ML20127C388
| ML20127C388 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1992 |
| From: | Siegel B NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20127C387 | List: |
| References | |
| FOIA-92-367 NACMUI, NUDOCS 9207200290 | |
| Download: ML20127C388 (10) | |
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UNITED STATES ON-i NUCLEAR REGULATORY COMMISSION (K
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MEMORANDUM FOR:
Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Barry A. Siegel, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes
SUBJECT:
SUMMARY
REPORT - MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF IS0 TOPES, MAY 7 AND 8, 1992 The Advisory Comittee on the Medical Uses of Isotopes held its semiannual meeting on May 7 and 8, 1992, at the Sheraton Reston Hotel in Reston, Virginia.
Committee members present at the meeting were:
Barry Siegel, M.D., Chairman Peter R. Almond, Ph.D.
William Briner, Capt., USPHS (Retired)
Judith Brown Steve Collins Daniel Flynn, M.D.
Melvin Griem, M.D.
A. Eric Jones, M.D.
Carol Marcus, M.D., Ph.D.
Cerald M. Pohost, M.D.
Edward Webster, Ph.D.
Also present: John E. Glenn, Ph.D, Nuclear Regulatory Commission (NRC),
(Designated Federal Official for the panel), and Larry W. Camper, Section Leader, Medical and Academic Section, NRC.
Prepared presentations were made l
by Kathleen Black, AE00, NRC; Fun Fong, M.D., Oak Ridge Associated Universities; Josephine Piccone, Ph.D., NRC; Myron Pollycove, M.D., NRC l
Medical Visiting Fellow; John Glenn, Ph.D., NRC; John Telford, NRC; Leon S.
Malmud, M.D., President, Society of Nuclear Medicine; C. Douglas Maynard, M.D., American Board of Radiology; and Gretchen Wheeler, Institute for Nuclear Medicine Education, Inc.
l The ACMUI discussed the issues and made the recommendations indicated below.
l 1.
Administrative issues l
Prior to the meeting, the Committee was sequestered to hear instructions from John Szabo, of the NRC's Office of the General Counsel, regarding conflict of interest issues.
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John E. Glenn, Ph.D., NRC, announced that a closed session of the Committee would be held to discuss the credentials of three physicians.
(This closed session was held at the end of the public meeting on May 7th.)
2.
Abnganal Occurrence Criteria Kathlecn Black provided a historical perspective of the development of Abnormal Occurrence (AO) criteria and introduced Fun Fong, M.D., of Oak Ridge Associated Universities. Dr. Fong, an NRC consultant, is assisting in the development of revised guidelines for reporting misadministrations as A0s.
Dr. Fong suggested that there should be some definite adverse effect on the patient as the basis for characterizing events as A0s and proposed that A0s should include those medical misadministrations reported to NRC as follows:
multiple misadministrations to more than or,e patient that arise from a common error in technique or equipment; any therapeutic misadministration which is clearly out of the therapy range for that particular treatment to a given organ; two or more therapeutic misadministrations that are directed at the wrong portion of the body; misadministrations to unintended organs or whole body that would cause an overall increase in risk of developing cancer in that organ of greater than 0.01, using the standards of BEIR V; or a misadministration causing a 25-50 percent chance of a deterministic effect.
Dr. Siegel conmented that the use of medical misadministrations reported to NRC as a criterion limits the selection of A0s to the pool of events labeled as misadministrations and thus might miss the opportunity to report events that are of generic significance.
Kathleen Black clarified that NRC has other A0 criteria that are not necessarily tied to misadministrations.
The Committee discussed the necessity of NRC's requirement to report abnormal occurrences to Congress, and the selection of incidents that are included.
The Committee questioned who in Congress receives the report and how the information is used, and the staff responded with a historical perspective to explain the origin of the requirement.
The Committee expressed its concern that some of the medical A0s reported may not be at all relevant to Congress.
The Committee urged that the Commission reassess its understanding of Congressional intent with respect to medical A0 reporting.
Dr. Siegel asked the group to focus on A0s within the medical misadministration framework under discussion. Dr. Siegel asked if all were in agreement that what is reported to Congress currently doesn't always meet those criteria? Hs. Brown said that the low incidence of misadministrations occurring with uses of byproduct material compared with error rates of other medical specialties might be related to the NRC reporting requirement. A discussion followed that ended with a comparison of reporting requirements for incidents involving FDA-regulated activities (uses of drugs and devices) versus NRC-regulated uses of byproduct material.
The Committee questioned the cost of the program to identify, evaluate, and report abnormal occurrences.
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Dr. Siegel provided summary comments that A0 reports should contain more information that would put the contents of the report into perspective (i.e.,
reporting of denominators) and supported the staff's efforts to revise the A0 criteria.
The Committee proceeded to review the guidelines presented by Dr. Fong. Dr.
Siegel concluded that the Committee was in general agreement with the general principles presented by Dr. Fong.
However, the Committee was in general disagreement with the specific A0 reporting criteria proposed by Dr. Fong, questioned whether events involving single patients were ever appropriately classified as A0s, and emphasized that A0s should be signal events that might forewarn of more serious systematic safety failures.
The Committee also questioned whether the more appropriate audience for some of the A0s reported currently is licensees, by way of the NMSS Newsletter and other vehicles for dissemination of this type of information, rather than Congress by way of the quarterly A0 report.
3.
Broad Ssppe Licensino Josephine Piccone, Ph.D. described new guidance for the licensing of broad scope medical programs.
The guidance was developed in response to questions regarding what broad scope medical licensees were authorized to do and to clarify misconceptions held by some in the regulated community, that the 1987 Part 35 revision had a negative effect on broad scope program flexibility.
This guidance was developed to: clarify and formalize the intent of'the Part 35 revision through the use of revised standard license conditions; maintain uniformity among the regions-by the use of a model license; and provide guidance for assignment of program codes.
Dr, Piccone described the medical broad scope licensing criteria and emphasized that broad scope medical licensees may authorize the use of any byproduct material in medical use and research activities, by anyone, in accordance with review and approval procedures and criteria established by the licensee's Radiation Safety Committee.
Dr. Piccone explained that broad scope licensees would be required to comply with the proposed prescriptive and performance criteria of Part 35, with exceptions for:
licensee approval of-medical (physician) authorized users; use of alternate suppliers of byproduct material and reagent kits to those specified in 35.49; and use of non-IND/NDA radiopharmaceuticals. Broad scope licensees may also request exceptions to the Subpart J, training and experience criteria for physicians.
A discussion followed that clarified that there was no need to seek an exception for those individuals who would be working under the supervision of an authorized user.
Dr. Marcus questioned why broad scope licensees were limited to byproduct material with atomic numbers from 1 to 83. Dr. Piccone responded that broad scope licensees were not so limited, and that other byproduct material radionuclides could be added to a license as line items.
Dr. Marcus asked if broad scope licensees would be exempted from the requirements of the Interim Final Rule relating to derivations in
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manufacturer's instructions for the preparation of radiopharmaceuticals.
Mr. Camper responded that they are.
At the end of the presentation, Dr. Siegel, summarizing the consensus of the Committee, confirmed that this clarifying guidance appears to have " fixed" the perceived problems related to broad scope licenses.
Dr. Siegel asked if there would be a Regulatory Guide regarding broad licenses. Dr. Piccone responded that in addition to the guidance that would be sent to the regions, NRC is working on a revision to the standard review plan for broad licenses.
A discussion followed regarding the best way to inform the Agreement States and those licensees most affected.
It was agreea that a NHSS newsletter article would be most appropriate. Dr. Siegel further suggested that the Journal of Nuclear Medicine might wish to publish an informational article on this topic in its Newsline section.
Dr. Siegel introduced teon Malmud, M.D., president of the Society of Nuclear Medicine.
Dr. Haloud addressed three points:
(1) support for the regulation of>harmaceuticalsanddevicesbythefoodandDrugAdministration(FDA) ratier than by the NRC, except with respect to NRC s responsibility for overseeing radiation safety; (2) maintaining the flexibility provided by broad licenses; and (3) the reaffirmation that the responsibility for treating patients rests with physicians and not the NRC.
4.
Clarification of Trai_nina and fxperience Reautrements for MhoriLPJi_IliCL1 Hyron Pollycove, M.D., Medical Visiting fellow, discussed recent efforts to clarify training __ and experience requirements for physician authorized users who are not board certified but request authorization under one of the other training pathways allowed by the regulations. 'A task group, chaired by Dr.
Pollycove, has been formed to include Ors. Siegel, Webster and H. William Strauss (Massachusetts General Hospital) to evaluate the current training and experience criteria. Dr. pollycove proposed that the current training requirement of six months be maintained to include a minimum of 1,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> of training, and the current subcategories of 200, 500, and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> (for the didactic, handling, and clinical components, respectively) be eliminated.
As an alternative, there would be two interrelated components to be completed in a minimum of 1000 hour0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br />s: (1) the didactic instruction with correlated supervised laboratory exportei.ce; and (2) supervised clinical experience.
The proposed training modules.would be task oriented with increased emphasis on documentation by the preceptor regarding the mastery of the learning objectives by the applicant. He then described in' detail the subject matter
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to be covered in the didactic portion. Dr. Pollycove also discussed two issues associated with the preceptoring process, namely the qualifications of-the preceptor and the content-of the preceptor statement (s) that accompany a license application.
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Dr. Haynard, as a representative of the American Coard of Radiology (ABR),
offered the following coments:
(1) certification by ABR should continue to be recognized by NRC in the licensing process; (2) NRC should continue to review the training and experience credentials described in Subpart J; (3)
ABR would like the opportunity to review proposed training and experience criteria; and (4) 1000-hours versus a six-month rotation is preferred because every training program is designed differently and may or may not encompass six-month blocks dedicated to one discipline.
The general consensus of ACHUI was that the more detailed list of tasks, skills and knowledge components to be completed in a minimum of 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br />, as proposed by the task force, ap) ears to be an improvement over the current more general list, and allows for tie current variations in training-program format.
The ACHUI also recomended that NRC (or a contractor) prepare a syllabus that can serve as the basis for didactic basic-science training of-physicians for licensure.
Dr. Pohost suggested that a single-organ specialists, e.g., cardiologists, need less training than 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br />, because they do not require the same depth of clinical experience as a general nuclear medicine specialist. Chairman Siegel responded that the consensus of the Committee is, and has been, that both types of specialists require the same amount of training time to observe the problems with the radiopharmaceuticals, equipment, and general quality control activities in the nuclear medicine facility, and to gain enough experience to be able to train supervised individuals.
Dr. Pohost referred to a meeting, that had occurred approximately 8 years ago at the request of Congress, that brought together various groups in the medical community to discuss the duration of training (4 versus 6 months). Mr. Cunningham suggested that, at the next ACHUI meeting, the staff should provide a synopsis of the evolution of this ie ue over the last ten years for the benefit of some Committee members who ma) not be fully aware of its history.
Gretchen Wheeler, of the Institute for Nuclear Medical Education, stated that the Institute agrees with the integrated approach to fulfilling the training and experience criteria as proposed by Dr. Pollycove.
She encouraged NRC to continue to consider "non-traditional" educational facilities (" universities without walls") as viable education sources for applicants to obtain this required specialized education.
The discussion then moved to the staff's current effort to revise the format -
of the preceptor statements in order that these will effectively document that a preceptor or group of preceptors has certified that the training actually occurred and that the training led to an understanding or expertise in-the requisite concepts. The Committee suggested that the current process used by residency review committees, through ACGHE, for documentation of adequate training might be useful to NRC.
The next subject considered was the qualifications of the preceptor.
The comittee agreed that being an authorized-user physician is not, in and of_
itself, a sufficient qualification _ to be a preceptor, furthermore, the Committee noted that it would be best if all training occurred within the-
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setting of medical institutions with established residency training programs,
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since these facilities have institutional oversight comittees that evaluate the quality of the residency training (in addition to ACGME approval of specific programs, if applicable).
However, there are non-traditional approaches to training that must continue to be available to applicants and acceptable to NRC. Currently, NRC does not have a mechanism in place to evaluate and approve training programs in advance. One alternative would be for NRC to rely on professional organizations to audit and accredit training programs in medical practice setting outside of formal training programs. Mr.
Larry Camper informed the Committee that similar concerns have recently been expressed by Agreement State program representative regarding the quality of non-traditional training programs.
In addition, W. Camper suggested that the task group provide the following for discussion at the next semiannual ACMUI-meeting:
(1) revised preceptor statements; (2) a mechanism for the approval of training programs (perhaps by testing the participants or observation of 4
the training sessions); and (3) how ACMUI might be involved in the review of the content of the training programs reviewed by NRC.
It was suggested that Dr. Pohost join the task group to provide cardiology representation; Dr.
Pohost agreed.
5.
Arapping.g_pL(ertification in Nuclear Medicine by the Royal Co11eae of I
Physicians _and_SyLqtons of Cana_d.1 Larry Camper presented the request from the Royal College of Physicians and r
Surgeons of Canada (RCPSC) for recognition of certification in Nuclear Medicine by that professional board as a basis for physician licensure under 10 CFR Part 35, Subpart J, " Training and Experience Requirements." The staff 4
reviewed the specialty training criteria provided by the RCPSC and found them equivalent to those of the American Board of Nuclear Medicine, and ecommended to the Committee that certification by the RCPSC be approved for recognition in Part 35, Subpart J.
3 Dr. Siegel entertained a motion, which was made by Dr. Marcus and was seconded and passed by ACHUI unanimously, that NRC accept certification by the RCPSC in Nuclear Medicine as acceptable training and experience criteria.
Part 35 will be-revised to recognize the RCPSC at the next appropriate rulemaking opportunity.
6.
VjlddLon_theXNP/SNM Radiopharmaceutical Petition Rulemkino ACMV1 offered recommendations on particular sections of the draft language at the November 1991 meeting.
The staff considered ACMVI's recommendations and made appropriate revisions. Mr. John Telford, NRC, discussed only those items that had been revised since the November meeting.
The term " medical use" was 4
modified to include human research. With respect to-human use by-unauthorized individuals, an individual that does not meet the training and experience -
criteria described in Subpart-J may use byproduct material for human research under the supe _rvision of an authorized user. Mr. Telford pr_oposed the following for use of radiolabeled biologics:
(1) diagnostic radiolabeled i
biologics be treated the same as diagnostic radiopharmaceuticals; and (2) the safe use of therapeutic radiolabe'ed biologics be reviewed on a case-by-case a
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basis.
The proposed durations of training and experience for an authorized nuclear pharmacist (ANP) and a nuclear pharmacist (NP) are 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> and 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, respectively.
NRC would recuire that the training be documented on a i
preceptor statement. The ANP could delegate all responsibilities except the responsibility for the development of the radiopharmaceutical procedures manual. ANPs and NPs would be permitted to supervise a limited number of radiopharmacy technicians (with the maximum number as specified by State law i
or up to six, whichever is fewer).
Mr. Telford stated that the draft language is silent on the issue of whether a Part 35 authorized-user physician may compound in the absence of an ANP or NP.
Capt. Briner noted that under a state license to practice medicine, a-physician may compound radio)harmaceuticals for his or'her own patients only.
The proposed language might se inconsistent with State and FDA regulations, and does not appear to adequately eddress one of the elements of the petition.
Therefore, the staff will need to revisit these issues.
No specific guidance was given by the Committee with respect to whether current Part 35 training and experience criteria is adequate to authorize physicians to compound.
However, Dr. Siegel offered one philosophical construct wherein NRC could discard the Subpart J criteria in their entirety and rely on the prescriptive and performance requirements of Parts 20 and 35 to govern the uses of byproduct material by physicians.
Mr. Telford then introduced four new items for discussion:
(1) a.1 of the current provisions described in the Interim final Rule would be eliminated except one; (2) 10 CFR 32.72 would be revised to require licensees to demonstrate that they are either registered with FDA or a have a State license-to practice pharmacy; (3) 10 CFR 35.25 would be revised to add an item to require the conduct of an annual review; and (4) 10 CFR 35.49 would be revised to increase the authorized suppliers of byproduct. material.
The general consensus of the ACMul was that the' draft radio)harmacy language is considerably more complex than necessary to respond to tie concepts in the -
petition for rulemaking.
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The ACMUI indicated that most medical licensees do not have the necessary
- equipment available to perform direct radioactitity measurements for individual patient dosages of radiopharmaceuticals that contain alpha-or beta-emitters and recommended that NRC provide licentees with additional guidance to assist in compliance.
7.
Jeplementation of the Ouality ManagenenLivig Larry Camper discussed implementation of the I;uality Management-(QM)_ Rule which will include:. (1) contract support for review of'QM program submittals;
_ (2) regional training. conducted to stress performance-based inspections; _and (3) coordination of enforcement _ actions with headquarters' staff. Mr. Camper summarized the changes in the rule:
(1) revised and_new definitions in 10 CFR 35.2; (2) revised notification and reporting requirements in 10 CFR 35.33; and (3) revised supervision: requirements in 10 CFR 35.25. _He noted that the 5-rem effective dose equivalent threshold limit for diagnostic
Mr. Richard E. Cunningham 8
misadministrations will nearly eliminate reporting of incidents that i. ave heretofore been reportable. ACMUl reminded the staff that some regulatory guidance will need to be developed with respect to the calculation of effective dose equivalent given the current discrepancies between Part 20 and ICRP definitions.
Mr. Camper briefly discussed each objective described in the QM rule and stated that the representative sampling of patient procedures selected for review by the licensee can be determined through mechanisms other than those suggested in Regulatory Guide 8.33.
The regions have been instructed as "a rule of thumb" that a licensee should sample all patient procedures for those numbering fifty or less, and a twenty percent sampling of all patient procedures numbering greater than fifty.
NRC has received approximately 90% of required QM program submittals. Non-submittals apacar to be due to:
(1) a " lack of understanding" that some materials autiorized by the license required submission of a QM program; and
- 2) the belief that the rule was not in ef fect as a result of " confusion" regarding clearance from the Office of Management and Budget.
Licensees have been notified by letter that the deadline for submittals was extended to June 8, 1992.
Carol Marcus, M.D., noted that the statement of work for contract support should be reviewed by physicians and by the ACMUI.
Daniel Flynn, H.O., also suggested that ACHUI review the standard review plan to be used by the contractor.
Dr. Siegel suggested that it might be possible for a subcommittee of ACHUI, including radiation oncologists, to review the plan.
8.
Ainssment of Nursina and Prt9 M ard Rd en king John Telford stated that NRC considered tne recommendations made by the Committee during the November 1991 *nceting and has drafted appropriate revisions.
He discussed a 1976 r ticle by Drs. Stoffer and Hamburger that presented 237 cases of therapeuti: administrations of I-131 during the first trimester of pregnancy. The art cle concluded that routine pregnancy testing should be done.
In addition, Mr. Telford discussed ICRP Report No. 52, which recommends interviewing the patint, testing for pregnancy prior to treatment, and taking " great reservation" with the administration of 1-131 and P-32.
He presented NRC recommendations and revised proposed language that requires selection among various methods for alerting patients to the importance of revealing pregnancy or nursing status prior to diagnostic administrations.
1 Mr. Telford then discussed new language for therapeutic administrations.
Unintended administrations were discussed with concern directed toward classification of misadministrations for cases in which the patient-is judged not to be pregnant at the time of treatment, but the patient conceives soon
-afterward, the patient provides misleading information, or the pregnancy is-too early to be detected by available laboratory methods, _ Hr. Cunningham noted that NRC will reexamine the language to'er.sure that such cases _would not be reportable. Dr. Siegel noted that the Committee felt that the_ language
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i should me "it eminently clear that those situations are not i
misadministrations."
l Mr. Telford stated that Oak Ridge Associated Universities would be assisting in assessing the need for or selection of reporting thresholds for unintended diagnostic administrations to pregnant or nursing patients.
Ors. ihbster and Siegel noted that the Committee should revisit the threshold determinations in the future.
Mr. Telford presented cost estimates associated with methods for alerting patients and condutting physical examinations for comparison with those that had been prepared by Dr. Marcus. Ors. Marcus and Siegel expressed serious concern regarding the reliability of the values used in the NRC's cost estimates and suggested that new values should be sought to derive more realistic estimates. Mr. Camper noted that the values were presented as a basis of discussion and would be revisited before a formal regulatory impact analysis would be done.
Dr. pollycove noted that the actual incremental cost of assessing patient pregnancy is small, approximately less than 0.1%, because most licensees already employ one of the methods allowed by the proposed rule.
He discussed a draft form that could be used by licensees as the written directive for ordering patient dosages and that would facilitate documentation that the patient's pregnancy and nursing status had been assessed by the authorized-user physician.
Dr. Marcus questioned whether there are nuclear medicine departments without procedures for asking and determining patient pregnancy. Mr. Camper noted that incidents have been reported where either a procedure for inquiring about patient pregnancy did not exist or where an established procedure was not followed.
Mr. Camper suggested that the Committee should provide input during the process of developing draft language for the regulatory guide on the rulemaking.
Dr. Marcus made a motion to, " recommend to the NRC that no regulation or license condition involving pregnancy and/or lactation be considered further
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by tha staff." The motion was seconded, but was defeated by the ACMUI (3 for;-
7 against; I abstention.)
9.
SitLttLRep_grt on the Doansion of ACMVJ The staff informed the members of the intention __to solicit nominations of persons to fill three new positions on ACMUl:
(1) an individual qualified to address medical research issues.to include expertise with monoclonal antibodies; (2) an individual with experience in hospital administration or management; and (3) a radiation oncologist with expertise in teletherapy, brachythera)y, and/or stereotactic radiosurgery.
In addition, the staff plans to rotate t1ree members during 1992.
All new members will' serve a two-year t ernc,
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Mr. Richard E. Cunningham 10 3
i with possible-re-appointment for an additional two-year term.
A motion was i
made and the Committee unanimously agreed that a two-year term is too short i
for a member of ACHUI to become an effective participant in Committee deliberations.
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