By Aliyah Rashid, Case Manager, Medical Protection, and Dr Zoë Neill, Medicolegal Consultant, Medical Protection
GP Dr C contacted the Medical Protection advice line because she had been informed in an email from the GP out of hours service that one of her patients was going to attend a clinic for a termination of pregnancy.
The patient was taking isotretinoin prescribed by a dermatologist, and the patient had signed a disclaimer stating that there was no chance of her becoming pregnant because she was not sexually active, and therefore was not participating in the pregnancy prevention programme, as is usual practice for patients taking isotretinoin.
The patient asked Dr C not to disclose that she had become pregnant to the dermatologist as she feared they would stop prescribing isotretinoin.
Dr C did not know if the patient had attended for termination of pregnancy when she phoned Medical Protection. She had spoken to the patient who described the pregnancy as “an error” and told Dr C that she did not want to get pregnant. Dr C had “strongly advised” that the patient discuss the risks of isotretinoin during pregnancy, as well as the risks of not using contraception, and had discussed the case with her other GP colleagues. Dr C was still unsure whether the fact of the pregnancy could or should be disclosed to the dermatologist when the patient had told her not to inform them.
How did Medical Protection assist?
Dr C discussed the situation in detail with a Medical Protection medicolegal consultant. He advised that Dr C should have a face-to-face conversation with the patient about the situation to discuss the ongoing risk of pregnancy, and to discern the circumstances of the pregnancy. For example, was the patient having a termination because she did not want to stop taking isotretinoin?
Our medicolegal consultant also advised that with the dermatologist not being informed, the risks associated with that should be considered. The patient’s confidentiality could be breached if disclosure would be in the public interest or if serious harm to others would result. The unborn foetus does not have legal protection in this scenario, and disclosure to protect the unborn foetus would not be deemed adequate grounds for breaching patient confidentiality for disclosure to the dermatologist.
Dr C was also invited to consider if there were any risks associated with having a termination whilst taking isotretinoin. She was also advised that a clinician can usually share relevant information with another involved in clinical care providing the patient has not objected to the disclosure. Where a patient has capacity and does not give consent to disclosure, personal information cannot be disclosed except where it is required by law or justified in the public interest. What an individual chooses to do with their pregnancy is personal to them. An unborn child has no legal rights, so the risk to an unborn child would not constitute public interest.
In this case, there did not appear to be any obligation on Dr C to disclose this information to the patient’s dermatologist. Dr C was advised to document the discussions she had with the patient carefully, including her agreement not to share information with the dermatologist, and explain the consequences of the patient’s decisions.
The patient was entitled to make a request not to disclose personal information, and therefore in this case, Dr C should not disclose this information without her consent.
Oral retinoids are teratogenic, exerting their effect by inducing hypervitaminosis A. This can result in craniofacial, central nervous system, cardiovascular and thymic malformations. The MHRA1
advises that women and girls of childbearing potential being treated with the oral retinoids acitretin, alitretinoin, or isotretinoin must be supported on a pregnancy prevention programme with regular follow-up and pregnancy testing. Before starting isotretinoin, patients must use at least one, and preferably two, forms of effective contraception for at least one month before starting treatment. In exceptional circumstances, females capable of becoming pregnant but who are not sexually active may be exempted from the pregnancy prevention programme.
Every oral retinoid has a dedicated and specific pregnancy prevention programme (PPP).
Under exceptional circumstances, isotretinoin may be prescribed to a woman who is not at risk of pregnancy without following the rules of the PPP. Examples of such circumstances might be a non-sexually active woman who is able to be certain that sexual activity will not start during the period of teratogenic risk, or a woman who does not have childbearing potential, eg. following a hysterectomy.
Dermatologists should take every action to ensure that all women being considered for treatment understand the risks and consequences of pregnancy.
If a woman is to be exempted from the PPP, she must:
- Receive written information of the methods of contraception (contraceptive brochure provided by the drug supplier).
- Receive written information of the risks of teratogenicity with isotretinoin (patient information leaflet provided by the drug supplier).
- Sign the form (provided by the supplier of the isotretinoin) to confirm that she has received information of the teratogenic risk of the drug and the methods of contraception.
- Agree to contact the prescriber of the isotretinoin and the GP if there is any chance of pregnancy occurring during or immediately after the course of treatment.
The prescriber of isotretinoin outside the PPP should:
- Document the reason for exclusion from the PPP.
- Discuss the teratogenic risks of the drug and the necessity of seeing the patient rapidly if the risk of pregnancy changes during the course of treatment.
- Record on each prescription of isotretinoin that the patient is exempted from the PPP.
The prescriber may wish to take extra written documentation that the patient was aware that she was exempted from the normal PPP and was fully aware of the teratogenic risks of the treatment.
Disclosure of information to a secondary care colleague, and breach of patient confidentiality, would not be easily justifiable in this case, where “serious harm to others” does not apply because the unborn foetus does not have legal protection.
In addition, this is a challenging ethical dilemma. While there is extensive evidence that oral retinoids are teratogenic, a British Association of Dermatologists 2004 audit of 16 pregnancies resulted in seven terminations and one normal healthy baby, while the other eight had unknown outcomes.
1For those outside the UK – the MHRA is the Medicines and Healthcare products Regulatory Agency