Mandatory patient registry can place limits on care

Ethics Forum. Aug. 7, 2006.

Scenario: How can dermatologists manage the challenges of prescribing isotretinoin?

Despite a physician's every precaution to ensure that patients taking the medication aren't -- and don't become -- pregnant, nothing is fail-safe.

Reply:

Isotretinoin is a potent teratogen. Even small amounts taken very early in the first weeks of pregnancy can result in devastating birth defects. It is also by far the most effective treatment we have for acne, curing the disorder in approximately two-thirds of the patients who complete a single five-month course.

In response to the rate of pregnancy among women taking isotretinoin, in March of this year the Food and Drug Administration mandated the iPledge program with the goals that "no female patient starts isotretinoin therapy if pregnant" and "no female patient on isotretinoin therapy becomes pregnant."

If zero tolerance is the absolute objective, then iPledge is destined to fail by design.

Many opponents of the use of this medication would say that assuming such a risk for acne treatment is wholly unnecessary. Yet the lifelong sequelae of acne can transcend the temporary facial lesions and permanent scarring.

Acne predominantly affects adolescents in a time when their self-esteem is most vulnerable in a society where appearance is ruthlessly prioritized. Studies have shown that having acne can negatively impact the social and psychological well-being of affected individuals to the same degree that chronic disabling asthma, epilepsy, diabetes or arthritis can.