ML18051A725
| ML18051A725 | |
| Person / Time | |
|---|---|
| Issue date: | 02/19/2018 |
| From: | Metter D, Suh J, Weil L Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18051A725 (3) | |
Text
NuclearRegulatoryCommission(NRC)
AdvisoryCommitteeontheMedicalUsesofIsotopes(ACMUI)
SubcommitteeonTrainingandExperienceRequirementsforAllModalities SubcommitteeDraftInterimReport February19,2018 SubcommitteeMembers Dr.DarleneMetter Dr.ChristopherPalestro(Chair)
Dr.JohnSuh Ms.LauraWeil Charge Thespecificchargeofthissubcommitteeistoperiodicallyreviewthetrainingandexperience requirements(T&E)currentlyineffectforallmodalities,whichincludesbothunsealed byproductmaterials(10CFR35.100,35.200,35.300,&35.1000)andsealedbyproduct materials(10CFR35.400,35.500,35.600,&35.1000)andtomakerecommendationsfor changesasneeded.
Guidingprinciple ThesubcommitteerecognizesthatanyrecommendationsfororagainstchangesinT&Eshould ensurethattherequirementsandprovisionsinpart35,whichprovidefortheradiationsafety ofworkers,thegeneralpublic,patients,andhumanresearchsubjectsaresatisfied,while simultaneouslyensuringthatpatientaccesstotheseproceduresisnotunnecessarily compromised.
Background
InJune2015,asaresultofconcernsexpressedbyvariousstakeholders,asubcommitteewas formedtodetermineifthe700hourtrainingrequirementplacedahardshiponpatientaccess toalphaandbetaemittingtherapeuticradiopharmaceuticalsandifnecessary,tomake recommendationsforpotentialchangesandestablishrecommendationsforthetotalnumber ofhoursofTraining&ExperienceforUseofUnsealedByproductMaterialforWhichaWritten DirectiveisRequired(10CFR35.390).Basedonitsinvestigation,thesubcommitteeconcluded
thatthecurrentrequirementof700hoursforauthorizedusers(AUs)doesnotadverselyaffect patientaccesstotheseradiopharmaceuticalsandthatnochangeintheT&Erequirementswas warranted.Thesubcommitteedidnote,however,thatnearly15yearshadpassedsincethe requirementshadbeenupdatedandrecommendedthattheACMUIformasubcommitteeto periodicallyreviewtheT&Erequirementsforallmodalitiescurrentlyineffectandtomake recommendationsforchangesasneeded.TheACMUIacceptedthisrecommendationandthe SubcommitteeonTrainingandExperienceRequirementsforAllModalitieswasformed.The subcommitteedevelopedaprocedureforreviewoftheT&Erequirementsandinorderto optimizethereviewprocesstheplanwastobeginwith10CFR35.100,followedby35.200, 35.300,etc.Duetoongoingconcernsaboutpatientaccess,however,thesubcommitteewas directedtoprioritizethereviewoftheTraining&ExperienceRequirementsforUseofUnsealed ByproductMaterialforwhichawrittendirectiveisrequired.(10CFR35.390)
CurrentStatus TherehavebeentwodevelopmentssincetheACMUIrecommendedagainstchangingT&E requirementsunder10CFR35.390.OnJanuary26,2018theUSFDAapprovedlutetium177 dotatatefortreatmentofcertainneuroendocrinetumorsgiventheencouragingresults obtainedwiththisagentinclinicaltrials.Incontrasttoothertherapeuticradiopharmaceuticals whichhavebeenapprovedforveryspecificsituations/indications,suchaswhenother treatmentshavefailed,theindicationsforlutetium177dotatatearemuchbroader:treatment ofsomatostatinreceptorpositivegastroenteropancreaticneuroendocrinetumors(GEPNETs),
includingforegut,midgutandhindgutneuroendocrinetumorsinadults(NDA208700Approval Letter).Giventheexcellentresultsobtainedwithlutetium177dotatateinclinicaltrials,the broadindicationsforitsuse,andthefactthatneuroendocrinetumorsarethesecondmost commongastrointestinaltumor,itislikelythattherewillbeconsiderabledemandforthis agent.
Inanotherinterimdevelopment,thesubcommitteenotes,withsomeconcern,theprecipitous decreaseinthenumberoffirsttimecandidatessittingfortheCertificationExaminationofthe AmericanBoardofNuclearMedicine;in2016fewerthan50individualssatforthis examination,incontrastto80100individualsinthepast.Furthermore,areviewofthe AccreditationCouncilforGraduateMedicalEducationdatabaseshowsasteadydeclineover thepastdecadeinboththenumberofNuclearMedicineResidencyProgramsandthenumber ofresidentsenrolledinthoseprograms:from57programswith161residentsinacademicyear 20072008to41programswith75residentsinacademicyear20172018.Whileitisdifficultto judgetheimpactofthisdeclineonpatientaccess,thenumerouslettersthathavebeenwritten, andthediscussionsandpresentationsonthistopicthathavetakenplaceoverthepastfew yearshavefocusedonwhetherornotthereisasufficientnumberofAUs;nodatahavebeen
offeredtosuggestthereisasurplus,norhavefutureneedsbeenaddressed.Thusthe subcommitteeviewsthedecreaseinthenumberofnuclearmedicinephysiciansasapotentially seriousproblem,perhapsnotimmediately,butcertainlyinthefuture.
Inviewofthepotentialproblemsinpatientaccessthatcouldbecreatedbyanincreaseinthe numberofprocedurescombinedwithadecreaseinthenumberofAUs,thesubcommittee believesthatitistimetoreconsiderthecreationofanalternativepathwayforAUsfor10CFR 35.390,TrainingforUseofUnsealedByproductMaterialforWhichaWrittenDirectiveis Required.Whiletherequirementsofanalternativepathwayarebeyondthescopeofthis interimreport,thesubcommitteeoffersthefollowingitemsforconsideration:thelengthand scopeofthetraining,theminimumnumberofadministrationsthatanindividualmustperform andwhetheratotalnumberissufficientoraspecificnumberperclass(alphaandbeta),written certificationversusformalexamination,andmaintenanceofcompetence.
Thesubcommitteewelcomescommentsandsuggestions.