Case histories in pharmaceutical risk management

Drug and Alcohol Dependence

Volumn 105, Issue SUPPL. 1, 2009, Pages

  McCormick, Cynthia G ^a   Henningfield, Jack E ^b,c   Haddox, J David ^d   Varughese, Sajan ^e   Lindholm, Anders ^e   Rosen, Susan ^e   Wissel, Janne ^f   Waxman, Deborah ^f   Carter, Lawrence P ^f   Seeger, Vickie ^g   Johnson, Rolley E ^g  

^a McCormick Consultation   (United States)

^b PINNEY ASSOCIATES   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d PURDUE PHARMA L P   (United States)

^e SHIRE   (United States)

^f JAZZ PHARMACEUTICALS   (United States)

^g RECKITT BENCKISER   (United Kingdom)

Author keywords

Abuse liability; Amphetamine; Buprenorphine; Food and Drug Administration; Lisdexamfetamine; Medications; Methylphenidate; Opioids; Oxycodone; Post marketing surveillance; Regulation; REMS; Risk management; Sodium oxybate

Indexed keywords

BUPRENORPHINE; BUPRENORPHINE PLUS NALOXONE; DEXAMPHETAMINE; LISDEXAMFETAMINE; METHYLPHENIDATE; NALOXONE; OXYBATE SODIUM; OXYCODONE;

ADDICTION; ARTICLE; CASE REPORT; DRUG CONTROL; DRUG INDUSTRY; HISTORY; HUMAN; METHODOLOGY; POSTMARKETING SURVEILLANCE; RISK MANAGEMENT;

BUPRENORPHINE; DEXTROAMPHETAMINE; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; METHYLPHENIDATE; NALOXONE; OXYCODONE; PRODUCT SURVEILLANCE, POSTMARKETING; RISK MANAGEMENT; SODIUM OXYBATE; SUBSTANCE-RELATED DISORDERS;

EID: 73949137820     PISSN: 03768716     EISSN: 18790046     Source Type: Journal    
DOI: 10.1016/j.drugalcdep.2009.08.003     Document Type: Article

References (75)

1. Abanades S., Farré M., Barral D., Closas N., Langohr K., Pastor A., de la Torre R. Relative abuse liability of gamma-hydroxybutyric acid, flunitrazepam, and ethanol in club drug users. J. Clin. Psychopharmacol. 2007, 27:625-638.
2. Abanades S., Farré M., Segura M., Pichini S., Barral D., Pacifici R., Pellegrini M., Fonseca F., Langohr K., De La Torre R. Gamma-hydroxybutyrate (GHB) in humans: pharmacodynamics and pharmacokinetics. Ann. N.Y. Acad. Sci. 2006, 1074:559-576.
3. Anderson I.B., Kim S.Y., Dyer J.E., Burkhardt C.B., Iknoian J.C., Walsh M.J., Blanc P.D. Trends in gamma-hydroxybutyrate (GHB) and related drug intoxication: 1999 to 2003. Ann. Emerg. Med. 2006, 47:177-183.
4. Bailey J.E., Campagna E., Dart R.C. The underrecognized toll of prescription opioid abuse on young children. Ann. Emerg. Med. 2009, 53:419-424. The RADARS System Poison Center Investigators.
5. Beardsley P.M., Balster R.L., Harris L.S. Evaluation of the discriminative stimulus and reinforcing effects of gammahyroxybutyrate (GHB). Psychopharmacology 1996, 127:315-322.
6. Bronstein A.C., Spyker D.A., Cantilena L.R., Green J., Rumack B.H., Heard S.E. 2006 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Clin. Toxicol. 2007, 45:815-917.
7. Carreyou J. Narcotic 'lollipop' is big seller despite FDA curbs. Wall Street J. 2006, (November):A1.
8. Carter L.P., Richards B.D., Mintzer M.Z., Griffiths R.R. Relative abuse liability of GHB in humans: a comparison of psychomotor, subjective, and cognitive effects of supratherapeutic doses of triazolam, pentobarbital, and GHB. Neuropsychopharmacology 2006, 31:2537-2551.
9. Cicero T.J., Adams E.H., Geller A., Inciardi J.A., Munoz A., Schnoll S.H., Senay E.C., Woody G.E. A postmarketing surveillance program to monitor Ultram (tramadol hydrochloride) abuse in the United States. Drug Alcohol Depend. 1999, 57:7-22.
10. ®). Pain Med. 2007, 8:157-170.
11. Cicero T.J., Surratt H.L., Inciardi J. Use and misuse of buprenorphine in the management of opioid addiction. J. Opioid Manag. 2007, 3:302-308.
12. Clark W. Verispan Total Patient Tracker. Presented at the Buprenorphine Summit 2008.
13. Dart R.C. Monitoring risk: post marketing surveillance and signal detection. Drug Alcohol Depend. 2009, 105(Suppl. 1):S26-S32.
14. Dasgupta N., Schnoll S.H. Signal detection in post-marketing surveillance for controlled substances. Drug Alcohol Depend. 2009, 105(Suppl. 1):S33-S41.
15. Denver Health and Hospital Authority, 2008a. Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System. Available at: (accessed on May 28, 2009). http://www.radars.org/.
16. Denver Health and Hospital Authority, 2008b. Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System 2nd Quarter 2008 Shire Development, Inc. Report of Amphetamine Data. November 2008.
17. Denver Health and Hospital Authority, 2008c. Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System 2nd Quarter 2008 Shire Development, Inc. Report of Methylphenidate Data. October 2008.
18. Drug Abuse Warning Network, 2008. Available at: (accessed December 17, 2008). http://dawninfo.samhsa.gov/.
19. Drug Addiction Treatment Act-2000-Public Law 106-310 Title XXXV Waiver Authority for Physicians who dispense or prescribe certain narcotic drugs for maintenance treatment or detoxification treatment. Section 3501-3502. Available at: (accessed on August 17, 2009). http://buprenorphine.samhsa.gov/fulllaw.html.
20. Drug Enforcement Administration, 2002. Schedule of Controlled Substances; Rrescheduling of Buprenorphine from Schedule V to Schedule III. Federal Register 67(194 (October 7)) 62354.
21. Drug Enforcement Administration, 2009. Title 21-Food and Drugs Chapter 13. Drug Abuse and Prevention and Control. Available at: (accessed on May 28, 2009). http://www.usdoj.gov/dea/pubs/csa.html.
22. Food and Drug Administration, 1998. FDA approves Actiq for marketing: drug offers cancer patients relief from breakthrough cancer pain. Available at: (accessed on May 28, 2009). http://www.fda.gov/bbs/topics/ANSWERS/ANS00921.html.
23. Food and Drug Administration, 2002. Suboxone administrative documents and correspondence, 2002. Available at: (accessed on March 6, 2009). http://www.fda.gov/cder/foi/nda/2002/20-733_Subutex_AdminCorres_P1.pdf.
24. Food and Drug Administration, 2002a. Approval History - Suboxone - Review - Administrative Documents & Correspondence Part 1. Available at: (accessed on November 28, 2008). http://www.fda.gov/cder/foi/nda/2002/20-733_Subutex_AdminCorres_P1.pdf.
25. Food and Drug Administration, 2002b. Approval Letter - Suboxone. Available at: (accessed on November 28, 2008). http://www.fda.gov/cder/foi/nda/2002/20-733_Subutex_Approv.pdf.
26. Food and Drug Administration, 2002c. Anesthetic and Life Support Drugs Advisory Committee meeting dated January 31, 2002. Available at: (accessed on February 20, 2009). http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3820t2.htm.
27. Food and Drug Administration, 2004. FDA announces enhancement to Isotretinoin Risk Management Program. Available at: (accessed on February 20, 2009). http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01328.html.
28. Food and Drug Administration, 2005a. Guidance for industry: premarketing risk assessment. Available at: (accessed on February 20, 2009). http://www.fda.gov/cder/guidance/6357fnl.htm.
29. Food and Drug Administration, 2005b. Development and Use of Risk Minimization Action Plans. Available at: (accessed on February 20, 2009). http://www.fda.gov/cder/guidance/6358fnl.htm.
30. Food and Drug Administration, 2005c. Good pharmacovigilance practices and pharmacoepidemiologic assessment. Available at: (accessed on February 20, 2009). http://www.fda.gov/cder/guidance/6359OCC.htm.
31. Food and Drug Administration, 2007. Food and Drug Administration Amendments Act of 2007. Congressional Record, 2007. Pub. L. No. 110-85, § 505-1 (2007).
32. U.S. General Accounting Office, 2003. Prescription drugs: OxyContin abuse and diversion and efforts to address the problem. Available at: (accessed on March 25, 2009). http://www.gao.gov/new.items/d04110.pdf.
33. Henningfield J.E., Schuster C.R. Commentary: risk management and post-marketing surveillance of CNS drugs. Drug Alcohol Depend. 2009, 105(Suppl. 1):S56-S64.
34. Inciardi J.A., Surratt H.L., Lugo Y., Cicero T.J. The diversion of prescription opioid analgesics. Law Enforcement Executive Forum 2007, (November):125-141.
35. Inflexxion, 2009a. MyStudentBody. Available at: (accessed May 28, 2009). http://www.inflexxion.com/offerings.aspx%3Fid=468.
36. Inflexxion, 2009b. InsideADHD.org. Available at: (accessed May 28, 2009). http://www.insideadhd.org/.
37. Jazz Pharmaceuticals Inc., 2008. Xyrem. Available at: (accessed on December 1, 2008). http://www.xyrem.com/.
38. JBS International, 2006. Diversion and abuse of buprenorphine: a brief assessment of emerging indicators, 2006. Available at: (accessed on November 28, 2008). http://buprenorphine.samhsa.gov/Buprenorphine_FinalReport_12.6.06.pdf.
39. Johanson C.-E., Balster R.L., Henningfield J.E., Schuster C.R., Anthony J.C., Barthwell A.G., Coleman J.J., Dart R.C., Gorodetzky C.W., O'Keeffe C., Sellers E.M., Vocci F., Walsh S.L. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report. Drug Alcohol Depend. 2009, 105(Suppl. 1):S65-S71.
40. Johnston, L.D., O'Malley, P.M., Bachman, J.G., Schulenberg, J.E., 2007. Monitoring the Future national results on adolescent drug use: overview of key findings, 2007. Available at: (accessed on February 20, 2009). http://monitoringthefuture.org/pubs/monographs/overview2007.pdf.
41. Kreek M.J., Nielsen D.A., Butelman E.R., LaForge K.S. Genetic influences on impulsivity, risk taking, stress responsivity and vulnerability to drug abuse and addiction. Nat. Neurosci. 2005, 8:1450-1457.
42. Leiderman D. Risk management of drug products and the FDA: Evolution and context. Drug Alcohal Depend 2009, 105(Suppl. 1):S9-S13.
43. National Drug Intelligence Center U.S. Department of Justice, 2007. National Drug Threat Assessment 2008. Available at: (accessed on July 17, 2008). http://www.usdoj.gov/ndic/topics/ndtas.htm%23y2008.
44. National Forensic Laboratory Information System, 2009. U.S. Drug Enforcement Administration Office of Diversion Control. 2000-2007 annual reports. Available at: (accessed on February 20, 2009). http://www.deadiversion.usdoj.gov/nflis/index.html.
45. Neuman, A., 2004. GHB's path to legitimacy: an administrative and legislative history of Xyrem. Available at: (accessed on February 23, 2009). http://leda.law.harvard.edu/leda/data/629/Neuman.html.
46. PRN Newswire, 2007. Barr Pharmaceuticals. Barr and Shire sign three agreements: a product acquisition agreement for ADDERALL(®); a product development agreement; and a settlement and license agreement for ADDERALL XR(®). [Internet] New Jersey: 2006 August 14. Available from: (accessed on May 31, 2009). http://www.prnewswire.com/cgi-bin/stories.pl%3FACCT=104%26STORY=/www/story/08-14-2006/0004416042.
47. Purdue Pharma, 2002. Press release: Purdue Pharma implements national surveillance system to track diversion and abuse of controlled pain medications. Available at: (accessed on February 20, 2009). http://www.purduepharma.com/pressroom/news/oxycontinnews/20020627.htm.
48. Purdue Pharma, 2003. Press release: Purdue Pharma sponsors ten communities that care locations - Grants total $250,000. Available at: (accessed on February 20, 2009). http://www.purduepharma.com/pressroom/news/oxycontinnews/20031218-01.htm.
49. Purdue Pharma, 2004. Press release: Purdue Pharma comments on GAO report on OxyContin abuse and diversion. Available at: (accessed on February 20, 2009). http://www.purduepharma.com/pressroom/news/oxycontinnews/20040122-01.htm.
50. Purdue Pharma, 2007a. OxyContin full prescribing information. Available at: (accessed on December 17, 2008). http://www.purduepharma.com/PI/Prescription/Oxycontin.pdf.
51. Purdue Pharma, 2007b. MS Contin full prescribing information. Available at: (accessed on May 28, 2009). http://www.purduepharma.com/PI/Prescription/MS_Contin.pdf.
52. Purdue Pharma, 2009. Rx pattern analysis tracking robberies & other losses. Available at: (accessed on May 28, 2009). http://www.rxpatrol.com/.
53. Reinberg, S., 2007. Congress moves closer to drug-safety bill. Washington Post. (accessed on February 20, 2009). http://www.washingtonpost.com/wp-dyn/content/article/2007/07/12/AR2007071201833.html.
54. Rush C.R., Frey J.M., Griffiths R.R. Zaleplon and triazolam in humans: acute behavioral effects and abuse potential. Psychopharmacology 1999, 145:39-51.
55. Schuster C.R., Barthwell A.G., Henningfield J.E. Introduction to College on Problems of Drug Dependence special Conference on risk management and post-marketing surveillance of CNS drugs. Drug Alcohol Depend. 2009, 105(Suppl. 1):S4-S8.
56. Shiffman S., Sweeney C.T. Ten years after the Rx-to-OTC switch of nicotine replacement therapy: What have we learned about the benefits and risks of non-prescription availability?. Health Policy 2008, 86:17-26.
57. Shire Pharmaceuticals, 2006a. Shire and Barr settle all pending litigation concerning ADDERALL XR® and enter into development and license agreement. Available at: (accessed on May 28, 2009). http://www.shire.com/shire/NewsAndMedia/PressReleases/showShirePress.jsp%3Fref=581%26tn=%26m1=%26m2=.
58. Shire Pharmaceuticals, 2006b. Ensuring appropriate use of stimulants: a parents' guide to being AWARE. Available at: (accessed on February 20, 2009). http://www.daytrana.com/downloads/AWAREBrochure.pdf.
59. Shire Pharmaceuticals, 2008a. Daytrana (methylphenidate transdermal patch) prescribing information. Available at: (accessed on February 23, 2009). http://www.daytrana.com/downloads/DaytranaPrescribingInfo.pdf.
60. Shire Pharmaceuticals, 2008b. Vyvanse (lisdexamfetamine dimesylate) prescribing information. Available at: (accessed on February 23, 2009). http://www.vyvanse.com/pdf/prescribing_information.pdf.
61. Schnoll S.H., Ertischek M.D., Henningfield J.E. Risk management programs: a supplement to the Controlled Substances Act. Food Drug Law Inst. 2006, 4:19-23.
62. Spillane J., McAllister W.B. Keeping the lid on: a century of drug regulation and control. Drug Alcohol Depend. 2003, 70:S5-S12.
63. Substance Abuse and Mental Health Services Administration, 2001. Opioid drugs in maintenance and detoxification treatment of opiate addiction, Final Rule. 21 CFR Part 291, 42 CFR Part 8. Federal Register, 66, 4076-4102, 2001. Available at: (accessed on August 17, 2009). http://www.dpt.samhsa.gov/pdf/regs.pdf.
64. Substance Abuse and Mental Health Services Administration Results from the 2002 National Survey on Drug Use and Health: National Findings 2003, Office of Applied Studies, Rockville, MD, (NHSDA Series H-22, DHHS Publication No. SMA 03-3836).
65. Substance Abuse and Mental Health Services Administration Results from the 2003 National Survey on Drug Use and Health: National Findings 2004, Office of Applied Studies, Rockville, MD, (NSDUH Series H-25, DHHS Publication No. SMA 04-3964).
66. Substance Abuse and Mental Health Services Administration Drug Abuse Warning Network, 2003: Interim National Estimates of Drug-Related Emergency Department Visits 2004, Office of Applied Studies, Rockville, MD, (DAWN Series D-26, DHHS Publication No. (SMA) 04-3972).
67. Substance Abuse and Mental Health Services Administration Results from the 2004 National Survey on Drug Use and Health: National Findings 2005, Office of Applied Studies, Rockville, MD, (NSDUH Series H-28, DHHS Publication No. SMA 05-4062).
68. Substance Abuse and Mental Health Services Administration Results from the 2005 National Survey on Drug Use and Health: National Findings 2006, Office of Applied Studies, Rockville, MD, (NSDUH Series H-30, DHHS Publication No. SMA 06-4194).
69. Substance Abuse and Mental Health Services Administration Drug Abuse Warning Network, 2004: National Estimates of Drug-related Emergency Department Visits 2006, Office of Applied Studies, Rockville, MD, (DAWN Series D-28, DHHS Publication No. (SMA) 06-4143).
70. Substance Abuse and Mental Health Services Administration, 2006c. DAWN Live! Available at: (accessed on May 28, 2009). http://dawninfo.samhsa.gov/build/whyhospitalsjoin/ed_dawnlive.asp.
71. Substance Abuse and Mental Health Services Administration Results from the 2006 National Survey on Drug Use and Health: National Findings 2007, Office of Applied Studies, Rockville, MD, (NSDUH Series H-32, DHHS Publication No. SMA 07-4293).
72. Substance Abuse and Mental Health Services Administration, 2007b. DAWN Live! October 2, 2007; as presented by Dr. Westley Clark, MD, JD, MPH at buprenorphine summit on February 21, 2008.
73. Substance Abuse and Mental Health Services Administration Results from the 2007 National Survey on Drug Use and Health: National Findings 2008, Office of Applied Studies, Rockville, MD, (NSDUH Series H-34, DHHS Publication No. SMA 08-4343).
74. Wedin G.P., Hornfeldt C.S., Ylitalo L.M. The clinical development of γ-hydroxybutyrate (GHB). Curr. Drug Saf. 2006, 1:99-106.
75. Woolverton W.L., Rowlett J.K., Winger G., Woods J.H., Gerak L.R., France C.P. Evaluation of the reinforcing and discriminative stimulus effects of gamma-hydroxybutyrate in rhesus monkeys. Drug Alcohol Depend. 1999, 54:137-143.