A 4-week-old baby with a croup stopped breathing, turned blue and went floppy after being given medicine that was five times the dose it should have been.

The mother was slowly using a syringe to put the oral steroid Redipred into the side of her baby’s mouth when the newborn inhaled the last 0.5ml of the 4.5ml dose and stopped breathing. Her mother performed CPR and the baby began to breathe again, before being rushed to the emergency department.

The Deputy Health and Disability Commissioner has found in a decision released today that the baby had been given five times the prescribed dose of steroid, due to a pharmacist error.

Dr Vanessa Caldwell said the mother was given medication labelled with the incorrect dose for her baby, which resulted in “an extremely serious situation” which required resuscitation and hospitalisation.

On examination, the baby was well except for an “ejection systolic heart murmur” and was discharged from hospital the following day, with the parents told to check with their GP/paediatrician regarding the murmur.

The mother told the commissioner the baby has recovered following intensive follow-up with a private paediatrician in the community team at the hospital and, while the “medium-term outlook for her is good, there are still uncertainties about the longer-term effects”.

She said it was the pharmacist’s job was to check the prescription.

“However, having admitted to not checking it, signing it as checked and then stating it was checked but not identifying the error was ‘reckless and unreasonable’,” the mother said.

“This should never have happened, and it must never happen again.”

What went wrong

According to the findings, the dispensed medication dose on the box given to the mother should have read 0.9ml but instead read 4.5ml.

When the mother got to the hospital, she informed the triage nurse that she had administered 4.5ml of Redipred as per the label instructions from the pharmacy.

Initially, staff at the hospital inferred the mother had misread the dose on the label of the medication and, as a result, she believed she’d made a mistake that caused her baby to stop breathing.

She then thought it might have been an error the GP had made, but it was soon discovered the mistake was made at the pharmacy.

The locum pharmacist, referred to as Ms B in the decision, admitted there was an error – she had not checked the label on the Redipred box against the prescription from the GP.

The initial mistake happened when a trainee pharmacy technician “misread” 4.5mg on the prescription from the baby’s GP as 4.5ml, and typed the prescription quickly into the system before printing the label for the pharmacist to check.

But, it was the pharmacist who was meant to complete the final check of the medication against the prescription.

Ms B, who had been a pharmacist for nearly 10 years, acknowledged she failed to identify the error in the stated dosage when she did the final check.

Dr Caldwell said while she couldn’t determine exactly what was discussed between the pharmacist and the mother when the medication was handed over, it was clear the pharmacist knew it was for a 4-week-old baby and necessary checks should have been done.

“While this is essential for any medication, it was especially important in this case given that the patient was a 4-week-old infant who would be particularly vulnerable to even the most minor adjustments to medication doses.”

The pharmacist signed the prescription, stating it had been “checked” against the label of the prescription, but Dr Caldwell found that if she had followed the pharmacy guidelines when she did this, the dosage error would have been caught.

“Ms B also failed to check for clinical appropriateness of the dose of the medication,” she said.

“For this reason, I do not accept that a proper ‘check’ was carried out by Ms B in line with the pharmacy’s standard operating procedures and the Pharmacy Council of New Zealand’s Competence Standards, and I am critical of this.”

Ms B also acknowledged that although she checked the baby’s address and identity, she did not give any counselling to the mother around how to give the medication.

“This, along with the failure to check [the baby’s] weight, was another missed opportunity to identify the dosage error. I am critical of this.”

Dr Caldwell was also critical of the pharmacist’s explanation for why she failed to check it.

“She considered that one of the factors was the slow pace of the pharmacy, and that because the script was straightforward, she may not have given it the attention it required,” Dr Caldwell said.

“In my view, if the pharmacy was not busy, this would allow more time for attention to be given to a script, and I consider this not to be a relevant factor in the error.”

Dr Caldwell found the pharmacist had breached the Code of Health and Disability Services Consumers’ Rights by not checking the dispensed medication against the prescription, not spotting the error, and failing to advise the mother on how to administer the medication.

Concerns about communication

Following the incident, the pharmacist contacted the parents of the baby to check how she was doing.

However, Dr Caldwell had “concerns” about the contact.

“Whilst it is understandable that [the pharmacist] wanted to check on [the baby’s] condition, clearly it was a stressful time for [the] family. I consider that they should have been given time to focus on [the baby’s] care and recovery at the hospital without having [the pharmacist] contact them for updates or offers of assistance.”

The parents said the pharmacist had called them “four times from multiple numbers” and then offered to sit with the baby while the mother had a break and looked after her other children.

The mother told the HDC that she declined the offer, and told the pharmacist she did not have the capacity to speak to her.

She told the HDC that during the call, the pharmacist told her that on the day the incorrect dose was given, the pharmacy had been busy and short on staff, and she offered this as an explanation for the mistake.

The decision said the mother described feeling “alarmed” and “deeply uncomfortable” during these conversations. She also felt they were ‘unprofessional and inappropriate’.

The pharmacist’s lawyer said that she “never offered to sit with [Baby A] while [Mrs A] had a break. This clearly would not have been appropriate. She made a general offer of help. This was intended to be an offer of help in her role as a pharmacist. For example, to provide any further information which [Baby A’s] treatment team might need from the Pharmacy.”

The pharmacist told HDC that she does not recall Mrs A saying that she did not want to be contacted further, and also denied telling her the mistake happened due to a busy pharmacy or understaffing.

However, Dr Caldwell found the pharmacist should have respected the request for no further contact and should have maintained appropriate professional boundaries.

“I am critical that this did not happen, and that Ms B continued to contact Mrs A.”

Recommendations

The pharmacist was told to provide a formal written apology to the baby’s parents for the breach.

Dr Caldwell noted the pharmacist had already completed recommended reading about both avoiding medication errors and about the importance of professional boundaries.

It was recommended she outline improvements she made to her practice as a result of this training, within three months of the HDC report.

The pharmacist also reviewed a best practice guide for avoiding medication errors in children, and had three months of mentoring, with a focus on paediatrics.

The trainee pharmacy technician was reminded of the importance of “slowing down and being meticulous when inputting information from prescriptions into the computer system”.

She was also told to complete the Improving Accuracy and Self-Checking Workbook provided by the Pharmaceutical Society of New Zealand and outline any further changes made to her practice as a result of this training.

It was recommended the pharmacy undertake a random audit of the “overall processing, dispensing, and checking of medication of 50 prescriptions over a one-month period”.

It also needed to do a yearly refresher training for staff, and review its induction programme to effectively train locum or temporary staff on its standard procedures.

It should also use this case as a basis for developing ongoing education/training on the dispensing process, managing dispensing errors, and dealing with customer complaints, for staff across all the pharmacy branches, including any new staff.

Hannah Bartlett is a Tauranga-based Open Justice reporter at NZME. She previously covered court and local government for the Nelson Mail, and before that was a radio reporter at Newstalk ZB.