With the increasing focus on the overprescribing of opioids, and the concurrent jump in opioid-related addiction and mortality, there is also a growing emphasis on provider competence and responsibility. This effort is highlighted by the 2016 release by the Centers for Disease Control and Prevention of provider guidelines pertaining to opioid prescribing, with the aims of improving patient safety and reducing associated risks.1
The analysis of closed malpractice claims can provide valuable insights into the various factors that may be common in these cases. In a 2010 analysis examining closed claims involving prescription opioids, it was determined that 82% of cases involved patients who were noncooperative in their care, physicians who inappropriately managed prescriptions, or both.2 Earlier findings from the American Society of Anesthesiologists Closed Claims Project are believed to have led to improvements in patient safety.3
“Vigilance for the aberrant drug behaviors identified in that study and identification of the prescribing patterns from that period associated with patient death may have raised physician awareness about the risks of opioid prescription and led to improved patient safety,” wrote the authors of a recent medicolegal analysis published in Anesthesia and Analgesia.4 The article follows a similar study by the same authors on the topic of implanted devices for chronic pain management.5
To add to and update results from prior analyses of closed malpractice claims, researchers at the University of California, San Francisco, and Brigham and Women’s Hospital in Boston, Massachusetts, examined closed cases from the large database (>350,000 claims) of Controlled Risk Insurance Company, a US malpractice carrier. They “hypothesized that there are identifiable patient comorbidities and behaviors as well as prescriber clinical practices associated with patient injury that may result in a malpractice claim.”4
Each file reviewed contained information regarding patient demographics, medical comorbidities, the event alleged to have caused damage and the alleged resulting outcome, testimony from expert witnesses, and the total financial compensation and legal fees incurred.
In a search spanning 2009 to 2013, the authors identified 37 cases (59.5% men; mean age, 43.5 years) involving noninterventional outpatient management of chronic pain. It was found that 27% of cases resulted in payments, which ranged from $7500 to $687,500 (median, $72,500).
Improper medication management was the alleged damaging event in 65% total cases, and in all cases involving death. Less common allegations included abandonment, failure to diagnose, and sexual misconduct.
The predominant diagnoses were degenerative joint disease of the spine (56.8%), followed by failed back surgery syndrome (16.2%), osteoarthritis of the knee (10.8%), peripheral neuropathy (10.8%), brachial plexopathy (2.7%), and migraine (2.7%). The most common anatomical location of pain was the back (46% of cases), followed by the neck (10.8%), lower extremities (8.1), and other sites. Multiple pain sites were noted in 21.6% of claims.
Death occurred in 49% of cases. Other outcomes resulting from the alleged damaging event included emotional trauma (38%) and addiction (5%). Cardiopulmonary comorbidities and the use of long-acting opioids were more common in claims that involved a death vs those that did not involve a death.
Consistent with earlier findings in other treatment settings, obstructive sleep apnea or obesity were observed in 22% of claims, and chronic obstructive pulmonary disease was present in 11% of cases. Such comorbidities were shown to be associated with death in the comparison of claims involving death vs nondeath claims (P =.029). Although no causal relationship can be inferred from this finding, the association suggests that special caution is warranted in prescribing opioids to patients with these conditions. Long-acting opioids were implicated in 35% of death claims vs 10% of other claims (P =.03).
The results further indicate that patient behavior, including treatment noncompliance and failure to complete follow-up appointments and tests, contributed to 54% of all claims. Poor clinical judgment, such as inadequate patient assessment, therapy selection, and monitoring, appeared to contribute to 43.2% of claims, whereas provider communication and documentation issues were identified as contributing factors in approximately 30% and 22% of claims, respectively. Less common contributing factors were technical and administrative issues (5.4% each).
None of the prescribing physicians had undertaken all the steps recommended in the guidelines from the Centers for Disease Control and Prevention, professional pain societies, and the US Food and Drug Administration, including the “use of a screening questionnaire such as the Opioid Risk Tool, 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,” according to the authors.6-8 “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,” they concluded.
- Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65:1-49.
- Fitzgibbon DR, Rathmell JP, Michna E, Stephens LS, Posner KL, Domino KB. Malpractice claims associated with medication management for chronic pain. Anesthesiology. 2010;112:948–956.
- Lee LA, Domino KB. The Closed Claims Project. Has it influenced anesthetic practice and outcome? Anesthesiol Clin North America. 2002; 20(3):485–501.
- Abrecht CR, Brovman EY, Greenberg P, Song E, Rathmell JP, Urman RD. A Contemporary medicolegal analysis of outpatient medication management in chronic pain. Anesth Analg. 2017;125(5):1761-1768.
- Abrecht CR, Greenberg P, Song E, Urman RD, Rathmell JP. A contemporary medicolegal analysis of implanted devices for chronic pain management. Anesth Analg. 2017;124(4):1304-1310.
- Bolden JL, Calixto F, Beakley BD, et al. Prescription opioid abuse in chronic pain: an updated review of opioid abuse predictors and strategies to curb opioid abuse: part 1. Pain Physician. 2017;20(2S):S93-109.
- Calixto F, Beakley BD, Galan V, et al. Prescription opioid abuse in chronic pain: an updated review of opioid abuse predictors and strategies to curb opioid abuse (part 2). Pain Physician. 2017; 20(2S):S111–33.
- US Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids. Available at: https://www.fda.gov/downloads/drugs/drugsafety/postmarketdrugsafetyinformation
forpatientsandproviders/ucm311290.pdf. Updated June 2015. Accessed December 4, 2017.