Top SOM Insights from 2021
The continuous development and sophistication of NavigateSOM, along with helping clients meet their objectives, pushes Pharma Solutions to stay on the cutting edge of Suspicious Order Monitoring.
Insight 1 of 10: SUPPORT Act
The SUPPORT Act was officially signed into law in 2018. The Act contained specific guidance for controlled substance suspicious order monitoring, including a requirement that a flagged order, or an “order of interest,” must be cleared for fulfillment within 7 days, or it must be marked as suspicious. The requirement was put forth as a proposed rule in Nov 2020 under RIN 1117-AB47. While the rule makes sense, in that it prevents flagged orders from remaining open for an excessive amount of time, the burden is fairly significant in practice because it creates specific liability/compliance risk: the DEA knows exactly when an order was placed, when it was eventually filled/cancelled, and if/when it was marked as suspicious. While it may not cause a problem for a registrant if it is the only finding, it can strengthen the DEA’s case in more serious situations. NavigateSOM addressed this by allowing clients to automatically mark flags as suspicious after the mandated 7 days. Further, the ability to add notes to Suspicious flags was also added. Key project management functionality, including cadenced reminders, will be available in a future release.
Insight 2 of 10: Enhancing Communication
In its 4 year history, NavigateSOM has developed to accommodate various business models including full-line drug distributors and 503B outsourcing facilities. Accommodating 3PLs, however, requires new workflows and consideration as they do not direct the sale of the product. The first insight we pulled from working with 3PLs is the significant benefit in providing their manufacturer clients a portal to perform their part of the due diligence on that manufacturer’s customer (e.g. wholesaler, pharmacy, etc.). Otherwise, 3PLs will often be forced to request and receive SOM due diligence manually, typically over email or phone.
Insight 3 of 10: State Compliance
Due to the patchwork of state regulation on the sale and shipment of controlled substances, there are significant opportunities for a SOM to address various state compliance requirements:
- Suspicious Order Monitoring Reporting (e.g. California, Georgia, Ohio) can, and should be addressed through task management functionality.
- Other State Suspicious Order Monitoring Requirements (e.g. Ohio double verification requirement)
- Controlled Substance State Volume Reporting (e.g. Florida, Idaho, Minnesota) lends itself to be addressed by an SOM capable of producing robust reports.
- Opioid Tax Calculation (e.g. Delaware, New York, Rhode Island) and Opioid License Fees (e.g. Maine, Minnesota) can be addressed by an SOM if there is Morphine Equivalency benchmarking (or in the case of NavigateSOM, a dedicated algorithm).
- Accommodating State Controlled Substances (e.g. Butalbital, Carisoprodol, Ephedrine, etc.) should be accounted for when shipping.
It is important to note, state compliance is only as good as the data a company has available to it. Although we use paid resources like the NABP Survey of Law, we have found significant discrepancies previously – so, it is highly recommend to vet information by visiting state agency websites and regulations to obtain reliable information.
Insights 4 through 10 of 10:
Please view our webinar for the rest of the content! A recording has been hosted for free here, https://www.pharmasolutions.training/courses/dea-suspicious-order-monitoring-2021 Pharma Solutions makes every effort to provide accurate information in the content it offers. However, the information provided is “as is” and Pharma Solutions makes no warranties, express or implied, as to the content provided. Pharma Solutions assumes no liability or responsibility for any errors or omissions in the content provided. Laws and regulations that are referenced herein may change over time and as such the content offered is not to be interpreted as advice. Pharma Solutions shall not be liable for any damages whatsoever incurred in connection with the use or performance of this information.