Pharmacytimes:Condition Center: Risk Evaluation and Mitigation Strategies http://www.pharmacytimes.com/condition-resources/rems/condition-rss Risk Evaluation and Mitigation Strategies | PharmacyTimes en-us Sat, 19 Apr 2014 07:24:29 EDT Sat, 19 Apr 2014 07:24:29 EDT FDA Announces Label Changes to Improve Opioid Safetyhttp://www.pharmacytimes.com/news/FDA-Announces-Label-Changes-to-Improve-Opioid-SafetyLabels on all extended-release and long-acting opioid analgesics will be amended to ensure they are used only by those who need them and to warn pregnant women of the risk of neonatal narcotic withdrawal syndrome.Fri, 13 Sep 2013 01:03:27 EDTFDA Bars Generic Version of OxyContinhttp://www.pharmacytimes.com/news/FDA-Bars-Generic-Version-of-OxycontinThe FDA will not approve generic forms of OxyContin that lack abuse-resistant features—and OxyContin’s manufacturer will be able to state that the drug has tamper-resistant properties.Wed, 17 Apr 2013 12:53:25 EDTFDA Drug Info Rounds: Distribution of Medication Guideshttp://www.pharmacytimes.com/videos/FDA-Drug-Info-Rounds-Distribution-of-Medication-GuidesA discussion of requirements for distributing medication guides when a drug is dispensed or distributed to a health care professional.Tue, 12 Feb 2013 10:47:16 ESTFDA Announces New REMS for Drugs to Treat Low Platelet Countshttp://www.pharmacytimes.com/news/FDA-Announces-New-REMS-for-Drugs-to-Treat-Low-Platelet-CountsChanges mean pharmacists are no longer are required to enroll in educational programs before dispensing the drugs to patients.Fri, 09 Dec 2011 08:59:28 ESTThe Changing Landscape of REMS in Pain Managementhttp://www.pharmacytimes.com/news/The-Changing-Landscape-of-REMS-in-Pain-Management-REMS programs in acute and chronic pain management continue to evolve to reduce risk associated with pain medications.Fri, 18 Nov 2011 12:21:51 ESTREMS Improvements Proposed for Version 5 of Prescription Drug User Fee Acthttp://www.pharmacytimes.com/news/REMS-Improvements-Proposed-for-Version-5-of-Prescription-Drug-User-Fee-ActAmong the actions supported by APhA is an outlined strategy and time frame for FDA to continue to discuss and gather public input on improving REMS programs.Fri, 04 Nov 2011 10:42:04 EDTConcerns about Prescribing Opioidshttp://www.pharmacytimes.com/videos/Concerns-about-Prescribing-OpioidsFri, 21 Oct 2011 04:05:30 EDTUpdated REMS for Rosiglitazone-containing Medicineshttp://www.pharmacytimes.com/podcasts/Updated-REMS-for-Rosiglitazone-containing-MedicinesFri, 21 Oct 2011 03:57:48 EDTDasatinib and the Risk of Pulmonary Arterial Hypertensionhttp://www.pharmacytimes.com/podcasts/Dasatinib-and-the-Risk-of-Pulmonary-Arterial-HypertensionFri, 21 Oct 2011 03:55:06 EDTImpact of Risk Evaluation and Mitigation Strategies in Oncologyhttp://www.pharmacytimes.com/news/Impact-of-Risk-Evaluation-and-Mitigation-Strategies-in-OncologyWhen used fittingly, REMS can ensure safe use of prescribed drugs. However, applying REMS to oncology and supportive-care drugs must be done carefully.Fri, 21 Oct 2011 03:15:08 EDTAssessing a REMS Strategy: Keep It Simple and Responsible http://www.pharmacytimes.com/news/Assessing-a-REMS-Strategy-Keep-It-Simple-and-Responsible-Manufactures are faced with multiple challenges as the FDA imposes far-reaching requirements for their production.Tue, 27 Sep 2011 05:12:53 EDTExamining the Role of REMS in Opioid Safetyhttp://www.pharmacytimes.com/news/Examining-the-Role-of-REMS-in-Opioid-SafetyAn expert questions why the risks and side effects of warfarin are explained much more carefully to patients than those of opioids.Fri, 16 Sep 2011 10:53:48 EDTFDA Initiative Focuses on Safe Use of Acetaminophenhttp://www.pharmacytimes.com/news/FDA-Initiative-Focuses-on-Safe-Use-of-AcetaminophenA new white paper offers suggestions on how to make it easier for patients to safely and effectively use medicines containing acetaminophen.Mon, 29 Aug 2011 04:40:03 EDTTen REMS Throw Retirement Partyhttp://www.pharmacytimes.com/news/Ten-REMS-Throw-Retirement-PartyWhat you need to know about the latest draft guidance for manufactures regarding medication guides and the current scene of classwide REMs.Wed, 03 Aug 2011 10:36:42 EDTFDA Approves REMS for Actiq and Fentorahttp://www.pharmacytimes.com/news/FDA-Approves-REMS-for-Actiq-and-FentoraCephalon to provide education modules for two products indicated for the management of breakthrough pain in opioid-tolerant patients with cancer.Wed, 27 Jul 2011 10:53:15 EDTConcentration of Popular Flu Drug Loweredhttp://www.pharmacytimes.com/news/Concentration-of-Popular-Flu-Drug-LoweredThe FDA announces changes to Tamiflu for oral suspension to help reduce the possibility of prescribing and dosing errors.Wed, 13 Jul 2011 09:30:08 EDTEpilepsy Drugs Pose Risk When Taken During Pregnancyhttp://www.pharmacytimes.com/news/Epilepsy-Drugs-Pose-Risk-When-Taken-During-PregnancySeveral new studies have linked the anti-seizure drug valproate to a risk for lower cognitive test scores among children whose mothers took it while pregnant.Wed, 06 Jul 2011 09:45:05 EDTSafety Information Added to Label of Diabetes Drughttp://www.pharmacytimes.com/news/Safety-Information-Added-to-Label-of-Diabetes-DrugFindings from an ongoing study show that long-term use of pioglitazone is associated with an increased risk of bladder cancer.Mon, 27 Jun 2011 10:17:48 EDTSmoking Cessation Aid May Increase Heart Attack Riskhttp://www.pharmacytimes.com/news/Smoking-Cessation-Aid-May-Increase-Heart-Attack-RiskThe FDA cautions that varenicline may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease.Thu, 16 Jun 2011 02:40:10 EDTFDA Announces Label Changes for Simvastatinhttp://www.pharmacytimes.com/news/FDA-Announces-Label-Changes-for-SimvastatinStudy results linking the drug to an elevated risk of myopathy prompt the FDA to revise its recommendations.Thu, 09 Jun 2011 11:49:03 EDT