Take-home naloxone expands to chronic pain patients on opioids

BETHESDA, MD. – Providing naloxone to illicit drug users has been successfully used to reduce risk in this population for about 20 years and is increasingly being used as a risk mitigation strategy in patients on opioids for chronic pain.

Coprescribing naloxone for patients already on opioids for chronic pain to reduce overdoses and mortality is not yet common practice, but “lay naloxone for patients prescribed opioids has a unique and compelling rationale, is expanding around the country, and may be important to have in place prior to interventions restricting access to opioids,” Dr. Phillip Coffin said at a National Institutes of Health Pathways to Prevention Workshop on the role of opioids in chronic pain treatment. Dr. Coffin, of the University of California, San Francisco, spoke during a session on the effectiveness of risk mitigation strategies for opioid treatment.

Preliminary results of a 2014 survey showed that this practice exists at some level in at least 16 states. In San Francisco, providing a prescription for take-home naloxone is now recommended for all patients on opioids for chronic pain at public health primary care clinics, said Dr. Coffin, who also serves as director of substance abuse research at the San Francisco Department of Public Health. The program has been well received by primary care providers, based on early survey results, he said.

In addition to the San Francisco Health Network, sites that provide naloxone to patients on chronic opioids for pain include the U.S. Department of Veterans Affairs, where it is widely implemented; the U.S. Army base in Fort Bragg, N.C.; and the Denver Health Medical Center.

The effectiveness of take-home naloxone in heroin users is well established and “is one of the few interventions with data that suggest a direct impact on opioid overdose mortality,” Dr. Coffin said, citing the precipitous drop in the number of heroin-related deaths in San Francisco and other cities after the distribution of naloxone to heroin users.

As with other strategies to reduce risk in patients on chronic opioid therapy, data on the effectiveness of the naloxone strategy are limited, Dr. Coffin noted. In San Francisco, he is conducting a study – the Naloxone Prescription for Opioid Safety Evaluation (NOSE) – which is evaluating the impact of providing take-home naloxone to patients on chronic opioid therapy at six San Francisco Department of Public Health primary care clinics.

Although randomized controlled trials evaluating this intervention would be ideal, there is a “compelling rationale” for using this approach in this population, and “it’s hard to argue against it logically,” Dr. Coffin said. There are no randomized trial data on the use of epinephrine pens for anaphylaxis, which is used widely as a preventive measure, he pointed out.

The increase in opioid prescribing for pain has been accompanied by an increase in prescription opioid overdose deaths in San Francisco, where more than 90% of the deaths from opioid overdoses are caused by opioid analgesics, Dr. Coffin said.

The decision to offer naloxone to all primary care patients on chronic opioid treatment in the San Francisco Health Network makes it simple, with the mind-set of prescribing it for “risky drugs, not risky patients,” he explained. He noted that it is difficult to accurately assess an individual’s risk of an overdose when starting treatment. This also “reduces the cognitive dissonance among providers, who might think, ‘I’m not going to prescribe naloxone because that means I think the person is at risk of an overdose,’ ” he added.

The language has been adjusted away from the use of the term “overdose,” toward “opioid safety,” because patients on prescription opioids do not perceive themselves as being at risk for an overdose, he said.

In the San Francisco program to date, take-home naloxone has been prescribed to more than 600 patients on opioids for pain. Data from a survey of 105 providers at clinics offering naloxone to these patients revealed that 77% had prescribed naloxone to at least one patient, and 98% said they would likely prescribe it again. In addition, 75% said that prescribing naloxone helped them open the communication about opioids with the patient, and 75% said it helped open a discussion about the alternatives to opioids for pain. None said that they thought prescribing naloxone had a negative effect on their relationship with their pain patients, Dr. Coffin said.

Examples of specific clinician responses provided in the survey included the following: “The act of prescribing naloxone has made clear to my patients that I really am concerned about the very real risk of overdose, and it has also shown them that I really do care,” and “The ability to prescribe naloxone has been the most positive change to our management of chronic pain.”

Naloxone is one of the safest drugs in the U.S. Pharmacopeial Convention, with minimal toxicity, and it is not a controlled substance, Dr. Coffin noted. It is available in a vial for injection, as an intranasal formulation given off-label, and as an autoinjector specifically designed for lay administration that was recently approved by the U.S. Food and Drug Administration. Two intranasal formulations are being developed.

Randomized, feasibility, and qualitative studies of the naloxone approach are underway. Obtaining data on the impact of take-home naloxone on events such as opioid analgesic overdoses and behavioral effects is a critical research need, Dr. Coffin said.

Dr. Coffin had no disclosures. The NOSE study is being funded by the National Institute on Drug Abuse (NIDA). The workshop was sponsored by the National Institutes of Health (NIH) Office of Disease Prevention, the NIH Pain Consortium, NIDA, and the National Institute of Neurological Disorders and Stroke.

emechcatie@frontlinemedcom.com

BETHESDA, MD. – Providing naloxone to illicit drug users has been successfully used to reduce risk in this population for about 20 years and is increasingly being used as a risk mitigation strategy in patients on opioids for chronic pain.

Coprescribing naloxone for patients already on opioids for chronic pain to reduce overdoses and mortality is not yet common practice, but “lay naloxone for patients prescribed opioids has a unique and compelling rationale, is expanding around the country, and may be important to have in place prior to interventions restricting access to opioids,” Dr. Phillip Coffin said at a National Institutes of Health Pathways to Prevention Workshop on the role of opioids in chronic pain treatment. Dr. Coffin, of the University of California, San Francisco, spoke during a session on the effectiveness of risk mitigation strategies for opioid treatment.

Preliminary results of a 2014 survey showed that this practice exists at some level in at least 16 states. In San Francisco, providing a prescription for take-home naloxone is now recommended for all patients on opioids for chronic pain at public health primary care clinics, said Dr. Coffin, who also serves as director of substance abuse research at the San Francisco Department of Public Health. The program has been well received by primary care providers, based on early survey results, he said.

In addition to the San Francisco Health Network, sites that provide naloxone to patients on chronic opioids for pain include the U.S. Department of Veterans Affairs, where it is widely implemented; the U.S. Army base in Fort Bragg, N.C.; and the Denver Health Medical Center.

The effectiveness of take-home naloxone in heroin users is well established and “is one of the few interventions with data that suggest a direct impact on opioid overdose mortality,” Dr. Coffin said, citing the precipitous drop in the number of heroin-related deaths in San Francisco and other cities after the distribution of naloxone to heroin users.

As with other strategies to reduce risk in patients on chronic opioid therapy, data on the effectiveness of the naloxone strategy are limited, Dr. Coffin noted. In San Francisco, he is conducting a study – the Naloxone Prescription for Opioid Safety Evaluation (NOSE) – which is evaluating the impact of providing take-home naloxone to patients on chronic opioid therapy at six San Francisco Department of Public Health primary care clinics.

Although randomized controlled trials evaluating this intervention would be ideal, there is a “compelling rationale” for using this approach in this population, and “it’s hard to argue against it logically,” Dr. Coffin said. There are no randomized trial data on the use of epinephrine pens for anaphylaxis, which is used widely as a preventive measure, he pointed out.

The increase in opioid prescribing for pain has been accompanied by an increase in prescription opioid overdose deaths in San Francisco, where more than 90% of the deaths from opioid overdoses are caused by opioid analgesics, Dr. Coffin said.

The decision to offer naloxone to all primary care patients on chronic opioid treatment in the San Francisco Health Network makes it simple, with the mind-set of prescribing it for “risky drugs, not risky patients,” he explained. He noted that it is difficult to accurately assess an individual’s risk of an overdose when starting treatment. This also “reduces the cognitive dissonance among providers, who might think, ‘I’m not going to prescribe naloxone because that means I think the person is at risk of an overdose,’ ” he added.

The language has been adjusted away from the use of the term “overdose,” toward “opioid safety,” because patients on prescription opioids do not perceive themselves as being at risk for an overdose, he said.

In the San Francisco program to date, take-home naloxone has been prescribed to more than 600 patients on opioids for pain. Data from a survey of 105 providers at clinics offering naloxone to these patients revealed that 77% had prescribed naloxone to at least one patient, and 98% said they would likely prescribe it again. In addition, 75% said that prescribing naloxone helped them open the communication about opioids with the patient, and 75% said it helped open a discussion about the alternatives to opioids for pain. None said that they thought prescribing naloxone had a negative effect on their relationship with their pain patients, Dr. Coffin said.

Examples of specific clinician responses provided in the survey included the following: “The act of prescribing naloxone has made clear to my patients that I really am concerned about the very real risk of overdose, and it has also shown them that I really do care,” and “The ability to prescribe naloxone has been the most positive change to our management of chronic pain.”

Naloxone is one of the safest drugs in the U.S. Pharmacopeial Convention, with minimal toxicity, and it is not a controlled substance, Dr. Coffin noted. It is available in a vial for injection, as an intranasal formulation given off-label, and as an autoinjector specifically designed for lay administration that was recently approved by the U.S. Food and Drug Administration. Two intranasal formulations are being developed.

Randomized, feasibility, and qualitative studies of the naloxone approach are underway. Obtaining data on the impact of take-home naloxone on events such as opioid analgesic overdoses and behavioral effects is a critical research need, Dr. Coffin said.

Dr. Coffin had no disclosures. The NOSE study is being funded by the National Institute on Drug Abuse (NIDA). The workshop was sponsored by the National Institutes of Health (NIH) Office of Disease Prevention, the NIH Pain Consortium, NIDA, and the National Institute of Neurological Disorders and Stroke.

emechcatie@frontlinemedcom.com

BETHESDA, MD. – Providing naloxone to illicit drug users has been successfully used to reduce risk in this population for about 20 years and is increasingly being used as a risk mitigation strategy in patients on opioids for chronic pain.

Coprescribing naloxone for patients already on opioids for chronic pain to reduce overdoses and mortality is not yet common practice, but “lay naloxone for patients prescribed opioids has a unique and compelling rationale, is expanding around the country, and may be important to have in place prior to interventions restricting access to opioids,” Dr. Phillip Coffin said at a National Institutes of Health Pathways to Prevention Workshop on the role of opioids in chronic pain treatment. Dr. Coffin, of the University of California, San Francisco, spoke during a session on the effectiveness of risk mitigation strategies for opioid treatment.

Preliminary results of a 2014 survey showed that this practice exists at some level in at least 16 states. In San Francisco, providing a prescription for take-home naloxone is now recommended for all patients on opioids for chronic pain at public health primary care clinics, said Dr. Coffin, who also serves as director of substance abuse research at the San Francisco Department of Public Health. The program has been well received by primary care providers, based on early survey results, he said.

In addition to the San Francisco Health Network, sites that provide naloxone to patients on chronic opioids for pain include the U.S. Department of Veterans Affairs, where it is widely implemented; the U.S. Army base in Fort Bragg, N.C.; and the Denver Health Medical Center.

The effectiveness of take-home naloxone in heroin users is well established and “is one of the few interventions with data that suggest a direct impact on opioid overdose mortality,” Dr. Coffin said, citing the precipitous drop in the number of heroin-related deaths in San Francisco and other cities after the distribution of naloxone to heroin users.

As with other strategies to reduce risk in patients on chronic opioid therapy, data on the effectiveness of the naloxone strategy are limited, Dr. Coffin noted. In San Francisco, he is conducting a study – the Naloxone Prescription for Opioid Safety Evaluation (NOSE) – which is evaluating the impact of providing take-home naloxone to patients on chronic opioid therapy at six San Francisco Department of Public Health primary care clinics.

Although randomized controlled trials evaluating this intervention would be ideal, there is a “compelling rationale” for using this approach in this population, and “it’s hard to argue against it logically,” Dr. Coffin said. There are no randomized trial data on the use of epinephrine pens for anaphylaxis, which is used widely as a preventive measure, he pointed out.

The increase in opioid prescribing for pain has been accompanied by an increase in prescription opioid overdose deaths in San Francisco, where more than 90% of the deaths from opioid overdoses are caused by opioid analgesics, Dr. Coffin said.

The decision to offer naloxone to all primary care patients on chronic opioid treatment in the San Francisco Health Network makes it simple, with the mind-set of prescribing it for “risky drugs, not risky patients,” he explained. He noted that it is difficult to accurately assess an individual’s risk of an overdose when starting treatment. This also “reduces the cognitive dissonance among providers, who might think, ‘I’m not going to prescribe naloxone because that means I think the person is at risk of an overdose,’ ” he added.

The language has been adjusted away from the use of the term “overdose,” toward “opioid safety,” because patients on prescription opioids do not perceive themselves as being at risk for an overdose, he said.

In the San Francisco program to date, take-home naloxone has been prescribed to more than 600 patients on opioids for pain. Data from a survey of 105 providers at clinics offering naloxone to these patients revealed that 77% had prescribed naloxone to at least one patient, and 98% said they would likely prescribe it again. In addition, 75% said that prescribing naloxone helped them open the communication about opioids with the patient, and 75% said it helped open a discussion about the alternatives to opioids for pain. None said that they thought prescribing naloxone had a negative effect on their relationship with their pain patients, Dr. Coffin said.

Examples of specific clinician responses provided in the survey included the following: “The act of prescribing naloxone has made clear to my patients that I really am concerned about the very real risk of overdose, and it has also shown them that I really do care,” and “The ability to prescribe naloxone has been the most positive change to our management of chronic pain.”

Naloxone is one of the safest drugs in the U.S. Pharmacopeial Convention, with minimal toxicity, and it is not a controlled substance, Dr. Coffin noted. It is available in a vial for injection, as an intranasal formulation given off-label, and as an autoinjector specifically designed for lay administration that was recently approved by the U.S. Food and Drug Administration. Two intranasal formulations are being developed.

Randomized, feasibility, and qualitative studies of the naloxone approach are underway. Obtaining data on the impact of take-home naloxone on events such as opioid analgesic overdoses and behavioral effects is a critical research need, Dr. Coffin said.

Dr. Coffin had no disclosures. The NOSE study is being funded by the National Institute on Drug Abuse (NIDA). The workshop was sponsored by the National Institutes of Health (NIH) Office of Disease Prevention, the NIH Pain Consortium, NIDA, and the National Institute of Neurological Disorders and Stroke.

emechcatie@frontlinemedcom.com