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11/3/2000

ASHP Responds to Flu Vaccine Shortage

Kate Traynor

ASHP Executive Vice President and Chief Executive Officer Henri R. Manasse, Jr., today called on Secretary of Health and Human Services Donna E. Shalala and Surgeon General David Satcher to review the distribution of this season's flu vaccine.

Manasse's letter requests that federal agencies respond to two aspects of vaccine distribution. The first involves the effect of the shortage on high-risk populations and health care workers unable to receive the vaccine. The second involves the sudden appearance of alternative distributors selling the vaccine at prices up to five times the prices listed in regular contracts.

In addition to Shalala and Satcher, ASHP wrote to Food and Drug Administration Commissioner Jane E. Henney and officials at the Centers for Disease Control and Prevention and the Federal Trade Commission.

November 3, 2000

 

The Honorable Donna E. Shalala
Secretary
Department of Health & Human Services
200 Independence Avenue, N.W.
Washington, DC 20201

Dear Secretary Shalala:

On behalf of the American Society of Health-System Pharmacists (ASHP), I am writing to bring to your attention a deep public health concern of our members, namely, the current situation in the nation concerning the distribution of this season's flu vaccine. Our members are experiencing and observing questionable practices in response to the well-publicized shortage of influenza vaccine for this season. We believe that these practices should be reviewed by the appropriate federal agencies to mitigate threats of influenza outbreaks, especially in high-risk populations, and to determine if costs of care to this population are unnecessarily inflated. ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals (including outpatient services), health maintenance organizations, long-term care facilities, home care agencies, and other components of health care systems.

Hospitals and hospital-based skilled nursing facilities, ambulatory care clinics, and home care services that serve a predominantly high-risk population and have employees working in high-risk situations are not receiving any or only a small percentage of the quantities of influenza vaccine ordered from their primary sources. They are reporting that influenza vaccine injections are available to individuals at shopping malls, supermarkets, and other retail outlets in their communities without regard to the recommendations of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).

Specifically, we would like to request a review of two aspects of this shortage. One relates to the potential public health risk, because some segments of the nation’s health care system are not following the CDC/ACIP recommendations for use of the flu vaccine. We have heard, in particular, that elderly and chronically ill patients served by hospitals and skilled nursing facilities are unable to receive shipment of the vaccine that was ordered as early as last spring from normal suppliers.

The second aspect of our requested review involves the sudden availability of vaccine from alternative distributors with apparently ample supplies of vaccine at prices as high as five times the contract price of their usual suppliers. Because manufacturers appear to be selling vaccine to these alternative distributors, the normal distribution channel has been disrupted. Hospitals are reporting that they are succumbing to these solicitations by alternative distributors and ordering substantial quantities of vaccine to meet the needs of their patients and staff. They have noted that the products being received are from the same manufacturers that are not fulfilling orders placed directly by the hospital or the hospital’s purchasing group.

Additionally, our members are concerned that these alternative distributors have been able to obtain vaccine and resell it to a variety of health care professionals and providers without regard to the CDC/ACIP recommendations.

The following are specific concerns that we have heard from our members that we would like you to address:

One major hospital in Houston has not received any of its shipment ordered from a manufacturer through its normal supplier. Shipping dates have been constantly revised. Most recently, the hospital was informed that the FDA and CDC notified the manufacturer that it must reprioritize shipping and ship to nursing facilities first. Unfortunately, there is no priority shipping for hospitals with skilled nursing units. Please verify if the FDA and/or CDC have mandated priority shipping only to nursing facilities.

Another large health system in the suburban Chicago area has been informed by a manufacturer that a certain percentage of its allotment would be shipped. Those shipping dates were rescheduled at least three times. The local community does not understand why a small hospital nearby is able to obtain a vaccine supply but a large eight-hospital system cannot. The manufacturer has told this hospital system that it is waiting for FDA to release batches of vaccine. While ASHP understands the need to maintain good manufacturing processes, we wish to encourage release of batches as expeditiously as possible. Moreover, if vaccine product is not going to be available in sufficient quantity, what alternatives would FDA and CDC suggest?

We hope these representative examples of our members' experiences help you understand the magnitude of the problem. Also enclosed are copies of offers for flu vaccine from various alternative distributors. Finally, our members have begun to hear of reported flu cases across the country. Our members are becoming increasingly disturbed that individuals and organizations in the nation’s health system are not following the CDC/ACIP recommendations for vaccine distribution. Please let me know what your agency’s response is to address this looming public health crisis this winter.

Sincerely,

Henri R. Manasse, Jr., Ph.D., Sc.D.
Executive Vice President and CEO

Today's New York Times reported on the high prices hospitals have been asked to pay to obtain supplies of the flu vaccine. In the article, ASHP Professional Practice Associate Joseph H. Deffenbaugh, M.P.H., discussed the problems encountered by hospital pharmacists across the country.