Post-marketing surveillance systems for psychoactive prescription drug abuse;Les systèmes d'évaluation de l'abus et de la dépendance des médicaments psychoactifs

Therapie

Volumn 66, Issue 3, 2011, Pages 263-272

  Nordmann, Sandra ^a,b   Frauger, Elisabeth ^a,b   Pauly, Vanessa ^c,d   Rouby, Frank ^a,b   Mallaret, Michel ^e   Micallef, Joëlle ^a,b   Thirion, Xavier ^c,d  

^a TIMONE HOSPITAL   (France)

^b AIX MARSEILLE UNIVERSITÉ   (France)

^c AIX MARSEILLE UNIVERSITY   (France)

^d AIX MARSEILLE UNIVERSITY   (France)

^e GRENOBLE UNIVERSITY HOSPITAL   (France)

Author keywords

pharmacoepidemiology; postmarketing surveillance; prescription study; psychoactive medications; substance related disorders

Indexed keywords

CENTRAL NERVOUS SYSTEM AGENTS; PRESCRIPTION DRUG; PSYCHOTROPIC AGENT;

ARTICLE; DRUG ABUSE; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; FRANCE; HEALTH BEHAVIOR; HEALTH SURVEY; HUMAN; PRIORITY JOURNAL;

EID: 80051758033     PISSN: 00405957     EISSN: 19585578     Source Type: Journal    
DOI: 10.2515/therapie/2011045     Document Type: Article

References (93)

1. American Psychiatric Association -DSM-IV-TR. Manuel diagnostique et statistique des troubles mentaux, 4ème édition, texte révisé (Washington D.C., 2000), Traduction française par J.-D. Guelfi et al. Masson, Paris, 2003
2. Guillon JM. Place and role of safety pharmacology in drug development. Ann Pharm Fr 2010 Sep; 68(5): 291-300
3. Carter LP, Griffiths RR. Principles of laboratory assessment of drug abuse liability and implications for clinical development. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S14-25
4. Fudala PJ, Johnson RE. Development of opioid formulations with limited diversion and abuse potential. Drug Alcohol Depend 2006 Jun; 83 Suppl 1: S40-7
5. Brady KT, Lydiard RB, Brady JV. Assessing abuse liability in clinical trials. Drug Alcohol Depend 2003 Jun 5; 70(3 Suppl): S87-95
6. Gerada C, Ashworth M. ABC of mental health. Addiction and dependence-I: Illicit drugs. BMJ 1997 Aug 2; 315(7103): 297-300
7. http://www.afssaps.fr/Activites/Pharmacodependance-Addictovigilance/ Organisation/(offset)/1
8. Micaleff J, Jolliet P, Victorri-Vigneau C, et al. First meeting of the French CEIP-A (centres d'évaluation et d'information sur la pharmacodépendance). Assessment of the abuse and pharmacodependence potential during drug development. Therapie 2008 Jan-Feb; 63(1): 55-65
9. Balster RL, Johanson CE, Walsh SL. Risk management and post-marketing surveillance of CNS drugs: An introduction. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S1-3
10. Dart RC. Monitoring risk: Post marketing surveillance and signal detection. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S26-32
11. Dasgupta N, Schnoll SH. Signal detection in post-marketing surveillance for controlled substances. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S33-41
12. Henningfield JE, Schuster CR. Risk management and post-marketing surveillance of CNS drugs. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S56-64
13. Johanson CE, Balster RL, Henningfield JE, et al. Risk management and postmarketing surveillance for the abuse of medications acting on the central nervous system: Expert panel report. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S65-71
14. Leiderman DB. Risk management of drug products and the U.S. Food and Drug Administration: Evolution and context. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S9-S13
15. McCormick CG, Henningfield JE, Haddox JD, et al. Case histories in pharmaceutical risk management. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S42-55
16. Schuster CR, Barthwell AG, Henningfield JE. Introduction to college on problems of drug dependence special conference on risk management and postmarketing surveillance of CNS drugs. Drug Alcohol Depend 2009 Dec 1; 105 Suppl 1: S4-8
17. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Surveillance/AdverseDrugEffects/default.Htm
18. http://www.afssaps.fr/Activites/Pharmacodependance-Addictovigilance/ Outils-de-surveillance-et-d-evaluation-Resultats-d-enquetes/(offset)/3
19. Baumevieille M, Miremont G, Haramburu F, et al. Le système français d'évaluation de la pharmacodépendance et de l'abus : Consécration juridique. Therapie 2001 Jan-Feb; 56(1): 15-22
20. Schwan S, Sundström A, Stjernberg E, et al. A signal for an abuse liability for pregabalin-results from the Swedish spontaneous adverse drug reaction reporting system. Eur J Clin Pharmacol 2010 Sep; 66(9): 947-53
21. Wang YG, Swick TJ, Carter LP, et al. Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem): Abuse, misuse, dependence, and diversion. J Clin Sleep Med 2009 Aug 15; 5(4): 365-71
22. Tjäderborn M, Jönsson AK, Ahlner J, et al. Tramadol dependence: A survey of spontaneously reported cases in Sweden. Pharmacoepidemiol Drug Saf 2009 Dec; 18(12): 1192-8
23. Cai R, Crane E, Poneleit K, et al. Emergency department visits involving nonmedical use of selected prescription drugs in the United States, 2004-2008. J Pain Palliat Care Pharmacother 2010 Sep; 24(3): 293-7
24. https://dawninfo.samhsa.gov/files/collect-2009-2011/ed-case-form-2009- 2011.pdf
25. http://www.aapcc.org/dnn/NPDSPoisonData/ NationalPoisonDataSystemInformation/tabid/311/Default.aspx
26. http://www.afssaps.fr/content/download/25214/333977/version/1/file/ enquete-drames-2008.pdf
27. Boulos J, Arditti G, Pepin M, et al. DRAMES, outil d'identification des causes de décès chez les toxicomanes : Résultats des études 2002-2006. Le courrier des addictions 2008; 1: 16-8
28. Spadari M, Glaizal M, Tichadou L, et al. Accidental cannabis poisoning in children: Experience of the Marseille poison center. Presse Med 2009 Nov; 38(11): 1563-7
29. http://www.invs.sante.fr/publications/2005/antipoison-toxicovigilance/ rapport-toxicovigilance.pdf
30. Le Moal M. Drug abuse: Vulnerability and transition to addiction. Pharmacopsychiatry 2009 May; 42 Suppl 1: S42-55
31. Becker H. Outsiders : études de sociologie de la déviance. Howard S. Becker, 1963. Traduit de l'américain par J.-P. Briand et J.-M. Chapoulie. Editions AM Métailié. Paris, 1985
32. https://nsduhweb.rti.org/
33. http://aspe.hhs.gov/hsp/06/catalog-AI-AN-NA/NESARC.htm
34. http://www.oas.samhsa.gov/nsduh/2k10MRB/2k10Q.pdf
35. http://www.emcdda.europa.eu/attachements.cfm/att-78300-EN-EMCDDA-TP-gps. pdf
36. INPES, baromètre santé 2005
37. http://www.monitoringthefuture.org/
38. Johnston LD. Prescription drug use by adolescents: What we are learning and what we still need to know. Journal of Adolescent Health 2009; 45(6): 539-40
39. Everett JS, Merkel S, Wheeler L, et al. Tobacco and other drug use among high school students with asthma. Journal of Adolescent Health 2006; 39: 291-4
40. http://www.monitoringthefuture.org/datavolumes/2008/2008dv.pdf
41. Kokkevi A, Richardson C, Florescu S, et al. Psychosocial correlates of substance use in adolescence: A cross-national study in six European countries. Drug Alcohol Depend 2007 Jan 5; 86(1): 67-74
42. Acquaviva E, Legleye S, Auleley GR, et al. Psychotropic medication in the French child and adolescent population: Prevalence estimation from health insurance data and national self-report survey data. BMC Psychiatry 2009 Nov 17; 9: 72
43. Peindl KS, Mannelli P,Wu LT, et al. Trends in nonheroin opioid abuse admissions: 1992-2004. J Opioid Manag 2007 Jul-Aug; 3(4): 215-23
44. Frauger E, Thirion X, Micallef J, et al. Le programme OPPIDUM déjà 20 ans d'expérience ! La lettre du pharmacologue 2009; 23(4): 128-33
45. Thirion X, Micallef J, Barrau K, et al. Observation of psychoactive substance consumption: Methods and results of the French OPPIDUM programme. Eur Addict Res 2001 Mar; 7(1): 32-6
46. http://www.afssaps.fr/var/afssaps-site/storage/original/application/ 4a43ffc0f2afeec432f0bb9b00b29cdc.pdf
47. http://www.afssaps.fr/var/afssaps-site/storage/original/application/ fffb2789f1449c2ce4aa437d896a5600.pdf
48. Plüddemann A, Myers BJ, Parry CD. Surge in treatment admissions related to methamphetamine use in Cape Town, South Africa: Implications for public health. Drug Alcohol Rev 2008 Mar; 27(2): 185-9
49. Küfner R. Monitoring of the misuse of prescription drugs by clients of outpatient addiction treatment centres (PHAR-MON, Formerly: Ebis-med). Gesundheitswesen 2008; 70: 305-14
50. https://nac.samhsa.gov/DTAB/Presentations/Aug08/DeMiaPetersDTAB0808.ppt
51. Sloboda Z. Changing patterns of "drug abuse" in the United States: Connecting findings from macro-and microepidemiologic studies. Subst Use Misuse 2002 Jun-Aug; 37(8-10): 1229-51
52. http://www.wk-pharma.fr/publication/upload/OSIAP-2007-1.pdf
53. Boeuf O, Lapeyre-Mestre M, French Network of Centers for Evaluation and Information Pharmacodependence (CEIP-A). Survey of forged prescriptions to investigate risk of psychoactive medications abuse in France: Results of OSIAP survey. Drug Saf 2007; 30(3): 265-76
54. Lapeyre-Mestre M, Damase-Michel C, Adams P, et al. Falsified or forged medical prescriptions as an indicator of pharmacodependence: A pilot study. Community pharmacists of the Midi-Pyrénées. Eur J Clin Pharmacol 1997; 52(1): 37-9
55. http://www.afssaps.fr/var/afssaps-site/storage/original/application/ cf8c0ec0196b07a8b73ef7494b38459e.pdf
56. Djezzar S, Questel F, Burin E, et al. French network of centers for evaluation and information on pharmacodependence. Chemical submission: Results of 4-year French inquiry. Int J Legal Med 2009 May; 123(3): 213-9
57. http://www.ofdt.fr/ofdtdev/live/publi/rapports/rap10/epfxacq1.html
58. http://www.radars.org/
59. Dasgupta N, Bailey EJ, Cicero T, et al. Post-marketing surveillance of methadone and buprenorphine in the United States. Pain Med 2010 Jul; 11(7): 1078-91
60. Spiller H, Bailey JE, Dart RC, et al. Investigation of temporal changes of abuse and misuse of prescription opioids. J Addict Dis 2010 Jan; 29(1): 78-83
61. Inciardi JA, Surratt HL, Cicero TJ, et al. The "black box" of prescription drug diversion. J Addict Dis 2009 Oct; 28(4): 332-47
62. Inciardi JA, Surratt HL, Stivers Y, et al. FDA approvals of generic drugs: Impact on the diversion of opioid analgesics with a potential for abuse. J Opioid Manag 2009 Mar-Apr; 5(2): 81-7
63. Bailey JE, Campagna E, Dart RC. The underrecognized toll of prescription opioid abuse on young children. Ann Emerg Med 2009 Apr; 53(4): 419-24
64. Cicero TJ, Dart RC, Inciardi JA, et al. The development of a comprehensive risk-management program for prescription opioid analgesics: Researched abuse, diversion and addiction-related surveillance (RADARS). Pain Med 2007 Mar; 8(2): 157-70
65. Cicero TJ, Inciardi JA, Muñoz A. Trends in abuse of Oxycontin and other opioid analgesics in the United States: 2002-2004. J Pain 2005 Oct; 6(10): 662-72
66. http://www.navippro.com
67. Green TC, Grimes Serrano JM, Licari A, et al.Women who abuse prescription opioids: Findings from the Addiction Severity Index-Multimedia Version Connect prescription opioid database. Drug Alcohol Depend 2009 Jul 1; 103(1-2): 65-73
68. Butler SF, Budman SH, Licari A, et al. National addictions vigilance intervention and prevention program (NAVIPPRO): A real-time, product-specific, public health surveillance system for monitoring prescription drug abuse. Pharmacoepidemiol Drug Saf 2008 Dec; 17(12): 1142-54
69. Katz N, Fernandez K, Chang A, et al. Internet-based survey of nonmedical prescription opioid use in the United States. Clin J Pain 2008 Jul-Aug; 24(6): 528-35
70. Butler SF, Yenuti SW, Benoit C, et al. Internet surveillance: Content analysis and monitoring of product-specific prescription opioid abuse related postings. Clin J Pain 2007; 23(7): 619-28
71. Mounteney J, Haugland S. Earlier warning: A multi-indicator approach to monitoring trends in the illicit use of medicines. Int J Drug Policy 2009 Mar; 20(2): 161-9
72. Wilsey BL, Fishman SM, Gilson AM, et al. Profiling multiple providers prescribing of opioids, benzodiazepines, stimulants, and anorectics. Drug Alcohol Depend 2010 Nov 1; 112(1-2): 99-106
73. Katz N, Panas L, Kim M, et al. Usefulness of prescription monitoring programs for surveillance-analysis of Schedule II opioid prescription data in Massachusetts, 1996-2006. Pharmacoepidemiol Drug Saf 2010 Feb; 19(2): 115-23
74. Martin-Latry K, Bégaud B. Pharmacoepidemiological research using French reimbursement databases: Yes we can! Pharmacoepidemiol Drug Saf 2010 Mar; 19(3): 256-65
75. Pauly V, Frauger E, Pradel V, et al. Which indicators can public health authorities use to monitor prescription drug abuse and evaluate the impact of regulatory measures? Controlling High Dosage Buprenorphine abuse. Drug Alcohol Depend 2011 Jan 1; 113(1): 29-36
76. Frauger E, Pauly V, Thirion X, et al. Estimation of clonazepam abuse liability: A new method using a reimbursed drug database. Int Clin Psychopharmacol 2009 Nov; 24(6): 318-24
77. Frauger E, Pradel V, Natali F, et al. Misuse of clonazepam (Rivotril): Recent trends. Thérapie 2006 Jan-Feb; 61(1): 49-55
78. Frauger E, Thirion X, Chanut C, et al. Misuse of trihexyphenidyl (Artane, Parkinane): Recent trends. Thérapie 2003 Nov-Dec; 58(6): 541-7
79. Pradel V, Delga C, Rouby F, et al. Assessment of abuse potential of benzodiazepines from a prescription database using 'doctor shopping' as an indicator. CNS Drugs 2010 Jul 1; 24(7): 611-20
80. Pradel V, Frauger E, Thirion X, et al. Impact of a prescription monitoring program on doctor-shopping for high dosage buprenorphine. Pharmacoepidemiol Drug Saf 2009 Jan; 18(1): 36-43
81. Pradel V, Thirion X, Ronfle E, et al. Assessment of doctor-shopping for high dosage buprenorphine maintenance treatment in a French region: Development of a new method for prescription database. Pharmacoepidemiol Drug Saf 2004 Jul; 13(7): 473-81
82. Martyres RF, Clode D, Burns JM. Seeking drugs or seeking help? Escalating "doctor shopping" by young heroin users before fatal overdose. Med J Aust 2004 Mar 1; 180(5): 211-4
83. Winther RB, Bramness JG. Prescription shopping of addictive drugs in Norway. Tidsskr Nor Laegeforen 2009 Mar 2; 129(6): 517-20
84. Gjerden P, Bramness JG, Slørdal L. The use and potential abuse of anticholinergic antiparkinson drugs in Norway: A pharmacoepidemiological study. Br J Clin Pharmacol 2009 Feb; 67(2): 228-33
85. Volkow ND, Swanson JM. Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. Am J Psychiatry 2003 Nov; 160(11): 1909-18
86. Sapienza FL. Abuse deterrent formulations and the Controlled Substances Act (CSA). Drug Alcohol Depend 2006 Jun; 83 Suppl 1: S23-30
87. Grudzinskas C, Balster RL, Gorodetzky CW, et al. Impact of formulation on the abuse liability, safety and regulation of medications: The expert panel report. Drug Alcohol Depend 2006 Jun; 83 Suppl 1: S77-82
88. Micallef J, Pradel V, Thirion X, et al. Use of the health insurance database by the centres for evaluation and information on pharmacodependance: Examples, interests and future prospects. Therapie 2004 Nov-Dec; 59(6): 581-8
89. Gfroerer JC, Greenblatt JC, Wright DA. Substance use in the US college-age population: Differences according to educational status and living arrangement. Am J Public Health 1997 Jan; 87(1): 62-5
90. Harrison L. The validity of self-reported drug use in survey research: An overview and critique of research methods. NIDA Res Monogr 1997; 167: 17-36
91. Grucza RA, Abbacchi AM, Przybeck TR, et al. Discrepancies in estimates of prevalence and correlates of substance use and disorders between two national surveys. Addiction 2007 Apr;102(4):623-9
92. Hernandez SH, Nelson LS. Prescription drug abuse: Insight into the epidemic. Clin Pharmacol Ther 2010 Sep; 88(3): 307-17
93. Buehler JW, Hopkins RS, Overhage JM. Framework for evaluating public health surveillance systems for early detection of outbreaks: Recommendations from the CDC working group. MMWR Recomm Rep 2004 May 7; 53(RR-5): 1-11