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Committee on Government Reform and Oversight Subcommittee on Human Resources

Nancy Tarleton Landis

Public Health 2000: Immune Globulin Shortages: Causes and Cures 

Testimony Provided by Douglas Scheckelhoff on Behalf of
Children's National Medical Center

May 7, 1998

Good morning, Mr. Chairman, members of the Subcommittee, and guests. My name is Douglas Scheckelhoff. I am the Director of Pharmacy at the Children's National Medical Center here in Washington, DC. I truly appreciate the opportunity to come before this Subcommittee and testify on the impact of the intravenous immune globulin shortage. 

Our pharmacy is responsible for the purchase, preparation and dispensing of intravenous immune globulin (IVIG) products for the patients in our hospital. The normal process is that our buying group bids out the product, establishes the best possible contract price, we buy it though the established distributor as needed, and then prepare the product pursuant to a physician's order. 

There have been many withdrawals and recalls of blood products and resulting shortages over the last few years, but they have primarily been with albumin. This has often resulted in higher prices and difficulty in obtaining an adequate supply. 

In 1997, we began seeing a larger number of withdrawals and recalls of blood products that included not only albumin but other blood products as well. We specifically began experiencing supply problems with immune globulin in the fall of last year. Our normal contracted manufacturers were not able to consistently supply product, which put us in the situation of trying to find product through alternate sources. 

When the normal distribution channels are exhausted, we have to turn to a group of companies that act as "specialty distributors." These companies typically only sell blood products like albumin, immune globulins, or antihemophilic factors and frequently are the only place to turn when the manufacturers have no product. There appears to be more and more specialty distributors as the blood product shortage has grown. These distributors have brand name products - usually on a sporadic basis - that they sell at significantly higher prices than the distributors we pay under contract. 

Our usual contract price with a manufacturer is $20 to $25 per gram of immune globulin, but since the shortage we commonly pay specialty distributors $40 to $50 per gram. When supply was extremely short, we paid as much as $85 per gram in some situations after making 12 to 15 phone calls with manufacturers, wholesalers, and any other supplier that would otherwise stock the product. We simply have no other options. We had to have a supply of this lifesaving product that has few therapeutic alternatives. 

Sometimes these specialty distributors "bundle" other products with immune globulin purchases. For example, they will sell you the immune globulin, but you must also buy a certain quantity of their albumin at a higher than normal price even though you may not need it. 

We now spend an average 6 to 8 hours per week of pharmacist and technician time trying to obtain immune globulins and control our very limited stock. Our doses are typically anywhere from a low of about 20 grams to well over 100 grams, usually based on the weight of the patient. On a good week we have 200 or 300 grams of product and could accommodate 3 or 4 patient's doses. When our supply drops below 100 grams, our situation becomes critical and our staff spend countless hours trying to obtain product, reluctantly paying high prices to avoid putting the patient at risk. 

We have had some luck in the last few weeks with some of the manufacturers. One in particular, has been able to supply product on an emergency basis, one dose at a time. So when we have a need, we contact the company, give the prescribers name and indication for use, and they ship us enough for that one dose and at our contracted price. This buys us time until the next dose is needed. 

By investing time, energy, and money, we have been fortunate and have not adversely affected patient care up to this point. When our supply is low, we notify all our physicians so that they can consider delaying elective use of immune globulins until we again have product. We have also been in the situation where we have rescheduled outpatient appointments to a time when we have adequate supply. They can also consider therapeutic alternatives, which in a few cases may exist. When we do get an order, our pharmacist contacts the prescriber, and they work through the most appropriate dose that will be therapeutically effective while allowing us to conserve our limited supply. 

We look forward to the subcommittee developing solutions to this important public health problem. Thank you for the opportunity to address this distinguished group. 

Douglas Scheckelhoff, M.S., R.Ph.
Director of Pharmacy
Children's National Medical Center
Washington, DC
(Contact Johnnie Hemphill at 202-884-4930)