June 23, 2009: FDA proposal for Risk Evaluation and Management Strategies (REMS)
The Michigan Cancer Pain Initiative Board of Directors has published a position statement on the FDA's proposal for Risk Evaluation and Management Strategies (REMS) for long-acting opioids.
The MCPI Board strongly believes that the care of patients in pain will be seriously compromised by the implementation of the REMS as currently proposed. We urge you speak out about this important issue.
The FDA website is open for public comment on this proposal until June 30, 2009. Comments can be submitted electronically here. Be sure to include "FDA-2009-N-0143" as the title of your comments.
The Board has submitted its position statement as a comment from the Michigan Cancer Pain Initiative, but it is very important that individuals respond to this proposal as well, both to the FDA as above and to Michigan's Senators and Congressional Representatives:
- Senator Debbie Stabenow (email)
- Senator Carl Levin (email)
- Find your Representative
More information about the REMS issue is readily available at the American Pain Foundation and the Center to Advance Palliative Care.
Here is the text of the message sent by Karen Ogle, MD, President of the MCPI Board of Directors:
I am writing as the President, on behalf on the Board of Directors and the members, of the Michigan Cancer Pain Initiative to express our serious concerns about the Risk Evaluation and Mitigation Strategies (REMS) for the use of long-acting oral opioids as currently proposed (FDA-2009-N-0143).
Achieving balance between the goals of providing effective pain management and preventing diversion of opioids is the hallmark of good policy, and federal law should reflect that balance. We certainly share concerns about and are committed to addressing the problems of diversion and abuse of prescription opioids. We are also committed to advocacy for the availability of these important medications for patients with medical indications for their use. Any effective REMS must have appropriate balance between these two legitimate public concerns: the current proposal does not have such balance.
The use of long-acting opioids is crucial for the effective relief of pain in Michigan citizens living with cancer and other painful conditions. Without the use of these medications, people will suffer unnecessarily, and their functional status and quality of life will be needlessly impaired. The risks associated with long-acting oral opioids have not been shown to be any different from that of short-acting oral opioids or transdermal administration of opioids, although those medication forms are not included in the REMS proposal. Hydrocodone, a short-acting oral opioid, is in fact the leading source of prescription opioid abuse - it would not be affected under this REMS proposal. There is no evidence to support the idea that long-acting opioids have an increased risk when used under medical supervision.
We strongly oppose the adoption of certification procedures for physicians to prescribe long-acting opioids. The expectation should be that all schools of medicine teach and that all physicians master the basics of analgesia, including the prescribing of opioids, both long-acting and shorter-acting. Prescribing opioids should not be viewed as an optional skill for those licensed to practice medicine. Having personally served in exam development for the United States Medical Licensure Exam Board, I can assure that such expertise is expected by the licensing authority used throughout the US.
We have abundant evidence of inadequate relief for patients with pain. Additional prescription barriers will only worsen this problem. With the exception of pain specialists, primary care physicians and sub-specialists (such as oncologists), are likely to be unwilling to pursue additional certification. The risks of this overly burdensome REMS proposal include:
- Promulgation of the myth that physicians may exempt themselves from the responsibility for effective pain management of their patients
- Reduced appropriate prescribing by physicians unwilling to go through the proposed certification process
- Increased use of more dangerous alternatives (such as steroids and non-steroidal anti-inflammatory drugs or poorly studied interventional techniques) to avoid the certification process
- A shift toward increased use of unrestricted opioid medications, such as hydrocodone
We see enormous risk in the proposed use of special patient registries. Such registries are costly to develop and maintain as well as highly stigmatizing and burdensome to patients and physicians. There is no evidence to support the use of registries for reducing abuse or diversion. The FDA should instead build on existing electronic Prescription Monitoring Programs, which have been shown to be of value and are now functioning in the majority of states. We support further educational efforts for both patients and physicians. This can be addressed through medication guides, prescribing guidelines, and package inserts. More public education about the dangers of prescription drug abuse may also be of benefit.
Whatever REMS are adopted, the FDA must develop mechanisms to monitor the potential adverse effects of the intervention on pain management. Populations at high risk of experiencing these adverse consequences include nursing home residents and other elderly people, those with cognitive impairment, children, and ethnic minorities, and other underserved populations. Monitoring should include methods to capture changes in prescribing practices in a range of practice settings. Under no circumstances should simplistic measures, such as reduced use of long-acting opioids, be confused with "improvement" in practice. Surveys of physicians and targeted patient populations should be included in the evaluation strategies.
The FDA should form an advisory board to assist in this monitoring and evaluation of REMS. Such a board should include lay and professional advocates for improved pain relief.
We believe that the care of patients with pain will be seriously compromised by the implementation of the REMS as currently proposed.
Karen Ogle, MD, President, Michigan Cancer Pain Initiative