- William L HarpExecutive Director of Board of Medicine
Virginia Opioid Treatment Crisis
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Virginia HB 2163 wants to restrict prescriptions and federally licensed OTP clinics from using mono buprenorphine (Subutex) for opioid dependence. The bill restricts it to only patients that are pregnant or patients that are switching from methadone to buprenorphine but they cannot have mono buprenorphine for more than 7 days, or whatever the Virginia board of medicine decides. This isn't a good idea, restrictions on prescriptions are fine but also allow people that cannot have Naloxone to also be able to get a prescription.
They need to also allow the federal OTP clinics to dispense it in take homes because the patients that have them earned them. I can see and understand why limits and things need to be put into place. It is not a good idea to make this bill law, though. The problem with the bill is the patients that are already in treatment, and have a documented hypersensitivity to Naloxone will lose access to treatment. Buprenorphine is the safest alternative of 3 medications available it doesn't matter if it has Naloxone or not. Addiction is a fight these patients will have to fight with for life. The patients that have a hypersensitivity shouldn't lose access to this medication. It isn't right that if they didn't have a hypersensitivity they could continue getting Buprenorphine but with the Naloxone. Most doctors will not prescribe Subutex unless you cannot have Suboxone anyway.
Methadone, and Buprenorphine both are proven medications used to treat addiction. Each of these medications has their uses but some patients cannot have suboxone they need a full agonist such as methadone. Some patients cannot have methadone and seek suboxone treatment. Every patient deserves the right to what medication they are being treated with. Not one of them works for everyone. Patients that have gone to federally licensed clinic need to be allowed to still have take homes, take homes they earned. Buprenorphine has a ceiling effect anything above 32 milligrams cannot be processed in a 24 hour time period so the chances of overdose are way below the average of other medications used. Some of these patients have been in maintenance replacement therapy and cannot afford to go to the clinic every day to get it. I ask the state of Virginia to look at the facts and make a decision that would save many people's lives that suffer from addiction and opioid dependency.
All of these medications are effective in treating addiction. Restrictions on prescriptions are fine, but also allow patients that have a documented allergy on file to get a prescription so these patients don't lose treatment and also allow the federally licensed clinics to continue to dispense it in take homes. While methadone is stronger than buprenorphine some people need a stronger medication. Everyone is different, and as with many medical problems, you cannot put everyone on the same medication. Experts across the nation are concerned about this bill as it will put patients back on the streets.
Buprenorphine has been offered as an atlernative at federally licensed otps across the nation for over a decade in most places. These patients deserve the right to keep their treatment with Buprenorphine just the same as the Methadone patients. Not everyone can take Methadone, and everyone cannot take buprenorphine. Both of these medications are life savers and too take this option away from otp clinics put patients in danger. The reason they seek treatment at an OTP is because most doctors will write Buprenorphine anyway. It costs clinics more to carry the combination tablet and that costs the patients more hundreds of dollars a month more to be exact. Naloxone was put into Suboxone to appease the DEA.
Naloxone was also used to help the Reckitt-Benckiser the maker of Suboxone file a patent as regular Buprenorphine has been around for over 30 years so they couldn't patent it. Generic Buprenorphine came out 4 years before generic Suboxone did. That is because they couldn't hold a patent for plain buprenorphine as long. While both drugs have their uses, some people just cannot have Naloxone. These people shouldn't be punished for an allergy nor should the patients at otps lose treatment because of a bad company. Regular Buprenorphine was available as a generic to the public 5 years before generic Suboxone was and that is because Reckitt-Benckiser couldn't hold a patient to a drug they didn't invent.
The Virginia Medical board is going to make a seriously bad decision to stop these clinics from dispensing this medication if this bill is signed into law. Many of the biggest addiction organizations also believe this to be a bad law.
If they take Buprenorphine treatment away today, what will they do tomorrow? Go after Methadone? Both are these drugs have helped many people get their lives back. SAMHSA has deemed it a safer alternative and those are their words. not mine. If the plan is to also go after Methadone there will be an even bigger crisis on our hands. These systems work, and limiting options to patients isn't a wise or just choice.
Virginia is full of rural areas and many people travel 50 plus miles one way to be able to get to dose. Until they earn their take homes they do this everyday, and it is extremely hard for these people to have a life, work, and everything in between. Most of these patients cannot travel every day to dose so I am asking you please do not punish the patients that have done what was are required by state and federal law to obtain take homes.
We need to have access to this medication, restrictions like that are not the answer. We are fighting a war and these medications need to be more accessible. I ask for the bill to be amended and allow people that have a hypersensitivity to Naloxone and have it documented to also be allowed to get a prescription and to allow federally licensed clinics to dispense it in take homes to the patients that have earned them. If they do not many of these patients will be forced to the streets more than likely, and if they overdose Narcan isn't an option because they are allergic to it. I believe every person should have a decision in what medication they are being treated with. All three of these medications have a potential for abuse, but methadone and suboxone aren't being limited. I believe if a patient has a documented hypersensitivity to Naloxone (Narcan) they should have the same access to therapy as a person would if they could have suboxone.
The OTPs are also conservative in providing patients with any take home medication. When take home medication is provided to the patient through the OTP, the OTP must meet eight clinical standards, which have been enforced singe the regulatory authority of the FDA that continued under the regulatory oversight of SAMHSA. These criteria include absence of recent drug abuse, which is determined through toxicology reports in addition to established regularity of clinic attendance, absence of serious behavioral problems, absence of known recent criminal activity, stability in the patient's home environment, length of time comprehensive maintenance treatment, ensuring that take home medication can be safely stored within the patient's home whether the rehabilitative benefit the patient derives from decreasing the frequency of clinic attendance outweighs potential risk. Compliance with the regulations is mandatory.
Restricting this medication will affect people currently in treatment at federally licensed facilities that already have diversion prevention protocols. Each take home at this moment is 1 days dose sealed in a bottle. So if a patient has 13 take homes he gets 13 sealed bottles. These bottles cannot be tampered with, if they were to be called in and a bottle be missing even the plastic on one before it was due to be taken the take homes are revoked.
Most patients being treated for addiction/opioid dependency get the combination pill anyway. Most patients that go to a clinic go because they cannot have suboxone or its the closest option they have.
These facts below represent all forms of buprenorphine products. Mono buprenorphine isn't the problem.
Tablets (Mono and Combined)
NATIONAL ESTIMATES FOR THE MOST FREQUENTLY IDENTIFIED CONTROLLED SUBSTANCES: Estimated number and percentage of total drug reports submitted to laboratories from January 1, 2014, through December 31, 2014, and analyzed by March 31, 2015.
Buprenorphine drug reports represented only 1.01% of all drug reports Nationwide.
Inability to access to treatment is a predictor of increased use of diverted buprenorphine. The finding that the most robust risk factor for buprenorphine use was failing to access legitimate buprenorphine treatment implies that increasing, not limiting, buprenorphine treatment access may be an effective response to buprenorphine diversion among persons not in treatment.
Studies have shown that buprenorphine is safe and highly efficacious,(11)decreases hospital admissions, morbidity, and mortality;(12) reduces illicit opioid use; (13 )increases treatment retention;(14)and is much more effective when used in ongoing maintenance treatment than when patients are tapered off the medication.(15)
(U.S. Drug Enforcement Administration, Office of Diversion Control. (2015). National Forensic Laboratory
Information System: Year 2014 Annual Report. Springfield, VA: U.S. Drug Enforcement Administration. Available at:
(Lofwall MR and Havens JR. Inability to access buprenorphine treatment as a risk factor for using diverted buprenorphine. Drug Alcohol Depend. 2012;126:379-383.+)
(11) Johan Kakko et al., 1-Year Retention & Social Function After Buprenorphine-Assisted Relapse Prevention Treatment
for Heroin Dependence in Sweden: a randomized, placebo-controlled trial, LANCET, VOL. 361 (Feb. 22, 2003).
(12)Sofie Mauger, Ronald Fraser, & Kathryn Grill, Utilizing buprenorphine to treat illicit and prescription opioid
dependence, NEUROPSYCHIATRIC DISEASE & TREATMENT 2014:10 587-598, 588 (2014).
(13) Roger D. Weiss et al., Adjunctive Counseling During Brief and Extended Buprenorphine Treatment for Prescription Opioid Dependence, ARCH. GEN. PSYCHIATRY (Dec. 2011), 9, available at
(14) Cindy Parks Thomas et al., Medication-Assisted Treatment with Buprenorphine: Assessing the Evidence,” Psychiatric
Services in Advance, (Nov. 18, 2013), 7.
- Executive Director of Board of Medicine
William L Harp
Virginia Buprenorphine Treatment doesn't need more restrictions it needs less restrictions. The amendment I purpose doesn't hurt anyone in the process. It puts the restriction in place, but also allows patients that cannot have suboxone to also be able to get a prescription. It also allows federally licensed clinics to dispense it in take homes because those patients went for a years to earn them. It isn't right, nor possible to make these patients travel 50 plus miles one way to dose than drive back. It puts undue hardships on patients in treatment already, and will have a drastic effect on these people's lives. If we could take a look at the data of diverted buprenorphine and that includes all forms of this medication with and without naloxone we would see the same results we did with Methadone. It was around 10 years ago that data was looked over and most of the diverted medication came from pain patients with little to no oversight. These clinics have multiple diversion protocols in place, and most patients suffering from opioid dependence cannot even get Buprenorphine Mono wrote to them anyway unless they cannot have Naloxone. Buprenorphine mono isn't the problem, the problem is treatment is inaccessible. Please take all of this information into consideration before making a decision that will alter thousands of Virginians life. I have linked multiple statistical facts, and the sources of those facts. Narcan isn't the deterrent in these drugs, it is buprenorphine itself. It binds to the receptors much more aggressively than other opioids and therefor makes those other drugs ineffective. Narcan has nothing to do with it, and all it effectively does is sky rocket the price of treatment because generics have to keep up with the price of brand names. I hope you make the right decision and support these people.
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