Drug Shortages Update

The shortages of sterile injectable medications, which includes parenteral nutrition (PN) components have been ongoing since 2010. These medications are manufactured by a limited number of pharmaceutical firms. Over the past 5 years the supplies of PN components have fluctuated from having none of a particular component to a supply sufficient to meet every patient’s daily needs. This fluctuation in supply may be associated with the release of product from the manufacturer. When product is released there is adequate supply of the PN component to meet patient needs and rationing and conservation strategies may be less rigorous. Clinicians perceive the shortage of the PN component has resolved. However, if the manufacturer is unable to regularly and consistently release product or the next release of the PN component is delayed supplies will diminish. Once again there is a shortage of the PN component and rationing and conservation of the product must be implemented in order to provide some product to those patients with the greatest need and at risk of deficiency.

Presently a number of PN components are in short supply (see list below) and clinicians are reporting the shortages of magnesium sulfate and L-cysteine as critical. A.S.P.E.N. has published recommendations to assist clinicians in managing shortages of PN components. These recommendations and other information on medication shortages may be accessed via the A.S.P.E.N. Product Shortage page

Currently the FDA considers the following PN components in short supply.
Calcium gluconate
Dextrose 70% water
L-cysteine hydrochloride
Magnesium sulfate
Multivitamins-adult and pediatric
Phosphate injection (Glycophos)
Potassium chloride
Selenium
Sodium chloride 23.4%
Sodium phosphate
Sterile water for injection
Trace elements
Zinc

A medication shortage is considered resolved when the following criteria are met.

  • The product is available through the normal supply chain.
  • The product can be obtained without allocations, direct orders or drop shipments.
  • The quantity of the product that can be procured is sufficient product to prescribe and administer full dose daily.  
  • The FDA considers shortage resolved.


The FDA has classified shortages of the following as resolved.
Chromic chloride (chromium)
Copper
B12 (cyanocobalamin)
Potassium phosphate
Vitamin A