The importance of adhering to professional standards and
pharmacy standard operating procedures was highlighted in a
decision by Deputy Health and Disability Commissioner Dr
Vanessa Caldwell, who found a pharmacy and pharmacist in
breach of the Code of Health and Disability Services
Consumers’ Rights (the Code).
A baby, aged four
weeks at the time of the events, was prescribed omeprazole
oral liquid by her family doctor for colic. The pharmacy
accidently mixed the baby’s prescribed omeprazole with
methadone (a synthetic opioid and controlled drug). The
pharmacist had left an unlabelled bottle containing
methadone on the dispensary bench, and a pharmacy technician
inadvertently used that bottle to prepare the omeprazole
prescription for the baby.
The baby was given a dose
of the omeprazole by her mother, and a short time later the
baby began breathing abnormally and became unresponsive. The
baby was taken to hospital by ambulance and later treated in
ICU. A urine sample confirmed that the baby had suffered a
methadone overdose.
In her decision, Dr Caldwell found
that the pharmacist did not dispense methadone safely, and
failed to carry out the appropriate checks in the dispensing
process, leading to the error in dispensing the baby’s
medication.
“As a registered pharmacist, he was
responsible for ensuring he provided services of an
appropriate standard. This includes compliance with
professional standards set by the Pharmacy Council of New
Zealand and the Ministry of Health.”
“In failing to
dispense the omeprazole in a safe and appropriate way, and
by failing to check the final product, the pharmacist did
not provide services to the baby in a manner consistent with
professional standards and competent pharmacist practice,”
says Dr Caldwell.
Dr Caldwell was critical of the
pharmacist’s management of the dispensing error, noting
the delay of 1.5 to 2 hours between discovery of the
dispensing error and the first attempt to contact the
baby’s mother was inadequate.
She concluded that the
multiple errors in the pharmacy’s dispensing practice
amounted to a service delivery failure for which the
pharmacy was responsible.
“The pharmacy had a duty to
ensure it provided services with reasonable care and skill.
This includes a responsibility to have adequate policies and
procedures in place to facilitate safe, accurate, and
efficient dispensing, and to ensure its staff followed those
policies,” says Dr Caldwell.
Dr Caldwell also made
adverse comment regarding a pharmacy technician’s
adherence to the pharmacy’s standard operating procedures,
noting that “standard operating procedures (SOPs) provide
important guidance to support compliance of staff with
professional and practice standards”.
However, Dr
Caldwell acknowledged that pharmacy technicians are directly
supervised by pharmacists, and both the pharmacy’s SOPs
and professional standards recognise that ultimately
pharmacists are responsible for the safe dispensing of
medication.
“I consider the ultimate responsibility
for the dispensing error sat with the pharmacist. He held
the responsibility to ensure the accurate dispensing of
medicine, and should have double checked the dispensed
medication,” says Dr Caldwell.
Dr Caldwell recommended
the pharmacist complete the “Addictions and opioid
substitution therapy” course prior to providing further
opioid substitution therapy services, and complete the
“Improving accuracy and self-checking” workbook provided by
the Pharmaceutical Society of New Zealand, should the
pharmacist remain actively in practice.
She further
recommended the pharmacy technician complete the “Improving
accuracy and self-checking” workbook provided by the
Pharmaceutical Society of New Zealand.
The pharmacist
has expressed sincere regret for this error and the pharmacy
has implemented a number of changes to their operation to
minimise the risk of this occurring again.
This was a
distressing incident and could have had the worst outcome if
the baby’s mother had not intervened as early as she
did.
Dr Caldwell has also referred the pharmacist to
the Director of Proceedings for the purpose of deciding
whether any proceedings should be
taken.
Editors notes
The full
report of this case 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).
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