Risk Evaluation and Mitigation Strategy (REMS)
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.
Approximately 65% of all the approved REMS (since 2008) required a medication 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/
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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.”
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 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.
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