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Lawyers, pharmacists, harm-reduction advocates and a former DEA employee say Njoku's case is emblematic of the DEA's aggressive stance on buprenorphine. An opioid itself, the medication can be misused, so the DEA works to limit its diversion to the streets. But many say the agency's policies are exacerbating the opioid epidemic by scaring pharmacies away from dispensing this medication when it's desperately needed.


Drug overdose deaths hit record highs last year, and despite medical experts considering medications like buprenorphine the gold standard, less than 20% of people with opioid use disorder typically receive them. The federal government has taken steps to increase the number of clinicians who prescribe buprenorphine, but many patients struggle to get those prescriptions filled. A recent study found that 1 in 5 U.S. pharmacies do not provide buprenorphine.


Many pharmacists fear ordering too much buprenorphine will trigger a DEA investigation, research in Kentucky and North Carolina has found. That creates a "prescribing cliff," says Bayla Ostrach, who researches substance use disorder treatment and health policy. Doctors might prescribe more, but if pharmacies won't fill the prescription, patients can't get their medication. Ainsley Bryce/KHN hide caption


The ramifications can be particularly acute in rural areas, where a dearth of addiction treatment providers, lack of transportation and stigma against these medications already create barriers. If pharmacies decline to provide buprenorphine too, patients will have few options left, Selby said.


Like many other prescription drugs, buprenorphine can be found illegally on the street. There are unscrupulous doctors who hand out prescriptions and pharmacists who fill them. Subutex, which consists of buprenorphine alone, is easier to misuse and typically has higher street value than Suboxone, a combination of buprenorphine and the overdose-reversal drug naloxone.


But research suggests that buprenorphine misuse has decreased in recent years even as prescribing has increased, and that most people who use diverted buprenorphine do so to avoid withdrawal symptoms and because they can't get a prescription.


Trish Mashburn works at two independent pharmacies in western North Carolina. When a nearby pharmacy stopped dispensing buprenorphine, she began getting five calls a day from prospective customers trying to get their prescriptions filled, she said. Although both her employers stock buprenorphine, they order only a set amount, so Mashburn often must turn patients away.


Research in North Carolina and Kentucky has found that many pharmacists worry that ordering more buprenorphine will trigger a DEA investigation. The DEA does not specify thresholds for controlled substances, but it requires wholesalers to flag suspicious orders. In turn, wholesalers limit how much a pharmacy can buy or create algorithms to detect orders that exceed projected need.


They base these limits, in part, on the DEA's enforcement actions, said Larry Cote, a former DEA attorney who now advises wholesalers, pharmacies and other clients on regulatory compliance. Since pharmacies are not typically privy to how these limits are set, many simply order small batches of buprenorphine out of caution.


That creates a "prescribing cliff," said Bayla Ostrach, lead author of a paper studying this issue in North Carolina. Doctors may prescribe buprenorphine to more patients, but pharmacies order enough for only a certain number of customers. Since many people stay on buprenorphine for years, once the pharmacy hits its self-established quota, it may rarely have openings for new patients.


If they can have a site for injection then why not offer buprenorphine there aswell. This would be another alternative atleast. I know how heroin addicts think. They want that immediate warm rush of heroin going to the brain and nothing else will do. Especially if nothing else is available. It would seem to me that having alternative medicine available is the key to stopping injections. Yeah, it might take time but we need alternatives more now than ever before in the history of America.


Its supposed to be for pregnant women that is true but its up to the prescribers discretion. I know a few recieving subutex buprenorphine sublingual. They are not pregnant. So im not sure why your prescriber decided to change your script.


Over time, the sequellae of interstitial cystitis became too much. At the time the problem with IC got out of hand I was licensed in two States each with very different attitudes towards physician use of narcotics. One of them at this point in time actually has recovering physicians on buprenorphine and even methadone. The other jurisdiction has what one might call draconian attitudes. The director of the impaired physicians in that jurisdiction was a ruthless guy who insisted that docs give urines 3 times per week at 60 dollars a shot. I had also become a medical review officer and knew that this was not necessary. Random urines a few times per month are all that is necessary.


The long and short of it is that eventually, I wound up on buprenorphine. It was prescribed for me and compounded. However, it caused havoc with my career because of the insane attitudes and ignorance of the medical board. I have been taking a stable dose of 2 to 4 mg a day since the 1990s! I have not escalated the dose. It has been prescribed legally by the physician writing on the Rx, For Chronic Pain.


Guidelines released by the U.S. Department of Health & Human Services in 2021 removed barriers to Suboxone care by exempting providers from time-intensive certification requirements to become qualified buprenorphine prescribers. State-licensed practitioners with a valid DEA (Drug Enforcement Administration) registration can now prescribe medications containing buprenorphine to people diagnosed with opioid use disorder. Ask your provider if they qualify to prescribe Suboxone or look for reputable online Suboxone doctors to help connect you with Suboxone care.


Somewhat controversially, Suboxone and other buprenorphine-based medications have certain special regulations in place that limit who can prescribe them and to what degree beyond the typical regulations that exist for other types of prescription medication.[1]


Physicians who want to prescribe these types of medications typically must complete a federally mandated 8-hour training program. Then, they can receive a DEA waiver that allows them to prescribe buprenorphine for addiction treatment purposes.


The Substance Abuse and Mental Health Services Administration (SAMHSA) maintains a practitioner locator to find treatment providers able to treat opioid use disorder with buprenorphine-based medications, including Suboxone.[3] This is likely the easiest way to see if a clinic may be able to provide you with Suboxone or a comparable medication.


As of December 29, 2022, and pursuant to Section 1262 of the Consolidated Appropriations Act of 2023, federal law no longer requires prescribers to obtain a DATA-Waiver or X-Waiver to prescribe medications, like buprenorphine, to treat patients with opioid use disorder. Read more


Not only does buprenorphine help people with an opioid use disorder resist cravings and stay away from drugs, but it also protects patients from the increasingly likely possibility that they will end up using an illicit drug laced with fentanyl and die.


But no ambulances routinely carried buprenorphine until 2019, when a group of paramedics in Camden, New Jersey, became the first to receive training on the addiction medication, and ambulances in the state were authorized to carry it.


They published a study this month that, for the first time, provides evidence that administering buprenorphine in the first few critical minutes after an overdose patient wakes up resulted in a substantial number of patients seeking treatment within 30 days.


"We weren't sure that would be the case," Carroll said. Depending on the dose of overdose-reversal drug naloxone they received and their reaction to it, he said, "We were concerned that buprenorphine could make their symptoms worse in some cases. That didn't happen in even a single patient."


In 2018, Cooper began dispatching some of its emergency department physicians who specialized in addiction to 911 overdose calls to carry and administer buprenorphine to patients who wanted it. They were able to adapt their clinical procedures to the back of an ambulance under tight time constraints.


When they found that giving buprenorphine to overdose patients provided quick relief from their withdrawal symptoms and took only a few minutes more than a routine overdose call, Carroll and his team asked the state health department to authorize paramedics to administer the drug. In June 2019, their request was granted.


Now, the study shows that administering buprenorphine to overdose patients within 10 minutes after resuscitation quickly alleviates withdrawal symptoms and results in a nearly six-fold increase in patients showing up for treatment within 30 days.


The study did not, however, find that overdose survivors who took an initial dose of buprenorphine in the ambulance were less likely to overdose again compared with patients who didn't receive the addiction drug.


"It should be standard procedure everywhere. But sadly, that's not likely to happen for a long time," Saloner said, given existing U.S. regulatory barriers, such as oversight of buprenorphine by the Drug Enforcement Administration and a continuing shortage of addiction treatment in most communities.


Although the Biden administration last year eliminated an eight-hour training requirement needed for physicians to administer buprenorphine, the drug is still not available in most hospital emergency departments, according to Saloner. And since EMS agencies typically coordinate their services with local hospitals, most don't offer the drug.


Still, the number of drug-related deaths continued to mount in Camden and opioid overdoses became the primary reason paramedics were called, Carroll said. Before the city started carrying buprenorphine on ambulances, he said, "Compassion fatigue was setting in, and paramedics were suffering from a sense of helplessness." 59ce067264






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