“The Opioid Blame Game”
I regularly hear the following scenario:
“I went to my pharmacy to fill my buprenorphine prescription for my opioid use disorder and the pharmacy told me they had no buprenorphine in stock.”
In the middle of an opioid overdose crisis – how can that be!
When you dig deeper, you find out that distributors are placing limits on pharmacy orders for buprenorphine when they cross a threshold (set by the distributors) that makes the order “suspicious”.
Now, here is where the blame game starts. The distributors tell you either that the DEA rules or the State Attorney Generals settlements of opioid litigation are the reason they’re not able to fill their orders or that both are responsible.
We worked on this issue at ONDCP, and my conclusion is that instead of trying to find out who is at fault, we should focus on resolving the matter by sending a clear message to all parties.
It is true that federal law requires manufacturers and distributors of controlled substances to have a suspicious ordering monitoring system in place and must halt orders which exceed thresholds which are set by the manufacturers and distributors. It is true that the DEA does not set the thresholds. It is also true that, as part of the opioid litigation settlements, the State Attorney Generals and the distributors and manufacturers of opioids agreed to put a suspicious ordering monitoring system in place and that it needed to be consistent with DEA requirements.
The current messaging has the DEA and the State Attorney Generals blaming each other for halted buprenorphine orders and that leaves pharmacies and their patients in the middle, without access to a live-saving medicine. The current DEA messaging is that companies have nothing to fear if they do business the “right way”. Hardly words that bring anyone comfort!! The State Attorney Generals tell you that they are not at fault.
We cannot allow the current situation to continue as it is impacting people being able to access a medicine that treats their opioid use disorder and helps them avoid a reoccurrence and the use of lethal street drugs to avoid withdrawal.
My suggestion is that the DEA and the State Attorney Generals show leadership and issue a joint statement to all stakeholders that with the repeal of the X-waiver, and the ever-increasing opioid related overdose deaths, we expect more combination buprenorphine products (buprenorphine combined with naloxone) to be prescribed and therefore manufacturers and distributors should adjust their thresholds upward accordingly.
Otherwise, we are left with another example of the actions we do or do not take that make it easier for people to die from lethal street drugs than it is to get available proven medical help.
Rob Kent, JD
President
Kent Strategic Advisors, LLC
(518) 669-8596