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In this section: Information by Drug Class
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 3. Drug Safety and Availability
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 5. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

 1. Information by Drug Class


OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)

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Extended-release, long-acting (ER/LA), and immediate-release (IR) opioid
analgesics, such as hydrocodone, oxycodone, and morphine, are powerful
pain-reducing medications that have both benefits as well as potentially serious
risks. The FDA has determined that a REMS is necessary for all opioid analgesics
intended for outpatient use to ensure that the benefits of these drugs continue
to outweigh the risks. The Opioid Analgesic REMS, approved on September 18,
2018, is one strategy among multiple national and state efforts to reduce the
risk of abuse, misuse, addiction, overdose, and deaths due to prescription
opioid analgesics.

The REMS program requires that training be made available to all health care
providers (HCPs) who are involved in the management of patients with pain,
including nurses and pharmacists. To meet this requirement, drug companies with
approved opioid analgesics will provide unrestricted grants to accredited
continuing education providers for the development of education courses for HCPs
based on the FDA’s Opioid Analgesic REMS Education Blueprint for Health Care
Providers Involved in the Treatment and Monitoring of Patients with Pain. The
FDA believes that all HCPs involved in the management of patients with pain
should be educated about the fundamentals of acute and chronic pain management
and the risks and safe use of opioids so that when they write or dispense a
prescription for an opioid analgesic, or monitor patients receiving these
medications, they can help ensure the proper product is selected for the patient
and used with appropriate clinical oversight.

There is no mandatory federal requirement that prescribers or other HCPs take
the training and no precondition to prescribing or dispensing opioid analgesics
to patients. However, the FDA’s Opioid Policy Steering Committee continues to
consider whether there are circumstances when the FDA should require some form
of mandatory education for HCPs, and how the agency would pursue such a goal.
The agency’s aim is to reduce unnecessary and/or inappropriate exposure to
opioids by making certain that HCPs are properly informed about appropriate
prescribing recommendations, that HCPs understand how to identify abuse by
individual patients, and know how to get patients with opioid use disorder into
treatment.

The FDA’s goal is to reduce serious adverse outcomes resulting from
inappropriate prescribing, misuse and abuse of opioid analgesics, while
maintaining patient access to pain medications.


ADDITIONAL RESOURCES

 * FDA takes important steps to encourage appropriate and rational prescribing
   of opioids through approval of new safety measures for immediate-release
   opioid analgesic medications  
 * FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers
   Involved in the Treatment and Monitoring of Patients with Pain (PDF - 141 KB)
 * Opioid Medications


BACKGROUND AND HISTORICAL INFORMATION

 * Safety Measures for Extended-release and Long-acting Opioids
 * Safety Measures for Immediate-Release Opioids
 * Historical Information on Opioid Analgesic REMS

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   CONTENT CURRENT AS OF:
   
   09/27/2018

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