iPLEDGE compliance: Program protects patient, prescriber from serious consequences

September 1, 2008

The iPLEDGE program is excellent for protecting the prescriber, so that he or she can continue to practice medicine and responsibly care for patients with severe acne, one dermatologist says. However, the issue of compliance remains a major hurdle.

Key Points

According to one expert, these initial growing pains served as a barrier to effective medical care and use of the curative drug isotretinoin.

"I was initially against the iPLEDGE program when it first came into existence, because of the sheer trouble encountered when attempting to understand the original fledgling Web site.

"iPLEDGE not only protects the prescriber, but also female patients who may sometimes not completely fathom the repercussions of a pregnancy while taking isotretinoin," he says.

According to Dr. Bikowski, if the prescribing healthcare provider abides by everything within the iPLEDGE program, then that prescriber can never be held liable.

Patient cooperation

When prescribing isotretinoin, Dr. Bikowski says he always has his acne patients write down in their medical record - in their own handwriting - that they understand what isotretinoin can do if they get pregnant, and that they agree to abstain from sexual relationships while taking the drug.

Dr. Bikowski says that even if women take the birth control pill the way they are supposed to, there is still a 0.5 percent chance of conceiving a child, and if the birth control pill is not taken correctly, there is a 3 percent chance of conceiving a child.

"It is difficult for me to believe that not only will an individual take the birth control pill every day, but also remember to use a second form of contraception for either themselves or their partner every time they have sexual relations.

"Therefore, it seems to me that there is always a risk, no matter how small, of conceiving a child, and I would not want to have a conversation with a patient of terminating a pregnancy," Dr. Bikowski tells Dermatology Times.

Abstinence is the only sure way that a patient will avoid pregnancy. Dr. Bikowski says that he is a lot more comfortable if his patients agree to abstinence, in writing, before the initiation of isotretinoin treatment. If the patient is under the age of 18, then the legal guardian must also sign and date the medical record.

This approach is the absolute protection for both patient and physician insofar as making sure that an individual truly understands the ramifications of this medication, he says.

Dr. Bikowski was initially against the iPLEDGE program, mainly because it was quite cumbersome to get his patients and his staff to go online and spend valuable time understanding a poorly constructed computer program.

"It was a logistical nightmare, and to this day, abiding to the iPLEDGE program is, financially, simply not profitable. However, insofar as protecting the patient and protecting the physician, I think it is an excellent program," Dr. Bikowski says.

According to Dr. Bikowski, the possible legal liability for the prescribers - as well as the possibility of teratogenicity and other potential adverse events of the drug - significantly outweigh the trials and tribulations that his staff and patients must go through to "deal" with the iPLEDGE program Web site.

Government data

According to U.S. government data, there were 122 pregnancies in the first year of iPLEDGE. Of these 122 patients, 18 percent of the women who conceived chose abstinence as their form of contraception, and 72 percent of the women who conceived chose two forms of contraception - birth control pills and condoms.

The U.S. government's own statistics say that abstinence is significantly safer/more effective than two forms of contraception in preventing unwanted pregnancies.

Dr. Bikowski says that often patients become quite irate because of the rigidity of the prescription process. Sometimes, patients do not fulfill their part of the responsibility, even though they were told verbally and in writing that they have to get their prescriptions filled within seven days; when they fail to do that, they can become quite "unpleasant," he says.

"Re-filling a prescription at the right time is another step in the program that makes the system a bit more difficult. Nevertheless, the system is a very good idea, and it works to protect my patients and me so that I can continue to prescribe this very effective medication, responsibly," Dr. Bikowski says.

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