May 16, 2018
Grassley, Feinstein, Capito, Durbin Introduce Bill to Prevent Diversion of Opioids
WASHINGTON – Senators Chuck Grassley (R-Iowa), Dianne Feinstein (D-Calif.), Shelley Moore Capito (R-W.Va.), and Dick Durbin (D-Ill.) introduced the Using Data to Prevent Opioid Diversion Act of 2018, legislation that will provide drug manufacturers and distributors with data to identify pharmacies that are suspiciously ordering prescription opioids.
The bill also grants law enforcement authority to hold drug manufacturers and distributors accountable if they fail to use these this data to identify, report and stop suspicious orders of prescription opioids.
Between 2006 and 2016, nearly 21 million opioids were distributed to two pharmacies in Williamson, West Virginia, which has a population of nearly 3,000. Between 2007 and 2008, nearly 9 million pills were distributed to a single pharmacy in Kermit, West Virginia, which has a population of only 392. Between 2007 and 2012, 780 million oxycodone and hydrocodone pills were distributed to pharmacies throughout West Virginia. During this same timeframe, these two drugs contributed to 1,700 drug overdose deaths in the state.
Despite the fact that opioid manufacturers and distributors are required to report the sale, delivery or other disposal of narcotics to the Drug Enforcement Administration (DEA) through the Automated Reports and Consolidated Ordering System (ARCOS), the DEA is not required to disclose to opioid manufacturers and distributors the total number of distributors serving a single pharmacy or practitioner, or the total quantity and type of opioids being distributed.
This means that the DEA knows how many total pills are being shipped to each pharmacy or practitioner, but manufacturers and distributors do not have access to the same information. This creates a barrier to identifying and stopping potentially suspicious orders if pharmacies are ordering from multiple manufacturers or distributors.
The Using Data to Prevent Opioid Diversion Act of 2018 removes this barrier, by requiring DEA to provide drug manufacturers and distributors with full visibility into the number of manufacturers and distributors serving each pharmacy and practitioner, as well as the total quantity and type of opioids being delivered to each. It then empowers law enforcement to hold companies shipping opioids to pharmacies accountable if they don’t report and stop filling orders when suspicious ordering patterns are evident.
“The opioid crisis has taken a devastating toll on American families and has caused significant strain on law enforcement as they work to keep our communities safe. Sadly, opioid addiction is often caused by the misuse of prescription narcotics peddled by disreputable pharmacies. This bill takes important steps to curb prescription opioid abuse by using existing data to identify suspicious opioid orders. Ensuring these medications are reserved only for those who actually need them is a critical front in the fight against opioid addiction,” Senator Grassley said.
“We know that a large percentage of misused opioids come from prescriptions, and opioid manufacturers and distributors have a unique vantage point from which to spot suspicious ordering patterns. In 2016, we lost 64,000 individuals to drug overdose deaths in our country. More than 42,000 of these were opioid related. Our bill will help ensure that we don’t have another situation in which 9 million pills are delivered to a single pharmacy in a town that has a population of less than 400 people. It will provide drug manufacturers and distributors with the tools they need to better prevent the distribution of opioids to bad actors, and will provide law enforcement with the authority to hold them accountable for failure to do so,” said Senator Feinstein.
“In West Virginia, we’ve seen so many instances where far too many prescription opioids are flowing into small communities. While there were red flags, having this additional data readily available will help ensure the warning signs never again go unnoticed,” Senator Capito said. “This legislation will make it easier to detect and stop suspicious orders of opioids and hold irresponsible manufacturers and distributors responsible.”
“Tackling the opioid crisis requires using every available tool to prevent addiction, and a coordinated effort from government, health care providers, drug companies, law enforcement, and the treatment community,” said Senator Durbin. “Increasing transparency in the distribution of opioids will mean more eyes on potential abuse in the system, and a better chance at stopping it.”
The full text of the legislation can be viewed here.
Key provisions of the bill include:
· Requiring DEA to make anonymized information available to those with access to the ARCOS database on a quarterly basis. This information includes the total number of distributors serving a single pharmacy or practitioner and the total number of opioid pills distributed to a single pharmacy or practitioner.
· Requiring the DEA to share information related to the amounts, outliers, and trends of distributor and pharmacy registrants with regulatory, licensing, attorneys general and law enforcement agencies of states on a semi-annual basis.
· Requiring reports from DEA registrants to be submitted electronically.
· Establishing civil and criminal fines for drug manufacturers and distributors who fail to consider ARCOS data when determining whether an order for opioids is suspicious and increasing existing civil and criminal fines for drug manufacturers and distributors who fail to report suspicious orders, keep accurate records, and utilize ARCOS data.
· Requiring DEA to submit a report to Congress detailing how it is using ARCOS data to identify and stop suspicious orders of opioids.
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