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ASAs Comments to FDA on Opioid REMs

June 30, 2009

Margaret Hamburg
Food and Drug Administration
U.S. Department of Health & Human Services
5630 Fishers Lane
Rockville, MD 20852

Re: Docket No. FDA-2009-N-0143; Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs

Dear Commissioner Hamburg:

On behalf of the 43,000 members of the American Society of Anesthesiologists (ASA), we appreciate the opportunity to provide comments in response to the Food and Drug Administration’s (FDA) April 20, 2009, Federal Register Notice regarding Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. As the medical specialty representing the largest number of practicing pain medicine physicians, ASA has significant interest in reducing the misuse, abuse and diversion of opioid medications that has lead to unintended deaths. However, we are concerned that regulations, meant to ensure the safe use of only certain opioid products, may have the unintended consequences of increasing the abuse of the less regulated products and reducing access to ALL opioid products used for the proper treatment of pain.

ASA agrees generally with the detailed comments provided by the American Medical Association on this issue, but with one exception: any program meant to address the abuse, misuse or diversion of opioids should cover ALL opioid classes to avoid the unintended consequences of shifting problems from one group of drugs to another and reducing the number of physicians available to prescribe necessary pain medications. ASA further believes that the Federal Government and provider organizations already have the ability to address these problems through expansion and improved coordination of existing tools such as provider notification networks, continuing medical education (CME) programs and Prescription Monitoring Programs (PMPs) authorized by the National All Schedules Prescription Electronic Reporting Act (NASPER).

Therefore, ASA urges the FDA to adopt a broad and balanced approach that addresses the current state of minimal education on pain management for medical students and all physicians; provides up-to-date and actionable information on opioid drug products for physicians and patients; and helps doctors identify patients seeking the same abusable medications from multiple prescribers through optimal use of PMPs.

Elements of the REMS: Unintended Consequences

It is well recognized that pain and the consequences of inadequate treatment represent a significant health problem for the United States. However, it is also well recognized that prescription drug abuse is a serious public health crisis that requires thoughtful solutions to ensure maximum safety for the public, as well as appropriate access to necessary pain relief. On balance, ASA believes that proposed REMS elements, such as provider/prescriber certification or enrollment of patients, providers or physicians in programs for specific products would not diminish abuse or misuse of opioids. Instead, they would very likely result in decreased access to appropriate therapy for some legitimate patients. In general, ASA believes that any burdensome requirement, such as mandatory certification or restricted distribution, placed on a single opioid or class of opioids would likely result in the following unintended consequences:
  • Primary care and other physicians opting out of prescribing Schedule II controlled substances and choosing not to manage patients with chronic pain due to burdens of registering or becoming certified for multiple systems;
  • Patients overwhelming pain medicine specialists and clinics when they are unable to be treated through their primary care physicians;
  • Reduced or no access for patients, particularly those in rural and underserved communities with no pain medicine specialists; and
  • A shift in prescribing from Schedule II to other, less effective, and more commonly abused, opioid products.
A further unintended consequence of certain REMS elements may be the future unavailability of generic opioids. Manufacturers of these products may be unlikely to undertake the costly process of developing REMS programs for drugs with low revenue yield leaving mostly costly, proprietary drugs. This could have a significant impact on access to lower cost generic opioids.

Therefore, any element of REMS, designed to assure safe use, should first demonstrate evidence of effectiveness in achieving its intended goal and be balanced against any unintended consequences of reducing access or creating a spike in the misuse or abuse of other drugs.

ASA Recommendations:

Expand use of existing provider notification networks:

Provider notification networks, such as the Health Care Notification Network (HCNN), are used by a growing number of provider organizations, including the ASA, and already provide a more efficient and “trackable” way to convey drug-related information to physicians. According to HCNN officials, the network and system is already equipped to provide the following elements related to REMS:
  • Informational letters
  • Medication guides
  • Package inserts
  • Educational information
  • Knowledge assessment using survey and CME applications
  • Certification
  • Authentication
Increased utilization of such trusted and established electronic networks will improve delivery of important REMS information and allow greater flexibility in the type of information to be conveyed. Use of these networks will also reduce confusion and the administrative burden by providing REMS information through a single source. We encourage the FDA to expand its use of these networks and work with medical associations to encourage greater physician participation so that important information, such as safety alerts, dosing information and pain management education, reaches physicians in the most efficient way possible.

Improve pain management and opioid education for all physicians:

Currently, medical students learn very little about pain management, although pain is the most common reason for a patient to seek medical care. This is also true for the vast majority of physicians as they participate in their residency training programs and subsequently go into practice. Improved education during training programs and ready access to CME programs for physicians in practice would improve basic understanding of pain and its treatment. It is important, however, that if CME programs are to be required by the FDA as part of its REMS strategy, they should be broad, not drug or class specific, and be mandatory for ALL physicians. Recent history demonstrates that efforts to impose more stringent requirements on the prescribing of Schedule II medications, leads to physicians opting out of prescribing those medications.

With the prevalence of prescription drug abuse in this country, a CME program developed with input from physician groups, FDA and DEA would be beneficial for all physicians. Such a program could addresses a number of important topics including: proper treatment and assessment of various levels of pain; recommendations for quantities of opioids to be prescribed in various situations; recognition of prescription drug abuse, “doctor shopping” behavior and techniques for intervention; treatment options for prescription drug abuse; proper storage and disposal of opioids; and addressing myths/fears physicians have regarding DEA enforcement.

Increase support and funding for the utilization of integrated prescription monitoring programs

Lastly, and perhaps most important, the ASA strongly agrees with the AMA that the most effective approach to reducing diversion is the development of real-time, state-based, prescription drug monitoring programs that can interface with each other. We therefore, also reiterate our strong support for funding and implementation of the National All Schedules Prescription Electronic Reporting (NASPER) Act. ASA believes that full-funding and support of this program is the most critical element for addressing the rising public health problem associated with misuse of opioids, and if implemented appropriately, will address both patient and prescriber-based inappropriate behavior.

ASA appreciates the FDA for seeking stakeholder input early in the process and we urge the Agency to solicit public comment once a proposed REMS has been developed.
We look forward to continuing to work with the FDA on this important initiative. Please feel free to contact Chip Amoe, J.D., M.P.A, Assistant Director, Federal Affairs at or 202-289-2222 if you have any questions or need additional information regarding this issue.


Roger A. Moore, M.D.
American Society of Anesthesiologists