Baby dies after pharmacy gives wrong dosage

Otago Daily Times

7 days ago

By Sam Sherwood of RNZ
Warning: This story has details of the death of an infant
A two-month-old baby died following an overdose after she was allegedly given medication at an adult dosage by a pharmacy.
Her grieving parents are calling for a law change that would make it mandatory for medication to be checked by two people before it is dispensed.
The revelations have prompted the Ministry of Health and Health New Zealand to "urgently" undertake a joint review into the incident, with Medsafe visiting the pharmacy to ensure they are safe to continue operating. The Pharmacy Council, which is also investigating, says it is "clear that an awful error has occurred".
Bellamere Arwyn Duncan was born at 31 weeks and five days at Palmerston North Hospital on May 2.
Her parents Tempest Puklowski and Tristan Duncan knew from the scans she was going to be "quite tiny", and were told she would be early but no-one expected she would come as early as she did.
"That was definitely on her own accord," Puklowski, a first-time mum, said.
"She sort of just made up her mind, and was like 'I'm coming out'."
Bellamere, who weighed 1023 grams when she was born, spent about two months in the neonatal unit.
Puklowski says she could not wait to bring her baby home and was excited when she was discharged on June 24.
While in hospital, Puklowski gave Bellamere her drops for Vitamin D. Nurses also administered her phosphate.
When they left hospital they were given some Vitamin D in a little bottle, and a prescription for iron and Vitamin D.
The following day Duncan went to a Manawatu pharmacy with the prescriptions. He was given the iron, but says the pharmacy refused to give the Vitamin D as the staff thought the dosage was "too high for her age and her weight".
The staff said they would call the neonatal unit and follow-up.
A few days later Puklowski received a call from the unit to organise a home care visit. During the call she was asked if she had any concerns, and Puklowski asked if they had been contacted about the Vitamin D. They had not, and said they would follow up and rewrite the prescription along with a prescription for phosphate.
The homecare visit went well. Bellamere had put on weight, and was "doing well", Puklowski recalls.
"She was settling in perfect."
A day after the phone call, on July 2, Duncan went to the pharmacy to collect the medication and came home with just the phosphate. Unbeknown to the parents, they had allegedly been given an adult dosage of phosphate.
The label on the medication directed them to dissolve one 500mg tablet of phosphate twice daily in a glass of water.
Puklowski said given the pharmacy's refusal to give them the Vitamin D, they did not even think to question the dosage.
That evening they gave Bellamere her first dose of the medicine in her formula water. They would give her three bottles in 24 hours as was recommended.
The couple noticed in that period that her eating was off, and thought she was "extra gassy", Puklowski says.
"She was still feeding fine. She just wasn't maybe going through a whole bottle compared to what she was," she recalls.
Then, the day after she got her first dosage, Bellamere suddenly stopped breathing.
"We were like oh shit, I went straight into panic," Puklowski says.
"Tristan had to start administering CPR, and I was on the phone to the ambulance which arrived very quickly, within at least five to 10 minutes."
Bellamere was taken to hospital and rushed to the emergency department. Once she was stabilised she was taken to the neonatal unit where she stayed overnight before she was flown to Starship Hospital.
"We were definitely terrified and more confused than anything about what was going on," Puklowski says.
The couple told the doctors they were worried they had overfed her, and her body was struggling to get it out.
"I was trying to think of what had changed in the past 24 hours, which was her phosphate," Puklowski says.
The couple had taken a bottle of the medicine with them to Starship Hospital. She gave it to the staff who saw that they had been given an adult dose. The staff then requested the original prescription which confirmed the script had been written with the correct dosage, but somehow the pharmacy had given the wrong dosage, Puklowski says.
"I keep thinking about how much she ended up having and it just makes me feel sick."
Once at Starship Hospital the couple were told they would "have to make some hard decisions".
"But then we went and saw her. She was still moving and her eyes were still opening.
"So we were like, 'No. She's our strong little fighter. I mean, look at how well she's done so far'."
Tragically, Bellamere died at Starship Hospital on July 19.
"It was completely horrible," Puklowski says of having to say goodbye to her baby.
A preliminary coroner's opinion is that Bellamere died of phosphate toxicity, her parents confirmed.
A week on from their daughter's death, the couple are still in shock. Puklowski says she is in "disbelief".
"They're just numb," Puklowski's mother, Rachelle Puklowski says.
"It's completely traumatised them. They just watched Bella pass twice, once in their home and then again up at the hospital." Pharmacy responds
The owner of the Manawatu pharmacy that dispensed the medication said in a statement the baby's death was "a tragedy".
"Our sympathy is with the family and whānau. This is a very difficult time.
"We are looking into what has happened to try to understand how this took place. There will also be external reviews which we will work with."
The owner was asked how the medication was given at the wrong dosage, whether they disputed the allegations, when the pharmacy became aware the wrong dosage had been given, and what confidence people could have about other medication received from the pharmacy.
The owner said the pharmacy was "devastated about what has happened and are investigating to find out how this occurred".
"It is not appropriate to comment further at this stage."
Duncan describes what happened to his daughter as "negligence".
"How was it overlooked?" Puklowski wants to know.
"Not even just in the initial making of it, but in the handing of it to us. They denied us the Vitamin D because they thought the dosage was too high for her age and weight, but can proceed to give us a full adult dosage of phosphate, like it just makes no absolute sense," she said.
"They have to make sure they realise the kind of mistake that they have made, and that something has been done about it."
The couple are adamant they want changes to the system for giving out medication.
"It's the sort of thing that can't really be overlooked.
"There needs to be something better in effect, rather than just relying on one person to make sure you're getting the right prescription, having at least a few eyes."
Pharmacy Council chief executive Michael Pead said in a statement the council's "heartfelt thoughts" were with Bellamere's family following the "absolute tragedy".
"It is clear that an awful error has occurred, and as the regulator for pharmacists, ​we are working on understanding every detail of what happened, what went wrong, how it went wrong, and who was involved. The Pharmacy Council is working promptly to take any immediate steps required to ensure public safety.
"Our enquiry and investigation processes are currently underway and, until these are complete, we cannot provide any further details. At the end of the process, we will make any recommended changes to ensure as best as possible an event like this does not happen again."
The Pharmacy Council operated within a wider framework of organisations responsible for the protection of public health and safety, Pead said.
"We have also referred the incident to other relevant organisations to ensure they can act on any matters that may fall into their remit.
"We would emphasise that situations of this nature are extremely rare. No health practitioner goes to work aiming to cause harm, and New Zealanders can have faith that the pharmacists working in their communities and hospitals are vigilant about medicine dosage and patient safety."
Pead said the council set the standard that all pharmacists follow a "logical, safe and methodical procedure" to dispense therapeutic products.
Every pharmacy would have their own standard operating procedures that covered the dispensing and checking process, he said.
"It involves checking the prescription for legality and eligibility, clinical assessment and accuracy check.
"The check by a second person (separation of dispenser and checker roles) is considered best practice and is often built into the checking process in a pharmacy's procedures. The pharmacist is responsible for the final check. Sometimes this may not be possible for a sole charge pharmacist, working alone in the dispensary. It is recommended that a second self-check should be carried out, taking a few moments between the prescriptions to 'reset' and performing the final check with care."
Health New Zealand and the Ministry of Health released a joint statement, extending their "heartfelt condolences" to Bellamere's family.
"Health New Zealand and the Ministry of Health take very seriously incidents like these, which while rare, are always thoroughly investigated to identify any lessons that can be learned.
"Both agencies involved are acting urgently in undertaking a joint review into this incident, exploring all aspects of the care provided."
Health New Zealand is undertaking a serious incident review and the Ministry of Health will be looking at actions taken by health services in the community.
"This will occur alongside providing any information requested by the coroner."
On Friday, a Ministry of Health spokesperson said that Medsafe had visited the pharmacy where the medicine was dispensed and completed an initial assessment that the pharmacy was safe to continue operating.
"That initial assessment is part of a rapid audit and site visit of the pharmacy which is being carried out by Medsafe, aimed to provide additional assurance that the pharmacy is meeting expected standards."
The actions taken by Medsafe and the Pharmacy Council would help inform the ongoing review, the spokesperson said.
"These measures are occurring alongside providing any information requested by the coroner."
Health Minister Simeon Brown said he was "heartbroken" for Bellamere's family who had "inexplicably lost their baby in tragic circumstances".
"My thoughts are with them at this incredibly difficult time.
"I am advised that the Pharmacy Council has taken immediate action and is investigating this incident. The council has also advised other appropriate regulators."