diff --git a/.gitignore b/.gitignore index 0721a57..39600b8 100644 --- a/.gitignore +++ b/.gitignore @@ -20,6 +20,7 @@ gradle/gradle-4.10.1/* request-generator/* server/src/main/resources/react/node_modules/* +RuleUtils/.settings/ node_modules package-lock.json 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 1d33ba5..1880876 100644 --- a/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql +++ b/CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql @@ -29,6 +29,12 @@ define RESULT_QuestionnaireDispenseUri: define RESULT_QuestionnaireProgressNoteUri: 'Questionnaire/TuralioRemsPatientStatus' +define RESULT_QuestionnairePrescriberEnrollmentUri: + 'Questionnaire/TuralioPrescriberEnrollmentForm' + +define RESULT_QuestionnairePrescriberKnowledgeAssessmentUri: + 'Questionnaire/TuralioPrescriberKnowledgeAssessment' + define RESULT_requestId: medication_request diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json new file mode 100644 index 0000000..786ea90 --- /dev/null +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json @@ -0,0 +1,330 @@ +{ + "resourceType": "Questionnaire", + "id": "TuralioPrescriberEnrollmentForm", + "name": "TuralioPrescriberEnrollmentForm", + "title": "Turalio REMS Prescriber Enrollment Form", + "status": "draft", + "subjectType": [ + "Practitioner" + ], + "date": "2022-05-28", + "publisher": "FDA-REMS", + "item": [ + { + "linkId": "1", + "type": "group", + "text": "Prescriber Information", + "item": [ + { + "linkId": "1.1", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "1.2", + "text": "Last Name", + "type": "string", + "required": true + }, + { + "linkId": "1.3", + "text": "Middle Initial", + "type": "string", + "required": false + }, + { + "linkId": "1.4", + "text": "Credentials", + "type": "open-choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "MD", + "display": "MD" + } + }, + { + "valueCoding": { + "code": "DO", + "display": "DO" + } + }, + { + "valueCoding": { + "code": "NP", + "display": "NP" + } + }, + { + "valueCoding": { + "code": "PA", + "display": "PA" + } + }, + { + "valueCoding": { + "code": "Other", + "display": "Other" + } + } + ] + }, + { + "linkId": "1.5", + "text": "Specialty", + "type": "open-choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "Oncolgy", + "display": "Oncology" + } + }, + { + "valueCoding": { + "code": "Orthopedics", + "display": "Orthopedics" + } + }, + { + "valueCoding": { + "code": "Other", + "display": "Other" + } + } + ] + }, + { + "linkId": "1.6", + "text": "National Provider Identifier (NPI) #", + "type": "string", + "required": true + }, + { + "linkId": "1.7", + "text": "State License #", + "type": "string", + "required": false + }, + { + "linkId": "1.8", + "text": "Practice/Facility Name", + "type": "string", + "required": false + }, + { + "linkId": "1.9", + "text": "Street Address", + "type": "string", + "required": true + }, + { + "linkId": "1.10", + "text": "City", + "type": "string", + "required": true + }, + { + "linkId": "1.11", + "text": "State", + "type": "string", + "required": true + }, + { + "linkId": "1.12", + "text": "ZIP Code", + "type": "string", + "required": true + }, + { + "linkId": "1.13", + "text": "Office Phone Number", + "type": "string", + "required": true + }, + { + "linkId": "1.14", + "text": "Office Fax Number", + "type": "string", + "required": true + }, + { + "linkId": "1.15", + "text": "E-Mail", + "type": "string", + "required": true + }, + { + "linkId": "1.16", + "text": "Perfered Method of Communication", + "type": "open-choice", + "required": false, + "answerOption": [ + { + "valueCoding": { + "code": "Fax", + "display": "Fax" + } + }, + { + "valueCoding": { + "code": "Email", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "Phone", + "display": "Phone" + } + } + ] + }, + { + "linkId": "1.17", + "text": "Perferred Time of Contact", + "type": "open-choice", + "required": false, + "answerOption": [ + { + "valueCoding": { + "code": "AM", + "display": "AM" + } + }, + { + "valueCoding": { + "code": "PM", + "display": "PM" + } + } + ] + } + + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Office Contact Information", + "item": [ + { + "linkId": "2.1", + "text": "Prescribers may grant administrative rights to two (2) Office Contacts which allow them to view, edit, and initiate paperwork related to the TURALIO REMS via the REMS Portal.", + "type": "display" + }, + { + "linkId": "2.2", + "text": "I, the prescriber, grant administrative rights to the office contact(s) listed below and understand that I must review all paperwork and sign prior to submitting to the REMS.", + "type": "display" + }, + { + "linkId": "2.3", + "type": "group", + "text": "Office Contact #1 (Optional)", + "item": [ + { + "linkId": "2.3.1", + "text": "First Name", + "type": "string", + "required": false + }, + { + "linkId": "2.3.2", + "text": "Last Name", + "type": "string", + "required": false + }, + { + "linkId": "2.3.3", + "text": "Office Phone Number", + "type": "string", + "required": false + }, + { + "linkId": "2.3.4", + "text": "Office Fax Number", + "type": "string", + "required": false + }, + { + "linkId": "2.3.5", + "text": "Email", + "type": "string", + "required": false + } + ] + }, + { + "linkId": "2.4", + "type": "group", + "text": "Office Contact #2 (Optional)", + "item": [ + { + "linkId": "2.4.1", + "text": "First Name", + "type": "string", + "required": false + }, + { + "linkId": "2.4.2", + "text": "Last Name", + "type": "string", + "required": false + }, + { + "linkId": "2.4.3", + "text": "Office Phone Number", + "type": "string", + "required": false + }, + { + "linkId": "2.4.4", + "text": "Office Fax Number", + "type": "string", + "required": false + }, + { + "linkId": "2.4.5", + "text": "Email", + "type": "string", + "required": false + } + ] + }, + { + "linkId": "2.5", + "text": "Office Contacts can be updated by visiting www.turaliorems.com or contacting the TURALIO REMS Coordinating Center at 1-833-TURALIO (833-887-2546).", + "type": "display" + } + ] + }, + { + "linkId": "3", + "type": "group", + "text": "Prescriber Attestations", + "item": [ + { + "linkId": "3.1", + "text": "By signing this form, I agree TURALIO is only available through the TURALIO REMS and I agree to comply with the following TURALIO REMS requirements: \n\n I have: \n - Reviewed the Prescribing Information, Program Overview and Prescriber Training. \n - Successfully completed the Prescriber Knowledge Assessment and submitted it to the TURALIO REMS. \n\n Before treatment initiation and with the first dose of TURALIO: \n - I understand that I should counsel the patient on the risk of serious and potentially fatal liver injury, and liver test monitoring at baseline and periodically during treatment. \n - I must assess the patient by obtaining baseline liver tests. I must submit the results of the assessment on the Patient Enrollment Form. \n - I must enroll patients in the TURALIO REMS by completing and submitting the Patient Enrollment Form. \n\n During treatment with TURALIO: \n - I must assess the patient by obtaining liver tests weekly for the first 8 weeks, then every 2 weeks for 1 month, then every 3 months and modify the dose of TURALIO as needed in accordance with the Prescribing Information. \n - I must prescribe no more than a 30 days supply for each of the first 3 months of treatment. \n - I must complete the Patient Status Form every month for the first 3 months of treatment, at months 6, 9, and 12 and then every 6 months thereafter while the patient receives TURALIO. \n\n At all times: \n - I must report adverse events of serious and potentially fatal liver injury by submitting the Liver Adverse Event Reporting Form. \n - I understand that Daiichi Sankyo, Inc. and/or its agents may contact me by phone, mail or email to provide or obtain additional information related to the REMS program, including details regarding any reported liver adverse events. \n", + "type": "display", + "readOnly": true + }, + { + "linkId": "3.2", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire", + "valueCanonical": "questionnaire/provider-signature" + } + ], + "type": "display" + } + + ] + } + ] +} \ No newline at end of file diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json new file mode 100644 index 0000000..b1071a2 --- /dev/null +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment.json @@ -0,0 +1,333 @@ +{ + "resourceType": "Questionnaire", + "id": "TuralioPrescriberKnowledgeAssessment", + "name": "TuralioPrescriberKnowledgeAssessment", + "title": "Turalio REMS Prescriber Knowledge Assessment", + "status": "draft", + "subjectType": [ + "Prescriber" + ], + "date": "2022-05-28", + "publisher": "FDA-REMS", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/BasicPractitionerInfo-prepopulation" + } + ], + "item": [ + { + "linkId": "1", + "type": "group", + "text": "Prescriber Information", + "item": [ + { + "linkId": "1.1", + "text": "First Name", + "type": "string", + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderFirstName" + } + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/minLength", + "valueInteger": 2 + } + ] + }, + { + "linkId": "1.2", + "text": "Last Name", + "type": "string", + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderLastName" + } + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/minLength", + "valueInteger": 2 + } + ] + }, + { + "linkId": "1.3", + "text": "Middle Initial", + "type": "string", + "required": false, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderMiddleInitial" + } + } + ] + }, + { + "linkId": "1.4", + "text": "National Provider Identifier (NPI) #", + "type": "string", + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicClinicalInfoPrepopulation\".EncounterProviderNPI" + } + } + ] + }, + { + "linkId": "1.5", + "text": "Phone Number", + "type": "string", + "required": true + }, + { + "linkId": "1.6", + "text": "Fax Number", + "type": "string", + "required": true + }, + { + "linkId": "1.7", + "text": "Email", + "type": "string", + "required": true + } + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Knowledge Assessment: Questions 1-9", + "item": [ + { + "linkId": "2.1", + "text": "1. TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "True" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.2", + "text": "2. TURALIO is contraindicated in patients with hepatic impairment.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "True" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.3", + "text": "3. To prescribe TURALIO, I must enroll each patient in the TURALIO REMS by completing a Patient Enrollment Form with the patient and submitting it to the TURALIO REMS.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "True" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.4", + "text": "4. Before treating each patient with TURALIO, I must", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "Become certified in the TURALIO REMS", + "display": "Become certified in the TURALIO REMS" + } + }, + { + "valueCoding": { + "code": "Counsel the patient regarding the risk of serious and potentially fatal liver injury associated with TURALIO", + "display": "Counsel the patient regarding the risk of serious and potentially fatal liver injury associated with TURALIO" + } + }, + { + "valueCoding": { + "code": "Obtain and review baseline liver tests", + "display": "Obtain and review baseline liver tests" + } + }, + { + "valueCoding": { + "code": "All of the above", + "display": "All of the above" + } + } + ] + }, + { + "linkId": "2.5", + "text": "5. One of the primary counseling messages I must tell my patients before prescribing TURALIO is", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "Do not take TURALIO if you have vision issues", + "display": "Do not take TURALIO if you have vision issues" + } + }, + { + "valueCoding": { + "code": "Patients with renal impairment should not start TURALIO at a reduced dose", + "display": "Patients with renal impairment should not start TURALIO at a reduced dose" + } + }, + { + "valueCoding": { + "code": "There is a risk of liver injury associated with TURALIO and liver monitoring is required prior to treatment initiation and periodically while taking TURALIO", + "display": "There is a risk of liver injury associated with TURALIO and liver monitoring is required prior to treatment initiation and periodically while taking TURALIO" + } + }, + { + "valueCoding": { + "code": "None of the above", + "display": "None of the above" + } + } + ] + }, + { + "linkId": "2.6", + "text": "6. I am required to educate my patients on the signs and symptoms of liver injury and the need to notify me should they experience them.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "True" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.7", + "text": "7. If any dose modifications are required, they must be done in increments of 200 mg.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "True" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.8", + "text": "8. After treatment initiation, I need to monitor liver tests weekly for the first 8 weeks of treatment, every 2 weeks for the next month, and every 3 months thereafter.", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "true", + "display": "True" + } + }, + { + "valueCoding": { + "code": "false", + "display": "False" + } + } + ] + }, + { + "linkId": "2.9", + "text": "9. I must complete a Patient Status Form for each patient taking TURALIO and submit it to the TURALIO REMS:", + "type": "open-choice", + "answerOption": [ + { + "valueCoding": { + "code": "Every month during treatment", + "display": "Every month during treatment" + } + }, + { + "valueCoding": { + "code": "Weekly for 8 weeks of treatment, every 2 weeks for the next month, and every 3 months thereafter", + "display": "Weekly for 8 weeks of treatment, every 2 weeks for the next month, and every 3 months thereafter" + } + }, + { + "valueCoding": { + "code": "Every month for the first 3 months of treatment, month 6, month 9, and month 12 of treatment, and every 6 months thereafter", + "display": "Every month for the first 3 months of treatment, month 6, month 9, and month 12 of treatment, and every 6 months thereafter" + } + }, + { + "valueCoding": { + "code": "Every month for the first 6 months of treatment and every 6 months thereafter", + "display": "Every month for the first 6 months of treatment and every 6 months thereafter" + } + }, + { + "valueCoding": { + "code": "None of the above", + "display": "None of the above" + } + } + ] + } + ] + } + ] +} \ No newline at end of file diff --git a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json index 491b754..f0cbd0d 100644 --- a/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json +++ b/CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Turalio-ProgressNote.json @@ -9,10 +9,6 @@ ] }, "extension": [ - { - "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", - "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/RemsDrugs-prepopulation" - }, { "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/BasicClinicalInfo-prepopulation" @@ -62,15 +58,6 @@ { "linkId": "4", "text": "Current Other Diagnoses", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".CurrentDiagnoses" - } - } - ], "type": "open-choice", "repeats": true, "required": true, @@ -87,31 +74,13 @@ "text": "Transplants for Order", "type": "open-choice", "repeats": true, - "answerOption": [], - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".QualifyingTransplantCodings" - } - } - ] + "answerOption": [] }, { "linkId": "5.2", "text": "Date of transplant", "type": "date", - "required": true, - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".TransplantDate" - } - } - ] + "required": true }, { "linkId": "5.3", @@ -254,72 +223,27 @@ { "linkId": "9.1", "type": "text", - "text": "RxNorm Code", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationCode" - } - } - ] + "text": "RxNorm Code" }, { "linkId": "9.2", "type": "text", - "text": "Drug", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationName" - } - } - ] + "text": "Drug" }, { "linkId": "9.3", "type": "text", - "text": "Route", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationRoute" - } - } - ] + "text": "Route" }, { "linkId": "9.4", "type": "text", - "text": "Dose", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationDoseWithUnit" - } - } - ] + "text": "Dose" }, { "linkId": "9.5", "type": "text", - "text": "Frequency", - "extension": [ - { - "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", - "valueExpression": { - "language": "text/cql", - "expression": "\"RemsDrugsPrepopulation\".MedicationFrequency" - } - } - ] + "text": "Frequency" } ] },