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Opinions on Practice Management

Steven R. Feldman, MD, PhD

How Can we Better Communicate Drug Safety Risks to Patients?

Steven R. Feldman, MD, PhD

Wednesday, December 14, 2011

One of the critical factors that limits patients' use of medication is their fear of side effects. As patients play a greater role in their healthcare decisions, and as they attempt to educate themselves about their choices, they are increasingly being made aware of information on side effects - often rare side effects - associated with drug treatment. Some of these side effects may not even be real; they may be hypothetical side effects, as in the case of the black box lymphoma warnings associated with topical immunomodulatory drugs such as tacrolimus and pimecrolimus. Hearing of the potential of these side effects, even when rare, may paralyze patients from initiating or continuing a recommended treatment regimen.

Perceptions of Risks

Patients may perceive risks to be totally out of proportion to their true magnitude, and so physicians need to be able to communicate to patients more than just lists of potential side effects; we also need to communicate information that puts risks into perspective. For example, the 4-fold increased risk of myocardial infarction (MI) in young adults with severe psoriasis may be terrifying.1 But, patients need to realize that even a 4-fold increased risk isn't really much of a risk at all when the baseline risk of MI in healthy young adults is extremely small.

Graphs and pictures that illustrate the magnitude of risk and which compare that risk to other, better-understood risks may be particularly helpful.

Comparisons with Common and Uncommon Known Risks

When I bought my home, for example, it was tested for radon. The radon level was low, but not zero, and there was an increased risk of lung cancer; it sounded bad - terrifying even. But the radon information I was provided with explained that the increased risk was roughly equivalent to the likelihood of dying in a plane crash, which put the true risk into a much clearer perspective.

The Challenge

When it comes to older drugs, physicians and patients have a lot of data and experience on which to base treatment plans and their impressions of drug safety. For example, there is tremendous experience with topical corticosteroids, and physicians are very comfortable with prevention of side effects, their diagnosis, and their treatment. Even then, some patients have safety concerns. But with new, innovative treatments, our knowledge of safety is more limited, and patients' concerns may be that much greater.

We have tremendous new treatments for patients with psoriasis; however, they do have the potential for risk. Perhaps there's a 3-fold increased risk of lymphoma in patients on tumor necrosis factor (TNF) inhibitor treatment, which may sound rather scary to patients, even if they are informed that the increased risk may be because of the underlying disease and not a result of the drug itself. The risks of infections, demyelinating disease, and tuberculosis for patients on TNF inhibitors are quite low, assuming appropriate screening is carried out.2 

These risks are far less than the lifetime risk posed by more common ailments such as heart disease, stroke, and other forms of cancer. Nevertheless, fear of rare/serious adverse effects prevents some life-long psoriasis sufferers from using what could be the right choice of treatment. Putting risks and benefits in perspective may help. The "number needed to treat" concept may be useful in this regard. Only one or two people need to be treated with a biological agent to control psoriasis; hundreds may have to be treated before a severe adverse event would be expected to be observed.

Providing a graphical presentation of risk may further reassure patients that the potential risk is worth taking in order to achieve the expected benefit. For example, our research team estimated lifetime risks from TNF inhibitor treatments and of common causes of death and created a graphical presentation of these risks to help inform patients of the magnitude of TNF inhibitor treatment risks.3 

 

Figure 1. Graphical illustration of lifetime risk. Lifetime risk refers to the diagnosis or development of disease, unless otherwise noted. With tuberculosis screening, it is clear that the common causes of death in patients on TNF inhibitors are heart disease, cancer and stroke, and not rare disorders thought to be associated with TNF inhibitor treatment.3
MS, multiple sclerosis; MVA, motor vehicle accident; TB, tuberculosis; TNFi, tumor necrosis factor inhibitor. *Disease or event resulting in death. Reproduced with permission from Kaminka et al.

It is said that "a picture is worth 1000 words." The use of graphical presentations may help doctors use their time with patients more efficiently, particularly with regard to explainations of the benefit and risks of treatments, and especially for visits at which new treatments are initiated or considered. Patients often do not fill their medications and often take their medications poorly when the do fill the prescription. By giving patients a more accurate, reassuring assessment of the risks and benefits of treatment, better use of the medication and better outcomes may be possible.

Conclusions

This illustration not only puts the risk of TNF inhibitor treatment into perspective, but also helps educate patients about the need for tuberculosis screening while on TNF inhibitor therapy. Comparing adverse-event rates to commonly understood benchmarks in an accurately scaled graphical format may help patients conceptualize and understand medication risk and make more informed treatment decisions.  Close follow-up with new drugs may also help reassure patients and can help identify and control side effects earlier, leading to better outcomes for our patients.


References

  1. Gelfand JM, Neimann AL, Shin DB, et al. Risk of myocardial infarction in patients with psoriasis. JAMA 2006;296:1735-1741.
  2. Dharamsi JW, Bhosle M, Balkrishnan R, Yentzer BA, Feldman SR. Using 'number needed to treat' to help conceptualize the magnitude of benefit and risk of tumour necrosis factor-alpha inhibitors for patients with severe psoriasis. Br J Dermatol 2009;161:605-616.
  3. Kaminka E, Patel I, Dabade TS, et al. Comparing the lifetime risk of TNF-alpha inhibitor risk use to common benchmarks of risk. Journal of Dermatological Treatment 2011;ePub ahead of print.
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