The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month. The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia.
In addition to the information generally provided to regulators, the form requires the wholesaler to disclose the reason it classified the order as suspicious. If a wholesaler had no suspicious orders to report in a given month, the form also must be used to disclose that fact to the Board. The “zero reporting” requirement for suspicious orders is new. It was included in proposed changes to the Board’s suspicious order reporting rule—W. Va. Code St. R. § 15-2-4—which have not yet been formally adopted by the State.
The Board notified at least one wholesaler at the end of September that it must start using the new form. Charles “Buck” Selby, the Board’s Chief Compliance Officer, stated in the letter: “[The BOP] approved this form as a required report form to be used by every controlled drug wholesale facility shipping into our state. It is the only form to be used by a wholesale facility for issuing suspicious orders reports to the West Virginia Board of Pharmacy.” Mr. Selby stated the Board was trying to improve its review of suspicious orders after receiving “much adverse publicity and comments” in recent months about the way the Board previously handled suspicious order reports.
According to newspaper reports, only two suspicious order reports were sent to the West Virginia Board of Pharmacy between 2001 and June 2012. Then, on June 26, 2012, former Attorney General Darrell McGraw filed lawsuits against a dozen wholesalers alleging that the companies shipped an excessive number of pain pills to West Virginia and failed to report suspicious orders from pharmacies. After that, more than 7,200 suspicious order reports flooded in. The Board failed to investigate, follow-up with wholesalers or pharmacies, or inform law enforcement authorities of the reports. The new form is not posted on the Board’s website. Mr. Selby stated in the letter that wholesalers can request a copy of the form by emailing the Board.
In its rush to implement these new requirements, the Board either failed to account for or simply disregarded the fact that most wholesalers have systems in place to electronically report suspicious orders, and other required reports, to DEA and state regulators. Insisting on a paper form will significantly burden wholesalers. Perhaps more importantly, requiring a justification for why the order was flagged as suspicious is a meaningless and unhelpful burden to impose on wholesalers. As stated repeatedly by DEA and the courts, a suspicious order does not necessarily mean that diversion is occurring. The vast majority of orders reported as suspicious are suspicious only because they triggered a red flag based on volume, pattern, or frequency—the metrics listed in DEA’s regulations to define a suspicious order. Hopefully, the Board will work with wholesalers to allow the electronic filing of suspicious order reports and will reconsider its insistence on requiring a justification for categorizing an order as suspicious.