EXECUTIVE SUMMARY

A study of closed claims related to pain management shows the most common injuries. COVID-19 has brought new pain management risks.

  • Insufficient consent was a factor in 90% of claims.
  • Adverse reaction to medications was a common claim.
  • The spinal cord was the area most often involved.

An analysis of closed medical malpractice claims related to pain management identifies common areas of risk and reveals the COVID-19 pandemic has created new possibilities for liability.

The Doctors Company, a professional liability insurer based in Napa, CA, studied medical malpractice claims that closed between 2008 and 2018. A top contributing factor in 90% of all closed claims was insufficient consent between the physician and the patient or family. The most common injuries alleged in claims were adverse reaction to medications (16%), punctures/perforations (11%), and nerve damage (11%).

The spinal cord was the area most often involved in these claims. Improper performance of treatment or procedure was the most common case type. Technical performance was the leading factor that led to claims, followed closely by patient factors. (The study is available at: https://www.thedoctors.com/articles/pain-management-closed-claims-study/.)

The prevalence of some patient injuries changed over the 10-year study period. “While the injuries of adverse medication reaction and death remained steady, the other major injuries demonstrated increases over the studied years,” the study authors wrote. “Emotional distress and infections showed slight increases as the years proceeded. However, nerve damage and punctures/perforations rose at a steeper rate, with puncture/perforation having the most pronounced rise in major injuries.”

The severity of claims also showed variation through the 10 years. The low-severity category remained steady, but medium-severity claims decreased from 56% in the 2008-2013 period to 48% in the 2014-2018 period.

“This drop was manifested in the expanded percentage of high-severity claims during the 2014 to 2018 period, 41% of the claims, compared to 35% during the interval from 2008 to 2013, including a rise in deaths from 16% to 21% during 2014 to 2018,” the authors wrote.

Poor Communication a Problem

The most surprising finding in the study was the ongoing communication problem between physicians and patients, says study co-author Michelle Swift, RN, JD, CPHRM, senior patient safety risk manager with The Doctors Company. With insufficient informed consent as a top contributing factor in 90% of pain management claims, there clearly is a need for improved communication with patients and family members.

“The importance of informed consent cannot be overlooked. With that, we also look at health literacy as a factor to consider with these patients,” Swift says. “This lack of adequate informed consent occurred frequently among the paid claims.”

Educate Physicians on Communication

The 90% figure suggests the consent process is ineffective, she says. Either it is not happening at all, or perhaps the physician is just giving the patient a form to sign without truly explaining the potential risks and benefits. It also is possible the physician is making a good-faith effort to communicate but the patient does not understand.

If the physician is trying to communicate effectively but the patient does not understand, there could be a language barrier, or the information might be provided in a way that is too complicated for the patient to understand. “This happens in all settings, but more so in pain and the other high-level specialties that involve a lot of technical terms and procedures that maybe the patients have a hard time understanding,” Swift explains. “We know that the information must be at a fifth-grade level to be understood by most patients. There’s really a disconnect there. For us, that was surprising because I would think the top issue would be something more like technical or clinical judgment, which were still present in the claims study, but this popped out as the surprise for 90% of the claims.”

Swift says the solution will involve reminding physicians the informed consent process is more than just handing a patient a form. It should be an actual discussion and a time for teaching with models and illustrations, for instance, and it should be well documented. It also is important to allow the patient to acknowledge understanding. The physician should be confident the patient understands the information and is not just nodding yes to be compliant.

Swift notes pain patients may find it especially hard to focus and participate in informed consent. “When you’re in pain, you don’t always have the ability to hear information and focus on what is coming at you. It takes a lot of repetition in your communication, engaging in that discussion, and involving the family,” she says.

Timeouts Necessary for Pain Procedures

Swift says a good risk reduction tactic in pain management would be to ensure physician practices are following the timeout procedure in which the entire team pauses immediately before beginning the procedure to confirm crucial information such as the patient’s identity, surgery location, and the planned procedure. Although required as part of the Universal Protocol by The Joint Commission and other accrediting bodies, Swift says timeouts may not be routine at some physician practices performing pain procedures.

“Timeouts are pretty well recognized and followed at most hospitals and surgery centers, but pain practices that do a lot of procedures may not implement that timeout checklist within their organization,” Swift says. “Many of these physicians have in-office facilities, and that checklist should include correct site, review of medications the patient is currently taking, the correct identification, and having the patient participate in that timeout verification as much as possible.”

A separate anesthesia provider can be helpful, controlling the level of sedation so the patient can respond as needed during the timeout checklist and possibly during the procedure.

“The implementation of a checklist and a timeout for pain procedures is something I really advocate for, and I’m just not seeing it put into play,” Swift says.

COVID-19 Adds More Risks

COVID-19 has affected pain management, says Christopher Malinky, MD, chief medical officer of Interventional Pain Management in Colorado Springs, CO. Malinky contributed to the closed claims study.

If patient is infected, the procedure is delayed for two weeks until he or she is asymptomatic, Malinky says. For patients who test positive for long periods, the consensus has been to wait for 14 days, and if the patient is asymptomatic, then it is safe to proceed.

More complex procedures, such as spinal cord stimulation and intrathecal pumps, also can lead to delays depending on the policy of the ambulatory surgery center and anesthesia group, Malinky explains. Delays can lead to a wide range of issues, including increased narcotic consumption.

“As a physician, I am worried about patients who use opioids and the potential for adverse events if they become infected with COVID without realizing it, or have a fast decline. This sort of respiratory compromise combined with narcotics definitely increases the risk of respiratory issues and is very difficult to deal with or prevent,” he explains. “Patients in skilled nursing facilities where breakouts have occurred can be very difficult to adequately evaluate. My practice has not had those patients be seen in office as we want to prevent further spread to our staff or other patients.”

Trying to see those patients via telehealth can be challenging, especially if they are not tech savvy. “Other at-risk patients have also been seen via telehealth. As a provider, you cannot examine the patient, and it is hard to get any feel or sense of what is going on with the patient if there is a problem,” Malinky says. “Body language, patient behavior, and face-to-face interaction does provide some valuable information when treating patients, and theses variables are almost absent on telehealth visits.”

COVID-19 Patients at Greater Risk

Patients who have been ill with COVID-19 and required hospitalizations often are more anxious, as a healthcare office tends to bring memories and fears back to the patient, Malinky says. This can lead to larger doses or more patients than normal receiving sedation when procedures/injections are performed.

In theory, this can raise the risk of complications from IV sedation, such as aspiration, hypoxia, or nausea/vomiting. Patients have been more anxious about the future than in previous years, and are exhibiting more depression and anxiety.

“This can be from illness, family deaths, lack of social interaction, loss of job/income, or lack of any enjoyable activities and exercise,” Malinky explains. “Primary care providers have not been able to deal with this large increase in depression and anxiety, so patients have been self-treating or simply worsening as a result.”

Malinky notes an increase in abnormal urinalysis results for illicit drugs in his practice in 2020. The combination of drugs is dangerous, but also requires consideration of dismissing that patient from the clinic for breaking his or her narcotic contract.

In addition, depression and anxiety can worsen pain (or give a patient the sense of worsening pain) and can lead to repetitive requests for escalated narcotic doses. This can be dangerous; does not address the real, underlying problem; and places stress on medical providers, Malinky says.

“Having a discussion with patients in which you decline to prescribe more opioids is stressful, time-consuming, and frustrating for providers. It also requires a lot of energy to have these discussions repeatedly and not relent to their demands,” he says. “This, in addition to constant cleaning/sterilization, mask-wearing, and increased vigilance can lead to provider and staff burnout. This is becoming more of a problem as the pandemic continues with little hope for a quick resolution.”

Naloxone Necessary for Some Patients

Swift says that because of the drug use risks exacerbated by COVID-19, it is important for physicians to make naloxone available to the patients and families of patients who are at high risk for an overdose.

“Having naloxone at home with those patients is critical, and even more so now with COVID-19,” she says. “Patients having procedures may be on steroids or anticoagulants post-COVID treatment, so a pain physician really needs to focus on the COVID considerations with pain management, whereas previously that wasn’t really a consideration. It needs to be part of the treatment plan.”

Burnout and staff shortages can lead to less thorough care, missed details, and a decline of patient-provider relationships, Malinky says. The increase in patient depression and anxiety has been significant, and was not really considered early in the pandemic.

Malinky says he expects many of these issues will continue for the foreseeable future. The emergence of new strains and the lack of detailed medical knowledge about COVID-19 and all its potential health effects creates an atmosphere of ambiguity and confusion. These factors can create more risk.

“I think it will be important for all providers to continue to educate themselves about COVID and its effects. Professional societies have been updating policies continuously to help educate their members,” he says. “Physicians will need to stay up to date with the changing nature of the virus. Simply ignoring or procrastinating this type of learning will lead to more mistakes, higher liability, and a longer pandemic.”

SOURCES

  • Christopher Malinky, MD, Chief Medical Officer, Interventional Pain Management, Colorado Springs, CO. Phone: (719) 228-9440.
  • Michelle Swift, RN, JD, CPHRM, Senior Patient Safety Risk Manager, The Doctors Company, Napa, CA. Phone: (866) 804-2664.