I
107TH CONGRESS
2D SESSION
H. R. 4673
To amend the Public Health Service Act to provide for voluntary reporting
by health care providers of medication error information in order to
assist appropriate public and nonprofit private entities in developing
and disseminating recommendations and information with respect to pre-
venting medication errors.
IN THE HOUSE OF REPRESENTATIVES
MAY 7, 2002
Mrs. MORELLA introduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act to provide for
voluntary reporting by health care providers of medica-
tion error information in order to assist appropriate pub-
lic and nonprofit private entities in developing and dis-
seminating recommendations and information with re-
spect to preventing medication errors.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Medication Error Pre-
vention Act of 2002’’.
SEC. 2. VOLUNTARY REPORTING PROGRAM REGARDING
MEDICATION ERRORS; DEVELOPMENT AND
DISSEMINATION OF RECOMMENDATIONS FOR
PREVENTING MEDICATION ERRORS.
Part B of title II of the Public Health Service Act
(42 U.S.C. 238 et seq.) is amended by adding at the end
the following section:
‘‘SEC. 249. VOLUNTARY REPORTING PROGRAM REGARDING
MEDICATION ERRORS; DEVELOPMENT AND
DISSEMINATION OF RECOMMENDATIONS FOR
PREVENTING MEDICATION ERRORS.
‘‘(a) PRIVILEGED LEGAL STATUS OF REPORTED IN-
FORMATION.—If the Secretary approves a program as
meeting the criteria described in subsection (b) to serve
as the reporting program for purposes of this section, any
medication error information submitted to the reporting
program by a health care provider pursuant to an agree-
ment under paragraph (3) of such subsection is privileged
for purposes of Federal and State judicial proceedings in
civil matters, and for purposes of Federal and State ad-
ministrative proceedings, including with respect to dis-
covery and subpoenas.
‘‘(b) CRITERIA FOR REPORTING PROGRAM.—With re-
spect to the approval by the Secretary of a reporting pro-
gram for purposes of this section, the criteria referred to
in subsection (a) are as follows:
‘‘(1) The reporting program is operated by The
United States Pharmacopeial Convention, Incor-
porated (except that if such entity declines to oper-
ate a reporting program for purposes of this section,
the Secretary may accept another nonprofit private
entity for such purposes).
‘‘(2) Under such program, health care providers
voluntarily submit medication error information to
the program, and the program uses the information
for the purpose of developing and disseminating rec-
ommendations and information with respect to pre-
venting such errors, including recommendations in
the form of protocols, procedures, and best-practices
information.
‘‘(3) The use by the program of medication
error information submitted to the program by a
health care provider is governed by an agreement
entered into by the program and the provider.
‘‘(4) Such agreement includes the following
policies (without regard to whether the following lan-
guage is used in the agreement):
‘‘(A) Subject to subparagraph (B), the re-
porting program reserves the right to disclose
to third parties medication error information
submitted by a health care provider if, in the
judgment of the program, the information can
be used for purposes of furthering research,
education, standards setting, improvement in
processes, product improvement, public health,
or public safety.
‘‘(B) If such a disclosure is made, the ex-
tent of information disclosed will be limited to
the information required to meet the purposes
described in subparagraph (A).
‘‘(c) FEDERAL DISCLOSURES.—Officers and employ-
ees of a Federal agency may not disclose any medication
error information that is received by the agency from the
reporting program pursuant to an agreement between the
agency and the program, except to the extent that disclo-
sure of the information is authorized by the agreement.
The preceding sentence applies notwithstanding any other
provision of law.
‘‘(d) SCOPE OF PRIVILEGE.—With respect to Federal
and State judicial proceedings in civil matters, and Fed-
eral and State administrative proceedings:
‘‘(1) In the case of a health care provider:
‘‘(A) The privilege under subsection (a)
protects all medication error information of the
provider that is provided in a submission to the
reporting program or is developed for purposes
of such a submission, subject to subparagraph
(B).
‘‘(B) The privilege does not protect medi-
cation error information in patient medical
records of the provider, or other information
that is in the custody of the provider and is de-
veloped or maintained by the provider sepa-
rately from the process of developing medica-
tion error information for submission to the
program.
‘‘(2) In the case of the reporting program, the
privilege protects all medication error information
that is received by the program pursuant to agree-
ments under subsection (b)(3).
‘‘(3) In the case of other entities (whether pub-
lic or private), the privilege protects all medication
error information that is received by the entity from
the reporting program pursuant to an agreement be-
tween the entity and the program, except to the ex-
tent that disclosure of the information is authorized
by the agreement.
‘‘(e) RULE OF CONSTRUCTION.—The submission by
a health care provider of medication error information to
the reporting program may not be construed as waiving
any privilege that, under Federal or State constitutions
or laws, may exist with respect to the information.
‘‘(f) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘health care provider’ means in-
dividuals and organizations that provide health serv-
ices. Such term includes—
‘‘(A) physicians, nurses, pharmacists, and
other health professionals; and
‘‘(B) hospitals, pharmacies, clinics, long-
term care facilities, intermediate care facilities,
residential treatment centers, and other entities
that provide health services.
‘‘(2) The term ‘medication error’ means any
preventable event that may cause or lead to inappro-
priate medication use or patient harm while the
medication is in the control of the health care pro-
fessional, patient, or consumer. Such events may be
related to professional practice, health care products,
procedures, and systems, including prescribing;
order communication; product labeling, packaging,
and nomenclature; compounding; dispensing; dis-
tribution; administration; education; monitoring; and
use.
‘‘(3) The term ‘medication error information’
means information developed by or on behalf of a
health care provider in connection with a medication
error.
‘‘(4) The term ‘reporting program’ means the
program approved under subsection (a).’’.
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