Requests that the FDA take action to implement two initiatives for the co-prescribing of naloxone as part of FDA’s comprehensive action plan to respond to growing epidemic of opioid abuse, dependence, and overdose.
Citizen Petition CDER OPEN 2016-1889 Lachman Consultant Services, Inc. naloxone epidemic opioid abuse dependence overdose implement two initiatives co-prescribing Medically Assisted Therapy (MAT) Risk Evaluation and Mitigation Strategies REMS Elements to Assure Safe Use ETASU high-dose benzodiazepine Adapt Pharma Ltd.
2016-07-20 2016-09-21 2016-06-24 2016-10-07 2016-08-11 2016-07-20 2016-07-20 2016-06-24
FDA-2016-P-1090-0012 FDA-2016-P-1090-0019 FDA-2016-P-1090-0005 FDA-2016-P-1090-0021 FDA-2016-P-1090-0016 FDA-2016-P-1090-0014 FDA-2016-P-1090-0015 FDA-2016-P-1090-0006
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https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0012 https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0019 https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0005 https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0021 https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0016 https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0014 https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0015 https://api.regulations.gov/v4/comments/FDA-2016-P-1090-0006
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July 15, 2016Division of Dockets Management (HFA305)  Food and Drug Administration  Department of Health and Human Services  5630 Fishers Lane, Room 1061  Rockville, MD 20552    Dear Sir or Madam,   On behalf of the Partnership for Drug-Free Kids, a national non-profit organization that provides support and guidance to families struggling with their son or daughters substance use and advocates for greater understanding and more effective programs to treat the disease of addiction, I write to offer our position on the Citizens Petition requesting that the Food and Drug Administration (FDA) require naloxone co-prescribing with high dose opioid prescriptions, all products prescribed for medication assisted treatment of opioid disorders and simultaneous opioid and benzodiazepine prescriptions.  The Citizens Petition also asks the FDA to update specific Risk Evaluation and Mitigation Strategies (REMS). Currently there are 129 overdose deaths in the United States each day, most of which are caused by an opioid.  Co-prescribing naloxone to reverse potential opiate overdoses is a common-sense step to help address this crisis.  Despite the fact that the Centers for Disease Control and Prevention (CDC) has called on prescribers to consider co-prescribing in certain circumstances and the fact that three states (Maryland, Delaware and Massachusetts) have issued similar state-level recommendations, not enough physicians are acting.  IMS data shows that in the year that ended February 2015 there were 247 million opioid painkillers prescribed but only 40,000 prescriptions for naloxone. We need to make sure that physicians are getting naloxone in the hands of more patients and families.We urge the FDA to require naloxone co-prescribing under the conditions laid out in the Citizens Petition.  We also urge FDA to update the REMS to require that medication guides include information about opioid overdose and treatment and to update the Elements to Assure Safe use to require that naloxone be prescribed and distributed alongside all medicines to treat opioid use disorders, high-does opiates and opiates prescribed alongside benzodiazepines unless providers opt out on documented grounds.At the Partnership we work with far too many families who have lost a child to an overdose and countless more moms and dads who are terrified that their child will be the next overdose statistic.  Co-prescribing naloxone will dramatically increase access to this medication and will give families a fighting chance to save their loved ones life in the event of an overdose.I thank you for your attention to this important matter and look forward to continuing to work with the FDA to reduce opiate misuse and abuse in our country.Sincerely, Marcia Lee TaylorPresident and CEO I am a writing on behalf of the American Association for the Treatment of Opioid Dependence in support of the Adapt Pharma Citizens Petition. With best regards, Mark Parrino  Caregiver Action Network (CAN) supports the Citizen Petition submitted by Adapt Pharma. CAN is the nations leading non-profit organization advocating for the 90 million family caregivers across the country. We are aware and alarmed that the majority of opioid overuse and heroin deaths in the U.S. actually occur in the home. We believe, as do many experts, that co-prescribing naloxone, the opioid overdose antidote, is an effective way to combat the epidemic of opioid overuse deaths.Therefore, we support the recommendation that providers prescribe naloxone with all high-dose opioid products, all Medically Assisted Therapy (MAT) products, and all opioid drug products when combined with a benzodiazepine prescription. We further support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids, and all opioid dosages when combined with benzodiazepine, unless providers opt-out on documented grounds.We believe that these recommendations will help address the major implementation barriers to co-prescribing under the current guidance, including stigma and awareness and education levels. Requiring the offer of a prescription for naloxone as an ETASU within the REMS framework will raise the level of patient awareness and education both of naloxone and its use in an opioid overdose emergency. It will help create a more robust dialogue between a physician and patient around opioid risks, including the opportunity for physicians to discuss risk in the context of the benefit of naloxone as part of risk mitigation.  I have been a Family Physician for 30 years. I am now a federal government physician working in Baltimore, MD -- and we are one of the epicenters for the heroin epidemic. All of our patients prescribed narcotics, to include methadone, need to be offered intranasal naloxone. Period. They and their families need to also be educated on the correct use of the intranasal form of this drug. It is safe, it is effective, and it is saving lives. What is the down-side? August 5, 2016Comment on Docket ID: FDA - 2016-P-1090-0004Dear FDA reviewers,The US Pain Foundation supports the Citizens Petition submitted by Adapt Pharma. The mission of the US Pain Foundation is to educate, connect, inform and empower those living with pain while also advocating on behalf of the entire pain community. As a 501(c) ]3 non-profit dedicated to serving those who live with pain condition and their care providers, US Pain Foundation helps individuals find resources and inspiration. We are gravely concerned about the on-going opioid overdose epidemic in the United States, now resulting in an average 129 deaths daily according to Addiction Policy Forum. More than 75% of these take place outside medical settings, with the majority of these (54%) taking place in homes. The pain community is one of the most impacted by these unnecessary deaths. Not only are these loses unnecessary, there are enormous direct and indirect costs to families, healthcare systems, employers and society that may be greatly mitigated through existing channels. We acknowledge that co-prescribing naloxone, the opioid overdose antidote, has increasingly gained support across a broad range of stakeholders, including federal agencies, medical professional associations and patient advocates, as an effective way of increasing access to naloxone and tackling the crisis. Both the American Medical Association and the Centers for Disease Control and Prevention issued guidelines which call for physicians to offer naloxone when factors that increase risk for opioid overdose, such as a history of overdose, substance use disorder, high-dose opioids, or opioids prescribed concurrently with benzodiazepines, are present. However, in spite of a growing consensus to co-prescribe naloxone, IMS data shows little uptake of naloxone by prescription under the current opt-in approach. In the year ended February 2015 there were 247 million opioid painkiller prescriptions, but only 40,000 prescriptions for naloxone, which indicates that support for co-prescribing is not translating into every day practice.We therefore support the recommendation that providers prescribe naloxone with all high-dose opioid products, Medically Assisted Therapy (MAT) products and all opioid drug products when combined with benzodiazepine, unless providers opt-out on documented grounds. Moreover, we support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids and all opioid doses when combined with benzodiazepine, unless providers opt-out on documented grounds.These recommendations will help to systemize the existing broad support for co-prescribing. These will also drive greater awareness and education, and help to address stigma by enabling more discussion between physician and patient on opioid risks and the beneficial use of naloxone in emergency overdose situations. We support the Citizens Petition and encourage FDA to exercise its authority in order to help stem this crisis which is taking many of our best and brightest away from us.Paul GilenoPresidentUS Pain Foundation670 Newfield Street, Suite BMiddletown CT 06457www.uspainfoundation.org July 11, 2016Division of Dockets Management (HFA305)Food and Drug AdministrationDepartment of Health and Human Services5630 Fishers Lane, Room 1061Rockville, MD 20552Dear Sir or Madam,The Strengthening the Mid-Atlantic Region for Tomorrow (SMART) NFP supports the Citizens Petition submitted by Adapt Pharma. The SMART Congressional initiative is the integration of Regional Science and Technology activities, issues, events and projects that are shared among the 4 states (MD, DE, NJ and PA) to foster regional technical, economic development and education/workforce development.  SMART has 12 working groups comprised of industry and community leaders across the 4 states in healthcare, veterans issues, and workforce development.We are gravely concerned about the on-going opioid overdose epidemic in the United States, now resulting in an average 129 deaths daily according to Addiction Policy Forum. More than 75% of these take place outside medical settings, with the majority of these (54%) taking place in homes. Our 4 states are among the most impacted. Not only are these losses unnecessary, there are enormous direct and indirect costs to families, healthcare systems, employers and society that may be greatly mitigated through existing channels. We acknowledge that co-prescribing naloxone, the opioid overdose antidote, has increasingly gained support across a broad range of stakeholders, including federal agencies, medical professional associations and patient advocates, as an effective way of increasing access to naloxone and tackling the crisis. Both the American Medical Association and the Centers for Disease Control and Prevention issued guidelines which call for physicians to offer naloxone when factors that increase risk for opioid overdose, such as a history of overdose, substance use disorder, high-dose opioids, or opioids prescribed concurrently with benzodiazepines, are present. However, in spite of a growing consensus to co-prescribe naloxone, IMS data shows little uptake of naloxone by prescription under the current opt-in approach. In the year ended February 2015 there were 247 million opioid painkiller prescriptions, but only 40,000 prescriptions for naloxone, which indicates that support for co-prescribing is not translating into every day practice.  Each of the SMART states has been affected by this public health crisis.We therefore support the recommendation that providers prescribe naloxone with all high-dose opioid products, Medically Assisted Therapy (MAT) products and all opioid drug products when combined with benzodiazepine, unless providers opt-out on documented grounds. Moreover, we support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids and all opioid doses when combined with benzodiazepine, unless providers opt-out on documented grounds.These recommendations will help to systemize the existing broad support for co-prescribing. These will also drive greater awareness and education, and help to address stigma by enabling more discussion between physician and patient on opioid risks and the beneficial use of naloxone in emergency overdose situations. We support the Citizens Petition and encourage the FDA to exercise its authority in order to help stem this crisis which is not only ravaging the SMART states, but the entire country. Sincerely,Robert CarulloSMART Executive Director Dear Sir or Madam, Facing Addiction, a national non-profit organization dedicated to finding solutions to the addiction crisis by unifying the over 45 million Americans and their families directly impacted by addiction, understands that Adapt Pharma has submitted a Citizen Petition requesting the Food and Drug Administration (FDA) to require naloxone coprescribing with Centers for Disease Control and Prevention (CDC) defined high risk opioid prescriptions, such as high doses, simultaneous opioid and benzodiazepine prescriptions and all prescriptions for addiction medications for opioid use disorder. The petition also asks the FDA to require updates to specific opioid and addiction medicine Risk Evaluation and Mitigation Strategies (REMS). In light of the petition, Facing Addiction would like to support this needed requirement. The opioid overdose epidemic continues to ravage the United States, with 28,647 deaths from prescription drug and heroin deaths in 2014. 75% of these took place outside medical settings, with the majority of these (54%) taking place in homes. Co-prescribing naloxone, the opioid overdose antidote, has increasingly gained support across a broad range of stakeholders, including federal agencies, medical professional associations and patient advocates, as an effective way of increasing access to naloxone and tackling the crisis. Yet, there has been no sign of the meaningful growth in both naloxone prescribing and education of both prescribers and patients that is necessary to make a significant impact on the scale of this crisis. Facing Addiction supports coprescribing naloxone with highrisk opioid prescriptions, including highdose prescriptions and all prescriptions for medications to treat addiction involving opioid use. We thank you for your attention to this important matter and look forward to continuing working with the FDA to reduce the number of opioid overdose deaths and save lives. Sincerely, Greg Williams, Executive Vice President, Facing Addiction  Caregiver Action Network (CAN) supports the Citizen Petition submitted by Adapt Pharma. CAN is the nations leading non-profit organization advocating for the 90 million family caregivers across the country.We are aware and alarmed that the majority of opioid overuse and heroin deaths in the U.S. actually occur in the home. We believe, as do many experts, that co-prescribing naloxone, the opioid overdose antidote, is an effective way to combat the epidemic of opioid overuse deaths.Therefore, we support the recommendation that providers prescribe naloxone with all high-dose opioid products, all Medically Assisted Therapy (MAT) products, and all opioid drug products when combined with a benzodiazepine prescription. We further support adding the new Elements to Assure Safe Use (ETASU) requiring that naloxone be prescribed and distributed alongside all MATs, high-dose opioids, and all opioid dosages when combined with benzodiazepine, unless providers opt-out on documented grounds.We believe that these recommendations will help address the major implementation barriers to co-prescribing under the current guidance, including stigma and awareness and education levels. Requiring the offer of a prescription for naloxone as an ETASU within the REMS framework will raise the level of patient awareness and education both of naloxone and its use in an opioid overdose emergency. It will help create a more robust dialogue between a physician and patient around opioid risks, including the opportunity for physicians to discuss risk in the context of the benefit of naloxone as part of risk mitigation. 