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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