Selected Podcast
History of Opioid Crisis and Current Policies in Prescribing
James Besante M.D shares a historical perspective on the opioid crisis. He discusses the failure of regulatory bodies to address inappropriate opioid prescribing and he covers the new federal and state policy changes to reduce opioid use.
Featuring:
Learn more about James Besante, MD
James Besante, MD
James Besante, MD is an Addiction Medicine Physician.Learn more about James Besante, MD
Transcription:
Melanie Cole: Expert Insights is an ongoing medical education podcast. The Carle Division of Continuing education designates that each episode of this enduring material is worth a maximum of 0.25 AMA PRA category one credit. To collect credit, please click on the link and complete the episodes post-test.
Introduction: Another edition of our Integrated System Podcast Series, helping us to achieve world-class accessible care and to improve the health of the people we serve. This is Expert Insights. Here's Melanie Cole.
Host: Welcome. This is Expert Insights with the Carle Foundation Hospital. I'm Melanie Cole and today we're discussing the history of the opioid crisis and current policies for prescriptions. Joining me is Dr. James Besante. He's an Addiction Medicine Physician with the Karl Foundation Hospital. Dr. Besante, It's a pleasure to have you join us today. Give us a little historical perspective on the opioid crisis and kind of how it came about.
Dr. Besante: A very common story that I hear in my clinic is I'm using an opioid now recreationally or I have an opioid use disorder, which would be someone with a substance use disorder, their problem use of opioids and they tell me it started with an injury or a prescription for an opioid, and I really want to focus our discussion on this explosion of opioid prescribing that took place in the mid to late nineties. And continued an escalated in the early two thousands, and when we look at the data, we can see very clearly if we look at just OxyContin, which was introduced to the market in 1996. Initially sales were flat for this drug, but then through some very aggressive, and I'd say deceptive marketing tactics, OxyContin sales grew dramatically. Dramatically to where they were the number one selling drug in America in the mid two thousands. The number one selling drug in America. I'm talking a blockbuster drug and those sales were not related to the efficacy of the drug and that by that I mean the drug was no better than opioids we already had access to. What really took place was the marketing of the drug in communities across America. And when we look at the prescriptions as either a number or in kilograms of opioids sold, the rise from the 90s to maybe let's say 2009, 2010 is tripling, quadrupling, and along that we can trace another line of deaths from opioid overdose and illicit opioid overdose from drugs like heroin.
Host: Wow. That's quite a historical perspective, Dr. Besante. So what about the failure of regulatory bodies to address inappropriate prescriptions of opioids and for physicians that are conflicted about this whole situation that we're seeing today, what do you tell them?
Dr. Besante: That's a great question. And here this is really also a story about the SBA as a governing body and physicians as an organized body, to regulate and pass policies in the interest of the public. And it's truly a failure. What people should know is that the standard of proof to get a new drug approved in the US is non-inferiority, which means a drug, a new drug simply has to be no worse than what's already on the market. So this idea that a new drug is somehow better than an old drug is simply not true. In fact, most drugs approved in the US are not novel compounds and don't actually offer improved efficacy. Rather they're ways for drug companies to market them more aggressively, get new patents or intellectual property rights so they can sell them as a brand drug at higher prices. The FDA again is not first overseeing that we're making better newer drugs, hopefully safer drugs, but they're also failing in this case to regulate controlled substances like opioids.
Early on, there was very strong data as early as 1998 within a one to two years of the release of OxyContin that this drug was being diverted. Organizations like the DEA were seeing higher rates of overdoses and diversion and misuse and selling of these drugs on the street. This was not translated to effective policy measures or regulations until recently, and several States including Illinois, have really led the way for an acting policies to change prescriber habits and to put more regulation and reduce the risks of these prescriptions. And I should comment that physicians have come a long way as well. The prescribing practices of physicians have changed dramatically, not only in line with policies and regulations that have been passed, but also with professional organizations that also passed guidelines and recommendations for physicians. So overall prescribing of opioids has decreased dramatically and it's a much safer situation, although still not enough.
Host: Well, before we get to how that could be accomplished when we talk about new Federal and State policy changes to reduce opioid prescriptions, Dr. Besante, are there supply limits for initial first time prescriptions? Are States themselves setting these limits and along those lines, do you feel there's a clash of cultures as it were between law enforcement and medicine?
Dr. Besante: So yeah, several very good questions. The first thing I'll say is that yes, States are passing laws or regulations on the number of days someone can receive an opioid prescription. A lot of studies have been done to look at the risks of opioids, so who is at risk of getting that prescription of that pain medicine for perhaps a dental extraction or a surgery? Who's at risk for then developing a disease, an opioid use disorder, an unhealthy use of that drug that persists beyond the treatment of their pain. And one of the greatest risk factors is the length of time someone is exposed to the drug. So the fewer days someone is exposed to the drug, many studies have shown it reduces the risk that someone will then go on to develop this disease. So you know, when I had my wisdom teeth removed, I received a 30 day supply of pain medicine.
We now know that first of all, a lot of the pain medicines that are non opioids like Tylenol and other nonsteroidal anti-inflammatory drugs like ibuprofen. Ibuprofen actually worked quite well, much safer, and can be used in many instances where doctors were previously using an opioid pain medicine. And then if that drug needs to be prescribed, the fewer days the better. So in some States it's a limit of nine days. Some States it's seven, more conservative States are five. Most acute pain can be managed in three to five days with an opioid. And I will also say, corollary to this, there's very limited data to support opioid use for chronic pain and other diseases like migraines, neuropathy, the data's limited and like everything in medicine, we must weigh the risks and benefits and the risks of using these medicines are so tremendous. Oftentimes they outweigh the benefits.
To go onto your other point about this clash, so I will say here in Champagne County we are working with local and state officials. We look at our friends in law enforcement as partners. There's been a huge shift now to where we see first responders as one of the main players in the response to the opioid epidemic. These are the individuals who are administering lifesaving drugs like Narcan to patients early on. Oftentimes they're also advocates to get patients into treatment, so I think that is changing. More people are recognizing that people using opioids and other drugs have a very serious disease and they need treatment and that punitive measures are not the way to get these people help.
Host: Have you seen private parties like pharmacies, managed care organizations, mirroring legislative trends by setting their own limits? What do you see going on?
Dr. Besante: That's a really good question as well, so again, everyone is trying to respond to the opioid epidemic. It is a priority of all players and all payers in our healthcare system. It's also uniquely an issue that receives bipartisan support, so everyone acknowledges this is a very serious problem and we all need to be very focused on our response to it and not only that we should be using evidence-based measures. So when I talk about a solution or a way to address the problem, I'm citing the evidence that supports it. That's very important. Pharmacies and other outlets that sell medications are doing things like carrying drugs to treat opioid use disorder more readily. Those are drugs like Sub Oxone and they also are carrying Narcan. The drug I mentioned earlier that when administered is a lifesaving drug that can reverse an opioid overdose.
So we're seeing a lot of community partners taking a lead on this and we hope more will. In terms of payers, insurance companies are also recognizing this is a big issue, not just from a safety and a public health perspective, but a cost issue as well. These patients are very expensive. They utilize services in ways that are very expensive. Going to emergency departments frequently, you know, God forbid someone should overdose and you hopefully they survive perhaps the first responder administered Narcan in the field. Then that's a very complicated hospitalization. It is much better for everyone and better for payers if we engage people in treatment earlier in their disease. So payers are also looking for ways to get people into treatment.
Host: Do you think we should be looking at strategies for restricting supply, Dr. Besante? I saw one that suggested delivery systems that are resistant to abuse such as subcutaneous implants, things along those lines. If it's more of a chronic and less acute situation.
Dr. Besante: So many drugs have abuse prevention measures in them and they are helpful. Sub Oxone for example, has several built in abuse prevention measures, so there is some innovation in the way we deliver these drugs. You mentioned a subcutaneous implant. There is a subcutaneous implant available for one of the medications we use buprenorphine. The issue with that is it introduced new costs, new challenges and risks associated with these procedures without really showing that the drug works better. Some of these measures are just to make it so patients take the medicine every day. It improves the consistency of them dosing their medication. That's something like an implant would be helpful in addressing, but I will say this, the drugs that have been around for two decades more, they work really well.
And a lot of times we focus on innovation and new drugs coming down the pipeline. We have very good, very effective ways to treat opioid use disorder, but many people still do not get access to those treatments either because of geographic issues. Perhaps they live in an area with few providers or a shortage of clinics or other healthcare resources or they may be uninsured or under insured and can't afford the cost sharing to receive treatment. So I will say that yes, I always look for new drugs coming down the pipeline and it's something that's on my radar. But at the same time we have very good drugs that few people are accessing now for a host of issues. So part of this has to be us connecting people to drugs that are already available
Host: As we wrap up and what a fascinating topics, such a great episode that can really start a conversation among healthcare providers and you know even start commissions and panels of experts. Dr. Besante, what would you like other providers to take away regarding this historical perspective and some of the latest information that you've given us regarding best practices for use of opioids? How we can help and current policies?
Dr. Besante: Yeah, so this is a very unique illness because it touches everyone. Everyone has been affected by addiction in some way. Either a personal story, someone close to us or if we're providers, it's been involved in our practice. There are very few doctors who have not come in contact with the opioid epidemic and the relationship organized medicine has with the opioid epidemic is complex and it is very incumbent upon doctors and all other healthcare providers to be part of the solution moving forward. I will say that as a doctor who focuses primarily in addiction medicine, this is incredibly rewarding work. My patients are incredible individuals, they are mothers, they are daughters, they are teachers. Some are physicians, some are lawyers. So many wonderful people are experiencing this disease and need help, and all of us, not just providers, but all of us in our communities need to be part of the response to help expand access and really to reach out to these people. And let them know that we're here, and we're ready to help and we want to do better.
Host: Certainly great information. Dr. Besante, thank you so much for coming on and sharing your really incredible expertise today for other providers. And that concludes this episode of Expert Insights with the Carle Foundation Hospital. For a listing of Carle providers and to view Carle sponsored educational activities, please visit our website @carleconnect.com for more information and to get connected with one of our providers. We hope the information gained will be applicable to your work and life. I'm Melanie Cole.
Melanie Cole: Expert Insights is an ongoing medical education podcast. The Carle Division of Continuing education designates that each episode of this enduring material is worth a maximum of 0.25 AMA PRA category one credit. To collect credit, please click on the link and complete the episodes post-test.
Introduction: Another edition of our Integrated System Podcast Series, helping us to achieve world-class accessible care and to improve the health of the people we serve. This is Expert Insights. Here's Melanie Cole.
Host: Welcome. This is Expert Insights with the Carle Foundation Hospital. I'm Melanie Cole and today we're discussing the history of the opioid crisis and current policies for prescriptions. Joining me is Dr. James Besante. He's an Addiction Medicine Physician with the Karl Foundation Hospital. Dr. Besante, It's a pleasure to have you join us today. Give us a little historical perspective on the opioid crisis and kind of how it came about.
Dr. Besante: A very common story that I hear in my clinic is I'm using an opioid now recreationally or I have an opioid use disorder, which would be someone with a substance use disorder, their problem use of opioids and they tell me it started with an injury or a prescription for an opioid, and I really want to focus our discussion on this explosion of opioid prescribing that took place in the mid to late nineties. And continued an escalated in the early two thousands, and when we look at the data, we can see very clearly if we look at just OxyContin, which was introduced to the market in 1996. Initially sales were flat for this drug, but then through some very aggressive, and I'd say deceptive marketing tactics, OxyContin sales grew dramatically. Dramatically to where they were the number one selling drug in America in the mid two thousands. The number one selling drug in America. I'm talking a blockbuster drug and those sales were not related to the efficacy of the drug and that by that I mean the drug was no better than opioids we already had access to. What really took place was the marketing of the drug in communities across America. And when we look at the prescriptions as either a number or in kilograms of opioids sold, the rise from the 90s to maybe let's say 2009, 2010 is tripling, quadrupling, and along that we can trace another line of deaths from opioid overdose and illicit opioid overdose from drugs like heroin.
Host: Wow. That's quite a historical perspective, Dr. Besante. So what about the failure of regulatory bodies to address inappropriate prescriptions of opioids and for physicians that are conflicted about this whole situation that we're seeing today, what do you tell them?
Dr. Besante: That's a great question. And here this is really also a story about the SBA as a governing body and physicians as an organized body, to regulate and pass policies in the interest of the public. And it's truly a failure. What people should know is that the standard of proof to get a new drug approved in the US is non-inferiority, which means a drug, a new drug simply has to be no worse than what's already on the market. So this idea that a new drug is somehow better than an old drug is simply not true. In fact, most drugs approved in the US are not novel compounds and don't actually offer improved efficacy. Rather they're ways for drug companies to market them more aggressively, get new patents or intellectual property rights so they can sell them as a brand drug at higher prices. The FDA again is not first overseeing that we're making better newer drugs, hopefully safer drugs, but they're also failing in this case to regulate controlled substances like opioids.
Early on, there was very strong data as early as 1998 within a one to two years of the release of OxyContin that this drug was being diverted. Organizations like the DEA were seeing higher rates of overdoses and diversion and misuse and selling of these drugs on the street. This was not translated to effective policy measures or regulations until recently, and several States including Illinois, have really led the way for an acting policies to change prescriber habits and to put more regulation and reduce the risks of these prescriptions. And I should comment that physicians have come a long way as well. The prescribing practices of physicians have changed dramatically, not only in line with policies and regulations that have been passed, but also with professional organizations that also passed guidelines and recommendations for physicians. So overall prescribing of opioids has decreased dramatically and it's a much safer situation, although still not enough.
Host: Well, before we get to how that could be accomplished when we talk about new Federal and State policy changes to reduce opioid prescriptions, Dr. Besante, are there supply limits for initial first time prescriptions? Are States themselves setting these limits and along those lines, do you feel there's a clash of cultures as it were between law enforcement and medicine?
Dr. Besante: So yeah, several very good questions. The first thing I'll say is that yes, States are passing laws or regulations on the number of days someone can receive an opioid prescription. A lot of studies have been done to look at the risks of opioids, so who is at risk of getting that prescription of that pain medicine for perhaps a dental extraction or a surgery? Who's at risk for then developing a disease, an opioid use disorder, an unhealthy use of that drug that persists beyond the treatment of their pain. And one of the greatest risk factors is the length of time someone is exposed to the drug. So the fewer days someone is exposed to the drug, many studies have shown it reduces the risk that someone will then go on to develop this disease. So you know, when I had my wisdom teeth removed, I received a 30 day supply of pain medicine.
We now know that first of all, a lot of the pain medicines that are non opioids like Tylenol and other nonsteroidal anti-inflammatory drugs like ibuprofen. Ibuprofen actually worked quite well, much safer, and can be used in many instances where doctors were previously using an opioid pain medicine. And then if that drug needs to be prescribed, the fewer days the better. So in some States it's a limit of nine days. Some States it's seven, more conservative States are five. Most acute pain can be managed in three to five days with an opioid. And I will also say, corollary to this, there's very limited data to support opioid use for chronic pain and other diseases like migraines, neuropathy, the data's limited and like everything in medicine, we must weigh the risks and benefits and the risks of using these medicines are so tremendous. Oftentimes they outweigh the benefits.
To go onto your other point about this clash, so I will say here in Champagne County we are working with local and state officials. We look at our friends in law enforcement as partners. There's been a huge shift now to where we see first responders as one of the main players in the response to the opioid epidemic. These are the individuals who are administering lifesaving drugs like Narcan to patients early on. Oftentimes they're also advocates to get patients into treatment, so I think that is changing. More people are recognizing that people using opioids and other drugs have a very serious disease and they need treatment and that punitive measures are not the way to get these people help.
Host: Have you seen private parties like pharmacies, managed care organizations, mirroring legislative trends by setting their own limits? What do you see going on?
Dr. Besante: That's a really good question as well, so again, everyone is trying to respond to the opioid epidemic. It is a priority of all players and all payers in our healthcare system. It's also uniquely an issue that receives bipartisan support, so everyone acknowledges this is a very serious problem and we all need to be very focused on our response to it and not only that we should be using evidence-based measures. So when I talk about a solution or a way to address the problem, I'm citing the evidence that supports it. That's very important. Pharmacies and other outlets that sell medications are doing things like carrying drugs to treat opioid use disorder more readily. Those are drugs like Sub Oxone and they also are carrying Narcan. The drug I mentioned earlier that when administered is a lifesaving drug that can reverse an opioid overdose.
So we're seeing a lot of community partners taking a lead on this and we hope more will. In terms of payers, insurance companies are also recognizing this is a big issue, not just from a safety and a public health perspective, but a cost issue as well. These patients are very expensive. They utilize services in ways that are very expensive. Going to emergency departments frequently, you know, God forbid someone should overdose and you hopefully they survive perhaps the first responder administered Narcan in the field. Then that's a very complicated hospitalization. It is much better for everyone and better for payers if we engage people in treatment earlier in their disease. So payers are also looking for ways to get people into treatment.
Host: Do you think we should be looking at strategies for restricting supply, Dr. Besante? I saw one that suggested delivery systems that are resistant to abuse such as subcutaneous implants, things along those lines. If it's more of a chronic and less acute situation.
Dr. Besante: So many drugs have abuse prevention measures in them and they are helpful. Sub Oxone for example, has several built in abuse prevention measures, so there is some innovation in the way we deliver these drugs. You mentioned a subcutaneous implant. There is a subcutaneous implant available for one of the medications we use buprenorphine. The issue with that is it introduced new costs, new challenges and risks associated with these procedures without really showing that the drug works better. Some of these measures are just to make it so patients take the medicine every day. It improves the consistency of them dosing their medication. That's something like an implant would be helpful in addressing, but I will say this, the drugs that have been around for two decades more, they work really well.
And a lot of times we focus on innovation and new drugs coming down the pipeline. We have very good, very effective ways to treat opioid use disorder, but many people still do not get access to those treatments either because of geographic issues. Perhaps they live in an area with few providers or a shortage of clinics or other healthcare resources or they may be uninsured or under insured and can't afford the cost sharing to receive treatment. So I will say that yes, I always look for new drugs coming down the pipeline and it's something that's on my radar. But at the same time we have very good drugs that few people are accessing now for a host of issues. So part of this has to be us connecting people to drugs that are already available
Host: As we wrap up and what a fascinating topics, such a great episode that can really start a conversation among healthcare providers and you know even start commissions and panels of experts. Dr. Besante, what would you like other providers to take away regarding this historical perspective and some of the latest information that you've given us regarding best practices for use of opioids? How we can help and current policies?
Dr. Besante: Yeah, so this is a very unique illness because it touches everyone. Everyone has been affected by addiction in some way. Either a personal story, someone close to us or if we're providers, it's been involved in our practice. There are very few doctors who have not come in contact with the opioid epidemic and the relationship organized medicine has with the opioid epidemic is complex and it is very incumbent upon doctors and all other healthcare providers to be part of the solution moving forward. I will say that as a doctor who focuses primarily in addiction medicine, this is incredibly rewarding work. My patients are incredible individuals, they are mothers, they are daughters, they are teachers. Some are physicians, some are lawyers. So many wonderful people are experiencing this disease and need help, and all of us, not just providers, but all of us in our communities need to be part of the response to help expand access and really to reach out to these people. And let them know that we're here, and we're ready to help and we want to do better.
Host: Certainly great information. Dr. Besante, thank you so much for coming on and sharing your really incredible expertise today for other providers. And that concludes this episode of Expert Insights with the Carle Foundation Hospital. For a listing of Carle providers and to view Carle sponsored educational activities, please visit our website @carleconnect.com for more information and to get connected with one of our providers. We hope the information gained will be applicable to your work and life. I'm Melanie Cole.