Spotlight on Naloxone Co-Prescribing

As we recognize International Overdose Awareness Day, HHS is calling attention to the co-prescription of naloxone, the Food and Drug Administration (FDA)-approved medication that can save a person’s life when administered during an opioid overdose. Naloxone is available in three formulations – nasal spray, injectable, and auto-injector – and at least one form of naloxone is covered by most health insurance plans, including Medicaid and Medicare.

Since July 2016, prescriptions for naloxone in the U.S. have increased 773%. Expanding the availability and distribution of overdose-reversing drugs is one of the five pillars of HHS’s comprehensive, science-based strategy for combatting the opioid overdose epidemic. These efforts include co-prescribing naloxone in conjunction with an opioid prescription, or prescribing naloxone to at-risk individuals.

As of July 2020, the FDA announced it is requiring changes to the prescribing information for opioids and medications to treat opioid use disorder (OUD). These changes include recommending that as a routine part of prescribing these medications, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. Additionally, they should consider prescribing naloxone based on a patient’s risk factors for overdose. Previously, in December 2018, HHS released guidance for health care providers and patients detailing how naloxone should be prescribed to all patients at risk for opioid complications, including overdose. Naloxone co-prescribing is also recommended in the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.

Over the past several years, a growing number of states have implemented laws and regulations requiring health care providers to co-prescribe naloxone with opioid prescriptions to patients considered at risk of an overdose. As HHS regularly tracks the number of naloxone prescriptions dispensed in the US within mail order and retail pharmacies, we are greatly encouraged by continued increases in naloxone prescriptions, particularly within states that have recently implemented naloxone co-prescribing legislation.

Figure 1. California Naloxone Prescriptions: July 2016 - June 2020. Naloxone co-prescribing law goes into effect January 1, 2019. Prior to the effective date of the law, naloxone prescriptions averaged approximately 1,800 monthly. In the first month following the effective date of the law, naloxone prescriptions jumped 282% and have averaged approximately 13,800 monthly since. Source: IQVIA National Prescription Audit. Data retrieved August 4, 2020. Data presented for the retail and mail channels only.For example, a California law effective January 1, 2019, requires that prescribers offer a prescription for naloxone when certain conditions are met, including high daily doses of opioids, concurrent opioid and benzodiazepine prescriptions, and increased risk of an opioid overdose (e.g. a patient with a history of OUD or previous overdose). Prior to the effective date of the law, naloxone prescriptions averaged approximately 1,800 monthly. In the first month following the effective date of the law, naloxone prescriptions jumped 282% (Figure 1) and have averaged approximately 13,800 monthly since.

Figure 2. New Jersey Naloxone Prescriptions: Percent Change Over Previous Month, 2020. New Jersey Administrative Order issued May 21, 2020 directs practitioners to prescribe naloxone for any individual receiving high daily doses of opioids or concurrent opioid and benzodiazepine prescriptions. Even during a pandemic, naloxone co-prescribing laws lead to increased naloxone prescriptions. Data from June 2020 show an increase in naloxone prescriptions in New Jersey of 1,058% over May. Source: IQVIA National Prescription Audit. Data retrieved August 4, 2020. Data presented for the retail and mail channels only.Recent mail order and retail pharmacy data from New Jersey reflect similar trends. An administrative order issued on May 21, 2020 directs practitioners to prescribe naloxone for any individual receiving high daily doses of opioids or concurrent opioid and benzodiazepine prescriptions. Even during a pandemic, naloxone co-prescribing laws lead to increased naloxone prescriptions. Data from June 2020 show an increase in naloxone prescriptions in New Jersey of 1,058% over May (Figure 2).

Although the number of naloxone prescriptions is not necessarily representative of naloxone use or decreasing opioid overdose deaths, naloxone continues to play an important role as one pillar of our comprehensive strategy to address the opioid crisis.

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    A federal grand jury in the District of Columbia returned a superseding indictment Thursday charging a U.S. entertainer and businessman and a Malaysian national with orchestrating an unregistered, back-channel campaign beginning in or about 2017 to influence the then-administration of the President of the United States and the Department of Justice both to drop the investigation of Jho Low and others in connection with the international strategic and development company known as 1Malaysia Development Berhad (1MDB), and to send a Chinese dissident back to China.
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    In Travel
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  • State Department Terrorist Designation of Saraya al-Mukhtar
    In Crime Control and Security News
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  • The United States Imposes Sanctions on Chinese and Hong Kong Persons for Activities Related to Supporting the Islamic Republic of Iran Shipping Lines
    In Crime Control and Security News
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  • NASA-Developed Ventilator Authorized by FDA for Emergency Use
    In Space
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  • Owner of Bitcoin Exchange Convicted of Racketeering Conspiracy for Laundering Millions of Dollars in International Cyber Fraud Scheme
    In Crime News
    A Bulgarian national was found guilty today for his role in a transnational and multi-million dollar scheme to defraud American victims through online auction fraud.
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  • Former Deutsche Bank Commodities Trader Sentenced to Prison for Fraud Scheme
    In Crime News
    A former commodities trader was sentenced today in the Northern District of Illinois to 12 months and a day in prison for a scheme to commit wire fraud affecting a financial institution.
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  • Nigeria’s Twitter Suspension
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  • FBI Report on Crime Shows Decline in Violent Crime Rate for Third Consecutive Year
    In Crime News
    Today, the Federal Bureau of Investigation released its 2019 edition of Crime in the United States, which showed that violent crime decreased nationwide for the third consecutive year.  After decreases in both 2017 and 2018, the violent crime rate dropped an additional one percent this past year and the property crime rate decreased 4.5 percent.
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  • Priority Open Recommendations: Department of State
    In U.S GAO News
    What GAO Found In April 2020, GAO identified 12 priority recommendations for the Department of State. Since then, State has implemented 3 of those recommendations by, among other things, taking actions to improve embassy construction planning and agency reform efforts. In May 2021, GAO identified 2 additional priority recommendations for State, bringing the total number to 11. These recommendations involve the following areas: improving the security assistance vetting process; improving data quality; improving workforce management; improving embassy construction planning; improving cybersecurity;  complying with congressional reporting requirements. State’s continued attention to these issues could lead to significant improvements in its operations. Why GAO Did This Study Priority open recommendations are the GAO recommendations that warrant priority attention from heads of key departments or agencies because their implementation could save large amounts of money; improve congressional and/or executive branch decision-making on major issues; eliminate mismanagement, fraud, and abuse; or ensure that programs comply with laws and funds are legally spent, among other benefits. Since 2015 GAO has sent letters to selected agencies to highlight the importance of implementing such recommendations. For more information, contact Thomas Melito at (202) 512-9601 or melitot@gao.gov.
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  • Social Security Contracting: Relevant Guidance Should Be Revised to Reflect the Role of Contracting Personnel in Software Development
    In U.S GAO News
    The approach followed by the Social Security Administration (SSA) in awarding and overseeing contracts generally aligns with the requirements GAO reviewed. For the 27 contracts and orders GAO reviewed, SSA varied its approach depending on the contract type used and the dollar value. For example, one of SSA's written acquisition plans acknowledged the risks to the government associated with time-and-materials contracts. From fiscal year 2015 through 2019, SSA obligated 22.7 percent of its contract dollars on time-and-material contracts compared with 10.5 percent at other civilian agencies. In addition, from fiscal year 2015 through 2019, the rate at which SSA used competitive award procedures to achieve the best value for the agency increased by nearly 20 percentage points. This increase was the result of the agency's increased use of competition in its contracting for information technology (IT). SSA relies heavily on IT resources to support the administration of its programs and related activities. During fiscal years 2015 through 2019, about 65 percent of the $8.3 billion in contract obligations were for IT goods and services compared with about 16 percent at other civilian agencies. The figure shows the percentage of obligations for IT goods and services at SSA. Percentage of Social Security Administration's Contract Obligations for Goods and Services during Fiscal Years 2015 through 2019 SSA adopted an Agile approach to software development for some of its critical IT programs in 2015. An Agile approach to software development involves incremental improvements to software rather than the more traditional single-track approach. Subsequently, SSA developed an IT modernization plan in 2017 that states SSA will use an Agile methodology. GAO's draft Agile Assessment Guide states that an organization's acquisition policies and guidance should support an Agile development approach and identify clear roles for contracting personnel, since this is a different approach than federal agencies previously used. However, GAO found SSA's acquisition handbook does not specifically identify a role for contracting personnel with respect to contracts and task orders involving Agile, which GAO has identified as a leading practice. Identifying a role for contracting personnel in the Agile process should better position SSA to achieve its IT modernization goals and provide appropriate levels of oversight. SSA is responsible for delivering services that touch the lives of virtually every American. To do so, SSA relies on a variety of products and services, including information technology (IT) systems. SSA obligates approximately $1.5 billion annually to procure goods and services, 65 percent of which are IT-related. GAO was asked to assess how SSA implements its contracting and acquisition processes. This report examines: (1) how SSA awards and oversees contracts for products and services, and (2) the extent to which SSA has updated its guidance regarding the role of contracting personnel in software development efforts. GAO reviewed SSA's acquisition policies, interviewed contracting officials, and reviewed a non-generalizable sample of 27 high- and lower value contracts and orders with dollars obligated in fiscal years 2014 through 2018. GAO also examined data from fiscal years 2015-2019 to determine what SSA contracted for and reviewed IT guidance. GAO compared SSA's practices to leading practices for Agile software development with respect to the roles of contracting personnel. GAO recommends that SSA revise relevant guidance to identify the roles of contracting personnel in Agile software development. SSA agreed with this recommendation. For more information, contact William Woods at (202) 512-4841 or woodsw@gao.gov.
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  • Acting Assistant Attorney General Brian C. Rabbitt Delivers Remarks at Shinshu University 2nd White Collar Crime Workshop
    In Crime News
    Good morning. It is my pleasure to be with you today, even if only through a video screen. Thank you very much to Shinshu University and my hosts for your kind invitation to join the list of distinguished speakers, panelists, and participants in today’s important event. It is my great privilege to be here today representing the women and men of the Criminal Division of the U.S. Department of Justice, and I look forward to speaking with you about some of our important work over the past year enforcing the federal criminal laws.
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  • The U.S. Relationship with the United Arab Emirates Deepens
    In Crime Control and Security News
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  • Nevada Bottled Water Companies and Owners Ordered to Stop Distributing Adulterated and Misbranded Water Products
    In Crime News
    A federal court permanently enjoined a Henderson, Nevada, company from preparing, processing, and distributing adulterated and misbranded bottled water.
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  • Tax Preparer Pleads Guilty to Conspiring to Defraud the IRS
    In Crime News
    A Maryland tax return preparer pleaded guilty today to conspiracy to defraud the United States and aiding in the preparation of a false tax return. According to court documents and statements made in court, Anita Fortune, 56, of Upper Marlboro, provided return preparation services under multiple business names, including Tax Terminatorz Inc. Fortune prepared and filed returns using co-conspirators’ electronic filing identification numbers and identifiers, which they provided in exchange for fees and office space. For the tax years 2011 to 2018, Fortune and her associates fraudulently reduced their clients’ tax liabilities and increased their refunds by adding fictitious or inflated itemized deductions and business losses to the clients’ returns. In total, Fortune caused a tax loss to the IRS of $189,748.
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  • U.S.-Kenya Strategic Consultations
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  • Former DoD Employee Sentenced for Violently Assaulting Two Neighbors While Living Overseas
    In Crime News
    An Oklahoma City, Oklahoma man was sentenced today to 60 months in prison followed by three years of supervised release in the Western District of Oklahoma for assaulting two neighbors inside their apartment in Okinawa, Japan, while working for the U.S. Armed Forces overseas as a civilian engineer.
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  • Higher Education: Department of Education Should Further Assess College Access Grant Programs
    In U.S GAO News
    Why This Matters The Department of Education gives grants to schools and organizations that provide disadvantaged students with services to help them attend college. These eight grant programs are collectively known as “TRIO”, named for the original three programs. Congress provides over $1 billion each year to these programs, but Education could do more to understand how well these grants work to help students. Key Takeaways Education could improve the information it has about TRIO programs in two areas: (1) grantee performance data, and (2) program assessments. Schools and organizations report data to Education to show how the TRIO grants they receive have been working. For example, organizations that receive grants to encourage students to complete college report on the numbers and percentages of students who received services and earned degrees.  Education evaluates grantees’ performance using the self-reported data, but has done little to verify the data. Accurate performance data are important because returning grantees can earn points for past performance in the next grant competition—increasing the likelihood that they will receive new grants. Almost 80 percent of recent TRIO grants went to returning grantees.  Therefore, grantees may have an incentive to report a more positive picture than warranted. Officials from an organization representing TRIO grantees told us there is a risk that some grantees may report inaccurate information.  As for assessing the individual TRIO programs, studies of some programs are outdated. In addition, Education has never assessed the effectiveness of three of the seven TRIO programs that serve students, and did not have any new assessments planned as of August 2020. How GAO Did This Study We analyzed data from Education about TRIO grantees and applicants. We also reviewed relevant federal laws and regulations and agency documents, and interviewed Education officials and other TRIO stakeholders. Education should take additional steps to ensure the reliability of grantees' performance data and develop a plan for assessing the effectiveness of the TRIO programs that serve students. Education generally agreed with our recommendations. For more information, contact Melissa Emrey-Arras at (617) 788-0534 or emreyarrasm@gao.gov.
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  • State Department Employee and Spouse Plead Guilty to Trafficking in Counterfeit Goods from U.S. Embassy
    In Crime News
    A U.S. Department of State employee and his spouse pleaded guilty today to one count of conspiracy to traffic in counterfeit goods. The guilty pleas took place before U.S. District Judge Michael J. McShane, who has scheduled sentencing for March 18, 2021, for both defendants.
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  • Justice Department Settles Lawsuit Against Owners and Mangers of Housing Properties in Honolulu, Hawaii for Discriminating Against Families with Children
    In Crime News
    The Justice Department announced today that it has reached a settlement with the owners and managers of housing in Honolulu, Hawaii, to resolve a lawsuit filed last year alleging that the defendants refused to rent to families with children at properties they owned and managed, in violation of the Fair Housing Act.
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  • Physical Infrastructure: Preliminary Observations on Options for Improving Climate Resilience of Transportation Infrastructure
    In U.S GAO News
    What GAO Found GAO's Disaster Resilience Framework serves as a guide for analysis of federal actions to facilitate and promote resilience to natural disasters and changes in the climate across many policy areas, including transportation. The framework is organized around three guiding principles—information, integration, and incentives—and a series of questions that can help identify opportunities to enhance federal efforts to promote disaster resilience. Specifically, the integration principle states that integrated analysis and planning can help decision makers take coherent and coordinated actions to promote resilience. For example, in October 2019, GAO reported that no federal agency, interagency collaborative effort, or other organizational arrangement has been established to implement a strategic approach to climate resilience investment that includes periodically identifying and prioritizing projects. Such an approach could supplement individual agency climate resilience efforts and help target federal resources toward high-priority projects. GAO recommended that Congress consider establishing a federal organizational arrangement to periodically identify and prioritize climate resilience projects for federal investment. The Federal Highway Administration (FHWA) has taken steps to encourage states to enhance the climate resilience of federally funded roads by developing agency policy, providing technical assistance to states, and supporting climate resilience research funding, among other actions. In addition, as part of ongoing work on FHWA's federal-aid highway program, GAO identified options that could further enhance the climate resilience of federally funded roads, based on a literature review and interviews with knowledgeable stakeholders (see table). Some of these options are similar to recommendations made previously by GAO. Further, according to FHWA officials, some of these options would likely require additional congressional direction or authority to implement. Options to further enhance resilience of federally funded roads, as suggested by relevant literature and knowledgeable stakeholders Option Integrate climate resilience into Federal Highway Administration policy and guidance. Update design standards to account for climate change and resilience best practices. Provide authoritative, actionable, forward-looking climate information. Add climate resilience funding eligibility requirements, conditions, or criteria to formula grant programs. Expand the availability of discretionary funding for climate resilience improvements. Alter the Emergency Relief (ER) program by providing incentives for, or conditioning funding on, pre-disaster resilience actions. Expand the availability of ER funding for post-disaster climate resilience improvements. Establish additional climate resilience planning or project requirements. Link climate resilience actions or requirements to incentives or penalties. Condition eligibility, funding, or project approval on compliance with climate resilience policy and guidance. Source: GAO analysis of literature and interviews with knowledgeable stakeholders. | GAO-21-561T Why GAO Did This Study Since 2013, GAO has included Limiting the Federal Government's Fiscal Exposure by Better Managing Climate Change Risks in its High Risk List. In addition, according to the U.S. Global Change Research Program, a changing climate threatens the performance of the U.S. transportation system across all modes, including roads. Congress authorized approximately $43 billion of fiscal year 2021 formula funding for the U.S. Department of Transportation's FHWA's federal-aid highway program, which primarily funds highway planning and construction. This testimony discusses (1) GAO's framework for identifying opportunities to enhance the climate resilience of transportation infrastructure; and (2) preliminary observations on actions taken and options to further enhance the climate resilience of federally funded roads. This work is based on GAO reports issued from 2014 through 2019, a review of literature, and interviews conducted with FHWA officials and knowledgeable stakeholders conducted as part of on-going work. GAO expects to issue a report on the results of its ongoing work in summer 2021.
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  • The United States Targets Foundations Controlled by Iran’s Supreme Leader
    In Crime Control and Security News
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  • Statement by Acting Attorney General Monty Wilkinson on the Pakistani Supreme Court’s Ruling Relating to the Abduction and Murder of Daniel Pearl
    In Crime News
    Acting Attorney General Monty Wilkinson has released the following statement:
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  • Two Senior Managers in Italy Charged with Conspiracy to Cheat U.S. Emissions Tests and Defraud U.S. Consumers
    In Crime News
    An indictment was unsealed today in the Eastern District of Michigan charging two Italian nationals, along with a previously charged co-conspirator, for their alleged role in a conspiracy to defraud U.S. regulators and customers by making false and misleading statements about the emissions controls and fuel efficiency of more than 100,000 diesel vehicles sold in the United States by FCA US LLC.
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  • Revocation of the Terrorist Designations of Ansarallah
    In Crime Control and Security News
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  • Indiana Man Pleads Guilty to Hate Crime for Making Racially-Charged Motivated Threats Toward Black Neighbor and to Unlawful Possession of Firearms
    In Crime News
    The Justice Department announced today that Shepherd Hoehn, 51, pleaded guilty in federal court to making threats to intimidate and interfere with his neighbor, who is Black, because of the neighbor’s race and because the neighbor was exercising his right to fair housing, in violation of 42 U.S.C. § 3631. Hoehn also pleaded guilty to unlawfully possessing firearms, in violation of 18 U.S.C. § 922(g).
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  • U.S. Taxpayer in Panama Papers Investigation Sentenced to Prison
    In Crime News
    A former U.S. resident and taxpayer was sentenced in the Southern District of New York to four years in prison for wire fraud, tax fraud, money laundering, false statements, and other charges.
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