Woman not told properly drug posed birth defect risk

Source: 1News

A psychiatrist has been found to have been at fault for not fully disclosing the risks of taking a drug on unborn children to a patient who fell pregnant while on the medication.

A bottle of prescription drugs (file image).

In 2017, a woman had been prescribed Epilim (sodium valproate) for treatment of a mood disorder and became pregnant while taking the drug. Epilim can place the fetus at high risk of developing serious birth defects and affect the way in which a child develops.

Health and Disability deputy commissioner Rose Wall said the psychiatrist had not shared important information with the woman about the risks of taking Epilim while pregnant so that she could make an informed choice or give consent to her care.

As a result, the woman told the Health and Disability Commission her baby was generally well but had some features that may relate to Epilim exposure. She said his cognition may be mildly affected but she is yet to confirm that is the case.

Discussions between a second psychiatrist and the woman about the risks of Epilim and pregnancy were not documented. Incorrect information was also provided by an obstetrician to the woman about the risks of Epilim to an unborn child.

A midwife who retrospectively amended the woman’s antenatal records was also found to be at fault for not providing services that comply with legal, professional, ethical, and other relevant standards.

Wall recommended the psychiatrist, midwife and obstetrician apologise to the woman. She also made recommendations to improve the accessibility of information and processes around documentation and communication of the risks and benefits about Epilim to ensure patients have a clear understanding of these.

Wall further recommended that Medsafe, ACC, and the Health Quality and Safety Commission work together to have written materials about anti-seizure medications available to make information as accessible as possible.

"This case provides an opportunity to ensure information about Epilim and other teratogenic medications is shared widely. The recommendations made in this decision reflects my commitment to ensure this happens as a result of the woman’s experience," she said.