Flu Vaccine Tip of Drug Shortage

Last Editorial Review: 10/8/2004

Ongoing drug shortages are having far-ranging, negative effects on patient care and on health costs in the US, according to the American Society of Health-System Pharmacists (ASHP). As ASHP pharmacist David Witmer put it, "Because of shortages, pharmacists must select and purchase substitute products as well as determine proper dosing regimens, modify drug-use policies and procedures, educate various health care personnel, and restock the supplies through the facility. All of these extra steps increase risk and add unnecessary costs to the heath system."

Now the US has another disastrous drug shortage to contend with -- the flu vaccine. Chiron Corp. announced this week that it will be unable to supply flu vaccine to the US for the 2004-05 flu season, creating an instant and severe vaccine shortage just as the flu season begins.

Comment: This is a very bad situation in a country that considers itself a world leader. The flu vaccine problem is clearly just the tip of the iceberg. Just under it looms the vulnerable supplies of all vaccines used in the US. And beneath the vaccines is a massive mess with other drugs.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com

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Drug Shortages Negatively Affect Patient Safety, Costs of Care

Pharmacy Directors in U.S. Hospitals Agree that Shortages have Compromised Patient Care

BETHESDA, MD, 27 September 2004 - A study published in the October 1, 2004, issue of the American Journal of Health-System Pharmacy finds that ongoing drug shortages are having far-ranging, negative effects on patient care and hospital costs.

The survey, which is the first formal research to gauge the effect of drug shortages on patient care, polled close to 1,500 pharmacy directors in U.S. health systems. The study revealed that 95 percent of respondents believe shortages have created roadblocks and hurdles for treating patients with the best medication. Sixty-one percent believe the scarcity of certain drugs has compromised patient care. The survey was conducted by the American Society of Health-System Pharmacists (ASHP) and pharmacy residents at Johns Hopkins Hospital, Baltimore, in March 2003.

"Patients are at risk when a needed drug is not available or when health care providers must work with substitute medications," said Henri R. Manasse, Jr., Ph.D., Sc.D., ASHP executive vice president and CEO. "This public health issue must be addressed."

Pharmacy directors reported that drug shortages have affected patients in a number of ways, including contributing to the delay or cancellation of certain medical procedures, prolonged patient stays in hospitals, and serious medication errors.

Shortages have also affected drug prices as pharmacists are forced to buy the same product at higher than contracted prices or more-expensive alternative products in the same therapeutic class. Survey respondents reported that shortages force their hospitals to spend an annual average of $20,000 more in incremental drug purchasing costs. On a national level, this extrapolates to $99,260,000 in additional costs to the U.S. health care system each year. These figures do not take into account the significant personnel time required to manage shortages.

"Drug shortages have been a fact of life in our hospitals and health systems for almost a decade," said study co-author David R. Witmer, Pharm.D., ASHP's vice president of member services. "Because of shortages, pharmacists must select and purchase substitute products as well as determine proper dosing regimens, modify drug-use policies and procedures, educate various health care personnel, and restock the supplies through the facility. All of these extra steps increase risk and add unnecessary costs to the health system."

According to the survey, pharmacists are spending more time managing shortages, including tracking product availability; identifying therapeutic alternatives; contracting with vendors, manufacturers, and group purchasing organizations to buy therapeutic alternatives; and preparing written communications and training other health care providers on using other medications.

ASHP has worked for years to help health-system pharmacists deal with the problem of drug shortages, including launching a Drug Shortages Resource Center (www.ashp.org/shortage) that provides timely reports on medications in short supply as well as their therapeutic alternatives. Eighty-six percent of survey respondents reported using the information provided by the center.

The Society co-sponsored a conference with the American Medical Association in 2002 to identify solutions to the endemic problems that cause shortages in the U.S. pharmaceutical supply chain. In addition, ASHP has developed guidelines for managing drug product shortages. The Society also has adopted a policy position urging the Food and Drug Administration to broaden its term of "medically necessary" drugs so that manufacturers would be required to provide notification of discontinuations for a broader array of products.

For more information on the report, "National Survey of the Impact of Drug Shortages in Acute Care Hospitals," gotohttp://www.ashp.org/public/pubs/ajhp/showFile.cfm?cfid=2883648&CFToken=30948868&id=2072

For more than 60 years, ASHP has helped pharmacists who practice in hospitals and health systems improve medication use and enhance patient safety. The Society's 30,000 members include pharmacists and pharmacy technicians who practice in inpatient, outpatient, home-care, and long-term-care settings, as well as pharmacy students. For more information about the wide array of ASHP activities and the many ways in which pharmacists help people make the best use of medicines, visit ASHP's Web site, www.ashp.org, or its consumer Web site, www.SafeMedication.com.

Source: American Society of Health-Systems Pharmacists press release, September 27, 2004 (www.ashp.org)

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