I

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE AND PURPOSE.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Safe Medications Act of 1997’’.

6 (b) PURPOSE.—It is the purpose of this Act to have

7 the Secretary of Health and Human Services create a data
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1 bank for reports of deaths from the prescribing, dispens2 ing, and administration of drugs, to establish a program

3 using such data to assist in preventing such deaths, and

4 to educate and inform health care professionals of the

5 deaths that may occur in the course of drug therapy.

6 SEC. 2. REPORTING.

7 (a) IN GENERAL.—Any pharmacy, hospital, long8 term care facility, physician’s office, or other health care

9 facility, as defined by the Secretary of Health and Human

10 Services by regulation, in which a death occurs as a result

11 of the prescribing, dispensing, or administration of a drug

12 to an individual shall report such deaths to the Secretary

13 of Health and Human Services under section 3. Such a

14 report shall be made not later than 10 working days after

15 the date of the discovery of the deaths.

16 (b) REPORT REQUIREMENTS.—Each report of a

17 death from the prescribing, dispensing, or administration

18 of a drug to an individual shall at least contain—

19 (1) an identification of the person making the

20 report, including the address and telephone number

21 of such person, and the name and address of the fa22 cility in which the drug was prescribed, dispensed, or

23 administered;
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1 (2) a description of the error in the prescrip2 tion, dispensing, or administration of the drug if an

3 error occurred to include the following:

4 (A) the misunderstanding (if any) of an

5 oral communication for the prescription of the

6 drug involved,

7 (B) the misinterpretation or misreading (if

8 any) of a written prescription for the drug in9 volved,

10 (C) the improper identification (if any) of

11 the drug involved because of shelf placement,

12 (D) the confusion (if any) over the drug

13 involved because of product packaging or drug

14 name, and

15 (E) when and how the error was discov16 ered;

17 (3) the brand name of the drug involved (if

18 any), the generic name of such drug, the manufac19 turers of such drug, the labeler of such drug if dif20 ferent from the manufacturer, the dosage form of

21 such drug, the strength of such drug, and the type

22 and size of the drug containers;

23 (4) the lot number of the drug involved, if avail24 able;
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1 (5) information on the patient for whom the

2 drug involved was prescribed, dispensed, or adminis3 tered, including the patient’s age and sex;

4 (6) the diagnosis for which the drug involved

5 was prescribed, dispensed, or administered; and

6 (7) the date and time of the death.

7 Reporting requirements shall be updated as directed by

8 the Secretary.

9 SEC. 3. DATA BANK.

10 (a) ESTABLISHMENT.—The Secretary of Health and

11 Human Services shall establish and maintain in coopera12 tion with the compiler of the official compendia of drug

13 standards a data bank to receive reports under section 2

14 of deaths. If such compiler will not cooperate in connection

15 with such data bank, the Secretary shall establish or by

16 contract provide for such data bank.

17 (b) SECRETARIAL ACTION.—The Secretary shall re18 view information reported to the data bank on an ongoing

19 basis to determine trends relating to drugs and shall re20 port such information to the compiler of the official com21 pendia of drug standards on an ongoing basis for consider22 ation of revision of the packaging and labeling require23 ments or other standards for drugs for dissemination to

24 physicians, pharmacists, and other health professionals in25 volved in the prescribing, dispensing, and administration
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1 of drugs to patients. Such reporting of aggregate data

2 shall be done in a manner which assists such health pro3 fessionals in identifying and reducing patterns and inci4 dents of inappropriate use associated with certain drugs.

5 (c) CONFIDENTIALITY.—The identity of a person

6 making a report to the data bank, the deceased, and the

7 individual who prescribed, dispensed, or administered the

8 drug shall be considered as privileged and confidential in9 formation for purposes of any law requiring disclosure of

10 information.

11 (d) SHARED INFORMATION.—The Secretary shall

12 share the reported information with governmental licens13 ing, accreditation, and inspection agencies for their action

14 with the appropriate organizations to ensure that there

15 has not been a failure to report such deaths.

16 (e) ENFORCEMENT.—Whoever with false pretenses

17 reports to the data bank, requests information from the

18 data bank, or unlawfully gains access to the data bank

19 shall be fined not more than $15,000 or imprisoned for

20 not more than 3 years, or both, except that if a person

21 commits a violation of this subsection after a conviction

22 for a violation of this subsection has become final, such

23 person shall be fined not more than $25,000 or imprisoned

24 for not more than 3 years, or both.
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1 SEC. 4. PENALTIES.

2 (a) IMPOSITION OF FINE.—Any institution that does

3 not make a report as required by section 2 shall be subject

4 to a fine of $15,000 for each report not made. Within 60

5 days of a conviction under this subsection, a person shall

6 submit to the Secretary of Health and Human Services

7 a plan for the reporting to the data bank of deaths from

8 drugs and drug prescribing, dispensing, and administra9 tion errors.

10 (b) MANDATORY EXCLUSION FROM MEDICARE AND

11 STATE HEALTH CARE PROGRAMS.—Section 1128(a) of

12 the Social Security Act (42 U.S.C. 1320a–7(a)) is amend13 ed by adding at the end the following new paragraph:

14 ‘‘(5) FAILURE TO REPORT DEATHS RESULTING

15 FROM THE PRESCRIBING, DISPENSING, AND ADMIN16 ISTRATION OF DRUGS.—Any individual or entity that

17 has failed or refused to respond to a subpoena for

18 information on a reportable incident or has failed to

19 meet the requirements of section 2 of the Safe Medi20 cations Act of 1997.’’.

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