- The Cherokee Nation has filed a lawsuit in tribal court against several large pharmacy chains and healthcare providers for their alleged role in allowing opioids to flood into Native American communities, contributing to the widespread epidemic of abuse, addiction, and death.
The suit accuses Wal-Mart, Walgreens, CVS, Cardinal Health, AmerisourceBergen, and McKesson Corporation of ignoring “red flags” in prescription data patterns and supply chain losses that should have prevented certain individuals from accessing – and later selling or distributing – opioids to tribal members.
“The brunt of the epidemic could have been, and should have been, prevented by the defendant companies acting within the US drug distribution industry, which are some of the largest corporations in America,” challenges the suit.
“The distribution industry is supposed to serve as a ‘check’ in the drug delivery system, i.e. by securing and monitoring opioids at every step as they travel through commerce, protecting them from theft, and refusing to fulfill suspicious or unusual orders by downstream pharmacies, doctors, or patients.”
The lawsuit alleges that the defendants have “utterly failed in this duty” and “habitually turned a blind eye to known or knowable problems in their own supply chains.”
The named defendants have failed to prevent breakdowns in the pipeline from manufacture to legitimate delivery, the suit says, leading to “diversion” points that bring illicit drugs into the ecosystem.
Diversions can occur when opioids are lost or stolen in transit, when manufacturers and distributers fill suspiciously large orders for controlled substances, or when pharmacies fill prescriptions despite unusual patient characteristics that should raise suspicions of doctor shopping or intent to resell.
“These signs or ‘red flags’ should trigger closer scrutiny of the prescriptions by the pharmacist and require a determination that the patient is not seeking the medication for purposes other than to treat a legitimate medical condition,” the brief argues.
As a result of these oversight failures, opioid abuse and addiction have become significant public health problems in Cherokee communities, leading to higher healthcare and public safety costs, loss of economic productivity, negative social implications for children and families, and high levels of avoidable deaths.
Cherokee Nation healthcare providers currently utilize their own prescription monitoring program (PMP) databank to track and monitor the use of controlled substances, and all Cherokee healthcare facilities now employ electronic prescribing to eliminate the potential for illegal use of paper prescription pads.
But despite the use of health IT tools to manage population health within the community, the tribe’s close ties with external healthcare providers, pharmacies, and manufacturers makes it difficult to control the flow of opioids into its borders.
The lawsuit alleges that the defendants are in violation of the US Controlled Substances Act (CSA), which requires stakeholders to protect society from the potential harms of drug diversion.
“All opioid distributors are required to maintain effective controls against drug diversion. They are also required to create and use a system to identify and report downstream suspicious orders of controlled substances to law enforcement,” the suit states.
The system must include a distribution monitoring system, theft or other loss reports, and tracing of employees authorized to handle controlled substances.
Retail pharmacies and drug manufacturers “knew or should have known” that gaps in the supply chain were leading to patient harm, the Cherokee Nation says, especially in light of numerous DEA activities intended to improve control over opioid supplies at the source and several high-profile legal settlements related to insufficient actions.
Despite claims that the named healthcare companies are using advanced data analytics and electronic prescription monitoring tools to curb the movement of opioids into communities, the drug distribution continuum must improve its ability to monitor, address, and prevent drug diversions into tribal lands, the petition asserts.
Pharmacists should reevaluate their role as the “last line of defense” in the fight against opioid abuse, the suit urges, and should use their professional judgement more effectively to prevent individuals without legitimate medical need from accessing prescriptions.
The lawsuit raises interesting questions about the responsibility of the healthcare system as the opioid abuse epidemic rages on.
While every state except Missouri currently has some form of electronic prescription drug monitoring program in place, and many healthcare organizations are attempting to use health IT tools and population health management strategies to reduce unnecessary opioid prescriptions, millions of patients are still dying each year from addictions that start on the prescription pad.
Providers, manufacturers, pharmacists, and lawmakers will all need to reexamine their policies and best practices for pain management if they are to close the gaps in the supply chain.
The healthcare industry will need to take coordinated and concerted action to address the numerous avenues for patients to acquire illicit controlled substances, including well-intentioned pain management prescriptions, if it is to reduce the wide-ranging impact of opioid abuse on Native American soil and in a wide range of other communities across the nation.