OR WAIT 15 SECS
The letter asks the vice president to increase manufacturing of these medications based on current projections of critical care patient volume.
Last week, in a letter to Vice President Pence, ASHP Chief Executive Officer Paul W. Abramowitz, PharmD, requested that the Administration initiate significant increases in manufacturing of supportive medications critical to ventilating and treating patients with severe COVID-19.1
In the letter, Abramowitz explained that, although ASHP is grateful for the action the Administration has taken to provide hospitals with necessary personal protective equipment and ventilators, they “will be rendered useless without an adequate supply of the medications…that must administered concomitantly with mechanical ventilation in critically ill patients…to ensure the successful use of this life-saving supportive care.”1
Medications used in conjunction with ventilator include opioids (eg fentanyl, morphine hydromorphone), sedatives (eg midazolam, propofol), and paralytics (eg pancuronium, rocuronium, succinylcholine).1
This week, the Drug Enforcement Administration (DEA) announced it will take additional steps to allow for the increased production of controlled substances used in COVID-19 care.4
ASHP’s letter was sent last week, as the United States was entering peak rates of confirmed coronavirus cases. The US has surpassed 466,000 confirmed cases, 16,700 deaths, and 26,500 recoveries from the virus that causes COVID-19.2 NPR’s peak-projection-by-state tool suggested that New York, the state most acutely affected by the virus, peaked on April 9.3
ASHP’s letter elaborates that manufacturing rates of these medications should be based on current projections of critical care patient volume, not on historical allocations, which fail to address the current need.1
Abramowitz expressed his concern that, in the Department of Health & Human Services’ request for information regarding manufacturing capacity for critical drugs, these medications were designated Tier 2 importance. The letter asserts that “failure to treat these drugs as anything other than absolutely essential will render ventilators worthless and exact a heavy patient toll.”1
On April 7, the DEA announced that it will be increasing Aggregate Production Quotes available to pharmaceutical manufacturers for the production of controlled substance medication that are in high demand due to the pandemic. DEA will also approve increases in imports of medications necessary for patients on ventilators.4
“DEA is committed to ensuring an adequate and uninterrupted supply of critical medications during this public health emergency,” Acting Administrator Uttam Dhillon said in a statement.4 “This will ensure that manufacturers can increase production of these important drugs, should the need arise.”
1. Abramowitz PW. Shortages of Critical Medications for COVID-19 Patient Care. ASHP website. https://www.ashp.org/-/media/assets/advocacy-issues/docs/GRD-Letter-Pence-Supportive-Meds-Shortage.ashx?la=en&hash=CFC2A85F18B6BE2540836513C0300A93E3C24E7C. Published April 1, 2020. Accessed April 6, 2020.
2. Coronavirus Resource Center. Johns Hopkins University & Medicine website. https://coronavirus.jhu.edu/map.html. Accessed April 10, 2020.
3. McMinn S. Coronavirus State-By-State Projections: When Will Each State Peak? NPR. https://www.npr.org/sections/health-shots/2020/04/07/825479416/new-yorks-coronavirus-deaths-may-level-off-soon-when-might-your-state-s-peak#allstates. Published April 7, 2020. Accessed April 10, 2020.
4. DEA takes additional steps to allow increased production of controlled substances used in COVID-19 care. News Release. DEA; April 7, 2020. https://www.dea.gov/press-releases/2020/04/07/dea-takes-additional-steps-allow-increased-production-controlled. Accessed April 10, 2020.