As noted previously in these UPDATES, voices of the many millions of persons with chronic pain often seem to go unheard when it comes to policies and regulations governing their treatment, particularly when it comes to recent initiatives that threaten to limit access to opioid analgesics. Finally, they have spoken up, largely out of concern and fear that the day might come when they will be forced off of their medications — “cold turkey.”
Supported by a new research survey, with 2,840 participants from 10 patient groups, the International Adhesions Society (IAS; www.adhesions.org) submitted concerns to the U.S. Food and Drug Administration (FDA) regarding a petition from Physicians for Responsible Opioid Prescribing (PROP) to change labeling on opioid analgesic products. The PROP petition, most recently discussed in an UPDATE [here], requests 3 changes: (1) strike the term “moderate” from the indication of opioid analgesics for noncancer pain (leaving “severe pain” as the only indication); (2) add a maximum daily opioid dose, equivalent to 100 milligrams of morphine for noncancer pain; and (3) add a maximum duration of 90 days for continuous (daily) opioid use for noncancer pain.
According to David Wiseman, PhD, MRPharmS, founder of the IAS, their survey data submitted to the FDA represents the voices of more than 25 million Americans with chronic pelvic, abdominal, or spinal pain due in part to adhesions, endometriosis, interstitial cystitis, irritable bowel syndrome, and complications of gynecological surgery. Overall, the group asserts, the opioid requirements of almost all patients would be negatively impacted by proposed limits of the PROP petition and patients’ future access to opioids would be strongly compromised.
“None of our patients want to take pain medications,” Wiseman writes in his recommendations to the FDA [PDF available here]. “The vast majority, if not all, of the patients we serve are responsible users of these drugs. Opioids are the last resort for many patients unable to find alternative relief. We are concerned that the proposals will precipitate a ‘cold turkey’ [withdrawal] for millions of chronic pain patients.”
In the survey, which had been conducted online, patients responded to a range of questions about their pain and its treatment. Opioid therapy was being prescribed for the majority of respondents (62%, or 1766/2840), and several questions specifically addressed how components of the PROP petition would affect their care.
- Limiting indication to “severe” pain only — 46% of all respondents would be excluded from treatment with opioids because their pain is not rated as “severe.” Less than 1% of patients reported having only “mild” pain.
- Limiting duration of treatment — 86% of the cohort reporting opioid use would be excluded from further treatment because they have used opioids for more than 3 months; 55% of those patients had been prescribed opioids for more than 2 years.
- Limiting dose to 100mg morphine equivalent — 24% of patients taking opioids would be excluded from further treatment on the basis of this dose limit.
- Combining opioid dose and duration limits — the combined effect of these 2 restrictions would exclude from further opioid treatment 86% of all patients currently prescribed opioids.
- Combining dose, duration, and pain severity limits — applying all 3 restrictions would exclude 92% of the patients in this study from further opioid therapy.
One of the problematic aspects of the proposed label changes is defining what is meant by words like “severe pain.” Difficulties of ranking pain severity on a numeric rating scale (NRS) were most recently discussed in an UPDATE [here]. The IAS survey asked participants to select the lowest number that means to them pain described as “Mild,” “Moderate,” “Moderate to Severe,” or “Severe.” For the 1,754 respondents to this question, there is a diversity of opinion and significant overlap of categories when words are used to segment an 11 point NRS [see figure].
Wiseman observes, this means that attempting to categorize pain and determine qualification for opioid therapy by the use of word descriptors will be imprecise and inequitable. Some patients will be unfairly denied opioids, while others will undeservedly receive them, defeating the objectives of the proposed label changes.
A number of questions asked respondents their opinions about current opioid prescribing practices and how label changes might alter those. Overall, when considering each of the 3 proposed restrictions — relating to pain level, dose, and treatment duration — 57%, 43%, and 68% of patients, respectively, believed that their healthcare providers would be less willing or not willing to prescribe opioids for their pain. Furthermore, 53% believed that their health insurance carriers would be very likely or almost certain to deny coverage for opioid analgesics.
Overall, either because of prescribers’ reticence or lack of insurance coverage, respondents felt their access to pain medication and control would be greatly (62%) or somewhat (26%) reduced, with only 12% believing that their access would not change. In another question on this topic, 82% of respondents agreed somewhat or strongly with the statement: “Too many label restrictions will reduce my ability to get pain relief.”
In a question assessing patients’ perceptions about the use of opioids, 76% agreed somewhat or strongly with the statement: “We need opioid drugs, but I wish there were alternatives that were safer and with fewer side effects.” In this regard, survey respondents also were allowed to add personal comments, and here are several:
- “Chronic pain patients are responsible users of opioids, please do not treat us like criminals. Keep the government out of the practice of medicine.”
- “If you understood better how pain affects my life, you will understand why I need medication. Opioids help us live our lives.”
- “Punish those who are abusing opioids – find other ways to address abuse, you may not succeed but don’t hurt us in the meantime.”
- “Restrictions on opioids would increase suicide rates among chronic patients and drive patients to obtain drugs illegally.”
- “Educate doctors better on the treatment of pain — opioids can be used safely.”
Finally, proponents of the label-change petition have argued that the restrictions would not limit pain management practices, since “off label” prescribing of opioid medications still would be permitted. However, echoing the opinions of others in the field, Wiseman observes that such sentiments are “untenable and disingenuous,” and further asserts:
“In an environment of ever-more aggressive malpractice litigation and cost containment by hospitals and insurance providers, physicians will be reluctant to prescribe ‘off-label’ for fear of legal or professional reprisals, and payors may deny coverage for treatments that are ‘off-label’ and ‘experimental.’ Legitimate patients will have reduced access to opioid analgesia. This fear was expressed by more than 80% of patients in our survey of chronic pain patients, which also showed that the use of opioids would be considered off-label in 92.4% of the patients we surveyed, if all three limitations were implemented.”
Participants in this survey of patients in the USA were >18 years old, with chronic, noncancer pain, and 93% were female. Average age was about 47 years (range 18-83), and 5% of respondents were uninsured, 22% were covered by Medicare/Medicaid, and the remaining 73% were insured through their employers or otherwise. Patients reported an average of nearly 8 types of pain, including interstitial cystitis (71%), pain during or after intercourse (57%), back pain (53%), vulvodynia or vaginal pain (40%), irritable bowel syndrome (38%), other bladder pain or pain related to urination (35%), migraine (33%), arthritis or other joint pain (32%), hip pain (31%), pain due to adhesions (29%).
Almost all patients (97%) reported some pain lasting more than 2 years. Respondents reported using (at any time) an average of 2.68 different opioid analgesics (range 1-15, mode 1). The 5 most commonly used opioids in this population were hydrocodone (27%), oxycodone (20%), tramadol (15%), codeine (7%), and morphine (6%).
COMMENTARY: This was an important study and the only one that we know of to directly assess and reflect patients’ perceptions of the potential impact that label changes requested in the PROP petition would have on their treatment for chronic noncancer pain. Yet, it must be conceded that surveys of this sort have strong limitations.
Most significantly, the 2,840 total participants in this survey represent a relatively tiny and select sampling of all patients with chronic pain who might benefit from opioid therapy. Respondents were overwhelmingly female and comprised a subgroup that is not representative of all types of pain conditions. Also, since respondents volunteered online for the survey, there was likely a selection bias in that patients with strong interests or opinions regarding the issues may have more eagerly participated. Furthermore, some of the questions were speculative, asking respondents to imagine what would happen if the label changes were imposed in the future.
The survey was organized by the International Adhesions Society (IAS), which is funded by Synechion, Inc., a company owned by Wiseman that focuses on adhesions and nonpharmacologic therapies for related pain conditions. However, a commercial vested interest in outcomes of the survey seems unlikely. Other organizations, which encouraged participation by their audiences, included: Endometriosis Association, Interstitial Cystitis Association, Interstitial Cystitis Network, Endometriosis Research Center, Arachnoiditis Society for Awareness and Prevention, EaseNervePain.com, HysterSisters.com, LivinginPain.org, and DrugWatch.com.
Despite the limitations, if results of this survey are valid and can be reliably extrapolated to the much larger and broader population of persons with chronic pain, it seems clear that the proposed opioid label changes could have a devastating and enduring impact on the well-being of the majority of those patients who benefit from opioid analgesic therapy. This also is consistent with the many apprehensive comments from patients received in the past at various UPDATES articles addressing this topic, and it is in opposition to the claims of some professionals that the label changes would not negatively affect optimal patient care. Meanwhile, as of this writing, the FDA is pondering a decision on the PROP proposal.
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