Informed Consent Not Given For Off-label Medication Use, Says The HDC

Deputy Health and Disability Commissioner Deborah James has found Te Whatu Ora - Te Pae Hauora o Ruahine o Tararua MidCentral (formerly MidCentral DHB) breached the Code of Health and Disability Services Consumers Rights, for failing to ensure a woman had enough information to give informed consent to the off-label use of a sedative medication (droperidol). The woman experienced an adverse reaction after droperidol was administered.

The woman visited her ED with pain her leg during a very busy time. Without being reviewed by a medical practitioner, she was administered an off-label sedative (droperidol) for pain relief by a registered nurse.

Droperidol is approved for use as a sedative in New Zealand, and use as pain relief is considered "off-label". It is recommended that patients are monitored carefully after its administration, but no such monitoring occurred.

The woman stated that if she had been told the drug was a sedative, she would not have given consent as she is a busy mum and knows sedatives make people sleepy and she never would have been "ok with this".

As the prescribing doctor could not be identified, Ms James considered the DHB was responsible for failing to ensure the woman was provided sufficient information about droperidol and its off-label use.

"Mrs A should have been told what was being prescribed (droperidol), the primary use of that medication (as a sedative), its primary side effects, why it was being prescribed for her (to relieve her pain), and that such a use was not an approved use of the medication. This was information that a reasonable consumer in Mrs A’s circumstances would expect to receive, and needed to receive to give informed consent."

Ms James was also critical that staff failed to monitor the woman after droperidol was administered.

"Despite a clear expectation that the woman should have been monitored after droperidol was administered, there is no evidence that the prescriber gave any instructions for monitoring, or that any staff member thought to observe her regardless of any instructions, which meant that her adverse reaction went un-noticed."

Deborah James made a number of recommendations including that the DHB provide a written apology to the woman; provide HDC with an audit of ED medication charts over the past six months to check the compliance of doctors entering Medical Council of New Zealand registration numbers on the medication chart; and provide HDC with an updated plan for improving waiting times in the ED.

MidCentral DHB has since devised a medication charting guideline for patients waiting to be seen in ED, and a list of medications allowed to be given to patients waiting to be seen. This includes which medications can be given by registered medical officers and which areas of ED are appropriate for the administration of specific medications.

ENDS

Editors notes

The full report of this case (20HDC00962) will be available on HDC’s website. Names have been removed from the report to protect privacy of the individuals involved in this case.

The Commissioner will usually name providers 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.

More information for the media and 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).

Communications team, Health and Disability Commissioner

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