The medical and psychiatric comorbidities of the patients and an overview of the pharmacologic agents involved in the claims, comparing those claims associated with death with the nondeath claims, are detailed in Table 3. The pulmonary and cardiac medical comorbidities were present in a total of 7 patients. Four patients had 1 cardiopulmonary comorbidity, 2 patients had 2 cardiopulmonary comorbidities, and 1 patient had 3 cardiopulmonary comorbidities. All the cases resulting in patient death involved patients prescribed opioids; the majority of cases not resulting in death also involved patients prescribed opioids. Methadone was implicated in 6 of the cases resulting in patient death and 3 of the cases resulting in other patient outcomes. Buprenorphine was implicated in none of the cases in this series.
Allegations of improper medication management represented 65% of claims, and all the cases resulting in patient death were associated with alleged improper medication management. Of the cases involving a patient death, in 4 cases, aberrant drug behaviors were apparent before the patient death. In 1 instance, a prescription of >300 mg daily of oral morphine equivalents was provided to a 44-year-old man with obstructive sleep apnea (OSA) for cervical degenerative joint disease pain despite multiple lost prescriptions and early refill requests, and without urine toxicology screening or other compliance measures. This patient was transitioned at the patient’s request to methadone and found dead a few days later having overdosed on methadone and nonprescribed benzodiazepines. In 4 other cases, no aberrant drug behaviors were apparent until after the patient was found dead. For example, a 53-year-old man without significant medical or psychiatric comorbidities with lumbar degenerative joint disease had a longstanding prescription of methadone and low doses of oxycodone for breakthrough pain. This patient underwent frequent urine toxicology tests, had an opioid contract, displayed no aberrant behaviors, and also underwent interventional pain procedures as part of a multimodal treatment plan. He was found dead with cocaine and nonprescribed benzodiazepines in his system. In the remaining 9 cases involving a patient death, the patient was found to have cooperated in their care. One such case described a prescription of a fentanyl patch to a 28-year-old woman with a connective tissue disorder with failed back surgery syndrome as well as an aortic dissection who underwent appropriate compliance testing but was found dead. No autopsy was performed because it was thought her underlying cardiac pathology was more likely the cause of death than her stable opioid regimen.
Five cases involved abandonment claims, all resulting from physicians refusing to provide opioid refills or imposing an opioid taper when patients had inappropriate urine toxicology tests or other red flags—including 1 case in which a patient repeatedly presented in an intoxicated state to the clinic. Abandonment claims also occurred in instances in which physicians initiated termination of the patient–physician relationship and simultaneously provided a short course of opioids to prevent potential withdrawal and an instance in which a physician recommended that a patient with multiple psychiatric comorbidities be comanaged with an addiction psychiatrist. None of these 5 cases resulted in a payment to the claimant; median and mean total amount incurred by the insurance carrier in these cases were $750 and $2653, respectively. A related allegation was of iatrogenic addiction, representing 3 cases, which in this series usually involved younger patients. In 1 case, a 22-year-old man referred to a pain physician for sciatica was prescribed oxycodone 30 mg 4 times daily, acetaminophen/hydrocodone 10–325 mg 4 times daily, amphetamine/dextroamphetamine 20 mg 3 times daily, and alprazolam 2 mg 3 times daily. No treatment modalities other than medication were offered, and no imaging other than an x-ray was obtained. This patient was later arrested for heroin use and claimed addiction. Two of these 3 cases were settled; the median and mean total amount incurred were $68,133 and $110,778, respectively.
Other cases in this series pertained not directly to the medications prescribed, but to issues that arose during medication management. For example, one such case described an allegation of “failure to diagnose,” which was the result of a patient managed medically across multiple office visits for knee pain, with the treating pain physician having failed to notice that the available knee imaging showed an operative tibial plateau fracture. In a “wrong procedure” allegation, a physician ordered a cervical spine magnetic resonance imaging despite the patient having shrapnel in his eyes, resulting in vision deficits. Allegations of “sexual misconduct” stemmed from physician sexual advances; in 1 case, a physician later admitted to exchanging sexual intercourse for opioid prescriptions.
The factors determined to most frequently contribute to the filing of a claim in this series are listed in Table 4. From the categories listed in Table 4, 2 cases had no factors, 9 cases had 1 factor, 17 cases had 2 factors, 6 cases had 3 factors, 1 case had 4 factors, 1 case had 5 factors, and 1 case had 6 factors.
These factors were derived from the CRICO taxonomy system. Most common were patient behavior–related factors, followed by deficits in clinical judgment, communication, and documentation.
In our chronic pain medicine analysis, outpatient medication management represented 22% of claims. Previous malpractice studies have shown a similar incidence of this type of claim: The ASA Closed Claims Project noted that from 2000 to 2012, medication management represented 17% of all chronic pain medicine claims.14 In this CRICO analysis of closed claims related to outpatient medication management for chronic pain, approximately half (49%) of cases involved an allegation of patient death due to improper medication management of nonmalignant chronic pain. Patient medical comorbidities (ie, cardiopulmonary disease) and long-acting opioids were more closely associated with death than with other outcomes. Psychiatric comorbidities and aberrant drug behaviors were not as closely associated with death as were medical and pharmacologic factors. Other claims ranged from alleged addiction to opioids from improper prescribing to alleged abandonment with withdrawal of care. The analysis suggested that patient behavior contributed to over half of these claims, whereas deficits in clinical judgment contributed to approximately 40% of the claims filed. When treating opioid-dependent patients with complex medical and psychiatric comorbidities, our analysis leads us to suggest that physicians should educate patients about the risks, benefits, and alternatives of opioid therapy, perform compliance monitoring, and maintain vigilance for aberrant behaviors. These recommendations echo the recent CDC guidelines for prescribing opioids for chronic pain. We propose that these efforts would improve patient safety and minimize legal risk.
Claims Involving Patient Death
Our analysis builds on previous literature showing that opioid overdose and death are associated with certain cardiopulmonary and psychiatric comorbidities. Prior clinical studies have illustrated a dose-dependent relationship between chronic opioid use with sleep apnea and disordered breathing,16–18 as well as a relationship between pulmonary disease or sleep apnea with opioid overdose in patients taking opioids for chronic lower back pain.19 Prior closed claims studies have also shown that, in the perioperative setting, obesity and OSA are associated with fatal respiratory depression in patients receiving opioids.20 In that perioperative claims study, obesity was noted in 66% of cases and OSA or a high suspicion of OSA was noted in 25% of cases. In our outpatient claims study, in cases involving patient death, obesity or OSA was noted in 22% of cases and chronic obstructive pulmonary disease (COPD) was noted in 11% of cases. Comparing the cases in our series involving death versus some other outcome, the presence of medical conditions affecting the pulmonary system (ie, OSA, obesity, COPD) were associated with death (P = .029). Based on this information alone, no causal relationship can be made between these pulmonary conditions and death in patients prescribed opioids, in part because the precise inciting etiology of death (eg, apnea versus cardiac arrhythmia) is often not known in outpatient claims. As previously stated, the small size and observational nature of this analysis also substantially limit the ability to make clinically significant conclusions or comment on any causal relationships. The association does, however, suggest additional caution should be exercised in patients with pulmonary comorbidities, such as OSA or COPD, who are prescribed opioids.
Furthermore, prior clinical trials have demonstrated an association between mood disorders, substance use disorders, and other psychiatric comorbidities with opioid misuse and overdose.21–23 Our study did not show that claims involving a patient death were more likely to involve a psychiatric comorbidity (eg, major depressive disorder, suicide attempt, prior substance use disorder) (P = .07), although the claim numbers in our analysis were small. The 2010 ASA closed claims study on medication management in pain medicine has shown depression, history of a suicide attempt, and substance use disorder present in 86% of claims. Our study showed that these same factors as well as psychosis were present in 61% of all claims, indicating a correlation between these factors and medicolegal activity.
Both medical and psychiatric comorbidities likely contribute to patient death, although the extent to which each type of comorbidity precisely contributes remains unclear and strong conclusions cannot be drawn from the present study. Interestingly, in this analysis, medical comorbidities appeared to be more strongly associated with patient death than were psychiatric comorbidities. In previous studies, aberrant drug–related behaviors (eg, using prescription analgesics faster than prescribed, obtaining prescription pain medications from nonprescription sources) were linked to opioid use disorders24 and death.25 Such aberrant drug–related behaviors were indeed present in many of the claims in this series involving a patient death. These behaviors were, however, statistically significantly more common in claims in this series not involving a patient death (P = .04). The 2010 ASA closed claims study on medication management in pain medicine identified 43 adverse drug–related behaviors (ADBs) in the 51 claims studied, with claims associated with death more likely to have 3 or more ADBs. Analyzing the same behaviors in our study, we identified 22 ADBs in the 31 claims studied, but did not note claims associated with death being more likely to have 3 or more ADBs (P ≥ .05). Together, these observations suggest that medical cardiopulmonary comorbidities may play a greater role in increasing a patient’s risk for death from opioid misuse than do psychiatric comorbidities or aberrant drug behaviors such as “doctor shopping” or “failing” a urine toxicology test.
Our analysis also builds on previous literature linking opioids and patient death. Prior clinical studies have associated prescription of long-acting opioids for chronic noncancer pain with death.26 The 2010 ASA closed claims study on outpatient pain medicine has also associated long-acting opioids for noncancer pain with death, compared to other outcomes (93% of death claims, 59% of nondeath claims, P = .005). Similarly, the present study showed a statistically significant preponderance of long-acting opioid prescriptions in the claims involving patient death compared to other outcomes (35% of death claims, 10% of other claims, P = .03). Due to the small sample size and insufficient information in some instances on dosage, we cannot comment, as has been done in previous studies, on an increased risk of death when crossing a certain threshold of morphine equivalent dose.27 Similarly, while previous work has illustrated an increased risk of death when opioids are combined with benzodiazepines or other psychotropic medications,28,29 we could not with our sample size perform a detailed analysis on the coadministration of opioids with other sedating medications. We did note, however, that among cases involving a patient death, all of which involved prescription of opioids, there was an association with psychotropic or sedating medications (P = .03). Likewise, methadone has been associated with an increased risk of out-of-hospital patient death30,31 but did not reach statistical significance with the patient death claims in this series (P = .18), despite being present in approximately one-third of death claims. The coprescription of an opioid with a psychotropic medication and the relative frequent administration of methadone—usually not a prescriber’s analgesic first choice—could instead reflect that the patients in this series are medically complex and high risk. That is, even if the patient does not have a verified permanent disabling outcome as a result of the pain care provided, that patient requiring medical management of psychiatric comorbidities and methadone maintenance is potentially more likely to be involved in a legal claim. Furthermore, the absence of claims involving buprenorphine, a partial agonist opioid with a respiratory depression ceiling effect, could reflect the overall superior safety margin and manageability of this medication compared to methadone.30
Addiction and Abandonment
The notion that allegations of addiction as well as abandonment are part of the risk of prescribing pain medications is supported by the current series, as well as the existing literature. The 2010 ASA closed claims study on medication management in pain medicine found, for instance, that allegations of addiction represent 24% of all claims. Indeed, patients may complain of iatrogenic addiction to opioids (or some other medication) and then abandonment when a change is made in the care plan. In that vein, in the present study, 21% of all claims pertained to either allegations of addiction, abandonment, or both. To identify the patients who are most appropriate for chronic opioid therapy, pain society guidelines,33,34 CDC guidelines, and risk evaluation and mitigation strategies from the Food and Drug Administration for long-acting opioids offer some guidance.35 Among these recommendations are the use of a screening questionnaire such as the Opioid Risk Tool,36 a clear assessment of the patient’s chronic pain diagnosis, and documentation at each visit of the opioid’s effect on analgesia, activities of daily living, adverse side effects, and any aberrant drug behaviors. No prescribing physician in this series utilized all of those assessment tools.
Similarly, physicians are at risk for claims of abandonment, defined as “A unilateral severance of the physician-patient relationship without reasonable notice, at a time when there is still the necessity for continued medical attention.”37 Prior studies have suggested that to avoid claims of abandonment, physicians should document informed consent regarding the risk of addiction with opioid treatment.38 Also, if care is terminated, then the reasons for termination should be documented in the chart, a letter sent to the patient via certified mail, a 30-day notice offered, the need for continued medical care conveyed, and the patient given a referral to a number of other providers.39 Again, no physician named in this series with an allegation of abandonment had documented following all those steps.
From a financial perspective, the observation that none of the abandonment cases settled and that the legal fees for these cases were very low (median, $750; mean, $2653) might provide reassurance to physicians hesitant to deny inappropriate and harmful patient demands. Concomitantly, the higher incidence of settlement and the higher legal fees for claims related to iatrogenic addiction are yet another reason to give pause to a physician practicing medical management.
Global Contributors to Claims
Ultimately, the factors contributing to the alleged patient injuries and the legal claims originate from both the patient and the physician. Prior closed claims studies on outpatient medication management in pain medicine have identified risk stemming from patient noncompliance, physician error due to knowledge deficits, and system-based problems.40,41 The present study uses algorithmically determined contributing factors to support this idea. Patient behavior was thought to contribute to over half of claims, deficits in clinical judgment to over 40% of claims, communication to approximately a 30% of claims, and documentation to approximately 20% of claims.
The limitations of closed claim studies have been described previously.42 These studies do not include all the complications in pain medicine and are more likely to represent instances where severe injury has occurred, in part because these cases are more likely to result in financial compensation. Closed claim analyses are also retrospective and without a control, unable to comment definitively on a cause–effect relationship. These data are also not randomized and are blinded in terms of geography; applicability to a particular provider’s practice is therefore diminished. In addition, the small sample size of this study results in a low power to detect clinically important differences. The presence of multiple comparisons within a small data set also increases the risk of falsely finding an association where none is present. While we attempted to control for this risk through calculation of the FDR, we cannot exclude the occurrence of a type I error. Finally, the contributing factor criteria and other coded fields provided by CRICO are proprietary and cannot be independently verified.
Claims related to outpatient medication management in pain medicine are multifactorial, stemming from deficits in clinical judgment by physicians and noncooperation in care by patients. Minimization of both legal risk and patient harm can be achieved by carefully selecting patients for chronic opioid therapy and evaluating compliance and improvement with the treatment plan. Medical comorbidities and the use of long-acting opioids in combination may be particularly dangerous.
Name: Christopher R. Abrecht, MD.
Contribution: This author helped design the work, collect and analyze the data, draft and revise the manuscript, and coordinate the other authors’ contributions.
Name: Ethan Y. Brovman, MD.
Contribution: This author helped design the work, collect and analyze the data, include the statistical analysis, and revise the manuscript.
Name: Penny Greenberg, RN, MS.
Contribution: This author helped design the work, analyze the data, and revise the manuscript.
Name: Ellen Song, BA.
Contribution: This author helped collect and analyze the data and revise the manuscript.
Name: James P. Rathmell, MD.
Contribution: This author helped design the work and revise the manuscript.
Name: Richard D. Urman, MD, MBA.
Contribution: This author helped design the work, revise the manuscript, and coordinate the other authors’ contributions.
This manuscript was handled by: Honorio T. Benzon, MD.
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© 2017 International Anesthesia Research Society
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