Ohio imposing new rules on distributors to battle opioid epidemic
Citing “vague and inconsistent” federal reporting standards, Ohio will require drug distributors to report and halt suspicious orders of prescription painkillers in hopes of further reducing opioid addiction and deaths.
The state’s proposed rules, expected to take effect in three to four months, would require drug distributors to detect — and not ship — suspicious orders of opioids to pharmacies and hospitals, such as orders that are large when compared to past purchases.
Ohio Board of Pharmacy officials and Gov. John Kasich outlined the proposal at a Thursday press conference at the Statehouse while admitting much still needs to be done to rein in street sales of opioids fueling an ever-increasing number of overdose deaths.
The more than 500 state-licensed drug distributors and wholesalers will be required to report more-detailed information to the state for analysis to flag distributors and pharmacies that may attempt to sidestep the new rules. Violations could lead to the loss of distributors’ state license.
The rules, which are being posted for public comment and feedback from distributors, would deem any opioid order in excess of 5,000 doses a month as suspicious and require further scrutiny.
A Cardinal Health, based in suburban Columbus, is one of the country’s largest distributors. A spokesman said in a statement, “We look forward to working with the governor and Board of Pharmacy on these important rules. 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.”
Reporting requirements for pharmacies and physicians and limits on opioid prescriptions have reduced the amount dispensed by 20 percent from 2012 to 2016 while also reducing deaths,
but the availability of street drugs, particularly deadly fentanyl, remains alarming, Kasich said.
“The time has come for our communities to work to kill this devil that lurks on our streets, in our schools and in our communities,” the governor said of illicit opioid sales.
Drug overdoses, largely from opioids, killed 4,329 people in Ohio in 2016, a 24-percent increase over 2015 and the second-highest death rate in the nation, according to federal figures.
As part of the battle to fight opioid abuse and availability, a law that took effect Sept. 1 placed limits on the pain-pill prescriptions written by Ohio physicians, dentists and others. The new requirements limit patients to a seven-day supply of opioids — five days for minors — for the treatment of short-term pain. Refills can be prescribed only if physicians or other medical professionals document the need for extending pain-relief medication.
Prior to the law, voluntary guidelines cut the number of overdose deaths from opioid prescriptions from 667 in 2015 to 564 in 2016. State officials say 80 percent of those who died from drug overdoses in 2016 previously had received legally prescribed opioids.
Joined by several cities and counties in separate actions, the office of Attorney General Mike DeWine is suing five drug manufacturers for improperly peddling and profiting from opioid sales. Talks have started with some of the companies about a potential settlement to generate funds for opioid education and treatment.
DeWine has indicated he may sue drug distributors, but still is reviewing the matter, spokesman Dan Tierney said.
The attorney general was “encouraged” after attending a hearing in federal court in Cleveland on Wednesday before a judge working to broker a settlement of more than 200 opioid-related lawsuits filed by counties and municipalities against drug manufacturers and distributors.
“While our office is confident we will prevail in our lawsuit should it proceed to trial in Ross County, the process underway in federal court in Cleveland is notable in that it is seeking to provide substantive help to governments dealing with the opioid epidemic through reaching a settlement sooner,” Tierney said.
Someone needs to do the MATH on 5000 doses/month purchased by a pharmacy/month.. the average dose of Norco 10 is ONE TABLET FOUR TIMES DAILY… so any pharmacy filling more than 10 prescriptions PER WEEK would be exceeding this ARBITRARY MONTHLY LIMIT
Ohio has a population of 11.6 million.. so using conservative average estimates… Ohio would have 600,000 chronic pain pts are are 24/7 dependent on a opiate. and another 3+ million of chronic pain pts that have AT LEAST a “as needed” need for opiates to treat their pain.
On the other side of the coin… a dose of FENTANYL patch … a pt will only use 10 doses/month… so 5000 doses of Fentanyl would cover the needs of 500 pts for a month but 5000 Norco doses would only cover the needs of 40 + pts. Some very busy pharmacies will dispense 5000 Norco doses EVERY DAY.
Then there are reports out of Ohio where 99% of the OD’s … illegal Fentanyl showed up in toxicology
Dayton Ohio area: 99% of opiate OD’s tested positive for ILLEGAL FENTANYL ANALOG
And how is restricting opiate distribution from wholesalers going to address the illegal opiates that are flooding the streets in Ohio ?
Since it seem apparent that this new law could be in violation of the Americans with Disability Act… since a lot of the restriction are focused directly at the millions of Ohio pts who have a valid medical need for opiates.
One thing that my money is on is that the ACLU will NOT GIVE A SHIT about all of these civil rights and human rights being denied by the state of Ohio. Since violation of the civil rights of chronic pain pts has never been part of their agenda.
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