I
104TH CONGRESS
1ST SESSION
H. R. 1914
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
JUNE 22, 1995
Mr. COYNE (for himself, Mr. STARK, and Mr. LEWIS of Georgia) introduced
the following bill; which was referred to the Committee on Commerce,
and in addition to the Committees on Ways and Means, and the Judici-
ary, 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 pro-
grams, 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 1995’’.
(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, dispens-
ing, 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 fa-
cility in which the drug was prescribed, dispensed, or
administered;
(2) a description of the error in the prescrip-
tion, 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 in-
volved,
(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 discov-
ered,
(3) the brand name of the drug involved (if
any), the generic name of such drug, the manufac-
turers of such drug, the labeler of such drug if dif-
ferent 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 avail-
able;
(5) information on the patient for whom the
drug involved was prescribed, dispensed, or adminis-
tered, 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 coopera-
tion 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 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 compiler of the official com-
pendia of drug standards on an ongoing basis for consider-
ation of revision of the packaging and labeling require-
ments or other standards for drugs for dissemination to
physicians, pharmacists, and other health professionals in-
volved 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 pro-
fessionals in identifying and reducing patterns and inci-
dents 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 in-
formation for purposes of any law requiring disclosure of
information.
(d) SHARED INFORMATION.—The Secretary shall
share the reported information with governmental licens-
ing, 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 administra-
tion 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 THE PRESCRIBING, DISPENSING, AND ADMIN-
ISTRATION 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 Medi-
cations Act of 1995.’’.
Æ