Prescription Opioid Diversion & Abuse – a powerpoint presentation by John J. Coleman, PhD, DEA Assistant Administrator for Operations – Mar 2016
This is an interesting glimpse into how the DEA sees the “opioid crisis” as arising from diversion of medication prescribed to pain patients, instead of being fueled by the massive thefts from the supply chain.
The workers handling all those pills aren’t as monitored and scrutinized nearly as carefully as individual patients, who have to submit to random pill counts.
Drug Diversion: How It’s Done…
Doctor Shoppers (casual & pro): Probably account for more diversion than estimated
No: PDMP’s have shown there are fewer “doctor shoppers” than expected.
Pill Mills: Major ones in FL mostly closed; smaller ones still operating throughout US.
Rogue Physicians: If only 1% of all DEA-registered physicians (January 2016: 1,219,563) = 12,196 docs
Rogue Internet Pharmacies: Greatly reduced since 2008 passage of Ryan Haight Online Pharmacy Consumer Protection Act
Friends and relatives: NSDUH reports 53% of users of pain relievers in 2012-1013 obtained them free; 14.6% bought or took them from friend/relative –Source for friend/relative: one doctor: 83.8%; more than one doctor: 3.3%; Street dealer: 1.4%; Internet: 0.3%; Other: 1.2%
Pharmacy thefts: Between 2009 and 2012, pharmacies reported 41,645 thefts of controlled substances to DEA.
Distributors: Between 2009 and 2012, DEA-registered distributors reported 5,163 thefts of controlled substances to DEA.
And I’d bet those thefts weren’t of 30-120 pills, but of thousands.
Practitioners: Between 2009 and 2012, DEA-registered practitioners reported 2,756 thefts of controlled substances to DEA.
Cargo theft: Once a major source of diverted drugs, cargo theft has diminished considerably in the past decade because of covert GPS devices hidden in shipments.
Hospital/Clinic thefts: Between 2009 and 2012, hospitals/clinics reported 12,265 thefts of controlled substances to DEA.
Drug Diversion Within the Supply Chain
This is where I believe all the black market pills came from, not individual prescriptions.
There are 915 Distributors of controlled substances registered with DEA (as of 2/2016)
Top 7 states: CA (93); TX (78); FL (60); PA (47); NJ (35); NY (35); TN (33)
90% of product distribution in pharma industry is managed by three major distributors: McKesson, Cardinal Health, and AmerisourceBergen
The “Big Three” have more than 81 DEA-registered drug distribution centers (as of 2013)
Others include: GE Healthcare (26); Walgreens (12); MWI Veterinary Supply (10); CVS Pharmacy (10); UPS Supply Chain (7), and Wal-Mart (6) (as of 2013)
The wholesale drug distributor became the focus of DEA law enforcement operations after investigations of rogue internet pharmacies and pill mills revealed serious lapses by distributors in identifying and reporting suspicious orders as required by law.
Using its ARCOS data and its administrative inspection authority DEA was able to collect sufficient evidence of wrongdoing to file charges against a number of registrants.
So, the DEA uses its ARCOS database to find evidence of diversion, but it refused to answer questions from the distributors regarding suspicious orders.
It sounds like the DEA was saying “we don’t know if this is a valid shipment” and “it’s a business decision” (see Opioids allocated based on business decision) but once it’s been delivered we’ll inspect the ARCOS database to find evidence of diversion and charge you with a crime.
Rather than litigate charges that were often largely based on their own in-house records, most distributors charged by DEA elected to settle with the Government, usually by acknowledging culpability, agreeing to implement new and improved anti-diversion safeguards, and paying a sizable civil fine.
The next slide we show a number of significant regulatory cases brought by DEA against distributors and their common carriers.
Author: John J. Coleman, PhD
DEA Assistant Administrator for Operations (Retired)
PresidentPrescription Drug Research Center LLC