Patient Safety and Drug Diversion

0
817

Post By: Christie Moon, JD, CHC

Patient safety is or should be a paramount concern of all health care providers. Even though the current Public Health Emergency (PHE), declared due to Coronavirus (COVID-19), continues to create significant challenges to health care staffing needs, acute care and other providers must continue to do everything they can to maintain patient safety.  This is despite the staff turnover and financial challenges caused by the COVID-19 PHE.  Drug diversion is one area that has potential to significantly impact patient safety.

Let’s look at three examples of drug diversion scenarios that led to significant patient safety concerns. These situations also ended up causing health care employers significant liability as well as reputational harm:

  1. Rocky Allen, a former Colorado surgical technician was indicted by a grand jury in Denver on charges of tampering with a consumer product and obtaining a controlled substance by fraud. According to the indictment, in January of 2016 Allen was caught tampering with a syringe containing fentanyl and replacing it with a syringe containing saline solution. In June of 2016 Allen was confirmed to be positive for HIV, causing hundreds of patients to be asked to submit to HIV testing and to fear transmission of HIV. Allen was sentenced to 78 months in federal prison in November of 2016. So, not only were patients placed at risk due to Allen’s HIV status, patients in need of fentanyl during surgical procedures may have received saline solution instead of fentanyl. Both risks impact patient safety.
  2. David Kiwiatkowski, a former medical technician was sentenced in New Hampshire in 2013 to 39 years in prison in connection with a hepatitis C outbreak. Kiwiatkowski pleaded guilty to eight counts of tampering with a consumer product and eight counts of obtaining controlled substances by fraud. Ten months after being diagnosed with hepatitis C, Kiwiatkowski, stole syringes containing fentanyl and injected himself with them, causing the syringes to become tainted with infected blood. He then filled the syringes with saline and replaced them for use in medical procedures. Thirty patients were thereafter diagnosed with hepatitis C after being injected with the tainted syringes full of saline that were also infected with hepatitis C instead of fentanyl, a controlled drug and surgical anesthetic. Patients impacted by this scenario were at risk for hepatitis C as well as receiving saline solution instead of fentanyl.
  3. Kristen D. Parker, a former hospital technician in Colorado engaged in a similar scenario involving stealing fentanyl, self-injecting, replacing the fentanyl with water, and placing the infected syringes back in stock for use on surgical patients. Parker also had hepatitis C and her illegal conduct infected at least three dozen patients. In 2009 Parker was charged via a grand jury with 42 criminal counts, including 21 counts of tampering with a consumer product, and 21 counts of obtaining a controlled substance by fraud. In 2010 Parker was sentenced to thirty years in prison after the court rejected the agreed sentence of twenty years. The judge issued the longer sentence in light of the harmful nature of her conduct.

Although these patient safety related diversion situations are extreme scenarios, they seriously harmed over 60 patients and placed thousands of patients at significant risk. These scenarios also caused the impacted health care facilities significant reputational harm as well as expense and liability. Additionally, the fact that three such events happened in within a six-year period relate to why the DEA and state boards of pharmacy take drug diversion so seriously.

Additionally, the CDC reports that Drug Diversion puts patients at risk for healthcare-associated infections, noting that “these activities can result in several types of patient harm, including:

  • Substandard care delivered by an impaired healthcare provider
  • Denial of essential pain medication or therapy
  • Risks of infection (e.g., with hepatitis C virus or bacterial pathogens) if a provider tampers with injectable drugs”

The CDC also notes that “addiction to prescription narcotics has reached epidemic proportions and is a major driver of drug diversion.”

Moreover, health care entities are also at risk for substantial fines and penalties for allowing drug diversion activities to occur involving controlled substances they purchase for use in surgeries and other health care procedures. For example in 2018 the United States Department of Justice entered into a settlement agreement with the University of Michigan Health System (UMHS). The DEA investigation that led to this settlement was initiated by the DEA based on drug diversion and overdose incidents occurring at UMHS.

As part of that agreement UMHS had to pay $4.3 million dollars, which at the time was the nation’s largest settlement of its kind involving allegations of drug diversion at a hospital. In addition, UMHS had to enter into a three-year memorandum of agreement (MOA) with the DEA which outlined the hospital’s controlled drug handling protocols going forward.

These matters illustrate the importance of proactively and effectively managing controlled substances in hospitals and other health care facilities. Failure to do so could result in patient safety concerns as well as significant regulatory and reputational risks.

In April of 2019 The Joint Commission (TJC) published a Quick Safety Advisory on Drug diversion and impaired health care workers. This advisory noted the following as essential components of an effective controlled substance diversion prevention program:

Core administrative elements:

  • Legal and regulatory requirements
  • Organization oversight and accountability

System-level controls:

  • Human resources management
  • Automation and technology
  • Monitoring and surveillance
  • Investigation and reporting

Provider-level controls:

  • Chain of custody
  • Storage and security
  • Internal pharmacy controls
  • Prescribing and administration
  • Returns, waste, and disposal

In addition, TJC advised that providers should be on the lookout for patterns and trends that indicate potential diversion. In addition, on the issue of patient safety TJC noted that “patient and workplace safety require effective reliable safeguards to maintain the integrity of safe medication practices to protect against diversion. Diversion prevention requires continuous prioritization and active management to guard against complacency.”

From a compliance perspective, health care entities administering controlled substances must effectively prevent and detect drug diversion.  Doing so will help protect patient safety as well as prevent regulatory and reputational risks. These activities and obligations are ongoing, even during the PHE. In fact, the PHE and the stresses of providing health care during the pandemic, may increase the risk of diversion and related consequences, from patient safety to regulatory risks.

For a detailed overview an effective drug diversion prevention, detection and response program, please see HCCA Presentation, Drug Diversion: A Multidisciplinary Approach, by Sokya and Ferrell, University Hospitals, Cleveland, Ohio, March 14, 2019.