Risky prescriptions


Risky prescriptions

Prescription drug abuse is an epidemic with medical professional risks. Michelle Foster Earle, president of OmniSure Consulting Group, gives a personal perspective and outlines strategies for curbing the problem.

In order to examine how best to tackle the issue of prescription drug abuse it is helpful to start with a real-life example.

"Patients who have learned to manage this chronic condition with the help of their peers and the medical community have launched a grassroots campaign to educate policymakers."

 A doctor’s insurance broker called the OmniSure helpline for risk management support, voicing the initial concern that a procedure performed by his client, a cosmetic surgeon, had resulted in a patient’s death at home on the following day.

When our consultant called the doctor to discuss the details, however, she discovered that the more likely cause of death was prescription overdose. The doctor suspected that his patient had a problem with opioid abuse, and he was regretting the fact that he had nevertheless sent her home with powerful painkillers following a breast augmentation and tummy tuck.

This is just one of the many calls OmniSure receives on a regular basis about events with the potential to result in expensive medical professional liability claims, many centered around the nation’s prescription drug abuse epidemic, specifically opioid painkillers.

A costly problem

For an idea of the financial impact to the insurance industry, consider that for workers’ compensation insurance companies, medical payments have increased from 46 percent of claim costs in 1987 to approximately 60 percent, with much of the shift related to pain management and the use or abuse of prescription pain medications.

A recent article in Property Casualty 360 quotes one well-known carrier calling opioids “workers’ compensation’s worst enemy”.

Even non-medical use of painkillers results in more $72.5 billion in direct healthcare costs. The Centers for Disease Control and Prevention (CDC), the White House, the National Institute on Drug Abuse (NIDA), the American Medical Association (AMA), The Joint Commission, and numerous other organizations and associations are all looking for ways to combat the epidemic. And although there is not much data on the impact of opioid abuse on medical malpractice claims, medical professional liability carriers are taking notice.

A Sentinel Event Alert by The Joint Commission in August 2012 noted that adverse events can occur with the use of any opioid—medications such as fentanyl, hydrocodone, morphine, oxycodone, methadone, and others.

Drug-to-drug interactions are common, as are falls due to dizziness or hypotension, respiratory depression, and addiction. But the adverse outcome that has received the most attention is the alarming number of deaths, specifically overdose deaths, which have more than tripled in the past 20 years, killing more than 16,651 people in the US in 2010, and doubling emergency department visits in the last five years to half a million.

Widespread abuse

All this is just the tip of the iceberg according to Dr Nora Volkow, director of NIDA, who addressed thousands of medical professionals, political officials, and law enforcement professionals at the National Rx Drug Abuse Summit in April.

She’s right. This author can name a long list of colleagues, clients, family members, former employees, and celebrities who have battled a dependence on opioids. Client physicians and even a former family physician developed an addiction to opioids.

Nothing signifies that this is the tip of the iceberg quite as clearly as the fact that in May 500 former professional football players filed suit against the National Football League claiming the NFL doctors never told them about the effects of painkillers. At the same time, two counties in California and the city of Chicago filed suits against opioid drug makers alleging their responsibility for the addiction epidemic.

Although Volkow doesn’t go into detail about what might be under the surface, the CDC estimates that for every overdose death, 10 people are admitted to the hospital for treatment following abuse, 32 are seen in the emergency room, 130 are abusing or addicted, and 825 are using opioids for non-medical use.

Legal implications

Add to that the dramatic increase of neonatal abstinence syndrome, a medical term to describe infants suffering from withdrawal symptoms after birth by an addicted mother, and it’s not hard for a healthcare risk manager to imagine the list of potential medical professional liability claims that might result. Allegations would include:

  • Lack of informed consent;
  • Over-prescribing, under-prescribing, irresponsible prescribing of opioids;
  • Failure to screen for risk of drug interactions;
  • Failure to screen for opioid addiction or risks;
  • Failure to diagnose opioid addiction; 
  • Failure to treat opioid addiction;
  • Lax procedures to protect prescription pads;
  • Failure to educate patient on proper disposal to prevent theft or unintentional overdose by a minor; and
  • Failure to screen for, diagnose, and treat neonatal abstinence syndrome.

It’s also not hard to imagine the plaintiff’s bar seizing the opportunity to turn an epidemic into an opportunity the way some seized the opportunity afforded by publicly available nursing home survey data to create the lucrative elder abuse legal profession.

For example, law firms such as Heygood, Orr, and Pearson have leveraged the internet generation’s search capabilities and access to quick information by launching websites with words such as ‘painkiller’, ‘overdose’, and ‘lawyer’ in the name.

Risk management strategies

What can be done to improve patient safety and reduce the risk of malpractice litigation? Here are OmniSure’s recommendations and some other useful information.

If in a state with a Prescription Drug Monitoring Program (PDMP), insist that providers use it. Forty-nine states have an active PDMP, but only 16 require its mandatory use by providers. Some complain about the time and administrative burden required, but the fact is PDMPs help to identify problem prescribers, prevent addicted patients from filling duplicate prescriptions, alert authorities to possible drug diversions, and provide a host of data to help combat the opioid epidemic.

Missouri is the only state without a PDMP. Doctors in Missouri should beware of the likelihood that they could become subject to ‘doctor shopping’ by abusers and thus have a higher risk of being implicated in an adverse outcome or overdose death.

For state-by-state information on prescription drug abuse and the steps each has taken to address the epidemic, see the Trust for America’s Health report at http://healthyamericans.org/reports/drugabuse2013/.

Provider education should be mandatory, from a source other than the pharmaceutical companies. The Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy for extended release opioids in July 2012 that required drug manufacturers to fund training programs for providers to prevent providers from prescribing incorrectly and to make sure they are aware of possible drug interactions.

Provider training was not made mandatory by the FDA. And while manufacturer training is extremely helpful, more comprehensive training on pain management should include non-opioid and non-pharmaceutical alternatives to treat pain.

One of the factors that leads physicians to over-prescribe opioids is the misconception that they are not addictive when used to treat legitimate pain. Purdue Pharma’s I Got My Life Back videos in 1998 and 2000 are examples of the type of education physicians received on Oxycontin. In these videos, Dr Alan Spanos, a North Carolina pain specialist, asserted that long-term use of opioids should be prescribed for chronic pain and that concerns about the addiction potential were unfounded. That same message was shared by many presenters at medical schools, associations, and other groups.

See the educational materials and resources recommended by Physicians for Responsible Opioid Prescribing at http://www.supportprop.org or the Association of Addictive Medicine at http://www.softconference.com/asam/generic.asp?ID=8707. Some insurance companies have also taken a proactive approach to educate prescribers.

Follow medical evidence-based treatment guidelines. On March 17 the American College of Occupational and Environmental Medicine (ACOEM) released new, evidence-based treatment guidelines for using opioids. This is a crucial tool, and can be extremely helpful for physicians. http://insurancenewsnet.com/oarticle/2014/03/20/reed-group-releases-new-opioid-treatment-guidance-in-disability-guidelines-a-476867.html#.U4ZrzyiwXVo

Another resource for excellent information is the interdisciplinary Provider’s Clinical Support System for Opioid Therapies funded by the Substance Abuse & Mental Health Services Administration (SAMHSA) that includes training, mobile applications, forms, and tools: http://www.pcss-o.org/

In addition, many state medical boards have issued guidelines or policies to govern opioid prescription practices. A state-by-state listing can be found at http://www.medscape.com/resource/opioid/opioid-alabama

De-stigmatize addiction

Medical imaging technology has made it possible for scientists to document the pathology in the human brain showing how drug addiction is a disease of the brain just like myocardial infarct is a disease of the heart.

According to Volkow, “This understanding is key to getting people with substance use disorders the help they need and deserve, a task made difficult by the enduring stigma surrounding addiction.” In the litany of diseases that have emerged from the shadows—she mentions HIV/AIDS and epilepsy—she even counts ‘typical psychiatric disorders’ as easier to accept and seek treatment for than addiction.

It’s not just the NIDA and members of the medical and scientific communities that are working to de-stigmatize addiction and overcome the negative effects of discrimination in medical care. Patients who have learned to manage this chronic condition with the help of their peers and the medical community have launched a grassroots campaign to educate policymakers and the general public about the issue, spotlighting people in highly successful positions who live in recovery from addiction, see www.facesandvoicesofrecovery.org/

Nursing and medical schools are also starting to add education to de-stigmatize addiction. Dr Angela Nash, assistant professor for the Department of Nursing Systems at the University Texas Health School of Nursing, has created a training module for her students that includes exposure to recovery communities, lectures by leaders in addiction recovery, education on Trauma Informed Care, and the use of materials from the Association for Medical Education and Research in Substance Abuse (AMERSA), SAMHSA, CDC, and the NIDA.

One of the best resources for educating medical and nursing students, according to Nash, is the HBO Addiction project which is produced by HBO in partnership with the Robert Wood Johnson Foundation, the NIDA and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) which can be found at http://www.hbo.com/addiction/. Patients are more likely to cooperate in their care when working with an educated provider who offers a therapeutic, unstigmatizing approach.

Make educational materials and resources readily available

Patient education is an excellent risk management technique and can empower patients to improve their health behaviors. By improving a patient or family member’s understanding of addiction as a disease, and introducing methods to manage aspects of the medical condition, providers can increase the likelihood that patients will be motivated, comply with the treatment plan, and experience fewer complications.

A more fully informed patient may be less likely to abuse prescription drugs, and those who have developed a tolerance may be more likely to seek help before their condition progresses to addiction and/or overdose, especially if they know treatment is available.

According to a report by the Trust for America’s Health project, Washington, DC and 25 states are participating in Medicaid Expansion, which helps expand coverage of substance abuse services and treatment. Providers in those states can inform patients who might not otherwise know treatment is covered.

Michelle Foster Earle, OmniSure, US