Letters
email asking for compensation, but not if a patient uses the telephone to request compensation. In one sense it is probably true that the problem of NPDB reporting is more modest than physicians may recognize. Physicians dread these reports, but there is little evidence to suggest that the reports typically carry the feared consequences, such as reputational damage and problems maintaining licensure or hospital credentials. Nevertheless, as with many aspects of the medical malpractice system, perceptions are powerful and obdurate and they drive behavior. Hence, greater physician willingness to engage in early resolution will lag without clear and reliable relief from NPDB reporting. Michelle M. Mello, JD, PhD, MPhil David M. Studdert, LLB, ScD, MPH Allen Kachalia, MD, JD Author Affiliations: Stanford Law School, Stanford, California (Mello); Department of Medicine, Stanford University School of Medicine, Stanford, California (Studdert); Department of Medicine, Harvard Medical School, Boston, Massachusetts (Kachalia). Corresponding Author: Michelle M. Mello, JD, PhD, MPhil, Stanford Law School, 559 Nathan Abbott Way, Stanford, CA 94305 ([email protected] .edu). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Mello and Kachalia reported that they served as investigators on several of the demonstration and planning projects described in their article that tested communication-and-resolution programs and that they have served as consultants to the State of Oregon on medical liability issues. Dr Kachalia also reported receiving personal fees for educational presentations on patient safety from Quantia MD. No other disclosures were reported. 1. Mello MM, Senecal SK, Kuznetsov Y, Cohn JS. Implementing hospital-based communication-and-resolution programs: lessons learned in New York City. Health Aff (Millwood). 2014;33(1):30-38.
Preventing Prescription Opioid Abuse To the Editor The United States, with only 5% of the world’s population, is consuming more than 80% of the world’s opioid supplies.1 The sharp increase in opioid prescribing that began in the 1990s was largely driven by pain advocacy groups and groups of pain specialists lobbying state medical boards and legislatures to lift the prohibitions on opioid use and by the Joint Commission’s mandate to identify and treat pain.2 According to the US Centers for Disease Control and Prevention, the increasing use of opioids has led to parallel increases in opioid addiction and overdose deaths.3 Despite the enormous public health price being paid for the increased use of opioids, no evidence exists that their use has been associated with improvements in outcomes for patients with chronic pain.4 The premise of Dr Jones and colleagues5 in their Viewpoint is that the mechanisms put in place by the US Food and Drug Administration (FDA) to improve safe use of extendedrelease opioids, such as modest label changes and voluntary, industry-sponsored educational programs, will be effective in stemming the tide of opioid addiction and overdose deaths. We are skeptical about this. We believe the FDA should prohibit marketing of opioids for long-term, daily use. We do not want to impede prescribing or reduce access to opioids for those who can benefit, but opioids
have been oversold. Patients with nonstructural low back pain, fibromyalgia, and chronic headache do not exhibit improvements in function and quality of life and are at high risk of developing dependence, functional deterioration, or addiction.4 If the FDA appropriately enforced the federal Food, Drug and Cosmetic Act, the marketing of opioids for conditions in which risks are likely to outweigh benefits would be prohibited. The authors unfairly criticize state health officials and lawmakers for singling out policies against Zohydro ER (hydrocodone bitartrate extended release) as a solution to a complex problem.5 State and local governments, as well as consumer advocacy groups, medical experts, and addiction organizations that objected to the approval of Zohydro ER are aware of the need for a multifaceted approach, and many are already engaged in frontline efforts across the country to reduce overdose deaths. It is time for the FDA to do its part by exercising its regulatory authority and responsibility to prohibit marketing of opioids for common, chronic conditions. Jane C. Ballantyne, MD Andrew Kolodny, MD Author Affiliations: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle (Ballantyne); Phoenix House Foundation Inc, New York, New York (Kolodny). Corresponding Author: Jane C. Ballantyne, MD, Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific St, Seattle, WA 98195 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ballantyne reported being the president and Dr Kolodny reported being the director of Physicians for Responsible Opioid Prescribing. Dr Ballantyne also reported receiving consultancy fees from Cohen Milstein Sellers & Toll PLLC for expert opinion on the scientific evidence concerning opioid treatment of chronic pain. 1. University of Wisconsin–Madison Pain and Policy Studies Group. International Narcotics Control Board opioid consumption data. http://www.painpolicy.wisc .edu/opioid-consumption-data. Accessed October 14, 2014. 2. Franklin GM; American Academy of Neurology. Opioids for chronic noncancer pain: a position paper of the American Academy of Neurology. Neurology. 2014;83(14):1277-1284. 3. Centers for Disease Control and Prevention. CDC grand rounds: prescription drug overdoses—a US epidemic. http://www.cdc.gov/mmwr/preview /mmwrhtml/mm6101a3.htm. Accessed January 17, 2015. 4. Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009;22(1):62-68. 5. Jones CM, Lurie P, Woodcock J. Addressing prescription opioid overdose: data support a comprehensive policy approach. JAMA. 2014;312(17):1733-1734.
To the Editor Although Dr Jones and colleagues1 claimed that the FDA regards “Preventing prescription opioid deaths [as] a public health priority,” this is not consistent with the FDA’s behavior. For example, the FDA instituted the untested, class-wide Risk Evaluation and Mitigation Strategy (REMS) program but continued to approve new extended release/longacting (ER/LA) opioids with no evidence that the REMS actually reduces ER/LA opioid-related morbidity. In addition, 4 months ago, without even holding an advisory committee meeting, the FDA approved Targiniq ER brand of oxycodone/naloxone despite the fact that “the tablets may release all their contents at once if chewed, crushed, broken or dissolved.”2
jama.com
(Reprinted) JAMA March 10, 2015 Volume 313, Number 10
Copyright 2015 American Medical Association. All rights reserved.
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Letters
Is the reaction to Zohydro ER from the public, state officials, and scientists unwarranted? Hydrocodone is the most abused opioid in the United States.3 Zohydro ER is the first acetaminophen-free, extended-release formulation of hydrocodone in a pill that can be easily crushed, freeing up immediate-release hydrocodone. Zohydro ER contains pure hydrocodone, whereas the original OxyContin contained pure oxycodone; otherwise, the characteristics of Zohydro ER are precisely those of the original OxyContin, which launched the prescription opioid epidemic. Jones and colleagues noted that Randall Flick, chairman of the FDA scientific advisory committee that voted 11-2 against approval of Zohydro ER, affirmed that Zogenix had done exactly what the FDA asked it to do. But explaining the Committee vote, Flick said: “…with the Committee, I struggled with what I believe is also part of the charge of the committee, and that is to see to the best interests of the American people and the public health … emerging evidence would suggest that tamper-deterrent formulations are likely to reduce the incidence of morbidity and mortality associated with this class of drugs, and we should not be approving new formulations in that setting.”4 With more than 150 000 US residents already dead from accidental overdoses of prescription opioids,5 I believe the FDA must redirect itself away from its usual criteria and toward actions that can truly make a difference in bringing the opioid epidemic to an end. Daniel A. Busch, MD Author Affiliation: Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Corresponding Author: Daniel A. Busch, MD, Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, 737 N Michigan Ave, Chicago, IL 60611 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Jones CM, Lurie P, Woodcock J. Addressing prescription opioid overdose: data support a comprehensive policy approach. JAMA. 2014;312(17):1733-1734. 2. Therapeutic Goods Administration, Department of Health, Government of Australia. Targin tablets: consumer medicine information. https://www.ebs.tga .gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI -04502-3. Accessed January 11, 2015. 3. Inter-university Consortium for Political and Social Research. National survey on drug use and health, 2013. http://www.icpsr.umich.edu/SDA/SAMHDA /35509-0001/CODEBOOK/2013.htm. Accessed January 11, 2015. 4. US Food and Drug Administration. Anesthetic and Analgesic Drug Products Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees /CommitteesMeetingMaterials/Drugs /AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM339619.pdf. Accessed April 4, 2014. 5. Centers for Disease Control and Prevention. National Vital Statistics System. http://www.cdc.gov/nchs/nvss.htm. Accessed November 15, 2014.
In Reply We agree with Drs Ballantyne and Kolodny that opioid analgesics are not the most effective treatment option for certain types of chronic pain. This recognition, combined with the public health risks associated with opioid analgesics, prompted revisions to the indications for ER/LA opioid analgesics in 2013. 1060
Manufacturers must now instruct prescribers to “reserve [ER/LA opioid analgesics] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”1 In addition, in recent years, the FDA has approved several nonopioid medications to treat some of the most common chronic pain conditions. Ballantyne and Kolodny appear to misinterpret our Viewpoint when they say our premise was that the mechanisms put in place by the FDA to improve safe use of extended-release opioids will be effective in stemming the tide of opioid addiction and overdose deaths. On the contrary, our premise was that actions taken by the FDA are only a small component of a much broader strategy. We believe actions taken by states such as Washington and Florida that target inappropriate prescribing behaviors represent powerful levers to address this problem. Research indicates these efforts have been successful2,3 and therefore should be considered for adoption by other states. Ballantyne and Kolodny also state that we unfairly criticize state health officials and lawmakers for singling out policies against Zohydro ER as a solution to a complex problem. Our intent was not to criticize but to encourage broader action. State requirements to check the prescription drug monitoring program for patients’ controlled prescription drug history, screen patients for abuse risk, and document medical need before prescribing opioids are essential to ensure appropriate prescribing. Requiring these actions only for Zohydro ER is insufficient to address the opioid problem because they should apply to all opioid analgesics. Dr Busch suggests the approval of Zohydro ER in 2013 will mimic the explosive prescribing and associated public health consequences seen with the launch of OxyContin in 1996. To date, dispensing data do not support this concern. Zohydro ER prescriptions in outpatient retail pharmacies have been relatively flat since July 2014. Prescriptions increased marginally from 3600 in July to 4800 in October and then declined to 4600 in November. During this same period, there were, on average, 1.6 million ER/LA opioid and 20 million total opioid prescriptions each month; Zohydro ER represented 0.27% and 0.02% of these, respectively.4 Additionally, Busch expresses concern about the FDA’s untested ER/LA opioid analgesic REMS. Like all REMS, the ER/LA opioid analgesic REMS will be assessed by a rigorous analysis and the FDA will make any needed changes to the REMS that are supported by the assessment. Emerging data suggest positive signs in efforts to reduce prescription drug abuse. The percentage of people initiating nonmedical use of opioids and reporting past-year nonmedical use are at their lowest levels since 2002, and in 2012 opioidrelated overdose deaths declined for the first time since 1999.5,6 The FDA stands ready to work with all stakeholders to make further progress on this public health epidemic. Christopher M. Jones, PharmD, MPH Peter Lurie, MD, MPH Janet Woodcock, MD
JAMA March 10, 2015 Volume 313, Number 10 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a New York University User on 05/31/2015
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Letters
Author Affiliations: Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland (Jones, Lurie); Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (Woodcock). Corresponding Author: Christopher M. Jones, PharmD, MPH, Office of the Commissioner, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 ([email protected]).
CORRECTION Incorrect Time in Figure: In the Original Investigation entitled “Percutaneous Left Atrial Appendage Closure vs Warfarin for Atrial Fibrillation: A Randomized Clinical Trial,” published in the November 19, 2014, issue of JAMA (2014;312[19]:19881998. doi:10.1001/jama.2014.15192), Figure 2 had incorrectly labeled axes, on which the unit of time should have been months. This article was corrected online.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Disclaimer: The views and opinions expressed in this letter are those of the authors and should not be construed to represent the views of the US Food and Drug Administration or the US government. 1. US Food and Drug Administration. Labeling supplement and PMR required. http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass /ucm367697.pdf[fda.gov]. Accessed February 3, 2015. 2. Johnson H, Paulozzi L, Porucznik C, Mack K, Herter B; Hal Johnson Consulting and Division of Disease Control and Health Promotion, Florida Department of Health. Decline in drug overdose deaths after state policy changes—Florida, 2010-2012. MMWR Morb Mortal Wkly Rep. 2014;63(26):569574. 3. Franklin G, Sabel J, Jones CM, et al. A comprehensive approach to address the prescription opioid epidemic in Washington State: milestones and lessons learned [published online January 20, 2015]. Am J Public Health. doi: 10.2105 /AJPH.2014.302367. 4. IMS Health. National prescription audit, 2014. https://websolutions.imshealth .com. Accessed September 1, 2014. 5. Centers for Disease Control and Prevention. Trends in drug-poisoning deaths involving opioid analgesics and heroin: United States, 1999-2012. http://www .cdc.gov/nchs/data/hestat/drug_poisoning/drug_poisoning_deaths_1999-2012 .pdf. Accessed December 26, 2014. 6. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: detailed tables. http: //www.samhsa.gov/data/sites/default/files/NSDUH-DetTabsPDFWHTML2013 /Web/HTML/NSDUH-DetTabsTOC2013.htm. Accessed December 26, 2014.
Guidelines for Letters Letters discussing a recent JAMA article should be submitted within 4 weeks of the article's publication in print. Letters received after 4 weeks will rarely be considered. Letters should not exceed 400 words of text and 5 references and may have no more than 3 authors. Letters reporting original research should not exceed 600 words of text and 6 references and may have no more than 7 authors. They may include up to 2 tables or figures but online supplementary material is not allowed. All letters should include a word count. Letters must not duplicate other material published or submitted for publication. Letters not meeting these specifications are generally not considered. Letters being considered for publication ordinarily will be sent to the authors of the JAMA article, who will be given the opportunity to reply. Letters will be published at the discretion of the editors and are subject to abridgement and editing. Further instructions can be found at http://jama.com/public /InstructionsForAuthors.aspx. A signed statement for authorship criteria and responsibility, financial disclosure, copyright transfer, and acknowledgment and the ICMJE Form for Disclosure of Potential Conflicts of Interest are required before publication. Letters should be submitted via the JAMA online submission and review system at http: //manuscripts.jama.com. For technical assistance, please contact [email protected]. Section Editor: Jody W. Zylke, MD, Deputy Editor.
jama.com
(Reprinted) JAMA March 10, 2015 Volume 313, Number 10
Copyright 2015 American Medical Association. All rights reserved.
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1061
email asking for compensation, but not if a patient uses the telephone to request compensation. In one sense it is probably true that the problem of NPDB reporting is more modest than physicians may recognize. Physicians dread these reports, but there is little evidence to suggest that the reports typically carry the feared consequences, such as reputational damage and problems maintaining licensure or hospital credentials. Nevertheless, as with many aspects of the medical malpractice system, perceptions are powerful and obdurate and they drive behavior. Hence, greater physician willingness to engage in early resolution will lag without clear and reliable relief from NPDB reporting. Michelle M. Mello, JD, PhD, MPhil David M. Studdert, LLB, ScD, MPH Allen Kachalia, MD, JD Author Affiliations: Stanford Law School, Stanford, California (Mello); Department of Medicine, Stanford University School of Medicine, Stanford, California (Studdert); Department of Medicine, Harvard Medical School, Boston, Massachusetts (Kachalia). Corresponding Author: Michelle M. Mello, JD, PhD, MPhil, Stanford Law School, 559 Nathan Abbott Way, Stanford, CA 94305 ([email protected] .edu). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Mello and Kachalia reported that they served as investigators on several of the demonstration and planning projects described in their article that tested communication-and-resolution programs and that they have served as consultants to the State of Oregon on medical liability issues. Dr Kachalia also reported receiving personal fees for educational presentations on patient safety from Quantia MD. No other disclosures were reported. 1. Mello MM, Senecal SK, Kuznetsov Y, Cohn JS. Implementing hospital-based communication-and-resolution programs: lessons learned in New York City. Health Aff (Millwood). 2014;33(1):30-38.
Preventing Prescription Opioid Abuse To the Editor The United States, with only 5% of the world’s population, is consuming more than 80% of the world’s opioid supplies.1 The sharp increase in opioid prescribing that began in the 1990s was largely driven by pain advocacy groups and groups of pain specialists lobbying state medical boards and legislatures to lift the prohibitions on opioid use and by the Joint Commission’s mandate to identify and treat pain.2 According to the US Centers for Disease Control and Prevention, the increasing use of opioids has led to parallel increases in opioid addiction and overdose deaths.3 Despite the enormous public health price being paid for the increased use of opioids, no evidence exists that their use has been associated with improvements in outcomes for patients with chronic pain.4 The premise of Dr Jones and colleagues5 in their Viewpoint is that the mechanisms put in place by the US Food and Drug Administration (FDA) to improve safe use of extendedrelease opioids, such as modest label changes and voluntary, industry-sponsored educational programs, will be effective in stemming the tide of opioid addiction and overdose deaths. We are skeptical about this. We believe the FDA should prohibit marketing of opioids for long-term, daily use. We do not want to impede prescribing or reduce access to opioids for those who can benefit, but opioids
have been oversold. Patients with nonstructural low back pain, fibromyalgia, and chronic headache do not exhibit improvements in function and quality of life and are at high risk of developing dependence, functional deterioration, or addiction.4 If the FDA appropriately enforced the federal Food, Drug and Cosmetic Act, the marketing of opioids for conditions in which risks are likely to outweigh benefits would be prohibited. The authors unfairly criticize state health officials and lawmakers for singling out policies against Zohydro ER (hydrocodone bitartrate extended release) as a solution to a complex problem.5 State and local governments, as well as consumer advocacy groups, medical experts, and addiction organizations that objected to the approval of Zohydro ER are aware of the need for a multifaceted approach, and many are already engaged in frontline efforts across the country to reduce overdose deaths. It is time for the FDA to do its part by exercising its regulatory authority and responsibility to prohibit marketing of opioids for common, chronic conditions. Jane C. Ballantyne, MD Andrew Kolodny, MD Author Affiliations: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle (Ballantyne); Phoenix House Foundation Inc, New York, New York (Kolodny). Corresponding Author: Jane C. Ballantyne, MD, Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific St, Seattle, WA 98195 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ballantyne reported being the president and Dr Kolodny reported being the director of Physicians for Responsible Opioid Prescribing. Dr Ballantyne also reported receiving consultancy fees from Cohen Milstein Sellers & Toll PLLC for expert opinion on the scientific evidence concerning opioid treatment of chronic pain. 1. University of Wisconsin–Madison Pain and Policy Studies Group. International Narcotics Control Board opioid consumption data. http://www.painpolicy.wisc .edu/opioid-consumption-data. Accessed October 14, 2014. 2. Franklin GM; American Academy of Neurology. Opioids for chronic noncancer pain: a position paper of the American Academy of Neurology. Neurology. 2014;83(14):1277-1284. 3. Centers for Disease Control and Prevention. CDC grand rounds: prescription drug overdoses—a US epidemic. http://www.cdc.gov/mmwr/preview /mmwrhtml/mm6101a3.htm. Accessed January 17, 2015. 4. Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009;22(1):62-68. 5. Jones CM, Lurie P, Woodcock J. Addressing prescription opioid overdose: data support a comprehensive policy approach. JAMA. 2014;312(17):1733-1734.
To the Editor Although Dr Jones and colleagues1 claimed that the FDA regards “Preventing prescription opioid deaths [as] a public health priority,” this is not consistent with the FDA’s behavior. For example, the FDA instituted the untested, class-wide Risk Evaluation and Mitigation Strategy (REMS) program but continued to approve new extended release/longacting (ER/LA) opioids with no evidence that the REMS actually reduces ER/LA opioid-related morbidity. In addition, 4 months ago, without even holding an advisory committee meeting, the FDA approved Targiniq ER brand of oxycodone/naloxone despite the fact that “the tablets may release all their contents at once if chewed, crushed, broken or dissolved.”2
jama.com
(Reprinted) JAMA March 10, 2015 Volume 313, Number 10
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a New York University User on 05/31/2015
1059
Letters
Is the reaction to Zohydro ER from the public, state officials, and scientists unwarranted? Hydrocodone is the most abused opioid in the United States.3 Zohydro ER is the first acetaminophen-free, extended-release formulation of hydrocodone in a pill that can be easily crushed, freeing up immediate-release hydrocodone. Zohydro ER contains pure hydrocodone, whereas the original OxyContin contained pure oxycodone; otherwise, the characteristics of Zohydro ER are precisely those of the original OxyContin, which launched the prescription opioid epidemic. Jones and colleagues noted that Randall Flick, chairman of the FDA scientific advisory committee that voted 11-2 against approval of Zohydro ER, affirmed that Zogenix had done exactly what the FDA asked it to do. But explaining the Committee vote, Flick said: “…with the Committee, I struggled with what I believe is also part of the charge of the committee, and that is to see to the best interests of the American people and the public health … emerging evidence would suggest that tamper-deterrent formulations are likely to reduce the incidence of morbidity and mortality associated with this class of drugs, and we should not be approving new formulations in that setting.”4 With more than 150 000 US residents already dead from accidental overdoses of prescription opioids,5 I believe the FDA must redirect itself away from its usual criteria and toward actions that can truly make a difference in bringing the opioid epidemic to an end. Daniel A. Busch, MD Author Affiliation: Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Corresponding Author: Daniel A. Busch, MD, Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, 737 N Michigan Ave, Chicago, IL 60611 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Jones CM, Lurie P, Woodcock J. Addressing prescription opioid overdose: data support a comprehensive policy approach. JAMA. 2014;312(17):1733-1734. 2. Therapeutic Goods Administration, Department of Health, Government of Australia. Targin tablets: consumer medicine information. https://www.ebs.tga .gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI -04502-3. Accessed January 11, 2015. 3. Inter-university Consortium for Political and Social Research. National survey on drug use and health, 2013. http://www.icpsr.umich.edu/SDA/SAMHDA /35509-0001/CODEBOOK/2013.htm. Accessed January 11, 2015. 4. US Food and Drug Administration. Anesthetic and Analgesic Drug Products Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees /CommitteesMeetingMaterials/Drugs /AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM339619.pdf. Accessed April 4, 2014. 5. Centers for Disease Control and Prevention. National Vital Statistics System. http://www.cdc.gov/nchs/nvss.htm. Accessed November 15, 2014.
In Reply We agree with Drs Ballantyne and Kolodny that opioid analgesics are not the most effective treatment option for certain types of chronic pain. This recognition, combined with the public health risks associated with opioid analgesics, prompted revisions to the indications for ER/LA opioid analgesics in 2013. 1060
Manufacturers must now instruct prescribers to “reserve [ER/LA opioid analgesics] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”1 In addition, in recent years, the FDA has approved several nonopioid medications to treat some of the most common chronic pain conditions. Ballantyne and Kolodny appear to misinterpret our Viewpoint when they say our premise was that the mechanisms put in place by the FDA to improve safe use of extended-release opioids will be effective in stemming the tide of opioid addiction and overdose deaths. On the contrary, our premise was that actions taken by the FDA are only a small component of a much broader strategy. We believe actions taken by states such as Washington and Florida that target inappropriate prescribing behaviors represent powerful levers to address this problem. Research indicates these efforts have been successful2,3 and therefore should be considered for adoption by other states. Ballantyne and Kolodny also state that we unfairly criticize state health officials and lawmakers for singling out policies against Zohydro ER as a solution to a complex problem. Our intent was not to criticize but to encourage broader action. State requirements to check the prescription drug monitoring program for patients’ controlled prescription drug history, screen patients for abuse risk, and document medical need before prescribing opioids are essential to ensure appropriate prescribing. Requiring these actions only for Zohydro ER is insufficient to address the opioid problem because they should apply to all opioid analgesics. Dr Busch suggests the approval of Zohydro ER in 2013 will mimic the explosive prescribing and associated public health consequences seen with the launch of OxyContin in 1996. To date, dispensing data do not support this concern. Zohydro ER prescriptions in outpatient retail pharmacies have been relatively flat since July 2014. Prescriptions increased marginally from 3600 in July to 4800 in October and then declined to 4600 in November. During this same period, there were, on average, 1.6 million ER/LA opioid and 20 million total opioid prescriptions each month; Zohydro ER represented 0.27% and 0.02% of these, respectively.4 Additionally, Busch expresses concern about the FDA’s untested ER/LA opioid analgesic REMS. Like all REMS, the ER/LA opioid analgesic REMS will be assessed by a rigorous analysis and the FDA will make any needed changes to the REMS that are supported by the assessment. Emerging data suggest positive signs in efforts to reduce prescription drug abuse. The percentage of people initiating nonmedical use of opioids and reporting past-year nonmedical use are at their lowest levels since 2002, and in 2012 opioidrelated overdose deaths declined for the first time since 1999.5,6 The FDA stands ready to work with all stakeholders to make further progress on this public health epidemic. Christopher M. Jones, PharmD, MPH Peter Lurie, MD, MPH Janet Woodcock, MD
JAMA March 10, 2015 Volume 313, Number 10 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a New York University User on 05/31/2015
jama.com
Letters
Author Affiliations: Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland (Jones, Lurie); Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (Woodcock). Corresponding Author: Christopher M. Jones, PharmD, MPH, Office of the Commissioner, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 ([email protected]).
CORRECTION Incorrect Time in Figure: In the Original Investigation entitled “Percutaneous Left Atrial Appendage Closure vs Warfarin for Atrial Fibrillation: A Randomized Clinical Trial,” published in the November 19, 2014, issue of JAMA (2014;312[19]:19881998. doi:10.1001/jama.2014.15192), Figure 2 had incorrectly labeled axes, on which the unit of time should have been months. This article was corrected online.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. Disclaimer: The views and opinions expressed in this letter are those of the authors and should not be construed to represent the views of the US Food and Drug Administration or the US government. 1. US Food and Drug Administration. Labeling supplement and PMR required. http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass /ucm367697.pdf[fda.gov]. Accessed February 3, 2015. 2. Johnson H, Paulozzi L, Porucznik C, Mack K, Herter B; Hal Johnson Consulting and Division of Disease Control and Health Promotion, Florida Department of Health. Decline in drug overdose deaths after state policy changes—Florida, 2010-2012. MMWR Morb Mortal Wkly Rep. 2014;63(26):569574. 3. Franklin G, Sabel J, Jones CM, et al. A comprehensive approach to address the prescription opioid epidemic in Washington State: milestones and lessons learned [published online January 20, 2015]. Am J Public Health. doi: 10.2105 /AJPH.2014.302367. 4. IMS Health. National prescription audit, 2014. https://websolutions.imshealth .com. Accessed September 1, 2014. 5. Centers for Disease Control and Prevention. Trends in drug-poisoning deaths involving opioid analgesics and heroin: United States, 1999-2012. http://www .cdc.gov/nchs/data/hestat/drug_poisoning/drug_poisoning_deaths_1999-2012 .pdf. Accessed December 26, 2014. 6. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: detailed tables. http: //www.samhsa.gov/data/sites/default/files/NSDUH-DetTabsPDFWHTML2013 /Web/HTML/NSDUH-DetTabsTOC2013.htm. Accessed December 26, 2014.
Guidelines for Letters Letters discussing a recent JAMA article should be submitted within 4 weeks of the article's publication in print. Letters received after 4 weeks will rarely be considered. Letters should not exceed 400 words of text and 5 references and may have no more than 3 authors. Letters reporting original research should not exceed 600 words of text and 6 references and may have no more than 7 authors. They may include up to 2 tables or figures but online supplementary material is not allowed. All letters should include a word count. Letters must not duplicate other material published or submitted for publication. Letters not meeting these specifications are generally not considered. Letters being considered for publication ordinarily will be sent to the authors of the JAMA article, who will be given the opportunity to reply. Letters will be published at the discretion of the editors and are subject to abridgement and editing. Further instructions can be found at http://jama.com/public /InstructionsForAuthors.aspx. A signed statement for authorship criteria and responsibility, financial disclosure, copyright transfer, and acknowledgment and the ICMJE Form for Disclosure of Potential Conflicts of Interest are required before publication. Letters should be submitted via the JAMA online submission and review system at http: //manuscripts.jama.com. For technical assistance, please contact [email protected]. Section Editor: Jody W. Zylke, MD, Deputy Editor.
jama.com
(Reprinted) JAMA March 10, 2015 Volume 313, Number 10
Copyright 2015 American Medical Association. All rights reserved.
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1061
