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.

"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.

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."

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

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)

HEALTH & SCIENCE