ML20126D212

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Requests Review of Licensee Requests to Use Radiopharms for Procedures Not Described on Package Inserts.Comment Requested by 840827
ML20126D212
Person / Time
Issue date: 07/17/1984
From: Miller V
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Almond
Advisory Committee on Reactor Safeguards
Shared Package
ML20126D070 List:
References
FRN-50FR15752, RULE-PR-35 AB72-1, NUDOCS 8506140678
Download: ML20126D212 (16)
v • d • e


Text

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6"* " % UNITED STATES

. y NUCLEAR REGULATORY COMMtsslON I o WASHINGTON D.C. 20555 I

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..... JUL17 1984 l

. l MEMORANDUM FOR: Members of the Advisory Committee on the Medical Uses of Isotopes Dr. Almond FROM: Vandy L. Miller, Chief Material Licensing Branch Division of Fuel Cycle and Material Safety

SUBJECT:

REQUEST TO AUTHORIZE APPROVED RADI0 PHARMACEUTICALS FOR UNAPPROVED USES The Nuclear Regulatory Commission has received three requests to allow licensees to use radiopharmaceuticals for procedures that are not described on their respective package inserts. NRC has provided a mechanism for handling such requests in 48 FR 5217 (enclosed). The three requests are described below:

1. Use of diagnosite radiopharmaceuticals for assessing the patency of Leveen shunt, ventriculo-atrial shunt, and ventriculo-peritoneal shunt.

Dosage: 1-5 millicuries Tc-99n as sulfur colloid or pertechnetate 5-10 millicuries Tc-99m as macroaggregated human serum albumin

2. Use of a diagnostic radiopharmaceutical for dacryocystography.

Dosage: 100-250 microcuries/ eye drop Tc-99m as pertechnetate

3. Use of a diagnostic radiopharmaceutical for cystography Dosage: 1 millicurie Tc-99m as pertechnetate Please review each request and using the enclosed comment sheet, submit your comments to me by AtlG 2 7 1984 . Following your review, we will publish the r,equests in the Federal Register for public comment.

andy L M r, Chief a

Materia Licensing Branch Division of Fuel Cycle and Material Safety

Enclosures:

1. ACNP request
2. 48 FR 5217 0506140678 850611 PDR PR 35 PDR

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Vandy L. Miller, Chief

. MEMORANDUM FOR:

. . Material Licensing Branch FRPh:

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SUBJECT:

Co mENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M i FOR CYSTOGRAPHY These are my responses to your questions about the subject request.

Question
Do you agree with the dosimetry calculations submitted by

- the requester?

1 Yes X No Abstain Comments Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes X No Abstain Comments _

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4 Question: Are any special radiation safety precautions needed for l

workers, the patient or the public?

Yes X N'o Abstain Comnents What about the creanant l l

woman or the lactatino female? '

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w 51gnature' Melvin L. Griem. M.D. ,

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  • MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch FROM: *

SUBJECT:

COMMENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR DACRY0 CYST 0 GRAPHY These are my responses to your questions about the subject request.

. Question: Do you agree with the dosimetry calculations submitted by the requester?

Yes X No Abstain Comments Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes X No Abstain Comments Question: Are any special radiation safety precautions needed for workers, the patient or the public?

Yes X ' No Abstain Comments What precautions should be taken for infants and children or the pregnant or lactatino patient where the potential for contamination or irradiation of the developing human may be more sensitive?

e' Signatufe Melvin L. Griem, M.D.

e' EfiORANDUM FOR: Vandy L. Millsr, Chiaf Material Licensing Branch FR0!(

1

SUBJECT:

COMMENTS ON THE USE OF SULFUR COLLOID, PERTECHNETATE AND MACR 0 AGGREGATED HUMAN SERUM ALBUMIN FOR ASSESSING PATENCY OF LEVEEN SHUNTS, VENTRICULO-ATRIAL SHUNTS AND VENTRICULO-PERITONEAL SHUNTS These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

Yes No X Abstain Cornents The dose in tha naritnnaal cavity is oiven. The dose in the ovarv could be similar tn tha noritnnon1 cavity

_since it is a Deritoneal structure.

  • Whv is it difforont? 1 1 raac is not .

a trivial dose to the ovarv. What is the genetic effect?

n Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes X No Abstain Comnents naaf atinn ane.e <m, er procedures includino C.T. scannino would anornach the 1.1 rade man +1oned for the peritoneal cavity. Likewise. the dnto tn the lunn fe aR egds is eouivalent to some c.T. Scannino nrneadnroe.

Question: Are- any special radiation safety precautions needed for workers, the patient or the public?

Yes X No Abstain Comments What should be done with pregnant women and women that might be lactatino? Should thev be tw-cluded?

l' signature Melvin L. Griem, M.D.

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MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch i _.

FROM: .'

SUBJECT:

COMMENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR DACRY0 CYST 0 GRAPHY These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

Yes,,, / No Abstain Comments Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Comments Question: Are any special radiation safety precautions needed for

. werkers, the patient or the public?

Yes No Abstain Coments

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MEM6?4NDUM FOR: Vandy L. Millcr, Chicf

\ Material Licensing Branch F OM: -

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SUBJECT:

COMMENTS ON THE USE OF SULFUR COLLOID, PERTECHNETATE AND MACR 0 AGGREGATED HUMAN SERUM ALBUMIN FOR ASSESSING PATENCY OF LEVEEN SHUNTS, VENTRICULO-ATRIAL SHUNTS AND VENTRICULO-PERITONEAL SHUNTS These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester? -

Yes No Abstain Cocnents

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Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Coments Question: Are any special radiation safety precautions needed for workers, the patient or the public?

Yes No Abstain Cornents b

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m hRANDL,MFOR: Vandy L. Millsr, Chief

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SUBJECT:

C0tmENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR CYST 0 GRAPHY These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

Yes No Abstain Comments

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Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Comments Question: Are any special radiation safety precautions needed for workers, the patient or the public?

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s t MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch FROM: .

SUBJECT:

COMMENTS ON THE USE OF SULFUR COLLOIO, PERTECHNETATE AND MACR 0 AGGREGATED HUMAN SERUM ALBUMIN FOR ASSESSING PATENCY OF LEVEEN SHUNTS, VENTRICULO-ATRIAL SHUNTS AND VENTRICULO-PERITONEAL SHUNTS These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

! Yes No Abstain Comments Defer to physicists.

Question: Do you believe the potential benefit of the study justifies

, the radiation dose to the patient?

Yes No Abstain Comments The benefit is of crucial importance and the dose is insignificant.

Question: Are- any special radiation safety precautions needed for workers, he patient or the public?

Yes No Abstain Conments nm .-ma4 ~,,c,4am 4e in nnnrnuna n vi c-n tiem 4m e4 43m. er ~.

with offmtivo vndinHnn enfntv nrenvi4-4nne 51 gnat.ure -

, i MEMORANDUM FOR: Vandy L. Miller, Chief

. Material Licensing Branch FROM: C V. P. Collins, M.D. l 9000 Westheimer i Suite 53 i Houston, TX 77063 I

SUBJECT:

COMMENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR DACRY0 CYST 0 GRAPHY These are my responses to your questions about the subject request.

Questio'n: Do you agree with the dosimetry calculations subnitted by the requester?

Yes No Abstain Comments Deferred to physicist members of the advisory ccanittee.

Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Comments Although I have not had personal experience with this examination, opthamologists here indicate an interest and increase usage for an atraumatic procedure.

Question: Are any special radiation safety precautions needed for workers, the patient or the public?

Yes ' No Abstain Comments A familiar radionuclide in very low dosage should present no radiation safety problem.

  • 9 Signature p V. P. Collins, M. D.

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MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch l FROM:

SUBJECT:

COMMENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR CYST 0 GRAPHY These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

Yes No Abstain Comments Defer to chvsicists.

Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Comments _

Radiographic procedure with contrast medium is simpler, quicker and produces an image with better resolution. Even if patient dosage is acceptable the examination is unnecessary.

Question: Are any special radiation safety precautions needed for workers, the patient or the public?

Yes N'o Abstain Comnents Don't do it!

Even if the hazard is small the contamination of equignent and personnel is unacceptable. __

SignatVrJV

e MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch FROM:

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SUBJECT:

CdMMENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR DACRY0 CYSTOGRAPHY These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

Yes / No Abstain Comments Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Comments

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Question: Are any special radiation safety precautions needed for 1

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Yes No / Abstain Comments N w (do m. m.b. '

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MEMORANDUM FOR: Vandy L. Millcr Chief Material Licensing Branch FROM: ,

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SUBJECT:

COMMENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR CYSTOGRAPHY These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

Yes No Abstain Comments Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Comments _

Question: Are any special radiation safety precautions needed for workers, the patient or the public?

Yes N'o Abstain Comnents Sipature/>4ef 1

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. MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch FROM: .--& S:gp(( S,g)c h p,b,

SUBJECT:

COMMENTS ON THE USE OF SULFUR COLLOIO PERTECHNETATE AND MACR 0 AGGREGATED HUMAN SERUM ALBUMIN FOR ASSESSING PATENCY OF LEVEEN SHUNTS, VENTRICULO-ATRIAL SHUNTS AND VENTRICULO-PERITONEAL SHUNTS These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester? -

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Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

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Question: Are any special radiation safety precautions needed for workers, the patient or the public?

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SUBJECT:

COMMENTS ON THE USE OF SULFUR COLLO10, PERTECHNETATE AND MACR 0 AGGREGATED HUMAN SERUM ALBUMIN FOR ASSESSING PATENCY OF LEVEEN SHUNTS, VENTRICULO-ATRIAL SHUNTS AND VENTRICULO-PERITONEAL SHUNTS These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations submitted by the requester?

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Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

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SUBJECT:

C0W1ENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR DACRYOCVSTOGRAPHY These are my responses to your questions about the subject request.

Question: Do you agree with the dosimetry calculations subnitted by the requester?

Yes No Abstain Comments 1

Question: Do you believe the potential benefit of the study justifies the radiation dose to the patient?

Yes No Abstain Comments Question: Are any special radiation safety precautions needed for workers, the patient or the public?

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SUBJECT:

COMMENTS ON THE USE OF PERTECHNETATE TECHNETIUM-99M FOR CYST 0 GRAPHY These are my responses to your questions about the subject request.

Question: Do you agree with the dosinetry calculations submitted by the requester?

Yes No v Abstain Comments i

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Yes No Abstain Comments

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