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14 changes: 7 additions & 7 deletions CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json
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Expand Up @@ -108,12 +108,12 @@
"item": [
{
"linkId": "3.1",
"text": "You have indicated that this patient is a patient who cannot become pregnant. The questions that follow will assign a risk category for this patient, based on the reproductive potential according to the requirements of the iPLEDGE REMS. All patients who cannot get pregnant are considered patients who can get pregnant unless one or more of the following applies: 1. Patient is cicgender male (borm a male, aka cis-male) 2. Patient has had a hysterectomy 3. Patient has had a bilateral oophorectomy 4. Patient is post-menopausal",
"text": "You have indicated that this patient is a patient who cannot become pregnant. The questions that follow will assign a risk category for this patient, based on the reproductive potential according to the requirements of the iPLEDGE REMS. All patients who cannot get pregnant are considered patients who can get pregnant unless one or more of the following applies: 1. Patient is cisgender male (born a male, aka cis-male) 2. Patient has had a hysterectomy 3. Patient has had a bilateral oophorectomy 4. Patient is post-menopausal",
"type": "display"
},
{
"linkId": "3.2",
"text": "Please note that the following conditions DO NOT qualify a patient to be moved from the patient who can become pregnant risk category • Tubal sterilization • Male vasectomy • Abstinence • Patient has not had a first menstrual period (pre-menarche) • Patient is currently in menopause (but not yet post-menupausal)",
"text": "Please note that the following conditions DO NOT qualify a patient to be moved from the patient who can become pregnant risk category • Tubal sterilization • Male vasectomy • Abstinence • Patient has not had a first menstrual period (pre-menarche) • Patient is currently in menopause (but not yet post-menopausal)",
"type": "display"
},
{
Expand Down Expand Up @@ -155,7 +155,7 @@
},
{
"linkId": "4.4",
"text": "For the iPLEDGE REMS, a patient is considered post-menopausal upon cessation of previously occurring menses as a reuslt of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., spontaneous menopause). Hormonal deficiency should be properly documented in the case of spontaneuous menopause as follows: 1. If age > 54 years and with absence of normal menses: serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed 2. If age < 54 years and with the absence of normal menses: negative serum or urine -hCG with concurrently elevated serum FSH (Follicle Stiumulating Hormone) level in the post-menopausal, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assay is performed.",
"text": "For the iPLEDGE REMS, a patient is considered post-menopausal upon cessation of previously occurring menses as a result of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., spontaneous menopause). Hormonal deficiency should be properly documented in the case of spontaneous menopause as follows: 1. If age > 54 years and with absence of normal menses: serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed 2. If age < 54 years and with the absence of normal menses: negative serum or urine -hCG with concurrently elevated serum FSH (Follicle Stimulating Hormone) level in the post-menopausal, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assay is performed.",
"type": "display"
},
{
Expand Down Expand Up @@ -457,7 +457,7 @@
},
{
"linkId": "7.4",
"text": "3. I understand that I must completely avoid having any sexual contact (penis-vaginal) with a partner who coud get me pregnant, or I must use two separate effective forms of birth control (contraception) at the same time. The only exceptions are if I have had any surgery to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal.",
"text": "3. I understand that I must completely avoid having any sexual contact (penis-vaginal) with a partner who could get me pregnant, or I must use two separate effective forms of birth control (contraception) at the same time. The only exceptions are if I have had any surgery to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal.",
"type": "boolean",
"required": true
},
Expand Down Expand Up @@ -515,13 +515,13 @@
},
{
"linkId": "7.10",
"text": "9. I cannot get my first prescription for isotretinoin unless my doctor has told me that I have two negative pregnancy test results. The first pregnancy test should be done when my doctor decides to prescribe isotretinoin. The second pregnancy test must be done in a lab during the first 5 days of my menstural period right before starting isotretinoin therapy treatment, or as instructed by my doctor. I will then have one pregnancy test; in a lab: • every month during treatment • at the end of treatment • and 1 month after stopping treatment. I must not start taking isotretinoin until I am sure that I am not pregnant, have negative results from two pregnancy tests, and the second test has been done in a lab.",
"text": "9. I cannot get my first prescription for isotretinoin unless my doctor has told me that I have two negative pregnancy test results. The first pregnancy test should be done when my doctor decides to prescribe isotretinoin. The second pregnancy test must be done in a lab during the first 5 days of my menstrual period right before starting isotretinoin therapy treatment, or as instructed by my doctor. I will then have one pregnancy test; in a lab: • every month during treatment • at the end of treatment • and 1 month after stopping treatment. I must not start taking isotretinoin until I am sure that I am not pregnant, have negative results from two pregnancy tests, and the second test has been done in a lab.",
"type": "boolean",
"required": true
},
{
"linkId": "7.11",
"text": "10. I have read and understand the materials my doctor has provided to me, including the iPLEDGE REMS Guide for Patients who Can Get Pregnant and iPLEDGE REMS Fact Sheet. I have recieved information on emergency birth control.",
"text": "10. I have read and understand the materials my doctor has provided to me, including the iPLEDGE REMS Guide for Patients who Can Get Pregnant and iPLEDGE REMS Fact Sheet. I have received information on emergency birth control.",
"type": "boolean",
"required": true
},
Expand All @@ -539,7 +539,7 @@
},
{
"linkId": "7.14",
"text": "13. I understand that being qualified to receive isotretinoin in the iPLEDGE REMS means that I: • have had two negative urine or blood pregnancy tests before receiving the first isotretinoin prescription. The second test must be done in a lab. I must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before I recieve another isotretinoin prescription • have chosen and agreed to use two forms of effective birth control at the same time. At least one method must be a primary method of birth control unless I have chosen never to have sexual contact (penis-vaginal) with a partner who could get me pregnant (abstinence), or I have undergone a hysterectomy or bilateral oophorectomy, or I have been medically confirmed to be post-menopausal. I must use two forms of birth control for at least one month before I start isotretinoin therapy. I must receieve counseling, repeated on a monthly basis, about birth control and behaviors associated with an increased risk of pregnancy • have signed an Informed Consent For Patients Who Can Get Pregnant (for patients who can get pregnant) that contains warmings about the chance of possible birth defects if I am pregnant or becoming pregnant and my unborn baby is exposed to isotretinoin • have been informed of and understand the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within 1 month of the last dose • have interacted with the iPLEDGE REMS before starting isotretinoin and on a monthly basis to answer questions on the program requirements and to enter my two chosen forms of birth control",
"text": "13. I understand that being qualified to receive isotretinoin in the iPLEDGE REMS means that I: • have had two negative urine or blood pregnancy tests before receiving the first isotretinoin prescription. The second test must be done in a lab. I must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before I receive another isotretinoin prescription • have chosen and agreed to use two forms of effective birth control at the same time. At least one method must be a primary method of birth control unless I have chosen never to have sexual contact (penis-vaginal) with a partner who could get me pregnant (abstinence), or I have undergone a hysterectomy or bilateral oophorectomy, or I have been medically confirmed to be post-menopausal. I must use two forms of birth control for at least one month before I start isotretinoin therapy. I must receive counseling, repeated on a monthly basis, about birth control and behaviors associated with an increased risk of pregnancy • have signed an Informed Consent For Patients Who Can Get Pregnant (for patients who can get pregnant) that contains warnings about the chance of possible birth defects if I am pregnant or becoming pregnant and my unborn baby is exposed to isotretinoin • have been informed of and understand the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within 1 month of the last dose • have interacted with the iPLEDGE REMS before starting isotretinoin and on a monthly basis to answer questions on the program requirements and to enter my two chosen forms of birth control",
"type": "boolean",
"required": true
},
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Expand Up @@ -375,7 +375,7 @@
},
{
"linkId": "3.3",
"text": "I know the risk factors for unplanned pregnancy and the effective measures for avoidance of unplaned pregnancy.",
"text": "I know the risk factors for unplanned pregnancy and the effective measures for avoidance of unplanned pregnancy.",
"type": "display"
},
{
Expand All @@ -390,12 +390,12 @@
},
{
"linkId": "3.6",
"text": "Before beginning treatment of patients who can become pregnant with isotretinoin, and on a monthly basis, the patient will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continously for at least one month prior to initiation of isotretinoin treatment, during isotretinoin treatment and for one month after discontinuing isotretinoin treatment, unless the patient commits to continous abstinence, not having any sexual contact with a partner that could result in pregnancy.",
"text": "Before beginning treatment of patients who can become pregnant with isotretinoin, and on a monthly basis, the patient will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continuously for at least one month prior to initiation of isotretinoin treatment, during isotretinoin treatment and for one month after discontinuing isotretinoin treatment, unless the patient commits to continuous abstinence, not having any sexual contact with a partner that could result in pregnancy.",
"type": "display"
},
{
"linkId": "3.7",
"text": "I will not prescribe isotretinoin to any patient who can become pregnant until verifying the patient has a negative screening pregnancy test and monthly CLIA-certified (Clinical Laboratory Improvement Amendment) pregnancy tests. Patients should have a pregnancy test at the completion of the entire course of isotretinoin and another pregnancy test one month laer.",
"text": "I will not prescribe isotretinoin to any patient who can become pregnant until verifying the patient has a negative screening pregnancy test and monthly CLIA-certified (Clinical Laboratory Improvement Amendment) pregnancy tests. Patients should have a pregnancy test at the completion of the entire course of isotretinoin and another pregnancy test one month later.",
"type": "display"
},
{
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Expand Up @@ -237,7 +237,7 @@
"valueString": "Morning"
},
{
"valueString": "Afternnon"
"valueString": "Afternoon"
},
{
"valueString": "Evening"
Expand Down Expand Up @@ -323,7 +323,7 @@
"valueString": "Morning"
},
{
"valueString": "Afternnon"
"valueString": "Afternoon"
},
{
"valueString": "Evening"
Expand Down Expand Up @@ -405,7 +405,7 @@
"item": [
{
"linkId": "4.1",
"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",
"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 risk 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 tolerance 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
},
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2 changes: 1 addition & 1 deletion CRD-DTR/TIRF/R4/resources/Questionnaire-R4-TIRF.json
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Expand Up @@ -163,7 +163,7 @@
"valueString": "Morning"
},
{
"valueString": "Afternnon"
"valueString": "Afternoon"
},
{
"valueString": "Evening"
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@@ -1,4 +1,4 @@
library DrugHasREMSPrepopulation version '0.1.0'
library TuralioPrepopulation version '0.1.0'
using FHIR version '4.0.0'
include FHIRHelpers version '4.0.0' called FHIRHelpers
include CDS_Connect_Commons_for_FHIRv400 version '1.0.2' called CDS
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