risk evaluation and mitigation strategy (rems)

1. Risk Evaluation and Mitigation Strategy (REMS)

2. Risk Evaluation and Mitigation Strategies (REMS) to Ensure Safe Use of Opioids Importance and efficacy of opioids in pain management is well known and acknowledged by organizations such as the American Pain Society (APS), American Academy of Pain Medicine (AAPM) and World Health Organization (WHO). However, nonmedical use including misuse, abuse, addiction and overdose are some of the significant risks associated with opioids. Opioid prescription drug abuse has shown an alarming increase over the last few years. Number of hydrocodone and oxycodone prescriptions increased from approximately 141 million in 2004 to 179 million in 2009. In an effort to minimize these risks, opioids are made available through REMS. REMS ensure that opioids’ benefits outweigh its safety risks and that healthcare professionals are aware will allow appropriate patients continued access to opioids. A class wide REMS for long-acting opioids has been suggested by the FDA but the design remains to be specified. REMS Elements such as ETASU have seen increased implementation in the recent past Since the introduction of the Food and Drug Administration Amendments Act (FDAAA), the FDA approved 23 REMS in 2008, 72 REMS in 2009 and 63 REMS in 2010. Approximately 65% of all the approved REMS (since 2008) required a medication

3. guide. However, medication guide-only REMS have decreased and components such as ETASUs and implementation systems have become key elements of REMS. ETASUs may be required if the drug is associated with serious adverse events and the medication guide In an interview with GBI Research (April 2011), David Kirk, Commercial Development Director for ParagonRx, said “One of three small molecules approved since 2008 have required REMS. MedGuide-only REMS have decreased as a percentage of total REMS approved in each year.” FDA mandates REMS for Erythropoiesis-Stimulating Agents (ESAs) ESAs are indicated for the treatment of anemia resulting from chronic kidney failure, chemotherapy, Human Immunodeficiency Virus (HIV) infection, and are also used to reduce the number of blood transfusions during and after certain major surgeries. ESAs are associated with an increase in risk of tumor growth and reduction in survival rate in patients with cancer who use ESAs. Studies have also shown that ESAs can For further details, please click or add the below link to your browser: http://www.gbiresearch.com/Report.aspx?ID=Risk-Evaluation-and-Mitigation-Strategy-REMS-Opioids-Erythropoesis-Stimulating-Agents-and-Cancer-Therapeutics-are-the-Most-Important-Classes-That-Require-REMS&Title=Pharmaceuticals_and_Healthcare&ReportType=Industry_Report

4. increase the risk of heart attack, heart failure, stroke, or blood clots in patients who use these drugs for other conditions. ESAs included in the REMS program are Amgen’s Epogen (epoetin alfa), Procrit (epoetin alfa), and Aranesp (darbepoetin alfa).The ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program, launched on March 24, 2010, was developed by Amgen in collaboration with Centocor Ortho Biotech Products for healthcare professionals who prescribe ESAs to patients with cancer. All ESAs are required to be prescribed with REMS to ensure their safe use. GBI Research, the leading business intelligence provider, has released its latest research, “Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS”. It provides key data, information and analysis on the risk management and mitigation strategies, mandated by the FDA and being implemented by pharmaceutical companies. The report provides information on the Risk Management and Mitigation Strategies (REMS), the reasons why companies implement REMS and the importance of REMS. This report provides comprehensive analysis of REMS approved up to date, components of REMS and safety issues involved in the requirement of REMS using case studies. The report also provides information on major drug classes that require REMS

5. such as opioids and erythropoesis-stimulating agents in cancer management. It also reviews the impact of REMS on various stakeholders including patients, healthcare providers and pharma and biotech industries. Major REMS consulting companies are covered in the report. It is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts For further details, please click or add the below link to your browser: http://www.gbiresearch.com/Report.aspx?ID=Risk-Evaluation-and-Mitigation-Strategy-REMS-Opioids-Erythropoesis-Stimulating-Agents-and-Cancer-Therapeutics-are-the-Most-Important-Classes-That-Require-REMS&Title=Pharmaceuticals_and_Healthcare&ReportType=Industry_Report Visit our report store: http://www.gbiresearch.com For more details contact: pressreleases@gbiresearch.com

6. North America: +1 646 395 5477 Europe: +44 207 753 4299 +44 1204 543 533 Asia Pacific: +91 40 6616 6782