Food and Drug Administration Plan Focuses on Patient Safety and Reducing Medication Errors
On Mar 13, 2003
Secretary Tommy Thompson Unveils New Proposal at National Patient Safety Foundation’s 2003 Patient Safety Congress
WASHINGTON – March 13, 2003 — Health and Human Services Secretary Tommy G. Thompson today announced two new proposals from the Food and Drug Administration (FDA) aimed at improving patient safety by reducing medical errors and by more quickly identifying potential errors that may occur. Secretary Thompson spoke this morning at the National Patient Safety Foundation’s (NPSF) 2003 Patient Safety Congress called “Let’s Get Results: Improving the Safety of Patients.”
The proposed rules, which are part of FDA’s strategic initiative to reduce adverse events involving the products it regulates, would require bar coding on medications and will improve reporting requirements for safety problems involving medicines.
“Today’s announcement by Secretary Thompson is an important and welcomed step in protecting the safety of patients in all healthcare settings,” said Robert Krawisz, executive director of the NPSF.
Secretary Thompson spoke to more than one thousand healthcare leaders and patient safety advocates who are attending the event this week in Washington DC. The three-day Congress offers presentations, interactive discussions, and breakout sessions all aimed at ways to improve patient safety.
In addition to causing human suffering, medication errors also represent a significant economic cost to the United States. The expected annual benefit from preventing adverse events due to medication errors is equivalent to $3.9 billion, according to the FDA.
One of the major initiatives announced today — the proposed requirement for bar codes — adopts a technology that is widely used in other industries to reduce the number of medication errors in hospitals and other health care settings. The required bar code would contain the National Drug Code (NDC) number, unique identifying information about the drug that is to be dispensed to the patient, in a linear bar code as part of the drug label. The proposed design would allow manufacturers to include additional information, and more information could also be added to the bar code standards as information technology progresses.
“This is a prime example of taking a well-developed application of imaging technology and apply it to healthcare to prevent injury,” says Henri R. Manasse, Jr. PhD, ScD, NPSF Board Member and executive vice president and CEO of American Society of Health-System Pharmacists. Dr. Manasse is also the immediate past chair of the NPSF.
The second action the FDA announced — the proposed revamping of safety reporting requirements — aims to enhance the agency’s ability to effectively monitor and improve the safe use of medications including drugs and biologics.
The proposed rule would:
These steps would provide the FDA with more useful, timely, and extensive information to support quicker, more effective actions by the agency to prevent adverse events. The measure would require all healthcare groups – including pharmaceutical companies — to submit to FDA, within 15 calendar days, all reports they receive of actual and potential (i.e., “near miss”) medication errors occurring in the United States. About the National Patient Safety Foundation |
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