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IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE Program system via the internet ( www.ipledgeprogram.com ), telephone (1-866-495-0654) or throughIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE Program system via the internet ( www.ipledgeprogram.com ), telephone (1-866-495-0654) or throughIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance. RISKS ASSOCIATED WITH LEFTOVER MEDICATION AND … August 2012 SAFETY NOTICE Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, TIPS FROM PRESCRIBERS WHO HAVE HAD SUCCESS IN OBTAINING August 2015 . Tips from Prescribers Who Have Had Success in Obtaining . Post-Treatment Pregnancy Tests in the iPLEDGE Program . The iPLEDGE Program wants to emphasize to prescribers the importance of MOST COMMON REASONS REPORTED FOR AN IPLEDGE PREGNANCY BY June 2013 Most Common Reasons Reported for an iPLEDGE Pregnancy By iPLEDGE Prescribers and Patients Analysis of iPLEDGE pregnancy data over the past several years hasIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE Program system via the internet ( www.ipledgeprogram.com ), telephone (1-866-495-0654) or throughIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance. PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy andIPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE Program system via the internet ( www.ipledgeprogram.com ), telephone (1-866-495-0654) or throughIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance. PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy andIPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance. RISKS ASSOCIATED WITH LEFTOVER MEDICATION AND … August 2012 SAFETY NOTICE Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, TIPS FROM PRESCRIBERS WHO HAVE HAD SUCCESS IN OBTAINING August 2015 . Tips from Prescribers Who Have Had Success in Obtaining . Post-Treatment Pregnancy Tests in the iPLEDGE Program . The iPLEDGE Program wants to emphasize to prescribers the importance of MOST COMMON REASONS REPORTED FOR AN IPLEDGE PREGNANCY BY June 2013 Most Common Reasons Reported for an iPLEDGE Pregnancy By iPLEDGE Prescribers and Patients Analysis of iPLEDGE pregnancy data over the past several years hasIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE Program system via the internet ( www.ipledgeprogram.com ), telephone (1-866-495-0654) or throughIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
IPLEDGE NON-COMPLIANCE ACTION POLICY 2. DEFINITIONS 2.1. For the purposes of the iPLEDGE Program, the definition Non-Compliance- of Non-Compliance is a stakeholder (patient, pharmacy, prescriber, designee orIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE Program system via the internet ( www.ipledgeprogram.com ), telephone (1-866-495-0654) or throughIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
IPLEDGE NON-COMPLIANCE ACTION POLICY 2. DEFINITIONS 2.1. For the purposes of the iPLEDGE Program, the definition Non-Compliance- of Non-Compliance is a stakeholder (patient, pharmacy, prescriber, designee or PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and TIPS FROM PRESCRIBERS WHO HAVE HAD SUCCESS IN OBTAINING August 2015 . Tips from Prescribers Who Have Had Success in Obtaining . Post-Treatment Pregnancy Tests in the iPLEDGE Program . The iPLEDGE Program wants to emphasize to prescribers the importance of RISKS ASSOCIATED WITH LEFTOVER MEDICATION AND … August 2012 SAFETY NOTICE Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount,IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance. MOST COMMON REASONS REPORTED FOR AN IPLEDGE PREGNANCY BY June 2013 Most Common Reasons Reported for an iPLEDGE Pregnancy By iPLEDGE Prescribers and Patients Analysis of iPLEDGE pregnancy data over the past several years hasIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program is a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. The program strives to ensure that: NoIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
IPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
The iPLEDGE Program is a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. The program strives to ensure that: NoIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.IPLEDGE REMS
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with itsuse
IPLEDGE REMS
The upgrades to the iPLEDGE ® Program system are complete.. The website has a new look and feel, but the content and user experience should be familiar. Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity(the switch).
PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and PRESCRIBER ISOTRETINOIN EDUCATIONAL KIT WARNING Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin inany
PATIENT INTRODUCTORY BROCHURE What Is The iPLEDGE® Program? The iPLEDGE Program is a set of steps all patients, doctors/prescribers, and pharmacists must follow. The main goal is preventing pregnancy and RISKS ASSOCIATED WITH LEFTOVER MEDICATION AND … August 2012 SAFETY NOTICE Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, TIPS FROM PRESCRIBERS WHO HAVE HAD SUCCESS IN OBTAINING August 2015 . Tips from Prescribers Who Have Had Success in Obtaining . Post-Treatment Pregnancy Tests in the iPLEDGE Program . The iPLEDGE Program wants to emphasize to prescribers the importance of MOST COMMON REASONS REPORTED FOR AN IPLEDGE PREGNANCY BY June 2013 Most Common Reasons Reported for an iPLEDGE Pregnancy By iPLEDGE Prescribers and Patients Analysis of iPLEDGE pregnancy data over the past several years hasIPLEDGE REMS
Requirement Changes due to COVID-19; Telemedicine • Prescriber to use best medical judgement to manage their patients. • Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance.PROGRAM UPDATE
PROGRAM UPDATE
IMPORTANT PROGRAM UPDATE FOR THE IPLEDGE® PROGRAMREQUIREMENT
CHANGES DUE TO COVID-19Telemedicine
• Prescriber to use best medical judgement to manage theirpatients.
• Please refer to the March 17, 2020 notice from The Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”)
for guidance.
Pregnancy Testing
• Pregnancy test can be “at-home”. The tests can be obtained at drug store, grocery store, or online retailer. • The test results and date performed must be communicated toprescriber.
• Prescriber or designee would enter the date performed (specimen collection date) and test results per usual iPLEDGE Program process.Prescription Window
• This requirement will not change. Two Forms of Birth Control or Abstinence • This requirement will not change. THE UPGRADES TO THE IPLEDGE® PROGRAM SYSTEM ARE COMPLETE. * The website has a new look and feel, but the content and user experience should be familiar. * Pharmacies will now be able to obtain Risk Management Authorizations (RMAs) using Pharmacy Network Connectivity (theswitch).
NOTE: There are NO CHANGES TO THE IPLEDGE PROGRAM SAFETY REQUIREMENTS with the new system enhancements. _Please see below for how this affects you._PATIENTS
For patients, iPLEDGE Program website has a new look and feel. All iPLEDGE Program safety requirements and patient functionality remainsunchanged.
PRESCRIBERS AND DESIGNEES For prescribers and designees, there are some enhancements for managing patients, including enhanced patient search functionality. The enhancements to the iPLEDGE Program system will also require prescribers, upon initial login, to: * Confirm/provide their National Provider Identifier (NPI) number * Confirm/provide their Drug Enforcement Administration (DEA) Number(if available)
FAILURE TO SUPPLY THESE IDENTIFIERS MAY RESULT IN THE PRESCRIBER'S PATIENTS' PRESCRIPTIONS NOT BEING AUTHORIZED FOR DISPENSING.PHARMACIES
The iPLEDGE Program system will allow Pharmacy Network Connectivity(the switch).
* For _chain pharmacies_, your corporate headquarters will providemore information.
* For _non-chain pharmacies_, instructions for connecting to the Pharmacy Network are available on the Pharmacy Homepage on the iPLEDGE Program Website on a link titled: "For information on connecting to the Pharmacy Network" IF YOUR PHARMACY WANTS TO CONTINUE TO OBTAIN A RISK MANAGEMENT AUTHORIZATION TO DISPENSE ISOTRETINOIN VIA THE WEB SITE, WWW.IPLEDGEPROGRAM.COM , OR THE AUTOMATED PHONE SYSTEM, 1-866-495-0654, NO FURTHER ACTION IS REQUIRED.Welcome
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SAFETY NOTICE
Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for a short period of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Because of this toxicity, isotretinoin can only be marketed under a special restricted distribution program. This program is called iPLEDGE®. Under this program, prescribers must be registered and activated with the iPLEDGE Program and can prescribe isotretinoin only to registered patients who meet all the requirements of iPLEDGE. Isotretinoin can be dispensed only by a pharmacy registered and activated with iPLEDGE. Registered and activated pharmacies can only receive isotretinoin from wholesalers registered with iPLEDGE. Patients on isotretinoin have been known to become depressed or to develop other serious mental health problems. Some people have had thoughts of hurting themselves or putting an end to their own lives. Some people tried to end their own lives and some have ended their own lives. There have been reports that people on isotretinoin were aggressive or violent. No one knows if isotretinoin caused these problems or behaviors or if they would have happened even if the person did not take isotretinoin. Isotretinoin use has been associated with pseudotumor cerebri, a condition caused by increased pressure on the brain. This condition may occur more often in patients also taking tetracycline. Patients should be aware of other serious side effects, including problems with the skin, pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. The most common, less serious adverse events include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Patients should be advised about these adverse events and routinely monitored by a doctor during treatment with isotretinoin. Please refer to the isotretinoin package inserts for full prescribing and dispensing instructions.REGISTRATION
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Call our toll free number 1-866-495-0654 to report any of thefollowing:
An Adverse Event: If you or someone you know has experienced an adverse event, please call 1-866-495-0654. A Pregnancy: If you are an activated prescriber, report pregnancy results by logging in and clicking on “Manage Patients .” Otherwise, please call1-866-495-0654.
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