Mary: EVERY MEDICATION APPROVED BY THE FDA
HAS BENEFITS AS WELL AS RISKS.
IT'S IMPORTANT THAT PATIENTS HEAR BOTH AND HAVE A CLEAR
UNDERSTANDING SO THEY CAN MAKE INFORMED DECISIONS
WITH THEIR HEALTH CARE PROFESSIONAL.
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.
Mary: I SPOKE WITH FDA PHARMACIST,
LIEUTENANT COMMANDER BETH CARR WHO WILL TALK
ABOUT HOW HEALTH CARE PROFESSIONALS CAN HELP
PATIENTS UNDERSTAND THE SENSE OF BALANCE BETWEEN
BENEFITS AND RISKS FROM FDA'S PERSPECTIVE.
Mary: (to Beth) LET'S START BY ADDRESSING HOW FDA PERCEIVES
THE BENEFIT RISK BALANCE AND HOW THIS CAN HELP HEALTH CARE
PROFESSIONALS APPROACH THE TOPIC WITH THEIR PATIENTS; BETH?
Beth: WE RECOGNIZE THAT AS PHARMACISTS
AND HEALTHCARE PROFESSIONALS,
MOST CLINICIANS UNDERSTAND THE LIMITATIONS OF CLINICAL TRIALS
AND RECOGNIZE THAT EVEN WITH A RIGOROUS
EVALUATION PROCESS, SOME SAFETY PROBLEMS SURFACE ONLY
AFTER A DRUG HAS BEEN ON THE MARKET FOR A LONGER PERIOD
OF TIME AND HAS BEEN USED IN A BROADER POPULATION.
Beth: WHAT WE AS HEALTHCARE PROFESSIONALS SOMETIMES
FORGET IS THAT RISK COMMUNICATION IS ABOUT
CONVEYING THE POSSIBILITY OF BOTH GOOD AND BAD OUTCOMES.
FOR MEDICAL PRODUCTS IN GENERAL,
WITHOUT THE EXPECTATION OF BENEFIT,
PEOPLE ARE UNLIKELY TO ACCEPT EVEN A SMALL AMOUNT OF RISK.
Mary: I WOULD SAY THAT FDA'S RESPONSIBILITIES
FALL INTO TWO BROAD CATEGORIES; WOULD YOU AGREE?
Beth: YES, I THINK THE FIRST IS
PATIENT-ORIENTED AND IS ABOUT HEALTHCARE
PROFESSIONALS AND PHARMACISTS INTERACTIVELY
SHARING BENEFIT AND RISK INFORMATION TO ENABLE
PATIENTS TO MAKE INFORMED DECISIONS ABOUT USE OF
FDA-APPROVED DRUG PRODUCTS, AND THE SECOND IS
SPONSOR-DIRECTED, BY FDA PROVIDING GUIDANCE TO DRUG
MANUFACTURERS ABOUT HOW THEY CAN MOST EFFECTIVELY
COMMUNICATE THE BENEFITS AND RISKS OF THEIR PRODUCTS.
Beth: AS AN EXAMPLE OF THE FIRST CATEGORY OF RISK
COMMUNICATION, SINCE 1999 FDA HAS REQUIRED THAT
MEDICATION GUIDES BE ISSUED WITH SPECIFIC PRESCRIBED
DRUGS WHEN THE AGENCY DETERMINES THAT:
CERTAIN INFORMATION IS NECESSARY
TO PREVENT SERIOUS ADVERSE EFFECTS
PATIENT DECISION-MAKING SHOULD BE
DETERMINED BY INFORMATION ABOUT A KNOWN SERIOUS SIDE
EFFECT WITH A PRODUCT,
OR PATIENT ADHERENCE TO DIRECTIONS FOR THE USE
OF A PRODUCT ARE ESSENTIAL TO ITS EFFECTIVENESS.
Mary: THAT IS A GREAT EXAMPLE.
WE SHOULD ALSO MENTION THAT FDA IS REVISITING THE CURRENT
APPROACH TO THE CONTENT AND FORMAT OF WRITTEN
PRESCRIPTION DRUG INFORMATION PROVIDED TO PATIENTS.
WE ARE EVALUATING HOW BEST TO ENSURE THAT
PATIENTS, WHEN RECEIVING PRESCRIPTION DRUGS,
ARE ALSO GETTING THE INFORMATION THEY NEED.
ON A SIMILAR TOPIC, LET'S TOUCH ON DRUG ADVERTISEMENTS THAT
PATIENTS SEE ON TELEVISION.
CAN YOU EXPLAIN FDA'S ROLE IN THIS CONTEXT?
Beth: YES, I THINK THIS IS A GOOD
EXAMPLE OF THE SECOND CATEGORY OF RISK
COMMUNICATION WHERE FDA PROVIDES GUIDANCE TO DRUG
MANUFACTURERS MAKING SURE THAT THE ADVERTISEMENTS:
ARE NOT FALSE OR MISLEADING IN ANY RESPECT
PRESENT A FAIR BALANCE BETWEEN INFORMATION
ABOUT EFFECTIVENESS AND RISK
INCLUDE A THOROUGH MAJOR STATEMENT CONVEYING THE
PRODUCT'S MOST IMPORTANT RISK INFORMATION IN
CONSUMER-FRIENDLY LANGUAGE,
AND COMMUNICATE ALL INFORMATION RELEVANT TO
THE PRODUCT'S INDICATION (INCLUDING LIMITATIONS TO USE).
Mary: WE AS PHARMACISTS WOULD LIKE TO REMIND ALL HEALTHCARE
PROFESSIONALS THAT THE BENEFIT AND RISK DISCUSSION
IS AN ESSENTIAL PART OF ANY CONSULTATION,
AND THAT FDA IS COMMITTED TO ENSURING THAT PRESCRIBERS,
PATIENTS, AND THEIR FAMILIES HAVE THE INFORMATION NEEDED TO
SUPPORT THE SAFE AND EFFECTIVE USE
OF PRESCRIPTION MEDICATIONS.
IF YOU HAVE QUESTIONS ABOUT COMMUNICATING DRUG BENEFITS
AND RISKS TO PATIENTS, CALL OR EMAIL
THE FDA'S DIVISION OF DRUG INFORMATION.