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      Abuse risks and routes of administration of different prescription opioid compounds and formulations

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          Abstract

          Background

          Evaluation of tamper resistant formulations (TRFs) and classwide Risk Evaluation and Mitigation Strategies (REMS) for prescription opioid analgesics will require baseline descriptions of abuse patterns of existing opioid analgesics, including the relative risk of abuse of existing prescription opioids and characteristic patterns of abuse by alternate routes of administration (ROAs). This article presents, for one population at high risk for abuse of prescription opioids, the unadjusted relative risk of abuse of hydrocodone, immediate release (IR) and extended release (ER) oxycodone, methadone, IR and ER morphine, hydromorphone, IR and ER fentanyl, IR and ER oxymorphone. How relative risks change when adjusted for prescription volume of the products was examined along with patterns of abuse via ROAs for the products.

          Methods

          Using data on prescription opioid abuse and ROAs used from 2009 Addiction Severity Index-Multimedia Version (ASI-MV ®) Connect assessments of 59,792 patients entering treatment for substance use disorders at 464 treatment facilities in 34 states and prescription volume data from SDI Health LLC, unadjusted and adjusted risk for abuse were estimated using log-binomial regression models. A random effects binary logistic regression model estimated the predicted probabilities of abusing a product by one of five ROAs, intended ROA (i.e., swallowing whole), snorting, injection, chewing, and other.

          Results

          Unadjusted relative risk of abuse for the 11 compound/formulations determined hydrocodone and IR oxycodone to be most highly abused while IR oxymorphone and IR fentanyl were least often abused. Adjusting for prescription volume suggested hydrocodone and IR oxycodone were least often abused on a prescription-by-prescription basis. Methadone and morphine, especially IR morphine, showed increases in relative risk of abuse. Examination of the data without methadone revealed ER oxycodone as the drug with greatest risk after adjusting for prescription volume. Specific ROA patterns were identified for the compounds/formulations, with morphine and hydromorphone most likely to be injected.

          Conclusions

          Unadjusted risks observed here were consistent with rankings of prescription opioid abuse obtained by others using different populations/methods. Adjusted risk estimates suggest that some, less widely prescribed analgesics are more often abused than prescription volume would predict. The compounds/formulations investigated evidenced unique ROA patterns. Baseline abuse patterns will be important for future evaluations of TRFs and REMS.

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          Most cited references30

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          Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain.

          Use of chronic opioid therapy for chronic noncancer pain has increased substantially. The American Pain Society and the American Academy of Pain Medicine commissioned a systematic review of the evidence on chronic opioid therapy for chronic noncancer pain and convened a multidisciplinary expert panel to review the evidence and formulate recommendations. Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain. However, opioids are also associated with potentially serious harms, including opioid-related adverse effects and outcomes related to the abuse potential of opioids. The recommendations presented in this document provide guidance on patient selection and risk stratification; informed consent and opioid management plans; initiation and titration of chronic opioid therapy; use of methadone; monitoring of patients on chronic opioid therapy; dose escalations, high-dose opioid therapy, opioid rotation, and indications for discontinuation of therapy; prevention and management of opioid-related adverse effects; driving and work safety; identifying a medical home and when to obtain consultation; management of breakthrough pain; chronic opioid therapy in pregnancy; and opioid-related policies. Safe and effective chronic opioid therapy for chronic noncancer pain requires clinical skills and knowledge in both the principles of opioid prescribing and on the assessment and management of risks associated with opioid abuse, addiction, and diversion. Although evidence is limited in many areas related to use of opioids for chronic noncancer pain, this guideline provides recommendations developed by a multidisciplinary expert panel after a systematic review of the evidence.
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            Increasing deaths from opioid analgesics in the United States.

            Since 1990, numerous jurisdictions in the United States (US) have reported increases in drug poisoning mortality. During the same time period, the use of opioid analgesics has increased markedly as part of more aggressive pain management. This study documented a dramatic increase in poisoning mortality rates and compared it to sales of opioid analgesics nationwide. Trend analysis of drug poisoning deaths using underlying cause of death and multiple cause of death mortality data from the Centers for Disease Control and Prevention and opioid analgesic sales data from the US Drug Enforcement Administration. Unintentional drug poisoning mortality rates increased on average 5.3% per year from 1979 to 1990 and 18.1% per year from 1990 to 2002. The rapid increase during the 1990s reflects the rising number of deaths attributed to narcotics and unspecified drugs. Between 1999 and 2002, the number of opioid analgesic poisonings on death certificates increased 91.2%, while heroin and cocaine poisonings increased 12.4% and 22.8%, respectively. By 2002, opioid analgesic poisoning was listed in 5528 deaths-more than either heroin or cocaine. The increase in deaths generally matched the increase in sales for each type of opioid. The increase in deaths involving methadone tracked the increase in methadone used as an analgesic rather than methadone used in narcotics treatment programs. A national epidemic of drug poisoning deaths began in the 1990s. Prescriptions for opioid analgesics also increased in this time frame and may have inadvertently contributed to the increases in drug poisoning deaths.
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              The validity of self-reports of alcohol consumption: state of the science and challenges for research.

              To review three topics pertaining to the validity of alcohol self-reports: factors that influence response accuracy; the relative merits of different self-report approaches; and the utility of using alternative measures to confirm verbal reports. Response behavior is influenced by the interaction of social context factors, respondent characteristics, and task attributes. Although research has advanced our knowledge about self-report methods, many questions remain unanswered. In particular, there is a need to investigate how task demands interact with different patterns of drinking behavior to affect response accuracy. There is also a continuing need to use multiple data sources to examine the extent of self-report response bias, and to determine whether it varies as a function of respondent characteristics or assessment timing. Self-report methods offer a reliable and valid approach to measuring alcohol consumption. The accuracy of such methods, however, can be improved by research directed at understanding the processes involved in response behavior.
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                Author and article information

                Journal
                Harm Reduct J
                Harm Reduction Journal
                BioMed Central
                1477-7517
                2011
                19 October 2011
                : 8
                : 29
                Affiliations
                [1 ]Inflexxion, Inc. 320 Needham St. Suite 100, Newton, MA 02464, USA
                Article
                1477-7517-8-29
                10.1186/1477-7517-8-29
                3213066
                22011626
                23c8b1ac-85da-49c4-913d-0411d9d5e010
                Copyright ©2011 Butler et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 1 September 2010
                : 19 October 2011
                Categories
                Research

                Health & Social care
                Health & Social care

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