Risk evaluation and mitigation strategies for drugs with abuse liability: Public interest, special interest, conflicts of interest, and the industry perspective

Annals of the New York Academy of Sciences

Volumn 1141, Issue , 2008, Pages 284-303

  Wright IV, Curtis ^a,d   Schnoll, Sidney ^b   Bernstein, David ^c  

^a Rock Creek Pharmaceuticals Inc   (United States)

^b PINNEY ASSOCIATES   (United States)

^c Javelin Pharmaceuticals Inc   (United States)

^d Star Pharmaceuticals Medical   (United States)

Author keywords

Abuse potential; Conflict of interest; Drug abuse; Drug control policy; Epidemiology; FDA; Medication development; REMS; Risk management; RiskMAP

Indexed keywords

CHLORAMPHENICOL; DEXTROMETHORPHAN; DEZOCINE; FENTANYL; FENTANYL CITRATE; GUAIFENESIN; ISOTRETINOIN; MORPHINE SULFATE; MSCONTIN; NALTREXONE; OXYCODONE; PENTAZOCINE; TALWIN NX; THALIDOMIDE; TRAMADOL; UNCLASSIFIED DRUG;

ADDICTION; ANXIETY DISORDER; ATTENTION DEFICIT DISORDER; CONFLICT OF INTEREST; CRIMINAL JUSTICE; DRUG ABUSE; DRUG SURVEILLANCE PROGRAM; DRUG USE; HEALTH PROMOTION; LAW SUIT; LEGAL LIABILITY; MEDICAL ETHICS; PAIN; POPULATION RISK; POSTMARKETING SURVEILLANCE; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; RISK REDUCTION;

EID: 54949095073     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1196/annals.1441.026     Document Type: Review

References (54)

1. Musto, D.F. & P. Korsmeyer. 2002. The Quest for Drug Control: Politics and Federal Policy in a Period of Increasing Substance Abuse, 1963-1981. Yale University Press. New Haven, CT.
2. Weintraub, M. et al. 1991. Consequences of the 1989 New York State triplicate benzodiazepine prescription regulations. JAMA 266 : 2392 2397.
3. Compton, W.M. & N.D. Volkow. 2006. Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend. 81 : 103 107.
4. World Health Organization. 2000. Narcotics and Psychotropic Drugs- Achieving balance in national opioids policy, guidelines for assessment. WHO/EDM/QSM/2000.4, 4-5. WHO. Geneva, Switzerland.
5. Reed, D.A. & Schnoll, S.H. 1986 Abuse of pentazocine-naloxone combinations. JAMA 256 : 2562 2564.
6. Kauffman, R.E. 1983. The role of chloramphenicol in pediatric therapy. Prog. Clin. Biol. Res. 135 : 315 327.
7. Smadel, J.E. 1949. Chloramphenicol in the treatment of infectious disease. Am. J. Med. 7 : 671 685.
8. Volini, I.F., I. Greenspan, L. Erlich, et al. 1950. Hematopoetic changes following chloramphenicol (Chloromycetin). JAMA 142 : 1333 1335.
9. Rich, M.I., R.J. Ritterhof & R.J. Hoffmann. 1950. A fatal case of aplastic anemia following chloramphenicol (Chloromycetin) therapy. Annals of Internal Medicine 33 : 1459 1467.
10. Venning, G.R. 1983. Identification of adverse reactions to new drugs. II How were 18 important adverse reactions discovered and with what delays? British Medical Journal 286 : 289 292.
11. Multiple. 1966. National Halothane Study: Possible association between halothane anesthesia and postoperative hepatic necrosis. JAMA 197 : 775 808.
12. Yunis, A.A., A.M. Miller & Z. Salem. 1980. Chloramphenicol toxicity: pathogenic mechanisms and the role of p-NO2 in aplastic anemia. Clin. Toxicol. 17 : 359 373.
13. Dameshek, W. 1960. Chloramphenicol- a new warning. JAMA 174 : 1853 1854.
14. Anonymous. 1968, Feb. 16. The Dangers of Chloromycetin. Time. Available at http://www.time.com/time/magazine/article/0,9171,837894,00.htm
15. Salmon v. Parke, Davis & Co., 520 F.2d 1359, (4th Cir. 1975).
16. Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653 (1973).
17. Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971).
18. Whitley v. Cubberly, 24 N.C.App. 204, 210 S.E.2d 289 (1974).
19. Love v. Wolf, 249 Cal.App.2d 822, 58 Cal.Rptr. 42 (1967).
20. Ray, W.A., C.F. Pederspeil & W. Schaffner. 1976. Prescribing of chloramphenicol in Ambulatory practice. Ann. Intern. Med. 84 : 266 270.
21. Schaffner, W., W.A. Ray, C.F. Federspiel & W.O. Miller. 1983. Improving antibiotic prescribing in office practice. A controlled trial of three educational methods. JAMA 250 : 1728 1732.
22. Schaffner, W., W.A. Ray & C.F. Federspiel. 1983. Surveillance of antibiotic prescribing in office practice. Ann. Intern. Med. 89 (5 Pt. 2 Suppl. 796 799.
23. White, L.L., T.D. Holimin, J.T. Tepedino, et al. 1996. Antimicrobials prescribed for otitis medial in a pediatric Medicaid population. Am. J. Health System Pharmacy 53 : 2963 2969.
24. Maselli, J.H. & R. Gonzales. 2001. Measuring antibiotic prescribing practices among ambulatory physicians: accuracy of administrative claims data. J. Clin. Epidem. 54 : 196 201.
25. Cicero, T.J., E.H. Adams, A. Geller, et al. 1999. A postmarketing surveillance program to monitor Ultram (tramadol hydrochloride) abuse in the United States. Drug Alcohol Depend. 57 : 7 22.
26. Knisely, J.S., E.D. Campbell, K.S. Dawson & S.H. Schnoll. 2002. Tramadol abuse among health care professionals. Drug Alcohol Depend. 68 : 15 22.
27. Adams, E.H., R.C. Dart, J.S. Knisely & S.H. Schnoll. 2005. Tramadol abuse and dependence among physicians. JAMA 293 : 1977.
28. Inciardi, J.A., T.J. Cicero, A. Munoz, et al. 2006. The diversion of Ultram, Ultracet, and generic tramadol HCl. J. Addict. Dis. 25 : 53 58.
29. Central Hudson Gas & Electric v. Public Serv Comm US 557 (1980).
30. Preston, K.L. & D.R. Jasinski. 1991. Abuse liability of opioid agonist-antagonists in humans. Drug Alcohol Depend. 28 : 49 82.
31. Darboe, M.N., G.R. Keenan & T.K. Richards. 1996. The abuse of dextromethorphan-based cough syrup- a pilot study of the community of Waynesboro Pennsylvania. Adolescence 31 : 633 644.
32. Ritter, A.J. 2002. Naltrexone in the treatment of heroin dependence: relationship with depression and risk of overdose. Aust. NZ Psychiatry 36 : 224 228.
33. FDA. 2005. Development and Use of Risk Minimization Action Plans. USHHS. FDA Guidance Documents.
34. FDA. 2005. Good Pharmacovigilance Practices and Pharmacoepidemiological Assessment. USHHS. FDA Guidance Document.
35. FDA. 2005. Premarketing Risk Assessment. USHHS. FDA Guidance Document.
36. Dasgupta, N., E.D. Kramer, M.A. Zalman, et al. 2006. Association between non-medical and prescriptive usage of opioids. Drug Alcohol Depend. 82 : 135 142.
37. Inciardi, J.A. et al. 2007. Mechanisms of prescription drug diversion among drug-involved club- and street-based populations. Pain Med. 8 : 171 183.
38. McCabe, S.E. & C.J. Boyd. 2005. Sources of prescription drugs for illicit use. Addict. Behav. 30 : 1342 1350.
39. Angell, M. 1997. Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case. Trade Paperback ed. Random House Trade Paperback. New York.
40. Cicero, T.J., R.C. Dart, J.A. Indciardi, et al. 2007. The development of a comprehensive risk-management program for prescriptions opioid analgesics: researched abuse, diversion and addictions-related surveillance (RADARS). Pain Med. 8 : 157 170.
41. Strom, B.L. et al. 1996. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA 275 : 376 382.
42. Arnold, S.R. & S.E. Straus. 2007. Interventions to improve antibiotic prescribing practices in ambulatory care (review). 1 57. Wiley. Cochrane Collaboration Series Library.
43. Edlund, M.J. 2007. Risk Factors for clinically recognized opioid abuse and dependence among veterans using opioids for non-cancer pain. Pain 126 : 355 362.
44. Malone, T.J. 2006. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Services Research 6 : 46.
45. Westerholm, B. 1974. Adverse reactions from chemotherapeutic agents as seen in a National Monitoring Center. Int. J. Clin. Pharmacol. 9 : 276 282.
46. Fleischer, A.B. Jr. 2006. Black box warning for topical calcineurin inhibitors and the death of common sense. Dermatol. Online 12 : 2.
47. Ennett, S.J., C.L. Ringwalt, J. Thorne, et al. 2003. A comparison of current practice in school-based substance use prevention programs with meta-analysis findings. Prev. Sci. 4 : 1 14.
48. Dreitlzer, Bob. 2000. Officials Hope Doctor's Arrest Will Stem Flow of Illegal Drugs Scioto County Man Charged. Columbus Dispatch. p1b March 11.
49. Gold, Donna. 2000. A Prescription for Crime: Abuse of 2 Painkillers Blamed for Rise in Violence in Maine's Poorest County. The Boston Globe. pD22 May 21.
50. Cannizaro, Steve. 2000. Potent New Painkiller on the Street, Cops Say; Task Force Investigating Street Sales of 'New Vicodin'. Times-Picayune. pA01 June 27.
51. Associated Press. 2001. National News Briefs; Raids in Kentucky Aim at Deadly New Drug. The New York Times. pA20 February 8.
52. Tough, Paul. 2001. The Alchemy of OxyContin: From Pain Relief to Drug Addiction. The New York Times Magazine. p32 July 29.
53. Cicero, T.J., H. Surratt, J.A. Inciardi, et al. 2007. Relationship between therapeutic use and abuse of opioid analgesics in rural, suburban, and urban locations in the United States. Pharmacoepidemiol. Drug Saf. 16 : 827 840.
54. Rosenblum, A., M. Parrino, S.H. Schnoll, et al. 2007. Prescription opioid abuse among enrollees into methadone maintenance treatment. Drug Alcohol Depend. 90 : 64 71.