Adhering to professional guidelines and standard operating procedures vital for the safe dispensing of medication

The importance of adhering to professional standards and pharmacy standard operating procedures was highlighted in a decision by Deputy Health and Disability Commissioner Dr Vanessa Caldwell, who found a pharmacy and pharmacist in breach of the Code of Health and Disability Services Consumers’ Rights (the Code).

A baby, aged four weeks at the time of the events, was prescribed omeprazole oral liquid by her family doctor for colic. The pharmacy accidently mixed the baby’s prescribed omeprazole with methadone (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 her mother, and a short time later the baby began breathing abnormally and became unresponsive. The baby was taken to hospital by ambulance and later treated in ICU. A urine sample confirmed that the baby had suffered a methadone overdose.

In her decision, Dr Caldwell found that the pharmacist did not 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.”

“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,” says Dr Caldwell.

Dr Caldwell was critical of the pharmacist’s management of the dispensing error, noting the delay of 1.5 to 2 hours between discovery of the dispensing error and the first attempt to contact the baby’s mother was inadequate.

She concluded that the multiple errors in the pharmacy’s dispensing practice amounted to a service delivery failure for which the pharmacy 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,” says Dr Caldwell.

Dr Caldwell also made adverse comment regarding a 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 acknowledged that pharmacy technicians are directly supervised by pharmacists, and both the pharmacy’s SOPs and professional standards recognise that ultimately pharmacists are 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,” says Dr Caldwell.

Dr Caldwell 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.

She further recommended the pharmacy technician complete the “Improving accuracy and self-checking” workbook provided by the Pharmaceutical Society of New Zealand.

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.

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 for the purpose of deciding whether any proceedings should be taken.