Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations

JOURNAL OF PAIN

卷:18

Article

Smith, Shannon M.¹  Jones, Judith K.^4,5,6,7  Katz, Nathaniel P.^8,9,10  Roland, Carl L.¹¹  Setnik, Beatrice¹²  Trudeau, Jeremiah J.¹³  Wright, Stephen¹⁴  Burke, Laurie B.^15,16  Corner, Sandra D.¹⁷  Dart, Richard C.^18,19  Dionne, Raymond²⁰  Haddox, J. David^9,10,21  Jaffe, Jerome H.²²  Kopecky, Ernest A.²³  Martell, Bridget A.^24,25  Montoya, Ivan D.²⁶  Stanton, Marsha²⁷  Wasan, Ajay D.^28,29  Turk, Dennis C.³⁰  Dworkin, Robert H.^2,3 

[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, 601 Elmwood Ave,Box 604, Rochester, NY 14642 USA

[2] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Neurol, Rochester, NY 14642 USA

[3] Univ Rochester, Sch Med & Dent, Ctr Human Expt Therapeut, Rochester, NY 14642 USA

[4] Degge Grp, Fairfax, VA USA

[5] Georgetown Univ, Sch Med, Dept Pharmacol, Washington, DC USA

[6] Georgetown Univ, Sch Med, Dept Hlth Sci, Washington, DC USA

[7] Univ Michigan, Sch Publ Hlth, Ann Arbor, MI 48109 USA

[8] Analgesic Solut, Natick, MA USA

[9] Tufts Univ, Dept Anesthesiol, Boston, MA 02111 USA

[10] Tufts Univ, Dept Publ Hlth & Community Med, Boston, MA 02111 USA

[11] Pfizer Inc, Cary, NC USA

[12] INC Res, Raleigh, NC USA

[13] Boehringer Ingelheim GmbH & Co KG, Ridgefield, CT USA

[14] GW Pharmaceut Plc, London, England

[15] LORA Grp LLC, Royal Oak, MI USA

[16] Univ Maryland, Sch Pharm, Baltimore, MD 21201 USA

[17] Columbia Univ, Dept Psychiat, New York State Psychiat Inst, New York, NY USA

[18] Univ Colorado, Sch Med, Div Clin Pharmacol & Toxicol, Denver, CO USA

[19] Denver Hlth, Rocky Mt Poison & Drug Ctr, Denver, CO USA

[20] East Carolina Univ, Brody Sch Med, Dept Pharmacol & Toxicol, Greenville, NC USA

[21] Purdue Pharma LP, Stamford, CT USA

[22] Univ Maryland, Sch Med, Dept Psychiat, Baltimore, MD 21201 USA

[23] Coll Pharmaceut Inc, Canton, MA USA

[24] BAM Consultants, Guilford, CT USA

[25] Yale Univ, Sch Med, Dept Internal Med, New Haven, CT 06510 USA

[26] NIDA, Bethesda, MD 20892 USA

[27] Horizon Pharma Inc, Deerfield, IL USA

[28] Univ Pittsburgh, Sch Med, Dept Anesthesiol, Pittsburgh, PA 15261 USA

[29] Univ Pittsburgh, Sch Med, Dept Psychiat, Pittsburgh, PA USA

[30] Univ Washington, Dept Anesthesiol & Pain Med, Seattle, WA 98195 USA

关键词: Medication abuse;    medication misuse;    abuse potential;   

DOI  :  10.1016/j.jpain.2017.03.015

来源: Elsevier

【 摘 要 】

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) 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. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events 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 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 MADDERS as well as SR-MAD. Perspective: Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 publisbed methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation. (C) 2017 by the American Pain Society

【 授权许可】

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