New REMS@FDA Website: Benefits for Pharmacists

The FDA launched a new website in July to provide information about medications approved with Risk Evaluation and Mitigation Strategies (REMS). ¹

REMS are applied to medications or drug classes that have certain associated risks.² They consist of precautions to ensure that patients maintain an appropriate risk-benefit ratio while receiving treatment, and health care providers are required to comply with the program.

Applying REMS components to medications is also critical for pharmacists to provide proper patient care. All REMS medications have at least 1 REMS component, which may include 1 or more of the following: Medication Guide (MedGuide), Communication Plan, Elements to Assure Safe Use (ETASU), and Implementation System (Table 1).³

Table 1. REMS components

REMS components

Description

Medication Guides (MedGuide)⁴

• Standardized and individualized information for a particular drug that is required to be given to patients each time that drug is dispensed.
• Consumer medication sheets in the pharmacy cannot replace a MedGuide.
• Some REMS medications may have a MedGuide that is not affiliated with the REMS program if the FDA decides it is lower risk.

Communication Plan³

• Methods that drug companies use to advocate for applying REMS to high-risk medication products.
• Generic bioequivalent medications do not have communication plans.
• An example of a communication plan may include a letter to health care providers from the manufacturer pertaining to safety information.

Elements to Assure Safe Use (ETASU)³

• Complex safety precautions to reduce the number of adverse events from certain high-risk medications.
• Examples of ETASU may include specialized training for the prescriber or pharmacist and special monitoring through lab tests or observation.

Implementation System³

• Methods that drug companies use to ensure that the specific ETASU are incorporated into the drug’s prescribing, dispensing, and monitoring process.

New REMS@FDA website

The new REMS@FDA website is useful for pharmacists because it increases access to a variety of drug information resources for each REMS medication.

The main webpage for each REMS medication contains direct links to the drug’s package insert on DailyMed, as well as regulatory information. The regulatory information webpage includes a link to pharmaceutical and therapeutic equivalency information for all brand-name and generic versions on the market (Orange Book), as well as links to label information, approval history, reviews, and MedGuide, if applicable.

For medications that have shared system REMS, the DailyMed and regulatory information is listed in the table next to each drug product that contains the REMS ingredient.

REMS@FDA also includes safety information, education materials for pharmacists, letters to pharmacists containing important information, pharmacy enrollment forms, and required actions for pharmacists to legally dispense the REMS medication.

The section covering the appropriate dispensing process is particularly useful to pharmacists because it includes useful information for certain medications such as:

• Informing pharmacists not to dispense more than a certain days’ supply
• Only accepting paper prescriptions
• Whether a certification is needed to dispense the drug
• What to do before, during, and after dispensing

REMS@FDA has enhanced organization compared with the old website. For instance, the list of REMS medications can now be sorted alphabetically or by most recently updated. The new website also provides a filter mechanism that allows users to search for medications by typing in the brand or generic name to find the desired REMS medication.⁵

First Impression

Overall, REMS@FDA has made several improvements from the old website. Enhanced sorting and direct links to multiple drug information sources allow for increased access to important facts.

With the growing number of REMS medications, high quality and organized drug information resources such as REMS@FDA are essential for pharmacists. There is potential for the new website to give the practicing pharmacist a greater understanding of the REMS process, and it may also allow a pharmacy to dispense a wider range of REMS medications.

Every practicing pharmacist can benefit from getting familiarized with REMS@FDA.

This article was co-authored by Stephanie Hipp, PharmD Candidate 2016 at the University of Kansas School of Pharmacy.

References:

1. Approved Risk Evaluation and Mitigation Strategies (REMS). FDA. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm#information. Accessed: July 12, 2015.

2. Hoffman JM, Carias DC. REMS Resource Center. ASHP. http://www.ashp.org/rems. Accessed: July 12, 2015.

3. A Brief Overview of Risk Evaluation & Mitigation Strategies (REMS). FDA. http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf. Accessed: July 12, 2015.

4. Medication Guides. FDA. http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. Accessed: July 12, 2015.

5. REMS@FDA. Approved Risk Evaluation and Mitigation Strategies (REMS). U.S. Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. Accessed: July 12, 2015.