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May 2002
Volume 66 |
Number 5
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| DRUG SHORTAGE:
Injectable Corticosteroid Product in Short Supply |
Almost exactly one year after dealing with a severe shortage of
fentanyl, ASA members who practice pain medicine have now reported
growing shortages of methylprednisolone (Depo-Medrol™, Pharmacia),
a long-acting, injectable corticosteroid suspension administered
epidurally to control chronic and severe low back pain.
Bruce F. Cullen, M.D., Vice-President for Scientific Affairs,
recently learned that the U.S. Food and Drug Administration (FDA)
is aware of the newest shortage concerns and is working with the
manufacturer to improve production and distribution. The FDA has
advised ASA that it expects adequate supplies of the product to
be available by late May.
Currently reported in short supply is methylprednisolone acetate
20, 40 and 80 mg/mL suspension for injection in 1 mL, 5 mL and
10 mL vials. Pharmacia Customer Service reports that the product
is on nationwide back order due to manufacturing problems. Also
reported on nationwide back order is triamcinolone hexacetonide
(Aristrospan™, Fujisawa) and reported in short supply of
some vial sizes is trimcinolone acetonide (Kenalog-40™, Squibb).
Because some preparations contain benzyl alcohol as a preservative,
they are not suitable alternatives for epidural use.
Dr. Cullen said drug shortages are not a problem limited to the
practice of anesthesiology. For the past few years, physicians
all over the country have been experiencing a variety of drug
shortages, including the well-publicized shortages of immunization
products. After a particularly acute shortage of fentanyl, succinyulcholine
and naloxone last year, ASA convened a meeting of representatives
of the FDA, the Pharmaceutical Research and Manufacturers of America,
the American Hospital Association and the American Society of
Health-System Pharmacists (ASHP) on April 16, 2001, in Washington,
D.C.
Discussion at the meeting revealed that such drug shortages are
a multifactorial problem and that no single entity, governmental
or private, has either the power or resources to immediately address
or fix the problem. ASA is seeking a follow-up meeting with FDA
officials.
Dr. Cullen is suggesting that ASA members who are experiencing
serious shortages of these or other medically necessary drugs
should contact the FDA Center for Drug Evaluation and Research
(CDER) by e-mail < drugshortages@cder.fda.gov
> or call CDER Drug Information at (888) INFOFDA or (301) 827-4570.
Periodic updates on drug shortages are also posted to the CDER
Web site at < http://www.fda.gov/cder/drug/shortages/
>.
Regular drug shortage updates also are posted on the Web site
of the American Society of Health-System Pharmacists, Drug Product
Shortages Management Resource Center, Bethesda, Maryland, at <
www.ashp.org/ shortage
>. To contact Pharmacia Customer Service for updates, call 1-800-821-7000.
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