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Monitoring of patient following administration of an unapproved, prescription-only medication (13HDC00966)
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(13HDC00966, 16 June
Rural GP ~ Clinic ~ Unregistered provider ~ Unapproved
medication ~ Drug addiction ~ Rights 6(1), 7(6), 4(1),
A 45-year-old woman with a history of opiate drug use sought
assistance with her drug addiction from a clinic offering treatment
using an unapproved medicine under the Medicines Act. The clinic is
run by a doctor who is a qualified rural medicine general
practitioner, and his assistant.
The woman was booked for treatment. Prior to treatment the woman
had an ECG done and bloods taken to assist the doctor to assess her
suitability for treatment.
The woman missed her flight to the clinic and arrived one day
late for her scheduled treatment. The doctor told HDC that he
assessed the woman prior to commencing treatment, including
reviewing her blood test findings and ECG, and carrying out a
physical examination, but this assessment was not documented.
The treatment was commenced. The first dose of the medicine was
administered at 7.50am. Further doses were then administered at
8.50am, 5.45pm, 7.25pm and 8.40pm on the first day, and at 7am the
following day. The woman's blood pressure was recorded once at 9am
following the administration of the final dose. At midday the
doctor then left the country, leaving sole responsibility for
ongoing monitoring of the woman with his assistant.
The woman was noted throughout the rest of the day to be lying
still sleeping. The assistant carried out her final check of the
woman at 11pm that night. At 6am the following day the assistant
found the woman was dead, lying in the same position as she had
been at the final check.
It was held that the doctor breached Right 6(1) for failing to
provide the woman with adequate information about the risks and
side effects of the medicine, or about the experimental nature of
its use to treat drug addiction. Furthermore, the doctor also
breached Right 7(6) for failing to obtain the woman's written
informed consent for treatment, which was required because of the
experimental nature of the treatment.
The doctor was found to have departed from the treatment
protocol, and he did not monitor the woman adequately and therefore
breached Right 4(1). He did not keep comprehensive and accurate
records and, as such, failed to comply with professional standards
and breached Right 4(2).
The assistant was found to have breached Right 4(1) for failing
to monitor the woman adequately. Concern is also raised about the
assistant's immediate response when she found the woman dead.
The clinic did not operate safely, and failed to provide the
woman with services with reasonable care and skill, in breach of