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May 2001
Volume 65 |
Number 5
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ADMINISTRATIVE UPDATE
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| Anesthetic
Drug Shortages: What’s Going On? |
Bruce F. Cullen, M.D.
Vice-President for Scientific Affairs
Without advanced warning, it appears that anesthesiologists are
now confronting shortages of several important and frequently
used anesthetic drugs. Lack of ready availability of drugs has
hit other sectors of the medical community in the past couple
of years, with some well-publicized shortages such as tetanus
vaccine or penicillin G, but anesthesiology seemed to be unaffected.
Now, however, anesthesiologists and hospitals throughout the country
are finding it difficult to stock such drugs as fentanyl, succinylcholine
and naloxone.
The problem hit home at my hospital one day when our supply of
succinylcholine in the operating room was reduced to one vial.
We had already experienced intermittent shortages of fentanyl
but were able to get by with alternate opioids. There is not,
however, any good alternative to succinylcholine. Our hospital
is a level I trauma center, and it is our opinion that succinylcholine
substitutes are neither as safe nor as effective in that setting.
Furthermore, rapacuronium, a drug touted by some as the alternative
choice to succinylcholine, was also on backorder*. Through a few
telephone calls to some personal friends in the pharmaceutical
industry, we were able to avert a crisis, after a shipment of
succinylcholine was sent by airfreight to us the next day. [It
should be noted here that Raplon™ (rapacuronium) has recently
been withdrawn from the market by its maker, Organon, due to a
high incidence of life-threatening bronchospasm, which resulted
in a few deaths.]
No one can accurately identify the extent of the shortages or
provide ready explanations. In November and again in February,
ASA sent out an informal survey to its officers and district directors
asking them whether or not they had experienced anesthetic drug
shortages, what drugs were involved, whether the situation was
critical and how it was affecting patient care. Forty-eight individuals
responded to the survey, and 35 of them (73 percent) had observed
a noticeable or critical shortage of common anesthetic drugs,
most notably fentanyl and succinylcholine. Other drugs mentioned
as being in short supply included rapacuronium, sufentanil, oxycodone,
oxymorphone, hyaluronidase, isoproterenol, naloxone, glycopyrrolate
and even epinephrine. As might be anticipated with such a wide
range of involved drugs, the shortages could not be attributed
to one or two pharmaceutical manufacturers. No one surveyed mentioned
knowing of any patient harm resulting from the drug shortage,
although several reported that the shortages had impacted their
facility's surgical schedule.
It would be nice if one central source of information existed
that could monitor drug production and provide some sort of control
to avert critical shortages. Unfortunately, one does not exist.
The Food and Drug Administration (FDA) maintains a Web site www.fda.gov/cder/drug/shortages/default.htm,
but it is not wholly accurate. For example, fentanyl is the only
anesthetic drug mentioned to be in short supply, and the shortage
is attributed to an irrational unexpected increased demand. Furthermore,
the FDA does not have legal authority to dictate drug production
and inventory. The American Society of Health-System Pharmacists
posts an interesting Web site of drug shortages www.ashp.com/shortage/,
but it also has no regulatory authority. The organization representing
the pharmaceutical industry, the Pharmaceutical Research and Manufacturers
of America (PhRMA), does not even mention drug shortages on its
Web site www.pharma.org.
There appears to be no clear, single answer to explain the relatively
recent onset of critical anesthetic drug shortages. Some manufacturers
attribute it to problems in obtaining raw materials and difficulties
in the production process. Others attribute it to the FDA's closing
of some manufacturers for bad practices and an inability of the
remaining producers to meet the resulting shortfall. In an era
of major cost cutting in medicine, it is common protocol for hospitals,
drug distributors and drug manufacturers to keep their in-house
inventories low. Some cynics point out that most of the shortage
drugs are generic and that poor profit margins cause manufacturers
to produce the generic drugs in limited quantities so they can
concentrate their efforts on more lucrative proprietary drugs.
So where do we go from here? ASA has taken two actions. First,
it has informed the media of the crisis in an attempt to educate
the public. Second, ASA has taken the lead and has asked representatives
from the FDA, PhRMA, the Drug Enforcement Administration (DEA)
and four major anesthetic drug manufacturers to get together for
a discussion of the issues. The purpose is to get those interested
in the problem at the same table, with a goal of developing both
short- and long-term solutions to the problem. Unfortunately,
that meeting is not scheduled to occur until after the deadline
for submission of this article. Hopefully by the time you read
this, we will have some answers.
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