America’s opioid epidemic continues to strike the country with alarming force, with some projecting it could claim the lives of as many as 650,000 Americans over the next decade. The stories describing the devastating effects of this crisis on the people experiencing it, their loved ones — and in some cases entire American towns — are even more harrowing than the statistics.
There has been significant debate within both the public and private sectors focused on what can be done to address this issue head-on. As policymakers, experts and leaders throughout the health care industry convene in an effort to combat opioid abuse, one of the first orders of business should be to understand how to best halt prescriptions that are not legitimate.
As CEO of AmerisourceBergen, one of the largest pharmaceutical distribution companies, I can assure you that as an organization we spend a great deal of time and resources trying to identify ways to keep medicines from reaching the wrong hands. Given that distributors like us are responsible for helping to deliver safely physician-prescribed medications to pharmacies, we have a unique perspective into how this supply chain works — and the ways it can be subverted by bad actors.
This is why I know that what would be most effective would be better collaboration, coordination and cooperation between the Drug Enforcement Administration, its registrants and distributors.
There are a number of ways to achieve this. Each time a distributor ships an order of an opioid-based medication, a detailed report is sent to DEA including the quantity, type and receiving pharmacy. As multiple distributors may be shipping opioid-based medicines to a pharmacy, the logical next step, in theory, would be for distributors to perform a “cross check” to determine the total volume of opioids the pharmacy is receiving from all distributors. This information would also enhance the ability to determine whether a new order should be considered suspicious.
In practice, however, the DEA keeps this data to itself; AmerisourceBergen does not have data about other distributors’ shipments to pharmacies. This practice prevents distributors from having full visibility into whether the order from the pharmacy should be flagged for further investigation.
As a result, a potentially valuable checkpoint is squandered, enabling many orders that do not raise flags when considered in isolation — but could be potentially suspicious when seeing the whole picture — to go unreported.
In a recent Washington Post/“60 Minutes” story, former DEA officials looked past this DEA policy shortcoming, suggesting that, in an effort to maximize profits, distributors are delinquent in reporting and stopping suspicious orders. This is misleading and, indeed, false.
AmerisourceBergen, for one, has stopped tens of thousands of suspicious orders since 2007, with the help of sophisticated algorithms and data analytics overseen by a diversion control team that includes former law enforcement professionals, diversion investigators, pharmacists and pharmacy technicians.
What could make our efforts most effective would be increased transparency and visibility through the enactment of sound policy.
This could be achieved if DEA took the step of sharing ARCOS (Automation of Reports and Consolidated Orders System) data, the central database all registered distributors report to, with the companies whose data the system contains. This access to “scrubbed” and de-identified data would enable distributors to evaluate the full picture of any opioid order from a particular pharmacy.
Moreover, all opioid orders should be placed digitally through the existing DEA Controlled Substance Ordering System. At this time, orders for opioid-based medicines from pharmacies to distributors are placed through a DEA-managed system that verifies a pharmacy has an active registration and license with the DEA. Surprisingly, however, there are still some orders that are manually handwritten and mailed. In this scenario there is no electronic verification process available, and instead, distributors must physically compare each handwritten form to the DEA registration files.
By requiring that all orders for controlled substances be placed electronically through CSOS, we would ensure the confirmation of DEA registration; and with modification, could even facilitate a system where the DEA flags orders as suspicious before they ever reach a distributor. In doing so, we can return the focus on law enforcement to the enforcement agency itself.
Other ideas worth implementing to further enhance meaningful data transparency include the creation of new DEA registration classifications, such as “Pain Specialty Pharmacy,” for businesses that plan to serve a patient population that requires high quantities of opioid-based medicines.
Under this proposed registration classification, clinicians who focus on managing pain, versus a more traditional community pharmacy for example, would require a deeper investigation by DEA and Boards of Pharmacy before being issued a registration or license, as well as a higher registration fee.
The separate classification could assist distributors in better identifying potentially suspicious orders while increased DEA registrant fees on its 1.7 million registrants, including on distributors, could fund IT infrastructure improvements related to these policy ideas.
At AmerisourceBergen, we are committed to aligning our philanthropic efforts with what our industry needs to address the opioid epidemic, and we would welcome the opportunity to further support the necessary infrastructure upgrades through grants.
People are rightfully demanding action on this tragic issue. We must push forward practical solutions that can yield results in the near-term on opioids. A more cohesive, connected and transparent system will be the most effective way to allow distributors to better combat the diversion of opioid-based medications.