Opioid Pandemic

By elizabethnadeau

  • Introduction

    The opioid epidemic began to be a huge issue for the US beginning around the 1980s. This timeline will introduce key events, legislation, and actions taken to end this pandemic.

  • Oxycontin

    The first formula of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours. OxyContin would soon become the main drug that would lead to opioid abuse for years to come.

  • Stronger warning labels issued

    Additional stronger warnings about the potential for misuse and abuse were added to the OxyContin label.To help prescribers choose patients that should receive OxyContin the verbiage was changed. The label was also changed to say that OxyContin is not appropriate for “as needed” pain. Purdue Pharma which is the company that manufactured OxyContin agreed to include a Risk Management Program and issued a professional letter to healthcare to try to reduce the abuse of OxyContin.

  • FDA Warning Letter

    http://wayback.archive-it.org/7993/20170112065652/http:/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168946.pdf
    Purdue Pharma comes under fire for misleading advertisements regarding the sale of OxyContin. The FDA issued this warning as a result of Purdue Pharma minimizing risks that may be associated with the drug.

  • Food and Drug Administration Amendments Act (FDAAA) became law

    This allowed there to be new authority to enhance drug safety. One of these is the authority to require Risk Evaluation and Mitigation Strategies (REMS) in order to ensure the benefits of the drugs outweigh their risks. REMS ensure that manufacturers implement various safety measures for their drugs. This new law helped provide the basis for a future comprehensive REMS program for all FDA-approved Extended- Release (ER)/Long Acting (LA) opioid products

  • FDA supported the White House Office of National Drug Control Policy (ONDCP) report

    https://obamawhitehouse.archives.gov/sites/default/files/ondcp/ndcs2011.pdf This policy was a comprehensive action plan to address the national prescription drug abuse epidemic. It included efforts to prevent drug use, early intervention opportunities, how to disrupt domestic drug trafficking, and how to improve information that is available.

  • FDA Takes Action Against OxyContin

    FDA has determined that the original formulation of OxyContin was withdrawn from the market for safety reasons. As a result, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of these products.

  • Conclusion

    Conclusion
    This graph shows death rates from synthetic opioids, natural and semi-synthetic opioids, and heroin have increased significantly among both males and females since 2000, but males have consistently had higher rates of overdose deaths for all opioids. This graph proves that although action has been taken to end this pandemic in the US, it still persists. Although deaths from all three forms of opioids have increased since 2000, their trends have differed.