Skip to content
This repository was archived by the owner on Sep 11, 2023. It is now read-only.

REMS 160 #7

Merged
smalho01 merged 10 commits into from
Jun 2, 2022
Merged

REMS 160 #7

Show file tree
Hide file tree
Changes from all commits
Commits
Show all changes
10 commits
Select commit Hold shift + click to select a range
4a65a81
Created Questionnaire for enrollment and CES
zacharyrobin May 31, 2022
d8f8e8d
Added provider CES Quesitonnaire
zacharyrobin May 31, 2022
79de524
rename files and various fixes
kghoreshi May 31, 2022
478d3ef
revert settings file and gitignore it
kghoreshi Jun 1, 2022
f027dfc
prescriber enrollment attestation
smalho01 Jun 1, 2022
cb3afcc
Merge branch 'REMS-160' of https://github.com/mcode/CDS-Library into …
smalho01 Jun 1, 2022
3174a6d
cql reference modifications
kghoreshi Jun 1, 2022
8aa8edc
Merge remote-tracking branch 'origin/REMS-160' into REMS-160
kghoreshi Jun 1, 2022
17510dc
fix typos
kghoreshi Jun 1, 2022
18a9837
minor fix
kghoreshi Jun 1, 2022
File filter

Filter by extension

Filter by extension
Conversations
Failed to load comments.
Loading
Jump to
Jump to file
Failed to load files.
Loading
Diff view
Diff view
1 change: 1 addition & 0 deletions .gitignore
View file
Open in desktop
Original file line number Diff line number Diff line change
Expand Up @@ -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

Expand Down
6 changes: 6 additions & 0 deletions CRD-DTR/DrugHasREMS/R4/files/DrugHasREMSRule-0.1.0.cql
View file
Open in desktop
Original file line number Diff line number Diff line change
Expand Up @@ -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

Expand Down
330 changes: 330 additions & 0 deletions CRD-DTR/DrugHasREMS/R4/resources/Questionnaire-R4-Prescriber-Enrollment.json
View file
Open in desktop
Original file line number Diff line number Diff line change
@@ -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"
}

]
}
]
}
Loading