Widespread use of narcotic pain medication in orthopaedic surgery is risky—not only to patients, but to prescribing physicians as well—according to a group of experts assembled for the AAOS webinar on “Risk Evaluation and Management Strategies For Prescribing Opioids.” The webinar focused on the increasing risks and regulations surrounding the prescription of narcotic pain medication in orthopaedic surgery.
Moderated by Thomas B. Fleeter, MD, chair of the AAOS Medical Liability Committee, the webinar featured a stellar faculty. Representatives from government, pain management, and orthopaedic surgery reviewed the problem and outlined risk management strategies.
The degree of diversion
According to Sharon Hertz, MD, deputy director at the U.S. Food and Drug Administration (FDA) division of anesthesia, analgesia, and rheumatology products, diversion of narcotic pain medications from legal to illegal uses is increasing.
Dr. Hertz noted that more than 50 million Americans were prescribed some type of narcotic pain medication in 2011. This represents almost double the number who used narcotics in 2008. This increase in the use of narcotics for medical uses corresponds to an increase in the diversion of narcotics to nonmedical users.
For example, in 1990, an estimated 627,000 people used narcotics recreationally for the first time. By 2005, that number had more than tripled—to 2.2 million recreational drug users. More worrisome is the fact that most recreational drug users don’t get their pills from street dealers, but from friends or relatives. The implication is that physicians are prescribing too many pills when dispensing narcotic pain medication.
To address this issue, the FDA has introduced the “Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy,” or ER-LA Opioid REMS program for physicians. This voluntary program seeks to curb abuse by educating physicians who prescribe these powerful, long-acting narcotic pain medications and providing them with tools that enable them to counsel patients and improve safety.
The 3-hour education program is approved for continuing medical education credit and is advised for physicians who prescribe long-acting medications such as listed in Table 1. It is not intended for those prescribing shorter acting medications such as hydrocodone or Endocet.
The program also aims to increase patient awareness of risks with narcotic pain medication by developing one-page summaries of the drug medication guides. Information on the program is available at www.ER-LA-opioidREMS.com
The dangers of abuse
Michael Ashburn, MD, MPH, MBA, professor of anesthesiology and pain management at the University of Pennsylvania, then discussed some of the medical dangers of narcotic abuse. He agreed that addiction is becoming an increasingly serious problem. The United States consumes 99 percent of the world’s supply of narcotics, and the use continues to accelerate. During the decade from 1997 to 2007, U.S. per capita retail purchases of hydrocodone increased 4-fold, while purchases of oxycodone increased 9-fold, and methadone use increased 13-fold. During that same period, opioid overdose fatalities increased 68 percent.
Dr. Ashburn noted that no compelling reason exists for prescribing this volume of narcotics. He said that there is no good evidence that narcotics control chronic noncancer pain. In his opinion, opioids are best used when integrated with other pain management modalities such as physical therapy, exercise, and healthy lifestyle habits. When opioids are used to manage chronic pain, efficacy to justify continued use should be documented, and physicians must stop writing or renewing prescriptions if there is any evidence of abuse or diversion.
As chief of shoulder and sports medicine at the University of Toledo, an attorney, and a member of the AAOS Medical Liability Committee, I was asked to discuss the legal liabilities of prescribing narcotics for pain management. I noted that physicians are caught between the need to help control pain and the risk of overprescribing narcotic pain medication.
For example, a California internist was sued for $1.5 million for inadequately controlling back pain in a patient with terminal, metastatic disease. Although the jury agreed that the physician did not violate any standards of care, the physician was successfully prosecuted under elder abuse statutes. On the other hand, a Florida physician who performed a cursory physical exam and conducted a 5-minute patient interview triggered an audit when he dispensed 120 oxycodone pills. The audit revealed that many of the physician’s patients had criminal records, and he was subsequently prosecuted for drug trafficking under the Controlled Substances Act (CSA).
Unfortunately, no guidelines exist for the dispensation of pain medications. Title 21 of the CSA states: “No controlled substance may be dispensed without a prescription, except when dispensed directly by a practitioner to the ultimate user.” The Drug Enforcement Agency interprets this to mean that the prescription must be issued for a “legitimate medical purpose” by a registered physician acting within the usual course of professional practice.
Although the statute is vague on what constitutes “legitimate medical purpose,” case law provides some guidance. For example, the Fifth Circuit noted the following red flags that may indicate illegitimate use:
- Inordinate quantities prescribed
- No physical exam performed
- Prescriptions given even after the physician was told that the patient was selling the medication
- Inconsistent intervals between prescriptions
- Use of street slang instead of formal names (eg, “Vikes”)
- No logical relationship between medications and the underlying condition
For these reasons, pain medication should be prescribed according to set protocols. For example, after rotator cuff repair, narcotic pain medication will be prescribed at defined intervals in defined quantities. Narcotics should only be prescribed under the direction and supervision of physicians and preferably only after physical exams are performed.
To protect against underprescription lawsuits, physicians should document any abuse. If normal pain protocols are insufficient to control the pain, the physician should refer the patient to a pain management service for consultation or, if the patient is terminally ill, to hospice.
Pain medications and patient safety
After the AAOS Patient Safety Summit in 2012, a group of hand and foot surgeons looked at major safety issues regarding outpatient surgery. According to David C. Ring, MD, chief of the Harvard Hand Service, opioid misuse was one of the major safety risks identified. Because the number one cause of death in young adults is opioid overdose, the group believes that the way physicians think about and manage postoperative pain needs to undergo a paradigm shift.
Dr. Ring noted that neither fracture severity nor the number of fractures can predict a patient’s heavy use of postoperative narcotics. However, psychological factors such as anxiety, depression, and catastrophic thinking are good predictors. He explained that catastrophic thinking focuses on the worst possible negative outcomes of any situation. For example, a patient who will need to miss 6 weeks of work and thinks constantly about how he will likely lose his job, then lose his house, and become completely incapacitated, engages in catastrophic thinking.
Dr. Ring also suggested postoperative pain may be controlled with drugs other than narcotics. He cited an international study comparing the management of postoperative pain after surgical treatment of ankle fractures. In the Netherlands, acetaminophen or tramadol is used to control pain, while oxycodone is used in the United States. However, in both situations, pain relief and patient satisfaction are the same.
Another study looked at the amount of narcotics administered during hospitalization after fracture surgery to see if a correlation could be found among narcotics given, pain relief, and patient satisfaction. Dr. Ring reported that increasing narcotics dosage did not correlate with better pain relief and that the factors that predicted higher use of narcotics were depression, anxiety, smoking, and previous narcotics use. He pointed out that these studies illustrate the need for physicians to rethink an opioid-centric model of controlling postoperative pain.
Is there an answer?
In summary, it is clear that narcotics are being overprescribed. Diversion is an increasingly common problem, leading to abuse and overdose-related deaths. Additionally, physicians who prescribe high-risk narcotics should strongly consider participation in the FDA’s ER-LA Opioid REMS program.
Physicians should also consider adopting pain management protocols to mitigate risk and reach out to pain management and hospice services when those protocols do not adequately control pain. Finally, physicians may need to reconsider the liberal use of narcotics in managing postoperative pain. Large dosages of narcotics may not be as necessary or effective as previously thought and may be a good deal more harmful from a public health perspective.
David H. Sohn, JD, MD, is the editor of Orthopaedic Risk Manager articles.
Editor’s Note: Articles labeled Orthopaedic Risk Manager (ORM) are presented by the Medical Liability Committee under the direction of David H. Sohn, JD, MD, ORM editor.
Articles are provided for general information and are not legal advice; for legal advice, consult a qualified professional.
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- Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy www.er-la-opioidrems.com
- Bergman v. Chin, No. H205732-1 (Cal. App Dept Super Ct 1999)
- United States v. Rosen, 582 F.2d 1032 (5th Cir 1978)