From Black Boxes to Screening Guidelines and Antibiotic Use: What Is It All About?

Article Outline

• What Is a Caregiver to Do?
• Black Box Warning on Erythropoitens
• Do We Adhere to Guidelines and Recommendations?
• Copyright

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• Dr. Barbara Resnick

Over the past few years we have been informed of black box warnings for drugs, or groups of drugs, that are particularly relevant to care of the older adults. A black box warning means that research has indicated that a specific drug, or drug group, carries a significant risk of serious or even life-threatening adverse effects. Based on these findings, the U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug or in literature describing it. The black box is the strongest warning that the FDA requires on a drug and is so named for the black border that usually surrounds the text of the warning. When we see a black box, we pause, pen in hand, and think twice about writing that prescription or giving that medication.

We have also been inundated with Screening Guidelines from groups such as the American Cancer Society, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Physicians–American Society of Internal Medicine, American Gastroenterological Association, and the American Geriatrics Society. Likewise, we are updated with the Medicare guidelines, which tell us what is covered as a Medicare benefit and at what age coverage may end. Sometimes these guidelines are consistent with each other, and sometimes they are not.

The increased prevalence of antibiotic resistance has hit the cover of Newsweek and is of major concern for all of us in health care settings. Antibiotic resistance is considered an outcome of evolution. An antibiotic may kill some bacteria but leave behind those that can resist it. These renegade bacteria then multiply, increase in number, and become the predominant microorganism. The antibiotic does not technically cause the resistance but allows it to happen by creating a situation in which an already existing variant can flourish.

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What Is a Caregiver to Do? 

How are we going to respond to the new black box warning for darbepoetin alfa and epoetin alfa that was issued by the FDA? This warning was issued as a way to caution providers that patients have an increased risk of death and serious adverse cardiovascular events when these products are administered to target a hemoglobin of greater than 12 g/dL. With black box warnings, providers may become fearful and simply will not want to use the drug at all. With screening, however, we fear being damned if we do and damned if we don’t! In geriatrics we know well that if we seek, we may be likely to find, and one never knows what impact that finding can have on a patient and the caregivers. If we test a urine sample or do a chest x-ray and are faced with evidence of infection, do we treat and risk a secondary infection? Why is it so clear and easy in a textbook?

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Black Box Warning on Erythropoitens 

So how do we proceed with regard to our new black box warning on erythropoitens? Currently there is insufficient evidence either to support or refute the “statistically significant” benefits in terms of physical outcomes or quality of life measures among appropriately treated older individuals, particularly those in long-term care settings. Many of us, however, have noted important qualitative findings and can provide case examples in which the treatment of anemia with erythropoitens seemed to allow older individuals to engage in activities they were previously unable or unwilling to do, such as going to exercise classes and the dining room; to decrease the number of falls; and to optimize quality of life. Research is currently ongoing to help confirm or negate these qualitative findings. In the meantime, we should not withhold the opportunity for treatment for older individuals who, once aware of the risks, are particularly interested in receiving this treatment. Rather, recommendations for the safe use of these drugs should be incorporated into practice.

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Do We Adhere to Guidelines and Recommendations? 

Do we avoid screenings, or screen everything? What about the management of infections? Do we treat symptomatic infections or withhold treatment because of fear of causing more harm? I believe this is where individualized care is best implemented. It is, after all, about the individual patient. The population-based findings that support clinical guidelines and recommendations for treatment are certainly critical to good clinical practice overall. The guidelines need to be considered because that N of 1 may be you, your parent, grandparent, friend or relative, or the patient who has been under your care for decades. It is our job as health care providers to teach patients and their proxies what the evidence is and together establish a plan of care that is consistent with the individual’s (in some cases articulated by the proxy) wishes. There will be times, in retrospect, that our care decisions will not be the best ones. We may implement a plan of care that ultimately exacerbated symptoms or worsened quality of life. We may make the decision, given life expectancy, not to screen for cancer or not to treat a small lesion that then results in a festering wound that causes discomfort to the patient. Lastly, we may implement a plan of care that involves exposure of the patient to antibiotics that then result in a 12-month, unrelenting course of Clostridium difficile. If we use the individualized approach, however, we, with our patient or proxy, have made those care decisions together, and you know what it will then be a lot easier to deal with the consequences as a team.

So onward and upward as we incorporate this new black box warning into our clinical lives, continue to deal with the ever-raging issues associated with screening or not screening and treating or not treating infections. Our mission, if we decide to take it on, is to help all older adults achieve their optimal health and function across the long term care continuum. Hopefully, the articles on these topics in this journal will help each of you in those endeavors.