Opioid REMS Becomes a Reality

When PainEDU.org last covered the topic of the Food and Drug Administration (FDA’s) intended plans for curbing opioid risk, we felt confident one thing was for sure – that education would likely be a key ingredient in the ultimate implemented solution.

On Tuesday, April 19th, 2011, a press conference was held to announce the White House’s National Prescription Drug Abuse Action Plan. The plan underscores the national crisis that exists with respect to abuse, misuse, and unintended deaths resulting from prescription pain medications. This plan will involve a number of different governmental agencies working in concert to battle the problem.

At the press conference, Dr. Howard K. Koh, Assistant Secretary for Health for the U.S. Department of Health and Human Services (HHS), described the impetus for this plan. In addition to other critical statistics, he identified some key motivating factors described as “suffocating our society”:

  • In 7 states, the number of people dying from prescription pain medication overdoses has surpassed the number of motor vehicle-related deaths.
  • The number of emergency department visits for overdoses of “legal” drugs (prescription and over-the-counter) now equals the number of visits for illicit substance overdose.
    • – 1,000,000 visits per year for each category
  • Nearly 1/3 of people who use illicit drugs for the first time, begin by using prescription drugs.
    • – 7 of 10 people get these drugs from the medicine cabinet

Dr. Koh stressed that along with a number of other mitigating circumstances, a lack of health care provider education was a major contributing factor to the crisis. He stated that until now, the approach has been an individual one, not a coordinated, group effort.

This newly announced national plan will have a 4-pronged approach to battling the crisis surrounding abuse, misuse, inappropriate prescribing, and diversion of prescription pain medications:

  • Education
    • Pharmaceutical manufacturers will be required to fund educational initiatives about safe and appropriate use devoted to both health care providers and patients.
  • Monitoring
    • There will be implementation of prescription monitoring programs across the United States.
  • Disposal
    • Issues surrounding drug disposal and drug “take-back” programs need to be made more available and consistent.
  • Enforcement
    • ‘Pill mills’ and other health care providers contributing to the problem through illegal or unethical practices, need to be brought to justice, and shut down.

Dr. Margaret Hamburg, Commissioner of the FDA, announced a major component of this national plan at the press conference. Dr. Hamburg described the implementation of a Risk Evaluation and Mitigation Strategy (REMS) that will now apply to all prescription long-acting and extended-release opioid medications. She underscored the value of opioid medications, but also pointed out the risk and apparent failure of prior educational efforts and initiatives to mitigate risk. She said that, “Despite these prior efforts, the incidence of abuse, misuse, and accidental overdose are on the rise.” Dr. Hamburg stated that the goal is “Above all … to ensure that health professionals have the knowledge and training to deliver effective pain management and care and that patients understand the risks involved with these medications.” She described the framework of the opioid REMS:

  • – Pharmaceutical companies will be required to develop risk management plans that take the risk/benefit ratio into consideration for this class of medications.
  • Educational materials and programs will need to be developed that specifically target health care professionals and patients.
    • Two key features of these materials were identified:
      • 1. Medication guides to help patients understand benefits and risks
      • 2. Rigorous education for health care professionals

Dr. Hamburg stressed that education of health care professionals is a critical component of success, and that while the FDA supports the idea that education programs for health care professionals should be mandatory, this requires federal legislation to enact, so at this time education is voluntary.

Letters were sent from the FDA to all manufacturers of these products requiring them to submit their plan of action within the next 120 days. The FDA expects the education to be provided by reputable and established educational providers.

The educational content for health care providers must include all of these components:

  1. 1. General information for safe opioid prescribing:
    • Patient selection and assessment:
      • Determine goal of therapy
      • Assess the risk of abuse, including history of substance abuse and serious mental illness
      • When relevant, determine if the patient is opioid tolerant
    • Consider when prescribing opioids:
      • Pharmacokinetics and potential for overdose
      • Addiction, abuse, and misuse
      • Intentional abuse by patient or household contacts
      • Interactions with other medications/substances
    • Managing patients taking chronic opioids:
      • Establish goals for treatment
      • Evaluate pain control
      • Use Patient-Provider Agreements (PPAs)
      • Adhere to a treatment plan
      • Recognize aberrant behavior
      • Manage adverse events
    • Steps for initiating and modifying dosing of opioids for chronic pain:
      • Choose first opioid for a trial
      • Convert from one opioid to another
      • Convert from immediate-release to extended-release and long-acting products
      • Convert from one extended-release and long-acting product to another
      • Titrate to effect/tolerability
      • How to deal with missed doses
    • Maintenance:
      • Reassessment over time
      • Tolerance
    • Monitoring patients for misuse and abuse:
      • Utilize prescription monitoring programs to identify potential abuse
      • Understand the role of [urine] drug testing
      • Screen and refer for substance abuse treatment
      • Know how to discontinue opioid therapy when it is no longer needed
  2. 2. Product Specific Information
  3. Pharmacokinetic characteristics
  4. Product specific toxicity
  5. Requirements for determining opioid tolerance for certain long-acting and extended- release products
    • Individual product information modules:
      • Fentanyl transdermal system
      • Hydromorphone ER
      • Methadone (for the treatment of moderate to severe pain not responsive to non-narcotic analgesics)
      • Morphine ER
      • Oxycodone ER
      • Oxymorphone ER
      • Buprenorphine (for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time)
      • New products
      • 3. Patient Counseling Materials

– Information about the prescribed opioid (Medication Guide)

  • – Adherence to dosing regimen

– Risk of breaking, chewing or crushing certain products

– How to take an opioid properly

– How to be aware of and report opioid adverse effects

– Hazards of concomitant use of opioids and other CNS depressants, alcohol, and/or illegal drugs

– How to discontinue opioid therapy

– Risks associated with sharing opioid prescription medications

– Proper household storage of prescription pain medications

– How to avoid accidental exposure to opioids

– How to avoid unsafe exposure to prescription pain medication by preventing theft and using proper methods of disposal

– The purpose and content of a prescription pain medication Patient-Provider Agreement

– The educational content for patients will be required to include:

– How to take an opioid properly

– Adherence to dosing regimen

– Risk of breaking, chewing, crushing certain medications

– Signs and symptoms of overdose

  • – Reporting/recognizing opioid adverse effects

– Hazards of concomitant use of opioids with other CNS depressing medications, such as alcohol, or other illicit drugs

– Discontinuation of an opioid

– Risks associated with opioid medication sharing

  • – How to avoid accidental exposure
  • – Proper opioid storage in the household
  • – Avoiding unsafe exposure by preventing theft of opioid medications
  • – Proper disposal of opioid medications
  • – Purpose and content of prescription pain medication Patient Treatment Agreements
  • – Links to websites with more information about the above-mentioned topics

There is likely to be a flurry of activity in the near future as plans of action are prepared to be submitted. Discussions will surely take place about the value of a voluntary program, and how health care providers and patients will be encouraged to participate in the education necessary to make a significant change. The speakers at the press conference clearly supported this education becoming mandatory and linked to DEA registration. However, they noted it would require federal amendment to existing legislation, which generally takes some time.

Another important point was made by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, at the FDA. Dr. Woodcock said that this is really an opportunity to start filling in the educational gaps that exist in pain management in general, from assessment to diagnosis, from treatment to follow up. Dr. Woodcock’s intentions seem fitting since more than 50% of the visits to a primary care clinician are pain-related in nature.

PainEDU.org plans to stay committed to exactly what Dr. Woodcock describes as the real vision of the opioid REMS. Our team is very proud of the fact that education about pain management is a critical piece of this health care puzzle, and not likely to diminish in significance.

While our resources span the gamut of pain and its management, we at PainEDU.org are proud that our direction and focus on opioids and associated risk has been appropriately targeted. Along with our patient-facing web-based resource, painACTION.com, we now offer materials and resources to our subscribers that meet or exceed the content outlined by the FDA for this REMS. We plan to continue our focus to be a valued resource for health care professionals and patients.

From our perspective, it is all about education, and ultimately all about the patient. As always, stay tuned; there will undoubtedly be more about the opioid REMS and its potential and inevitable clinical impact coming in the future on PainEDU.org.


  1. From RiskMAPs to REMS (10/20/2009)