Injunctive Relief Agreement Creates Sweeping Guidance for Suspicious Order Monitoring
Written-by: Sumeet Singh, CEO
The Opioid Epidemic is one of the greater tragedies to occur within the last few decades and will forever be a black mark on the drug supply chain. Although it could be argued that some companies were more responsible than others, each business model has felt the wrath of the federal and state regulation and litigation.
In fact, over 46 states came together to sue various members of the drug supply chain. As a part of that “multi-district litigation,” AmerisourceBergen, Cardinal, and McKesson (“the Big 3”) have agreed to pay up to $21 billion and to make their Controlled Substance Monitoring Programs (“CSMP”) much more diverse. The “Injunctive Relief,” link here, has 55 pages of succinct obligations on how the Big 3 must conduct Know Your Customer (“KYC”) and Suspicious Order Monitoring (“SOM”) activities.
It is crucial for the rest of industry to understand the CSMP obligations because they are, in effect, the minimum expectations from state regulators. Accordingly, please find key insights from the Injunctive Relief below!
a. No major provisional changes of note in this section.
2. Term & Scope
a. The term is 10 years.
b. Covers not just physical distribution, but sales as well. Aligns perfectly with DEA’s action against a manufacturer as they want to hold everyone involved liable for diversion.
a. The Injunctive Relief is limited to Chain Customers and Independent Retail Pharmacy Customers. Their definition of “Customers” does not include long-term care facilities, hospital pharmacies, and pharmacies that serve exclusively inpatient facilities.
b. The Injunctive Relief defines 10 product families as “Highly Diverted Controlled Substances,” including: (i) oxycodone; (ii) hydrocodone; (iii) hydromorphone; (iv) tramadol; (v) oxymorphone; (vi) morphine; (vii) methadone; (viii) carisoprodol; (ix) alprazolam; and (x) fentanyl.
c. Gabapentin is to be treated as a controlled substance.
4. CSMP Personnel
a. The Big 3 must establish/maintain the position of “Chief Diversion Control Officer” to oversee the Controlled Substance Monitoring Program (“CSMP”).
a. Sales personnel are not to be compensated solely for sales of controlled substances, although they can be compensated for total sales volume.
b. The Big 3 must set up a “whistleblower” hotline for employees and customers and maintain a detailed log of those complaints.
a. The Injunctive Relief creates an environment where executive leadership and ownership must be directly involved with the CSMP.
i. The CSMP must be overseen by a specific CSMP Committee, which is ultimately responsible for execution of the CSMP.
ii. Executive leadership (i.e. CEO, CFO, CLO) and the Board of Directors must receive quarterly Reports from the CSMP Committee.
iii. The Board of Directors must additionally establish their own Board Compliance Committee.
7. Mandatory Training
a. Annual training is required for all CSMP employees, and tri-annual training is required for sales, operations, and senior executive employees as well.
PART 2 – Coming Soon
8. Red Flags
10. Ongoing Due Diligence
11. Site Visits
13. Suspicious Order Reporting And Non-Shipment
14. Terminated Customers
16. Compliance With Laws and Recordkeeping
19. Enforcement Of Injunctive Relief Terms
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