Changes sought to combat drug, vaccine shortages
Flu vaccine delays and shortages of drugs and diagnostic agents are
triggering calls for changes in distribution and more public health system
involvement.
By
Victoria Stagg Elliott, AMNews staff. Dec. 24/31, 2001.
Additional information
San Francisco -- It was the flu season without vaccine. Doctors, if
they could place an order, were quoted double and triple prices, and then
the vaccine arrived late, or not at all.
There were offers of the vaccine for $200 per vial, 10 times the
regular price, cash, to be delivered at night.
And grocery stores vaccinated thousands of healthy individuals, while
physicians couldn't get any vaccine for their sickest patients.
That was the flu season of 2000. And it wasn't supposed to happen
again. But the resulting steps taken to prevent its repeat have focused
additional attention on other difficulties with the pharmaceutical
pipeline. More often, physicians are facing shortages of several everyday
drugs and diagnostics -- and asking for solutions to what is increasingly
being viewed as a systemic problem.
It is in regard to flu shot supplies, though, that the discourse began.
In the past year, the AMA, other medical societies and government
agencies such as the Centers for Disease Control and Prevention have met
with a wide range of stakeholders -- including drug manufacturers and mass
vaccinators.
One flu vaccine distributor still has lots of supply, but no demand.
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"We remember last year all too well," said AMA Trustee Ronald Davis,
MD. "We believe we've made significant progress in improving the
situation."
AMA staff received fewer phone calls this year from physicians
complaining about the flu vaccine situation. Some doctors even received
the vaccine they ordered as early as September. By year's end,
manufacturers had made 87 million doses available, 12 million more than
last year.
But for many physicians, it still was not enough.
"The only thing different this year is better communication," said
Ronald Bangasser, MD, medical director of Beaver Medical Group in
Redlands, Calif., during a hearing at the AMA Interim Meeting. "Otherwise,
it's the same. One of the reasons there aren't as many phone calls is
because a lot of physicians in California have just given up trying to get
the vaccine. Because of the price-gouging, they just say they're not going
to do it."
For those doctors, it has been another season marred by difficulty in
even placing orders, by being quoted much higher prices than last year,
and by waiting for a supply that didn't arrive when expected. And while
some retail outlets and other mass vaccinators signed agreements with
local medical societies and public health agencies to provide flu shots to
high-risk individuals in accordance with CDC guidelines, many did not.
"It's the same as last year in our area," said Morton Kurtz, MD, a
general practitioner from Flushing, N.Y., whose vaccine arrived at the end
of November. "We demand a rectification of the system."
Other vaccines, drugs and agents are in short supply.
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Dr. Davis concedes that significant problems remain, and the AMA
intends to keep working with the government on the flu vaccine issue.
But that's just one item that's difficult to come by.
The tetanus vaccine has been in short supply for the past year, and
there have been reports of hepatitis B vaccine shortages. In addition,
several vital drugs and diagnostic agents have been scarce. Physicians
complain that chemicals used in gallbladder scans have been disappearing
from the shelves and have not been restocked. The blue dye used in
sentinel lymph node biopsies after breast cancer surgery is not available
in some areas. And even some of the most basic items are sometimes hard to
find.
"There's no shortage of Cipro or Viagra, but you can't get penicillin,"
said George Green, MD, an allergist from Abington, Pa.
A systemwide approach?
Because of this, many physicians are advocating a more system-wide
approach, which would address all the current shortages of drugs, vaccines
and diagnostic agents they need.
"We really need a systematic interdepartmental public-private
partnership to address everything from manufacturing to sales and
distribution," said Michael Parkinson, MD, a preventive medicine
specialist from Alexandria, Va. "We can't do it vaccine by vaccine. We
need an overarching approach."
The FDA, for example, monitors drug shortages, but not diagnostic
agents. The agency also has little influence if the drugs are useful but
not determined to be crucial and it has no early warning system.
"The U.S. Dept. of Agriculture monitors how many soybeans, oats and
corn are planted in this country. I'm not sure why we can't keep track of
how much tetanus toxoid has been produced," said Paul Wertsch, MD, a
family physician from Madison, Wis. "Let it be known, so the free market
can act."
But some say that the free market is the problem and call for more
public-sector involvement.
"We need to ask the government to take a more active role, not only in
recommendation of what needs to be done, but in terms of purchasing if
necessary, organization and a variety of other things," said Jonathan B.
Weisbuch, MD, a public health physician from Phoenix.
Many experts feel, however, that this would not be practical and point
out that this year's flu season is better, albeit far from perfect.
Despite delays and what some feel to be maldistribution, most
physicians should have received their vaccine. Still, it appears that some
of the supply may go unused.
Henry Schein Inc., the largest vaccine distributor in the United
States, already has delivered 16 million doses to customers, but has
another 2.5 million doses sitting in a warehouse. The firm has alerted
regular customers to the stock's existence but has no takers. Officials
are trying to donate it.
"The CDC recommendations say shots can be given in December and beyond,
but we don't have any real buyers for the flu vaccine," said Michael
Racioppi, RPh, president of Henry Schein's Medical Group. "There are still
a lot of doctors out there who believe once you hit Thanksgiving, why
bother."
Last year, the CDC bought 9 million doses to distribute late in the
season, but they went unused. In years without distribution problems,
manufacturers have reported that too much of their stock never leaves the
warehouse. Because the vaccine changes every year, it is then useless.
Many experts believe that for the flu vaccine situation to improve, the
product must be commercially viable.
"The FDA needs to get more manufacturers interested in producing the
flu vaccine," Racioppi said. "But if you're going to be a manufacturer and
be stuck with 10% of what you make, you probably won't be interested in
expanding capacity."
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ADDITIONAL INFORMATION:
Problems in the pipeline
The House of Delegates adopted a series of new policies addressing
vaccine, diagnostic agent and drug shortages, calling on the Association
to:
- Ask the Health and Human Services Secretary to establish a task
force to explore causes of shortages or maldistribution and find
solutions.
- Work with the Food and Drug Administration to educate physicians
about reporting potential shortages.
- Work with the FDA to expand its list of medically necessary products
to include vaccines and diagnostic agents.
- Urge the FDA to monitor production, inventory and planned cessation
of production of medically necessary items.
- Support adequate FDA funding.
- Work with government agencies and other medical societies to
determine the feasibility of establishing a communication system to
provide early warnings of shortages.
- Report back at the 2002 Annual Meeting about the current situation.
Source: AMA Interim Meeting, December
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Weblink
FDA drug shortage
list (http://www.fda.gov/cder/drug/shortages/)
CDC flu season page (http://www.cdc.gov/nip/flu/)
AMA
flu season page (http://www.ama-assn.org/ama/pub/article/1826-4907.html)
AMA
Interim Meeting program (http://www.ama-assn.org/ama/pub/category/6068.html)
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Copyright 2001 American Medical
Association. All rights reserved.
