Health and Disability Commissioner report: Baby overdoses on methadone following pharmacy mix-up

Health and Disability Commissioner report: Baby overdoses on methadone following pharmacy mix-up
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A baby suffered an overdose after they were accidentally given methadone instead of medication to treat colic.

The four-week-old was prescribed omeprazole oral liquid by her family doctor for colic, but the pharmacy accidentally mixed the baby's prescribed omeprazole with methadone, which is 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 their mother and a short time later they began breathing abnormally and became unresponsive. The baby was then taken to hospital by ambulance and later treated in ICU. A urine sample confirmed the four-week-old had suffered a methadone overdose.

In a report from the Health and Disability Commission, Deputy Commissioner Dr Vanessa Caldwell found the pharmacy and pharmacist in breach of the Code of Health and Disability Services Consumers' Rights.

In her decision, Dr Caldwell found the pharmacist didn't 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," she said.

"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."

Dr Caldwell was critical of the pharmacist's management of the dispensing error, noting the delay of 1.5 to two hours between discovering the dispensing error and the first attempt to contact the baby's mother was inadequate.

She said the multiple errors in the pharmacy's dispensing practice amounted to a service delivery failure, which the pharmacy was responsible for.

"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," Dr Caldwell said.

She also commented on the 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 said pharmacy technicians are directly supervised by pharmacists and both the pharmacy's SOPs and professional standards recognise that pharmacists are ultimately 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," Dr Caldwell said.

She recommended the pharmacist complete the "Addictions and opioid substitution therapy" course and the "Improving accuracy and self-checking" workbook. Dr Caldwell also recommended the pharmacy technician complete this workbook too.

"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," Dr Caldwell said.

"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 to decide whether any proceedings should be taken.