FDA Proposes New Amendments
HHS Secretary Tommy G. Thompson announced two proposed rules from the Food and Drug Administration (FDA) that will improve patient safety by reducing medication errors and by more quickly identifying potential errors that may occur. The new rules, part of FDA’s strategic initiative to reduce adverse events involving the products it regulates, will require bar coding on medications and will improve reporting requirements for safety problems involving medicines.
“These proposals are key steps in reducing medication problems through using state-of-the-art technology,” Secretary Thompson said.
“Today’s actions are the start of a comprehensive strategy to build a medical patient protection system for the 21st Century,” said FDA Commissioner, Mark B. McClellan, M.D., Ph.D.
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. When used with bar code scanners and computerized patient information systems, bar code technology can prevent many medication errors including administering the wrong drug, administering a drug to a patient who is known to be allergic, administering the wrong dose, administering the drug at the wrong time, or using the wrong route of administration (for example, by injection rather than by mouth).
In addition to the human suffering they cause, medication errors represent a significant economic cost to the United States. According to the Institute of Medicine and other experts, thousands of deaths and millions of hospitalizations result from medication errors. The expected annual benefit from preventing adverse events due to medication errors is equivalent to $3.9 billion.
The proposed rule would apply to all prescription drug products, including biological products and vaccines (except for physician samples), and OTC drugs that are commonly used in hospitals and dispensed in a hospital pursuant to an order. Standardized bar codes would also be required on prescription drug products used in other settings such as retail pharmacies.
The second action the agency is announcing — 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: •Improve the quality and usefulness of safety reports submitted to the agency as well as facilitating the consistency of safety reporting around the world. •Require the submission of all suspected serious reactions for blood and blood products on the market. •Require reports on important potential medication errors.
These steps would provide FDA with more useful, timely, and extensive information to support quicker, more effective actions by the agency to prevent adverse events.
To expedite the agency’s review of and response to medication errors, the proposed amendments would require 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. An example of a potential medication error – from the standpoint of the rule – is a situation in which a pharmacist selects the wrong medication because of a similar sounding name but catches the error prior to dispensing the medication. In this case, no patient was the recipient of an actual medication error. However, if the pharmacist reported what happened in an effort to alert the company to this potential problem, then the company would be required to report the “potential” (or “near miss”) medication error to FDA. In this manner, FDA could work with the company to make changes to help ensure that actual medication errors because of this problem do not happen.
The proposal would also raise the quality and consistency of safety reports by requiring the use of internationally agreed definitions reporting formats, and other safety reporting standards. If the proposed safety reporting standards are implemented, companies will be able to devote their resources to preparing a single, high-quality report for submission to all major regulatory agencies around the world.
Under this proposal, blood establishments would be required to submit to FDA reports of all suspected serious reactions, not just fatalities, which currently is the case.
The proposal refines and clarifies the expectations for the amounts of data needed in various safety reports. The net effect will be to lessen some of industry’s reporting burdens — especially for certain non-serious suspected adverse reactions — thus allowing companies to focus their resources on producing quality reports of serious suspected adverse reactions which potentially have a much greater public health impact.