FDA Implements Risk Management Safeguards for Select Drugs

Under the FDA Amendment Act of 2007, the FDA was authorized to require manufacturers of medications already on the market to develop Risk Evaluation and Mitigation Strategies (REMS) for select drugs.

What is REMS?

The goal behind REMS is to implement safeguards for those drugs in which the benefit of usage may outweigh the risk of abuse and/or side effects.  Dependent upon the type of risk management required for the particular drug, each REMS protocol may differ and may include several different components such as:

  • Medication guides which are geared toward the patient to facilitate understanding of possible adverse side effects and risks of the drug
  • Communication plans which target hospitals, pharmacists, or prescribers to promote safe use and prescribing of the medications
  • Elements to Assume Safe Use (ETASU) which include programs that hospitals or prescribers must adhere to such as prescriber-patient agreements, mandatory education plans & prescriber enrollment programs
  • Periodic assessments by the manufacturer to monitor the success of the REMS protocols and to assess compliance by the prescribers as well as hospitals.  These periodic assessments by the manufacturers are subject to review by the FDA.   

Recent REMS approved by the FDA

Recently, there were two classes of medications that came under scrutiny by the FDA for the development of REMS due to their potential for misuse, inappropriate prescribing, and abuse: Transmucosal Immediate Release Fentanyl (TIRF) products and extended release/long acting opioids. 

In January of 2012, the FDA approved REMS for the entire class of TIRFs.  This was the first REMS which covered an entire category of opioids, including Actiq, Fentora, Abstral, Lazanda, Onsolis, and Subsys.   TIRFs, a very potent class of narcotics with rapid release and absorption, are FDA approved for the management of breakthrough pain in patients diagnosed with cancer who are tolerant to opioids. Often times however, TIRFS are used in an off-label manner for chronic pain not related to cancer.

The FDA then took a further step in July of 2012 to approve REMS for all extended release and long acting opioids, such as Oxycontin, MS Contin, Kadian and Opana ER.  These drugs are FDA approved for treatment of moderate to severe pain in patients requiring 24-hour pain management for an extended period of time.

What is the impact of these REMS to workers’ compensation claims and WCMSAs?

The workers’ compensation industry is aware of the impact that opioids have on claim costs, especially TIRFs.  The aforementioned TIRFs are usually prescribed off-label and do not have an impact on MSA prescription allocations.  However, Actiq was listed as number 11 of the top 20 workers’ compensation medications per total spend in 2011 by the PMSI 2012 Drug Trends Report.  Oxycontin, MSContin, Kadian (and their generics) along with brand Opana ER were also listed in the top 20 workers’ compensation  medications per total transaction and total spend.   

As prescription costs directly impact the cost of a workers’ compensation claim, it is vital to quickly become aware of cases where misuse and abuse may occur.  PMSI remains hopeful that REMS will not only succeed at the prescriber, pharmacy and patient level to help reduce claim costs, but also to ensure the safety of the injured individual that may be prescribed a drug covered under REMS.

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