By Neal Bhatia, MD
It began with a patient, a young woman who complained of dry lips and dry skin. Her acne was not improving, she observed, despite the pills. "What pills are you taking?" I asked.
"Accutane," she replied nonchalantly. "I've been taking it for three months."
I was curious, to say the least, because she was not a regular patient of mine.
"Who’s been managing your prescription?" I inquired.
"No one," she answered. "I just get it online. It’s really easy. A friend showed me how."
I almost fell off my chair. Follow-up questioning revealed that she had no understanding of the dosage she was taking or the risks involved. She had not taken any pregnancy tests nor been enjoined to follow an aggressive birth control regimen. My disbelief gave way to anger. I wanted to ask her what she was thinking. Did she realize that she could give herself liver problems? Did she know that the medication could mess up her cholesterol? What if she got pregnant? I thought to myself, horrified.
Used with careful supervision, isotretinoin is one of the most potent weapons in the fight against severe acne. It can do a world of good for a patient who has struggled with the condition and not shown positive results from other forms of treatment. Using it without supervision, on the other hand, greatly increases the risk of a range of health problems. Perhaps most disturbing is the danger of severe birth defects, miscarriage, or infant death in pregnant women.
I explained to the patient that what she had done was not much different from undergoing chemotherapy without a doctor’s supervision.
It is for these reasons that the Food and Drug Administration (FDA) heavily regulates the prescription use of isotretinoin. Any dermatologist who has prescribed the medication is familiar with the strictures of the iPLEDGE system. Patients must be informed about the health risks and commit to monthly follow-up examinations. Women who may become pregnant are required to follow rigorous birth control practices and to submit to pregnancy tests to initiate and refill their prescriptions. Doctors, pharmacists, and patients are all required to register through the system.
Steeling myself to maintain my composure, I explained to the patient that what she had done was not much different from undergoing chemotherapy without a doctor’s supervision. Having impressed upon her the severity of the situation, I asked her where she had gotten the prescription. A quick search for "isotretinoin online" produced a list of overseas pharmacies from which the drug could be purchased, cheaply and without a prescription. I was freaking out that it was so easy to obtain the medication. Then and there, I resolved to do what I could to bring attention to the issue.
My friend and colleague was scheduled to give a presentation about isotretinoin at an upcoming acne symposium. “Put this in your talk,” I advised him, relating the story. He allowed me time to address the self-dispensing issue in a brief presentation. In my quest to raise awareness, I also worked closely with the AAD’s Web team to add prominent warning language about self-dispensing to the entry about isotretinoin in the Academy's consumer information resource, Dermatology A to Z.
What more can be done? The first and easiest step is for dermatologists to become more aware of the situation. When dealing with patients and dispensing information about isotretinoin, we need to be sure to stress the importance of doctor’s supervision and to warn against purchasing the drug from illicit online sources.
Beyond that, we need to flex what political muscle we have to advocate for shutting down the pipelines of illicit isotretinoin from overseas. It makes no sense to heavily regulate the legal, prescription use of the drug while turning a blind eye to these illegal sources. Shutting them down entirely may be too much to hope for, but we should encourage the FDA to seek sanctions against them where possible. The legally compliant manufacturers of branded isotretinoin also have an interest and a role to play in this fight.
And that patient — the young lady who heedlessly gambled her health by self-dispensing isotretinoin? It turned out her acne was not that bad to begin with, and I was able to treat her successfully without the need for oral therapy. How many more like her slip by us unnoticed — or never even enter our practices? It is up to us to protect them in any way we can.
Dr. Bhatia is a board-certified dermatologist who is in private practice in Long Beach, Calif., and was named interim program director and associate clinical professor at Harbor-UCLA Medical Center Division of Dermatology. In addition to his involvement on several AAD committees, he was appointed to fill the one-year vacant term on the AAD Board of Directors in 2012 and will begin his four-year term in 2014.
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