A man died shortly after a large area of bleeding on the right side of his brain was discovered. Photo / 123rf
When a man who was on blood thinners started getting worsening headaches and nausea, his wife began to worry.
The man insisted he was fine, but did tell her his headache was “extreme” and he could hear “swishing noises” in his ears.
His condition worsened, he collapsed, and his wife phoned an ambulance on September 8, 2021.
At first, it was thought he was having a stroke, but after losing consciousness and having a CT scan, a large area of bleeding on the right side of his brain was discovered, with extensive swelling.
Surgery wasn’t an option, and he subsequently died.
The man had been taking prescribed blood thinners, and a pharmacist has now been criticised by the Deputy Health and Disability Commissioner for failing to consult the man’s GP when routine blood tests indicated things might be going awry.
The man, referred to as “Mr A” in Deputy Health and Disability Commissioner Carolyn Cooper’s report, was on Warfarin, a medication used to prevent blood clots, and as part of his treatment, his pharmacist, “Mr B”, was required to regularly do INR testing – international normalised ratio blood test, which tests how long it takes blood to clot.
If the result was outside a “normal” range, the pharmacist was meant to contact the patient’s GP.
Pharmacies operate under “standing orders”, and the ones in place for the pharmacy gave guidance for the range in which a pharmacist could accept a dosage recommendation generated by a software system, without consulting a GP.
On three occasions, the patient’s INR fell outside the range acceptable for pharmacist management, and in one instance, it was well outside the normal range.
In her investigation, Cooper accepted the independent advice of pharmacist Julie Kilkelly, that there should have been a discussion between the GP and the pharmacist, as stipulated in the standing orders.
Cooper was “highly critical” of Mr B’s decision to instead provide his own instructions on Warfarin management.
The decision details the notes Mr B wrote from his consultation with Mr A, when the man came in and was found to have a very high reading.
It was 5.6, where the normal range was between 1.5 and 4. This had followed consultations in the weeks prior, beginning on August 17, 2021, where the dosage had been changed as the readings had been on the lower side, putting the man at risk of developing a clot.
The now-high reading left him at risk of excessive bleeding, and Mr B asked the man about any changes to his diet or medicines that may have caused the unusually high reading.
The pharmacist made changes to the dosage, gave the man instructions about what to take and when, and told him to come back in a week for another test.
His notes said he made this recommendation based on “successful past experience with patients who like Mr A, had consistent INR results overall, and their INR corrected well after the two missed doses [as instructed]”.
The following evening, Mr A was taken to hospital by ambulance, where he was found to have had a brain bleed, and later died.
The GP told the deputy commissioner he was under the impression the pharmacy would call if there were any concerns about a result significantly outside the range.
He didn’t recall getting a call. Mr B is now overseas and didn’t respond to the inquiries from the commissioner.
“[Mr B] took it upon himself to provide advice based on his own judgement and, in doing so, stepped outside his scope as a pharmacist working under a standing order,” Cooper said in her report, released today.
“In my view, Mr B should have either received email confirmation of GP approval of the treatment plan, or contacted Mr A’s GP by phone ...”
The pharmacy used a software system where, if the pharmacist overrode the software recommendation as Mr B did in these instances, they had to tick a box to document that a “medical review” had occurred.
Mr B ticked the box, despite having had no discussions with the GP, and without recording the rationale for changes made to the recommendation generated by the software system’s algorithm.
It turned out the GP had not been receiving email notifications of the patient’s results being outside the normal range, generated automatically by the system, because the email address had been wrong.
In addition to the complaint about her husband’s treatment plan, the wife said that when she raised concerns with the pharmacy, the owner, “Mr C”, was “defensive” and “constantly interrupting”.
She said she felt “intimidated and bullied” at a time when she was still grieving.
Mr C had a different perspective and said he had attempted to “gather information on her concerns, determine the pharmacy’s involvement, and express empathy”.
Cooper said that although she was unable to reconcile these differences, it was clear Mrs A did not perceive Mr C’s approach as empathetic.
“I trust Mr C will reflect on his communication style and make adjustments when dealing with consumer complaints in future.”
She was critical of the pharmacy’s complaint process as there was no written acknowledgment of Mrs A’s concerns.
There was no follow-up outlining the results of the investigation, nor did they share any measures put in place to prevent a recurrence. Mrs A also did not receive an apology.
The Deputy Commissioner recommended the pharmacy provide Mrs A with a written apology, which they did.
The pharmacy initially increased staff training on how to manage INR results, and ensure they follow the parameters of the standing orders.
However, since July 2024, they no longer offer the testing programme.
The pharmacy told the HDC, “the stress of the HDC’s investigation, and the absence of the pharmacist involved led to its inability to provide the appropriate responses and affected Mr C and his team, forcing them to reconsider offering the service”.
Mr C said that as an owner, he needed to “trust that qualified and accredited pharmacists are competent in the services they provide and practice safely”.
The Deputy Commissioner said while she understood his decision, it was “a disappointing outcome for the region’s community”.
She made recommendations to the software provider, including suggesting a review of email contact details, and the review tick box system, to be more robust in ensuring oversight from a GP.
Mr B was found to have breached the Code of Health and Disability Services Consumers’ Rights.
Cooper said that should he return to New Zealand and reapply for a pracitising certificate, she recommends the Pharmacy Council of New Zealand consider whether a review of his competence is necessary.
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.