Rx Monitoring Doesn’t Stem Opioid Overdose Deaths

Prescription drug overdoses and fatalities, largely involving opioid analgesics, have been called an American epidemic. One measure expected to stem the problems of opioid misuse, abuse, diversion, overdose, and death has been the Prescription Drug Monitoring Program, or PDMP. While PDMPs have been implemented in the U.S. by a majority of states during the past decade, a new research report from the CDC raises significant questions about their effectiveness.

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Botox Ineffective for Chronic Migraine?

As announced in a Pain-Topics UPDATE [here] last November 2010, Allergan Inc. received FDA approval for Botox® (onabotulinumtoxinA) as preventative therapy for chronic migraine, and the drug also was licensed for this indication in the UK. However, a new report in Drug and Therapeutics Bulletin — or DTB, a publication of the British Medical Journal Group — suggests that the published evidence for Botox's effectiveness as a treatment for chronic migraine is limited and unconvincing [abstract here].

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“Murses” Burden Men’s Backs, Causing Brutal Pain

Sporting a weighty male version of a purse — colloquially called a “murse” — may be a growing fashion fad for gents but it can cause poor posture and serious back and shoulder pain, according to the British Chiropractic Association (BCA). Their report would seem almost humorous were it not for the fact that 3 in 5 men are toting a bag of some sort these days and two-thirds of men suffer from pain that may be due at least in part to their man-bags.

Trendsetters such as soccer star David Beckham, rapper Jay-Z, and popular actors Brad Pitt, Robert Downey Jr, and Hugh Jackman have all been spotted carrying the functional fashion accessory that the BCA claims can be brutal for backs. According to the BCA report [PDF here] a man-bag in its various guises — from traditional over the shoulder laptop cases, to messenger bags and satchels — should be used with caution.

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Should State Laws Dictate Pain-Care Practices?

Alarmed and frustrated by escalating opioid analgesic misuse, abuse, diversion, and overdose, elected officials in certain U.S. states seem determined to take matters into their own hands — even if it means venturing into and shaping medical practice. While the opioid-related problems appear to be real, and the intentions of legislators are sincere, the possible unintended consequences seem clear; a great many patients may suffer due to decreased access to appropriate care and medications for their chronic pain conditions.

Actions of individual state legislatures may supplement or, in some cases, preempt guidelines and regulations coming from federal agencies, such as the FDA, and national medical organizations. The result could be that elected officials will be dictating medical practices and healthcare providers will need to consult their state’s laws before selecting treatment for their patients with pain; whether or not it is the best care for the particular patient may become a secondary concern. Recent reports of initiatives in West Virginia and Washington State may be harbingers of what lies ahead.

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Role of Age in Origin of Chronic Low Back Pain

New data suggest that intervertebral lumbar disc disruptions are the most common cause of chronic low back pain in younger adults; whereas, facet or sacroiliac joints are the more likely sources of pain as people age. At the same time, spinal stenosis is a common cause of lower back pain in older adults, and the use of more complex and costly surgeries to correct this problem is surprisingly increasing dramatically.

Researchers at Virginia Commonwealth University conducted a retrospective chart review to estimate the association of prevalence and age of several painful lower back conditions: lumbar internal intervertebral disc disruption, lumbar facet joint pain, sacroiliac joint pain, spinal and pelvic insufficiency fractures, interspinous ligament injury/Baastrup's Disease, and soft tissue irritation due to spinal-fusion hardware [DePalma et al. 2011]. A total of 170 cases from 156 patients who underwent a number of diagnostic procedures to determine the source of chronic low back pain were included in the final analysis.

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Arthritis Due to Lyme Disease Often Overlooked

Lyme disease is the most common tick-borne disease in the United States and Europe, according to a recent review, but it can be difficult to distinguish from other disease processes in acute and late stages. Lyme-related arthritis is a common clinical manifestation of untreated Lyme disease and should be considered in patients with pain in only one or a few joints, and who have been exposed to geographic areas where Lyme disease is endemic — yet, this diagnosis is often overlooked.

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Alarming New Evidence About Painful Shingles-PHN

Conventional medical wisdom about shingles, or herpes zoster, has been that it is a one-time occurrence and, thereafter, patients are protected from re-emergence of the varicella zoster virus that causes shingles. However, according to new evidence published in the February edition of Mayo Clinic Proceedings, recurrences of shingles may be more common than previously suspected. At the same time, other research reports that, while herpes zoster vaccine can be effective in reducing first time occurrences of shingles, relatively few persons at risk bother to get vaccinated.

Shingles is estimated to afflict 1 in 3 people during their lifetime, resulting in an estimated 1 million new episodes in the United States each year. It can occur at any age, but the greatest incidence and morbidity is seen in older adults — up to about 70% of cases are in those aged 50 years and older — and in immunocompromised patients. Postherpetic neuralgia (PHN), defined as pain persisting more than 3 months beyond healing of the typical shingles rash, is painful, debilitating, and often difficult to manage [Eastern 2010; Sampathkumar et al. 2009].

A research team from the Olmsted Medical Center, Rochester, MN, examined a medical records database, spanning 1996 to 2001, of nearly 1,700 immunocompetent patients >22 years of age who had a documented episode of shingles [Yawn et al. 2011]. They then searched followup medical records to determine if those patients had been treated for a second occurrence at any point in time. With an average followup of 8 years, the data revealed an estimated recurrence rate of 6.2%, or about the same rate at which persons of the same age would be expected to develop a first case of shingles. Some patients had experienced as many as 3 recurrences during the followup period, and the authors suspected that if all patients could be followed throughout their lifetimes the recurrence rate would be much higher.

The researchers, writing in the February 2011 edition of Mayo Clinic Proceedings, note that women and anyone ≥50 years of age were more likely to experience a recurrence of the disease. Another significant determinant for recurrence was patients' pain during the initial episode; those who had experienced pain lasting more than 30 days after onset of shingles were more likely to have a recurrence, particularly in the first 3 to 4 years after the initial episode. As might be expected, persons who developed compromised immune systems, such as from chemotherapy or medical conditions, were more likely to have shingles recurrences.

In sum, cases of shingles in immunocompetent individuals not only recur, but at rates much higher than might be expected. It also might be suspected that repeat occurrences increase the odds of developing painful PHN. All of this suggests that preventative vaccination against initial outbreaks of shingles could be worthwhile.

Accordingly, a report in the online February 5, 2011 edition of JAMA by researchers from the Kaiser Permanente Department of Research and Evaluation in Pasadena, California, notes that administration of the herpes zoster vaccine was linked to a 55% reduction in risk of developing shingles [Tseng et al. 2011]. Their retrospective cohort study, spanning 2 years and involving 300,000 immunocompetent patients ≥60 years of age, suggests that vaccinating all eligible people could prevent tens of thousands of cases of shingles each year in the U.S.

Using electronic health records, Tseng and colleagues compared the incidence of shingles among a diverse population of 75,761 vaccinated and 227,283 unvaccinated men and women. The participants were community-dwelling, had healthy immune systems, and those who were vaccinated had received their vaccine in a general practice setting. The results showed a significant reduced risk of shingles across all subgroups, including healthy patients and those with chronic conditions such as diabetes, heart, lung, or kidney diseases.

In a third recent report, appearing in the February 2011 edition of American Journal of Preventive Medicine researchers note that, although a herpes zoster vaccine to prevent shingles has been available since 2006, quite small percentages of eligible U.S. seniors ≥60 years of age chose to receive the vaccination as of 2008 [Liu et al. 2011]. The rate of vaccination was much lower among people aged 60-64 years (4.7%) compared with ages 65-67 (7.4%), 75-84 (7.6%), and ≥85 (8.2%).

Those more likely to have been vaccinated were older, female, non-Hispanic white, married, more educated, and also reporting influenza vaccination in the past year. Surprisingly, 95% of younger seniors had missed at least one opportunity to be vaccinated, even though they had seen their physician at least once, been hospitalized, or visited an emergency department that year.

COMMENTARY: Earlier research had concluded that the herpes zoster vaccine reduces the incidence of shingles by 51%, the burden of illness from shingles by 61%, and the risk of developing PHN by 66% [ref. in Sampathkumar et al. 2009]. Therefore, the vaccine is not perfect, but the success rates are substantial with a number-needed-to-treat (NNT) of only 2 or less — that is, for every 2 persons vaccinated at least 1 new case of shingles will be prevented — and those who do develop shingles may have a milder case. Whether or not vaccination reduces the chances of shingles recurrence if given after an initial episode does not appear to have been studied.

The shingles vaccine is relatively expensive and, while most insurance and Medicare plans cover the vaccine cost, other costs might be out-of-pocket. This could be burdensome for some patients, especially for those without adequate insurance. Still, the costs and suffering related to treating shingles and the possibility of developing chronically painful PHN might outweigh the expense and/or any inconvenience associated with vaccination.

ADDENDUM: Zoster (Shingles) Vaccine (Zostavax®) — FDA Lowers Age Approval
In late March 2011, the U.S. Food and Drug Administration and Merck announced an expansion of the approved age of 60 years and older for Zostavax administration in the prevention of herpes zoster — commonly referred to as shingles. The added approval for adults 50 to 59 years of age was based on the results of a large clinical trial that showed a 70% reduction in the risk of vaccinated persons developing shingles when compared with those receiving placebo. For more information, read the FDA Press Release

REFERENCES:
> Eastern JS. Herpes Zoster. WebMD eMedicine [online]. 2010(Oct) [article here].
> Liu P-j, Euler GL, Harpaz R. Herpes zoster vaccination among adults aged 60 years and over, in the U.S., 2008. Am J Prev Med. 2011(Feb);40(2):e1-e6 [abstract here]
> Sampathkumar P, Drage LA, Martin DP. Herpes Zoster (Shingles) and Postherpetic Neuralgia. Mayo Clin Proc. 2009;84(3):274-280 [article here].
> Tseng HF, Smith N, Harpaz R, et al. Herpes Zoster Vaccine in Older Adults and the Risk of Subsequent Herpes Zoster Disease. JAMA. 2011(Jan);305(2):160-166 [abstract here].
> Yawn BP, Wollan PC, Kurland MJ, et al. Herpes Zoster Recurrences More Frequent Than Previously Reported. Mayo Clin Proc. 2011(Feb);86(2):88-93 [abstract here].

Combination Drug Therapy for Pain: A Conundrum

Modern pharmacotherapies for pain often combine multiple drugs for added beneficial effects; however, there also can be unfavorable consequences of such therapy. According to a new critical review, clinical evidence supporting multidrug therapies is sparse, which may pose a challenging dilemma, or conundrum, for prescribers.

In the February 2011 edition of the Journal of Pain Jianren Mao, from Harvard Medical School, and colleagues observe that managing debilitating chronic pain can be a daunting responsibility for general healthcare providers and specialists — including neurologists, rheumatologists, oncologists, gynecologists, and pain practitioners [Mao et al. 2011]. As a vital part of multidisciplinary approaches, medications are often prescribed in combinations, which they refer to as “combination drug therapy (CDT).”

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Gua Sha Therapy for Reducing Chronic Neck Pain?

Researchers in Germany conducted a first-of-its-kind randomized, controlled trial of the traditional East Asian healing technique Gua sha in patients with chronic neck pain. While favorable pain-relief results were observed, there are questions about whether healthcare providers should recommend this therapy for their patients.

During Gua sha — sometimes referred to as “spooning” or “coining” — a lubricated section of the body surface is pressure-stroked with a smooth-edged instrument to intentionally raise a millet-like skin rash, or petechiae, representing extravasation of blood in subcutaneous layers. Gua sha (pronounced ‘gwa shah’) may be loosely translated from Chinese to mean “scraping away disease by allowing it to escape as sandy-looking objects through the skin.” Shortly after the scraping, petechiae become ecchymotic (reddish or purplish) patches or streaks that fade away during a period of several days. It also might be noted in passing that there are some similarities of Gua sha with traditional “cupping therapy,” which also involves that application of treatment to the body surface causing transitory petechiae.

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Back, Neck Pain Still Plague Computer Workers

Research in the pain management field appears to have largely overlooked a common cause of strain and pain incurring musculoskeletal disorders — working at computers. Ergonomic remedies have long been available but are rarely, if ever, discussed in the pain literature. Perhaps, now is a good time for renewed awareness of these problems and their solutions; especially since healthcare providers, themselves, are plagued by the problems.

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The Interpersonal Side of Pain: Emotions Reign!

Emotional support can be an important component of a successful treatment plan for any chronic pain condition. Conversely, a lack of support or the wrong kind of emotional support might drive increased physical pain and disability, and the underlying psychosocial dynamics at work may not be readily apparent to practitioners. Many healthcare providers may consider the interpersonal, emotion-laden relationships affecting their patients to be outside their purview of practice, even though overlooking or disregarding these influences might thwart effective pain management.

The scientific literature from disciplines such as psychiatry, psychology, and sociology discusses at length how interpersonal relationships may affect a person’s pain perception, physical disability, and emotional adjustment. While the research has raised many important questions, few definitive answers have evolved; still, this is a vital, albeit complex, area for pain practitioners to be aware of and to contemplate in everyday practice. Following, is a sampling of recently-published studies that highlight the relevance of these issues.

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Does Liberal Opioid Dosing Spur Misuse or Abuse?

It is often assumed that, as opioid analgesic dosing levels are increased, there may be directly-associated risks of medication misuse and abuse. Evidence from a recent, long-term study suggests this is not the case even among patients at high risk for such problems. However, these results are tentative, since this study is an example of well-intended research hampered and flawed by insurmountable limitations.

Writing in the February 2011 edition of the Journal of Pain researchers from the David Geffen School of Medicine at UCLA, Los Angeles, investigated the effectiveness of a conservative, hold-the-line (Stable Dose) opioid analgesic prescribing strategy compared with a more liberal dose titration approach (Escalating Dose) [Naliboff et al. 2011]. Using a prospective, parallel-group, randomized design, this clinical trial followed 135 patients for 12 months after referral to a specialty pain clinic at a local Veterans Affairs (VA) Healthcare System hospital.

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Feb2011 – Pain Product Announcements & Warnings

Featured Items: fentanyl sublingual tablets (Abstral) approval; gabapentin (Gralise) approval for post-herpetic neuralgia; acetaminophen 325 mg safety limit; morphine sulfate oral solution safety alert; tocilizumab (Actemra) extended approval; buprenorphine (Butrans) now available. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Fentanyl Sublingual Tablets (Abstral™) — FDA Approved
Orexo AB and ProStrakan Group received a January 2011 U.S. Food and Drug Administration approval for Abstral, a transmucosal tablet designed to manage breakthrough pain for adult patients already receiving opioid analgesics for cancer pain. The immediate-release sublingual tablet is a rapidly disintegrating form of fentanyl citrate administered through the soft tissue of the gums, tongue, or inside of the cheek.

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