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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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| ], | |
| "score": [ | |
| 0.9956, | |
| 0.9988, | |
| 0.9963, | |
| 0.9973, | |
| 0.9977, | |
| 0.9984, | |
| 0.9981, | |
| 0.9956, | |
| 0.998, | |
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| 0.998, | |
| 0.992, | |
| 0.9965, | |
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| 0.9871, | |
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| 0.9963, | |
| 0.9949, | |
| 0.9958, | |
| 0.9882, | |
| 0.9987, | |
| 0.997, | |
| 0.9986, | |
| 0.9965, | |
| 0.9349, | |
| 0.9887, | |
| 0.9234, | |
| 0.9848, | |
| 0.9923, | |
| 0.9873, | |
| 0.9983, | |
| 0.995, | |
| 0.9946, | |
| 0.9953, | |
| 0.7531, | |
| 0.9426 | |
| ], | |
| "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" | |
| ] | |
| } | |
| ] | |
| } |