I
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 continu-
ation 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 Representa-
tives 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,
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, in-
cluding the patient’s age and sex,
(6) the diagnosis for which the drug was pre-
scribed, 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 re-
view information reported to the data bank on an ongoing
basis to determine trends relating to drugs and shall re-
port such information to the compilers of the official com-
pendia on an ongoing basis for consideration of revision
of the packaging and labeling requirements or other stand-
ards for drugs for dissemination of information to physi-
cians, 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 inap-
propriate 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 con-
sidered as privileged and confidential information for pur-
poses of any law requiring disclosure of information.
(d) SHARED INFORMATION.—The Secretary shall
share the reported information with licensing, accredita-
tion, 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 prescrib-
ing, 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 amend-
ed 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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