Dermatologists need to be aware that it is possible for patients to easily purchase isotretinoin online without a prescription, without physician oversight, and without adhering to the FDA-mandated iPledge compliance program.

A female patient recently presented to my office for a case of dry lips and acne flare-ups. We were discussing her therapy and within the first minute or two of the discussion, she said, “I've been on this pill I've been getting online called Accutane and I'm on my third month.” Upon inquiring about where she'd gotten the drug and who her dermatologist was, she said she didn't have a prescription and had been getting it online, and that the process was simple. We had been talking about her dry lips and her acne flare-ups, and I had been thinking that she was in need of therapy—but she was already on her third month of isotretinoin without being on iPledge, without any dermatologist supervision, and without any understanding of her dosage protocol or the risks involved if she had gotten pregnant or had any problems with her serological profile. After my initial tirade and scolding, I discussed the nuts and bolts of managing isotretinoin use with her as well as the consequence of her behavior.

I, like a growing number of health officials, now know that patients can get a six-month supply of istoretinoin without a prescription by just using their credit card and their mailing address. A Google search for “buy isotretinoin” results in at least two pages filled with pharmacies that are based in Japan, India, Mexico, and Canada all offering a supply. Many offer a three-month supply and even give consumers discounts if they buy more than a three-month supply.

The big issues here are how these patients are getting these drugs so easily and the risks to us as a specialty when patients present to us already having been on this drug for a couple months, as in this case.

There are risks to the patients and risks to the providers. Who is responsible for the bad outcomes if someone gets pregnant, for example, or if they have a liver issue or something else as a result of being on this drug without a prescription and without supervision? Who is going to manage that? And more importantly, will there now be a discrepancy in how many dermatologists use the iPledge system? Are dermatologists who may be frustrated with the system and the requirements of iPledge going to tell their patients to go ahead and buy isotretinoin online and bypass the whole system, especially considering situations such as female patients who are on low-dose, long-term regimens, or patients who are using isotretinoin long-term for off-label indications such as treating rosacea? Are these patients going to be going to the Internet and getting isotretinoin without regulation, and, if so, is there going to be an increase in the number of bad outcomes we will need to deal with? We not only really need to protect our patients who may not know what's best for themselves, but we also need to protect ourselves.

The iPledge program is an FDA-approved computer-based risk management program designed to restrict distribution of istotretinoin to ensure that no female patient starts isotretinoin therapy if pregnant and that no female patient on isotretinoin therapy becomes pregnant. Prescribers must be a part of it, patients must be a part of it, and pharmacies must be a part of it. Everyone needs to comply and be part of the system in order to make isotretinoin available to the patient. As dermatologists participating in iPledge and prescribing isotretinoin, we have a responsibility to adhere to the rules of the iPledge program and make sure that any patients coming into our offices and taking isotretinoin are also participating in the program.

ADDRESSING THE PROBLEM

Thanks to the initiatives of some of the American Academy of Dermatology (AAD) staff members, adjustments are being made to the AAD's position statement on isotretinoin, which was revised in 2003, 2008, and 2010. Work is being done to re-establish points about the AAD's support of the iPledge program, the need for continuing education about the risks of the drug, and the opposition to online dispensing of this drug without a prescription. There have been updates on the AAD website that highlight the risks to patients of purchasing isotretinoin online, and not just for the safety issues but also a fraud issue if they buy it from an un-reputable source that may not actually give them active drug. A warning about the need to have a prescription to purchase isotretinoin now appears on the AAD's Dermatology A to Z entry page right after the content about the new app with links to the “Isotretinoin,” “Acne diagnosis and treatment,” and “BeSafeRx: Know your online pharmacy” pages. A warning also appears on the AAD's isotretinoin entry page, which states, “Warning: You put your health at serious risk when you buy this medicine from an online site that does not require a prescription.” This issue will also be discussed when an update to the current acne guidelines are being developed.

The academy has done a good job updating the website, we've had more patient initiatives directing toward the risks of managing their acne without physician supervision, and many individual dermatology offices have posted information on their websites to warn patients about the dangers of purchasing isotretinoin online. It's important for dermatologists to educate patients about this safety issue. The AAD is a resource to dermatologists, and the AAD's website has multiple links to safety information about isotretinoin that can be shared on dermatology practice websites. Isotretinoin prescribers are also encouraged to use specialty pharmacies to ensure quality of therapy and access to medicine. Most importantly, the FDA must try to regulate some of this online dispensing, and dermatologists should encourage the FDA to do so.

Isotretinoin has had so many black eyes with what the lawyers have done, with what the government has done, and all the bad press it has gotten. And it is one of our wonder drugs. It has done many good things for patients who have had no other option,s and we get yet another step back with something like this for using isotretinoin for the right patients— that's what's really concerning.

Neal Bhatia, MD is an Associate Professor of Dermatology at Harbor UCLA and is also in private practice in Long Beach, CA.

To see Neal Bhatia, MD, FAAD discuss the increase in access to isotretinoin without a prescription with Joshua Zeichner, MD, FAAD on a recent DermTube Journal Club, visit www.dermtube.com. Searchkey: isotretinoin