
#6
Theresa A Cassidy, Natasha Oyedele, Travis C Mickle, Sven Guenther, Simon H Budman
PURPOSE: Prescriptions for hydrocodone immediate-release (IR) combination products have recently decreased, yet they represent the majority of opioid prescriptions dispensed and are commonly abused analgesics among both adults and adolescents. Little data exist to understand the contribution of IR products to the problem of prescription opioid abuse. This study aimed to better understand abuse patterns for hydrocodone IR combination products among adult and adolescent substance abusers...
August 3, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28726042/reproductive-desires-and-considerations-of-hiv-positive-men-in-heterosexual-relationships-in-new-york-city
#7
Karolynn Siegel, Étienne Meunier, Jack Ume Tocco, Helen-Maria Lekas
The reproductive desires of HIV-positive men have been investigated far less than those of HIV-positive women, especially in the US. This qualitative study of a sample of 94 HIV-positive men in New York City who were in a relationship with a woman of reproductive age examined their reasons for wanting a child as well as the conditions under which they would feel ready to attempt conception. Participants felt a child would make them feel normal, give meaning to their lives, or make others in their life happy...
July 19, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/28700587/community-and-health-system-intervention-to-reduce-disrespect-and-abuse-during-childbirth-in-tanga-region-tanzania-a-comparative-before-and-after-study
#8
Stephanie A Kujawski, Lynn P Freedman, Kate Ramsey, Godfrey Mbaruku, Selemani Mbuyita, Wema Moyo, Margaret E Kruk
BACKGROUND: Abusive treatment of women during childbirth has been documented in low-resource countries and is a deterrent to facility utilization for delivery. Evidence for interventions to address women's poor experience is scant. We assessed a participatory community and health system intervention to reduce the prevalence of disrespect and abuse during childbirth in Tanzania. METHODS AND FINDINGS: We used a comparative before-and-after evaluation design to test the combined intervention to reduce disrespect and abuse...
July 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28653782/changes-in-drug-use-patterns-reported-on-the-web-after-the-introduction-of-adf-oxycontin-findings-from-the-researched-abuse-diversion-and-addiction-related-surveillance-radars-system-web-monitoring-program
#9
Suzanne K Vosburg, Colleen Haynes, Andrea Besharat, Jody L Green
This qualitative study summarizes information that individuals shared online about use of OxyContin following the August 2010 introduction of the abuse deterrent formulation (ADF). PURPOSE: The primary objective was to study online posts that endorsed continued use of OxyContin or a switch from OxyContin to another formulation of oxycodone or another substance altogether following the introduction of the ADF. A secondary objective was to determine whether posts revealed that the ADF led to cessation of OxyContin use...
September 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28640970/prevalence-of-new-psychoactive-substances-and-prescription-drugs-in-the-belgian-driving-under-the-influence-of-drugs-population
#10
S M R Wille, C Richeval, M Nachon-Phanithavong, J M Gaulier, V Di Fazio, L Humbert, N Samyn, D Allorge
Driving under the influence of drugs (DUID) is a worldwide problem. Several countries have adopted DUID legislations which prove their deterrent effect and impact on road safety. However, the use of new psychoactive substances (NPS) and prescription drugs is not known, as the applied roadside screening tests have not yet been adapted for these compounds. In this study, 558 blood samples obtained during roadside controls in Belgium (January to August 2015) after a positive Drugwipe 5S® test and 199 oral fluid (OF) samples obtained from negatively screened test pads were analyzed...
June 22, 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/28635354/the-effects-of-food-on-opioid-induced-nausea-and-vomiting-and-pharmacological-parameters-a-systematic-review
#11
REVIEW
Robert B Raffa, Robert Colucci, Joseph V Pergolizzi
Opioids remain the standard of care for treating moderate to severe pain resulting from surgery or injury in cases of acute pain, and are recommended for patients who have not responded to nonopioid analgesics. Effective management of pain has an impact on clinical course and often depends on achieving an acceptable balance between opioid efficacy, safety, and tolerability. Common opioid-related adverse events such as nausea and vomiting are associated with an overall lower achievement of effective pain management and patient satisfaction...
September 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28609421/abuse-deterrent-opioids
#12
(no author information available yet)
No abstract text is available yet for this article.
June 5, 2017: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/28602044/the-dynamic-interaction-between-pain-and-opioid-misuse
#13
REVIEW
Adrianne R Wilson-Poe, Jose A Morón
In 2014, drug overdose surpassed automobile accidents as the number one cause of accidental death for the first time in the history of the United States. The overdose epidemic is largely driven by opioids, and genuine prescription opioid analgesics play the biggest role in this phenomenon. Despite advancements in abuse deterrent formulations, prescription drug monitoring programmes and clinical assessments for the detection of abuse potential, drug overdoses continue to escalate. The Center for Disease Control has recently issued new guidelines for opioid prescription, yet even these recommendations have their shortcomings...
June 11, 2017: British Journal of Pharmacology
https://www.readbyqxmd.com/read/28570346/child-welfare-professionals-determination-of-when-children-s-access-or-potential-access-to-loaded-firearms-constitutes-child-neglect
#14
Erin M Evans, Charles A Jennissen, Resmiye Oral, Gerene M Denning
BACKGROUND: Pediatric deaths and injuries from access to firearms are a significant public health problem. No studies have examined how experts determine child neglect regarding firearm access in the home. Our study objectives were to identify factors that influenced pediatric experts' finding of firearm-related child neglect and to assess their attitudes toward child access prevention (CAP) laws. METHODS: A survey was distributed to American Academy of Pediatrics Section on Child Abuse and Neglect members...
May 30, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28567699/effects-of-nalfurafine-on-the-reinforcing-thermal-antinociceptive-and-respiratory-depressant-effects-of-oxycodone-modeling-an-abuse-deterrent-opioid-analgesic-in-rats
#15
E Andrew Townsend, Jennifer E Naylor, S Stevens Negus, Shelley R Edwards, Hina N Qureshi, Hunter W McLendon, Christopher R McCurdy, Coco N Kapanda, Jussara M do Carmo, Fernanda S da Silva, John E Hall, Kenneth J Sufka, Kevin B Freeman
RATIONALE: Strategies to reduce the misuse of mu opioid agonists are critically needed. Previous work has shown that kappa opioid agonists can diminish the abuse-related effects and augment the antinociceptive effects of mu agonists. However, use of traditional kappa agonists is limited by their dysphoric side effects. OBJECTIVES: The current study examined the effects of nalfurafine, a clinically available atypical kappa agonist, on the reinforcing, thermal antinociceptive, and respiratory-depressant effects of oxycodone in male rats...
May 31, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28564568/abuse-deterrent-opioid-formulations-putting-the-potential-benefits-into-perspective
#16
William C Becker, David A Fiellin
Death rates among middle-aged adults, the largest demographic group in the United States, are on the rise for the first time in several decades. This trend can largely be explained by an increase in drug-overdose deaths, the majority of which involve opioids. The opioid crisis has attracted..
June 1, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28511685/respectful-maternity-care-in-ethiopian-public-health-facilities
#17
Ephrem D Sheferaw, Eva Bazant, Hannah Gibson, Hone B Fenta, Firew Ayalew, Tsigereda B Belay, Maria M Worku, Aelaf E Kebebu, Sintayehu A Woldie, Young-Mi Kim, T van den Akker, Jelle Stekelenburg
BACKGROUND: Disrespect and abuse of women during institutional childbirth services is one of the deterrents to utilization of maternity care services in Ethiopia and other low- and middle-income countries. This paper describes the prevalence of respectful maternity care (RMC) and mistreatment of women in hospitals and health centers, and identifies factors associated with occurrence of RMC and mistreatment of women during institutional labor and childbirth services. METHODS: This study had a cross sectional study design...
May 16, 2017: Reproductive Health
https://www.readbyqxmd.com/read/28448223/the-alerrt-%C3%A2-instrument-a-quantitative-measure-of-the-effort-required-to-compromise-prescription-opioid-abuse-deterrent-tablets
#18
Edward J Cone, August R Buchhalter, Karsten Lindhardt, Torben Elhauge, Jeffrey M Dayno
BACKGROUND: US FDA guidance recommends measuring the degree of effort needed to manipulate abuse-deterrent (AD) opioids. The ALERRT(®) instrument (PinneyAssociates; Bethesda, MD) uses visual analog scales to assess the labor, effort, and resources necessary to physically compromise AD product candidates in standardized settings. OBJECTIVE: Use the ALERRT(®) instrument for testing morphine abuse-deterrent, extended-release, injection-molded tablets (ADER-IMT) 60 and 100 mg and the comparators immediate-release (IR) morphine sulfate 30 mg and extended-release (ER) morphine sulfate 60 mg...
May 2017: American Journal of Drug and Alcohol Abuse
https://www.readbyqxmd.com/read/28419074/arymo-er-a-new-abuse-deterrent-morphine-formulation
#19
(no author information available yet)
No abstract text is available yet for this article.
April 24, 2017: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/28414990/medical-outcomes-associated-with-prescription-opioid-abuse-via-oral-and-non-oral-routes-of-administration
#20
Jody L Green, Becki Bucher Bartelson, M Claire Le Lait, Carl L Roland, Elizabeth T Masters, Jack Mardekian, J Elise Bailey, Richard C Dart
BACKGROUND: Prescription opioid abuse and misuse is a serious and growing public health issue. While the most common form of abuse is swallowing intact tablets/capsules, some abusers manipulate, or tamper with, these medications by altering the dosage form to allow for non-oral routes of administration (e.g., injection, inhalation) in order to achieve more rapid or enhanced psychoactive effects. Because administration of opioids via non-oral routes results in greater systemic availability and more rapid central nervous system penetration, we hypothesized that death and major medical outcomes occur more frequently with non-oral routes compared to oral route alone...
March 28, 2017: Drug and Alcohol Dependence
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