Kenneth L. Kirsh

A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy.

BACKGROUND Opioid analgesics are the cornerstone of management for malignant pain. Their use in managing chronic, nonmalignant pain, albeit controversial, has increased in recent years. The decisions about whether to initiate opioid therapy or continue it over time should be guided by a comprehensive patient assessment. During long-term treatment, this assessment should focus on a broad range of outcomes, each of which should be documented in the medical record. OBJECTIVE The goal of this study was to develop an instrument, the Pain Assessment and Documentation Tool (PADT), to focus on key outcomes and provide a consistent way to document progress in pain management therapy over time. METHODS Items that assess 4 domains (pain relief, patient functioning, adverse events, and drug-related behaviors) were generated with input from a MEDLINE literature search and experts in pain and addiction management. The original tool was field tested by clinicians who applied it to the assessment of patients receiving long-term opioid therapy for the management of chronic, nonmalignant pain. Data analysis and debriefing telephone interviews with a formalized set of questions were then used to rephrase, delete, and refine items to create the final tool. RESULTS A 6-member expert panel contributed to the initial development of the PADT. Twenty-seven clinicians completed the preliminary version of PADT for 388 patients. The original 59-item tool was modified to create a 41-item tool. The revised PADT was formatted for use as a chart note designed to assist clinicians in assessing and documenting 4 main outcome domains during long-term opioid use. CONCLUSIONS In this study, the PADT appeared to be a useful tool for clinicians to guide the evaluation of several important outcomes during opioid therapy and provide a simple means of documenting patient care.

Pain and aberrant drug-related behaviors in medically ill patients with and without histories of substance abuse.

Objectives:This study evaluated the prevalence and correlates of aberrant drug-taking behaviors in two populations: patients with HIV-related pain and a history of substance abuse (n = 73) and patients with cancer pain and no history of substance abuse (n = 100). Methods:All patients completed a Drug-Taking Behaviors Interview, the Brief Symptom Inventory (BSI), Brief Pain Inventory (BPI), Memorial Symptom Assessment Scale (MSAS), and the Marlowe Crowne Social Desirability Scale (MCSDS). The Pain Management Index was calculated to assess the adequacy of opioid prescribing. Results:The cancer sample comprised 38 men and 62 women, and the AIDS sample comprised 63 men and 10 women. Patients with AIDS-related pain had higher global distress on the MSAS (F1, 170 = 20.05, P < 0.001), greater pain-related interference in their daily functioning on the BPI (F1, 161 = 22.87, P < 0.001), and a lower percentage of relief from their current medications (F1, 156 = 76.14, P < 0.001). AIDS patients also reported more than twice as many examples of aberrant drug-related behaviors per patient (mean = 6.14, SD = 4.60) as the cancer patients (mean = 1.42, SD = 1.91). Conclusion:These data suggest that AIDS patients with histories of substance abuse receiving opioid therapy are more symptomatic, have more distress, experience more interference from residual pain, and engage in more problematic drug-related behaviors than patients with no history of drug abuse receiving opioids for cancer pain. Treatment of substance abusers with pain requires skills that complement best practices in opioid prescribing. Better approaches to the long-term treatment of these populations are needed.

Psychiatrie and Pain Characteristics of Prescription Drug Abusers Entering Drug Rehabilitation

There has been intense interest in the problem of prescription drug abuse on the parts of health professionals, law enforcement, the media, and the general public. Clinicians not only need to know how to assess risk but also what drugs are being diverted most in their region. We conducted a prospective survey of prescription drug abusers entering a treatment facility in central Kentucky. Participants (n = 109) were enrolled and completed a structured clinical interview and prescription drug abuse survey. The prescription drug abusers assessed in the study had a mean age of 30.95 years (SD = 10.21), were comprised of 75 men (69%) and 34 women (31%), and were mostly Caucasian (98%). The majority (84%) stated that they had legitimately been given a prescription for opioids for pain at some point from a physician and 61% reported chronic pain concerns. The most commonly abused drugs were hydrocodone-containing formulations (78%) and oxycodone-containing products (69%), while products containing methadone (23%) or fentanyl (7%) were abused much less frequently. Most respondents (91%) stated that they had purchased prescription opioids from a street dealer at least once and the majority (80%) had altered the delivery system of the prescription drug by chewing, snorting, or using IV administration. Implications for pain management are discussed, focusing on the need for clinicians treating chronic pain to more thoroughly assess patients for their risk of abuse and addiction before starting an opioid regimen.

Abuse and addiction issues in medically ill patients with pain: attempts at clarification of terms and empirical study.

The assessment of addiction-related outcomes is crucial to the management of chronic pain with opioid drugs in all patients. Pain management for patients who have concomitant drug abuse or addiction issues is a particularly complex task involving a need for a common nomenclature as well as empirically derived data to support management strategies during treatment regimens. Complicating the issue is the notion of pseudoaddiction, which is an abuse of medications driven by unrelieved pain that appears on the surface to be very similar to the behavior patterns of addicts. For proper adherence to medical therapy and safety during treatment, it is necessary to address and manage substance abuse-related behaviors. Aberrant drug-taking behavior presents many threats to the integrity of pain treatment. Unfortunately, the current state of the art still has a long way to go before clear guidelines for treatment and management can emerge. What is ultimately needed is a broad-based spectrum of research that high-lights the epidemiology of drug-taking behaviors for different medical illnesses ranging from cancer to back pain. This article focuses on some of these issues as well as recounting attempts by our research group to address these issues systematically in hopes of shedding light on the nature of abuse issues in the medically ill. Although advances have been made, there is a definite need for large-scale studies that address the issues of identification and treatment of aberrant behavior in medically ill patients in the effort to provide the best possible outcomes for patients with chronic pain.

A Phase I Trial of Olanzapine (Zyprexa) for the Prevention of Delayed Emesis in Cancer Patients: A Hoosier Oncology Group Study

Chemotherapy-induced delayed emesis (DE) can affect up to 50% to 70% of patients receiving moderately and highly emetogenic chemotherapy, although rates are improving. DE most commonly occurs within the first 24 to 48 hours of chemotherapy administration and can persist for 2 to 5 days. Olanzapine, due to its activity at multiple dopaminergic, serotonergic, muscarinic, and histaminic receptor sites, has potential as antiemetic therapy. A phase I study was designed with olanzapine, using a four-cohort dose escalation of 3 to 6 patients per cohort, for the prevention of DE in cancer patients receiving their first cycle of chemotherapy consisting of cyclophosphamide, doxorubicin, platinum, and/or irinotecan. All patients received standard premedication. Olanzapine was administered on days − 2 and − 1 prior to chemotherapy and continued for 8 days (days 0–7). Episodes of vomiting as well as daily measurements of nausea, sedation, and toxicity were monitored at each dose level. Fifteen patients completed the protocol. No grade 4 toxicities were seen, and three patients experienced a dose-limiting toxicity (grade 3) of a depressed level of consciousness during the study. The maximum tolerated dose appeared to be 5 mg (for days − 2 and − 1) and 10 mg (for days 0–7). Four of six patients receiving highly emetogenic chemotherapy (cisplatin, ≥ 70 mg/m2) and nine of nine patients receiving moderately emetogenic chemotherapy (doxorubicin, ≥ 50 mg/m2) had complete control (no vomiting episodes) of DE. Therefore, olanzapine may be an effective agent for the prevention of chemotherapy-induced DE. A phase II trial is underway.

Opioid therapy in patients with a history of substance abuse.

A range of aberrant drug-taking behaviours can occur in patients who are undergoing treatment for chronic pain, especially if opioid therapy is involved. Assessing and understanding these behaviours, and their relationship to addiction (or substance use disorder), can be difficult but it is necessary for assuring quality pain management. Aberrant drug-taking behaviour may be evident, for example, when a patient with pain is unilaterally escalating doses of opioids or using the medications to treat other symptoms or when prescriptions are being mishandled. In patients with a history of substance abuse, these are often serious developments to which a clinician must know how to react. These complex behaviours may be indicative of addiction or may be simply a reaction to under-medicated pain. The clinician therefore is challenged to understand such behaviours and plan interventions accordingly.Although it is becoming increasingly common to avoid opioid therapy in patients demonstrating such challenging behaviours for fear of regulatory scrutiny, clinical management can be tailored to address the many possibilities that might be giving rise to such behaviours. In addition, control over prescriptions can be accomplished without necessarily terminating the prescribing of controlled substances entirely. Optimal medical management of chronic pain in those patients with addiction problems or engaging in problematic behaviours involves careful, ongoing assessment by the clinician as well as a tailored management approach. This approach should use multiple structures including strict contracts, prudent drug selection and frequent follow-ups to pain and addiction treatments, including the use of urine toxicology screening, to maximise the likelihood of a good outcome.

Assessing self‐efficacy for coping with cancer: development and psychometric analysis of the brief version of the Cancer Behavior Inventory (CBI‐B)

Objective: The Cancer Behavior Inventory‐Brief Version (CBI‐B), a 12‐item measure of self‐efficacy for coping with cancer derived from the longer 33‐item version, was subjected to psychometric analysis.

Initial development of a survey tool to detect issues of chemical coping in chronic pain patients.

OBJECTIVE Completely compliant drug-taking behavior is associated with opioid therapy that is usually highly beneficial to the pain patient, whereas frequent and severe aberrant behavior is generally associated with therapy that is potentially harmful to the patient and borders on addiction. There is a large group of patients in the middle between these two extremes: those who display aberrant behaviors periodically, who may additionally have a mixed response to opioid therapy, the overall results of which are less than satisfying (often in the domain of functionality) to the clinician. We have used the term chemical coping to describe this vast middle ground and seek to begin a line of research starting with the development of a clinically useful tool to identify this subset of patients. METHODS A background review is provided to highlight the need for better understanding of chemical coping. In addition, the first steps in creating a chemical coping tool are discussed, including the results of focus group interviews to determine the clarity, understandability of the items, and to assure that they are not objectionable or offensive. A total of 15 patients and 15 professionals completed this phase of the project. RESULTS Both the professionals and patients reported that the items were generally clear and understandable. In addition, although the items cover potentially sensitive topics and some were designed with a provocative edge, the respondents had few requested changes. The researchers are moving forward with the next phase of research. SIGNIFICANCE OF RESULTS The middle ground between compliant medication use and addiction, which we call chemical coping, is poorly understood and woefully underresearched. Despite this gap in our knowledge base, it is an often observed phenomenon. Creating a tool to identify these characteristics can lead to better treatment outcomes and earlier interventions to help improve compliance with medication regimens.

A retrospective chart review of the use of olanzapine for the prevention of delayed emesis in cancer patients.

Chemotherapy-induced delayed emesis (DE) affects approximately 50-70% of patients receiving moderately and highly emetogenic chemotherapy. DE most commonly occurs within the first 24-48 hours of chemotherapy administration and can persist for 2-5 days. Olanzapine, which has been used anecdotally for chronic nausea in advanced cancer patients, might be a useful treatment for the prevention of delayed emesis in chemotherapy patients. We conducted a chart review to explore this hypothesis and to plan potential studies. Using pharmacy records or an electronic medical record, we identified all patients who had received olanzapine in the oncology clinic (n = 98). We reviewed these records and selected all patients (n = 28) who had received olanzapine for the prevention of delayed emesis for structured review. There were 17 women (60.7%) and 11 men (39.3%). Eleven patients (39.3%) had at least one instance of nausea recorded while undergoing olanzapine treatment and seven (25%) had an episode of vomiting recorded. During 95 total cycles of chemotherapy with olanzapine (mean = 3.4 cycles per patient), there were 21 incidents of nausea (22.1%) and 10 instances of vomiting (10.5%). Side effects were rarely noted. These data suggest that olanzapine was well tolerated and may reduce the incidence of delayed emesis in patients receiving moderate to highly emetogenic chemotherapy. A series of prospective trials are underway.

Use of a Depression Screening Tool and a Fluoxetine-Based Algorithm to Improve the Recognition and Treatment of Depression in Cancer Patients: A Demonstration Project

Helping oncologists to identify and treat depression is an important step in improving the overall care of people with cancer. In previous work performed in our community-based, ambulatory oncology outreach network, we validated a depression screening tool, put into place depression screening programs, and taught oncologists how to follow up on screening with brief, reliable clinical interviews. Subsequently, we provided these oncologists with a fluoxetine-based antidepressant algorithm to follow for the treatment of their depressed patients. In this article, we report on the initial experience identifying and treating 35 ambulatory oncology patients who were screened with the Zung Self-rating Depression Scale (ZSDS). Structured follow-up interviews by their oncologist determined whether the patients qualified for a diagnosis of a major depressive episode. These patients then received 1 of 4 treatments based on the algorithm (no treatment, fluoxetine alone, fluoxetine plus bedtime doxepin, or fluoxetine plus methylphenidate). Patients were matched by their oncologist to a prototype patient for each treatment arm based on their symptomatic presentation (i.e., patients requiring a side effect minimization approach were to be placed on fluoxetine alone; patients who had significant insomnia, weight loss, or neuropathic pain were placed on the fluoxetine plus doxepin regimen; those with prominent fatigue were to receive fluoxetine plus methylphenidate). Patients were followed weekly for one month, and then every two weeks for two more months, with telephone assessments of their depression, associated symptoms and overall quality of life. Results suggested that oncologists most often chose the simplest regimen (fluoxetine alone) but that patients uniformly benefited in terms of improved mood and overall quality of life throughout the 12 weeks of follow-up. Our initial experience suggests that oncologists can be empowered to recognize and treat depression in their patients with a screen-and-intervene approach. Such an approach may benefit patients, and, if kept simple, can be incorporated into day-to-day care of people with cancer.