ML20216D075

Discusses Issue Raised by Comments in Current Rulemaking on Patient Release Criteria Re Dose That Members of Public Could Receive from Sitting Next to Patient w/I-131 in Their Systems After Therapy Dose

ML20216D075
Person / Time
Issue date:	01/11/1995
From:	Crane P NRC
To:	Mark Miller, Olmstead W NRC
Shared Package
ML20013H248	List: ML20216C904 ML20216C919 ML20216D019 ML20216D034 ML20216D075 ML20216D086 ML20216D113 ML20216D128 ML20216D163
References
FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-086, AE41-2-86, NUDOCS 9804150166
Download: ML20216D075 (1)

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From:

Peter G. Crane (PGC)

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age, wjo Date:

Wednesday, January 11, 1995 2:34 pm subject:

Patient release criteria one of the issues raised by comments in the current rulemaking on,

. patient release criteria is the dose that members of the public

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could receive from sitting next to a patient with I-131 in their systems after a therapy dose.

We now have more exact information as to what that dose might be, because of a patient who, after receiving an I-131 treatment at Mass. General in Boston, left the hospital before receiving permission from the Radiation Safety department.

The incident is described in PNO-I-94-074 and -074A.

The patient had been tested 22 hours2.546296e-4 days <br />0.00611 hours <br />3.637566e-5 weeks <br />8.371e-6 months <br /> after receiving her treatment 4

and, at 7.2 mrem /hr, did not meet the 5 mrem /hr standard of NRC regulations.

(The assumption is that if you are putting out 5 mrom/hr, you have about 30 millicuries of I-131 in your system.)

Rather than wait to be tested again (the next day), she left,

'saying she had a plane to catch that afternoon.

In the end, however, she spent the night in a hotel room and did not fly until the following morning.

The hospital estimates that by the time she actually left the hospital, three hours af ter being tested, she had eliminated enough of the I-131 in her system that she in fact met NRC regulatory standards; they put the level of I-131 in her system at 22 millicuries.

If she went from over 30 millicuries to 22 millicuries in three or four hours, we can assume that by the following morning, when she flew to Boca Raton, the level of I-131 in her body was a lot lower than 22 millicuries. Nevertheless, the licensee calculates that the person sitting next to her on her three-hour flight could have received as much as 108 millirem.

That might be a data point worth considering as the Commission i

decides whether to allow people to get 150 or 200 or 300 millicuries of I-131 as outpatients, with no period of radiological isolation.

To get personal for a moment, the other moral of the story is that 4

if you have to get a 150-millicurie dose of I-131, it's nice if the woman from Radiation Safety who tests you in the early af ternoon of the day following treatment is the sort of person to say, "Look, 3

you're not that much above the limits for release now, I get of f at i

5, by then you'11 probably be below 5 millirem, why don't I come by then and test you again and see if we can't get you out of here tonight."

That happened to me one October 31, and as a result, I i

got to see my kids in their Halloween costumes.

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UNIVEllSITY OF CALIFollNIA, LOS ANGELES UCLA m

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9 January 24, 1995

'O UCLA SCilOOL OF MEDICINE fiARBOH - UCLA MEDICAL CENTER The Honorable Ivan Selin, Ph.D.

1. ^**$CARSO ST Chairman ToRRANCE, CALIFORNIA 90509 US Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852

Dear Chairman Selin:

The purpose of this letter is to inquire about the reason for the puzzling delay concerning the " Patient Discharge Rule".

This is NRC's rule which is supposed to state that the most exposed contact of a patient treated with radionuclide therapy should remain at the 500 mrem maximum, and that the methodology published by the National Council for Radiation Protection and Measurements (NCRP) in 1970 (NCRP no. 37) should be employed for estimating such doses.

This would end needless and expensive hospitalizations, rx As a representative of the Society of Nuclear Medicine (SNM) and

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the American College of Nuclear Physicians (ACNP), I met with you

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on the subject of poor performance by NRC on this Proposed Rule published in the Federal Register on 15 June 94 (Criteria for the Release of Patients Administered Radioactive Material, RIN 3150-AE41, 59FR 30724-30732, and associated analysis and regulatory guidance).

Our meeting was held in your office the third week of Sept. 1994, and dealt with the points made in my 18-page letter to NRC pointing out its serious scientific, mathematical, and medical mistakes.

You agreed with my points, stated that NRC "had not done.its homework", and vowed that it would be repaired.

Given the fact that I did all the physics, math, pharmacokin-ethics, and pathophysiology for NRC, and contributed model calculations, model language and the pertinent references, one would assume that it would require no more than about an hour of NRC time to complete the rule.

After all, it was NRC that asked me to write a petition on the subject in the first place, in December of 1990.

The reason for pushing for progress on this rulemaking is very simple.

NRC is frivolously wasting medical dollars for no good reason at all.

Let us see what NRC's delays are costing those who pay for health care in this country.

According to NRC's estimates in the y

regulatory analysis of this rule, we treat about 50,000 patients

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a year for hyperthyroidism.

In my experience, about 20% require i

f' total administered activities of NaI-131 greater than 30 mci, your present outpatient limit. As my experience is skewed by working in a public hospital whose patients often present with advanced disease, let us say that only 10% nationally require greater than 30 mci, or 5000 patients / year.

In addition, about NWOfW W. 4} o

Jcnu3ry 24, 1995 The Honorable Ivan Selin, Ph.D.

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T Page h 10,000 patients a year are treated with NaI-131 for thyroid cancer, virtually all of whom require more than 30 mci per therapy.

I Let us say that the average inpatient hospital cost for the hyperthyroid patient is $3000, and that the average cost for a thyroid cancer patient is $2000.

That is (3000) (5000)+(2000)

(10,000)=15,000,000+20,000,000=$35 million per '0:r, of f

unnecessary expenses.

For 25 years, NRC has failed to understand NCRP no. 37, and these costs, in 1995 dollars, amount to about $675 million (assuming a mean population of 200 million).

For 4 years NRC has delayed my 1

petition, at a patient cost of $140 million and a User Fee of

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perhaps $0.5-1 million.

For 6 months, all NRC had to do was copy my comment letter but instead cost patients $17.5 million.

During the 4 months after our meeting, NRC has cost America's patients about $12 million.

While many physicians "get around" NRC's "30 mci" rule, mainly for hyperthyroid patients, by breaking up administered activity into 30 mci chunks or less, no radiation dose is saved by the public, inpatient costs are avoided, but the patient may be ill for several extra months.

It is not ethically acceptable that NRC should impose several extra r~w) 3

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months of illness on patients who need to avoid costs that result j

from a scientifically unrespectable and foolish NRC regulation in x~-

the first place.

I recommend that you rectify this situation immediately. If your staff and management still find it too difficult to accomplish, then perhaps you could either copy my recommendations or those of an intelligent Agreement State, such as California.

Thank you for your attention and consideration.

j Sincerely, b)kd46M7 Carol S. Marcus, Ph.D., M.D.

l Director, Nuclear Med. Outpt. Clinic and Professor of Radiological Sciences

UCLA, Vice-President, Society of Nuclear Medicine and President, American College of Nuclear Physicians, California Chapter

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Phone:

(310', 222-2845 k/

FAX:

(310) 533-7159 cc:

Commissioner E.

Gail de Planque Hugh Thompson, Deputy EDO David Nichols, ACNP/SNM Conjoint Office

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File RESEARCH ACTION ITEM J

January 30, 1995 MAIL CONTROL FORM 7:26 am FROM:

C. MARCUS RES No.:

950029 TO: CHAIRMAN EDO No.: 62 ACTION NECES/APPR?: N FOIA No.:

WITS No.:

DESCRIPTION: DELAY CONCERNING THE "PATicNT DISCHARGE RULE" SPECIAL INSTRUCTIONS:

DOCUMENT DATE: January DUE TO RES: February 24'6,1995 1995 RECEIVED BY RES: January 30',1995 February 9 1995 DUE TO EDO:

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ASSIGNED TO: B. MORRIS, DRA FOR SIGNATURE OF:

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DUE:,02/09/95 EDO CONTROL: 0000062 DOC DT: 01/24/95 FINAL REPLY:.

Carol S. Marcus UCLA TO:

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CRC NO: 9,5-dd68..

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FOR SIGNATURE OF :

• • GRN Beckjord DESC:

ROUTING:

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7AY CONCERNING THE " PATIENT DISCHARGE RULE" Taylor V

Milhoan Thompson Blaha Bernero, NMSS Bangart, SP DATE: 01/26/95 Cyr, OGC ASSIGNED To:

CONTACT:

RES nonkiord SPECIAL INSTRUCTIONS OR REMARKS:

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OFFICE OF THE SECRETARY CORRESPONDENCE CONTROL TICKET PAPER NUMBER:

CRC-95-0068 LOGGING DATE: Jan 26 95 ACTION OFFICE:

EDO

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AUTHOR:

CAROL MARCUS AFFILIATION:

CA (CALIFORNIA)

ADDRESSEE:

CHAIRMAN SELIN LETTCn D.'.TE:

Jan 24 95 FILE CODE: IDR-14 PART 35

SUBJECT:

DELAY CONCERNING THE " PATIENT DISCHARGE RULE" ACTION:

Direct Reply DISTRIBUTION:

CHAIRMAN, COMRS j

SPECIAL HANDLING: NONE i

CONSTITUENT:

j NOTES:

DATE DUE:

Feb 9 95 SIGNATURE:

DATE SIGNED:

AFFILIATION:

EDO --- 000062