Drug shortages a matter of national security

June 18, 2018

Drug shortages remain a serious ongoing public health concern in the U.S. that has been heightened by the effect of Hurricane Maria on pharmaceutical manufacturing in Puerto Rico.

At the 2018 AMA Annual Meeting, delegates declared the issue an urgent public health crisis and urged the federal government to consider drug shortages a national security initiative and consider vital pharmaceutical production sites as critical infrastructure.

The AMA House of Delegates (HOD) modified existing policy to say that the AMA:

  • Urge the FDA to require manufacturers to provide greater transparency regarding production locations of drugs and provide more detailed information regarding the causes and anticipated duration of drug shortages.
  • Encourage electronic health records vendors to make changes to their systems to ease the burden of making drug product changes.
  • Urge the FDA to evaluate and provide current information regarding the quality of outsourcer compounding facilities.
  • Urge DHHS and the U.S. Department of Homeland Security (DHS) to examine and consider drug shortages as a national security initiative and include vital drug production sites in the critical infrastructure plan.
  • Consider drug shortages to be an urgent public health crisis, and recent shortages have had a dramatic and negative impact on the delivery and safety of appropriate healthcare to patients.

The policy also calls on the AMA Council on Science and Public Health to continue to evaluate the drug shortage issue—including the impact of group purchasing organizations on drug shortages—and report back at least annually to the HOD on progress made in addressing drug shortages.

In other action with a potential impact on the supply of prescription drugs available for use, the AMA responded to concerns about wastage and expiration of unused pharmaceutical products prompting their disposal. Delegates adopted policy calling on the AMA to encourage:

  • States with laws establishing prescription drug repository or “return and reuse” programs to implement such laws and to consider integrating them with existing recycling or disposal programs.
  • States that lack drug repository or “return and reuse” programs to enact such laws in consultation with their state board pharmacy.

The adopted policy also encourages state medical associations in states where there is a prescription repository or a “return and reuse” program for unused medication supplies to educate physicians regarding the existence of such programs.

AMA has the full release