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The FDA has now taken its first major step in strengthening strategies for minimizing the risks of extended-release (ER) opioid medications. On Tuesday, March 3rd, Agency officials met with representatives from companies that manufacture ER opioids to initiate the process of developing a new, and potentially class-wide, Risk Evaluation and Mitigation Strategy (REMS).
Below, Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion, explores a key challenge for the companies moving forward: developing meaningful educational components for the REMS that can effectively minimize the risks associated with opioid medications without overburdening the clinicians who prescribe them.
“In designing a system for training clinicians, it’s critical that we avoid the unintended consequence of denying patients, en masse, the medications that may be most effective for treating their pain,” says Zacharoff. “To do that, we need to ensure that training is as cost-effective, convenient, and ’friction-free’ as possible.”
Read on for the full essay, and stay tuned for future issues as we explore developments that may change the shape of contemporary pharmaceutical risk management.
Sincerely,
The NAVIPPRO team
Designing a REMS that works
The importance of developing “user-friendly” opioid risk training
By Kevin Zacharoff, M.D.
The gauntlet has been thrown. On March 3rd, the FDA held the first in a series of meetings to develop what’s expected to be new class-wide Risk Evaluation and Mitigation Strategy (REMS) program for extended-release (ER) opioid medications.
It would be difficult to overstate the enormity and complexity of the challenges for the companies that manufacture these medications. To develop a REMS that moves beyond yesterday's risk minimization action plans (RiskMAPs), companies need to figure out the best way to build on past strategies to address the diversion, misuse, and abuse problems that persist. Critically, they have to devise a strategy for measuring the impact of their initiatives over time. And, to meet requirements for compliance, they must act swiftly, potentially in cooperation with one another as well as the FDA, to complete the REMS on time and keep their products available to the public.
The challenges don't stop there, however. As the slides from FDA's presentation at the meeting demonstrate, there is now little doubt that the program will require:
- ongoing, opioid-specific training and possibly certification for clinicians and pharmacists;
- a higher level of clinician vigilance than previously required;
- expanded use of doctor-patient opioid agreements, detailing the responsibilities of both clinician and patient, including review of the Medication Guide, information about the safe and appropriate use of medications, and the dangers of sharing medications; and
- continued monitoring of these initiatives to ensure that goals are being met.
These requirements may have important clinical implications. In designing a system for training clinicians, it’s critical that we avoid the unintended consequence of denying patients, en masse, the medications that may be most effective for treating their pain. To do that, we need to ensure that training is as cost-effective, convenient, and “friction-free” as possible. History tells us that if an undue burden is placed on health care providers, clinicians will migrate to methods and treatment plans that do not interrupt workflow, entail more paperwork, or require increased expenditure of time and money. In a society where more of us are living longer lives, and many with chronic pain, a poorly designed training system runs the risk of lowering the quality of care, leading to undertreatment of pain and needless suffering.
Fortunately, current technology gives us a multitude of options for innovation that can increase the quality and cost-effectiveness of health care, including clinician education. At Inflexxion, one of our strongest areas of expertise is developing scientifically validated tools and educational programs that leverage technology so that clinicians can better navigate the risks of pain medications and provide the highest quality of care to patients.
One example of Inflexxion’s established role in this arena is our development of the Screener and Opioid Assessment for Patients with Pain (SOAPP®) a brief, paper-and-pencil self-report tool that enables clinicians to assess a patient’s risk of addiction before initiating opioid therapy. Designed to fit into the clinician workflow, SOAPP is broadly available through PainEDU.org a leading online pain management-education website that has opened lines of communication with nearly 20,000 registered subscribers. The accessibility of the PainEDU site has helped to extend SOAPP’s reach in the pain treatment community; in September 2008, it became the first risk management tool to be recommended across the Kaiser Permanente network by its Pain Management Advisory Group. SOAPP is also highlighted in a recently published set of clinical practice guidelines for opioid management of chronic noncancer pain, which were developed by the American Pain Society and the American Academy of Pain Medicine.
As someone with more 25 years of clinical experience in Anesthesiology and Pain Medicine, it’s my sincere hope that the educational component for the new REMS is designed to help clinicians deliver the standard of care that patients deserve. By making the right design and implementation choices now, the stakeholders in this process can help bring about the kind of broad systemic change that can improve the quality of care and make a significant, positive impact on public health.
Inflexxion specializes in opioid risk management that reaches multiple constituencies. If you would like to talk to us about our experience working with companies to develop comprehensive risk management plans, please feel free to contact me.
About NAVIPPRO
The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a public health-oriented risk management solution that integrates the four key components of an effective Risk Evaluation and Mitigation Strategy (REMS): national, real-time, product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.
NAVIPPRO began in 2001 with a series of grants from the National Institute on Drug Abuse (NIDA). In 2005, Endo Pharmaceuticals became the founding industry sponsor of NAVIPPRO and in 2006 Alpharma Pharmaceuticals LLC. (now King Pharmaceuticals, Inc.) became the second industry founder. Since that time other pharmaceutical companies have become subscribers. With NIDA’s continued support of ongoing research and product development, NAVIPPRO is constantly evolving to meet our goal of advancing public health.
American Pain Society: 28th Annual Scientific Meeting
May 7, 2009 San Diego, California
The College on Problems of Drug Dependence: CPDD 71st Annual Meeting
June 20, 2009 Reno, Nevada
- NAVIPPRO
- Surveillance
- Signal detection
- Signal verification
- Prevention & intervention
- FDA presentation: Industry Meeting on REMS for Certain Opioid Drugs
- PainEDU
- About Inflexxion
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Support
The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., and Endo Pharmaceuticals in the development of NAVIPPRO.
The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., and Endo Pharmaceuticals in the development of NAVIPPRO.
The contents of this newsletter are for informational purposes only and are not intended to be a substitute for professional medical advice, diagnosis or treatment. Reliance on any information provided in this newsletter is at your own risk.
You should consult your physician or other qualified health provider if you have questions about a medical condition. If you think you have a medical emergency, call your doctor or 911 immediately.
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