CAPT KREMZNER: DRUG BENEFITS AND RISKS.
TODAY WE'LL LEARN ABOUT THE MANY COMPONENTS OF RISK EVALUATION
AND MITIGATION STRATEGIES, OR REMS, AND HOW THEY CAN HELP
MANAGE A DRUG PRODUCT WITH KNOWN OR POTENTIAL SERIOUS RISKS.
HI, I'M CAPTAIN MARY KREMZNER AND THIS IS DRUG INFO ROUNDS,
BROUGHT TO YOU BY THE PHARMACISTS IN THE FDA'S
DIVISION OF DRUG INFORMATION.
REMS ARE REQUIRED RISK MANAGEMENT PLANS THAT USE RISK
MINIMIZATION STRATEGIES BEYOND THE PROFESSIONAL LABELING TO
ENSURE THAT THE BENEFITS OF CERTAIN PRESCRIPTION DRUGS
OUTWEIGH THEIR RISKS.
REMS SERVE AS AN IMPORTANT TOOL USED TO MANAGE SERIOUS RISKS
ASSOCIATED WITH A MEDICATION.
THEY ALSO ENABLE PATIENTS TO HAVE ACCESS TO MEDICALLY
NECESSARY DRUG PRODUCTS, WHICH, WITHOUT REMS, MAY NOT RECEIVE
FDA APPROVAL OR BE ALLOWED TO REMAIN ON THE MARKET.
I'M JOINED TODAY BY FDA PHARMACIST DR. KIMBERLY CHIU WHO
HAS FURTHER INFORMATION ON THE INTRICACIES OF REMS.
DR. CHIU: A REMS MAY BE REQUIRED BY THE FDA BEFORE OR AFTER A
DRUG IS APPROVED.
THE DRUG SPONSORS DEVELOP REMS PROGRAMS AND THE AGENCY APPROVES
ALL REMS PROGRAMS BEFORE THEY ARE IMPLEMENTED.
HOWEVER, THE RESPONSIBILITY ULTIMATELY FALLS UPON THE DRUG
SPONSOR TO SUCCESSFULLY IMPLEMENT THE PROGRAM.
POTENTIAL COMPONENTS OF A REMS MAY INCLUDE: A MEDICATION GUIDE-
PAPER HANDOUTS CONTAINING FDA APPROVED INFORMATION THAT CAN
ALERT PATIENTS TO POTENTIAL SERIOUS ADVERSE EVENTS OR
INFORMATION ABOUT HOW TO SAFELY USE THE DRUG.
A COMMUNICATION PLAN, TO INFORM HEALTH CARE PROVIDERS ABOUT
SAFETY RISKS ASSOCIATED WITH THE DRUG OR TO SUPPORT
IMPLEMENTATION OF THE REMS.
THIS MAY INCLUDE LETTERS TO HEALTH CARE PROVIDERS.
ELEMENTS TO ASSURE SAFE USE ARE INTENDED TO ADDRESS SPECIFIC
SERIOUS RISKS LISTED IN THE LABELING OF THE DRUG.
DEPENDING ON THE RISK, A REMS MAY REQUIRE ONE OR MORE OF THE
FOLLOWING: PRESCRIBER TRAINING OR CERTIFICATION, SPECIAL
CERTIFICATIONS FOR PHARMACIES OR OTHER DISPENSERS, LIMITING THE
KINDS OF HEALTH CARE SETTINGS IN WHICH THE DRUG MAY BE DISPENSED,
DOCUMENTATION OR OTHER EVIDENCE OF SAFE USE CONDITIONS PRIOR TO
DISPENSING, SPECIFIC PATIENT MONITORING, ENROLLING PATIENTS
IN A REGISTRY, AN IMPLEMENTATION SYSTEM THROUGH WHICH THE
ELEMENTS TO ASSURE SAFE USE CAN BE MONITORED, EVALUATED AND
IMPROVED.
DEPENDING ON THE RISKS INVOLVED, FDA MAY APPROVE A MEDICATION
GUIDE AS PART OF LABELING WITHOUT REQUIRING A REMS WHEN IT
IS ADEQUATE TO ADDRESS THE SPECIFIC SERIOUS RISK AT ISSUE.
IN OTHER CASES, THE AGENCY MAY DETERMINE THAT A MEDICATION
GUIDE AND OTHER REMS COMPONENTS (SUCH AS ELEMENTS TO ASSURE SAFE
USE OR A COMMUNICATION PLAN) ARE NECESSARY TO ENSURE THAT THE
BENEFITS OF A DRUG OUTWEIGH THE RISKS.
IN MOST CASES, FDA REQUIRES A MEDICATION GUIDE AS PART OF A
REMS WHEN OTHER REMS COMPONENTS ARE REQUIRED FOR THE PRODUCT.
TO VIEW IF A DRUG PRODUCT HAS A REMS, YOU MAY USE THE AGENCY'S
DRUGS@FDA WEBSITE.
LET'S USE AVANDIA AS AN EXAMPLE.
SEARCH FOR "AVANDIA" WITHIN THE SITE AND ACCESS ITS "DRUG
DETAILS" PAGE.
IF A DRUG HAS A REMS, THERE WILL BE A REMS HYPERLINK ON THIS PAGE
JUST AS THERE IS ONE ON AVANDIA'S.
IF A DRUG DOES NOT HAVE A REMS, THERE WILL NOT BE A REMS
HYPERLINK ON THE PAGE.
ALTERNATIVELY, THERE IS ALSO AN FDA WEBPAGE CONTAINING A LISTING
OF ALL FDA APPROVED REMS.
ANYTHING THAT MAY HELP MITIGATE DRUG RISKS IS AN IMPORTANT TOOL
FOR PHARMACISTS AND THEIR PATIENTS.
IF YOU HAVE QUESTIONS ABOUT RISK EVALUATION AND MITIGATION
STRATEGIES, YOU CAN CALL OR EMAIL
FDA'S DIVISION OF DRUG INFORMATION.