The DEA expects opioid supply-chain wholesalers to report “suspicious” orders without the necessary information which is collected, but not shared, by the DEA itself. Below is a statement given by an opioid wholesaler to the House of Represenatives in May 2018 that explains the problem:
“WRITTEN STATEMENT OF JAMES CHRISTOPHER SMITH FORMER PRESIDENT AND CHIEF EXECUTIVE OFFICER, H.D.SMITH LLC BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS COMMITTEE ON ENERGY AND COMMERCE U.S. HOUSE OF REPRESENTATIVES PRESENTED MAY 8, 2018″
H.D.Smith was only one part of a complex supply chain, and we could not see all the information up and down the chain that could flag a potential problem.
As a wholesale distributor, H.D.Smith could not second-guess physicians’ prescribing decisions, and could not itself assess the medical needs of the patients of those prescribing physicians.
This is exactly the problem with asking wholesalers, distributors, and pharmacies to report “suspicious” opioid orders and prescriptions. At such a high level, these entities have no way of knowing anything about the individual patients, their doctors, their diagnoses, or their medication doses.
There are difficult policy and medical decisions that are needed to balance access against diversion and we did the very best we could with the limited information to which we had access.
H.D.Smith was a wholesaler. We purchased prescription and generic medicines directly from manufacturers, and distributed them to the licensed pharmacies that ordered them for patients with prescriptions.
As a wholesale distributor, H.D.Smith did not interact directly with patients, nor were we in a position to make or second-guess clinical decisions.
Yet, this is exactly what they are being asked to do: make or second-guess clinical decisions that should be made (in private) between a doctor and their patient.
We also had no way of knowing whether or to what extent our customers were purchasing medicines, including opioids, from other distributors, unless this information was voluntarily disclosed.
As the DEA’s expectations changed, in May of 2008, we implemented an electronic controlled substance order monitoring program(the “CSOMP”), and provided extensive training to our personnel in how best to reliably utilize that system, just as we trained our sales representatives to be alert to any signs of diversion or irregularities at the individual pharmacies we served
H.D.Smith changed our reporting practices upon learning from the DEA that we were over-reporting and that orders were not “suspicious” simply because they were flagged for initial review by the company’s electronic anti-diversion CSOMP.
So, the DEA was compalining that this wholesaler was reporting too many orders as “suspicious” and, instead of doing their job and tracking them down, they merely asked the wholesaler not to report so many.
After this time, H.D.Smith reported orders to the DEA only if we determined after further review and due diligence that the order was indeed “suspicious” and should be rejected.
H.D.Smith also reported a number of physicians and pharmacies to the DEA when concerns arose.
DEA’s complaints that H.D.Smith was reporting too many orders as suspicious because they exceeded the ordering limitations imposed on a particular customer.
We experienced some frustration in working with the DEA, however; during some periods of time, the DEA rebuffed the industry and refused to give guidance to help distributors in their efforts to detect suspicious orders.
Additionally, the Prescription Drug Monitoring Programs (PDMPs) in many states require physicians and pharmacists to provide patient and prescription information to state-run databases about the prescriptions they write or fill for opioids.
In West Virginia in particular, the DEA and other federal and State law enforcement agencies have immediate and unlimited access to this database, as do various professional licensing boards, but notably distributors do not.
Thus, in addition to the ARCOS data that is automatically reported by manufacturers and distributors to the DEA, the DEA has access all the way down to
- pharmacy-specific, and
data on each and every opioid prescription written and filled and the patient to whom each opioid was dispensed.
Wholesale drug distributors, however, cannot access this data.
Without help from the DEA, and particularly guidance about the reporting of suspicious orders, distributors cannot make complete assessments about pharmacies’ purchasing habits, and are, therefore, limited in their ability to detect suspicious orders.