[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3632 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 3632

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 22, 1993

 Mr. Coyne (for himself and Mr. Stark) introduced the following bill; 
which was referred jointly to the Committees on Energy and Commerce and 
                             Ways and Means

_______________________________________________________________________

                                 A BILL


 
 To require the mandatory reporting of deaths resulting from errors in 
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 1993''.
    (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 errors 
in the prescribing, dispensing, and administration of drugs, to 
establish a program using such data to assist in preventing such 
errors, 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 an error 
occurs in the prescribing, dispensing, or administration of a drug to 
an individual which results in the individual's death shall report such 
error and resulting death 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 error resulting in such 
death.
    (b) Report Requirements.--Each report of an error in the 
prescribing, dispensing, or administration of a drug to an individual 
shall 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 error 
        occurred,
            (2) the brand names 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,
            (3) the lot number of the drugs, if available,
            (4) a description of the error,
            (5) information on the patient for whom the drug was 
        prescribed, dispensed, or administered, including the patient's 
        age and sex,
            (6) the diagnosis for which the drug was prescribed, 
        dispensed, or administered,
            (7) the date and time the death, and
            (8) when and how the error was discovered.

SEC. 3. DATA BANK.

    (a) Establishment.--The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall establish a 
data bank to receive reports under section 2 of errors resulting in 
deaths.
    (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 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. 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 and 
misuse associated with certain drugs.
    (c) Confidentiality.-- 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.
    (d) Shared Information.--The Secretary shall share the reported 
information with licensing, accreditation, and inspection organizations 
for their followup with the appropriate organization to ensure that 
there has not been underreporting of medication errors related to 
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 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:
            ``(3) Failure to report deaths resulting from errors in the 
        prescribing, dispensing, and administration of drugs.--Any 
        individual or entity that has failed to meet the requirements 
        of section 2 of the Safe Medications Act of 1993.''.

SEC. 5. AUTHORIZATION.

    There are authorized to be appropriated to carry out this Act and 
the amendment made by this Act such sums as may be necessary.

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