diff --git a/CRD-DTR/TIRF/R4/files/TIRFRule-0.1.0.cql b/CRD-DTR/TIRF/R4/files/TIRFRule-0.1.0.cql new file mode 100644 index 0000000..c837c3d --- /dev/null +++ b/CRD-DTR/TIRF/R4/files/TIRFRule-0.1.0.cql @@ -0,0 +1,36 @@ +library TIRFRule version '0.1.0' +using FHIR version '4.0.0' +include FHIRHelpers version '4.0.0' called FHIRHelpers + + +parameter Patient Patient +parameter medication_request MedicationRequest +parameter medication_dispense MedicationDispense +parameter medication_statement MedicationStatement + +define RULE_APPLIES: + true + +define PRIORAUTH_REQUIRED: + false + +define DOCUMENTATION_REQUIRED: + true + +define RESULT_InfoLink: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_08_04_REMS_Full.pdf' + +define RESULT_QuestionnaireOrderUri: + 'Questionnaire/TIRFRemsPatientEnrollment' + +define RESULT_QuestionnairePrescriberEnrollmentUri: + 'Questionnaire/TIRFPrescriberEnrollmentForm' + +define RESULT_QuestionnairePrescriberKnowledgeAssessmentUri: + 'Questionnaire/TIRFPrescriberKnowledgeAssessment' + +define RESULT_requestId: + medication_request + +define RESULT_dispense: + medication_dispense \ No newline at end of file diff --git a/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment-TIRF.json b/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment-TIRF.json new file mode 100644 index 0000000..5e9ff91 --- /dev/null +++ b/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-Prescriber-Knowledge-Assessment-TIRF.json @@ -0,0 +1,315 @@ +{ + "resourceType": "Questionnaire", + "id": "TIRFPrescriberKnowledgeAssessment", + "name": "TIRFPrescriberKnowledgeAssessment", + "title": "TIRF 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", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire", + "valueCanonical": "questionnaire/practitioner-info-base" + }, + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire-expand", + "valueBoolean": true + } + ], + "type": "display" + }, + { + "linkId": "1.2", + "text": "Address", + "type": "string", + "required": false + }, + { + "linkId": "1.3", + "text": "City", + "type": "string", + "required": false + }, + { + "linkId": "1.4", + "text": "State", + "type": "string", + "required": false + }, + { + "linkId": "1.5", + "text": "Zip", + "type": "string", + "required": false + }, + { + "linkId": "1.6", + "text": "Phone", + "type": "string", + "required": false + }, + { + "linkId": "1.7", + "text": "Ext", + "type": "string", + "required": false + }, + { + "linkId": "1.8", + "text": "Fax", + "type": "string", + "required": false + }, + { + "linkId": "1.9", + "text": "Email Address", + "type": "string", + "required": false + } + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Knowledge Assessment", + "item": [ + { + "linkId": "2.1.1", + "type": "choice", + "text": "1. The patients described are all experiencing breakthrough cancer pain, but ONE is not an appropriate patient for a TIRF medicine. Which patient should not receive a TIRF medicine? Select one option", + "answerOption": [ + { + "valueString": "12-year-old sarcoma patient, using transdermal fentanyl for her underlying persistent cancer pain" + }, + { + "valueString": "Adult female with advanced breast cancer; on 60 mg of oral morphine daily for the past 4 weeks" + }, + { + "valueString": "Adult male with advanced lung cancer, his underlying persistent pain is managed with 25 mcg/hour transdermal fentanyl patches for the past 3 months" + }, + { + "valueString": "Adult male with multiple myeloma who has bone pain currently managed with 50 mg oral oxymorphone daily for the last 2 weeks" + } + ] + }, + { + "linkId": "2.1.2", + "type": "choice", + "text": "2. The patients described are experiencing breakthrough cancer pain. A TIRF medicine is NOT appropriate for one of them. Which patient should not receive a TIRF medicine? Select one option", + "answerOption": [ + { + "valueString": "Adult male with advanced lung cancer; underlying persistent cancer pain managed with 25 mcg/hour transdermal fentanyl patches for the past 2 months" + }, + { + "valueString": "Adult female with localized breast cancer; just completed a mastectomy and reconstructive surgery; persistent cancer pain managed with 30 mg oral morphine daily for the past 6 weeks" + }, + { + "valueString": "Adult male patient with advanced prostate cancer who, over the last 2 weeks, has been prescribed 100 mg oral morphine daily for pain due to bone metastasis" + }, + { + "valueString": "Adult female with advanced sarcoma who has been taking a daily dose of 12 mg oral hydromorphone for the last 3 weeks" + } + ] + }, + { + "linkId": "2.1.3", + "type": "choice", + "text": "3. Certain factors may increase the risk of abuse and/or diversion of opioid medications. Which of the following is most accurate? Select one option", + "answerOption": [ + { + "valueString": "A history of alcohol abuse with the patient or close family members" + }, + { + "valueString": "The patient has a household member with a street drug abuse problem" + }, + { + "valueString": "The patient has a history of prescription drug misuse" + }, + { + "valueString": "All of the above" + } + ] + }, + { + "linkId": "2.1.4", + "type": "choice", + "text": "4. A patient is already taking a TIRF medicine but wants to change their medicine. His/her doctor decides to prescribe a different TIRF medicine (that is not a bioequivalent generic version of a branded product) in its place. How should the prescriber proceed? Select one option", + "answerOption": [ + { + "valueString": "The prescriber can safely convert to the equivalent dosage of the new TIRF medicine as it has the same effect as other TIRF medicines" + }, + { + "valueString": "The prescriber must not convert from the first TIRF medicine dose to another TIRF medicine at the equivalent dose. The different TIRF medicines have different absorption and bioavailability profiles, and conversion to an equivalent dose of a second TIRF product could result in a fentanyl overdose" + }, + { + "valueString": "Convert from the other TIRF medicine to the new TIRF medicine at half of the dose" + }, + { + "valueString": "The prescriber should base the starting dose of the newly prescribed TIRF medicine on the dose of the opioid medicine used for their underlying persistent cancer pain" + } + ] + }, + { + "linkId": "2.1.5", + "type": "choice", + "text": "5. A patient is starting titration with a TIRF medicine. What dose must they start with? Select one option", + "answerOption": [ + { + "valueString": "An appropriate dose based on the dose of the opioid medicine used for underlying persistent cancer pain" + }, + { + "valueString": "The dose that the prescriber believes is appropriate based on their clinical experience" + }, + { + "valueString": "The lowest available dose, unless individual product Prescribing Information provides product-specific guidance" + }, + { + "valueString": "The median available dose" + } + ] + }, + { + "linkId": "2.1.6", + "type": "choice", + "text": "6. A prescriber has started titrating a patient with the lowest dose of a TIRF medicine. However, after 30 minutes, the breakthrough cancer pain has not been sufficiently relieved. What should they advise the patient to do? Select one option", + "answerOption": [ + { + "valueString": "Take another (identical) dose of the TIRF medicine immediately" + }, + { + "valueString": "Take a dose of an alternative rescue medicine" + }, + { + "valueString": "Provide guidance based on the product-specific Prescribing Information because the instructions are not the same for all TIRF medicines" + }, + { + "valueString": "Double the dose and take immediately" + } + ] + }, + { + "linkId": "2.1.7", + "type": "choice", + "text": "7. A patient is taking a TIRF medicine and the doctor would like to prescribe erythromycin, a CYP3A4 inhibitor. Which of the following statements is TRUE? Select one option", + "answerOption": [ + { + "valueString": "The patient can’t be prescribed erythromycin, because using it at the same time as a TIRF medicine could be fatal" + }, + { + "valueString": "Use of a TIRF medicine with a CYP3A4 inhibitor may require dosage adjustment of the TIRF medicine; carefully monitor the patient for opioid toxicity, otherwise such use may cause serious life threatening, and/or fatal respiratory depression" + }, + { + "valueString": "There is no possible drug interaction between CYP3A4 inhibitors and TIRF medicines" + }, + { + "valueString": "The dose of the TIRF medicine must be reduced by one half if a CYP3A4 inhibitor is prescribed in the same patient" + } + ] + }, + { + "linkId": "2.1.8", + "type": "choice", + "text": "8. Before initiating treatment with a TIRF medicine, prescribers must review the Medication Guide and Patient Counseling Guide with the patient. Which of the following counseling statements is FALSE? Select one option", + "answerOption": [ + { + "valueString": "TIRF medicines contain fentanyl in an amount that could be fatal to children of all ages, in individuals for whom they were not prescribed, and in those who are not opioid tolerant" + }, + { + "valueString": "Inform patients that TIRF medicines must not be used to treat acute or postoperative pain, including headache/migraine, dental pain or acute pain in the emergency department" + }, + { + "valueString": "Instruct patients that, if they stop taking their around-the-clock opioid medicine, they can continue to take their TIRF medicine" + }, + { + "valueString": "Instruct patients to never share their TIRF medicine with anyone else, even if that person has the same symptoms" + } + ] + }, + { + "linkId": "2.1.9", + "type": "choice", + "text": "9. There is a risk of fatal overdose with inappropriate use of TIRF medicines. Which one of the following answers is most accurate? Select one option", + "answerOption": [ + { + "valueString": "TIRF medicines can be fatal if taken by children" + }, + { + "valueString": "TIRF medicines can be fatal if taken by anyone for whom it is not prescribed" + }, + { + "valueString": "TIRF medicines can be fatal if taken by anyone who is not opioid-tolerant" + }, + { + "valueString": "All of the above" + } + ] + }, + { + "linkId": "2.1.10", + "type": "choice", + "text": "10. Which one of the following statements is most accurate regarding the safe storage and disposal of TIRF medicines? Select one option", + "answerOption": [ + { + "valueString": "TIRF medicines should be kept in in a safe and secure place, out of sight and out of reach of all others, especially children" + }, + { + "valueString": "TIRF medicines should be protected from theft" + }, + { + "valueString": "Dispose of partially used or unneeded TIRF medicine by following the TIRF medicine-specific procedure specified in the Medication Guide" + }, + { + "valueString": "All of the above" + } + ] + }, + { + "linkId": "2.1.11", + "type": "choice", + "text": "11. Which of the following statements is FALSE? Select one option", + "answerOption": [ + { + "valueString": "The TIRF REMS mitigates the risk of overdose by: Educating prescribers, pharmacist and patients that respiratory depression is more common in patients who are not opioid tolerant" + }, + { + "valueString": "The TIRF REMS mitigates the risk of overdose by: Requiring that patients remain opioid-tolerant throughout their treatment with TIRF medicines" + }, + { + "valueString": "The TIRF REMS mitigates the risk of overdose by: Requiring inpatient pharmacies to verify opioid tolerance in inpatients who require TIRF medicine while hospitalized" + }, + { + "valueString": "The TIRF REMS mitigates the risk of overdose by: Requiring documentation of opioid tolerance with only the initial prescription of a TIRF medicine" + } + ] + }, + { + "linkId": "2.2", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire", + "valueCanonical": "questionnaire/provider-signature" + } + ], + "type": "display" + } + ] + } + ] +} diff --git a/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-PrescriberEnrollment-TIRF.json b/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-PrescriberEnrollment-TIRF.json new file mode 100644 index 0000000..a858e88 --- /dev/null +++ b/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-PrescriberEnrollment-TIRF.json @@ -0,0 +1,289 @@ +{ + "resourceType": "Questionnaire", + "id": "TIRFPrescriberEnrollmentForm", + "name": "TIRFPrescriberEnrollmentForm", + "title": "TIRF REMS Prescriber Enrollment Form", + "status": "draft", + "subjectType": [ + "Practitioner" + ], + "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", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire", + "valueCanonical": "questionnaire/practitioner-info-base" + }, + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire-expand", + "valueBoolean": true + } + ], + "type": "display" + }, + { + "linkId": "1.2", + "text": "Clinic/Practice Name", + "type": "string", + "required": false + }, + { + "linkId": "1.3", + "text": "Specialty", + "type": "string", + "required": false + }, + { + "linkId": "1.4", + "text": "Credentials", + "type": "choice", + "required": false, + "answerOption": [ + { + "valueCoding": { + "code": "MD", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "MD" + } + }, + { + "valueCoding": { + "code": "NP", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "NP" + } + }, + { + "valueCoding": { + "code": "PA", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "PA" + } + }, + { + "valueCoding": { + "code": "DO", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "DO" + } + }, + { + "valueCoding": { + "code": "Other", + "display": "Other" + } + } + ] + }, + { + "linkId": "1.5", + "text": "Address", + "type": "string", + "required": false + }, + { + "linkId": "1.6", + "text": "City", + "type": "string", + "required": false + }, + { + "linkId": "1.7", + "text": "State", + "type": "string", + "required": false + }, + { + "linkId": "1.8", + "text": "Zip", + "type": "string", + "required": false + }, + { + "linkId": "1.9", + "text": "Phone", + "type": "string", + "required": false + }, + { + "linkId": "1.10", + "text": "Ext", + "type": "string", + "required": false + }, + { + "linkId": "1.11", + "text": "Fax", + "type": "string", + "required": false + }, + { + "linkId": "1.12", + "text": "Email Address", + "type": "string", + "required": false + }, + { + "linkId": "1.13", + "text": "Preferred Time of Contact", + "type": "choice", + "required": false, + "answerOption": [ + { + "valueString": "Morning" + }, + { + "valueString": "Afternnon" + }, + { + "valueString": "Evening" + } + ] + }, + { + "linkId": "1.14", + "text": "Preferred Method of Contact", + "type": "choice", + "required": false, + "answerOption": [ + { + "valueCoding": { + "code": "sms", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Text to Mobile #" + } + }, + { + "valueCoding": { + "code": "email", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "phone", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Phone Call" + } + } + ] + } + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Office Contact Information", + "item": [ + { + "linkId": "2.1", + "text": "First and Last Name", + "type": "string", + "required": false + }, + { + "linkId": "2.2", + "text": "Phone", + "type": "string", + "required": false + }, + { + "linkId": "2.3", + "text": "Fax", + "type": "string", + "required": false + }, + { + "linkId": "2.4", + "text": "Email Address", + "type": "string", + "required": false + }, + { + "linkId": "2.5", + "text": "Preferred Time of Contact", + "type": "choice", + "required": false, + "answerOption": [ + { + "valueString": "Morning" + }, + { + "valueString": "Afternnon" + }, + { + "valueString": "Evening" + } + ] + }, + { + "linkId": "2.6", + "text": "Preferred Method of Contact", + "type": "choice", + "required": false, + "answerOption": [ + { + "valueCoding": { + "code": "sms", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Text to Mobile #" + } + }, + { + "valueCoding": { + "code": "email", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "phone", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Phone Call" + } + } + ] + } + ] + }, + { + "linkId": "3", + "type": "group", + "text": "Prescriber Attestation", + "item": [ + { + "linkId": "3.1", + "text": "By signing below, you attest to the following: I have: • Reviewed each drug's Prescribing Information • Reviewed the Prescriber Education • Successfully completed the Prescriber Knowledge Assessment and submitted it to the REMS. Before treatment initiation, I must: • Assess the patient for rish factors of opioid addition, abuse, and misuse including personal and family history of substance abuse or mental illness • Counsel the patient on the safe use of TIRF medicines using the Medication Guide for the prescribed TIRF medicine and the Patient Counseling Guide • Provide a copy of the materials to the patient • Assess the patient's opioid tolerance • Document the patient's opioid tolerace using the Patient Enrollment Form and submit to the REMS • Enroll the patient by completing and submitting the Patient Enrollment Form to the TIRF REMS. During treatment, and before each prescription, I must: • Assess the patient's health status for opioid tolerance, appropriateness of dose, misuse, abuse, addiction, and overdose • Document and submit this information to the REMS using the Patient Status and Opioid Tolerance Form. During treatment, every 2 years, I must: • Counsel the patient on the safe use of TIRF medicines using the Medication Guide for the prescribed TIRF medicine, and the Patient Counseling Guide • Provide a copy of the materials to the patient • Re-enroll the patient in the REMS by completing the Patient Enrollment Form and submitting it to the REMS. Before treatment re-initiation, after a lapse in treatment of 6 months or longer, I must: • Counsel the Patient on the safe use of TIRF medicines using the Medication Guide for the prescribed TIRF medicine and the Patient Counseling Guide • Provide a copy of the materials to the patient. At all times, I must: • Counsel the patient using the Medication Guide for any new TIRF medicine not previously prescribed and provide a copy to the patient • Report serious adverse events of accidental exposure, misuse, abuse, addiction, and overdose to the REMS using the Adverse Events of Special Interest Reporting Form • Report treatment discontinuation to the REMS using the Patient Discontinuation Form. To maintain certification to prescribe, every 2 years, I must: • Review each drug's Prescribing Information • Review the Prescriber Education • Successfully complete the Prescriber Knowledge Assessment and submit it to the REMS • Re-enroll in the REMS by completing the Prescriber Enrollment Form", + "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/TIRF/R4/resources/Questionnaire-R4-TIRF.json b/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-TIRF.json new file mode 100644 index 0000000..f1d5831 --- /dev/null +++ b/CRD-DTR/TIRF/R4/resources/Questionnaire-R4-TIRF.json @@ -0,0 +1,694 @@ +{ + "resourceType": "Questionnaire", + "id": "TIRFRemsPatientEnrollment", + "name": "TIRFRemsPatientEnrollment", + "title": "TIRF Rems Patient Enrollment", + "status": "draft", + "subjectType": [ + "Patient" + ], + "date": "2020-05-20", + "publisher": "Da Vinci DTR", + "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": "Patient Information", + "item": [ + { + "linkId": "1.1", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire", + "valueCanonical": "questionnaire/patient-info-base" + }, + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire-expand", + "valueBoolean": true + } + ], + "type": "display" + }, + { + "linkId": "1.2", + "text": "Race", + "type": "open-choice", + "required": false, + "repeats": true, + "answerOption": [ + { + "valueCoding": { + "code": "White", + "display": "White" + } + }, + { + "valueCoding": { + "code": "Asian", + "display": "Asian" + } + }, + { + "valueCoding": { + "code": "Black or African American", + "display": "Black or African American" + } + }, + { + "valueCoding": { + "code": "American Indian or Alaskan Native", + "display": "American Indian or Alaskan Native" + } + }, + { + "valueCoding": { + "code": "Native Hawaiian or Other Pacific Islander", + "display": "Native Hawaiian or Other Pacific Islander" + } + } + ] + }, + { + "linkId": "1.3", + "text": "Ethnicity", + "type": "group", + "required": true, + "item": [ + { + "linkId": "1.3.1", + "text": "Are you Hispanic or Latino?", + "type": "boolean" + } + ] + }, + { + "linkId": "1.4", + "text": "Address", + "type": "string", + "required": true + }, + { + "linkId": "1.5", + "text": "City", + "type": "string", + "required": true + }, + { + "linkId": "1.6", + "text": "State", + "type": "string", + "required": true + }, + { + "linkId": "1.7", + "text": "Zip", + "type": "string", + "required": true + }, + { + "linkId": "1.8", + "text": "Phone", + "type": "string", + "required": true + }, + { + "linkId": "1.9", + "text": "Email Address", + "type": "string", + "required": true + }, + { + "linkId": "1.10", + "text": "Preferred Time of Contact", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueString": "Morning" + }, + { + "valueString": "Afternnon" + }, + { + "valueString": "Evening" + } + ] + }, + { + "linkId": "1.11", + "text": "Preferred Method of Contact", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "sms", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Text to Mobile #" + } + }, + { + "valueCoding": { + "code": "email", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "phone", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Phone Call" + } + }, + { + "valueCoding": { + "code": "other", + "system": "http://hl7.org/fhir/ValueSet/contact-point-system", + "display": "Postal Mail" + } + } + ] + }, + { + "linkId": "1.12", + "text": "Is there a child in the home or are you a caregiver of small children?", + "type": "boolean", + "required": true + }, + { + "linkId": "1.13", + "text": "Do you have a safe and secure place to store your medicine?", + "type": "boolean", + "required": true + } + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Patient Representative (if required)", + "item": [ + { + "linkId": "2.1", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "2.2", + "text": "Last Name", + "type": "string", + "required": true + }, + { + "linkId": "2.3", + "text": "Relationship to Patient", + "type": "string", + "required": true + }, + { + "linkId": "2.4", + "text": "Phone", + "type": "string", + "required": true + }, + { + "linkId": "2.5", + "text": "Email Address", + "type": "string", + "required": true + } + ] + }, + { + "linkId": "3", + "type": "group", + "text": "Patient Attestation", + "item": [ + { + "linkId": "3.1", + "text": "TIRF Medicines can cause your breathing to stop - which can lead to death. Safety Rules for TIRF Medicines You have agreed to take a TIRF Medicine and to follow all the safety rules to make it less likely you or others will experience serious harm • My healthcare provider has talked to me about the safe use of TIRF medicines using the Medication Guide and Patient Counseling Guide • I will only use this medicine if I am regularly using another opioid, around-the-clock, for constant pain • If I stop taking my around-the-clock-opioid pain medicine, I MUST stop taking my TIRF medicine • I will never share or give my TIRF medicine to anyone else, even if they have the same symptoms • My TIRF medicine could cause harm to others or even death. A dose that is okay for me could cause an overdose and death for someone else • I will store my TIRF medicine in a safe and secure place away from children. I understand that accidental use by a child, or anyone for whom the medicine was not prescribed, can cause death • I have been told how to properly dispose of my partially used or unneeded TIRF medicine remaining from my prescription. I will dispose of my TIRF medicine properly as soon as I no longer need it • I will contact my healthcare provider if my TIRF medicine does not relieve my pain. I will not change the dose of my TIRF medicine myself or take it more often than my healthcare provider has directed • I must enroll in the TIRF REMS and Patient Registry by completing the Patient Enrollment Form with my healthcare provider • I understand that the TIRF REMS and its agents may use and share my personal information to manage the program, and that information about patients who get TIRF medicines will be stored in a private and secure database. My health information may be shared with the U.S. Food and Drug Administration (FDA) to evaluate the TIRF REMS. However, my name will not be shared • I give permission for the TIRF REMS and its agents or vendors to contact me by phone, mail, or email to support the administration of the TIRF REMS Program • I will tell my healthcare provider if I, or anyone else, experience an adverse event of accidental exposure, abuse, misuse, addiction, and overdose • I will re-enroll in the TIRF REMS by completing the Patient Enrollment Form with my healthcare provider every two years during treatment.", + "type": "display", + "readOnly": true + }, + { + "linkId": "3.2", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/sub-questionnaire", + "valueCanonical": "questionnaire/patient-signature" + } + ], + "type": "display" + } + ] + }, + { + "linkId": "4", + "type": "group", + "text": "Prescriber Information", + "item": [ + { + "linkId": "4.1", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "4.2", + "text": "Last Name", + "type": "string", + "required": 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+ ] + }, + { + "linkId": "6.4", + "text": "Patients must remain on around-the-clock opioids while taking a TIRF medicine. This patient is opioid tolerant because he/she is currently prescribed (exclusive of a TIRF medicine) one or more of the following opioid regimens daily and has been prescribed this regimen(s) for one week or longer (check all that apply)", + "type": "choice", + "required": true, + "repeats": true, + "answerOption": [ + { + "valueCoding": { + "code": "≥ 60 mg oral morphine/day", + "display": "≥ 60 mg oral morphine/day" + } + }, + { + "valueCoding": { + "code": "≥ 25 micrograms transdermal fentanyl/hour", + "display": "≥ 25 micrograms transdermal fentanyl/hour" + } + }, + { + "valueCoding": { + "code": "≥ 30 mg oral oxycodone/day", + "display": "≥ 30 mg oral oxycodone/day" + } + }, + { + "valueCoding": { + "code": "≥ 8 mg oral hydromorphone/day", + "display": "≥ 8 mg oral hydromorphone/day" + } + }, + { + "valueCoding": { + "code": "≥ 25 mg oral oxymorphone/day", + "display": "≥ 25 mg oral oxymorphone/day" + } + }, + { + "valueCoding": { + "code": "≥ 60 mg oral hydrocodone/day", + "display": "≥ 60 mg oral hydrocodone/day" + } + }, + { + "valueCoding": { + "code": "an equianalgesic dose of another opioid", + "display": "an equianalgesic dose of another opioid" + } + } + ] + } + ] + }, + { + "linkId": "7", + "type": "group", + "text": "Concomitant Medications", + "item": [ + { + "linkId": "7.1", + "text": "Concomitant Medications (check all that apply)", + "type": "choice", + "required": true, + "repeats": true, + "answerOption": [ + { + "valueCoding": { + "code": "Benzodiazepines", + "display": "Benzodiazepines" + } + }, + { + "valueCoding": { + "code": "Gabapentinoids", + "display": "Gabapentinoids" + } + }, + { + "valueCoding": { + "code": "Sedative Hypnotics", + "display": "Sedative Hypnotics" + } + }, + { + "valueCoding": { + "code": "Tranquilizers", + "display": "Tranquilizers" + } + }, + { + "valueCoding": { + "code": "Muscle Relaxants", + "display": "Muscle Relaxants" + } + }, + { + "valueCoding": { + "code": "Barbiturates", + "display": "Barbiturates" + } + }, + { + "valueCoding": { + "code": "Antipsychotics", + "display": "Antipsychotics" + } + }, + { + "valueCoding": { + "code": "Sodium Oxybate", + "display": "Sodium Oxybate" + } + }, + { + "valueCoding": { + "code": "Alcohol", + "display": "Alcohol" + } + }, + { + "valueCoding": { + "code": "Prescription Cannabinoids", + "display": "Prescription Cannabinoids" + } + }, + { + "valueCoding": { + "code": "Prescription Insomnia Medications", + "display": "Prescription Insomnia Medications" + } + }, + { + "valueCoding": { + "code": "Other CNS depressant", + "display": "Other CNS depressant" + } + }, + { + "valueCoding": { + "code": "None", + "display": "None" + } + } + ] + }, + { + "linkId": "7.2", + "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/TIRF/TopicMetadata.json b/CRD-DTR/TIRF/TopicMetadata.json new file mode 100644 index 0000000..700f406 --- /dev/null +++ b/CRD-DTR/TIRF/TopicMetadata.json @@ -0,0 +1,17 @@ +{ + "topic": "TIRF", + "payers": [ + "cms" + ], + "mappings": [ + { + "codeSystem": "rxnorm", + "codes":[ + "1237051" + ] + } + ], + "fhirVersions": [ + "R4" + ] +}