[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 524 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 524

    To require the mandatory reporting of deaths resulting from the 
  prescribing, dispensing, and administration of drugs, to allow the 
 continuation of voluntary reporting programs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 4, 1997

  Mr. Coyne introduced the following bill; which was referred to the 
  Committee on Commerce, and in addition to the Committee on Ways and 
 Means, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
    To require the mandatory reporting of deaths resulting from the 
  prescribing, dispensing, and administration of drugs, to allow the 
 continuation of voluntary reporting programs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE AND PURPOSE.

    (a) Short Title.--This Act may be cited as the ``Safe Medications 
Act of 1997''.
    (b) Purpose.--It is the purpose of this Act to have the Secretary 
of Health and Human Services create a data bank for reports of deaths 
from the prescribing, dispensing, and administration of drugs, to 
establish a program using such data to assist in preventing such 
deaths, and to educate and inform health care professionals of the 
deaths that may occur in the course of drug therapy.

SEC. 2. REPORTING.

    (a) In General.--Any pharmacy, hospital, long-term care facility, 
physician's office, or other health care facility, as defined by the 
Secretary of Health and Human Services by regulation, in which a death 
occurs as a result of the prescribing, dispensing, or administration of 
a drug to an individual shall report such deaths to the Secretary of 
Health and Human Services under section 3. Such a report shall be made 
not later than 10 working days after the date of the discovery of the 
deaths.
    (b) Report Requirements.--Each report of a death from the 
prescribing, dispensing, or administration of a drug to an individual 
shall at least contain--
            (1) an identification of the person making the report, 
        including the address and telephone number of such person, and 
        the name and address of the facility in which the drug was 
        prescribed, dispensed, or administered;
            (2) a description of the error in the prescription, 
        dispensing, or administration of the drug if an error occurred 
        to include the following:
                    (A) the misunderstanding (if any) of an oral 
                communication for the prescription of the drug 
                involved,
                    (B) the misinterpretation or misreading (if any) of 
                a written prescription for the drug involved,
                    (C) the improper identification (if any) of the 
                drug involved because of shelf placement,
                    (D) the confusion (if any) over the drug involved 
                because of product packaging or drug name, and
                    (E) when and how the error was discovered;
            (3) the brand name of the drug involved (if any), the 
        generic name of such drug, the manufacturers of such drug, the 
        labeler of such drug if different from the manufacturer, the 
        dosage form of such drug, the strength of such drug, and the 
        type and size of the drug containers;
            (4) the lot number of the drug involved, if available;
            (5) information on the patient for whom the drug involved 
        was prescribed, dispensed, or administered, including the 
        patient's age and sex;
            (6) the diagnosis for which the drug involved was 
        prescribed, dispensed, or administered; and
            (7) the date and time of the death.
Reporting requirements shall be updated as directed by the Secretary.

SEC. 3. DATA BANK.

    (a) Establishment.--The Secretary of Health and Human Services 
shall establish and maintain in cooperation with the compiler of the 
official compendia of drug standards a data bank to receive reports 
under section 2 of deaths. If such compiler will not cooperate in 
connection with such data bank, the Secretary shall establish or by 
contract provide for such data bank.
    (b) Secretarial Action.--The Secretary shall review information 
reported to the data bank on an ongoing basis to determine trends 
relating to drugs and shall report such information to the compiler of 
the official compendia of drug standards on an ongoing basis for 
consideration of revision of the packaging and labeling requirements or 
other standards for drugs for dissemination to physicians, pharmacists, 
and other health professionals involved in the prescribing, dispensing, 
and administration of drugs to patients. Such reporting of aggregate 
data shall be done in a manner which assists such health professionals 
in identifying and reducing patterns and incidents of inappropriate use 
associated with certain drugs.
    (c) Confidentiality.--The identity of a person making a report to 
the data bank, the deceased, and the individual who prescribed, 
dispensed, or administered the drug shall be considered as privileged 
and confidential information for purposes of any law requiring 
disclosure of information.
    (d) Shared Information.--The Secretary shall share the reported 
information with governmental licensing, accreditation, and inspection 
agencies for their action with the appropriate organizations to ensure 
that there has not been a failure to report such deaths.
    (e) Enforcement.--Whoever with false pretenses reports to the data 
bank, requests information from the data bank, or unlawfully gains 
access to the data bank shall be fined not more than $15,000 or 
imprisoned for not more than 3 years, or both, except that if a person 
commits a violation of this subsection after a conviction for a 
violation of this subsection has become final, such person shall be 
fined not more than $25,000 or imprisoned for not more than 3 years, or 
both.

SEC. 4. PENALTIES.

    (a) Imposition of Fine.--Any institution that does not make a 
report as required by section 2 shall be subject to a fine of $15,000 
for each report not made. Within 60 days of a conviction under this 
subsection, a person shall submit to the Secretary of Health and Human 
Services a plan for the reporting to the data bank of deaths from drugs 
and drug prescribing, dispensing, and administration errors.
    (b) Mandatory Exclusion From Medicare and State Health Care 
Programs.--Section 1128(a) of the Social Security Act (42 U.S.C. 1320a-
7(a)) is amended by adding at the end the following new paragraph:
            ``(5) Failure to report deaths resulting from the 
        prescribing, dispensing, and administration of drugs.--Any 
        individual or entity that has failed or refused to respond to a 
        subpoena for information on a reportable incident or has failed 
        to meet the requirements of section 2 of the Safe Medications 
        Act of 1997.''.
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