Pēpi accidentally given methadone by pharmacy, stops breathing

By Contributor

A newborn baby suffered an methadone overdose and was taken to hospital by ambulance after it stopped breathing following a medication mix-up by busy pharmacy staff. Photo /File

By Leighton Keith, Open Justice multimedia journalist, Whanganui

A four-week-old baby stopped breathing after being given methadone instead of colic medication by busy pharmacy staff.

The newborn spent 10 days in hospital and was lucky to survive after the mistake which resulted in a complaint to the Health and Disability Commissioner.

Deputy HDC Doctor Vanessa Caldwell has now highlighted the importance of adhering to professional standards and pharmacy standard operating procedures.

In a decision released today Caldwell found the pharmacy and pharmacist in breach of the Code of Health and Disability Services Consumers' Rights.

She said the medicine mix-up was a distressing incident and could have had the worst possible outcome if the baby's mother had not intervened as early as she did.

On June 5, 2018 the newborn's mother went to fill a repeat prescription for omeprazole oral liquid, prescribed by the family doctor to treat colic, but was instead given the powerful synthetic opioid.

At home the mother gave her baby a dose of the medicine. Soon after, the newborn started breathing abnormally and became unresponsive. It was rushed to hospital in an ambulance and treated in ICU.

"A urine sample confirmed that the baby had suffered a methadone overdose," Caldwell said in her decision.

The mix-up happened on a day when the sole charge pharmacist arrived at work at 8.25am to prepare methadone for a patient.

To avoid interruptions the pharmacist's process was to prepare the client's methadone before opening so it was ready when they habitually arrived at 8.35am for their daily dose.

The pharmacist had poured 6ml of methadone liquid into an unlabelled 30ml bottle and left it on top of the prescription on the dispensary bench but the patient didn't turn up at the usual time.

A pharmacy technician later moved the bottle and prescription along the bench to give herself more working space.

About 11am the baby's mother arrived to have the colic prescription filled.

The medication had to be made, as there were no commercially available products, by another technician who had the pharmacist check the volume while it was still in the measuring cylinder.

It was then mistakenly poured into the bottle containing the methadone.

The technician told the HDC she didn't rinse the bottle with water prior to filling it with the medication and wasn't aware it was a requirement.

The error was discovered between 11.30am and 12noon but the pharmacy didn't attempt to contact the family until around 12.30pm on a landline.

It took two years for the baby's mother to make a complaint to the HDC due to the immense stress the family had suffered dealing with the incident.

"Mrs B told HDC that Baby B has experienced health problems since the overdose, and her GP considers that these can be traced back to Baby B's treatment."

The mother sought financial compensation from the pharmacist for the error and the claim was resolved in a confidential settlement to reflect the significant impact of the incident, Caldwell said.

In the decision Caldwell found the pharmacist did not dispense methadone safely, and failed to carry out the appropriate checks in the dispensing process, which led to the mistake in dispensing the baby's medication.

"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."

The pharmacist's management of the error was criticised by Caldwell noting the delay between the discovery of the mistake and the first attempt to contact the baby's mother, which she described as inadequate.

Caldwell found the multiple errors in the pharmacy's dispensing practice amounted to a service delivery failure for which it 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."

She also made adverse comments regarding the technician's adherence to the pharmacy's standard operating procedures noting the SOP provided important guidance to support compliance with professional standards.

However, Caldwell acknowledged technicians were directly supervised by pharmacists, and both the pharmacy's SOPs and professional standards recognised that ultimately pharmacists were responsible for the safe dispensing of medication.

It was 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.

It was also recommended the technician complete the 'Improving accuracy and self-checking' workbook.

The pharmacist, who sent a written apology to the baby's mother two days after the error, had expressed sincere regret for the mistake and the pharmacy had implemented a number of changes to its operation to minimise the risk of this occurring again, Dr Caldwell said.

She had also referred the pharmacist to the Director of Proceedings for the purpose of deciding whether any proceedings should be taken.