USE OF RADIONUCLIDE AGENTS IN THERAPEUTIC TREATMENT OF PATIENTS PROCEDURE

Transcription

1 Divisin f Nuclear Medicine Prcedure USE OF RADIONUCLIDE AGENTS IN THERAPEUTIC TREATMENT OF PATIENTS PROCEDURE Purpse: The purpse f this versight utline is t define the rles, respnsibilities and prcesses used in the rdering, preparatin, administratin, and dcumentatin f radinuclide therapies fr patients at the University f Wiscnsin Hspital and Clinics. These prcedures are intended t ensure the safe use f these therapies thrugh detailed standardized prcedures and prvide an versight infrastructure t review and apprve radinuclide agent/prtclspecific prcedures, maintain updated plicies and prtcls, and implement quality imprvement initiatives in cncrdance with applicable institutinal plicies and regulatry agencies. Plicy: All therapeutic radinuclide regimens will be reviewed and apprved by the Human Radiatin Use Cmmittee and result in the develpment f an agent/prtcl-specific, cmprehensive and multidisciplinary prcedural dcument. Such dcuments will be develped fr any human use therapy, either nn-research and research, and will detail the flw frm the prescribing f the radipharmaceutical t filing the paperwrk at the cmpletin f administratin. This plicy cvers multiple departments including Nuclear Pharmacy, Nuclear Medicine, Radiatin Onclgy, and Inverventinal Radilgy. The Human Radiatin Use Cmmittee prcess will ensure all the elements f this prcedure are embdied in the regimen specific wrksheet. Review by the Radiatin Human Use Cmmittee des nt bviate additinal review by ther cmmittees, as required by institutinal r regulatry plicy. Definitins: Authrized User = Medical Physician licensed by the State f Wiscnsin and apprved by the UW Radiatin Safety Cmmittee t prescribe radipharmaceuticals Authrized Nuclear Pharmacist = Pharmacist licensed by the State f Wiscnsin and apprved by the UW Radiatin Safety Cmmittee t handle, cmpund, and dispense radiactive material Authrized Medical Physicist = Medical Physicist added t the UW license t handle radiactive material Administering Clinician = Authrized User, Medical Physicist, Nuclear Medicine Technlgist, Physician, Registered Nurse Cntracted Nuclear Pharmacy = Licensed facility external t UWHC apprved fr the cmpunding and dispensing f radipharmaceuticals Nuclear Pharmacy, Nuclear Pharmacist r Nuclear Pharmacy Technician= UWHC Nuclear Pharmacy facility r UWHC persnnel f the Nuclear Pharmacy 1

2 Patient = Individuals receiving the therapeutic radinuclide agent regardless f nn-research r research ( subjects ) status Radinuclide Therapy Dse Dcumentatin Frm (Appendix B) an agent and prtcl specific written directive that is designed t incrprate all elements utlined in this plicy related t the rdering, preparatin, administratin and dcumentatin f the radinuclide including the written directive. Prcedure: 1. The apprpriate radinuclide therapy agent/prtcl-specific prcedural dcument will detail the prcedures t be fllwed and will capture the general prcedures utlined belw. See Appendix A fr template 2. All therapeutic radinuclide agents shall be rdered using HRUC apprved preprinted physician rders, the department standard requisitin prcess, r prviding a cmpleted written directive t the Authrized Nuclear Pharmacist, Authrized Medical Physicist r Senir Nuclear Medicine Technlgist. Fr inventry verificatin and patient cnvenience, the Nuclear Pharmacist may rder therapeutic inventry via telephne r rder t ensure that prduct will be available. A written directive will be frwarded t the Nuclear Pharmacist r Medical Physicist, wh will frward t the Authrized User Research prtcls will utilize preprinted physician rders r written directives prcessed and apprved by multidisciplinary review in accrdance applicable hspital plicies and apprved by the Human Radiatin Use Cmmittee as part f the agent/prtcl-specific develpment prcess 3. Upn receipt f the rder/requisitin, the Authrized User will: 3.1. Determine apprpriateness f the rder and calculate r cnfirm the requested dse based n apprpriate clinical determinatins, cmmercial agent dsing parameters and/r prtcl stipulatins 3.2. Sign the written directive utilizing the Radinuclide Therapy Dse Dcumentatin frm specific t that radinuclide and prtcl. 4. Other Patient Infrmatin/Educatin Verificatins: Prir t administratin f the radinuclide, the Authrized User will cmplete and dcument the fllwing n the Radinuclide Therapy Dse Dcumentatin Frm: Cnfirmatin that the prescribing physician has explained the dse and treatment t the Administering Clinician Cnfirmatin (reasnable assurance) f negative pregnancy test r excluding clinical cnditin Cnfirmatin that the patient is nt currently breast feeding The identity f the patient accrding t hspital prcedures using tw (2) methds f identificatin Verify (r btain) infrmed cnsent Written radiatin safety instructins prvided t the patient If applicable, prvisin f the applicable Health Facts fr Yu t the patient Other elements as prmpted n the Radinuclide Therapy Dse Dcumentatin frm Fr therapy dses that will be administered at a future appintment, the written directive is frwarded t the Nuclear Pharmacy befre the cmpletin f the Patient Infrmatin/Educatin Verificatins. These verificatins will be dne, hwever, when the patient arrives at the clinic and meets with the physician. 2

3 5. The written directive is frwarded t the Nuclear Pharmacy r Radiatin Onclgy 6. Upn receipt f the written directive within the Nuclear Pharmacy r Radiatin Onclgy 6.1. Written Directive Verificatin: The Nuclear Pharmacist r Medical Physicist will verify the cmpleteness and accuracy f the written directive and dcument his/her verificatin n the Radinuclide Therapy Dse Dcumentatin frm (sectin A) The written directive verificatin prcess will ensure the therapy is apprpriate and prperly cmpleted. The written directive shall cntain the fllwing:: Dse in mci Indicatin Clinical versus Research Status Pertinent Lab Values, if applicable Signed, dated and timed by Authrized User 6.2. Radinuclide Cmputer Order Entry: Once the written directive has been verified, it will be entered int the Nuclear Pharmacy cmputer system by the Nuclear Pharmacy 6.3. Radinuclide Preparatin: The radipharmaceutical can be prepared by nuclear pharmacy persnnel fllwing standard safe handling prcedures and labeled, with the dse preparatin dcumented (including dse assay) n the Radinuclide Therapy Dse Dcumentatin Frm A prescriptin label will be prduced frm the Nuclear Pharmacy cmputer system and attached t the radipharmaceutical 6.4. Radinuclide Cmputer Order Entry and Preparatin Verificatin: In rder t ensure the crrect patient, crrect therapy, crrect dse and crrect time, the administering nuclear medicine technlgist r med physicist will duble check the cmpleteness f the dcumentatin The verificatin prcess will include cmparisn f the written directive against the pharmacy cmputer entry and activity cnfirmatin using a dse calibratr The administering technlgist r med physicist will cnfirm the fllwing: Patient Name MR Number Radinuclide therapy Dse in mci, and crrect istpe selectin n the dse calibratr Date f administratin (Calibratin Date) Time f administratin 3

4 Prducts prepared by Cntracted Pharmacy: The pharmacy prduct verificatin prcess will invlve the placement f the dse int the dse calibratr, and cmparisn f the assay t the Cntracted Pharmacy s radinuclide therapy label, the prduct label generated at the cmpletin f dse assay, and the written directive. Any further verificatin steps required will be detailed in the Radinuclide Therapy: Agent/Prtcl Specific Prcedure dcument The Nuclear Pharmacy rder entry label will be attached t the prduct received frm the Cntracted Pharmacy after verificatin has been cmpleted. Upn cmpletin f the radinuclide therapy agent preparatin and its verificatin, an Administering Clinician will btain the final prduct frm the Nuclear Pharmacy 7. The Administering Clinician will perfrm the final patient identificatin checks befre administratin 8. The Administering Clinician will administer the radinuclide therapy agent and will prvide apprpriate patient mnitring during the administratin 9. The Authrized User will be respnsible fr the apprpriateness f the patient s release frm administratin area and will prvide the patient with the apprpriate discharge instructins, dcumenting the cmpletin f this step n the Radinuclide Therapy Dse Dcumentatin frm 10. The Authrized User r designate will determine any expsure calculatins required and dcument them in the apprpriate sectins f the Radinuclide Therapy Dse Dcumentatin frm 11. The cmpleted, riginal Written Directive/Radinuclide Therapy Dse Dcumentatin frm will be retained in the department the therapy is administered.. Respnsibilities Human Radiatin Use Cmmittee (HRUC) 1. Charge this cmmittee functins t prvide an infrastructure fr The establishment and maintenance f all radinuclide therapy standard perating prcedures The assessment f new radipharmaceuticals and prtcls invlving radiatin expsure t humans prpsed fr utilizatin within the UWHC The assessment f the clinical apprpriateness, scientific integrity, lgistical practicability and safe delivery f research prtcls utilizing therapeutic radinuclides The develpment, review and apprval f radinuclide therapy agent/prtcl-specific prcedure dcuments The identificatin and implementatin f quality imprvement initiatives t enhance the safe delivery f radipharmaceuticals The establishment and maintenance f cre training and cmpetency requirements The creatin f ther best practice r re-engineering strategies as deemed necessary Apprval f UWHC Authrized Users, Authrized Nuclear Pharmacists, and Authrized Medical Physicists Oversight f brachytherapy Investigatin f diagnstic radinuclide misadministratins 4

5 2. Cmpsitin this cmmittee will be multidisciplinary in nature and cnsist f representatin frm the fllwing stakehlders Nuclear Medicine Physician (Chair f Nuclear Medicine) UWHC Administratin Nuclear Pharmacy Nuclear Medicine Radiatin Onclgy 3. Frequency this cmmittee will meet quarterly and n an ad hc basis if additinal meetings are necessary. 4. Radinuclide therapy Agent/Prtcl-Specific Prcedure Dcument will Detail prcedural steps beginning frm the identificatin f the patient targeted fr radinuclide therapy t the cmpletin f therapy Detail the rdering prcedures t be utilized (preparatin lcatin; use f preprinted physician rder r standard requisitin prcess; etc) and in the case f preprinted physician rders will Establish the elements t be stipulated in the preprinted physician rder including required dsing parameters and their crrespnding time limits, if applicable (example: platelet cunt t be within X days f radinuclide therapy dsing) Obtain the institutinal requirement fr multidisciplinary review and apprval f preprinted physician rders Be apprpriately disseminated t invlved individuals/departments Be retained by the Radinuclide Therapy Crdinating Cmmittee and Nuclear Pharmacy, the Nuclear Pharmacy, the Principal Investigatr s f therapeutic radinuclide therapy research prtcls (if applicable) and ther individuals/departments as necessary Be frmally reviewed every three years by the Radinuclide Therapy Crdinating Cmmittee Frms Appendix A: Therapeutic Radinuclide therapy Agent/Prtcl Specific Prcedure Dcument Appendix B: Radinuclide Therapy Dse Dcumentatin frm (UW Nuclear Medicine Divisin; incrprates the Written Directive and assciated verificatin prcedures within this frm) Related Plicies Nuclear Medicine Prcedure Manual Applicable state and federal regulatry plicies Crdinatin Human Radiatin Use Cmmittee 5

6 Reviewed By: S. Perlman, D. Fuerbringer, S. Knishka Sctt B. Perlman, MD, MS Derek Fuerbringer, CMNT Sctt Knishka RPh, BCNP Chief, Nuclear Medicine Radilgy Technical Manager Radipharmacist Versin Date: March2016 Expiratin Date: March2019 Original Apprval Date: September 2005 File/Path Name lcatin: \\r-radnas\pcusers\nucleargrup\prtcls\radipharm Therapy Plicy dc 6