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Obama Authorizes FDA to Address Drug Shortage

The order addresses shortages that affect "cancer treatments...and other drugs that are critical to the treatment and preventtion of serious diseases and life threatening conditions" that need to be accessible to healthcare providers.

One day you are providing patients safe and effective prescription cancer medications and the next those same drugs are unavailable—without warning or explanation. Such is the state of the national drug shortage, which is reaching epidemic proportions.

On October 31, 2011, President Obama issued an executive order, Reducing Prescription Drug Shortages. Executive orders are presidential regulations that give government offices or agencies administrative authority to interpret and implement provisions of the constitution, law, or a treaty.

The order addresses shortages that affect “cancer treatments . . . and other drugs that are critical to the treatment and prevention of serious diseases and life threatening conditions” that need to be accessible to healthcare providers.

It further states that certain cancer treatments have “increased by about 20%, without a corresponding increase in production capacity,” and that “interruptions in the supplies of these drugs endanger patient safety” and limit treatment options.

With the force of law, the U.S. Food and Drug Administration (FDA) has now been directed “to prevent and reduce current and future disruptions in the supply of lifesaving medications.” Specifically, the order instructs the FDA to

  • Work with “manufacturers to provide adequate advance notice” when discontinuances are imminent.
  • “Expand its current efforts to expedite its regulatory reviews” over drugs.
  • “Communicate to the Department of Justice any findings that shortages have led market participants to stockpile” drugs that would cause price gauging.

As the drug shortage issues continues to be addressed in the policy arena, ONS will report on the latest developments. To read the full executive order, visit www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortages.

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Comments

Posted by linda (not verified) on Jan 11, 2012 1:15pm
I think a great solution would be to make most chemos MDV! I mix and aminister and it is disheartening to throw away the remainder of chemotherapies such as 5FU and cytoxan because of billing units NOT authorized as 1mg units. Therefore, it would be fraud if the remainder of the vial was used to administer to another patient. Medicare needs to have a nurse or md assist them to determine appropriate medication reimbursement.

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