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  1. Article ; Online: The Public Health Value of Opioid Litigation.

    Haffajee, Rebecca L

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2020  Volume 48, Issue 2, Page(s) 279–292

    Abstract: Opioid litigation continues a growing public health litigation trend in which governments seek to hold companies responsible for population harms related to their products. The litigation can serve to address gaps in regulatory and legislative ... ...

    Abstract Opioid litigation continues a growing public health litigation trend in which governments seek to hold companies responsible for population harms related to their products. The litigation can serve to address gaps in regulatory and legislative policymaking and in market self-regulation pervasive in the prescription opioid domain. Moreover, prior opioid settlements have satisfied civil tort litigation objectives of obtaining compensation for injured parties, deterring harmful behavior, and holding certain opioid manufacturers, distributors and pharmacies accountable for their actions. In this way, opioid litigation represents progress over prior public health litigation campaigns involving tobacco, lead paint, and asbestos, which had more limited tort litigation effects. Although opioid litigation is not a comprehensive solution to the opioid crisis, it can complement other strategies and infuse much needed money, behavior changes, and public accountability for prescription opioid and related harms.
    MeSH term(s) Compensation and Redress/legislation & jurisprudence ; Drug Industry/legislation & jurisprudence ; Goals ; History, 20th Century ; Humans ; Jurisprudence/history ; Liability, Legal ; Opioid Epidemic ; Public Health/legislation & jurisprudence ; Social Responsibility ; United States
    Language English
    Publishing date 2020-08-25
    Publishing country England
    Document type Historical Article ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1177/1073110520935340
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  2. Article ; Online: Prescription Drug Monitoring Programs - Friend or Folly in Addressing the Opioid-Overdose Crisis?

    Haffajee, Rebecca L

    The New England journal of medicine

    2019  Volume 381, Issue 8, Page(s) 699–701

    MeSH term(s) Analgesics, Opioid/therapeutic use ; Databases, Factual ; Drug and Narcotic Control/legislation & jurisprudence ; Drug and Narcotic Control/trends ; Humans ; Law Enforcement ; Prescription Drug Monitoring Programs/legislation & jurisprudence ; Prescription Drug Monitoring Programs/trends ; Prescriptions/statistics & numerical data ; State Government ; United States
    Chemical Substances Analgesics, Opioid
    Language English
    Publishing date 2019-08-21
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMp1904714
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  3. Article ; Online: Evidence-Based Health Policy in the Biden-Harris Administration.

    Haffajee, Rebecca L / Sommers, Benjamin D

    JAMA health forum

    2021  Volume 2, Issue 7, Page(s) e212598

    MeSH term(s) Federal Government ; Health Policy
    Language English
    Publishing date 2021-07-02
    Publishing country United States
    Document type Journal Article
    ISSN 2689-0186
    ISSN (online) 2689-0186
    DOI 10.1001/jamahealthforum.2021.2598
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  4. Article ; Online: Federal Policies to Expand Health Insurance Coverage During the COVID-19 Pandemic and Beyond.

    Sommers, Benjamin D / Haffajee, Rebecca L

    JAMA health forum

    2021  Volume 2, Issue 11, Page(s) e214608

    MeSH term(s) COVID-19 ; Humans ; Insurance Coverage ; Insurance, Health ; Pandemics ; Policy
    Language English
    Publishing date 2021-11-02
    Publishing country United States
    Document type Journal Article
    ISSN 2689-0186
    ISSN (online) 2689-0186
    DOI 10.1001/jamahealthforum.2021.4608
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  5. Article ; Online: Legal review of state emergency medical services policies and protocols for naloxone administration.

    Smart, Rosanna / Haffajee, Rebecca L / Davis, Corey S

    Drug and alcohol dependence

    2022  Volume 238, Page(s) 109589

    Abstract: Background: Given the continued rise in opioid-related overdoses, many states have expanded access to the opioid antagonist naloxone. We sought to provide comprehensive data on one such strategy: the authority of providers at different emergency medical ...

    Abstract Background: Given the continued rise in opioid-related overdoses, many states have expanded access to the opioid antagonist naloxone. We sought to provide comprehensive data on one such strategy: the authority of providers at different emergency medical services (EMS) licensure levels to administer naloxone.
    Methods: We conducted a systematic legal review of state laws and protocols governing the authority of different EMS licensure levels to administer naloxone. We used Westlaw, state government websites and scope of practice protocols. We coded relevant policies regarding which, if any, administration routes and dosages of naloxone are permitted for each licensure level: emergency medical responder (EMR), emergency medical technician (EMT), advanced emergency medical technician (AEMT), and paramedic.
    Results: As of July 2020, all states with relevant laws or protocols authorize paramedics, AEMTs, and EMTs to administer naloxone. Thirty-nine states with an EMR licensure level and statewide protocol authorize naloxone administration by EMRs, up from only two in 2013. Permissible routes of administration have increased across all EMS provider levels, providing advanced life support providers (i.e., paramedics and AEMTs) with expanded discretion; however, authorization for intravenous and intramuscular administration remains relatively uncommon for basic life support (BLS) providers. When specified, maximum doses authorized ranged widely, from 2.0 to 12.0 milligrams.
    Conclusions: Naloxone administration authority is now widely granted to EMS providers. Most states allow all licensed EMS provider levels to administer naloxone, a substantial increase for EMRs and EMTs since 2013. Paramedics and AEMTs have the greatest authority to select the dosage and route of administration.
    MeSH term(s) Drug Overdose/drug therapy ; Emergency Medical Services/methods ; Humans ; Naloxone/therapeutic use ; Narcotic Antagonists/therapeutic use ; Policy
    Chemical Substances Narcotic Antagonists ; Naloxone (36B82AMQ7N)
    Language English
    Publishing date 2022-07-30
    Publishing country Ireland
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 519918-9
    ISSN 1879-0046 ; 0376-8716
    ISSN (online) 1879-0046
    ISSN 0376-8716
    DOI 10.1016/j.drugalcdep.2022.109589
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  6. Article ; Online: Thinking Globally, Acting Locally - The U.S. Response to Covid-19.

    Haffajee, Rebecca L / Mello, Michelle M

    The New England journal of medicine

    2020  Volume 382, Issue 22, Page(s) e75

    MeSH term(s) Betacoronavirus ; COVID-19 ; Centers for Disease Control and Prevention, U.S. ; Communicable Disease Control/legislation & jurisprudence ; Communicable Disease Control/methods ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Federal Government ; Humans ; Local Government ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/prevention & control ; Public Health Administration/legislation & jurisprudence ; SARS-CoV-2 ; State Government ; United States/epidemiology
    Keywords covid19
    Language English
    Publishing date 2020-04-02
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMp2006740
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  7. Article ; Online: Abuses of FDA Regulatory Procedures - The Case of Suboxone.

    Haffajee, Rebecca L / Frank, Richard G

    The New England journal of medicine

    2020  Volume 382, Issue 6, Page(s) 496–498

    MeSH term(s) Buprenorphine/economics ; Buprenorphine/therapeutic use ; Buprenorphine, Naloxone Drug Combination/economics ; Buprenorphine, Naloxone Drug Combination/therapeutic use ; Drug Approval/legislation & jurisprudence ; Drug Development/economics ; Drug Development/legislation & jurisprudence ; Drug Industry/economics ; Drug Industry/ethics ; Drug Industry/legislation & jurisprudence ; Drugs, Generic ; Economic Competition ; Government Regulation ; Humans ; Narcotic Antagonists/economics ; Narcotic Antagonists/therapeutic use ; Orphan Drug Production/economics ; Orphan Drug Production/legislation & jurisprudence ; United States ; United States Food and Drug Administration
    Chemical Substances Buprenorphine, Naloxone Drug Combination ; Drugs, Generic ; Narcotic Antagonists ; Buprenorphine (40D3SCR4GZ)
    Language English
    Publishing date 2020-01-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMp1906680
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  8. Article ; Online: Generic Drug Policy and Suboxone to Treat Opioid Use Disorder.

    Haffajee, Rebecca L / Frank, Richard G

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2020  Volume 47, Issue 4_suppl, Page(s) 43–53

    Abstract: Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs ... ...

    Abstract Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone - including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses - helped to maintain high prices by extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017.
    MeSH term(s) Buprenorphine, Naloxone Drug Combination/economics ; Buprenorphine, Naloxone Drug Combination/therapeutic use ; Drugs, Generic/economics ; Health Policy/legislation & jurisprudence ; Humans ; Legislation, Drug ; Narcotic Antagonists/economics ; Narcotic Antagonists/therapeutic use ; Opiate Substitution Treatment/economics ; Opioid-Related Disorders/drug therapy ; United States ; United States Food and Drug Administration
    Chemical Substances Buprenorphine, Naloxone Drug Combination ; Drugs, Generic ; Narcotic Antagonists
    Language English
    Publishing date 2020-02-06
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1177/1073110519898042
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  9. Article ; Online: Medical Cannabis Use: The Authors Reply.

    Boehnke, Kevin F / Haffajee, Rebecca L

    Health affairs (Project Hope)

    2019  Volume 38, Issue 5, Page(s) 874

    MeSH term(s) Medical Marijuana ; Politics ; United States ; United States Food and Drug Administration
    Chemical Substances Medical Marijuana
    Language English
    Publishing date 2019-05-06
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 632712-6
    ISSN 1544-5208 ; 0278-2715
    ISSN (online) 1544-5208
    ISSN 0278-2715
    DOI 10.1377/hlthaff.2019.00249
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  10. Article ; Online: Pregnant Women with Substance Use Disorders - The Harm Associated with Punitive Approaches.

    Haffajee, Rebecca L / Faherty, Laura J / Zivin, Kara

    The New England journal of medicine

    2021  Volume 384, Issue 25, Page(s) 2364–2367

    MeSH term(s) Behavior Therapy ; Female ; Health Policy ; Humans ; Infant, Newborn ; Mandatory Reporting ; Mandatory Testing/legislation & jurisprudence ; Pregnancy ; Pregnancy Complications/diagnosis ; Pregnancy Complications/therapy ; Pregnant Women ; Prenatal Care ; Punishment ; Social Control, Formal ; State Government ; Substance Abuse Detection/legislation & jurisprudence ; Substance-Related Disorders/diagnosis ; Substance-Related Disorders/therapy ; United States
    Language English
    Publishing date 2021-06-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMp2101051
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