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Executive Summary

MANDATORY REPORTING OF MEDICATION ERRORS THAT RESULT IN DEATH is called for by Reps. Coyne (D-Penn.) and Stark (D-Calif.), through the Nov. 22 introduction of the Safe Medications Act of 1993. Claiming that a reporting system is necessary to eliminate duplication of fatal mistakes, Coyne developed HR 3632, to require "mandatory reporting of deaths resulting from errors in the prescribing, dispensing and administration of drugs," while "allowing the continuation of voluntary reporting programs." Within 10 working days after the date of the discovery of the error resulting in death, the pharmacy, hospital, long-term care facility, physician's office, or other health care facility in which the error occurred would be required to report the error and death to the secretary of HHS. As part of the report, the entity would be required to include "the brand name of the drugs involved, the generic names of the drugs, the manufacturers of the drugs, the labeler of the drug if different from the manufacturer, the dosage form of the drugs, the strength of the drugs, and the type and size of the containers; the lot number of the drugs, if available; a description of the error; information on the patient for whom the drug was prescribed, dispensed or administered, including the patient's age and sex; the diagnosis for which the drug was prescribed, dispensed or administered; the date and time of the death; and when and how the error was discovered," the bill states. The legislation instructs the HHS secretary to create a data bank for reports of fatal medication errors, establish a program using the data to help prevent those errors, and "educate and inform health care professionals of the deaths that may occur in the course of drug therapy." The secretary would review the information submitted to the data bank "on an ongoing basis" to identify trends and then report the information to "compilers of the official compendia on an ongoing basis for consideration of revision of the packaging and labeling requirements or other standards for drugs for dissemination of information to physicians, pharmacists and other health professionals involved in the prescribing dispensing and administration of drugs to patients." The aim of aggregate data reports should be to "assist health professionals in identifying and reducing patterns and incidents of inappropriate use and misuse associated with certain drugs," the bill states. The HHS secretary would share reported information with licensing, accreditation and inspection groups for their follow- up, in order to ensure that there is no under-reporting of medication errors related to deaths. The legislation states that "the identity of a person making a report to the data bank, the deceased, or the individual believed to have caused the error shall be considered as privileged and confidential information for purposes of any law requiring disclosure of information." The bill provides a fine of not more than $15,000 or imprisonment of not more than three years as the first-offense penalty for anyone who "with false pretenses reports to the data bank, requests information from the data bank, or unlawfully gains access to the data bank." Failure to make a required report would result in a fine of $15,000 for each report not made, as well as exclusion from Medicare and state health care programs.

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