In 2007, Congress granted FDA the authority to require pharmaceutical companies to implement Risk Evaluation and Mitigation Strategies (REMS) before allowing certain high-risk drugs on the market. FDA uses REMS to reduce risks and improve safe use while continuing to provide access to these medications for patients who need them. REMS are part of the agency’s efforts to address prescription drug abuse and misuse.
Components of a REMS program may include a Medication Guide (MedGuide), patient package insert, patient registry, communication plans, elements to assure safe use, and an implementation system. All REMS also must include a plan for assessing impact. Companies that do not adhere to REMS requirements face fines of up to $250,000 per violation or a total of $10 million for continued violations.
Counseling patients about high-risk REMS drugs enables pharmacists to expand their role in health care and patient safety. When dispensing these medications, pharmacists and other health professionals must provide extensive FDA-approved safety information supplied by pharmaceutical companies and review these documents with patients.
MedGuides are key components of REMS. As of January 2011, FDA had approved more than 150 MedGuides for new drug applications and biologic license applications. For some drugs, MedGuides alone may be sufficient to convey their serious and significant health concerns.
Give patients the MedGuide the first time you dispense a high-risk drug, and review the guide thoroughly with them. Counsel patients on the serious risks of a drug relative to its benefits. Explain that these risks could affect their decision to use or continue using a drug and that adhering to directions is crucial for a drug’s effectiveness.
In addition, provide and review a MedGuide whenever changes have been made—for example, because a drug has a new indication or new safety information—and when a patient or caregiver requests a guide.
FDA requires pharmacies and prescribers to register in special restricted programs before they are allowed to prescribe and dispense some drugs with REMS. To dispense isotretinoin (Accutane—Roche), for example, which has an extremely high risk of causing severe birth defects, pharmacies must enroll in the computer-based iPLEDGE registry. Patients must meet qualification criteria and agree to follow monthly requirements. Before patients receive their prescription each month, prescribers must counsel them about isotretinoin’s risks and document the counseling session via iPLEDGE.
Refer patients to the National Council on Patient Education and Information’s (NCPIE) three Rs of safe medication use, or review the following safety tips together:
Patients can also refer to “Your Medicine: Be Smart, Be Safe,” a brochure from NCPIE and the Agency for Healthcare Research and Quality.
A list of individual and shared system REMS is available on the FDA website. The American Society of Health-System Pharmacists also maintains an online REMS resource center, including a members-only database listing each drug with a REMS and answers to 12 basic questions, allowing users to determine the drugs’ REMS requirements quickly and easily.