A Critical Problem: Drug Shortages

Pharmaceutical Shortages in the NICU

by Dr. Mitchell Goldstein, neonatologist and NPIHC Steering Committee member

The healthcare system as we know it is changing. Certain systematic changes bode well for perinatal and neonatal care. The new laws which provide for enhanced coverage for young mothers and recognition that pre-existing conditions cannot be excluded will favorably impact babies and their mothers.

However, despite these systematic changes, the healthcare system is reeling from the effects of unanticipated medication shortages. Nowhere is this more critical than in the NICU. There are a myriad of root causes. As pharmaceutical manufacturers gear up for changes in remuneration, less productive product lines are discontinued. Group Purchasing Organizations (GPOs) attempt to secure the best price for their client hospitals, but single sourcing further complicates issues with remuneration as pharmaceutical suppliers are unable to sell into a competitive marketplace. Faced with uncertain supply, hospitals and their suppliers hoard medications and other crucial pharmaceutical supplies. Moreover, issues with compounding pharmacies have restricted the possibility of second sourcing to first line pharmaceutical manufacturers. Food and Drug Administration (FDA) regulations may add many months or years to the wait for a replacement.

Total Parenteral Nutrition (TPN) is nutrition that is provided by vein and depends on the availability of a large number of varied pharmaceutical supplies. Most Neonatal Intensive Care Units have had to weather shortages of vitamins, iron, trace elements, electrolytes, protein, and even glucose during the past several years. Sometimes one set of electrolytes can be substituted for another, but glucose, protein, vitamins, and trace elements are essential to provide nutrition to babies who cannot tolerate traditional feeds. If a baby is TPN dependent for a long period of time, these shortages can be life threatening.

We must send a message to those change agents that the needs of our babies must be given the highest priority in this new paradigm for healthcare delivery, or watch helplessly as our preterm and other at risk babies are ravaged by nutritional deficiencies that have not been seen in the USA since the early 1900s.