FDA Opioid Action Plan

by pharmacy on April 13, 2016

opioid regulation pharmacyOver the past several years, there has been a great deal of attention focused on the increasing number of individuals addicted to and abusing opioids. State legislatures, healthcare providers, and the federal government have all been looking at ways to reduce dependency.

What is the plan?

The FDA is considering a variety of ways to help alleviate the issues surrounding opioid abuse including:

  • Increasing the role of advisory committees.
  • Changing the warning labels on opioids.
  • Require companies to study long term use effects of opioids.
  • Increase provider training on safe opioid use and pain management.
  • Encourage development of abuse-deterrent formulation opioids.
  • Increased access to overdose treatments.
  • New classes of pain medications with lower associated risks.
  • New guidelines for the risk-benefit portion of the approval process that focuses more on the health implications of opioid abuse.

The plan is designed to not only be utilized within the FDA, but also in conjunction with other state and federal agencies in order to have the greatest impact. It is clear that the agency will be advocating for medications that fill the role of pain relief without causing the devastating consequences of opioids.

How to Prepare Patients

This issue has been gaining media coverage in part due to the recently released CDC Guideline for Prescribing Opioids for Chronic Pain. While not mandatory, as the rulings of the FDA will eventually be, they are a good indicator of the direction of healthcare and they have caused many patients across the country to worry about their own prescriptions.

Part of the problem in preparing clients lies in the fact that currently state guidelines are what dictate how painkillers are prescribed. Some states have limited new prescriptions to seven day supplies, and others are working on new guidelines. While pain management specialists and drug companies fiercely oppose many of the new measures, they are coming, and patients are worried.

Provide resources to your state agency and local legislative representatives so patients know where to seek the most current information. Consider printing and displaying the newest CDC guidelines, as well as new state laws, as they are issued. Talk with patients and explain that most people who have been on prescriptions have little reason to worry about their medications being taken from them. By making clients more aware of the process and discussion, you can help reduce their anxiety.

The FDA has made several pushes recently to really address the issue of opioid abuse. According to a recent statement, more people die each year from drug overdose than automobile crashes. By changing how new medications enter the market, how the FDA and pharmaceutical companies communicate with providers, and increasing the transparency in the entire process, a new era of pain management is emerging.

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