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Ethical Promotion of Addiction Treatment Medications

by | Sep 25, 2017

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Background

Significant and rapid progress has been made in both the scientific understanding of the disease of addiction and the medical interventions available to treat it. There has been especially notable expansion in the number of prescription pharmacotherapies available to treat patients with addiction, with the pharmaceutical arsenal of addiction medicine physicians nearly doubling since 2000. For example, approvals over the past 15 years by the Food and Drug Administration (FDA) of medications to treat addiction include:

  • Buprenorphine (2002) and extended-release injectable naltrexone (2010) for opioid use disorder
  • Acamprosate (2004) and extended-release injectable naltrexone (2006) for alcohol use disorder
  • Varenicline (2006) for tobacco use disorder

Many of these prescription medications are currently sold under brand names by major pharmaceutical companies. Since addiction treatment was long characterized by nonpharmacological interventions and the use of generic medicines, the approval of these new brand-name products has introduced new questions about the role that pharmaceutical companies play in influencing treatment decisions and policy for addiction treatment. Many aspects of the role of pharmaceutical companies merit thoughtful debate, such as how they develop and test their products, how they interact with academic medicine, and how they interact with clinicians, prescribers, and regulators. This public policy statement focuses on guiding principles for pharmaceutical companies’ ethical marketing, advertising, information sharing, and advocacy practices related to addiction medications (collectively referred to as “promotion” of addiction medications).

Because addiction is a highly stigmatized disease that disproportionately affects vulnerable populations (e.g. persons who have experienced adverse childhood events) and uniquely can lead to adverse social consequences due to illness (e.g., involvement with the criminal justice system), pharmaceutical companies should adhere to the highest ethical standards when promoting addiction treatment medications.

Recommendations

The American Society of Addiction Medicine recommends pharmaceutical companies that manufacture addiction treatment medications should:

  1. Comply with FDA’s regulations governing direct-to-consumer advertising, and should apply these principles to their marketing and information sharing with all consumer groups. This includes clinicians, payers, legislators, family and patient groups, and the criminal justice system. The FDA requires all direct-to-consumer communications to be (1) accurate and not misleading; (2) only include information that is supported by strong evidence; (3) balance the risk and benefit information; and (4) be consistent with the prescribing information approved by FDA.
  2. Avoid language that stigmatizes patients or disparages other evidence-based treatment options in all promotional and advocacy communications.
  3. Engage in no significant activity that may result in legislative or regulatory action limiting access to competitors' approved products.
  4. Use accurate terminology and presentation of data that aligns with the scientific understanding and accepted definitions of substance use disorders.

 

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Ethical Promotion of Addiction Treatment Medications

by | Sep 25, 2017

PDF

Background

Significant and rapid progress has been made in both the scientific understanding of the disease of addiction and the medical interventions available to treat it. There has been especially notable expansion in the number of prescription pharmacotherapies available to treat patients with addiction, with the pharmaceutical arsenal of addiction medicine physicians nearly doubling since 2000. For example, approvals over the past 15 years by the Food and Drug Administration (FDA) of medications to treat addiction include:

  • Buprenorphine (2002) and extended-release injectable naltrexone (2010) for opioid use disorder
  • Acamprosate (2004) and extended-release injectable naltrexone (2006) for alcohol use disorder
  • Varenicline (2006) for tobacco use disorder

Many of these prescription medications are currently sold under brand names by major pharmaceutical companies. Since addiction treatment was long characterized by nonpharmacological interventions and the use of generic medicines, the approval of these new brand-name products has introduced new questions about the role that pharmaceutical companies play in influencing treatment decisions and policy for addiction treatment. Many aspects of the role of pharmaceutical companies merit thoughtful debate, such as how they develop and test their products, how they interact with academic medicine, and how they interact with clinicians, prescribers, and regulators. This public policy statement focuses on guiding principles for pharmaceutical companies’ ethical marketing, advertising, information sharing, and advocacy practices related to addiction medications (collectively referred to as “promotion” of addiction medications).

Because addiction is a highly stigmatized disease that disproportionately affects vulnerable populations (e.g. persons who have experienced adverse childhood events) and uniquely can lead to adverse social consequences due to illness (e.g., involvement with the criminal justice system), pharmaceutical companies should adhere to the highest ethical standards when promoting addiction treatment medications.

Recommendations

The American Society of Addiction Medicine recommends pharmaceutical companies that manufacture addiction treatment medications should:

  1. Comply with FDA’s regulations governing direct-to-consumer advertising, and should apply these principles to their marketing and information sharing with all consumer groups. This includes clinicians, payers, legislators, family and patient groups, and the criminal justice system. The FDA requires all direct-to-consumer communications to be (1) accurate and not misleading; (2) only include information that is supported by strong evidence; (3) balance the risk and benefit information; and (4) be consistent with the prescribing information approved by FDA.
  2. Avoid language that stigmatizes patients or disparages other evidence-based treatment options in all promotional and advocacy communications.
  3. Engage in no significant activity that may result in legislative or regulatory action limiting access to competitors' approved products.
  4. Use accurate terminology and presentation of data that aligns with the scientific understanding and accepted definitions of substance use disorders.

 

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Education

Review Course 2019

The ASAM Review Course in Addiction Medicine is widely recognized as the essential primer for physicians preparing for the ABPM Addiction Medicine Exam and primary care providers who wish to increase their skills in identifying and managing patients whose medical problems are caused or exacerbated by substance use disorders. 

Learn More

MOC Guide

Considering a career in Addiction Medicine or expanding your practice services?

Physicians who have a primary ABMS board may apply to take the ABPM Addiction Medicine exam to become or continue to be an addiction medicine specialist. This specific pathway will expire in 2021. Download the NEW ASAM Information Guide on Certification and MOC.

Click here

Opportunities

ASAM invites applications for the position of Editor-in-Chief of The ASAM Criteria

The ASAM Criteria® is the most widely used set of guidelines for placement, continued stay and transfer/discharge of patients with addiction and co-occurring conditions. The ongoing advances in the addiction medicine field and lessons learned from real-world implementations of The ASAM Criteria call for more regular updates to these guidelines.

The Editor-in-Chief is expected to participate in the development and execution of a process for reviewing data from real-world implementations of the ASAM Criteria, including the ASAM CONTINUUM Software, and working with the editorial team to make empirically-driven revisions of the ASAM Criteria text.

Interested individuals are referred to the position description online at https://www.asam.org/about-us/jobs/editor-in-chief-the-asam-criteria for detailed information about qualifications, duties, and responsibilities.

Applications for this position must be received by close of business on June 6, 2019.

New Resources

JAM Podcast
 
In episode eleven of Addiction Medicine: Beyond the Abstract, we are joined by Dr. Honora Englander, an Associate Professor of Medicine at Oregon Health & Science University and the Director and Principal Investigator of the Improving Addiction Care Team (IMPACT). In her recent article, Dr. Englander and her colleagues discuss using hospitalization as a "reachable moment" for highly vulnerable patients who are not engaged in treatment elsewhere and utilizing the IMPACT team in this process.

 

Journal of Addiction Medicine March/April 2019, Volume 13, Issue 2;

Drug court resources

Drug Court Resources

Tens of thousands of Americans access addiction pharmacotherapies through drug courts every year. New resources are now available. Created in partnership with the NADCP National Association of Drug Court Professionals.