FDA approves opioid analgesic risk evaluation, mitigation strategy
The Food and Drug Administration is taking new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy, or REMS.
This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.
The REMS program requires, for the first time, that training is made available to health care providers who are involved in the management of patients with pain, not only to prescribers. For example, the training provided through the REMS must be made available to nurses and pharmacists.
It also requires that education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency also is approving new product labeling containing information about health care provider education available through the new REMS.
“Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities. As part of our comprehensive work in this area, we’re taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction. Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients," FDA commissioner Scott Gottlieb said.
Gottlieb went on to say, "Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use. Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements. The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications.”
Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS that requires as its primary component, that training be made available to prescribers of those products. To meet this requirement, drug companies with approved ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for prescribers based on content outlined by the FDA.
“Appropriate prescribing practices and education are important steps that we’re prioritizing to help address the human and financial toll of this crisis. Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products. At the same time, we’re also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids," Gottlieb said.
As part of the final action, these REMS requirements now also apply to IR opioid analgesic products intended for outpatient use. The IR drugs account for about 90% of all opioid pain medications prescribed for outpatient use. Additionally, the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011.
"The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines,” the statement said.
In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content.
Today’s action greatly expands the number of products covered by the REMS. Prior to today, the ER/LA Opioid Analgesic REMS included 62 products. The modified Opioid Analgesic REMS now requires that 347 opioid analgesics intended for outpatient use be subject to these REMS requirements. The REMS program continues to include Medication Guides for patients and caregivers to read, new Patient Counseling Guides to assist health care providers with important discussions with patients, and plans for assessing the program’s effectiveness.
The FDA is also approving new safety labeling changes for all opioid analgesic products intended for use in an outpatient setting. For the first time, the FDA is requiring the labeling for those products to include information about the availability of education through the REMS for prescribers and other healthcare providers who are involved in the treatment and monitoring of patients with pain.
The new labeling includes information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections of labeling and strongly encourages providers to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist; and to consider other tools to improve patient, household and community safety.
There is no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients. However, the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal.
The FDA also recently awarded a contract to the National Academies of Sciences, Engineering, and Medicine to help develop a framework to assist medical professional societies in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed.
This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.
The REMS program requires, for the first time, that training is made available to health care providers who are involved in the management of patients with pain, not only to prescribers. For example, the training provided through the REMS must be made available to nurses and pharmacists.
It also requires that education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency also is approving new product labeling containing information about health care provider education available through the new REMS.
“Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities. As part of our comprehensive work in this area, we’re taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction. Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients," FDA commissioner Scott Gottlieb said.
Gottlieb went on to say, "Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use. Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements. The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications.”
Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS that requires as its primary component, that training be made available to prescribers of those products. To meet this requirement, drug companies with approved ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for prescribers based on content outlined by the FDA.
“Appropriate prescribing practices and education are important steps that we’re prioritizing to help address the human and financial toll of this crisis. Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products. At the same time, we’re also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids," Gottlieb said.
As part of the final action, these REMS requirements now also apply to IR opioid analgesic products intended for outpatient use. The IR drugs account for about 90% of all opioid pain medications prescribed for outpatient use. Additionally, the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011.
"The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines,” the statement said.
In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content.
Today’s action greatly expands the number of products covered by the REMS. Prior to today, the ER/LA Opioid Analgesic REMS included 62 products. The modified Opioid Analgesic REMS now requires that 347 opioid analgesics intended for outpatient use be subject to these REMS requirements. The REMS program continues to include Medication Guides for patients and caregivers to read, new Patient Counseling Guides to assist health care providers with important discussions with patients, and plans for assessing the program’s effectiveness.
The FDA is also approving new safety labeling changes for all opioid analgesic products intended for use in an outpatient setting. For the first time, the FDA is requiring the labeling for those products to include information about the availability of education through the REMS for prescribers and other healthcare providers who are involved in the treatment and monitoring of patients with pain.
The new labeling includes information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections of labeling and strongly encourages providers to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist; and to consider other tools to improve patient, household and community safety.
There is no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients. However, the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal.
The FDA also recently awarded a contract to the National Academies of Sciences, Engineering, and Medicine to help develop a framework to assist medical professional societies in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed.