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Critical shortages of drugs essential to surviving on a ventilator: fentanyl, succinylcholine, propofol all are low already. What will our government do about this problem?

2020-04-07

(photo courtesy of pixabay.com)

This morning I received an email from MPR (sorry, I couldn’t find what this is an abbreviation for) Daily Dose; as usual, these emails promote multiple articles about COVID-19.  Today, they reported on a letter written by the ASHP (American Society of Hospital Pharmacists; this is an educated guess).  The letter, which was dated April 1, is addressed to Vice President Pence (in his capacity as head of the White House COVID team?) and can be seen in a .pdf file here.

The Medscape web article reporting ASHP’s letter states:

Rather than basing supply on historical allocation, the organization is calling for an immediate increase in production to keep up with the rising demand prompted by the pandemic. With regard to controlled substances used for supportive care, the ASHP has requested that the Drug Enforcement Administration (DEA) increase annual production quota allocations of the most critical medications.

In addition, ASHP is asking the government to release drugs from the Strategic National Stockpile to states that have the greatest number of cases.

There are two aspects of this problem that particularly concern me.  The first is that some of these medications that are looming-shortage-prone exist under Schedule II from the Drug Enforcement Administration (DEA) and are subject to annual production quotas.  These quotas are narrowly tailored to prevent drug companies from making more than the government believes should be on the market to supply “legitimate needs” (that is, not available for use and abuse by those who “don’t really need them”).  These annual quotas are strict, to put it mildly, and utterly inadequate for such sudden crises as we are currently experiencing.  If past history is any guide, it will be supremely difficult to get these quotas increased, and without that, the supply of fentanyl (and certain other opioids) will run out very shortly.  If you try to intubate someone without fentanyl (or its equivalent) they will experience excruciating pain, even if they are paralyzed with a curare-like (eg, pancuronium, succinylcholine) drug (and the curare-like drugs are also on the soon-to-be shortage list).  Apparently, fentanyl and morphine have already been on the drug-shortage list for months before the current emergency.

The other aspect I am concerned about is the “immediate increase in production”.  As noted elsewhere, most of these drugs are manufactured overseas, in China, India, and other countries.  The primary active ingredients for synthesis of the drugs are produced in one place, shipped to another, and further processed elsewhere.  The drug industry is globalized, and just-in-time manufacturing practices have been fully utilized because of stiff price competition.  This means that, with just-in-time principles in place, there exist no large stocks of precursors available to soften sudden demand shocks when raising production quantities.  Globalization means that materials have to cross multiple borders, and shipping has already seen an impact from the pandemic which will only get worse.

See my next post for a discussion of the situation with hydroxychloroquine, which has been pushed by our Dear Leader as a “game changer” for the new virus.

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