HOST: CAPT MARY KREMZNER
PHARMACIST: LCDR BETH CARR
CAPT Kremzner: 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 FDA’s Division of Drug Information.
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.
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?
LCDR Carr: We recognize that as pharmacists and health care 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.
What we as health care 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.
CAPT Kremzner: I would say that FDA’s responsibilities fall into two broad categories; would you agree?
LCDR Carr: Yes, I think the first is patient-oriented and is about health care 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.
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.
CAPT Kremzner: 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 the FDA’s role in this context?
LCDR Carr: 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.
CAPT Kremzner: We as pharmacists would like to remind all health care 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.