The food and drug administration risk evaluation and mitigation strategy

Journal of Pain and Palliative Care Pharmacotherapy

Volumn 24, Issue 2, 2010, Pages 145-148

  Craig, David S ^a  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

Author keywords

Analgesic; Opioid; REMS; Risk reduction

Indexed keywords

FENTANYL; GENERIC DRUG; HYDROMORPHONE; METHADONE; MORPHINE; NARCOTIC ANALGESIC AGENT; ONSOLIS; OXYCODONE; OXYMORPHONE; UNCLASSIFIED DRUG;

AWARENESS; CERTIFICATION; CONTINUING EDUCATION; CONTROLLED DRUG RELEASE; DRUG ABUSE; DRUG INDUSTRY; DRUG INFORMATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH PERSONNEL ATTITUDE; LAW; PATIENT ATTITUDE; PATIENT SELECTION; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK REDUCTION; SHORT SURVEY;

ANALGESICS, OPIOID; DELAYED-ACTION PREPARATIONS; HUMANS; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; RISK MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77952972582     PISSN: 15360288     EISSN: 15360539     Source Type: Journal    
DOI: 10.3109/15360281003713834     Document Type: Short Survey

References (6)

1. US Food and Drug Administration Web site. Accessed January 26, 2010, from http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm187975.htm. Accessed January 26, 2010.
2. US. Food and Drug Administration. March 3, 2009, Industry Meeting on Risk Evaluation and Mitigation Strategy (REMS) for Certain Opioid Drugs. accessed January 26, 2010, from http://www.fda.gov/downloads/Drugs/DrugSafety/ InformationbyDrugClass/UCM163675.pdf.
3. American Academy of Pain Medicine Comments to docket #FDA-2009-N-0143. June 3, 2009. accessed January 26, 2010, from http://www.regulations.gov/search/ Regs/home. html#document Detail?R=09000064809b9094.
4. American Pain Society's comments to docket #FDA-2009-N-0143. July 7, 2009. accessed January 26, 2010, from http://www.regulations.gov/search/Regs/ home.html#docketDetail?R= FDA-2009-N-0143.
5. Meda Pharmaceuticals. Healthcare Professional Program Overview: The FOCUS Program for Onsolis. Available at: http://onsolisfocus.com/pdf/ professionalOverview.pdf. Accessed February 17, 2010.
6. FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan. July 16, 2009. accessed January 26, 2010, from http://www.fda.gov/NewsEvents/ Newsroom/Press Announcements/2009/ucm172366.htm.