From Our 2011 Archives
Survey: Hospital Drug Shortages Hurt Patient Care
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Hospital Pharmacists Must Divert Time From Patients in Order to Manage Drug Shortage Problems
By Kathleen Doheny
Reviewed by Laura J. Martin, MD
July 14, 2011-- Hospital drug shortages cost hospitals millions each year and may adversely affect patient care, according to a new survey.
''Drug shortages are essentially touching health care systems across the board," says researcher Burgunda V. Sweet, PharmD, director of the drug information and medication use policy at the University of Michigan Health System, Ann Arbor.
She surveyed hospital pharmacy directors nationwide, asking how the growing problem of drug shortages has affected them and the patients.
The report is published online in the American Journal of Health-System Pharmacists.
The pharmacists' survey was released at the same time as a survey by the American Hospital Association, which found similar problems. The American Hospital Association survey found that 99.5% of the 820 hospitals responding had had one or more drug shortages in the last six months. As a result, 82% of hospitals said they delayed patient treatment.
Survey of Pharmacists
Sweet and colleagues sent an online survey to 1,322 members of the American Society of Health-System Pharmacists, which publishes the journal.
All were directors of pharmacy. The directors were asked to identify which of the 30 most recent drug shortages had affected their health system.
They were asked to tell what they did to manage the shortage. They also estimated staff time needed to solve the problem and calculated labor costs due to the shortages.
In all, 353 responded. Among the findings:
"Compared to six or seven years ago, the time they spend has tripled," says Cynthia Reilly, RPh, director of practice development division at the American Society of Health-System Pharmacists. She is a co-author on the study.
"Pharmacists and other health care providers who should be providing care to patients are being diverted," she tells WebMD.
More than 80% of the respondents had a shortage with three different drugs, including:
In 2010, the number of drug shortages totaled 211, the researchers say, citing data from the University of Utah. It is the highest number recorded in a single year. In 2007, there were 120 drug shortages. The FDA tally for 2010 is slightly lower, at 178.
Why Drug Shortages Occur
According to the FDA web site, many shortages involve older, sterile injectable drugs.
The shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, and drugs needed for emergency medicine.
The manufacture of sterile injectable drugs is particularly complex, according to the FDA. That is because there are multiple steps in the process. So it increases the things that can go wrong.
Shortages also occur due to discontinuation of drugs, according to the FDA.
The FDA works with a company when shortage issues involve quality or manufacturing. However, a company does not have to notify FDA of shortages.
A company does need to notify the FDA of their plan to discontinue a drug six months in advance if it is medically necessary and it is the sole source.
Proposed Legislation on Drug Shortages
In February, proposed legislation known as the Preserving Access to Life-Saving Medications Act was introduced.
It proposes to give the FDA new power to work with shortages. It would require manufacturers to report to the FDA if a shortage is expected, among other measures.
The bill has been referred to the Senate Health, Education, Labor and Pension Committee, according to Linden Zakula, a spokesperson for Sen. Amy Klobuchar, D-Minn. She introduced it with Sen. Bob Casey, D-Pa.
Kate Connors, a spokeswoman for the Pharmaceutical Research and Manufacturers of America (PhRMA), says the industry group would not comment on pending legislation.
In a news release, PhRMA Deputy Vice President Karl Uhlendorf says many factors can contribute to drug shortages. These include natural disasters, shortages of raw material, and decisions to discontinue medicines.
He says the group's member companies work with the FDA when shortages occur.
SOURCES: Kaakeh, R. American Journal of Health-System Pharmacists, published online July 12, 2011.Burgunda V.Sweet, PharmD, director, drug information and medication use policy, University of Michigan Health System, Ann Arbor.Cynthia Reilly, RPh, director, practice development division, American Society of Health-System Pharmacists.Linden Zakula, spokesperson, Sen. Amy Klobuchar, D-Minn.News release, Pharmaceutical Research and Manufacturers of America.Kate Connors, spokeswoman, Pharmaceutical Research and Manufacturers of America. ©2011 WebMD, LLC. All Rights Reserved.
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