Wholesalers that distribute prescription drugs to pharmacies, doctors and hospitals would have to report more information about suspicious orders to Ohio regulators, as part of the state’s fight against the deadly opioid epidemic.
The proposed rules were announced by Gov. John Kasich on Thursday.
The state also wants to require that drug distributors do a better job researching their customers and to hold onto suspicious orders until questions are answered about the drugs’ destination.
Companies that don’t comply could have their drug distribution license for Ohio revoked. Red flags could be large orders of controlled substances like pain pills or cash-only orders.
“You have to know your customer,” the Republican Kasich said. “If you know that a particular pharmacy is receiving an inordinate increase in the number of pills that they normally do, we want to know about that.”
The rules are open for public input and wouldn’t take effect for three to four months. They would be tougher than current federal standards, which are considered vague, said Megan Marchal, president of the state pharmacy board and a pharmacist at Ohio State’s medical center.
Pharmacy board officials say Ohio’s rules are needed in part because of a 2016 federal law they say considerably weakened the Drug Enforcement Administration’s ability to freeze suspicious narcotic shipments from drug distributors.
Ohio’s rules will be the strongest in the country, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Other states require the reporting of suspicious orders, but are often buried in the responses which come in a variety of forms and are up to state pharmacy boards to interpret, Catizone said Thursday.
Ohio is creating a uniform system that gives companies clear guidelines for reporting, he said.
Drug overdoses killed a record 4,050 Ohioans in 2016, with 2017 numbers expected to be higher.
Despite those fatalities, the state is making progress cracking down on prescription painkiller abuse, thanks to new regulation of prescriptions for pain.
Deaths from painkillers — as opposed to heroin or the even deadlier fentanyl — are at a six-year low. The number of painkillers prescribed in Ohio dropped 162 million from 2012 to 2016.
Street drugs like illegal fentanyl — different from legal pain patches given to terminally ill patients — are driving current overdose increases.
Several drug distributors are named in lawsuits pending in a federal court in Cleveland, where numerous cities and counties accuse the companies of not doing enough to monitor suspicious sales.
The companies have said they don’t believe litigation is the answer but have pledged to help solve the crisis.
Cardinal Health, based in Dublin in suburban Columbus, is one of the country’s biggest drug distributors. It pledged Thursday to work with Kasich and the pharmacy board.
“We take our role in the supply chain seriously and as such we operate a state of the art system to prevent the diversion of opioids from legitimate medical use,” the company said in a statement.
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