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Sharing Clear Information And Risks About Medication Vital For Informed Choice And Informed Consent

The importance of providing clear information to consumers so they can give informed consent about their care was highlighted in a decision by Deputy Commissioner Rose Wall who found a psychiatrist in breach of the Code of Health and Disability Services Consumers’ Rights (the Code).

This case concerns a woman who became pregnant whilst taking Epilim (sodium valproate), for treatment of a mood disorder which was prescribed to her by the psychiatrist. Epilim can place the fetus at high risk of developing serious birth defects, and affect the way in which the child develops. The psychiatrist had not shared important information with the woman about the risks of taking Epilim to enable her to make an informed choice or give informed consent about her care.

The case reinforces the significance of the informed consent process, and highlights in the context of fetal anticonvulsant syndrome, the importance of prescribing clinicians sharing with women clear information about the risks and benefits of taking Epilim when there is a possibility that they may become pregnant whilst taking the medication.

It also highlights the need for Government agencies involved in safe prescribing practices to review the adequacy of current safeguards for mitigating the risk of fetal abnormalities in babies exposed to certain drugs while in the womb.

Ms Wall found failure of the DHB to have in place procedures relating to the prescribing of Epilim to women of childbearing age, and the practice of its psychiatrists not recording detailed clinical records, were systemic factors that contributed to the lack of information provided to the woman.

The psychiatrist who initially prescribed Epilim to the woman did not provide her with information that a reasonable consumer would expect to receive. She therefore found the psychiatrist in breach of the Code.

Ms Wall made adverse comments relating to discussions between a second psychiatrist and the women about the risks of Epilim and pregnancy that 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 have breached the Code for not providing services that comply with legal, professional, ethical, and other relevant standards.

Ms Wall recommended the psychiatrist, midwife and obstetrician apologise to the woman. She also made recommendations to relevant professional colleges 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. Ms Wall further recommended that Medsafe, ACC, and the Health Quality and Safety Commission work together to have written materials about anti-seizure medications available in plain English, and in other languages, to make information as accessible as possible.

Ms Wall said; "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.

"I am pleased to see there has been a concerted effort from multiple organisations to ensure there is clear information available about the risks of Epilim and pregnancy. I also note that based on information provided by Medsafe, numbers of women being dispensed Epilim in the ten months prior to delivering a baby has reduced significantly over the past ten years.

"While this reduction is encouraging, I consider there is still work to be done and I will continue to pay close attention to people’s concerns as they raise them.

"I encourage anyone who has an issue with informed consent or the standard of care they have received for a health and disability service to report their concerns to my office directly at 0800 11 22 33 or to make a complaint at," said Ms Wall.

Editors notes

The full report of this case can be viewed on HDC’s website - see HDC's ' Latest Decisions'.

Names have been removed from the report to protect privacy of the individual involved in this case. We anticipate that the Commissioner will name DHBs and public hospitals found in breach of the Code unless it would not be in the public interest or would unfairly compromise the privacy interests of an individual provider or a consumer. HDC’s naming policy can be found on our website here.

HDC promotes and protects the rights of people using health and disability services as set out in the Code of Health and Disability Services Consumers' Rights (the Code).

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