QPharma and Five Rivers Rx collaborate on DEA compliance

The two companies have announced that they will cross-promote their respective offerings: NavigateSOM from Five Rivers, and QPharma’s Titanium CRM platform, which will now include a module called Ti Risk, which analyzes claims data, patient data, and prescribing patterns for healthcare practitioners (HCPs) to identify HCPs with the higher risk of potential diversion and non-compliance. Together, the two offerings “allow for a 360-degree evaluation for sales of controlled substances through robust supply chain analysis: NavigateSOM analyzes the downstream supply chain, and Ti Risk enables pharmaceutical companies to identify and investigate the behavior of HCPs with the potential for diversion and abuse.”

As a longtime provider of validation services for regulatory-compliant software, QPharma has validated NavigateSOM for Five Rivers Rx.

Suspicious order monitoring (SOM) has been a sore spot between DEA, and manufacturers and distributors, for years, with the topic becoming a national priority in the past couple years in the wake of the opioid overdose crisis. Current DEA regulations require controlled-substance distributors to report orders that are of unusual size or frequency, or deviate “substantially” from a “normal” pattern, but none of these criteria are defined by hard numbers or objective factors. Distributors have long contended that the criteria are too vague, and that DEA itself, since it represents the only repository where all drug orders are filed, is in the best position to identify a high-volume operation that might be practicing illegally. DEA and the Dept. of Justice have announced that new rules are intended to be proposed by February 2019—ultimately to clarify the matter, but in the short term to require close attention by the manufacturers and distributors.