Chronic Opioid Therapy in Cancer Survivors at a Specialty Oncology Pain Clinic: Opioid Dosing, Efficacy, and Safety During Five Years of Pain Management.

There are limited data regarding long-term safety and efficacy in cancer survivors receiving chronic opioid therapy. With conflicting recommendations on opioid-prescribing practices and lack of available outcome data, this study aimed to provide a longitudinal perspective on opioid prescribing in cancer survivors. A retrospective chart review at a comprehensive cancer care center pain clinic used data from pain clinic provider notes from 2013 to 2018. Inclusion criteria were patients in clinical remission not receiving active chemotherapy or immunotherapy and receiving opioids during the study period. Opioid dosing changes and outcomes between zero and five years were evaluated by standard statistical analysis. Thirty-two patients met inclusion criteria. Solid malignancies were more common than hematologic malignancies (72% vs. 28%). Common pain complaints were related to postsurgical changes (43%), postradiation (32%), and chemotherapy-induced pain syndromes (25%). There were no serious adverse events. One patient exhibited possible aberrant behavior. At the initial visit, the median morphine milligram equivalent per day (MME/day) was 130. Median MME/day at Year 0 (study start) and Year 5 was 135 and 159, respectively (P = 0.475). Functional status was satisfactory in 58% at Year 0 and increased to 91% of patients meeting their functional goals at Year 5. In a carefully monitored group of cancer survivors with persistent pain, chronic opioid therapy was safely managed during extended periods without significant opioid escalation or evidence of serious adverse events including aberrant behaviors. This population benefited when opioid therapy was managed with a focus on function rather than reduction of pain intensity scores.

Injury and Liability Associated with Implantable Devices for Chronic Pain.

BACKGROUND: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. METHODS: After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. RESULTS: The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). CONCLUSIONS: Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

Trends in Pain Medicine Liability.

BACKGROUND: The authors examined changes in the frequency of pain medicine malpractice claims and associated treatment modalities and outcomes over time. METHODS: The authors analyzed trends in pain medicine claims from 1980 to 2012 in the Anesthesia Closed Claims Project database by binary logistic regression on year of event. Pain procedures in claims from 2000 to 2012 were compared with the proportion of pain procedures reported to the National Anesthesia Clinical Outcomes Registry in 2010-2014. RESULTS: Malpractice claims for pain medicine increased from 3% of 2,966 total malpractice claims in the Anesthesia Closed Claims Project database in 1980-1989 to 18% of 2,743 anesthesia claims in 2000-2012 (odds ratio [OR], 1.088 per year; 95% CI, 1.078 to 1.098; P < 0.001). Outcomes in pain claims became more severe over time, with increases in death and permanent disabling injury (OR, 1.094 per year; P < 0.001). Nonneurolytic cervical injections increased to 27% of pain claims in 2000-2012 (OR, 1.054; P < 0.001), whereas National Anesthesia Clinical Outcomes Registry demonstrates that lumbar injections are a more common procedure. Claims associated with medication management increased to 17% of pain claims in 2000-2012 (OR, 1.116 per year; P < 0.001). CONCLUSIONS: Pain medicine claims have increased over time and have increased in severity. Claims related to cervical procedures were out of proportion to the frequency with which they are performed. These liability findings suggest that pain specialists should aggressively continue the search for safer and more effective therapies.

Injury and liability associated with cervical procedures for chronic pain.

BACKGROUND: Prompted by an increase in interventional pain treatments performed at the level of the cervical spine, we investigated the characteristics and patterns of injury in malpractice claims collected from January 1, 2005 to December 31, 2008. METHODS: We compared claims arising from cervical pain treatments with all other chronic pain claims collected from the American Society of Anesthesiologists' closed claims database between 2005 and 2008. Claims for spinal cord injury underwent in-depth analysis for mechanisms of injury and use of sedation during the procedure. RESULTS: Claims related to cervical interventions represented 22% (64/294) of chronic pain treatment claims. Patients who underwent cervical procedures were healthier (American Society of Anesthesiologists' score, 1-2; P < 0.001) and were more often women (P = 0.011). Of the patients who underwent a cervical procedure, 59% experienced spinal cord damage compared with 11% of patients with other chronic pain (P < 0.001), with direct needle trauma as the predominant cause (31%). General anesthesia or sedation was used in 67% of cervical procedure claims associated with spinal cord injuries but in only 19% of cervical procedure claims not associated with spinal cord injuries (P < 0.001). Of the patients who underwent cervical procedures and had spinal cord injuries, 25% were nonresponsive during the procedure compared with 5% of the patients who underwent cervical procedures and did not have spinal cord injuries (P < 0.05, κ = 0.52). CONCLUSIONS: Injuries related to cervical interventional pain treatment were often severe and related to direct needle trauma to the spinal cord. Traumatic spinal cord injury was more common in patients who received sedation or general anesthesia and in those who were unresponsive during the procedure. Further studies are crucial to define the usefulness of cervical interventions and to improve their safety.

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 >or= 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 >or= 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.

Ultra-low dose ketamine and memantine treatment for pain in an opioid-tolerant oncology patient.

Patients taking high-dose opioids chronically for tumor-related or neuropathic pain may develop pain that is refractory to opioids. One option for control of such pain is the use of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine. We describe a case of opioid-refractory pain that responded to a low-dose IV infusion of ketamine in the inpatient setting. The patient was then successfully transitioned to oral memantine for long-term outpatient management, in a novel use of this oral NMDA receptor antagonist. We present recent findings from basic research on pain mechanisms to explain why opioid tolerance, as in this patient, may contribute to the analgesic benefit of NMDA receptor antagonists.

Clinical use of opioids for cancer pain.

Successful management of pain in the cancer patient requires careful assessment of the components of the pain complaint and accurate diagnosis of the cause of pain. Symptomatic management of pain involves pharmacotherapeutic strategies that focus on opioid use. Factors influencing the choice of opioid in patients with cancer pain include the severity of pain, the presence of coexisting disease, response to previous analgesic therapy, pharmacokinetic factors, available formulations, and patient compliance. Long-term opioid prescription always requires individual titration of medication to adequate pain relief, which is determined on an individual patient basis and/or based on manageable adverse effects. Failure to continuously monitor opioid use generally results in overtreatment or undertreatment of pain. The cognitive and psychomotor effects of long-term opioid therapy are not well-defined and merit further study.

Continuous intrathecal meperidine for severe refractory cancer pain: a case report.

The control of severe cancer pain may be problematic despite advances in pain management. Patients with severe intractable pain and/or intractable side effects may require aggressive interventional pain management strategies including the administration of medications by the continuous intrathecal route and/or neurosurgical procedures. Various medications, including opioids, local anesthetics, and alpha-2 agonists may be used intrathecally for the control of cancer pain. Failure of the intrathecal route may require the additional use of neurosurgical procedures such as cordotomy for pain control. We describe a case of severe cancer pain refractory to conventional intrathecal medications and cordotomy that was successfully managed by the addition of meperidine to the intrathecal regimen.

Chronic pain management: American Society of Anesthesiologists Closed Claims Project.

BACKGROUND: The practice of chronic pain management has grown steadily in recent years. The purpose of this study was to identify and describe issues and trends in liability related to chronic pain management by anesthesiologists. METHODS: Data from 5,475 claims in the American Society of Anesthesiologists Closed Claims Project database between 1970 and 1999 were reviewed to compare liability related to chronic pain management with that related to surgical and obstetric (surgical/obstetric) anesthesia. Acute pain management claims were excluded from analysis. Outcomes and liability characteristics between 284 pain management claims and 5,125 surgical/obstetric claims were compared. RESULTS: Claims related to chronic pain management increased over time (P < 0.01) and accounted for 10% of all claims in the 1990s. Compensatory payment amounts were lower in chronic pain management claims than in surgical/obstetric anesthesia claims from 1970 to 1989 (P < 0.05), but during the 1990s, there was no difference in size of payments. Nerve injury and pneumothorax were the most common outcomes in invasive pain management claims. Epidural steroid injections accounted for 40% of all chronic pain management claims. Serious injuries, involving brain damage or death, occurred with epidural steroid injections with local anesthetics and/or opioids and with maintenance of implantable devices. CONCLUSIONS: Frequency and payments of claims associated with chronic pain management by anesthesiologists increased in the 1990s. Brain damage and death were associated with epidural steroid injection only when opioids or local anesthetics were included. Anesthesiologists involved in home care of patients with implanted devices such as morphine pumps and epidural injections or patient-controlled analgesia should be aware of potential complications that may have severe outcomes.

Initial pharmacokinetic, safety and efficacy evaluation of nasal morphine gluconate for breakthrough pain in cancer patients.

Patients with controlled background pain associated with cancer frequently also experience episodes of moderate to severe intensity breakthrough pain. Opioid pharmacotherapy, particularly with oral morphine, remains the cornerstone for the management of cancer pain. Nasal administration of opioids provides a mechanism for more rapid drug absorption and more rapid onset of pain relief compared with oral dosing. This non-randomized, open-label, uncontrolled investigation evaluated the pharmacokinetics, safety and efficacy of a single 40 mg dose of nasal morphine gluconate, administered to cancer patients in response to an episode of breakthrough pain. Single dose nasal morphine gluconate administered to 11 patients was associated with effective plasma morphine concentrations (mean C(max) 64 ng/ml; range 33.8-121 ng/ml) and low plasma morphine metabolites (morphine-6-glucuronide mean C(max) 114 ng/ml; range 46-189 ng/ml; morphine-3-glucuronide mean C(max) 572 ng/ml; range 257-990 ng/ml). Side effects were minor and limited to nasal irritation. Patients reported rapid onset of pain relief (perceptible pain relief achieved in 10/11 patients, time to onset 2.4+/-2.1 min; and meaningful pain relief, achieved in five patients, 6.8+/-7.3 min to onset, mean t(max) 0.36 h). Pain intensity scores were significantly reduced at all times after dosing; pain relief scores were unchanged. Patient satisfaction ratings were high. These results show that nasal morphine has rapid absorption and apparent onset of effect. Additional multi-dose, dose-ranging and placebo-controlled studies of nasal morphine for cancer pain are warranted.

The control of severe cancer pain by continuous intrathecal infusion and patient controlled intrathecal analgesia with morphine, bupivacaine and clonidine.

The management of severe cancer pain may be problematic in spite of recent advances in pain management. A small percentage of patients with severe intractable pain and/or intractable side effects may require more aggressive interventional pain management strategies including the administration of medications continuously by the intrathecal route. A variety of medications, including morphine, bupivacaine, and clonidine, may be used intrathecally for the control of cancer pain. Optimal use of these medications requires individual titration to the patient's needs. We describe a case of severe cancer pain where these medications were used successfully by continuous intrathecal infusion and patient controlled intrathecal analgesia.

Intravenous high-dose methadone administered by patient controlled analgesia and continuous infusion for the treatment of cancer pain refractory to high-dose morphine.

The management of severe tumor-related pain in the patient with cancer may be problematic. Systemically administered opioids remain the cornerstone of treatment for moderate to severe cancer pain, while parenteral routes should be considered for patients who require rapid onset of analgesia, and for highly tolerant patients whose dose requirements cannot be conveniently administered. The use of intravenous methadone by patient controlled analgesia (PCA) is attractive for the management of severe, intractable cancer pain and may offer some advantages over morphine. We describe the safe and effective use of high-dose intravenous methadone by PCA and continuous infusion for a patient with intractable tumor-associated cancer pain who experienced inadequate pain control and dose-limiting side-effects with high-dose intravenous morphine.

The efficacy of opioids in cancer pain syndromes.

The treatment of pain in the patient with cancer necessitates careful assessment and definition of factors contributing to the pain complaint. We describe 3 cases of patients who had cancer, complained of pain, and were inappropriately treated with escalating doses of opioids. Opioid analgesic medications are commonly used in the management of pain in patients with cancer. Failure to respond to this treatment, the development of increasing pain, and the report of new side effects should prompt reassessment of opioid use.