Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations
Abstract Accurate assessment of inappropriate medication use events (i.e., misuse, abuse, and related events [MAREs]) occurring in clinical trials is an important component in evaluating a medication’s abuse potential. A meeting was convened to review all instruments measuring such events in clinica...
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| Veröffentlicht in: | The journal of pain 2017-11, Vol.18 (11), p.1287-1294 |
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| container_title | The journal of pain |
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| creator | Smith, Shannon M Jones, Judith K Katz, Nathaniel P Roland, Carl L Setnik, Beatrice Trudeau, Jeremiah J Wright, Stephen Burke, Laurie B Comer, Sandra D Dart, Richard C Dionne, Raymond Haddox, J. David Jaffe, Jerome H Kopecky, Ernest A Martell, Bridget A Montoya, Ivan D Stanton, Marsha Wasan, Ajay D Turk, Dennis C Dworkin, Robert H |
| description | Abstract Accurate assessment of inappropriate medication use events (i.e., misuse, abuse, and related events [MAREs]) occurring in clinical trials is an important component in evaluating a medication’s abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions [27] . Only 2 approaches have been reported that are specifically designed to identify and classify MAREs occurring in clinical trials, rather than to measure an individual’s risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS]. The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively in order to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of both MADDERS and SR-MAD. |
| doi_str_mv | 10.1016/j.jpain.2017.03.015 |
| format | Article |
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David ; Jaffe, Jerome H ; Kopecky, Ernest A ; Martell, Bridget A ; Montoya, Ivan D ; Stanton, Marsha ; Wasan, Ajay D ; Turk, Dennis C ; Dworkin, Robert H</creator><creatorcontrib>Smith, Shannon M ; Jones, Judith K ; Katz, Nathaniel P ; Roland, Carl L ; Setnik, Beatrice ; Trudeau, Jeremiah J ; Wright, Stephen ; Burke, Laurie B ; Comer, Sandra D ; Dart, Richard C ; Dionne, Raymond ; Haddox, J. David ; Jaffe, Jerome H ; Kopecky, Ernest A ; Martell, Bridget A ; Montoya, Ivan D ; Stanton, Marsha ; Wasan, Ajay D ; Turk, Dennis C ; Dworkin, Robert H</creatorcontrib><description>Abstract Accurate assessment of inappropriate medication use events (i.e., misuse, abuse, and related events [MAREs]) occurring in clinical trials is an important component in evaluating a medication’s abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions [27] . Only 2 approaches have been reported that are specifically designed to identify and classify MAREs occurring in clinical trials, rather than to measure an individual’s risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS]. The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively in order to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of both MADDERS and SR-MAD.</description><identifier>ISSN: 1526-5900</identifier><identifier>EISSN: 1528-8447</identifier><identifier>DOI: 10.1016/j.jpain.2017.03.015</identifier><identifier>PMID: 28479207</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>abuse potential ; Analgesics, Opioid - therapeutic use ; Anesthesia & Perioperative Care ; Clinical Trials as Topic - methods ; Humans ; Medication abuse ; medication misuse ; Opioid-Related Disorders - diagnosis ; Pain Medicine ; Prescription Drug Misuse</subject><ispartof>The journal of pain, 2017-11, Vol.18 (11), p.1287-1294</ispartof><rights>2017 American Pain Society</rights><rights>Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c514t-e9c6736eededa2af42cdaa4a56e09e09e340ee49fe6d1ef71e1ada87bf91b0453</citedby><cites>FETCH-LOGICAL-c514t-e9c6736eededa2af42cdaa4a56e09e09e340ee49fe6d1ef71e1ada87bf91b0453</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpain.2017.03.015$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,780,784,885,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28479207$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Smith, Shannon M</creatorcontrib><creatorcontrib>Jones, Judith K</creatorcontrib><creatorcontrib>Katz, Nathaniel P</creatorcontrib><creatorcontrib>Roland, Carl L</creatorcontrib><creatorcontrib>Setnik, Beatrice</creatorcontrib><creatorcontrib>Trudeau, Jeremiah J</creatorcontrib><creatorcontrib>Wright, Stephen</creatorcontrib><creatorcontrib>Burke, Laurie B</creatorcontrib><creatorcontrib>Comer, Sandra D</creatorcontrib><creatorcontrib>Dart, Richard C</creatorcontrib><creatorcontrib>Dionne, Raymond</creatorcontrib><creatorcontrib>Haddox, J. David</creatorcontrib><creatorcontrib>Jaffe, Jerome H</creatorcontrib><creatorcontrib>Kopecky, Ernest A</creatorcontrib><creatorcontrib>Martell, Bridget A</creatorcontrib><creatorcontrib>Montoya, Ivan D</creatorcontrib><creatorcontrib>Stanton, Marsha</creatorcontrib><creatorcontrib>Wasan, Ajay D</creatorcontrib><creatorcontrib>Turk, Dennis C</creatorcontrib><creatorcontrib>Dworkin, Robert H</creatorcontrib><title>Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations</title><title>The journal of pain</title><addtitle>J Pain</addtitle><description>Abstract Accurate assessment of inappropriate medication use events (i.e., misuse, abuse, and related events [MAREs]) occurring in clinical trials is an important component in evaluating a medication’s abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions [27] . Only 2 approaches have been reported that are specifically designed to identify and classify MAREs occurring in clinical trials, rather than to measure an individual’s risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS]. The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively in order to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of both MADDERS and SR-MAD.</description><subject>abuse potential</subject><subject>Analgesics, Opioid - therapeutic use</subject><subject>Anesthesia & Perioperative Care</subject><subject>Clinical Trials as Topic - methods</subject><subject>Humans</subject><subject>Medication abuse</subject><subject>medication misuse</subject><subject>Opioid-Related Disorders - diagnosis</subject><subject>Pain Medicine</subject><subject>Prescription Drug Misuse</subject><issn>1526-5900</issn><issn>1528-8447</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkt1u1DAQhS0EoqXwBEjID0BSO_7bIFGpWgGtVOgFy7XldSbUIesE21lp34MHxtm0FXCDZMkje74z9pxB6DUlJSVUnndlNxrny4pQVRJWEiqeoFMqqlWx4lw9PcayEDUhJ-hFjB0hlAqlnqOTasVVXRF1in59BhOnABGnO5Owa8An1x7wmI9scGNyg8c7aJw1S-jiFOEtNttl8w0O0JsEDYZ9ZiN2Htve-Qz0OAVn-vgOX643m-vbLzgrJvdzgnvODrsd-CazdvAx1w7HIvEletZmDl7d72fo28cPm_VVcXP76Xp9eVNYQXkqoLZSMQmQFUxlWl7ZxhhuhARSz4txAsDrFmRDoVUUqGnMSm3bmm4JF-wMXSy647TNf7T5_cH0egxuZ8JBD8bpv2-8u9Pfh70WUhLJZgG2CNgwxBigfWQp0bNJutNHk_RskiZMZ5My9ebPso_Mgys54f2SAPnzewdBR-vA22xDblrSzeD-U-DiH_7BkR9wgNgNU_C5r5rqWGmiv85zMo8JVYwIWVfsN1yIv1A</recordid><startdate>20171101</startdate><enddate>20171101</enddate><creator>Smith, Shannon M</creator><creator>Jones, Judith K</creator><creator>Katz, Nathaniel P</creator><creator>Roland, Carl L</creator><creator>Setnik, Beatrice</creator><creator>Trudeau, Jeremiah J</creator><creator>Wright, Stephen</creator><creator>Burke, Laurie B</creator><creator>Comer, Sandra D</creator><creator>Dart, Richard C</creator><creator>Dionne, Raymond</creator><creator>Haddox, J. 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David</au><au>Jaffe, Jerome H</au><au>Kopecky, Ernest A</au><au>Martell, Bridget A</au><au>Montoya, Ivan D</au><au>Stanton, Marsha</au><au>Wasan, Ajay D</au><au>Turk, Dennis C</au><au>Dworkin, Robert H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations</atitle><jtitle>The journal of pain</jtitle><addtitle>J Pain</addtitle><date>2017-11-01</date><risdate>2017</risdate><volume>18</volume><issue>11</issue><spage>1287</spage><epage>1294</epage><pages>1287-1294</pages><issn>1526-5900</issn><eissn>1528-8447</eissn><abstract>Abstract Accurate assessment of inappropriate medication use events (i.e., misuse, abuse, and related events [MAREs]) occurring in clinical trials is an important component in evaluating a medication’s abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions [27] . Only 2 approaches have been reported that are specifically designed to identify and classify MAREs occurring in clinical trials, rather than to measure an individual’s risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS]. The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively in order to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of both MADDERS and SR-MAD.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28479207</pmid><doi>10.1016/j.jpain.2017.03.015</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | abuse potential Analgesics, Opioid - therapeutic use Anesthesia & Perioperative Care Clinical Trials as Topic - methods Humans Medication abuse medication misuse Opioid-Related Disorders - diagnosis Pain Medicine Prescription Drug Misuse |
| title | Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations |
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