First three paragraphs: Undertreated pain is a long-standing problem in health care. The American Cancer Society suggests that up to 50% of seriously ill and dying cancer patients in the United States suffer from pain that could be adequately treated with available drugs. Myriad factors contribute to the problem; chief among them is that many doctors are not well trained in pain management, particularly with opiates such as methadone, morphine, and oxycodone. But also part of the problem, says Russ Portenoy, M.D., chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Hospital in New York, is that oncologists and physicians alike are increasingly reluctant to prescribe adequate pain relief to their patients because they fear subsequent investigations from law enforcement, particularly the U.S. Drug Enforcement Agency (DEA). "The DEA had previously been viewed [by physicians] as relatively enlightened," Portenoy said. "Sadly, events during the last 6 months suggest the agency has become confused about its mission and is now willing to pursue policies that worsen undertreatment [of pain] in an effort to reduce prescription drug abuse."

PubMed citation: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=10735341 Abstract: Nonmalignant, chronic pain is associated with physical, emotional and financial disability. Recent animal studies have shown that remodeling within the central nervous system causes the physical pathogenesis of chronic pain. This central neural plasticity results in persistent pain after correction of pathology, hyperalgesia, allodynia, and the spread of pain to areas other than those involved with the initial pathology. Patient evaluation and management focus on pain symptoms, functional disabilities, contributory comorbid illnesses, and medication use or overuse. Treatment of chronic pain involves a comprehensive approach using medication and functional rehabilitation. Functional rehabilitation includes patient education, the identification and management of contributing illnesses, the determination of reachable treatment goals and regular reassessment. (Am Fam Physician 2000;61:1331-8,1345-6.)

Consensus document: The American Society of Addiction Medicine (ASAM), the American Academy of Pain Medicine (AAPM) and the American Pain Society (APS), 2001. Excerpt: Pseudoaddiction is a term which has been used to describe patient behaviors that may occur when pain is undertreated. Patients with unrelieved pain may become focused on obtaining medications, may "clock watch," and may otherwise seem inappropriately "drug seeking." Even such behaviors as illicit drug use and deception can occur in the patient's efforts to obtain relief. Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when pain is effectively treated.

The American Society of Addiction Medicine (ASAM), the American Academy of Pain Medicine (AAPM) and the American Pain Society (APS), 2006. Excerpt: "Healthcare professional (HCP) concerns regarding the potential for harm to patients, as well as possible legal, regulatory, licensing or other third party sanctions related to the prescription of opioids, contribute significantly to the mistreatment of pain. HCPs are obligated to act in the best interest of their patients. This action may include the addition of opioid medication to the treatment plan of patients whose symptoms include pain [and] opioids are often indicated as a component of effective pain treatment. It is sometimes a difficult medical judgment as to whether opioid therapy is indicated in patients complaining of pain because objective signs are not always present." A decision whether to prescribe opioids may be particularly difficult in patients with concurrent addictive disorders, or with risk factors for addiction, such as a personal or family history of addictive disorder. For such persons, exposure to potentially rewarding substances may reinforce drug taking behavior and therefore present special risks. It is, nonetheless, a medical judgment that must be made by a HCP in the context of the provider-patient relationship based on knowledge of the patient, awareness of the patient's medical and psychiatric conditions and on observation of the patient's response to treatment.

First paragraph: On October 5, 2005, the U.S. Supreme Court heard oral arguments in Gonzales v. Oregon. On the surface, this case is about the legitimacy of physicians' prescribing of medications under Oregon's Death with Dignity Act and whether the federal government can overrule the states in defining "legitimate medical practice." Just beneath the surface, however, lies the risk of empowering agents of the Drug Enforcement Agency (DEA) — whose traditional role is to prevent drug abuse and diversion — to evaluate the end-of-life practices of physicians whose patients die while receiving prescribed opioids or barbiturates. A finding in favor of the Justice Department would not only nullify the Death with Dignity Act, permitting the DEA to penalize physicians for providing medications to hasten the deaths of terminally ill patients, but also have a chilling effect on physicians' willingness to treat patients' terminal symptoms.

In this article, we review the principal objectives and ideal elements of opioid contracts, as articulated by proponents of the practice. We examine the limited empirical evidence for the effectiveness of opioid contracts in achieving their intended objectives and identify areas of uncertainty and of ethical concern regarding their implementation. We argue that the challenge in deciding about implementing opioid contracts in clinical practice relates to the multiplicity of potential objectives they might serve, to a lack of empirical evidence regarding their effectiveness, and to ethical concerns over their implementation. Specialty and primary care clinicians contemplating the use of opioid contracts in treating patients with chronic nonmalignant pain need to be sensitive to these considerations, and further debate and research is necessary to establish the proper objectives, elements, effectiveness, and ethical justifications of opioid contracts in clinical practice.

Patients with neuropathic pain (NP) are challenging to manage and evidence-based clinical recommendations for pharmacologic management are needed. Systematic literature reviews, randomized clinical trials, and existing guidelines were evaluated at a consensus meeting. Medications were considered for recommendation if their efficacy was supported by at least one methodologically-sound, randomized clinical trial (RCT) demonstrating superiority to placebo or a relevant comparison treatment. Recommendations were based on the amount and consistency of evidence, degree of efficacy, safety, and clinical experience of the authors. Available RCTs typically evaluated chronic NP of moderate to severe intensity. Recommended first-line treatments include certain antidepressants (i.e., tricyclic antidepressants and dual reuptake inhibitors of both serotonin and norepinephrine), calcium channel α2-δ ligands (i.e., gabapentin and pregabalin), and topical lidocaine. Opioid analgesics and tramadol are recommended as generally second-line treatments that can be considered for first-line use in select clinical circumstances. Other medications that would generally be used as third-line treatments but that could also be used as second-line treatments in some circumstances include certain antiepileptic and antidepressant medications, mexiletine, N-methyl-d-aspartate receptor antagonists, and topical capsaicin. Medication selection should be individualized, considering side effects, potential beneficial or deleterious effects on comorbidities, and whether prompt onset of pain relief is necessary. To date, no medications have demonstrated efficacy in lumbosacral radiculopathy, which is probably the most common type of NP. Long-term studies, head-to-head comparisons between medications, studies involving combinations of medications, and RCTs examining treatment of central NP are lacking and should be a priority for future research.

Links to FULL TEXT. ABSTRACT: The principle of double effect is used to justify the administration of medication to relieve pain even though it may lead to the unintended, although foreseen, consequence of hastening death by causing respiratory depression. Although a review of the medical literature reveals that the risk of respiratory depression from opioid analgesic is more myth than fact and that there is little evidence that the use of medication to control pain hastens death, the belief in the double effect of pain medication remains widespread. Applying the principle of double effect to end-of-life issues perpetuates this myth and results in the undertreatment of physical suffering at the end of life. The concept of double effect of opioids also has been used in support of legalization of physician-assisted suicide and euthanasia.

Context Patient-controlled analgesia (PCA) with morphine is commonly used to provide acute postoperative pain control after major surgery. The fentanyl hydrochloride patient-controlled transdermal system eliminates the need for venous access and complicated programming of pumps. Objective To assess the efficacy and safety of an investigational patient-controlled iontophoretic transdermal system using fentanyl hydrochloride compared with a standard intravenous morphine patient-controlled pump. Design, Setting, and Patients Prospective randomized controlled parallel-group trial conducted between September 2000 and March 2001 at 33 North American hospitals, enrolling 636 adult patients who had just undergone major surgery. Interventions In surgical recovery rooms, patients were randomly assigned to intravenous morphine (1-mg bolus every 5 minutes; maximum of 10 mg/h) by a patient-controlled analgesia pump (n = 320) or iontophoretic fentanyl hydrochloride (40-µg infusion over 10 minutes) by a patient-controlled transdermal system (n = 316). Supplemental analgesia (morphine or fentanyl intravenous boluses) was administered as needed before and for the first 3 hours after activation of the PCA treatments. Patients then used the PCA treatments without additional analgesics for up to 72 hours. Main Outcome Measures The primary efficacy variable was patient global assessment of the method of pain control during the first 24 hours. Additional efficacy measures were the proportion of patients discontinuing the study because of inadequate analgesia for any reason, patient-reported pain intensity scores on a 100-mm visual analog scale (VAS), and patient global assessments at 48 and 72 hours. Adverse effects were also recorded. Results Ratings of good or excellent after 24 hours of treatment for the method of pain control were given by 73.7% of patients (233/316) who used transdermal fentanyl PCA and 76.9% of patients (246/320) who used intravenous morphine PCA; treatment difference was –3.2% (95% confidence interval, –9.9% to 3.5%; P = .36). Early patient discontinuations (25.9% fentanyl vs 25.0% morphine; P = .78) and last pain intensity scores (32.7 fentanyl vs 31.1 morphine on the VAS; P = .45) were not different between the 2 treatments. With continued treatment for up to 48 or 72 hours, more than 80% of patient assessments in each treatment group were good or excellent. The incidence of opioid-related adverse events was similar between the groups. Conclusion An investigational PCA transdermal system using iontophoresis to deliver fentanyl provided postsurgical pain control equivalent to that of a standard intravenous morphine regimen delivered by a PCA pump.

BACKGROUND: The use of opioid medications to manage chronic pain is complex and challenging, especially in primary care settings. Medication contracts are increasingly being used to monitor patient adherence, but little is known about the long-term outcomes of such contracts. OBJECTIVE: To describe the long-term outcomes of a medication contract agreement for patients receiving opioid medications in a primary care setting. DESIGN: Retrospective cohort study. SUBJECTS: All patients placed on a contract for opioid medication between 1998 and 2003 in an academic General Internal Medicine teaching clinic. MEASUREMENTS: Demographics, diagnoses, opiates prescribed, urine drug screens, and reasons for contract cancellation were recorded. The association of physician contract cancellation with patient factors and medication types were examined using the Chi-square test and multivariate logistic regression. RESULTS: A total of 330 patients constituting 4% of the clinic population were placed on contracts during the study period. Seventy percent were on indigent care programs. The majority had low back pain (38%) or fibromyalgia (23%). Contracts were discontinued in 37%. Only 17% were cancelled for substance abuse and noncompliance. Twenty percent discontinued contract voluntarily. Urine toxicology screens were obtained in 42% of patients of whom 38% were positive for illicit substances. CONCLUSIONS: Over 60% of patients adhered to the contract agreement for opioids with a median follow-up of 22.5 months. Our experience provides insight into establishing a systematic approach to opioid administration and monitoring in primary care practices. A more structured drug testing strategy is needed to identify nonadherent patients.