What medicines are included in the REMS? What is the purpose of the REMS? The goal of the Opioid Analgesic REMS is to educate prescribers and other healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain. The education provided through the REMS program is based on the Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (“FDA Blueprint”). Through better education, the healthcare team will have an improved understanding of how to manage pain and the role of opioid analgesics along with nonpharmacologic and non-opioid analgesics in pain management. The education will also provide information about the risks of opioids and use of other therapies which is intended to assist healthcare providers in reducing adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate prescribing, abuse, and misuse. The REMS will accomplish this goal by: • Ensuring that training based on the FDA Blueprint is effective in educating prescribers and other healthcare providers involved in the treatment and monitoring of patients in pain (including pharmacists and nurses) about recommended pain management practices and appropriate use of opioid analgesics. • Informing patients about their roles and responsibilities regarding their pain treatment plan, including the risks of opioid analgesics and how to use and store them safely, as outlined in the Medication Guides and Patient Counseling Guide for opioid analgesics. Material Name Material Name Link () () () () () Society_Licensing_Board_Letter_1.pdf () Society_Licensing_Board_Letter_2.pdf () () () https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18__REMS_Website_Screenshots.pdf. What updates have been made to the REMS? Date Summary of change REMS name changed to Opioid Analgesic REMS. EZ Mask 2.0 EZ Mask is an easy to use interactive image masking tool capable of extracting almost any object in an image-even if you are dealing with fine hair detail, smoke, or reflections. Apr 23, 2018 - Ez Mask 2.0 Serial Number. View and Download ASUS MAXIMUS III FORMULA user manual online. MAXIMUS III FORMULA Motherboard pdf. REMS modified to: • Include immediate-release (IR) opioid analgesics intended for use in an outpatient setting • Ensure that training is made available to healthcare providers involved in the treatment and monitoring of patients with pain (including nurses and pharmacists) • Implement an updated FDA Blueprint for Healthcare Provider (HCP) Education which requires the education to cover broader information about appropriate pain management. Modified to align the REMS document and materials with the labeling approved on December 16, 2016, as well as additional minor modifications. Modified to relocate the product-specific information section from the Blueprint for Prescriber Education to the FDA website located at Modified to add Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) product information to the shared system REMS. Modified to add Xtampza ER (oxycodone) product information to the shared system REMS. Modified to include the following information in the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education: • Incorporate information regarding the use of OxyContin in the pediatric population. • Add information to the titration recommendations of OxyContin for adult patients. • Add product-specific information for a recently approved ER/LA opioid analgesic, MorphaBond (morphine sulfate extended release) tablets. • Add product-specific information for a recently approved ER/LA opioid analgesic, Belbuca (buprenorphine) buccal film. Modified to add the Belbuca (buprenorphine), product to the shared system REMS. Modified to add the Morphabond (morphine sulfate) product to the shared system REMS. Mac OS 8.6 to 9.2 (and Mac OS X 10.1) are no longer supported but you can find the last supported release of R for these systems (which is R 1.7.1) here. To compile packages you may have to download tools from the tools directory and read the corresponding note below. Download Now Secure Download. Publisher's Description. From R core team You are logged in as. Please submit your review for R for Mac OS X. Mavericks os x download. Modified to: • Incorporate information regarding use of OXYCONTIN in the pediatric population • Add information to the titration recommendations for adult patients. Modified to: • Change the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education to incorporate: • Product-specific information for a recently approved ER/LA opioid analgesic, Hysingla ER (hydrocodone bitartrate extended-release) tablets. • Newly approved intermediate strengths of fentanyl transdermal systems. • Revised titration information for Dolophine (methadone HCl tablets). Modified to add three new dosage strengths for fentanyl transdermal system [ANDA 076258]. Modified to add the Hysingla ER product to the shared system REMS. Modified to: • Incorporate the following safety labeling changes to the ER/LA Opioid Analgesics REMS Blueprint, ER/LA opioid analgesic REMS Website, and the Dear Prescriber Letter (DHCP) letter: • New indication for ER/LA opioid analgesics. • New warning for Neonatal Opioid Withdraw Syndrome (NOWS). • Updated language for the following Warnings and Precautions: • Addiction, Abuse, and Misuse • Life-Threatening Respiratory Depression • Accidental Ingestion • Cytochrome P450 3A4 Interaction (for applicable products) • Revisions to the Blueprint to incorporate updated product-specific titration language. • Change the ER/LA Opioid Analgesics REMS Blueprint to include product-specific information for ER/LA opioids approved after the last ER/LA REMS modification on April 15, 2013 Modified to add the Targiniq ER product to the shared system REMS. Modified to add the 7.5 mcg/hour intermediate dosage strength [to the Butrans (buprenorphine) Transdermal System] to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics. Modified to add the Zohydro product to the shared system REMS. Modified to: • Revise Section VI. Specific Drug information for ER/LA Opioid Analgesic Products of the FDA Blueprint.
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