Kasich administration announces new regulations on prescription drug distributors

Photo by Ohio Statehouse Reporter Jason Aubry

COLUMBUS, Ohio (WDTN) – For years Governor John Kasich’s administration has been attacking the abuse of prescription opioids at where they could actually effect change; not on the street corners but in doctor’s offices, hospitals, and pharmacies.

Thursday, the Governor announced the next round of regulations that he says will further help with the effort to curb prescription drug addiction and abuse.

The administration’s message to wholesale drug distributors is to “know your customers.”

The new regulations standardize suspicious prescription drug order reporting; more detailed data reporting; greater due diligence; and creates additional disciplinary actions that can be taken against the wholesaler if they violate the new regulations.

But before we get into all of that; what is a wholesale prescription drug distributor?

Basically, a wholesale distributor is a company that gets the drugs from the pharmaceutical companies and then sells them to hospitals, doctors, pharmacies, and what not.

For example, a pharmacist may need some oxycodone to fill prescriptions so they place an order with a distributor who then fills the order.

Seems harmless, right? But what if the person making the order is not on the level? What if they are selling, or stealing those drugs and selling them on the black market?

Some wholesale distributors would report suspicious orders to the DEA and the State then go on to fill the order anyway; some simply neglects to report the suspicious order altogether.

The new regulations the Kasich administration is putting into place would prevent that from happening.

First, it would standardize the reporting of suspicious orders, require those reports be made even if they don’t fill the order; and make that reporting happen online directly to the State Board of Pharmacy.

That will give the State board staff an opportunity to do their own analysis of the data to see if there is a trend.

The state is working with the private industry to develop an investigation tool that the board can use to dig into these reports and catch the people who may be breaking the law.

The second thing the new regulations do is require the wholesalers to hold mandatory staff training on identifying suspicious orders, how to report them, and how to report to the board as a whistleblower if necessary.

Rules for what constitutes a suspicious order and what should be reported are still being worked out, but are expected to include information on any order in excess of 5,000 unit doses of an opioid or controlled substance; any order identified as a statistical outlier based on previous purchases; orders of unusual frequency or having an uncommon method of payment such as cash; any drugs that a prescriber is not authorized to use or would not  normally use in their practice; a suspicious mix of products like large quantities of just a few types of controlled substances together with a few, if any, other drugs; a disproportionate mix of controlled and non-controlled substances; and purchasers that do not take commercial or public insurance.

Much of a wholesaler’s ability to identify a suspicious order lies in their knowledge of their customer, and they will be expected to know more about their customer as a result.

They should know what their customers do, what drugs they typically would need or use in their practice, etc.

Distributors will also be required to collect sales forms with more detailed information and affirmative steps to confirm accuracy; validate customer data with on-site visits to their facilities; and to require customers confirm their authority to use drugs and the clinical business needs of the purchaser.

If wholesalers do not take this seriously, or simply ignore these new regulations they could have their license to operate in Ohio terminated.

Governor Kasich says because the efforts his administration has made prescription opioid related deaths are at a six year low.

But Kasich isn’t ready to unfurl the “Mission Accomplished” banner just yet. He says there is still a ton of work to do, and not just here in Ohio.

He points out that street drugs laced with Fentanyl are still killing people and that problem still needs to be addressed.

And Kasich says people need to do their part to help each other.

“If people are waiting on wealthy, powerful, well placed people to solve our problems… well we can do some things; but if we really want to take care of our families and our children and our community and our neighbors, it’s what we do. JFK was right; it’s not what your country can do for you, it’s what you can do for your country; and my message here in Ohio, and all across this country is: it’s not what the wealthy, the powerful and the well placed will do for you; it’s what you want to do to save our communities, and save our culture, and save our children, and save our depressed adults.”

Kasich’s new regulations are going through the rule making process and the opportunity for public comment is open.

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