On September 27, 2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), further amending the Food, Drug, and Cosmetic Act. The FDAAA authorizes the Food and Drug Administration (FDA) to require risk evaluation and mitigation strategies (REMS) on medications if necessary to minimize the risks associated with some drugs.

The FDA has a responsibility to ensure that the benefits of a medication outweigh the potential risks of that medication. To determine this, the FDA looks at the seriousness of the disease or condition to be treated, size of the patient population, expected benefit of the drug, expected duration of treatment, and seriousness of the known or potential adverse events.

If a medication's benefits outweigh the risks associated with it, the FDA approves it. Sometimes though, the medication therapy itself still carries a lot of risks with it. In that situation, the FDA may require REMS. These risk minimization strategies go beyond FDA professional labeling. FDA can require a REMS before a drug is approved if they have determined that a REMS is necessary to ensure the benefits of the drug outweigh its risks. Also, FDA can require a REMS post-approval if they become aware of new safety information and make the determination that a REMS is necessary, again, to ensure that the benefits of the drug outweigh its risks.

Elements of risk evaluation and mitigation strategies

REMS may contain any of the following elements:

• Medication Guide – Document written for patients highlighting important safety information about the drug; this document must be distributed by the pharmacist to every patient receiving the drug.
• Communication Plan – Plan to educate healthcare professionals on the safe and appropriate use of the drug and consists of tools and materials that will be disseminated to the appropriate stakeholders.
• Elements to Assure Safe Use (EASU) – These are strictly controlled systems or requirements put into place to enforce the appropriate use of a drug. Examples of EASUs include physician certification requirements in order to prescribe the drug, patient enrollment in a central registry, distribution of the drug restricted to certain specialty pharmacies, etc.
• Implementation Plan – A description of how certain EASUs will be implemented.
• Timetable for Submission of Assessments – The frequency of assessment of the REMS performance with regard to meeting the goal(s) and objective(s). FDA requires that assessments be conducted at 18 months, 3 years, and 7 years post-launch, at a minimum. Results of these evaluations must be reported to the FDA and will determine whether additional actions or modifications to the REMS program are required.

See also

Medication errors
Five rights
MedWatch
Drug recalls
Vaccine Adverse Event Reporting System
Antidote
Tallman lettering
High-alert medications
Barcoding technologies

References

1. FDA, Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
2. FDA, Approved Risk Evaluation and Mitigation Strategies (REMS), http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
3. Medscape, Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and Pharmacists, Claudia B. Karwoski, PharmD; Marcie A. Bough, PharmD; Todd M. Colonna, MD; Lisa A. Gorski, RN, MS, May 15, 2012, http://www.medscape.org/viewarticle/762673_transcript
4. ParagonRx, Risk Evaluation and Mitigation Strategies (REMS) - A Brief History. September 2009, http://www.paragonrx.com/rems-hub/rems-history/
5. FDA, Postmarket Drug Safety Information for Patients and Providers, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm