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Background: Because an increase of patients who misuse opioids has been identified in our cancer clinical setting through urine drug testing (UDT) and the Screener and Opioid Assessment for Patient's with Pain-Short Form (SOAPP-SF), we conducted this retrospective cohort study to identify patient characteristics that are associated with UDT that indicates noncompliance., Methods: Over a two-year period, 167 of 8,727 patients (2.4%) seen in the pain clinic and who underwent UDT were evaluated to determine compliance with prescribed opioid regimens. Descriptive clinical and demographic data were collected, and group differences based on compliance with opioid therapy were evaluated., Results: Fifty-eight percent of the patients were noncompliant with their prescribed opioid therapy. Noncompliant patients were younger than compliant patients, with a median age of 46 vs 49 years (P = 0.0408). Noncompliant patients were more likely to have higher morphine equivalent daily doses; however, the difference was not statistically significant. Patients with a history of alcohol (ETOH) (P = 0.0332), illicit drug use (P = 0.1014), and smoking (P = 0.4184) were more likely noncompliant. Univariate regression analysis showed that a history of ETOH use (P = 0.034), a history of anxiety (P = 0.027), younger age (P = 0.07), and a SOAPP-SF score of 4 or higher (P = 0.05) were associated with an abnormal UDT., Conclusions: History of ETOH use, anxiety, high SOAPP-SF score, and younger age were associated with UDT that indicates noncompliance. Given the very small percentage of UDT testing, it is quite likely that a significant number of patients who did not undergo UDT were also nonadherent with treatment recommendations.

Background: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use., Objectives: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique., Methods: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Background: Opioids are recognized as an integral part of the armamentarium in the management of cancer pain. There has been a growing awareness of the misuse of prescription opioids among cancer patients. More research is needed to detail risk factors and incidence for opioid misuse among cancer pain patients., Methods: We reviewed 522 patient charts that were seen in our Pain Center from January 1, 2009 to June 30, 2009 for risk stratification of opioid misuse with demographic and clinical factors utilizing the Screener and Opioid Assessment for Patients with Pain-short form (SOAPP-SF). Group differences based on High (≥4) and Low (<4) SOAPP-SF scores were evaluated at initial visit, follow-up within a month and 6-9 months., Results: One hundred forty-nine of the 522 (29%) patients had a SOAPP-SF score of ≥4. The mean age for patients with high SOAPP-SF score (≥4) was 50 ± 14 vs 56 ± 14 for patients with low SOAPP-SF score (<4) (P < 0.0001). The pain scores were higher for patients with high SOAPP-SF score compared with patients with low SOAPP-SF score at consult (P < 0.0001). Morphine equivalent daily dose (MEDD) was higher for patients with high SOAPP-SF score compared with patients with low SOAPP-SF score at consult (P = 0.0461). Fatigue, feeling of well-being, and poor appetite were higher among the high SOAPP-SF group at initial visit (P < 0.0001, <0.0001, <0.0149, respectively). The high SOAPP-SF score patients also had statistically significant (P < 0.05) higher anxiety and depression scores at all three time points. In the multivariate analysis, patients younger than 55 years have a higher odds of having a "high" SOAPP-SF score than patients 55 years and older {odds ratio (OR) (95% confidence interval [CI]) = 2.76 (1.58, 4.81), P = 0.0003} adjusting for employment status, disease status, treatment status, usual pain score, and morphine equivalency at consult. Patients with higher usual pain score at consult have higher odds of a "high" SOAPP-SF score (OR [95% CI] = 1.34 [1.19, 1.51], P < 0.0001) adjusting for age, employment status, disease status, treatment status, and morphine equivalency at consult., Conclusion: Patients classified by the SOAPP-SF in the current study as high risk tended to be younger, endorse more pain, have higher MEDD requirement, and endorse more symptoms of depression and anxiety. These findings are consistent with the literature on risk factors of opioid abuse in chronic pain patients which suggests that certain patient characteristics such as younger age, anxiety, and depression symptomatology are associated with greater risk for opioid misuse. However, a limitation of the current study is that other measures of opioid abuse were not available for validation and comparison with the SOAPP-SF., (Wiley Periodicals, Inc.)

Results: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. (, Evidence: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. (, Evidence: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. (, Evidence: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. (, Evidence: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. (, Evidence: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. (, Evidence: good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. (, Evidence: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. (, Evidence: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (, Evidence: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. (, Evidence: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. (, Evidence: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. (, Evidence: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. (, Evidence: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. (, Evidence: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. (, Evidence: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. (, Evidence: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. (, Evidence: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. (, Evidence: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. (, Evidence: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. (, Evidence: fair)., Disclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Background: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment., Objectives: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids., Results: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping., Disclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Background: In all recommended guidelines put forth for the treatment of cancer pain, opioids continue to be an important part of a physician's armamentarium. Though opioids are used regularly for cancer pain, there is a paucity of literature proving efficacy for long-term use. Cancer is no longer considered a "terminal disease"; 50% to 65% of patients survive for at least 2 years, and there are about 12 million cancer survivors in the United States. There is a concern about side effects, tolerance, abuse and addiction with long-term opioid use and a need to evaluate the effectiveness of opioids for cancer pain., Objective: The objective of this systematic review was to look at the effectiveness of opioids for cancer pain., Study Design: A systematic review of randomized trials of opioids for cancer pain., Methods: A comprehensive review of the current literature for randomized controlled trials (RCTs) of opioids for cancer pain was done. The literature search was done using PubMed, EMBASE, Cochrane library, clinical trials, national clearing house, Web of Science, previous narrative systematic reviews, and cross references. The studies were assessed using the modified Cochrane and Jadad criteria. Analysis of evidence was done utilizing the modified quality of evidence developed by United States Preventive Services Task Force (USPSTF)., Outcome Measures: Pain relief was the primary outcome measure. Secondary outcome measures are quality of life (QoL) and side effects including tolerance and addiction., Results: The level of evidence for pain relief based on the USPSTF criteria was fair for transdermal fentanyl and poor for morphine, tramadol, oxycodone, methadone, and codeine., Limitations: Randomized trials in a cancer setting are difficult to perform and justify. There is a paucity of long-term trials and this review included a follow-up period of only 4 weeks., Conclusion: This systematic review of RCTs of opioids for cancer pain showed fair evidence for the efficacy of transdermal fentanyl and poor evidence for morphine, tramadol, oxycodone, methadone, and codeine.

Background: Even though opioids have been used for pain for thousands of years, opioid therapy for chronic non-cancer pain is controversial due to concerns regarding the long-term effectiveness and safety, particularly the risk of tolerance, dependance, or abuse. While the debate continues, the use of chronic opioid therapy for chronic non-cancer pain has increased exponentially. Even though evidence is limited, multiple expert panels have concluded that chronic opioid therapy can be effective therapy for carefully selected and monitored patients with chronic non-cancer pain., Study Design: A systematic review of randomized trials of opioid management for chronic non-cancer pain., Objective: The objective of this systematic review is to evaluate the clinical efficacy of opioids in the treatment of chronic non-cancer pain., Methods: A comprehensive evaluation of the literature relating to opioids in chronic non-cancer pain was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs) and Jadad criteria. A literature search was conducted by using PubMed, EMBASE, Cochrane library, ECRI Institute Library, U.S. Food and Drug Administration (FDA) website, U.S. National Guideline Clearinghouse (NGC), Database of Abstracts of Reviews of Effectiveness (DARE), clinical trials, systematic reviews and cross references from systematic reviews. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) and used by other systematic reviews and guidelines., Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, withdrawals, and adverse effects., Results: Based on the USPSTF criteria, the indicated level of evidence was fair for Tramadol in managing osteoarthritis. For all the drugs assessed, including Tramadol, for all other conditions, the evidence was poor based on either weak positive evidence, indeterminate evidence, or negative evidence., Limitations: A paucity of literature, specifically with follow-up beyond 12 weeks for all types of opioids with controlled trials for various chronic non-cancer pain conditions., Conclusions: This systematic review illustrated fair evidence for Tramadol in managing osteoarthritis with poor evidence for all other drugs and conditions. Thus, recommendations must be based on non-randomized studies.

Background: The prevalence of cancer-related pain and residual pain in cancer survivors is high. Opioids serve as the gold standard for treating moderate to severe cancer pain. The evaluation of the effectiveness of opioids in chronic non-cancer pain has shown a lack of effectiveness, or rather weak evidence for some of the drugs. In contrast, in cancer pain, opioids are expected to be very effective. Due to the nature of the disease, there is evidence of a paucity of randomized trials investigating opioid effectiveness in cancer pain on a long-term basis. Consequently, the effectiveness of opioids in managing cancer-related pain warrants further evidence-based review beyond randomized trials, including observational studies and case reports., Methods: The comprehensive literature search was conducted for the period 1996 through June 2010. Databases for the search included PubMed, EMBASE, Cochrane Reviews, and clinicaltrials.gov, along with reviews and cross references. Methodologic quality assessment of the observational studies managing chronic cancer pain with opioids was conducted utilizing the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. Analysis of evidence included 5 levels of evidence developed by the United States Preventive Services Task Force (USPSTF) ranging from Level I to III with 3 subcategories in Level II. Grading recommendations were based on Guyatt et al's recommendations with 6 levels: 3 in the strong category and 3 in the weak category., Results: This evaluation is of 18 manuscripts considered for inclusion; 7 manuscripts met the inclusion criteria based on AHRQ quality assessment. Level of evidence for opioid therapy in cancer pain was Level II-3, and recommendations were 1C/strong recommendation based on observational studies, which could change based on future evidence., Conclusion: This systematic review of observational studies indicates Level II-3 evidence for effectiveness of opioids in cancer pain therapy, with 1C/strong recommendation based on observational studies, which could change based on future evidence.

Background: Use of opioids for chronic non-cancer pain (CNCP) has increased in recent years because this pain had been undertreated. There was also a simultaneous increase in misuse and abuse of opioids. Deaths due to such abuse and misuse also have risen as seen in the many reports published every day in local papers as well as in the medical literature. So, it is imperative that patients who are prescribed these medications be monitored for adherence so misuse and abuse can be curtailed and opioids are available to those who genuinely need them for chronic pain control. There are various screening tools available to monitor such adherence, and there is an abundance of literature about it in addiction and psychiatric medicine. There is, though, a paucity of such literature as applied to pain medicine., Objectives: Our objectives for this review were twofold. We wanted to identify which screening tools are available to monitor opioid adherence and we wanted to see if there were prospective comparative studies of these tools to identify a single best tool that can be applied to all chronic non-cancer pain patients managed with opioids., Study Design: We did a review of the current literature about monitoring of opioid adherence. We also looked at their use, validity, and comparative studies., Methods: We performed a literature search using PubMed, EMBASE, and the Cochrane library. The search was conducted using the terms opioids, non-cancer pain, monitoring, and adherence. The databases from 1996 to November 2010 were reviewed. The search included prospective and retrospective studies, review articles, and FDA records. Bibliographies and cross references were reviewed when deemed appropriate., Conclusion: We found 52 publications, of which 22 met the criteria to be included in this manuscript. We found only one study that was prospective, and compared the various screening tools that are available to monitor opioid adherence. In the majority of the studies the number treated was small. There was not a single screening tool that can be applied universally to all patients who are on opioid therapy for chronic non-cancer pain.