diff --git a/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql b/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql index 1880876..f84aeba 100644 --- a/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql +++ b/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql @@ -19,6 +19,16 @@ define DOCUMENTATION_REQUIRED: define RESULT_InfoLink: 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_08_04_REMS_Full.pdf' +define INFO_PATIENT_MedicationGuide: + 'https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Turalio_Med&inline=true' +define INFO_PATIENT_PatientGuide: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Patient_Guide.pdf' +define INFO_PRESCRIBER_PrescribingInformation: + 'https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Turalio&inline=true' +define INFO_PRESCRIBER_ProgramOverview: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Program_Overview.pdf' +define INFO_PRESCRIBER_PrescriberTraining: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Prescriber_Training.pdf' define RESULT_QuestionnaireOrderUri: 'Questionnaire/TuralioRemsPatientEnrollment' diff --git a/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql index fa8856a..9ecc441 100644 --- a/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql +++ b/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql @@ -18,7 +18,19 @@ define DOCUMENTATION_REQUIRED: true define RESULT_InfoLink: - 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/IPledge_2020_08_04_REMS_Full.pdf' + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_REMS_Document.pdf' + +define INFO_PATIENT_FactSheet: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Fact_Sheet.pdf' + +define INFO_PATIENT_GuideForPatientsWhoCanGetPregnant: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Guide_for_Patients_Who_Can_Get_pregnant.pdf' +define INFO_PATIENT_ContraceptiveCounselingGuide: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Contraception_Counseling_Guide.pdf' +define INFO_PRESCRIBER_PrescriberGuide: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Prescriber_Guide.pdf' +define INFO_PRESCRIBER_ComprehensionQuestions: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Comprehension_Questions.pdf' define RESULT_QuestionnaireOrderUri: 'Questionnaire/IPledgeRemsPatientEnrollment' diff --git a/CRD-DTR/TIRF/R4/files/TIRFRule-0.1.0.cql b/CRD-DTR/TIRF/R4/files/TIRFRule-0.1.0.cql index c837c3d..ec5dd2a 100644 --- a/CRD-DTR/TIRF/R4/files/TIRFRule-0.1.0.cql +++ b/CRD-DTR/TIRF/R4/files/TIRFRule-0.1.0.cql @@ -18,7 +18,15 @@ define DOCUMENTATION_REQUIRED: true define RESULT_InfoLink: - 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_08_04_REMS_Full.pdf' + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_REMS_Document.pdf' +define INFO_PATIENT_PatientCounselingGuide: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Patient_Counseling_Guide.pdf' +define INFO_PATIENT_PatientFAQ: + 'https://tirfstorageproduction.blob.core.windows.net/tirf-public/tirf-patientfaq-frequently-asked-questions.pdf?skoid=417a7522-f809-43c4-b6a8-6b192d44b69e&sktid=59fc620e-de8c-4745-abcc-18182d1bf20e&skt=2022-09-20T19%3A06%3A21Z&ske=2022-09-26T19%3A11%3A21Z&sks=b&skv=2020-04-08&sv=2020-04-08&st=2021-03-21T21%3A27%3A00Z&se=2031-03-21T23%3A59%3A59Z&sr=b&sp=rc&sig=owSGAoUBZuCtsLE41F2XC3o12x%2BG%2Bt5ogykOIt796es%3D' +define INFO_PRESCRIBER_PrescriberEducation: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Prescriber_Education.pdf' +define INFO_PRESCRIBER_PrescriberFAQ: + 'https://tirfstorageproduction.blob.core.windows.net/tirf-public/tirf-prfaq-frequently-asked-questions.pdf?skoid=417a7522-f809-43c4-b6a8-6b192d44b69e&sktid=59fc620e-de8c-4745-abcc-18182d1bf20e&skt=2022-09-20T19%3A06%3A53Z&ske=2022-09-26T19%3A11%3A53Z&sks=b&skv=2020-04-08&sv=2020-04-08&st=2021-03-21T21%3A35%3A43Z&se=2031-03-21T23%3A59%3A59Z&sr=b&sp=rc&sig=fqtDzsm7qi1G8MKau210Y3gNet%2Fi20zw2EThKODdEUM%3D' define RESULT_QuestionnaireOrderUri: 'Questionnaire/TIRFRemsPatientEnrollment'