- The Food and Drug Administration tracked more new drug shortages in 2017 than in either of the two years previous, as disruptions from a damaging hurricane season and production issues at a Kansas plant run by Pfizer interrupted supply of 39 drugs.
- While that figure was 50% higher than the 26 reported in 2016, newly occurring drug shortages have declined sharply since 2011, when 251 instances of constrained supply cropped up. That drop is due in part to outreach by the FDA, which helped prevent 145 shortages last year.
- In particular, supplies of saline fluid for intravenous infusion ran dangerously low after Baxter Healthcare, a major manufacturer, was hit hard by the impact of Hurricane Maria in Puerto Rico.
Shortages of medications can cause problems for providers and patients alike. Patients may run out of critical drugs, affecting their health, while physicians may be forced to ration drugs or spend time on sourcing supplies or finding alternatives.
The FDA has made resolving these supply constraints a priority and, by some measure, it's had success. The number of drugs in continuing shortage fell to 41 last year, down from 48 the year before and nearly 100 in 2013.
But, more new instances of shortage emerged than has in years past, and supplies of several crucial drugs remained constrained into 2018.
"While many of the shortages that occurred in 2017 have been resolved, unfortunately there are some that we are still working with companies to resolve," said Douglas Throckmorton, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, in a statement.
The FDA worked with Baxter after the hurricane affected the company's manufacturing on the island, temporarily granting a license to import IV supplies from other countries, as well as expediting review of product applications to add extra capacity to the market.
But hospitals still faced problems getting hold of IV fluids last year, which meant more work for healthcare professionals, such as having to dose drugs using syringes rather than drips. The shortages appear to beginning to resolve, with new supply from other companies helping to augment continuing temporary imports.
Production delays and manufacturing quality issues, on the other hand, led to shortages of injectable opioid analgesics produced by Pfizer at its troubled McPherson, Kansas-based facility.
Pfizer's woes have also played a role in the shortage of EpiPens, which are sold by Mylan. A Pfizer subsidiary called Meridian Medical Technologies supplies Mylan with the autoinjected epinephrine, but was hit with an FDA warning letter last fall. The FDA expects the shortage to be short-lived, however.