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FDA Officially Strives to Reduce Drug Errors

© Adelle Vancil Tilton

FOR IMMEDIATE RELEASE
P00-22 December 21, 2000 FOOD AND DRUG ADMINISTRATION Press Office: 301-827-6242 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA PHYSICIAN LABELING PROPOSAL

Prescription drug product labeling, also known as the package insert, represents a primary means of providing critical information about drugs to practitioners. As part of the drug review process, FDA reviews and approves drug product labeling that is initially proposed by manufacturers.

An FDA study showed that practitioners found drug product labeling to be lengthy, complex, and hard to use. The proposed new format would provide user-friendly labeling that would allow practitioners to quickly find the most important information about the product. One major change is inclusion of a new introductory "Highlights" section of bulleted prescribing information. This section would include the information that practitioners most commonly refer to and view as most important, and it would provide the location of further details elsewhere in the labeling.

The proposed new labeling is expected to reduce practitioners' time spent looking for information, decrease the number of preventable medical errors, and improve treatment effectiveness. The information will be easier to find, read and use, and it should also enhance the safe and effective use of prescription drugs and reduce medical errors caused by inadequate communication. Because these labeling revisions represent considerable effort and are most critical for newer and less familiar drugs, the proposal will apply only to relatively new prescription drug products.

The above is the official Press Release from the FDA which is aimed at addressing the problem of prescription drug accidents. It was released on the 21st of December, 2000, after a rash of accidents and prescription medication errors brought the issue of consumer safety to a head.

In previous columns, I have discussed the problems with prescriptions that have been occurring. Some of these issues are due to an unfortunate side effect that could not be anticipated. Others problems are due to the pushing through of medications on the "fast track" by a system willing to exchange safety for profit. But many other medication accidents result from mislabeling and physician error - unintentional? Of course! But it has become a problem that needs to be addressed and the FDA took the first steps in that direction yesterday.

"I think we’ll see a real difference,” said FDA Commissioner Jane Henney. Patients “will have a greater assurance that the drug prescribed will be the right one." With estimates recording that two million people are hospitalized with side effects yearly, 100,000 dying from these adverse reactions, this real difference is a necessary one. I found it interesting that seven out of ten medications pulled from the market were pulled not because of inherent problems with the medication, but because of the error of the physician in researching the medication as being appropriate for the patient. Doctors too busy by a system strained due to insurance company demands are a most likely cause for this problem.

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