WASHINGTON, April 16 /PRNewswire/ -- A critical shortage of anesthetic
drugs, which led to a fact-finding meeting of doctors, pharmacists and
manufacturing representatives today in Washington, D.C., may be just a symptom
of a larger problem with a U.S. health care system that is sick.
At the meeting chaired by the American Society of Anesthesiologists Vice-
President for Scientific Affairs Bruce F. Cullen, M.D., there was frank
discussion between representatives of the Food and Drug Administration (FDA),
the American Hospital Association, drug manufacturers and hospital pharmacists
in an attempt to build consensus on how to prevent, or at least prepare for,
shortages in the future.
At the meeting's conclusion, Lisa Hubbard of the FDA's Center for Drug
Evaluation and Research noted that FDA officials would consider convening a
public meeting of all stakeholders as quickly as possible. All participants
agreed to the merit of this idea.
"This is a multifaceted problem that is being influenced up and down the
chain," Dr. Cullen said. "But as one participant noted, it's no longer a
chain. It's a steel bar because there is no flexibility anymore."
Dr. Cullen explained that manufacturers may get their products' raw
materials from foreign countries, which could be affected by floods, drought
or even war. Distribution of each product also is a part of the process and
may include dealing with a "gray-market" of secondary distributors. On the
hospital level, hospital administrators must follow mandates set by managed
care or conglomerate health systems to buy less expensive product and to carry
This in turn leaves hospital pharmacies to deal with short supplies and to
bring such problems to the attention of the FDA and the manufacturers. It is
the end user, the doctors and their patients, who become tangled in this
complicated web, Dr. Cullen said.
"The current system of drug production in this country, from manufacturer
to distributor to user, no longer has the ability to readily pick up slack
from other areas when faced with a product crisis," Dr. Cullen said. "Our
health system is sick."
Dr. Cullen said the meeting did give him hope that solutions can be found.
"We just need to come up with basic principles and policies that we all can
agree upon," he said. For example, if manufacturers would notify the FDA
before discontinuing certain drugs, the medical and pharmaceutical communities
can prepare themselves for dealing with a shortage rather than reacting to a
crisis, Dr. Cullen said.
Right now, there is no mandate to contact the FDA, unless the manufacturer
is the sole producer of a closely defined "medically necessary" product.
Thus, a sudden drop in production by just one leading company can create an
over-demand on the other companies making the product, he said.
The shortages of several critical anesthesia drugs were reflected in a
series of three informal surveys conducted by ASA in recent months. The most
recent survey of anesthesiologists nationwide on April 11 shows that two-
thirds are still experiencing shortages of the painkiller fentanyl, the muscle
relaxant succinylcholine, the narcotic reversal agent naloxone and the anti-
inflammatory drug dexamethoxone used to limit tissue swelling during surgery,
Dr. Cullen said.
"ASA is proud to have spearheaded this movement from the physician's
viewpoint, but it doesn't end here," Dr. Cullen said. "We have taken the
first step toward addressing a problem that needs to be resolved for the sake
of safe patient care in all settings."
The American Society of Anesthesiologists (ASA) represents more than
36,000 physicians dedicated to patient safety and quality medical care.
Founded in 1905, ASA is a scientific and educational association of
anesthesiologists that was organized to advance the practice of anesthesiology
and to improve the quality of care of the anesthetized patient. It is the
largest organization of anesthesiologists in the world.
LIST OF MEETING PARTICIPANTS:
Lisa Hubbard, FDA
Bruce F. Cullen, M.D., ASA Vice-President for Scientific Affairs
Joseph H. Deffenbaugh and Gary Stein, American Society of Health-System
Roslyn Schulman and Anne Berdahl, American Hospital Association
Bert Spilker, Ph.D., M.D., Pharmaceutical Research and Manufacturers of
Sean J. Gallagher, Organon Inc.
SOURCE American Society of Anesthesiologists