Profession

Mandatory patient registry can place limits on care

A column that answers questions on ethical issues in medical practice

The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA. Posted Aug. 7, 2006.

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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.

Recently, after six years in practice, I had to report a pregnancy to the FDA. I never really thought it could happen in my practice. I adhere strictly to the pregnancy prevention guidelines, prescribe one month of medication at a time, and get pregnancy tests before starting and monthly tests thereafter.

My patient is 16 years old and has been battling an eating disorder for several years. She also had bad acne, unresponsive to many months of treatment. After extensive counseling on medication risks and contraception, the patient, her mother and I chose isotretinoin. She followed up every month without fail, relayed her two forms of birth control and recited the risks of isotretinoin for a fetus when asked. She answered her online iPledge patient questions and filled her medications monthly. However, she is a teenager, and teens can act irresponsibly.

When my patient told me she was pregnant, I asked her what I could do differently so another girl is not put in the same situation. With an uncharacteristic maturity, she answered that she knew all the risks, that I had given her all the information she needed to know and that there was nothing else I could have done. But is providing knowledge enough? Is that the end of my responsibility? After all she is a child. At what age can someone be held accountable for her actions?

The majority of pregnancies among those on isotretinoin therapy are not in teenagers, but in 20-year-olds. What will prevent further pregnancies? Should access to the medication be limited even further? Is the iPledge program doing too much or too little? Or is the answer, as I have read of one colleague, to sidestep the risk by providing the drug only to males?

Many of my colleagues no longer prescribe isotretinoin, some due to the liability issues, others to avoid the hassles of the iPledge program. Because of their decision, the number of isotretinoin patients that I treat has risen dramatically.

Determining the best course

Obviously the ethical issues that this scenario puts forth are numerous and illustrate the gamut of concerns that face dermatologists daily. Efforts to do what is best for the individual patient and what is best for society overall and to adhere to the guidelines set forth by the iPledge program frequently conflict with each other. Accomplishing all three without compromise is often impossible.

The initiation of a mandatory registry has many valid benefits. It will prevent prescribers who are not fully comfortable with the risks of isotretinoin from prescribing the medicine. It also will prevent women who are already pregnant from starting isotretinoin in almost every case. However, the logistical setup of the current iPledge program often forces a compromise in what I feel is best for my patients.

Without exception, the program demands that patients be seen on a greater than 30-day cycle. This is based on prescribing patterns with prescriptions being filled every 30 days. It is not the typical rhythm of a female menstrual cycle (28 days), or of my clinic. While the relationship between these two may not seem relevant, in the goal of pregnancy prevention they are.

I see patients at different clinic locations, but the same place each day of the week. I used to see isotretinoin patients at 4-week, 28-day, intervals. The initiation of iPledge has forced me to see patients typically at 35-day cycles.

I am now checking pregnancy tests at sporadic times in the menstrual cycle, sometimes at day 16, instead of trying to detect a pregnancy as early as possible. When I have a patient who has abstinence as her only choice for birth control, I am forced to see her at least twice a month: once to get an accurate, early pregnancy test and once to adhere to iPledge.

The iPledge schedule also means that patients go five to seven days a month without medication. With isotretinoin's prolonged half-life, this should not compromise the patient's therapeutic response, but it does extend the course of treatment for more than a month. So now instead of a typical five-month course, a patient will have to be treated for more than six months. The risk of getting pregnant on the medication also increases. Providing more than a 30-day supply of medication, to assure a continuous course, is in direct defiance of the iPledge program.

In response to the 30-day cycle, our institution has initiated a daily iPledge clinic where patients can be seen as close to the 30 days as possible, thus limiting medication interruptions. But patients who visit these daily clinics see a different physician each month, so continuity of care is interrupted. The preservation of a stable patient-doctor relationship is vital to effective, open communication, especially in dealing with matters of sex, contraception and teratogenicity.

Questions surround non-acne use

While undeniably the majority of patients on isotretinoin are adolescents and adults with acne, the therapeutic uses of isotretinoin are numerous. It is used in the treatment of congenital ichthyoses and other disorders of cornification as well as for chemoprevention of skin cancers in transplant patients and in the treatment of childhood neuroblastoma.

I have several patients on isotretinoin for congenital ichthyoses. The system as it is currently designed has no exception for these patients. They must fill out the consents and comply with the same rules that an acne patient would.

If I am to help them, I must recommend that they lie; and they in turn must do so. Once their initial six months of therapy has lapsed, I am not sure what lies ahead. For example, will they will be limited in access to the medicine? For these patients, isotretinoin is often the only therapy that has any effect on an otherwise devastating genetic disease. Special allowances and protections must be afforded these patients, and it is our responsibility to champion their cause.

The other group left behind in the bureaucratic implementation of iPledge is the poor. When isotretinoin went off-patent and other manufacturers took up production, companies no longer endorsed a compassionate-use program.

A month of isotretinoin costs about $400 and is beyond the reach of the majority of people without prescription coverage. This forces dermatologists to acquire medication for uninsured and underinsured patients through other means such as recycling of unused drug.

Nothing is perfect

One of the things I have realized from this experience is that the iPledge program gives a false sense of security. Recently, I listened to a speaker highlight the good that the mandatory registry is doing, including the fact that the registry would finally provide an accurate pregnancy rate. She also said that a consequence of the program would be "shared responsibility."

I wholly disagree. My fear is that these failures will be used as evidence against use of isotretinoin and motivate further restriction of the medication. I do not feel a sense of shared responsibility with iPledge, only with my patient and her mother.

Another ethical arena that isotretinoin bullishly enters is that of abortion. A colleague states upfront that if a patient became pregnant while on this medicine, he would unconditionally recommend an abortion. In theory it is easy to be dogmatic, but when issues of life and babies are at stake, my resolve fades into an uneasy sadness, and there is no good outcome.

Every day we make decisions to do things that have the potential for serious harm. We put children in cars going 65 miles per hour and put swimming pools in our backyards. As a result, babies die in crashes, and toddlers drown, despite prudent safety precautions.

If our principal adage in medicine were to do no harm, then we would often do no good either. Most of the medicines we use have the potential to harm, and bad things happen from their use. Our responsibility as physicians is to limit this potential, to educate our patients and parents about risks and to come to a treatment decision that is best for the patient. There is an inherent failure rate in being human, and we may be approaching it.

The first thing I said to the patient whose pregnancy I had reported to the FDA as I greeted her at her last visit was that she looked beautiful. She responded by telling me that she had not been taking her birth control for several months and that she was pregnant. The only saving grace was that she had not been taking the isotretinoin either.

Her baby is due in March.

Andrea L. Zaenglein, MD, assistant professor of dermatology and pediatrics, Pennsylvania State University College of Medicine, Milton S. Hershey Medical Center, Hershey, Pa.

The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA.

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