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February 06, 2012
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Drug Litigation News

 

Study Shows Lag Time in Reporting Drug Withdrawal Decisions to Healthcare Professionals

Charlottesville, Va., May 23, 2006—Only two of 15 drug data bases used by healthcare providers reported the recall of an often prescribed pain killer on the same day that the recall was announced. So says research completed by a team of physicians at the University of Virginia Health System and Tufts University School of Medicine. Their results appear in the May issue of the Journal of the American Medical Informatics Association.  By now most people know that the once popular painkiller Vioxx was recalled because of an increased risk of heart attack in people who took the drug. Bextra, also known as valdecoxib, belongs to the same family of Cox-2 inhibitors and also was withdrawn several months after Vioxx. Separate research recently reported that drugs like these increased the risk of heart attack within the first two weeks of taking them, making the need for doctors to inform patients all the more urgent.

“We were quite surprised by our results,” said Dr. Scott Strayer, assistant professor of family medicine at UVa Health System and lead researcher for the study. “It took the large institutional databases such as Lippincott’s an average of 109 days to update this type of information.”  Strayer, along with colleagues Dr. David Slawson, professor of family medicine at UVa, and Allen Shaughnessy, PharmD, adjunct professor of public health and community medicine at Tufts University School of Medicine, studied 15 drug reference and warning databases for several months after the recall of valdecoxib. The team monitored the databases for the first two weeks after the withdrawal of valdecoxib, weekly for the next month and then every two weeks up until the publication of their research. They developed a curve to illustrate the rise in the number of days it took to update information among the different databases. Only two sources reported the withdrawal on the day of its occurrence. They were Epocrates and MedScape Drug Reference. Several other sources including Lexi-comp and Tarascon updated their information within four days. When this study was published, PeerView Press had not yet been updated.

While pharmacies cannot dispense withdrawn medication, the study discusses how being prescribed a recalled medication may be disconcerting for patients on the receiving end.  Additionally, databases that do not update drug withdrawals in a timely manner are likely to be missing other important information such as new indications, significant interactions and new “black box” warnings that warn of potentially harmful effects of the drugs.  Currently, this type of information is sent to clinicians via postal mail. “As the prevalence of prescription medicines grows coupled with information that changes daily, it is very important that there be a coordinated warning and reference system for prescription awareness,” Strayer adds. In the meantime, Strayer and his research team are developing methodology that could be used to evaluate all clinical drug information tools and other clinical information tools for their effectiveness and accuracy. The ones that will score well will update information on a daily basis and will warn of important changes, like recalls, Strayer said.

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Did You Know?    
 
 
Many over the counter drugs were once prescription drugs
Americans buy about 5 billion over-the-counter drugs each year, according to government estimates, to treat their headaches, heartburn, coughs and colds, and other routine health problems. According to the Consumer Healthcare Products Association, a trade

 


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Study Shows Lag Time
Study Shows Lag Time in Reporting Drug Withdrawal Decisions to Healthcare Professionals

Charlottesville, Va., May 23, 2006...

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Drug Litigation Terms

 


Today's Terms

Product Number

Definition:
A product number is assigned to each drug product associated with an NDA (New Drug Application). If a drug product is available in multiple strengths, there are multiple product numbers.

Review

Definition:
A review is the basis of FDA's decision to approve a new drug application.

Discontinued Drug

Definition:
A discontinued drug is a drug product that has been removed from the market in the United States for reasons other than safety or effectiveness.

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Topics Related to Drug Litigation:

  • Adverse Effects
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  • Over the Counter Drugs
  • Drug Recalls
  • Dosage Errors
  • Drug Company Liability
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