Open Access Open Access  Restricted Access Subscription or Fee Access

Considerations for the upcoming FDA REMS proposal

John F. Peppin, DO, FACP, John J Coleman, PhD, Kenneth L. Kirsh, PhD

Abstract


-

Keywords


-

Full Text:

PDF

References


National Center on Addiction and Substance Abuse: Controlled prescription drug abuse at epidemic level. J Pain Palliat Care Pharmacother. 2006; 20: 61-64.

Paulozzi LJ, Y Xi: Recent changes in drug poisoning mortality in the United States by urban-rural status and by drug type. Pharmacoepidemiol Drug Saf. 2008; 17(10): 997-1005.

US House Committee on Government Reform. Statement of Robert J. Meyer, MD, Director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, Food and Drug Administration: FDA’s role in preventing prescription drug abuse: House Committee on Government Reform, US House of Representatives (September 13, 2005).

Passik SD, Heit H, Kirsh KL: Reality and responsibility: A commentary on the treatment of pain and suffering in a drugusing society. J Opioid Manage. 2006; 2: 123-127.

Rappaport BA, Food and Drug Administration: Elements of the proposed REMS for long-acting and extended-release opioid drug products (PowerPoint slide presentation, July 22, 2010, Joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees, UMUC Conference Center at the Marriot, Adelphi, MD). Available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/ucm220948.htm. Accessed December 20, 2010.

Food and Drug Administration: Background on Opioid REMS, 2009. Available at http://www.fda.gov/Drugs/DrugSafety/ Informat ionbyDrugClass/ucm187975.htm. Accessed April 14, 2011.

Food and Drug Administration Amendments Act of 2007; P.L. 110-85 (121 STAT. 930). Title 21, United States Code, Sect, 355-1.

Sloan PA: Opioid risk management: Understanding FDA mandated risk evaluation and mitigation strategies (REMS). J Opioid Manag. 2009; 5: 131-133.

Food and Drug Administration. Background on Opioid REMS, 2009. Available at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm187975.htm. Accessed April 14, 2011.

Substance Abuse and Mental Health Services Administration, 2010. National Survey on Drug Use and Health, 2009. Pill Card C: Stimulants (photographs of approximately 20 prescription stimulant drugs). Available at http://www.oas.samhsa.gov/nsduh/2k9MRB/2k9pillcards.pdf. Accessed March 14, 2011.

US Food and Drug Administration: Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, 2011. Available at http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm. Accessed March 14, 2011.

Substance Abuse and Mental Health Services Administration. Results from the 2008 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-36, HHS Publication No. SMA 09-4434); Appendix B (cf. p.142), 2009. Available at http://www.oas.samhsa.gov/nsduh/2k8nsduh/AppB.htm. Accessed March 14, 2011.

Ameringer CF: State Medical Boards and the Politics of Public Protection. Baltimore, MD: The Johns Hopkins University Press, 1999.

Drug Enforcement Administration: Electronic Prescriptions for Controlled Substances. Federal Register. March 31, 2010; 75(61): 16236-16319.

Food and Drug Administration: FDA Acts to Reduce Harm from Opioid Drugs. Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm251830.htm. Accessed, April 22, 2011.




DOI: https://doi.org/10.5055/jom.2011.0060

Refbacks

  • There are currently no refbacks.