Edward Michna

Urine toxicology screening among chronic pain patients on opioid therapy: frequency and predictability of abnormal findings.

ObjectiveTo examine the incidence of abnormal urine toxicology screening among chronic pain patients prescribed opioids for their pain and to relate these results to patient descriptors and type, number, and dose of prescribed opioids. MethodsA retrospective analysis of data from 470 patients who had urine screening at a pain management program in an urban teaching hospital was performed. Urine samples were analyzed using gas chromatography-mass spectrometry. Patients were categorized as having urine screens that were “normal” (expected findings based on their prescribed drugs) or abnormal. Abnormal findings were those of (1) absence of a prescribed opioid, (2) presence of an additional nonprescribed controlled substance, (3) detection of an illicit substance, and (4) an adulterated urine sample. ResultsForty-five percent of the patients were found to have abnormal urine screens. Twenty percent were categorized as having an illicit substance in their urine. Illicit substances and additional drugs were found more frequently in younger patients than in older patients (P<0.001). No other variables were found to predict abnormal urine screen results. DiscussionThese results confirm past findings that random urine toxicology screens among patients prescribed opioids for pain reveal a high incidence of abnormal findings. Common patient descriptors, and number, type, and dose of prescribed opioids were found to be poor predictors of abnormal results.

Substance misuse treatment for high-risk chronic pain patients on opioid therapy: A randomized trial

&NA; Chronic pain patients who show aberrant drug‐related behavior often are discontinued from treatment when they are noncompliant with their use of opioids for pain. The purpose of this study was to conduct a randomized trial in patients who were prescribed opioids for noncancer back pain and who showed risk potential for or demonstration of opioid misuse to see if close monitoring and cognitive behavioral substance misuse counseling could increase overall compliance with opioids. Forty‐two patients meeting criteria for high‐risk for opioid misuse were randomized to either standard control (High‐Risk Control; N = 21) or experimental compliance treatment consisting of monthly urine screens, compliance checklists, and individual and group motivational counseling (High‐Risk Experimental; N = 21). Twenty patients who met criteria indicating low potential for misuse were recruited to a low‐risk control group (Low‐Risk Control). Patients were followed for 6 months and completed pre‐ and post‐study questionnaires and monthly electronic diaries. Outcomes consisted of the percent with a positive Drug Misuse Index (DMI), which was a composite score of self‐reported drug misuse (Prescription Drug Use Questionnaire), physician‐reported abuse behavior (Addiction Behavior Checklist), and abnormal urine toxicology results. Significant differences were found between groups with 73.7% of the High‐Risk Control patients demonstrating positive scores on the DMI compared with 26.3% from the High‐Risk Experimental group and 25.0% from the Low‐Risk Controls (p < 0.05). The results of this study demonstrate support for the benefits of a brief behavioral intervention in the management of opioid compliance among chronic back pain patient at high‐risk for prescription opioid misuse.

Subcutaneous Methylnaltrexone for Treatment of Opioid-Induced Constipation in Patients With Chronic, Nonmalignant Pain: A Randomized Controlled Study

UNLABELLED Methylnaltrexone is effective for opioid-induced constipation (OIC) in advanced illness patients. This 4-week, double-blind, randomized, placebo-controlled study investigated the effect of subcutaneous methylnaltrexone on OIC in patients receiving opioids for chronic, nonmalignant pain. Patients (N = 460) received subcutaneous methylnaltrexone 12 mg once daily (QD) or every other day (alternating with placebo) compared with placebo. Assessments included bowel movement count, time of bowel movement, straining, sense of complete evacuation, Bristol Stool Form Scales, and quality of life. Within 4 hours of first dose, 34.2% of patients in both methylnaltrexone groups had rescue-free bowel movements (RFBMs) versus 9.9% on placebo (P < .001). The estimated number needed to treat was about 4. On average, 28.9% of methylnaltrexone QD and 30.2% of methylnaltrexone alternate-day dosing resulted in RFBMs within 4 hours versus 9.4% QD and 9.3% alternate-day placebo injections (both P < .001). Both methylnaltrexone groups had significantly shorter time to first RFBM (P < .001) and greater increase in number of weekly RFBMs (P < .05) versus placebo. Adverse events included abdominal pain, diarrhea, nausea, and hyperhidrosis. Bristol Stool Form Scale scores (P = .002) and sensation of complete evacuation (P < .04) were significantly superior with methylnaltrexone QD; both methylnaltrexone groups reported no or mild straining during RFBMs in the first 2 weeks (P < .02). At 4 weeks, a significantly greater improvement in patient-reported, constipation-specific quality of life was seen in the alternate-day dosing (P < .05) and QD (P < .001) groups. PERSPECTIVE We present data demonstrating that subcutaneous methylnaltrexone 12 mg given once daily (QD) or every other day provides significant relief of OIC and was generally well tolerated in patients with chronic, nonmalignant pain. These results expand on prior effectiveness observed for the treatment of OIC in advanced illness patients to a broader population.

Elevated pain sensitivity in chronic pain patients at risk for opioid misuse.

UNLABELLED This study employed quantitative sensory testing (QST) to evaluate pain responses in chronic spinal pain patients at low risk and high risk for opioid misuse, with risk classification based on scores on the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R). Patients were further subgrouped according to current use of prescription opioids. Of the 276 chronic pain patients tested, approximately 65% were taking opioids; a median split was used to further categorize these patients as being on lower or higher doses of opioids. The high-risk group (n = 161) reported higher levels of clinical pain, had lower pressure and thermal pain thresholds at multiple body sites, had lower heat pain tolerance, and rated repetitive mechanical stimuli as more painful relative to the low-risk group (n = 115; Ps < .01). In contrast, QST measures did not differ across opioid groups. Multiple linear regression analysis suggested that indices of pain-related distress (ie, anxiety and catastrophizing about pain) were also predictive of hyperalgesia, particularly in patients taking opioids. Collectively, regardless of opioid status, the high-risk group was hyperalgesic relative to the low-risk group; future opioid treatment studies may benefit from the classification of opioid risk, and the examination of pain sensitivity and other factors that differentiate high- and low-risk groups. PERSPECTIVE This study demonstrates that chronic spinal pain patients at high risk for misuse of prescription opioids are more pain-sensitive than low-risk patients, whether or not they are currently taking opioids. Indices of pain-related distress were important predictors of pain sensitivity, particularly among those patients taking opioids for pain.

Craving of Prescription Opioids in Patients With Chronic Pain: A Longitudinal Outcomes Trial

UNLABELLED Little is known about whether patients with chronic pain treated with opioids experience craving for their medications, whether contextual cues may influence craving, or if there is a relationship between craving and medication compliance. We hypothesized that craving for prescription opioids would be significantly correlated with the urge for more medication, preoccupation with the next dose, and current mood symptoms. We studied craving in 62 patients with chronic pain who were at low or high risk for opioid misuse, while they were enrolled in an RCT to improve prescription opioid medication compliance. Using electronic diaries, patients completed ratings of craving at monthly clinic visits and daily during a 14-day take-home period. Both groups consistently endorsed craving, whose levels were highly correlated (P < .001) with urge, preoccupation, and mood. The intervention to improve opioid compliance in the high-risk group was significantly associated with a rate of decrease in craving over time in comparison to a high-risk control group (P < .05). These findings indicate that craving is a potentially important psychological construct in pain patients prescribed opioids, regardless of their level of risk to misuse opioids. Targeting craving may be an important intervention to decrease misuse and improve prescription opioid compliance. PERSPECTIVE Patients with noncancer pain can crave their prescription opioids, regardless of their risk for opioid misuse. We found craving to be highly correlated with the urge to take more medication, fluctuations in mood, and preoccupation with the next dose, and to diminish with a behavioral intervention to improve opioid compliance.

Malpractice Claims Associated with Medication Management for Chronic Pain

Background:Medication management is an integral part of chronic pain management. Prompted by an increase in the role of medication management in anesthesia chronic pain liability, we investigated the characteristics of malpractice claims collected from 2005 to 2008. Methods:After Institutional Review Board approval, we compared medication management claims with other chronic pain claims from the American Society of Anesthesiologists Closed Claims Database of 8,954 claims. Claims for death underwent in-depth analysis. Results:Medication management represented 17% of 295 chronic non-cancer pain claims. Compared with other chronic pain claims, medication management patients tended to be younger men (P < 0.01) with back pain. Most patients were prescribed opioids (94%) and also additional psychoactive medications (58%). Eighty percent of patients had at least one factor commonly associated with medication misuse and 24% had ≥ 3 factors. Most claims (82%) involved patients who did not cooperate in their care (69%) or inappropriate medication management by physicians (59%). Death was the most common outcome in medication management claims (57% vs. 9% in other chronic pain claims, P < 0.01). Factors associated with death included long-acting opioids, additional psychoactive medications, and ≥ 3 factors commonly associated with medication misuse. Alleged addiction from prescribed opioids was the complaint in 24%. Appropriateness of care and payments was similar for medication management versus other chronic pain claims. Conclusions:Most anesthesia malpractice claims for medication management problems involved patients with a history of risk behaviors commonly associated with medication misuse. Malpractice claims arising from medication management had a high proportion of deaths with both patient and physician contributions to the outcome.

Assessment and Treatment of Abuse Risk in Opioid Prescribing for Chronic Pain

Opioid analgesics provide effective treatment for noncancer pain, but many physicians have concerns about adverse effects, tolerance, and addiction. Misuse of opioids is prominent in patients with chronic back pain and early recognition of misuse risk could help physicians offer adequate patient care while implementing appropriate levels of monitoring to reduce aberrant drug-related behaviors. In this review, we discuss opioid abuse and misuse issues that often arise in the treatment of patients with chronic back pain and present an overview of assessment and treatment strategies that can be effective in improving compliance with the use of prescription opioids for pain. Many persons with chronic back pain have significant medical, psychiatric and substance use comorbidities that affect treatment decisions and a comprehensive evaluation that includes a detailed history, physical, and mental health evaluation is essential. Although there is no “gold standard” for opioid misuse risk assessment, several validated measures have been shown to be useful. Controlled substance agreements, regular urine drug screens, and interventions such as motivational counseling have been shown to help improve patient compliance with opioids and to minimize aberrant drug-related behavior. Finally, we discuss the future of abuse-deterrent opioids and other potential strategies for back pain management.

Psychiatric Comorbidity Is Associated Prospectively with Diminished Opioid Analgesia and Increased Opioid Misuse in Patients with Chronic Low Back Pain.

Background:Opioids are frequently prescribed for chronic low back pain (CLBP), but there are little prospective data on which patient subgroups may benefit. Psychiatric comorbidity, such as high levels of depression and anxiety symptoms (termed comorbid negative affect [NA]), is a common presentation and may predict diminished opioid analgesia and/or increased opioid misuse. Methods:The authors conducted a 6½-month prospective cohort study of oral opioid therapy, with an active drug/placebo run-in period, in 81 CLBP patients with low, moderate, and high levels of NA. Treatment included an opioid titration phase with a prescribing physician blinded to NA group assignment and a 4-month continuation phase, during which subjects recorded daily pain levels using an electronic diary. The primary outcome was the percent improvement in average daily pain, summarized weekly. Results:There was an overall 25% dropout rate. Despite the high NA group being prescribed a higher average daily dose of morphine equivalents, linear mixed model analysis revealed that the 24 study completers in each of the high NA and low NA groups had an average 21 versus 39% improvement in pain, respectively (P < 0.01). The high NA group also had a significantly greater rate of opioid misuse (39 vs. 8%, P < 0.05) and significantly more and intense opioid side effects (P < 0.01). Conclusions:These results indicate that the benefit and risk considerations in CLBP patients with high NA versus low NA are distinctly different. Thus, NA is an important phenotypic variable to characterize at baseline, before deciding whether to prescribe opioids for CLBP.

Relationship of negative affect and outcome of an opioid therapy trial among low back pain patients.

Objectives:  Patients with chronic noncancer pain frequently report symptoms of depression and anxiety (negative affect), which are associated with higher ratings of pain intensity and a greater likelihood of being prescribed chronic opioid therapy. The purpose of this secondary analysis was to test the hypothesis that initial levels of negative affect can predict treatment‐related outcomes in a double‐blind, placebo‐controlled study of extended‐release (ER) hydromorphone among opioid‐tolerant patients with chronic low back pain.

Removal of Opioid/Acetaminophen Combination Prescription Pain Medications: Assessing the Evidence for Hepatotoxicity and Consequences of Removal of These Medications

Opioid/acetaminophen combination products are widely prescribed for the management of moderate to moderately severe pain. Acetaminophen, when improperly used, can lead to liver damage and even acute liver failure. In June 2009, an FDA advisory committee recommended elimination of prescription acetaminophen combination products because of the risk of hepatotoxicity associated with use of these medications. The FDA advisory committee reviewed numerous observational studies and adverse event reporting data. The aims of this article are to: 1) provide a summary and epidemiologic critique of the studies and evidence the FDA advisory committee reviewed; 2) examine the potential consequences, such as poorly managed pain or a shift to treatment with other medications with greater potential toxicity and/or restricted availability, if the FDA follows the advisory committee vote; and 3) outline alternate strategies the FDA should consider for reducing hepatotoxicity associated with opioid/acetaminophen combination products.