|Drug shortages aren't 'coming,' they're already here.
What APC and its partners anticipated in a March 27 letter to FDA - that many OTC and prescription drugs used in the treatment of COVID-19 were soon to go into shortage - has become a reality. Health systems have been hit hardest by the shortages of drugs used to place patients on ventilators. It's likely the shortages will only get worse.
For its part, FDA has in the past week added Midazolam and a version of Fentanyl, as well as the untested-but-highly-talked-about drug Hydroxychloroquine, to its
. But the agency's actions thus far are not sufficient to the growing need.
Pharmacy compounders can help meet this need if FDA will allow it.
This week APC wrote to FDA's CDER Director Gail Bormel to reiterate our request in last week's letter to FDA asking that the agency immediately issue guidance providing enforcement discretion for pharmacists to compound products that are "essentially a copy" of an FDA-approved drug that FDA identifies may be or is anticipated to be, in shortage during this public health emergency.
We also provided additional documentation of the urgent need of hospitals across the country, and urged FDA to immediately announce it will "exercise enforcement discretion on the compounding of critical medications needed by hospitals and physician practices for office administration in the treatment of COVID-19 patients during this public health emergency
when the drug is unavailable either in FDA-approved form or from an outsourcing facility and noted as such on the drug order. This could be done with the approval of state boards of pharmacy and other state health officials as needed to respond to the situation on the ground."
"FDA has acknowledged receipt of the communication," said APC President Shawn Hodges, "So for now we wait - and pull our hair out with frustration because compounders saw this coming. Had our requests to FDA been heeded, we could have been positioned two weeks ago to meet this great need. Once again, compounders are standing on the sidelines, ready to serve our patients during a crisis, waiting for the FDA."