Medical Justice provides free consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a free consultation – or use the tool shared below.

The doctor-patient relationship can be complicated. It doesn’t get easier adding one more person to that combination.

Into the weeds we go.

Isotretinoin is used in patients 12 years or older to treat severe acne when other treatments fail. 

Isotretinoin is quite effective. Mitigating severe acne in an adolescent may also promote improved psychological well-being. To state the obvious, it’s not easy being an adolescent in 2022. In general. Even more so with severe nodular acne.

Isotretinoin can cause serious side effects, including birth defects. The chance of birth defects occurring if an unborn baby’s mother takes isotretinoin is high. Very high. 

To prevent such birth defects, the FDA mandated a program called Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin.

The iPLEDGE REMS is a shared (and includes multiple manufacturers) system with requirements for prescribers, pharmacies, and patients. The iPLEDGE REMS also consists of a pregnancy registry for patients who get pregnant. The goals of iPLEDGE REMS are:

1. Prevent pregnancies in patients taking isotretinoin;
2. Prevent pregnant patients from taking isotretinoin.

Only enrolled and activated prescribers can prescribe isotretinoin, and only enrolled and activated pharmacies can dispense isotretinoin. To receive isotretinoin, all patients must be enrolled in the iPLEDGE REMS and agree to follow the requirements. Compliance is not trivial.

OK, let’s dig in.

Before starting isotretinoin treatment, there’s a 30-day waiting period where the patient must be on two forms of birth control. The patient must also take two pregnancy tests. The first test is done when the decision is made to take the medication. The second test is during the first five days of the menstrual period before starting isotretinoin.

These two pregnancy tests must come back negative. Of course, they do.

The patient must also have a negative pregnancy test before obtaining each monthly prescription.

As part of iPLEDGE REMS, the patient commits to using two effective forms of birth control together. Belt and suspenders approach. 

• For at least one month before starting isotretinoin
• During treatment, which generally lasts 5 to 5 months
• For one month after the last dose of isotretinoin

That’s a heavy commitment.

Never fear; the iPLEDGE REMS has an option. 

One does not need to commit to using two forms of birth control if:

(a) You commit to abstinence – and I’m quoting here – not having sexual contact (penis-vaginal) with a partner who could get you pregnant 24 hours a day, 7 days a week for 1 month before, during, and for 1 month after your isotretinoin treatment.

(b) You are unable to get pregnant because:

You do not have a uterus and/or you do not have any ovaries, and your doctor/ prescriber has confirmed this…

You have entered menopause, and your doctor/prescriber has confirmed this…

I just skimmed the surface of this program. 

One interesting fact about human nature: Sometimes, patients stretch the truth. Approximately 150 women annually become pregnant while taking isotretinoin despite participation in the iPLEDGE program. 

Approximately 20% of individuals reporting abstinence while “enrolled” in the iPLEDGE program are, in fact, sexually active while taking the medication. Twelve women (31%) admitted to having intercourse at least once using 1 or fewer forms of contraception; 10 failed to use condoms, and 1 reported completely unprotected intercourse. Among sexually active oral contraceptive pill users, 7 (39%) reported missing 1 or more pills in the previous month.

With that as background, here’s a clinical conundrum.

A fifteen-year-old patient with nodular acne sees a dermatologist for cystic acne. She has failed conservative treatment. Isotretinoin would be a good option. Mom and daughter are in the same room listening to the risks, benefits, and options. They seem to be on the same page. Isotretinoin it is. The daughter commits to abstinence.

Mom is beaming. 

Mom leaves to pay the bill.

The daughter then tells the dermatologist, in private, that she will not commit to abstinence. 

Mom expects that daughter will receive pregnancy tests and eventually a prescription for isotretinoin. 

Are there other options? What can or should the dermatologist tell Mom, if anything?

It depends on where you live. The rules vary state by state. 

In some states, such as Alabama, minors (14 or older or graduated high school, married or pregnant) can consent to contraceptive care. 

For contraceptive care, almost half of the states allowed only specific categories of minors to consent (n = 24), and 4 had no explicit laws regarding consent for this type of care. Most states allowed minors to consent for prenatal care; however, 12 lacked explicit policies.

In addition to variability in the ability to consent, states with laws pertaining to sensitive health care also demonstrated variability in privacy protection. Twenty states permitted providers to share information on access to Sexually Transmitted Illness (STI) services with the parent or guardian, 8 permitted the disclosure of information related to contraceptive services, 14 for prenatal care, 19 for substance abuse treatment, and 9 for mental health treatment.

This gets even more complicated regarding access to information if parents have access to their kids’ information on the patient portal…and if a child is on their parent’s insurance plan. 

In the vignette above, the patient can be on two forms of birth control and still satisfy iPLEDGE. If this 15-year-old is currently sexually active, perhaps she is already on one form of birth control. It may not be a large leap to add the second form – such as a condom – for the iPLEDGE commitment. Yes, I know, I know. And, if this patient is not on any form of birth control, does the dermatologist want to prescribe contraception? Unlikely.

Here, the 15-year-old told the doctor something in confidence –expecting that trust to be honored. There’s also a relationship with the mother, who expects the isotretinoin treatment to begin. Perhaps the simplest thing to do is explain the conundrum to the 15-year-old and see what she is willing to do. 

Sometimes it’s not easy to be a doctor. What do you think?

Medical Justice provides free consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a free consultation – or use the tool shared below.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2021 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.