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Prescription of contraindicated medication (13HDC01300)
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(13HDC01300, 20 June
General practitioner ~ Pharmacy ~ Rest home ~ District
health board ~ Contraindicated medication ~ Rights 4(1), 4(2),5(1),
An elderly rest home resident developed a severe rash, and her
general practitioner (GP) prescribed ketoconazole to treat this.
Ketoconazole has a high risk of causing liver injury and is
contraindicated with simvastatin, which the woman was taking at the
time for high cholesterol
The pharmacy which dispensed the ketoconazole (the pharmacy) had
dispensing software which highlighted drug interactions. However,
no one from the pharmacy contacted the GP about the drug
interaction between simvastatin and ketoconazole. The woman's rash
occurred a second time, and again the GP prescribed ketoconazole.
No one from the pharmacy advised the GP of the drug interaction.
When the woman presented a third time with the same rash, the GP
prescribed ketoconazole at double the previously prescribed dose
and for double the length of time. Again, no one from the pharmacy
advised the GP of the drug interaction. The GP did not monitor the
woman's liver function on any of the occasions on which he
Approximately two months later, the woman had a fall and was
taken to hospital. On arrival, her medications were documented but
ketoconazole was not included. Her creatine kinase (CK) levels were
recorded as 2,740 units per litre (normal levels being 30‒180).
A registrar viewed the CK test result electronically. Although
the result was highlighted on the system as being abnormal, the
registrar did not inform the ordering consultant. Two days later,
the woman's CK test was reviewed and due to the elevated result,
her simvastatin treatment was discontinued. Clinicians reviewed the
woman's computerised pharmacy dispensing records and discovered for
the first time that she had been prescribed ketoconazole. The woman
suffered from acute kidney failure and, sadly, died.
It was held that by failing to establish the woman's medical
history appropriately, either by questioning her adequately or
reviewing her medical notes, and by failing to monitor her liver
function adequately when prescribing ketoconazole, the GP breached
Right 4(1). By failing to communicate effectively with the woman,
in a manner that would have enabled her to understand the
information provided to her, the GP breached Right 5(1). By failing
to provide the woman with information that a reasonable consumer in
her circumstances would expect to receive, the GP breached Right
6(1)(b), and by not discussing the risks of ketoconazole, the woman
was not in a position to make an informed choice and give her
informed consent to taking ketoconazole, and, accordingly, the GP
also breached Right 7(1).
The pharmacy failed to have in place an appropriate dispensing
standard operating procedure, and failed to act on the alert when
prompted. In addition, several staff members, on three separate
occasions, failed to follow the professional standards for
dispensing medications. Accordingly, the pharmacy was found to have
breached Right 4(2).
The district health board breached Right 4(1) by not having in
place appropriate systems to ensure that the woman's recent
medications were known to staff. Criticism was also made of the
failure to ensure that an abnormal test result was acted on
Adverse comment was made about the rest home, regarding the
woman's progress notes having been completed on an irregular basis
while she resided at the rest home and for the lack of nursing
It was recommended that the Medical Council of New Zealand
consider whether a review of the GP's competence is warranted.
In response to recommendations made in the provisional opinion
the GP provided a written apology to the family for his breaches of
the Code, and underwent further training on good prescribing
It was recommended that the company that traded as the pharmacy
provide a written apology to the family for its breach of the Code,
obtain an independent review of the dispensing SOPs for all
pharmacies that it owns and report to HDC on the outcome of the
review, and provide training to its pharmacists on its dispensing
It was recommended that the district health board provide a
written apology to the family for its breach of the Code.