1000x dose error happened on ‘particularly busy’ day

tribunal hearing legal case

A “tired and hungry” pharmacist dispensed clonidine to a three-year-old at 1000 times the prescribed dose

The New Brunswick College of Pharmacists in Canada has released a decision of its Discipline and Fitness to Practice Committee on Merits and Sanction regarding a pharmacy where a potentially lethal dispensing error was made in gummy form.

The pharmacy received a script for clonidine in gummy form, for a three-year-old child.

Although the dose on the bottle in which the gummies were dispensed was listed at 0.025mg each, the gummies each contained 0.025g (25mg)… a lethal dose a thousand times more concentrated than prescribed.

The error was not caught by staff, and the gummies were dispensed.

The Committee heard that the script had been received and was dispensed on a day in December 2020 when the pharmacy was “particularly busy,” with only two pharmacists at work.

It noted in a full decision transcript that the prescription form was “clear, complete and unambiguous” and the pharmacist on duty felt no need to contact the prescriber for clarification.

The script required the compounding and refrigeration of a drug which had not been previously compounded at the store.

There was no pharmacist supervision at the compounding laboratory of the pharmacy: a pharmacist was only involved during the final check prior to dispensing, after compounding was complete.

But the employee who developed and entered the formula for the gummies into the pharmacy’s system entered 0.75g of clonidine for the batch of 30 gummies, instead of the 0.75mg that should have been used, as prescribed.

The pharmacist performed the final verification of the gummies at around 4pm, when they were “tired and hungry” and had eaten nothing all day, since 7.30am.

“The pharmacist was interrupted multiple times during her verification of the gummies and the work performed by the employee in the preparation of the gummies,” the Committee noted.

The child’s parents had difficulty in convincing them to eat a gummy that night, with the child spitting out pieces of gummy which had been hidden in a doughnut.

The child subsequently became unwell.

The next morning they were “lethargic” and asleep on the couch at 9.28am, at which point their mother contacted the doctor, who told them to visit the Emergency Department.

The child required urgent care at hospital for signs and symptoms consistent with clonidine toxicity.

That day, the pharmacy manager rang the prescriber to let him know there had been a dispensing error, and that the gummies were compounded at a concentration of 2.5mg clonidine.

The true concentration of the dose dispensed was discovered later.

Realising the dose dispensed would have been lethal if the child had consumed a gummy, the prescriber contacted the parents to let them know.

The child’s parents, along with their paediatrician, filed a joint complaint against the pharmacy to the New Brunswick College of Pharmacist.

In the light of a prior complaint about a dispensing error in 2017, it was decided that the pharmacy manager had committed professional misconduct as the dispensing error occurred as a result of laxity in dispensing processes and procedures within the compounding lab, coupled with inattention in the dispensing process. The manager agreed to this finding.

It was alleged that the pharmacy’s manager “did not ensure adherence to safety processes and procedures established within the pharmacy and by regulation, standards of practice and practice directive of the College necessary for the correct compounding of medication,” and “Did not respond to the error appropriately in terms of performance of a thorough root cause analysis which resulted in failure to implement necessary changes to policy and procedure”.

He pleaded guilty to the charges, and it was noted that both he and the pharmacist involved were “apologetic, forthcoming and truthful” with the patient and family.

It also noted that there was no evidence of malice or “ungovernable behaviour” by the owner, who cooperated with the investigation.

He admitted that his actions and omissions constituted incompetence and professional misconduct.

The College ordered that he be given a formal written reprimand which will remain on his file with the College for the next five years, as well as on the public register.

The pharmacy will be monitored and/or inspected by the College for up to three years, and the pharmacy manager will have to pay to retain the services of an independent expert to work with the new pharmacy manager.

He was fined CAD$10,000 (AUD$10,855) and his registration as a pharmacy manager suspended for four years.

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