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FDA Requiring REMS for Certain Opioid Drugs REMS Elements May Include Requirement
for Patient Monitoring
On March 3, 2009, the Food and Drug Administration (FDA) held an industry meeting
to discuss design of Risk Evaluation and Mitigation Strategies (REMS) for certain
opioid drugs. FDA issued a press release on February 9, 2009 outlining its intent
to exercise its authority regarding development and implementation of REMS for these
drugs. The FDA believes REMS of certain opioid drugs are necessary to ensure the
benefits of these drugs continue to outweigh the risks (http://www.fda.gov/cder/drug/infopage/opioids/default.htm).
FDA’s opioid REMS request includes extended release formulations of hydromorphone,
morphine, oxycodone, and oxymorphone; all formulations of methadone; and transdermal
fentanyl (Opioids Products Chart). Over the past decade, the FDA worked
with manufacturers to implement risk management programs, but numerous studies have
shown a significant increase in the rates of misuse, abuse, and accidental overdoses
of opioids during this time. Under the Food and Drug Administration Amendments Act
of 2007 (FDAAA), the FDA has authority to require REMS when necessary.
The FDA desires cooperation with drug manufacturers to design an effective program
which balances the need to maintain access to opioid analgesics for legitimate pain
management patients with reduction in the misuse, abuse, addiction, and overdose
deaths associated with these drugs. In the March, 2009 meeting a presentation by
CDER outlined possible REMS elements including a requirement that each patient be
subject to monitoring. Content of FDA meeting presentations are available at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163660.htm.
Cerilliant offers numerous certified opioid reference standards and opioid monitoring
standards, including fentanyl, hydromorphone, methadone, morphine, oxycodone, and
oxymorphone as well as their metabolites and labeled analogs. Click on the links
below to view these featured drug standards:
Fentanyl Standards and Fentanyl Metabolite Standards
Hydromorphone Standards and Hydromorphone Metabolite Standards
Methadone Standards and Methadone Metabolite Standards
Morphine Standards and Morphine Metabolite Standards
Oxycodone Standards and Oxycodone Metabolite Standards
Oxymorphone Standards and Oxymorphone Metabolite Standards
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