Last week, Hawkins County joined a growing list of Tennessee counties that will be filing federal nuisance lawsuits against opioid distributors.
Approximately 90 similar nuisance lawsuits have been or are being filed separately in counties across Tennessee, West Virginia and Ohio in a cooperative effort by various law firms.
The lawsuits will allege that the three main distributors — McKesson, Cardinal and ABC — violated the terms of their federal permits by failing to red flag any irregularities in the opioid distribution pattern indicating that they were sending tons of narcotics into counties — more than the population rate could sustain.
The damage model is based upon damage to the sheriff’s office and safety; the damage to the health providers, ambulances, emergencies; and the damage to the education system.
On Friday, John Parker, who is senior vice president of the Healthcare Distribution Alliance, issued a written statement to the Times-News saying that distributors understand the tragic impact the opioid epidemic has had on communities across the country and they are deeply engaged in the issue and are taking their own steps to be part of the solution.
"But we aren’t willing to be scapegoats,” Parker added. “Distributors are logistics companies that arrange for the safe and secure storage, transport, and delivery of medicines from manufacturers to pharmacies, hospitals, long-term care facilities, and others based on prescriptions from licensed physicians. We don’t make medicines, market medicines, prescribe medicines, or dispense them to consumers. Given our role, the idea that distributors are solely responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and how it is regulated."
Parker added, “We are ready to have a serious conversation about solving a complex problem and are eager to work with political leaders and all stakeholders in finding forward-looking solutions.”
The Healthcare Distribution Alliance has issued several talking points in preparation for its lawsuit defense, including:
* Distributors do not manufacture opioids, license registrants, write prescriptions or dispense medicines.
Primary pharmaceutical distributors are not “pill mills.” Distributors fulfill orders only from entities licensed by the U.S. Drug Enforcement Administration (DEA) and state regulatory authorities.
* Distributors cannot make medical determinations regarding patient care or provider prescribing.
Distributors have no access to patient information, nor are they qualified to question a licensed physician’s recommended treatment plan for their patient, including prescriptions. Distributors must balance providing access to needed medications while taking all efforts to eliminate diversion of these same medications for inappropriate use.
* The DEA sets annual production quotas for opioids.
Distributors report controlled substance orders that are filled and those that are deemed suspicious to the DEA, and have robust controls in place to monitor distribution. A distributor only knows what it ships to a particular dispenser. It does not know what that particular dispenser may also be receiving from other wholesalers nor does it know the full scope, or total volume, of the medicine supply for a city, county or state.
* A public-private partnership between distributors and the DEA could help improve distributors' monitoring systems.
Targeted, rapid response against opioid abuse and diversion is a challenge and requires a positive relationship between distributors and the DEA. The DEA can assist distributors in their efforts by responding to compliance questions around patient safety monitoring and enforcement. In addition, by sharing data and information there will be additional opportunities to identify and curb misuse, overuse and abuse of prescription opioids.
* Recognizing the need for robust information sharing, Congress passed bipartisan legislation that represented a change in communication and enforcement across all parties.
In 2016, Congress enacted the Ensuring Patient Access and Effective Drug Enforcement Act. This law does not “decrease” DEA’s enforcement against distributors; it supports real-time communication between all parties in order to counter the constantly evolving methods of drug diversion.
* Distributors are strongly committed to finding systemic solutions to the challenges that contributed to the opioid epidemic.
They, like all actors in the system, recognize that the opioid epidemic was a systemic failure and that improvements are needed across the board. Distributors stand ready to work with all players across the system — physicians, pharmacists, manufacturers, federal and state regulators, law enforcement, and others — to identify and stop rogue actors who intentionally undermine patient safety and the public health.