Drug Shortages Point to Larger Health System Problems; Group Urges FDA to Hold Public Meeting to Address Concerns

Apr 16, 2001, 01:00 ET from American Society of Anesthesiologists

    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
 minimum inventory.
     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.
     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