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The opioid epidemic is without a doubt the biggest ongoing public health crisis right now. It’s especially bad in my home state of Pennsylvania, which has had some of the highest rates of opioid overdose deaths for a very long time. In June, Senate Bill 675 was passed in the PA State Senate and HB1005 passed in the house. Both of these bills were proposed and passed under the pretense that they would help stop opioid abuse and prevent opioid overdose deaths. SB675 heavily restricts the circumstances under which physicians can prescribe drugs such as methadone and buprenorphine to treat opioid-use disorder. SB675 would also severely punish any prescriber who violates the act, subjecting them to disciplinary action, license revocation, and possible fines. Put simply, this bill would put arbitrary constraints on the ability of physicians to treat opioid use disorder for absolutely no public health benefits. HB1005 would require healthcare providers to record all patient information if they treat them for what they suspect is a drug overdose in the PDMP for no real benefit to anyone. These bills have the potential to seriously impede the public health effort to prevent opioid deaths, and the politicians that proposed them clearly don’t understand opioid use disorder, buprenorphine, or the opioid epidemic. Let’s look at why.

SB675

PHARM 322: Intro to buprenorphine

Before we can talk about the effects of this bill, we have to talk about buprenorphine. Buprenorphine was patented in 1965 and approved for use in the 1980s, so it’s been around for a while now. SB675 sort of asserts that doctors need special training to prescribe buprenorphine. I was under the impression that doctors already had the necessary training; it’s called medical school, residency, and CME. While I have none of that special training, my googling skills are tough to match. Let’s look at what this drug does and why we really need it. Welcome to PHARM 322, it’s so easy a random programmer at a plastics company can figure it out.

Buprenorphine is an opioid just like oxycodone, fentanyl, or morphine; but it has some really cool properties that make it ideal for treating opioid use disorder. Buprenorphine is a partial opioid agonist, so it doesn’t exhibit the same effects as other opioids. Fentanyl is a full opioid agonist and binds very tightly to the opioid receptors and provides significant pain-relief at the proper dosage, but low blood pressure and respiratory depression at high dosages. Buprenorphine only partially binds to the receptor; while it has similar effects similar to other opioids at low dosages, the effects don’t increase as you increase the dosage. As a result, it isn’t really possible to get a euphoric effect or cause respiratory depression with buprenorphine.

Opioid use disorder is a serious medical condition, and the symptoms of opioid withdrawal can be absolutely brutal. Symptoms of opioid withdrawal include: restlessness, insomnia, body aches, vomiting, diarrhea, hallucination, and seizures. A Cochrane review determined that buprenorphine was much better at relieving the symptoms of opioid withdrawal compared to clonidine or lofexidine. Patients who received it would stay in treatment longer and be more likely to complete their scheduled treatment. But buprenorphine has properties that make it even better than other drugs for treating opioid use disorder.

Let’s say somebody is taking buprenorphine and decides to shoot up a ton of heroin, what happens? Nothing. Buprenorphine has a very high affinity for the mu-opioid receptors, and will out-compete most other opioids for the mu-opioid receptors. The one notable exception is fentanyl, which can compete with buprenorphine. Buprenorphine also has a half-life of 37 hours. It would be really, really hard to come up with a drug for treating opioid use disorder with more ideal properties than buprenorphine. So you’re probably wondering, since buprenorphine is an opioid couldn’t you abuse it like every other opioid? I guess, if you ignore the fact that it’s a partial opioid agonist and won’t really get you that high. There are also a lot of safeguards in place to prevent people from doing that. Suboxone, one of the most common buprenorphine formulations, also contains naloxone. When taken orally, the nalaxone simply isn’t absorbed, but if someone were to snort or inject it the medication the naloxone would also be absorbed and the buprenorphine would have little to no effect. Furthermore there are extended release injections that patients can receive on a weekly basis, so diverting or abusing it literally isn’t possible. Finally even if buprenorphine abuse was rampant, it’s not, it would still be better than everyone doing fentanyl.

SB675: Bad reasons and tall tales

The reasons that politicians have stated for proposing these bills are highly questionable. On Senator Michele Brook’s website, she explains her reasons for proposing a bill:

In the past few years, we have read many unsettling news stories pertaining to fraud and the illegal handling of the treatment drug Suboxone, which contains the opioid buprenorphine and naloxone…Suboxone has been sold and re-sold on the black market and has even become the drug of choice for some who are struggling with addiction.

It’s really hard to estimate the size of a black market for suboxone…because…ya know…it’s a black market. It’s true that suboxone has become the drug of choice for people who are struggling with addiction, that’s why doctors prescribe it. According to Dr. Michelle Lofwall, an addiction specialist, many people try to treat themselves when they fail to get into addiction treatment programs. Many people get buprenorphine off the black market because they have no other way to get it. By passing this bill you’re essentially forcing people suffering from opioid use disorder to either purchase it off the black market or buy other opioids. Which would you rather they buy off the black market: fentanyl or suboxone? Not-Pro Pro-Tip: Fentanyl is the one that people are overdosing on.

She cited several recent instances of abuse. A State Trooper in Huntingdon lost his life when a criminal traded his Suboxone for a firearm

Tragically, on December 30th 2016, State Trooper Landon Weaver was shot and killed when investigating a protection from abuse complaint. According to the police, his killer had traded five suboxone pills for a stolen handgun. While this was a tragic, one person using suboxone as a medium of exchange to buy a gun isn’t really relevant and not a good reason to restrict suboxone. They could’ve used any other medium of exchange, including, but not limited to: Pokémon cards, Beanie Babies, CSGO weapon skins and…oh right…cash. Weaver’s killer didn’t get a gun just because he had access to suboxone to trade for a gun.

A child in Scranton was seriously injured when he ingested a strip of Suboxone hidden in a Dora the Explorer book.

I’m sorry, but I don’t believe this story. The Dora the Explorer book thing just makes it too unbelievable. I looked at the PA court records attempting to find the case and charges reported in The Times Tribune , but came up empty. It probably didn’t happen. I’ve reviewed a lot of research on the pediatric toxicity of buprenorphine, accidental exposure is rare, and deaths are even more rare. A great write-up in Emergency Medicine News states “accidental oral BPN exposure is relatively safe when compared with the serious consequences of morphine or methadone ingestion in children”. A study published in Pediatrics looked at 86 cases of accidental buprenorphine ingestion and found that overdoses were generally well tolerated. Poison Control was able to manage 26% of cases at home without complications. There were no deaths and no report of serious injury. I don’t buy this story, and it’s certainly not a good reason to arbitrarily restrict suboxone. Parents should store their medications in a safe place outside the reach of young children.

In Pittsburgh, the founder and staff of an opioid treatment facility pleaded guilty to health care fraud after submitting claims to Medicaid and Medicare to cover the costs of unlawfully prescribed drugs. And in Philadelphia, a doctor admitted to submitting illegal prescriptions for more than 18,000 doses of buprenorphine, netting him $5 million through these illegal sales.

In both of these cases the providers were committing fraud. They also illegally dispensed these medications and fraudulently billed insurers for other opioids. It was highly likely that the people receiving the prescriptions were diverting those medications. This is the strongest argument you could make in favor of this bill and even then it isn’t a good argument.

DATA2K and SB675: More harm than good

So with the misinformation and bad arguments out of the way, let’s get into why these bills will hurt Pennsylvania’s fight against the opioid epidemic and will make it worse. Providers already have to jump through hoops to prescribe buprenorphine to begin with. In 2000 the Drug Addiction Treatment Act was passed that placed serious limits on physicians’ ability to prescribe buprenorphine. The act only allows physicians to prescribe buprenorphine and methadone for opioid use disorder outside of an opioid-treatment program if they get a special waiver. In order to apply for the waiver a physician has to, in addition to the usual stuff, have a specialty or subspecialty certification from the American Board of Medical Specialties, the American Society of Addiction Medicine, or the American Osteopathic Association. So how do you get one? You have to take an 8-hour course in buprenorphine. Many of these courses cost money, and would require taking a day off of work or doing it on the weekend.

After giving up a perfectly good Saturday and doing a bunch of nonsense paperwork as a physician, can you make it rain suboxone scripts now? Not quite. Once you obtain the waiver, you can only prescribe the drug to 30 patients until the next year, then you can increase you patient panel size. But don’t worry, after you prescribe at the 30 patient limit for a year, you can put in a request to increase your panel limit to 275. Now you might reasonably argue that it’s a bit suspicious a doctor would go from not prescribing buprenorphine at all to needing to prescribe it to more than 30 patients. Fair enough, but I never understood Dr. Gorski’s love for Gloryhammer. Spotify doesn’t limit how many times I can play their music just because I’ve only recently become enlightened. If doctors are prescribing negligently or nefariously, we can and should crack down them. We can do that without putting arbitrary constraints on providers who are trying to get the appropriate treatment to people who really need it.

Let’s say that physician really does have 31 patients who need treatment with suboxone. One of those patients is going to need to figure something else out, and that has real consequences. A JAMA article published in June looked at the characteristics of US counties with high opioid overdose deaths. 71% of rural counties, and 46% of non-rural counties, lacked access to a single provider that could prescribe buprenorphine or methadone. Counties at risk had higher rates of opioid prescriptions, and lower numbers of providers capable of providing buprenorphine or methadone treatment. Methadone treatment was associated with a 53% reduction in deaths, and buprenorphine was associated with a 37% reduction in those with opioid use disorder. The numbers show we need to expand the use of these medications, not restrict them.

So what does SB675 add to this absolute dumpster fire of a system for doctors trying to treat their patients? Well to be able to prescribe a patient buprenorphine under SB675, the following criteria has to be met:

(1) The patient provides evidence demonstrating active participation in an addiction treatment program licensed by the department.

(2) The evidence of participation in the addiction treatment program is documented in the patient’s medical record.

(3) The buprenorphine office-based prescriber is certified by the department as provided under subsection (a).

I think there’s an underlying assumption being made with these policies that doesn’t actually work. The assumption is that buprenorphine isn’t the first line treatment for opioid use disorder. Buprenorphine is the first line treatment for opioid use disorder according to the Veterans Health Association, Up-To-Date, the American Psychiatric Association, and the American Medical Association.

I’m not going to fault politicians for this misconception here, it’s really easy to see why they would think that. There’s this term being used by all of these very prestigious medical organizations and websites with regard to buprenorphine and methadone treatment: “Medication Assisted Treatment”. This term is literally only applied to the treatment of opioid use disorder using medication like buprenorphine and methadone. To those medical organizations, I must ask: could you from a purely PR perspective…stop using that term? It implies that taking medication is somehow abnormal or wrong. We don’t call taking amlodipine to treat hypertension “medication assisted treatment” of hypertension. The use of the term should be scrubbed from prominent publications in favor of a more apt term: “treatment”. I’m not pointing this out to be pedantic; our use of terminology when we communicate with the public really matters. If you want the public to see medications for treating opioid-use disorder as normal, you have to talk about them like they are normal.

While there are a fair amount of certified opioid treatment programs in Pennsylvania, there are still serious problems with access to them. Researchers at the West Chester University of Pennsylvania published an excellent review of the availability and efficacy of these programs. The short of it is there are a lot of people in Pennsylvania not able to access their care they desperately need. They found that treatment centers only partially cover the central and eastern portions of the state. Worse still, there was a lack of access to providers who could prescribe buprenorphine in northern-most and southern-most edges of Pennsylvania. Many of these programs have hours of operation that make it hard for people to get care from them. This bill will only make it harder for people to get access to the most effective treatment for opioid use disorder, and will lead to more overdose deaths as a result.

I want to take a moment to appreciate the absurdity of a world where this bill is law. Let’s say you are struggling to get off of opioids. Like with all medical problems, you should probably consult your primary care provider first. They could easily diagnose you with opioid use disorder, but they can’t prescribe you the medication that is the first-line therapy to treat it. In order for them to do that, you have to go participate in a certified opioid treatment program which may not even be available to you. Let’s assume you’re lucky enough to live in an area that has a certified OTP, you can both afford it and the OTP has operating hours slightly better than a bank. After the time it takes to begin active treatment with the OTP, only then you could you go back to your PCP to get the first line treatment to treat the medical condition that you have. In addition to paying for on-going treatment from the OTP that you may or may not need, you also have to pay for additional visits to your doctor.

Maybe you believe that a patient receiving buprenorphine treatment from a primary care physician instead of being active in a certified treatment program is less than ideal. Here’s the rub, we don’t live an ideal world. Our world is messy and imperfect. We have to make do with less than ideal circumstances. We can’t just wish our desired circumstances into reality. Buprenorphine and methadone are the first-line treatment for opioid use disorder, the keystone of an effective treatment plan. This bill does nothing to improve the quality of care those in an OTP are receiving, but limits access to the most effective treatment option for anyone who isn’t active in an OTP. This will undoubtedly make it harder for people to access quality medical care, and should be vetoed as a result.

HB1005

But, like, why though?

HB1005 is an amendment to a bill that was proposed in the House of Representatives and passed around the same time as SB675 passed in the senate. It would require that this system be created and that first responders and physicians document everything about an overdose event, including the name, date of birth, address, and gender of the victim. In addition to the date and time of the overdose event, address where the drug-related overdose took place, whether an opioid antagonist was administered, whether the overdose resulted in death, and the identity of the drug the person overdosed on within 2 weeks of the overdose event occurring.

There are a lot of ridiculous assumptions being made here. I really doubt such a system would be of much use to doctors in the case of opioid overdose because the treatment is the same regardless of what opioid was overdosed on. Did they overdose on opioids and are they suffering from respiratory depression? Then give Naloxone. The system would only be beneficial if a physician has already seen the patient for opioid overdose, and the record was in the system and could be found. Chances are high except that if someone overdoses and goes to the emergency room two times, they’re going to the same emergency room and probably seeing the same physician. The hospital wouldn’t need access to such records because they already have them, they’ve seen the person before. So really the only case this system would be beneficial is if someone suffered from an opioid overdose once, overdosed again and was taken to a different hospital, the physician successfully looked up the patient in the system, and physicians actually needed that information to successfully treat the patient in the first place. I would usually say something like “I’m sure there’s some hypothetical edge case where that might be a good idea, but also don’t do that”, but I can’t even come up with a good hypothetical edge case. The PA Medical Society (PAMED) has come out against the bill stating that it would require physicians and first responders to get information about the patient that may not be readily available. In my opinion it would require spending lots of money to modify an existing system that provides little to no benefit. I think that money could be better spent actually tackling the opioid epidemic and not annoying medical professionals.

Conclusion: Nope. Nope. Nope.

We do a lot of things better than other states here in Pennsylvania, and it’s hard not to feel a little tribalistic. We have neat stuff here that Californians could only dream of like water, and not selling plasma to pay for an apartment. We’re better than Florida at not being Florida. But we’re also showing up the lesser states in opioid deaths, where we are the uncontested champions. According to the CDC data in 2017, Pennsylvania had 5,388 overdose deaths, the highest number of opioid deaths in the entire country. There is a lot that could be done to combat this problem, and it would be easy to make headway on this issue.

HB1005 does nothing to empower healthcare professionals, gives them more meaningless paperwork, and would be a waste of public money. SB675 would arbitrarily restrict access to buprenorphine treatment to an even more absurd degree. These bills were based on nothing more than misconceptions about opioid use disorder and buprenorphine, and urban legends. SB675 will make Pennsylvania’s opioid problem far, far worse. When doctors get their license to prescribe controlled substances, they can prescribe whatever opioids are necessary with no issues. But if a patient gets addicted to those opioids by no fault of either party, doctors have to jump through all kinds of regulatory hoops to be able to take care of that patient. This is ridiculous and the most obvious opportunity for improvement. Why would we want to make this problem even worse with SB675? This is an epidemic and we have no margin for error.

Unfortunately, I think that both of these bills are going to pass the house and senate. Both of these bills have passed either the house or senate, and will probably pass the other chamber. Despite the objections of PAMED and the Pennsylvania College of Emergency Physicians. I don’t think we can sway a majority vote in either chamber, but we can convince one person to do the right thing and that’s all that matters. I’m going to need your help with this, but I think we can get PA Governor Tom Wolf to see this post.

A personal note for the Governor of Pennsylvania Tom Wolf

Hi there! I genuinely like you, Governor Wolf. You have consistently done the right thing and vetoed bills that are an affront to science, decency, and common sense. Like when you vetoed SB321, which would imposed nonsensical restrictions on doctors’ abilities to provide care and women’s right to make decisions about their health. I’m just asking you to go to bat for Team Science and more importantly Pennsylvania yet again. These bills will only make things worse. Don’t take it from me, listen to the experts at the American Medical Association, the American Psychiatric Association, the PA Medical Society, and the PA Psychiatric Society.

But while we’re on the topic, now is as good a time as any to talk about real ways to combat the opioid epidemic. The American College of Toxicology, the American Academy of Emergency Medicine and the American College of Emergency Physicians have all endorsed removing the buprenorphine waiver requirement. A public health campaign to teach the public about buprenorphine treatment would go a long way at fighting the myth that it’s “substituting on addiction for another”. I am more than happy to talk to anyone in the PA House of Representatives, Senate, or the governor’s office about these issues anytime. Governor Wolf, please treat SB675 and HB1005 like I treat de_train on FaceIt: veto that trash.