A dermatologist’s failure to order a pregnancy test before prescribing isotretinoin for a 26-year-old woman with severe acne has been criticised by the Health and Disability Commissioner.
The woman, who had told the dermatologist she was in a relationship and using condoms, found out she was pregnant after taking the drugs – known to cause birth defects – and the pregnancy was terminated.
Health and Disability Commissioner Antony Hill, in a report released today into the 2015 incident, found the dermatologist in breach of the Code for Health and Disablity Services for failing to test for pregnancy prior to prescribing isotretinoin. Isotretinoin is teratogenic and known to cause birth defects in an unborn child. Guidelines recommend pregnancy tests prior to starting the drug as well as ‘strict birth control procedures’.
The woman saw the dermatologist in July 2015 about severe acne, which had been successfully treated by isotretinoin when she was 16. But the acne had gradually recurred and had not responded to antibiotics or oral contraceptives. The young woman had visited the same dermatologist in 2011, but had decided not to proceed with isotretinoin at that time.
The dermatologist and patient in July 2015 agreed to try another course of isotretinoin and the doctor ordered some pre-treatment blood tests, but not a blood or urine pregnancy test. The patient told the dermatologist she had a long-term partner but had infrequent intercourse, and when she did they used a condom. The dermatologist told the HDC that she did not consider the patient a pregnancy risk as she had been using a barrier method of contraception for five years and had not fallen pregnant.
Medsafe advises not to prescribe isotretinoin in “women of childbearing potential” unless they had been on an “effective contraception without any interruption” for one month before beginning isotretinoin and had had a negative pregnancy test within two weeks of starting the drug. It was recommended that, while on the drug, two complementary forms of contraception, including a barrier method, should be used.
Mr Hill said whether the patient was pregnant or not at the time of the consultation was not relevant to the findings. The patient told the commissioner that the dermatologist had explained the risks associated with becoming pregnant while taking isotretinoin and given her a booklet, but she had not been made aware during the consultation that she should have been on two forms of contraception.
Mr Hill considered that by prescribing the woman isotretinoin without carrying out a pre-treatment pregnancy test, the dermatologist failed to provide services to the woman with reasonable care and skill. He also found the dermatologist’s company liable for the dermatologist’s actions.
The dermatologist said following the complaint she carried out a pre-treatment pregnancy test before prescribing isotretinoin to women of childbearing potential, required them to be on a secure form of contraception and had introduced a consent form, along with a handout for all patients.
The dermatologist had provided a written apology to the woman and arranged to enrol in a communication skills course.
The full report can be read here.