Prescribing Abuse-Deterrent Opioids
Prescribing Abuse-Deterrent Opioids
This is Dr Charles Argoff, professor of neurology at Albany Medical College and director of the Comprehensive Pain Center at Albany Medical Center in Albany, New York.
You may have heard of a growing number of so-called abuse-deterrent opioids that have become available. These include:
• Hysingla™ ER (hydrocodone bitartrate), an abuse-deterrent form of hydrocodone extended release approved by the US Food and Drug Administration (FDA) in November 2014
• Zohydro® ER (hydrocodone bitartrate), a newly developed form of Zohydro—which, you may recall, was the first extended-release form of hydrocodone without acetaminophen. The abuse-deterrent extended-release form is a different medication in a number of ways, including the number of times that it is dosed per day and the fact that, when it was first approved, it was approved without any abuse-deterrent features. A newly developed version of this particular medication is in the process of becoming available to us: A modified formulation including abuse-deterrent technology was approved by the FDA in January 2015. The FDA has not approved an abuse-deterrent labeling claim for that formulation.
• Embeda®, an extended-release form of morphine that has just recently been designated as an abuse-deterrent form of morphine. In this instance, it combines morphine with an opioid antagonist within the same substance and preparation (morphine sulfate and naltrexone hydrochloride)
• And, of course, OxyContin®, which has already been approved and been used in an abuse-deterrent, extended-release form called Targiniq™ ER (oxycodone hydrochloride and naloxone hydrochloride).
The question that I would like to raise, or at least discuss, is this: You are now seeing someone in your practice who has been on an immediate-release preparation of medication taking, let's say, 60 mg of hydrocodone for their chronic osteoarthritis and post-lumbar laminectomy surgical pain. Now they are asking for medication that is going to be longer-lasting. They are having pain 24 hours a day—around the clock. Their pain is severe enough to warrant around-the-clock treatment. These patients failed to respond to physical rehabilitation alone and to various other non-opioid strategies. They fit the criteria for considering an extended-release opiate.
You are venturing out into considering what to do for such a patient. Do you pick an abuse-deterrent preparation?
What does it really mean to be an abuse-deterrent medication? What data do we have about how much abuse it really deters? Are you in a position where there might be administrative hassles in picking an abuse-deterrent formulation? After all, is there a requirement for a payer, an insurance provider, to encourage and to only fill or accept prescriptions that are for abuse-deterrent preparations? No.
What we are facing is a sense that there are new medications that are available that may be considered abuse-deterrent—may be designated abuse-deterrent by the FDA, formally—but do we really know how well they deter abuse? No.
We have to keep in mind several things when treating a patient such as the one described:
• First, we need to keep in mind that there is no substitute for developing the skill set required for taking care of an individual needing a particular medical treatment. When it comes to managing a person on chronic opioid therapy, abuse-deterrent opioid or not, if you are going to manage someone on long-term opioid therapy—and long-term is typically 6 months, a year, or more—please keep in mind that there are monitoring strategies, ways to assess whether this medication is associated with benefit and whether it is associated with harm. There are many steps that should be taken. There are strategies to reduce harm at home. After all, we have learned that there are too many unintentional opioid-related overdoses and deaths for people who were not necessarily abusing or misusing these medications.
• We have to be vigilant and use the skills or gain the skills to do so. Merely having available a drug designated as an abuse-deterrent opioid—one that may be difficult to crush, one that may, if crushed, release an opioid antagonist—is not enough. Now, the purpose of this commentary is not to go through each abuse-deterrent strategy but to recognize that even with the availability of such strategies, we need to: (1) be vigilant about good medical practice; (2) recognize who is the right candidate for an opioid over the long term, and (3) realize that a person who may have benefited from opioids for 6 months may not necessarily have to be maintained on them in the present. There has to be a critical re-evaluation of not only the treatment plan but the diagnosis. This is very, very complicated, and it is not going to be cured or easily addressed by having abuse-deterrent formulations.
• At the same time—and this may sound a little contradictory—the availability of abuse-deterrent formulations does help to accomplish our tasks of trying to prescribe and monitor individuals and treat people with chronic opioid therapy in a safer manner than without an abuse-deterrent formulation.
• I would like us to understand—and perhaps going forward realize—that when we are faced with a choice of which extended-release opioid medication available to prescribe, what we also have to do as clinicians and prescribers is to ensure that safe prescribing does occur. Keep in mind that this involves having or developing a skill set that is equal to that treatment need.
• We also need to know that there are differences among the available extended-release opioids, and whenever possible, prescribe an extended-release opioid with abuse-deterrent properties, because that is certainly one step in keeping a person as safe as possible while treating them as effectively as possible.
• An important point that has been mentioned by me other times in other blogs: When focusing on chronic opioid therapy, we really do have to de-emphasize chronic opioid therapy as the only treatment for a person with chronic pain. Much evidence is available to support the idea that chronic opioid therapy is most effective when used as part of a multimodal strategy for managing a person's chronic pain.
• Part of that multimodal strategy is the use of the safest available agents. When an opioid is indicated, consider one with abuse-deterrent properties. I challenge anyone viewing this commentary to explain why you would not use such an agent because these are now available, and more are becoming available.
I hope this was interesting and of value to you. I am Dr Charles Argoff, professor of neurology at Albany Medical College and director of the Comprehensive Pain Center at Albany Medical Center. Please leave your comments below.
This is Dr Charles Argoff, professor of neurology at Albany Medical College and director of the Comprehensive Pain Center at Albany Medical Center in Albany, New York.
You may have heard of a growing number of so-called abuse-deterrent opioids that have become available. These include:
• Hysingla™ ER (hydrocodone bitartrate), an abuse-deterrent form of hydrocodone extended release approved by the US Food and Drug Administration (FDA) in November 2014
• Zohydro® ER (hydrocodone bitartrate), a newly developed form of Zohydro—which, you may recall, was the first extended-release form of hydrocodone without acetaminophen. The abuse-deterrent extended-release form is a different medication in a number of ways, including the number of times that it is dosed per day and the fact that, when it was first approved, it was approved without any abuse-deterrent features. A newly developed version of this particular medication is in the process of becoming available to us: A modified formulation including abuse-deterrent technology was approved by the FDA in January 2015. The FDA has not approved an abuse-deterrent labeling claim for that formulation.
• Embeda®, an extended-release form of morphine that has just recently been designated as an abuse-deterrent form of morphine. In this instance, it combines morphine with an opioid antagonist within the same substance and preparation (morphine sulfate and naltrexone hydrochloride)
• And, of course, OxyContin®, which has already been approved and been used in an abuse-deterrent, extended-release form called Targiniq™ ER (oxycodone hydrochloride and naloxone hydrochloride).
The question that I would like to raise, or at least discuss, is this: You are now seeing someone in your practice who has been on an immediate-release preparation of medication taking, let's say, 60 mg of hydrocodone for their chronic osteoarthritis and post-lumbar laminectomy surgical pain. Now they are asking for medication that is going to be longer-lasting. They are having pain 24 hours a day—around the clock. Their pain is severe enough to warrant around-the-clock treatment. These patients failed to respond to physical rehabilitation alone and to various other non-opioid strategies. They fit the criteria for considering an extended-release opiate.
You are venturing out into considering what to do for such a patient. Do you pick an abuse-deterrent preparation?
What does it really mean to be an abuse-deterrent medication? What data do we have about how much abuse it really deters? Are you in a position where there might be administrative hassles in picking an abuse-deterrent formulation? After all, is there a requirement for a payer, an insurance provider, to encourage and to only fill or accept prescriptions that are for abuse-deterrent preparations? No.
What we are facing is a sense that there are new medications that are available that may be considered abuse-deterrent—may be designated abuse-deterrent by the FDA, formally—but do we really know how well they deter abuse? No.
We have to keep in mind several things when treating a patient such as the one described:
• First, we need to keep in mind that there is no substitute for developing the skill set required for taking care of an individual needing a particular medical treatment. When it comes to managing a person on chronic opioid therapy, abuse-deterrent opioid or not, if you are going to manage someone on long-term opioid therapy—and long-term is typically 6 months, a year, or more—please keep in mind that there are monitoring strategies, ways to assess whether this medication is associated with benefit and whether it is associated with harm. There are many steps that should be taken. There are strategies to reduce harm at home. After all, we have learned that there are too many unintentional opioid-related overdoses and deaths for people who were not necessarily abusing or misusing these medications.
• We have to be vigilant and use the skills or gain the skills to do so. Merely having available a drug designated as an abuse-deterrent opioid—one that may be difficult to crush, one that may, if crushed, release an opioid antagonist—is not enough. Now, the purpose of this commentary is not to go through each abuse-deterrent strategy but to recognize that even with the availability of such strategies, we need to: (1) be vigilant about good medical practice; (2) recognize who is the right candidate for an opioid over the long term, and (3) realize that a person who may have benefited from opioids for 6 months may not necessarily have to be maintained on them in the present. There has to be a critical re-evaluation of not only the treatment plan but the diagnosis. This is very, very complicated, and it is not going to be cured or easily addressed by having abuse-deterrent formulations.
• At the same time—and this may sound a little contradictory—the availability of abuse-deterrent formulations does help to accomplish our tasks of trying to prescribe and monitor individuals and treat people with chronic opioid therapy in a safer manner than without an abuse-deterrent formulation.
• I would like us to understand—and perhaps going forward realize—that when we are faced with a choice of which extended-release opioid medication available to prescribe, what we also have to do as clinicians and prescribers is to ensure that safe prescribing does occur. Keep in mind that this involves having or developing a skill set that is equal to that treatment need.
• We also need to know that there are differences among the available extended-release opioids, and whenever possible, prescribe an extended-release opioid with abuse-deterrent properties, because that is certainly one step in keeping a person as safe as possible while treating them as effectively as possible.
• An important point that has been mentioned by me other times in other blogs: When focusing on chronic opioid therapy, we really do have to de-emphasize chronic opioid therapy as the only treatment for a person with chronic pain. Much evidence is available to support the idea that chronic opioid therapy is most effective when used as part of a multimodal strategy for managing a person's chronic pain.
• Part of that multimodal strategy is the use of the safest available agents. When an opioid is indicated, consider one with abuse-deterrent properties. I challenge anyone viewing this commentary to explain why you would not use such an agent because these are now available, and more are becoming available.
I hope this was interesting and of value to you. I am Dr Charles Argoff, professor of neurology at Albany Medical College and director of the Comprehensive Pain Center at Albany Medical Center. Please leave your comments below.
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