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.

REFERENCE: 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].

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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