vision_real / idl_wds /doc_00000002.json
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"text": [
"Professional Organization/Licensing Board Letter #2",
"FDA-Required REMS Program for Serious Drug Risks",
"Subject:",
"Availability of Risk Evaluation and Mitigation (REMS)-compliant training under the",
"REMS for all extended-release/long-acting opioid analgesic drug products.",
"Dear <Professional Organization/Licensing Board>:",
"Extended-release and long-acting (ER/LA) opioid analgesics¹ are approved for the management of chronic",
"moderate-to-severe pain in the U.S., and can be safe and effective in appropriately selected patients when",
"used as directed. However, opioid analgesics are also associated with serious risks and are at the center of a",
"major public health crisis of increased misuse, abuse, addiction, overdose, and death. The U.S. Food and Drug",
"Administration (FDA) determined that a Risk Evaluation and Mitigation Strategy (REMS) was necessary to",
"ensure that the benefits of ER/LA opioid analgesics continue to outweigh the risks of adverse outcomes",
"(addiction, unintentional overdose, and death) resulting from inappropriate prescribing, abuse, and misuse.",
"Several months ago, you received a letter announcing the REMS for all ER/LA opioid analgesic drug products,",
"which explained that the principal components of this REMS are:",
"a) Prescriber training on all ER/LA opioid analgesics,",
"b) the Patient Counseling Document on Extended-Release/Long-Acting Opioid Analgesics (PCD), and",
"c)",
"a unique Medication Guide for each ER/LA opioid analgesic drug product.",
"REMS-compliant Training Programs",
"The purpose of this letter is to provide notification of the upcoming availability of REMS-compliant training",
"on ER/LA opioid analgesics - provided at a nominal to no cost to prescribers. REMS-compliant training is a",
"critical component of the ER/LA Opioid Analgesics REMS program and constitutes essential safety education",
"for prescribers. REMS-compliant training will: (a) be delivered by accredited CE providers; (b) cover all",
"elements of the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid",
"Analgesics (\"FDA Blueprint\"); (c) include a post-course knowledge assessment; and (d) be subject to",
"independent audit of content and compliance with applicable accrediting standards.",
"REMS-compliant training will focus on the safe prescribing of ER/LA opioid analgesics. The FDA developed",
"core messages to be communicated to prescribers in the FDA Blueprint, which will be used by accredited CE",
"providers to design and deliver REMS-compliant training courses. The FDA Blueprint is available at",
"http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf",
"The core messages include:",
"Understand how to assess patients and determine which may be appropriate for treatment with",
"ER/LA opioid analgesics.",
"Be familiar with how to initiate therapy, modify dose, and discontinue use of ER/LA opioid",
"analgesics.",
"Be knowledgeable about how to manage and monitor ongoing therapy with ER/LA opioid analgesics.",
"Know how to counsel patients and caregivers about the safe use of ER/LA opioid analgesics,",
"including proper storage and disposal.",
"Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics.",
"1",
"The branded and generic drug products subject to this REMS include all: a) extended-release, oral-dosage forms containing:",
"hydromorphone, morphine, oxycodone, oxymorphone, or tapentadol; b) fentanyl and buprenorphine-containing transdermal delivery",
"systems; and c) methadone tablets and solutions that are indicated for use as analgesics.",
"DPOLB Letter 2",
"Page 1 of 2",
"Source: https://www.industrydocuments.ucsf.edu/docs/hlhj0239",
"MNKOI 0002417361"
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"text": [
"Professional Organization/Licensing Board Letter #2",
"REMS-compliant training for prescribers also includes information on weighing the benefits and risks of",
"opioid therapy and how to recognize evidence of, and the potential for, opioid misuse, abuse, addiction, and",
"overdose. REMS-compliant training may also be offered by academic institutions or learned societies",
"independent of REMS-related funding. We encourage you to successfully complete REMS-compliant training",
"from an accredited CE provider to improve your ability to prescribe these medications more safely.",
"Requested Action",
"We ask you to encourage your <members/licensees> to successfully complete REMS-compliant training to",
"improve their ability to prescribe these medications more safely. Under the REMS, prescribers are strongly",
"encouraged to do all of the following:",
"Train (Educate Themselves) - Complete REMS-compliant training offered by an accredited",
"provider of continuing education (CE) for their discipline.",
"Counsel Their Patients - Discuss the safe use, serious risks, storage, and disposal of ER/LA opioid",
"analgesics with patients and their caregivers every time you prescribe these medicines. Use the",
"enclosed Patient Counseling Document on Extended-Release/Long-Acting Opioid Analgesics (PCD) to",
"facilitate these discussions. Prescribers can re-order or print additional copies of the PCD from",
"www.ER-LA-opioidREMS.com.",
"Emphasize Patient and Caregiver Understanding of the Medication Guide - Stress to patients",
"and their caregivers the importance of reading the Medication Guide that they will receive from their",
"pharmacist every time an ER/LA opioid analgesic is dispensed to them, as information may have",
"changed.",
"Consider Using Other Tools - In addition to the PCD, there are other publicly-available tools to",
"improve patient, household, and community safety when using ER/LA opioids, as well as compliance",
"with conditions of treatment, including Patient-Prescriber Agreements (PPAs) and risk assessment",
"instruments.",
"A listing of REMS-compliant training funded under this REMS appears on www.ER-LA-opioidREMS.com.",
"Adverse Event Reporting",
"To report all suspected adverse reactions associated with the use of the ER/LA opioid analgesics, contact:",
"the pharmaceutical company that markets the specific product, or",
"the FDA MedWatch program:",
"-",
"by phone at 1-800-FDA-1088 (1-800-332-1088) or",
"-",
"online at www.fda.gov/medwatch/report.htm",
"More information about this REMS can be obtained at: www.ER-LA-opioidREMS.com or by calling the ER/LA",
"Opioid Analgesic REMS Call Center at 1-800-503-0784.",
"Sincerely,",
"The ER/LA Opioid Analgesic Companies",
"DPOLB Letter 2",
"Page 2 of 2",
"Source: ttps://www.industrydocuments.ucsf.edu/docs/hlhj0239",
"MNKOI 0002417362"
]
}
]
}