Good News for Pain Care in USA Healthcare Reforms

The tens of millions of persons with pain in the United States were not forgotten in recently passed healthcare reform legislation. While it may take some time, more attention and funding will be devoted to examining critical issues and needs, researching more effective pain therapies, and providing better training for health professionals in managing pain.

The historic healthcare reform initiatives — the “Patient Protection and Affordable Care Act” — recently approved by Congress and signed into U.S. law include several provisions of earlier legislation, titled the “National Pain Care Policy Act of 2009.” This Act was approved by the House of Representatives about a year ago but was still in a Senate committee awaiting further action; however, the following components were included in Section 4305 of the new healthcare reform legislation and can now move forward:

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Do Biomagnetic Therapies Provide Pain Relief?

Biomagnetic therapies date back centuries and have been applied in different forms to treat a variety of ailments. There are still questions about whether they heal or stop the progression of painful disorders, or merely provide temporary analgesic effects in some but not all cases.

Magnetic fields are fundamental components of our environment on Earth and interest in the potential therapeutic benefits of magnetism dates back centuries. For example, the famous 2nd Century A.D. physician, Galen of Pergamum, allegedly used natural magnets to help relieve pain in treating many illnesses. Modern medicine uses technologies to monitor magnetic fields, such as in electrocardiograms and magnetic resonance imaging. Increasing evidence is accumulating regarding biomagnetic therapies and increasing numbers of people are sleeping on magnetic pads at night and wearing small magnets during the day to achieve a various health benefits. Yet, this is not a widely accepted part of mainstream medicine in America.

Most research investigations into biomagnetic therapies have focused on two distinct areas: fixed or static magnets and, increasingly, pulsed bioelectric magnetic fields. As a complementary or alternative medicine (CAM) approach, biomagnetic therapies are noninvasive and mimic forces found in nature, so they also have been largely devoid of any adverse effects. This is currently an expansive and expanding field of exploration; somewhat controversial and oftentimes confusing. Much of the clinical research today is focusing on magnetic-pulse therapies, and two recent reports exemplify these initiatives.

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Should Drivers on Opioids Be Arrested for DUI?

The director of the U.S. White House Office of National Drug Control Policy (ONDCP) recently told an international conference that drugged driving while taking prescription medications is a serious and growing problem needing action. Will a crack-down mean that patients taking prescribed pain relievers, especially opioids, could be arrested for driving under the influence (DUI) if involved in accidents or stopped by police for traffic violations?

In published statements before the 53rd United Nations Commission on Narcotic Drugs on March 8, 2010, U.S. “drug czar” Gil Kerlikowske said that drugged driving is an emerging public health threat [see text of speech here]. He warned that, “Far too many people are using drugs and then getting behind the wheel, with deadly results.” While noting that roughly 1 in 8 (12%) weekend nighttime drivers test positive for illicit drugs, he asserted that another 5% have prescription or other pharmaceutical drugs in their systems. Kerlikowske did not specifically point to prescription opioids, or other analgesic agents that might affect alertness, as being responsible for all of the problems; however, there has long been concern about possible consequences of patients driving while taking prescribed pain relievers and being involved in an accident or even a minor traffic violation. There have been anecdotal reports of such patients being arrested for DUI offenses.

CAVEATS: The government’s call for action may be inaccurate and premature. Kerlikowske said his data came from a report by the U.S. National Highway Traffic Safety Administration [NHTSA, 2009, available here]. However, the report itself cites the prevalence of nighttime drivers testing positive for drugs of all types (illicit, prescribed, and OTC; excluding alcohol) as 13.8% to 16.3%, depending on the testing method used, and it does not specifically break out data on prescription drugs. In fact, the most commonly detected drugs were marijuana (8.6%), cocaine (3.9%), and methamphetamine (1.3%). Furthermore, the report warns, “whereas the impairment effects for various concentration levels of alcohol is well understood, little evidence is available to link concentrations of other drug types to driver performance.” The NHTSA report further notes several questions that must be answered to assess the drug-impaired driving problem:

1. Which drugs impair driving ability?
2. What drug dose levels impair driving?
3. Which drugs are associated with higher crash rates?

The report essentially concludes that much more research is needed to determine how drugs, other than alcohol, may affect driver performance. Meanwhile, a comprehensive review of available evidence found that opioid use is not associated with intoxicated driving, motor vehicle accidents, or deaths due to accidents [Fishbain et al. 2002]. Therefore, while drug-impaired driving is a problem of great concern, a cautious approach to finding solutions is needed so that patients well-stabilized on prescribed analgesics and/or other medications are not unjustly criminalized.

REFERENCES:
> Fishbain DA, Cutler RB, Rosomoff HL, Rosomoff RS. Can patients taking opioids drive safely? A structured evidence-based review. J Pain Palliat Care Pharmacother. 2002;16(1):9-28 [abstract here].
> For further research summaries on driving and opioids, see: IDMU (Independent Drug Monitoring Unit). Opiates and Driving Ability. Undated [available here].

Vertebroplasty Relieves Back Pain: New Evidence

Results of several recently-announced large studies demonstrate that percutaneous vertebroplasty for treating vertebral compression fractures (VCFs) may provide significant and sustained pain relief. These investigations are in contrast to earlier reports that vertebroplasty is effective but no better than placebo.

Percutaneous vertebroplasty is an outpatient procedure performed under local anesthesia and involves injecting bone cement into one or more collapsed vertebral bodies [see illustration] that are causing back pain. Minimally invasive, the procedure stabilizes the fractures and expectedly stops the pain caused by bone rubbing against bone. It is indicated for painful VCFs that fail to respond to conventional medical therapy, such as minimal or no pain relief with back braces or medications. Two large studies demonstrating the effectiveness of vertebroplasty were presented at the Society of Interventional Radiology 35th Annual Scientific Meeting, March 13-18, 2010, and published as abstracts in the Journal of Vascular and Interventional Radiology. A third had been presented at the American Society of Spine Radiology's 2010 Annual Symposium in February.

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Acupuncture Unhelpful for Fibromyalgia: Review

German investigators conducted a systematic review and data meta-analysis to assess the efficacy of acupuncture for managing fibromyalgia syndrome (FMS). Although some pain relief was achieved immediately after treatment, acupuncture did not confer longer-term pain relief, or any improvements in fatigue, sleep disturbance, or physical function.

A search of clinical research on acupuncture for FMS through July 2009 uncovered 7 randomized controlled trials (RCTs), which included a total 385 patients receiving a median of 9 acupuncture sessions (range 6-25). Two of the trials reported longer followup of 26 weeks (median time). Immediately after treatment there was significant pain reduction (p = 0.04) conferred by acupuncture versus sham therapy (control), but no reductions in fatigue and sleep disturbances, or improvements in physical function. During followup of roughly 6-months there was no evidence for sustained pain reduction or other beneficial outcomes. Adjusting for the type of control condition (ie, penetrating versus non-penetrating sham acupuncture) did not change the results. Side effects of treatment were inconsistently reported. The researchers conclude that observed reductions in pain, although statistically significant, were modest, short-term, and most apparent in studies with potential sources of bias. Therefore, they do not recommend acupuncture for the management of FMS.

COMMENT: The total sample size (n=385) is not huge and long-term outcomes were available from only two trials, so further investigations of acupuncture for FMS might be worthwhile. It is remarkable that, even after centuries of use, neurobiological mechanisms behind acupuncture are still poorly understood, as we discussed in a prior blogpost [here].

REFERENCE: Langhorst J, Klose P, Musual F, et al. Efficacy of acupuncture in fibromyalgia syndrome — a systematic review with a meta-analysis of controlled clinical trials. Rheumatology. 2010;49(4):778-788 [abstract here].

NSAID Dangers May Limit Pain-Relief Options

With recent concerns about risks of opioid and acetaminophen analgesics, the inherent dangers of nonsteroidal anti-inflammatory drugs (NSAIDs) seem to have escaped attention. Yet, as a class, ubiquitous NSAIDs may be the most hazardous. The dilemma is that an over-emphasis on risk avoidance could result in having fewer analgesic options remaining for the millions of persons with daily pain.

The NSAID class of drugs includes traditional nonselective NSAIDs — like aspirin, ibuprofen, naproxen, and others — as well as selective COX-2 inhibitors, like celecoxib. In a recent blogpost [available here] we noted that NSAIDs are widely prescribed and many are accessible over-the-counter (OTC), so they are used by millions of persons to treat fever, inflammation, and acute or chronic pain. While there can be very serious risks associated with these agents, only a limited amount of high-quality evidence exists to guide their safe use. At the same time, the U.S. FDA is considering new restrictions, some quite severe, on acetaminophen products [see prior blogpost discussion here] and on opioid analgesics via REMS initiatives [blogposts here and here]. Furthermore, as we recently discussed [here], in many parts of the world access to opioid analgesics already is being denied to millions of patients who would benefit. Taken together, these developments may compel greater reliance on NSAID use, even though there is insufficient awareness of the risks or knowledge of safety-enhancing strategies.

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Music-Listening Soothes the Savage Beast of Pain

By guest contributor Winnie Dawson, MA, RN, BSN

Everyone agrees that music is one of life's great pleasures, but music-listening should not be over-looked as a valuable therapeutic tool. During the past few years, an increasing number of studies have evaluated the effectiveness of music as a healing therapy, including offering significant benefits for pain relief.

In late 2009, investigators in Sweden released the results of a systematic review of published literature on the effect of music on postoperative pain [Engwall et al. 2009]. Of 1,631 articles examined, 18 studies from 6 countries were included in the review. Participants had varied options for music choice in 11 studies, while researchers of the remaining 7 studies selected the music for participants. Study design, pain assessment tools, and patient population varied from study to study; all studies except one—which played live harp music—used recorded music.

Fifteen studies reported a significant positive effect of music on postoperative pain reduction, either alone or in combination with other complementary pain-relief strategies. Even the patients from the studies that showed no significant effect on pain felt that the music intervention had helped them in some manner. Of the studies that evaluated analgesic consumption, 5 reported that music-listening patients used fewer analgesics than control groups, while 5 other studies did not show a significant difference in the use of pain relievers. The researchers concluded that music can be beneficial as an adjunctive therapy for postoperative pain relief. Evidence from other studies supports the value of music-listening for relaxation and anxiety reduction, both of which can enhance pain relief. For example, two evaluations of cardiac patients in 2009 reported modest positive results in both areas:

• First, a Cochrane Systematic Review analyzed 23 studies with a total of 1,461 patients diagnosed with coronary heart disease [Brandt et al, 2009]. Most studies included in the review compared music interventions (primarily using pre-recorded music without the services of a music therapist) plus standard care with standard care alone. Results were not strong but showed decreases in anxiety levels, heart rate, respiratory rate, and blood pressure in patients with coronary heart disease.


• Second, researchers in Sweden randomly assigned 40 post-operative patients to bed rest plus music-listening or bed rest alone the day after their open-heart surgery [Nilsson, 2009]. Assessment of relaxation was based on a comparison of pre- and post-intervention serum oxytocin levels (a neurotransmitter that affects normal homeostatic cardiac and vascular regulation), heart rate, and mean arterial blood pressure, as well as arterial oxygen tension and saturation. After 30 minutes of relaxing music, patients in the music group demonstrated a significant increase in oxytocin serum levels, arterial oxygen tension (necessary for hemoglobin oxygen saturation), and higher subjective levels of relaxation when compared with the group assigned to bed rest alone. The researchers concluded that music-listening can positively affect the physiology of relaxation during bed rest following open-heart surgery.

While the mechanisms are not completely known, music can provide multidimensional affects and has been shown to enhance distraction, provide psychological support, increase relaxation, and relieve anxiety. Just the act of selecting music can give a patient a sense of control, while connecting with the rhythm of the music can change a person’s breathing pattern or heart rate which can trigger a relaxation response. And, by acting as a competing stimulus to pain, the music can distract the patient's attention away from the pain. According to Good et al. [1999], "when relaxation and music distract the mind, the result is selective attention mediated by the thalamus that alerts the prefrontal cortex to the sound rather than to the painful input, causing pain inhibition”. While studies have shown that soothing music particularly can reduce mental and muscular tension, positive benefits have been reported for music of all types. Future multicenter studies that focus on music type and the timing and duration of the music intervention would advance our understanding of its magnitude of usefulness as a pain reliever.

Based on current evidence, it appears music can provide an enjoyable, non-invasive, safe, and inexpensive adjunctive therapy for patients who are appropriate for interdisciplinary pain management. It appears to be underused by practitioners and patients alike as a complementary therapy. If you are interested in following new studies on music and pain relief as they are published, researchers at MedSearch — see, http://medsearchservices.com/music — post article summaries as they are released.

REFERENCES:
> Bradt J, Dileo C. Music for stress and anxiety reduction in coronary heart disease patients. Cochrane Database of Systematic Reviews. 2009(Apr15); Issue 2.
> Engwall M, Duppils GS. Music as a nursing intervention for postoperative pain: a systematic review. J Perianesth Nurs. 2009(Dec);24(6):370-383.
> Good M, Stanton-Hicks M, Grass JA, et al. Relief of postoperative pain with jaw relaxation, music and their combination. Pain. 1999(May);81(1-2):163-172.
> Nilsson U. Randomized clinical trial examining the effect of soothing music in response to relaxation during bed rest after open-heart surgery. J Clin Nurs. 2009(Aug);18(15);2153-2161.

APA Finally Gets Opioid “Addiction” Sorted Out

After years of confusion, a review draft of the American Psychiatric Association's (APA) latest Diagnostic and Statistical Manual of Mental Disorders (DSM-5) finally eliminates perplexing “Substance Abuse” and “Dependence” disease categories and suggests replacing them with a new "Addiction and Related Disorders" designation. Expectedly, the more appropriate language and definitions will help to dispel unfounded fears and accusations of addiction in patients taking opioid medications for pain.

As reported in Join Together Online [Curley 2010] and at a special APA website presenting the draft DSM-5 document [APA 2010], this is one of several major changes to the “psychiatry bible” widely used to diagnose (and get insurance reimbursement for) behavioral-health problems. The current edition — DSM-IV (Roman numeral designations for editions have been used until now) — was first published in 1994 and has been plagued by contention and controversy through the years. Many critics have claimed that the DSM series has “medicalized” many problems of everyday life into mental disorders, and it appears that this trend may continue to an extent in the new version. Work on the DSM-5 revision first began in 2000, has progressed most rapidly during the past few years, and the final document is expected in 2013.

Prior versions of the DSM have eschewed use of the term “addiction” in favor of “substance dependence,” plus a separate category for “substance abuse” as sort of a prodromal stage leading to substance dependence. This was a serious mistake because it created confusion with “physiological dependence” — eg, drug tolerance and withdrawal — which was considered a component of substance dependence but can naturally occur in persons taking prescribed opioid analgesics. Healthcare providers and their patients erroneously came to believe that signs of tolerance and withdrawal meant that patients were becoming dependent on or, in everyday language, addicted to opioid medications. Such confusion has been an important contributor to the undertreatment of pain [see, Leavitt 2006, p. 3]. The new approach will better differentiate between the compulsive drug-seeking behavior of addiction and normal responses of tolerance and withdrawal that some patients experience when using prescribed medications that affect the central nervous system. Presumably, any future use of the term “dependence” would strictly refer to physiological dependence.

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Europe in Dark Ages on Pain Relief. Is U.S. Next?

According to a newly reported study, patients with cancer in much of Europe are being denied access to pain relief because of over-zealous regulations restricting the availability and accessibility of opioid-based medications. While this appears to be an egregious breach of basic human rights, reminiscent of medieval medicine, equally disturbing is a possibility that the United States might be headed backward in that direction.

The study, published in the cancer journal Annals of Oncology on February 22 [Cherny et al. 2010] and also reported in Science Daily [2010], was a joint investigation of the availability and accessibility of opioids for the relief of cancer pain by the European Society for Medical Oncology (ESMO) and the European Association for Palliative Care (EAPC). Investigators examined data from 21 Eastern European countries in comparison with data from 20 Western European countries. In some countries, particularly in Western Europe, access to and availability of opioid analgesics was reasonably good, for example, the UK performed well in this respect. However, in Eastern Europe — including countries such as Lithuania, Tajikistan, Belarus, Albania, Georgia, and Ukraine — some essential opioid medicines were completely unavailable and restrictions on those at hand were intolerable.

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Friends, Relatives Key Source of Misused Opioids

According to a new study, patients are compliant for the most part in not overusing opioid medications, but they save any leftover drugs. And, almost all persons who illicitly obtain opioid pain relievers get the drugs from a friend or relative who has a prescription. In most cases, however, the purpose is “medical misuse” to treat pain rather than drug abuse. The true problem is a failure to educate.

The study conducted by researchers at the Utah Department of Health involved a randomized telephone survey in 2008 of more than 5,300 adults aged 18 years or older. It was published in the U.S. Center for Disease Control and Prevention's Morbidity and Mortality Weekly Report [Porucznik et al. 2010] and also reported in Healthday News [Reinberg 2010]. Here are highlights of the findings:

• Slightly more than 1 in 5 persons (20.8%) had been prescribed an opioid analgesic during the preceding 12 months; 71% for acute pain, 15% long-term pain, 14% both long- and short-term pain.


• Only about 3% of all respondents admitted to using their medication more frequently or in higher doses than had been prescribed, and 72% had leftover opioid medication. Roughly a quarter said that they disposed of leftover medication; however, 2.3% gave it away to someone else and 71% kept the excess opioids for themselves.


• Almost 2% of survey respondents said they had taken an opioid pain medicine not prescribed for them during the past year, and 97% of the time the drug came from a friend or relative. In most cases, roughly 85%, the medication was willingly shared, but 10% of the time the medication was pilfered and in 4% of cases it was purchased from a friend or relative.


• Importantly, the vast majority of persons who obtained opioids from a friend or relative did so to relieve pain (72.4%) and another 5.8% wanted to relieve anxiety or another physical symptom; about 15% abused diverted opioids “for fun.” Opioid misuse of any type was most common among person aged 45 to 54 years, although there were no statistically significant differences across age groups or by sex.

COMMENTARY: It is not surprising that so many persons (72%) had leftover pain medication or that the excess was saved by most of them; after all, people pay for these drugs and may need them again (so they believe). Who among our readers does not have a drawer or cabinet with at least a few containers of leftover prescription medications? Should prescribers be faulted for not anticipating precisely how much pain medication their patients will need? Here are several additional observations about this study report…

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Opioids & Pain Relief, It’s in the Genes

It is well known that not all opioid analgesics are created equal; for certain patients one may work wonders while another in the same class fails miserably. Critical differences appear to rest with the genetic makeup of patients, which explains the otherwise mysterious variable effects but is presently unhelpful in guiding clinical therapy.

A recent article in Pain Medicine News discusses a postsurgical patient who had no pain relief from hydrocodone but did well on oxycodone at a comparable dose [Miller 2010]. The chemical difference between the two opioid analgesics is just two atoms, one hydroxyl group, yet one helped the patient and the other did not. The question is not whether opioids are effective, since a sufficiently high opioid dose will overcome any pain (but with subsequently proportional side effects); rather, how can individual responses to opioids be explained and predicted? According to the article, in laboratory experiments there can be 10-fold differences in responses to morphine between animals, and the variability is likely even greater in humans. A study that looked at 3,200 patients recovering from back surgery found that some patients required as much as 40 times more morphine than others.

It is becoming increasingly clear that genetic variations may play a significant role in how patients respond to analgesics. Some of these have been well established, such as how differences in the expression of CYP450 enzymes in the liver can significantly affect the metabolism of certain opioids. Analgesics that require these enzymes for bioactivation — like codeine, for example — can be rendered useless if a person is genetically a poor metabolizer. Furthermore, genetic mutations that affect P-glycoprotein (a substance that transports opioid molecules across cell membranes) can influence analgesic potency or, in some cases, cause unexpected overdose as opioid serum levels rise. Another genetic influence on analgesia comes from the COMT gene, which makes enzymes that degrade catecholamine neurotransmitters like dopamine, epinephrine, and norepinephrine, and also affects mu-opioid receptor binding. Finally, it is suspected that polymorphisms of the mu-opioid receptor gene itself may significantly affect opioid response.

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March2010 – Pain Product Announcements & Warnings

Featured Items: tocilizumab (Actemra) approval; morphine sulfate oral solution approval; pregabalin (Lyrica) oral solution approval.
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Tocilizumab (Actemra®) — FDA-Approved for Rheumatoid Arthritis
Genentech announced the January 2010 approval of Actemra, a once-monthly intravenous treatment for adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to tumor necrosis factor (TNF) antagonist therapies. Actemra — the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA — blocks the effects of the IL-6 immune system protein that is over-abundant in people with RA. The drug's approval was based on the results of 5 clinical trials of Actemra monotherapy or Actemra in combination with methotrexate or other disease-modifying antirheumatic drugs (DMARDs). All trials reported greater improvement in treated patients’ tender-joint symptoms when compared with those of patients taking placebo. Since patients taking Actemra may have an increased risk for developing serious infections, practitioners are advised to assess each patient for infection risk and to order tuberculosis and blood tests before initiating treatment. To learn more, see the FDA press release, prescribing information, and the Actemra Medication Guide.

Morphine Sulfate Oral Solution — Roxane Receives FDA Approval
The FDA awarded a January 2010 approval of morphine sulfate oral solution to Roxane Laboratories. The company submitted a new drug application following the FDA's unapproved drugs initiative in 2009 and this product is now the only FDA-approved morphine sulfate oral solution currently available at the select concentrations. Morphine oral solution is intended for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. It is now available in three concentrations: 10 mg per 5 mL, 20 mg per 5 mL, and 100 mg per 5 mL. To improve safety, all packaging will be modified to reflect different product strengths. For additional safety information, see the Medication Guide for this product.

Pregabalin (Lyrica®) Oral Solution — Receives FDA Approval
Pfizer received a January 2010 approval of its new oral solution (20 mg/mL) formulation of Lyrica, a drug indicated for the treatment of diabetic peripheral neuropathic pain, post herpetic neuralgia, fibromyalgia, and certain types of seizures. The solution is good for 45 days after opening when stored at room temperature. Lyrica capsules are also available in 8 strengths. To learn more about administration and safety, read the Medication Guide and prescribing information.