An Overview of Conservative Treatment for Lower Back Pain

From International Journal of Clinical Rheumatology

Federico Balagué; Jean Dudler

Abstract and Introduction

Abstract

This article summarizes the available evidence on the management of patients with subacute or chronic low back pain. The largest part is devoted to nonspecific low back pain but the models of spinal stenosis and disk herniation/sciatica are also specifically addressed. The authors point out the limited evidence available and the importance of a tailored approach for the individual patient. As the effect sizes of most therapies are rather small (close to that of a placebo), patients' preferences and other variables important for individualized management are highlighted. The task for the practitioner is difficult and awareness of this is important. Some speculation regarding potential future ways of improving patient care are presented.

Introduction

Low back pain (LBP) remains the most frequent musculoskeletal complaint worldwide and all age groups are affected by these symptoms. They are classically stratified into acute, subacute and chronic, with respective cut-offs of <6 weeks, 6–12 weeks and >12 weeks.
By itself, it produces direct and indirect costs of hundreds of billions of dollars for the US alone. Recent studies in adults and elderly populations have shown a significant increase in LBP, both in numbers and costs, in terms of investigations, treatments and disability, an observation at least partially explained by a raise in prevalence.
However, the large differences in the rate of spinal surgical procedures observed between states within the US, as well as between countries worldwide, suggest that decision-making is certainly influenced by regulations and other sociopolitical factors.
As LBP is extremely prevalent, the main problem remains the chronic cases, in particular in term of investigations and costs. Acute episodes of LBP statistically have quite a good prognosis more or less independently of the chosen treatment. A recent review confirms that a variety of treatments of acute LBP are effective and supported by the literature. Moreover, there are excellent updated reviews on the management of acute pain not limited to but including LBP. The interested reader can download this electronically.
If until recently a figure of 8–10% was usually accepted as the number of acute LBP episodes evolving into chronic cases, recent studies have show much more ominous figures with frequent relapses and persistence of symptoms at 1 year in up to 10–30% of cases according to definitions used. On the other hand, more than a third of the patients with LBP for more than 3 months do recover within 12 months.

Defining if a patient is going to become chronic or establishing an individual prognosis based on epidemiological studies is a very difficult task. Certainly, a precise diagnosis would help. However, it is commonly accepted that a specific identifiable etiology is only found in around 15% of cases, including disk herniations, spinal stenosis, osteoporotic fractures, inflammatory diseases and the infrequent (approximately 1%) specific neoplastic or infectious destructive lesions. The largest part of this manuscript is devoted to the 85% of patients asking for medical attention and suffering from chronic LBP without any of those specific identifiable etiologies, the so-called nonspecific (NS) LBP. Furthermore, we included spinal stenosis and lumbar disc herniation in the discussion in regard to their frequency in daily practice.
It has been shown already in adolescent populations that psychosocial factors are stronger predictors of incident LBP than mechanical factors. In adult populations, psychosocial factors are risk factors for chronicity much more strongly related to outcome than any clinical or mechanical variables, while previous episodes of pain are strong predictors of future ones. Twin's cohort studies have shown that NS-LBP is >40% genetically determined, whilst work, leisure time and physical activities play a minor role.
If the natural history of acute episodes of LBP is favorable independently of the chosen treatment, our daily concern remains chronic LBP and we have focused this review on the management of chronic and subacute LBP cases.
Finally, there is an overwhelming amount of literature on the subject, as well as numerous guidelines and recommendations. This short overview is based, for practical reasons, on the latest guideline we were aware of,  an English study with several major strengths, such as including among their criteria for implementation the likelihood of impact on patients' outcome and efficient use of NHS resources, completed with relevant randomized controlled trials (RCT) or meta-analysis published more recently.

Management of LBP

All of us, including patients, would prefer to prevent rather than to treat. Primary prevention would ideally prevent the occurrence of LBP, while secondary preventive measures are aimed at preventing the recurrence of acute LBP episodes with their risk of chronification, which is the most relevant problem.

Primary Prevention

During the last few decades it has been shown that adolescents report NS spine pains with a frequency close to that of their adult counterparts. These figures indirectly preclude any major efficacy of primary prevention techniques and suggest that any preventive measures should be implemented very early in an individual's life to have any chance to prevent the occurrence of LBP.
Nevertheless, numerous interventions have been tested over the years, and the evidence available for primary prevention of back problems have been recently reviewed.
Only exercise interventions, without any specificity of type, have shown effectiveness using the highest quality criteria, with an effect size (ES) ranging from 0.39 to >0.69 (ES computation: ES = [mean1 - mean2]/[pooled SD]; with ES interpretation: <0.15 = negligible effect; >0.15 and <0.40 = small effect; >0.40 and <0.75 = medium effect; and >0.75 = large effect). Other techniques such as stress management, shoe inserts, back supports, ergonomic/back education and reduced lifting programs have not been found to be effective.

Secondary Prevention

As stated before, an acute episode of LBP has an intrinsically good prognosis more or less independent of the chosen treatment. A variety of treatments are efficient for the acute episode, but the question is if any early intervention in this setting could or would prevent the ominous chronification and persistence of the problem in a significant percentage of patients. Up to 30% of cases will evolve badly, but there is no specific validated therapy of an isolated acute phase that would prevent this evolution and work in secondary prevention of chronic NS-LBP, except the physical exercises previously recommended as primary prevention.

Conservative Treatment of Chronic NS-LBP

As no preventive measure has sufficient power to prevent chronic NS-LBP, we are left with managing the problem when it arises, which can be done with an array of approaches, from conservative therapy to surgical intervention. In 2009, Rainville et al. reported on the evidence on conservative treatments for chronic LBP looking at the nonsurgical arm of several RCTs comparing surgical and conservative management. Clearly, surgery primarily focused on the alteration of structures perceived to be the sources of pain whilst conservative management aims to improve patients' function, with or without simultaneous improvement of pain.
The poor results obtained in terms of public health are not due to a lack of therapeutic possibilities. In an amazing paper, Haldemann reported that nonexhaustive research identified more than 200 treatments for LBP. In fact, while lack of treatments is not a problem, overtreatment could be a more worrisome problem, and opinion leaders have even suggested that clinicians back off.
Finally, lack of a really efficient and universal therapy remains a problem. A review of the magnitude of the effect of different treatments in acute and chronic LBP shows that the average effects of treatments for NS-LBP are not much greater than those of placebos. For example, NSAIDs and muscle relaxants reduce the intensity of pain by less than 20 points on a 100-point scale both for acute and chronic LBP patients. The very few therapies that have demonstrated larger effect sizes (>30 on a 0–100 pain scale) have only been evaluated in single small studies, and not been reproduced in any larger cohort.
The overwhelming number of available guidelines and recommendations reflects the difficulty of managing a common problem in the absence of any universal efficient treatment. We chose to highlight and comment on the latest UK guidelines for NS-LBP between 6 weeks and 12 months duration, which have the advantage of not only summarizing the main recommendations for patients in seven headings (reused as subheadings below), but also to clearly define therapeutic modalities that should not be prescribed despite the urge to be proactive in front of a suffering patient.

Information, Education & Patient Preferences

Promoting self-management and encouraging physically activity certainly make sense and should be reasonably cheap. The question is how much resource should be invested in this direction. The limits of education and self-management have recently been highlighted for osteoarthritis, and the same caveat certainly applies for LBP.
Along the same lines, offering booklets and stand-alone formal education programs could appear appealing, as they are widely available. However, there is no scientific evidence, and it seems essential to take into account the person's expectations and preferences before using such programs.

Physical Activity & Exercise

Again, advising people with LBP to stay physically active is likely to be beneficial, and advising to exercise is adequate. Nevertheless, advising is only part of the problem. There are often a lot of concerns from practitioners to know which type of exercise program should be ideally prescribed, but most types of exercise will be appropriate, including aerobic activity, movement instruction, muscle strengthening, postural control or stretching. The real trick is actually to motivate the patient to exercise, and a structured group exercise program is the recommended first step. A one-to-one supervised exercise program may be offered if a group program appears unsuitable for a particular person, and is certainly more adequate than leaving the patient to exercise on their own, regardless of their good resolutions.
Van Midelkoop et al. have recently summarized the evidence for exercises. "Exercise therapy seems to be effective for the prevention of LBP, but only a few recent trials have been conducted. This therapy is not effective for acute LBP, whereas it is effective for chronic LBP; however, there is no evidence that any type of exercise is clearly more effective than others. Subgroups of patients with LBP might respond differently to various types of exercise therapy, but it is still unclear which patients benefit most from what type of exercise. Adherence to exercise prescription is usually poor, so supervision by a therapist is recommended. If home exercises are prescribed, strategies to improve adherence should be used. Patient's preferences and expectations should be considered when deciding which type of exercise to choose". In other words, one can prescribe exercise therapy without the fear of not being a specialist as there is no clear cut benefits for one type to the other, or rather we are still unable to precise who is going to benefit from exercises. Again, the most important and hardest part is getting the patients' adherence to the program; matching the patients' expectations and preferences should help.

Manual Therapy

The UK guideline proposes to consider offering a course of manual therapy, including spinal manipulation. However, not all patients feel comfortable with this type of approach, and, again, patient's expectation and preferences clearly dictate the use of such therapy.

Other Nonpharmacological Therapies

We can only agree with the guideline's authors in their strong recommendation not to offer any of the multiple therapies with no scientific support, including laser therapy, interferential therapy, therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), traction or lumbar supports.

Invasive Procedures

Injections and denervations are other fashionable procedures that have gained large acceptance in some countries. However, a systematic review on injection therapy and denervation procedures for chronic LBP has recently concluded that the evidence supporting these two categories of therapies over placebo is "low to very low quality". The authors highlight that it cannot be ruled out that in carefully selected patients some injection therapy or denervation procedures may be of some benefit; however, it remains equally false to push those procedures for the majority of patients and the British guidelines recommend not to offer injections of therapeutic substances into the back for NS-LBP.
Acupuncture is a special case that could be considered for a limited number of sessions, and is probably more beneficial if it matches the patient preferences.

Combined Physical & Psychological Treatment Program

Combined physical and psychological treatments (including cognitive behavioral approach and exercise) have been shown to be efficient. However, to demonstrate benefits they must be quite substantial, comprising around 100 h over a maximum of 8 weeks. Availability of such programs and of the patient are limiting factors, but cost issues remain the main limitation and such programs should be reserved for patients with high disability and/or significant psychological distress and who have failed at least one less intensive treatment program.
Group cognitive behavioral treatment has been shown to have a statistically significant effect (over 1 year) at much lower cost on troublesome subacute and chronic LBP in primary care, with effect sizes ranging from 0.1 for SF-12 mental to 0.5 for SF-12 physical and fear-avoidance beliefs. However, the benefits appear limited and are also clearly dependent on local availability of such programs.

Pharmacological Therapies

As in all pain-related guidelines, regular paracetamol is the first recommended medication option. However, paracetamol is not free of side effects when taken regularly at a recommended dose. NSAIDs and/or weak opioids are the next step, again despite the fact that their benefits are far from being established.
NSAIDs are also far from being side effect free, particularly in the elderly. It is important to take into account the individual risk, and in particular the gastrointestinal risk, and either a standard NSAID coprescribed with a proton pump inhibitor (PPI) or a COX-2 inhibitor is recommended. Again, the patient's profile, preferences and expectations should not be forgotten. Aspirin cancels the benefits of COX-2 inhibitors, while more than 25% of the patients never start their PPI cotherapy. In other words, we often take considerable risk for a therapy with limited evidence for efficacy.
If ineffective, recommendations consider offering tricyclic antidepressants for pain relief. However, these are not more efficient than the other analgesics discussed above. Selective serotonin reuptake inhibitors (SSRIs) are usually not proposed for treating pain, but a recent RCT on the efficacy of duloxetine in patients with non-neuropathic chronic LBP has shown a significant reduction in pain and improved function compared with placebo.
Finally, one can consider offering strong opioids for short-term use to people in severe pain. Referral for specialist assessment may be required for prolonged use of strong opioids given the risk of opioid dependency and side effects. There is also increasing concern about the utilization of opioids for chronic noncancer pain management.The adverse effects  and the utilization of these drugs in rheumatology have recently been reviewed. A recent Cochrane review, including, among others, seven studies on LBP patients, highlights the limits of the tolerance and efficacy of these drugs. While opioids are an alternative, they are not magical pills that will solve the problem of pain management in LBP.
If no treatment is universally and totally efficient, it certainly appears rational to combine different interventions, a commonly used practice for some LBP healthcare providers. A recent Cochrane review on combined chiropractic interventions reported that combined interventions slightly improved pain and disability in the short term and pain in the medium term, but only for acute and subacute LBP. No difference was demonstrated for chronic LBP and for studies including a mixed population of LBP. Even if combining several treatments improves the results, that approach is not always cost effective, as recently shown by Smeets et al. 
There is an urge to be proactive and we often use and abuse unproven therapeutics. However, we should at least base our decisions to continue such treatments on the individual response.

Conclusion

The societal burden of LBP keeps increasing despite, or perhaps because of, the ever increasing number of diagnostic and therapeutic procedures performed for this very common ailment. Happily, the natural history of acute episodes of LBP remains favorable in most cases, independently of the chosen treatment. Subacute and chronic cases represent the real challenge and our daily concern.
We are still unable to adequately identify the patients at high risk of becoming chronic, nor has any universal measure been demonstrated useful for primary or secondary prevention. Furthermore, overtreating patients with NS-LBP is probably more deleterious than beneficial and we should probably restrain from being overenthusiastic at using one of the hundreds of treatments described for the management of NS-LBP at the first sign of LBP.
Finally, the risk of potential side effects should also be weighted in the balance, as well as the individual patient's preferences taken into account, before starting any therapy. We should ensure that we have identified the reasons why the patient is sitting in front of us, bearing in mind that among individuals reporting LBP, "consulters" and "nonconsulters" cannot be distinguished in terms of pain intensity.We still misunderstand too often the motivation and/or expectations of the individual patient, a problem coupled with the limited knowledge of the psychological profile, patient preferences, CNS participation, and so on, based on the meager time available for a clinical appointment.
There is limited evidence for a majority of treatments in chronic LBP, and effect sizes are usually moderate for the few statistically significantly effective forms of treatment. We are also faced with difficulties in interpreting the evidence, as review articles may end up with significantly different conclusions based on the same literature,  and the difficulties in using evidence in clinical practice have been recently highlighted. However, the individual response cannot always be inferred from the limited evidence available, and patients should still be managed despite the absence of universally efficient treatment. We apply the same treatments with their limited evidence and small effect sizes to all chronic LBP patients. More precise diagnosis and subgrouping of NS-LBP for the purposes of treatment might improve the efficacy of therapies; however, a recent review of the topic has concluded: "At this point, the bulk of research evidence in defining subgroups of patients with LBP is in the hypothesis generation stage; no classification system is supported by sufficient evidence to recommend implementation into clinical practice". Spinal stenosis and disk herniation with sciatica are good examples that our subgrouping is still too vague to be really useful.
We should promote exercise and self-management programs for osteoarthritis and back pain. Despite weak evidence for chronic back pain, exercise programs appear to represent the best way forward, and there is also moderate-quality evidence that post-treatment exercise programs can prevent recurrences of back pain.
While patients' self-management and the promotion and encouragement of the maintenance of daily physical activities can, and certainly should, be encouraged in all patients at no risk and no cost, there are a multiplicity of treatments where the risk/cost– benefit ratio is not so clear.
Even simple measures such as the prescription of analgesics or NSAIDS should be monitored by means of validated tools in order to evaluate the outcome. In the absence of clear and established benefits for any therapy, it is essential that any prescribed treatment is evaluated and monitored at the individual level. More difficult with the urge to be proactive in front of a suffering patient, it is mandatory, particularly in a time of limited healthcare resources, to refrain from using all those therapies and procedures where clear lack of benefits has been demonstrated.
It is possible that some of those therapies remain valid for some individual patients or well-defined subgroups of LBP. However, so far we have been unable to identify and characterize such subgroup well enough to be applicable at the individual level. The concept of personalized and individualized healthcare should not be used to promote the use of inadequate therapies, whose evaluation in such settings should be clearly limited to well-designed trials.
More than anything, we should try to demedicalize LBP and promote self-management as much as possible. Promoting exercises with methods that do not require any contacts with healthcare providers, like walking, may be effective for the treatment of LBP (low-to-moderate evidence in a recent review), and as recently writen by Weiner and Nordin, "a large proportion of patients seeking care can manage their short term and even longer term incapacity".
It has been shown that acceptance of pain is significantly associated with quality of life.^[62] We still do not know to what extend this variable can be influenced by the healthcare providers, but it is all too easy to lure patients into hopes that specific diagnosis and miracle treatments are available.

New Infection Prevention Guidance for Outpatient Settings

Melissa Schaefer, MD

From CDC Expert Commentary

Hello, I'm Dr. Melissa Schaefer, medical officer in the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention. I'm pleased to speak with you today as part of the CDC Expert Video Commentary Series on Medscape about a new Infection Prevention Guide for Outpatient Settings just released by the CDC.
Over the last several decades, we have focused our attention on preventing infections in acute care settings and have seen tremendous successes. However, as healthcare continues to transition to settings outside the hospital, we need to extend our efforts and successes to all settings where patients are receiving care. CDC's new Infection Prevention Guide for Outpatient Settings distills existing evidence-based recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee. The recommendations included in this guide represent the minimum expectations for safe care, both for patients and healthcare personnel, in every outpatient setting.
As a clinician myself, I have helped investigate numerous outbreaks in outpatient settings and am concerned that these likely represent the tip of the iceberg with respect to bad practices happening in our healthcare system. For example, as part of an outbreak investigation at an endoscopy clinic in Nevada, providers were noted to reuse syringes to enter vials of propofol to obtain additional doses during a procedure. This practice contaminated the contents of the vials and those single-dose vials, which should have been discarded at the end of the procedures, were then used for subsequent patients. This unsafe practice led to transmission of hepatitis C virus to at least 7 patients on 2 separate days and more than 40,000 patients were notified that they may have been exposed to a blood-borne virus. Events like this continue to surface and cause us great concern at CDC. No patient should be subjected to these kinds of risks, which are completely preventable through adherence to standard precautions.
Although the recommendations contained in this guidance are not new, it provides a clear, concise, evidence-based resource designed specifically for infection prevention in outpatient settings. This new, 16 page document outlines the key policies, procedures, and practices that outpatient settings should have in place in order to deliver safe care.
Recommendations highlighted in the guidance focus on key components of standard precautions, including the following:

1. Good hand hygiene, including use of alcohol-based hand rubs and hand washing with soap and water, is critical to reduce the risk of spreading infections in outpatient settings.
2. Safe injection practices must always be followed. Healthcare personnel should use aseptic techniques when preparing and administering medications, and syringes and needles should not be reused either from patient to patient or to reenter medication vials.
3. Establish and follow procedures for the safe handling of potentially contaminated medical equipment. Reusable medical equipment should be cleaned and reprocessed appropriately prior to use on another patient, and equipment that is labeled for "single patient use" should be appropriately discarded after use.

Healthcare should provide no avenue for the transmission of potentially life-threatening infections. As healthcare professionals, we must recognize our responsibility to implement safe care practices. By working together, we can ensure that safe practices are understood and followed by all. We urge you to use this guidance document to assess the practices in your facility to ensure that patients are receiving the safe care that they expect and deserve.
To review the complete Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care follow the link or see the resources on this page.

New Guidelines Issued for Insomnia and Other Sleep Disorders

From Medscape Medical News
Laurie Barclay, MD

September 2, 2010 — The British Association for Psychopharmacology (BAP) has issued a consensus statement on evidence-based treatment of insomnia, parasomnias, and circadian rhythm disorders. The new recommendations, intended to guide psychiatrists and physicians caring for those with sleep problems, are published online September 2 in the Journal of Psychopharmacology.

"Sleep disorders are common in the general population and even more so in clinical practice, yet are relatively poorly understood by doctors and other health care practitioners," write Sue J. Wilson, from the Psychopharmacology Unit, University of Bristol, Bristol, United Kingdom, and colleagues.
"These ...BAP guidelines are designed to address this problem by providing an accessible yet up-to-date and evidence-based outline of the major issues, especially those relating to reliable diagnosis and appropriate treatment.
We limited ourselves to discussion of sleep problems that are not regarded as being secondary to respiratory problems (e.g. sleep apnoea – see NICE Guidance TA139), as these fall outside the remit of the BAP."

These guidelines also do not cover neuropsychiatric disorders, such as narcolepsy and restless legs, for which recent sets of guidelines already exist. The new recommendations were developed after a consensus meeting in London in May 2009 of BAP members, as well as clinicians, experts, and advocates in sleep disorders, based on literature reviews and a description of standard of evidence.

Recommendations for Diagnosis and Treatment

Specific evidence-based recommendations for diagnosis and treatment of insomnia and other sleep disorders, and their accompanying level of evidence rating, are as follows:

The diagnosis of insomnia is primarily based on complaints provided in the clinical interview by the patient, family, and/or caregiver, ideally corroborated by a patient diary.
Referral to a specialist sleep center may be indicated for other tests in some cases, such as actigraphy for differential diagnosis of circadian rhythm disorder, polysomnography for suspected parasomnia or other primary sleep disorder, or in the case of treatment failure.
Insomnia should be treated because it impairs quality of life and many areas of functioning and is associated with an increased risk for depression, anxiety, and possibly cardiovascular disorders. Treatment goals are to reduce distress and to improve daytime function. Choice of treatment modality is based on the particular pattern of problem, such as sleep-onset insomnia or sleep maintenance, as well as on the evidence supporting use of specific treatments.
For chronic insomnia, cognitive behavioral therapy (CBT)-based treatment packages are effective and should be offered to patients as a first-line treatment. CBT, which may include sleep restriction and stimulus control, should be made available in more settings.
When prescribing hypnotic drug treatment, clinicians need to consider efficacy, safety, and duration of action. Other issues to consider may include previous efficacy or adverse effects of the drug and history of substance abuse or dependence.
Recommendations for long-term hypnotic drug treatment are to use it as clinically indicated. To discontinue long-term hypnotic drug therapy, intermittent use should first be attempted if feasible. Depending on ongoing life circumstances and patient consent, discontinuation should be attempted every 3 to 6 months or at regular intervals. During taper of long-term hypnotic drug treatment, CBT improves outcome.
When using antidepressants, clinicians should apply their knowledge of pharmacology. When there is a comorbid mood disorder, antidepressants should be used at therapeutic dose. However, clinicians should beware that overdose of tricyclic antidepressants can be toxic even when low-unit doses are prescribed.
Because of frequent adverse effects of antipsychotic drugs, as well as a few reports of abuse, there is no indication for use as first-line treatment of insomnia or other sleep disorders.
Antihistamines have a limited role in psychiatric and primary care practice for the management of insomnia.

Recommendations for Certain Populations

Specific evidence-based recommendations for management of insomnia and other sleep disorders in special populations and conditions are as follows:

After menopause, the incidence of sleep-disordered breathing increases, and the clinical presentation is different in women vs men and often includes insomnia. Informed, individualized treatment of symptoms is needed for use of hormone therapy, considering risks and benefits clarified in recent studies.

Behavioral strategies are recommended for children with disturbed sleep.
In children with attention-deficit/hyperactive disorder not treated with stimulant drugs, melatonin administration may help advance sleep onset to normal values.
For children and adults with learning disabilities, clinical evaluation should describe the sleep disturbance and triggering and exacerbating factors

Recommended first-line therapy includes environmental, behavioral, and educational strategies.
Melatonin is effective in improving sleep. The treatment plan should be based on a capacity/best-interests framework.
For management of circadian rhythm disorders, clinical evaluation is essential in delayed sleep-phase syndrome and free-running disorder.
In delayed sleep-phase syndrome, free-running disorder, and jet lag, melatonin may be useful, but other strategies such as behavioral regimens and scheduled light exposure (in sighted individuals) can also be used .

J Psychopharmacol. Published online September 2, 2010.

FDA Strengthens Warnings on Sleep Drugs

From Medscape Medical News > Medscape Alerts

Yael Waknine
Posted: 03/15/2007

March 15, 2007 — Manufacturers of 13 sedative-hypnotic drugs have been asked to strengthen safety label warnings regarding adverse events associated with their use, the US Food and Drug Administration (FDA) announced yesterday. The drugs are used in the treatment of insomnia.

The request, issued in December 2006, addresses the risk for engaging in activities while somnolent with no memory of having taken a pill, according to an alert sent Wednesday from MedWatch, the FDA's safety information and adverse event reporting program. Requested label changes also emphasize the risks for anaphylaxis and angioedema, which can occur the first time the drug is taken.

The FDA notes that sleep behaviors while taking these drugs can be complex and may include sleep-driving, making phone calls, and preparing/eating meals. Because of potential variations in risk levels, makers have also been advised to conduct clinical investigations to assess event incidence rates for each individual product.

Along with these label changes, the FDA also asked manufacturers to develop patient medication guides for distribution with each prescription. These easy-to-read pamphlets are intended to inform patients of the risks associated with therapy and that appropriate precautions that should be taken, such as avoiding alcohol and contacting their physician before discontinuing therapy.

Affected products include zolpidem tartrate tablets and extended-release tablets ( Ambien and Ambien CR , Sanofi-Aventis); butisol sodium (Medpointe Pharm HLC); pentobarbital/carbromal ( Carbitral , Parke-Davis); flurazepam HCl capsules ( Dalmane , Valeant Pharm); quazepam tablets ( Doral , Questcor Pharms); and triazolam tablets ( Halcion , Pfizer).

Also included are eszopiclone tablets ( Lunesta , Sepracor); ethchlorvynol capsules ( Placidyl , Abbott); estazolam ( Prosom , Abbott); temazepam capsules ( Restoril , Tyco Healthcare); ramelteon tablets ( Rozerem , Takeda); seconal sodium capsules (Ranbaxy); and zaleplon capsules ( Sonata , King Pharmaceuticals).

Adverse events potentially related to use of these sedative-hypnotic products should be reported to the manufacturer and to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Chronic NSAID Use Doubles CV Deaths in Elderly

From Heartwire

Lisa Nainggolan

July 14, 2011 (Gainesville, Florida)

Older patients with hypertension and coronary artery disease who use nonsteroidal anti-inflammatory drugs (NSAIDs) chronically for pain are at significantly increased risk of cardiovascular events, a new post hoc analysis from the International Verapamil-Trandolapril Study (INVEST) demonstrates. The research is published in the July 2011 issue of the American Journal of Medicine.

"We found a significant increase in adverse cardiovascular outcomes, primary driven by an increase in cardiovascular mortality," lead author Dr Anthony A Bavry (University of Florida, Gainesville) told heartwire . "This is not the first study to show there is potential harm with these agents, but I think it further solidifies that concern."

He says the observational study, conducted within the hypertension trial INVEST, is particularly relevant to everyday practice because the patients included were typical of those seen in internal-medicine, geriatric, and cardiology clinics--they were older, with hypertension and clinically stable CAD.

Bavry and colleagues were not able to differentiate between NSAIDs in the study--most people were taking ibuprofen, naproxen, or celecoxib--and he says until further work is done, he considers the risks of NSAIDs "a class effect," and their use should be avoided wherever possible.

I try to get them to switch to an alternative agent, such as acetaminophen.

However, "Patients should not terminate these medicines on their own," he says. "They should have a discussion with their physician. When I see patients like these taking NSAIDs I will have an informed discussion with them and tell them there is evidence that these agents may be associated with harm. I try to get them to switch to an alternative agent, such as acetaminophen, or if that's not possible I at least try to get them to reduce the dose of NSAID or the frequency of dosing. But ultimately, it's up to them if this potential risk is worth taking depending upon the indication for their use."
 
Chronic NSAID Use More Than Doubles CV Mortality
Within the large cohort of more than 22 000 patients in INVEST, Bavry and colleagues identified patients who reported taking NSAIDs at every follow-up visit and termed them chronic users (n=882).
Most often, patients were taking these agents for conditions such as rheumatoid arthritis, osteoarthritis, and lower back pain, Bavry said.
They compared the chronic NSAID users with those who only intermittently (n=7286) or never (n=14 408) used NSAIDs over an average of 2.7 years and adjusted the findings for potential confounders.

The primary outcome--a composite of all-cause death, nonfatal MI, or nonfatal stroke--occurred at a rate of 4.4 events per 100 patient-years in the chronic-NSAID group vs 3.7 events per 100 patient-years in the nonchronic group (adjusted hazard ratio 1.47; p=0.0003).

As noted by Bavry, the end point was primarily driven by a more than doubling in the risk of death from CV causes in the chronic-NSAID group compared with never or infrequent users (adjusted HR 2.26; p<0.0001).
The association did not appear to be due to elevated blood pressure, the researchers say, because chronic NSAID users actually had slightly lower on-treatment BP over the follow-up period.

They note that a recent American Geriatrics Society panel on the treatment of chronic pain in the elderly recommends acetaminophen as a first-line agent and suggests that nonselective NSAIDs or COX-2 inhibitors be used only with extreme caution. "Our findings support this recommendation," they state.
Bavry added: "We do need more studies to further characterize the risks of these agents, which are widely used and widely available, and perhaps the risks are underappreciated. We are working on the next level of studies to try to identify which are the most harmful agents."
Bavry has no disclosures. Disclosures for the coauthors are listed in the paper.

Make No Mistake: Vaccine Administration, Storage, and Handling

CDC Expert Commentary

Andrew T. Kroger, MD, MPH

Vaccine Administration

Vaccine administration is a critical component of a successful immunization program. We label the 7 steps to successful immunization the "rights of medication administration." The word "right" implies "correct" -- the correct steps to ensuring successful administration.

1. Right #1 - the right patient. Make sure you are vaccinating the right person in the room, and also that screening has been performed to identify which vaccines are needed and which vaccines should be avoided because of medical conditions.
2. Right #2 - the right vaccine. Check your vials 3 times to make sure you have the correct vaccine in hand.
3. Right #3 - the right time. Make sure the patient is the appropriate age and is being vaccinated at an appropriate interval from other doses of the same or different vaccines. Vaccines and their diluents might expire as well, so check those dates.
4. Right #4 - the right dosage. Vaccine dosage is based on the age of the patient, not the weight. Vaccines differ from medications in this respect.
5. Right #5 - the right route. Whether oral, intranasal, subcutaneous, or intramuscular, this varies by the type of vaccine, and requires the appropriate administration technique. Correct needle length is also essential.
6. Right #6 - the right site. This is partially dependent on the correct route, and is also related to the age of the patient. Resources are available to assist in the determination of route, site, technique, and needle length. For instance, for vaccines administered by the intramuscular route, a table in the January 2011 General Recommendations on Immunization ^[1] (Table 10) guides administration by this route according to age, gender, site, and technique.
7. Right #7 - the right documentation. This is critical to ensure not only that your patient receives the correct number of doses to be adequately protected, but that excessive doses are not provided, which can cause mild local reactions and can waste valuable vaccine.

All staff (permanent and temporary) who administer vaccines should receive competency-based training and education on vaccine administration before administering vaccines to patients. Staff knowledge and skills should be validated with a skills checklist. Furthermore, all staff should receive continuing education when there are new schedules, vaccines, or recommendations.

Vaccine Storage and Handling

Each office should develop and maintain a detailed written storage and handling protocol; assign storage and handling responsibilities to a single person; designate a backup person; and provide training on vaccine storage and handling.
It is also important to prevent storage and handling errors. Maintaining vaccines at the correct temperature is critical to maintaining potency and protection. Vaccines must be stored properly from the time they are manufactured until they are administered to your patients. Vaccines stored at incorrect temperature can cost thousands of dollars in wasted vaccine and revaccination. The cold chain, which is a temperature-controlled supply chain, begins with the manufacturer and continues with the transfer of vaccine to the distributor; transfer from the distributor to the provider's office; and administration to the patient. Proper storage temperatures must be maintained at every link in the chain. These temperatures are defined in the package inserts for each product and in Table 11 of the General Recommendations on Immunization .

Vaccine storage units must be selected carefully and used properly. Refrigerators without freezers, and stand-alone freezers, are preferred because they are better than combination refrigerator-freezer units at maintaining the required temperatures. Any refrigerator or freezer used for vaccine storage must have its own exterior door and must be able to maintain the required temperature range throughout the year. It must be large enough to hold the year's largest vaccine inventory, and must be dedicated to the storage of biologics.
Proper temperature monitoring is vital to proper cold chain management. Check the storage temperatures twice a day -- once in the morning and once before you leave at the end of the workday -- and record the temperature readings twice daily. However, documentation is not enough. Equally important is taking immediate corrective action when the temperatures fall outside the recommended ranges. Remember, any mishandled or incorrectly stored vaccine should not be administered. It is especially important that inactivated vaccine that has been exposed to freezing temperature not be administered.

If you discover that your refrigerated vaccine has been exposed to freezing temperatures -- even if the vaccines do not appear to have been frozen -- you should remove and identify the exposed vaccine so it will not be used. Then contact the manufacturer or your state or local immunization program for advice. You should do the same thing if your freezer temperature rises above 5°F during other than the normal defrost cycle.

An Activist's Guide To Basic First Aid

Action First Aid, From the Black Cross Health Care Collective:

Be prepared and take care - read this short guide to keeping safe at protests

» Preparation
» Medication in jail
» Blood, Bruises and Broken-bones

Preparation

What to wear:
* Comfortable, protective shoes that you can run in.
* Shatter-resistant eye protection (ie. Sunglasses, swim goggles)
* Weather-related gear (ie. Rain gear or sun hat)

What to bring:
* Lots of water in a plastic bottle, to drink
* Energy snacks
* A small medi-kit with bandages, plasters, tape etc.
* Just enough money for pay-phone, food, transportation.
* Watch, paper, pen for accurate documentation of events, police brutality, injuries.
* Inhaler, epipen, insulin or other meds if applicable.
* Several days of prescription medication and doctor's note in case of arrest.
* Menstrual pads, if needed. Avoid using tampons - if you're arrested you may not have a chance to change it (tampons left in for more than six hours increase your risk of developing toxic shock syndrome)

What not to do:
* Don't wear things that can easily be grabbed (ie. Dangly earrings or other jewellery, ties, loose hair)
* Don't go to the demo alone, if you can help it. It is best to go with an affinity group or some friends who know you well.
* Don't forget to eat food and DRINK LOTS OF WATER.
* Don't drink alcohol before a demo.
* Don't take drugs before a demo or carry them with you. This includes cannabis.
* Don't bring any ID, if possible.

Medication in jail
If you are risking arrest and take medication for any health condition that might pose serious problems were your medication to be interrupted ( such as: behavioural disorders, HIV, diabetes, hypertension) you should be aware that you may not have access to proper medication while you are in jail.

A letter from a doctor will help. Three copies are needed, one for the legal team, one for the medical team, and one for you. It should include your name, diagnosis, that you must have access to medication at all times, a list of all meds required and a statement that you can must be allowed to keep meds on person to administer properly, and that no substitutions are acceptable.

Since your name will be on the document, you may want to hide it on your body as a sort of insurance policy - perhaps you won't need it and then could eat it and participate in jail solidarity tactics, but perhaps you'll be worn out already at the time of arrest and will want to cite out in order to take care of yourself. Better to cite than pass out.

Make sure that your affinity group and the legal team is aware of your needs so they can help care and advocate for you.