Heartbroken, scared and angry: those are some of the reactions to the findings of the chief coroner who has ruled the deaths of six people were not linked to a recent epilepsy medication change.
Andre Maddock with partner Nadia Jooste and their then 18-month-old son Lucas. Photo: Supplied.
Judge Deborah Marshall was not able to confirm a switch to the lamotrigine brand Logem caused the deaths, although could not rule it out as a background factor for two of them.
As such no recommendations were made.
Arabella Gubay, a patient advocate whose daughter has epilepsy, was furious.
"I'm absolutely shocked and heartbroken that the coroner was looking for 100 percent certainty that the brand switch alone had caused these deaths, and in the absence of finding that, she's made no recommendations whatsoever for a system that's clearly in crisis."
She called it a wasted opportunity and was terrified it would embolden Pharmac to switch brands again when the tender was up for renewal next year.
"I'm really terrified ... there were over 200 families whose loved ones were harmed by this. We know that at least 11 people died after switching drugs and only six of those were looked at by the coroner.
"Something has gone seriously wrong and the coroner's findings don't seem to reflect the gravity of what's happened."
Arabella Gubay with her son Marlowe and daughter Matilda, who has epilepsy. Photo: Supplied
She said other coroner's reports made recommendations in the absence of an absolute cause of death and, in this case, the families of the deceased had been let down.
"The death rate in the year after the switch trebled and the incidents of adverse reaction reports went up 30 times ... something has gone seriously wrong here."
In the months leading up to his death 31-year-old father-of-one Andre Maddock became sluggish and tired and told his partner, colleagues and doctor he was not feeling well.
His partner Nadia Jooste believed that was a result of switching to the Logem brand of medication, and also believed it was the switch that caused his fatal seizure a week before Christmas in 2019.
"His health deteriorated immensely soon after he started taking the new medication and it was a domino effects of events from there."
The coroner did not rule out the brand switch for Maddock's cause of death, but said the fatal seizure could be attributed to a number of things.
Andre Maddock with son Lucas. Photo: Nadia Jooste
Jooste said she knew deaths from epilepsy were complex but she felt Maddock's had been shelved in the too-hard-basket.
"It was a hard one to swallow. It almost seemed like it was in the too-hard-basket to dig a little bit deeper, but you just have to take it as it comes."
When Pharmac first proposed funding only Logem - a generic brand of the original product Lamictal - Medsafe advised against it.
It said, in its submission, if a switch was to happen patients should be reviewed first by their GP and counselling should be available.
It also said all patients should be followed up to check they were coping with the change.
An internal Pharmac memo noted 10,700 people would have to switch and there was a risk that if adverse effects happened, they would be linked to the brand switch.
Regardless, the change went ahead from October 2019.
Epilepsy New Zealand accepted the findings that the deaths were not caused by the brand switch but its chief executive Ross Smith maintained Pharmac went against best practise when it chose to forge ahead with the funding change.
"People should never have been switched their brands of a drug like lamotrigine at the pharmacy counter with no advice, no warning and no one communicating with them."
He was hopeful that, despite no formal recommendations, the report would lead to changes.
The coroner did make several observations, including criticism over communication to patients about the switch.
None of the six were told about special funding which meant they could have applied to stay on their original product, and only one was told there could be adverse effects from switching brands.
Jooste believed, had Andre's doctors, the pharmacists and Pharmac managed the switch better, he might still be alive.
"I do believe that if all the boxes were ticked and if they looked at absolutely everything, we would be having a different story right now."
She was disappointed with no formal recommendations, but was hopeful the report would be widely read by GPs and pharmacists who would do things differently the next time there was a brand change.
In a statement Pharmac accepted that not all patients received the required information.
Operations director Lisa Williams said it would be working with the Ministry of Health to improve how information was shared and to clarify who was responsible for passing this on to patients.
"This is a joint project that will also include the Medical Council, the Pharmacy Council and the Royal New Zealand College of General Practitioners."
"We offer our deepest condolences to the families and friends of Ricky Blackler, Reuben Brown, Krystle Loye, Andre Maddock, William Oliver, and Jessica Reid.
"I attended every day of the inquest and listened to all evidence shared. The strength of the families of those who passed away was inspiring and I applaud them for taking part," Williams said.
The coroner also made the observation that a national dispensing database, available to all pharmacists, would allow them to keep track of what brand of medication patients had been prescribed.
People taking Logem are being advised to continue to do so and if they have any concerns to talk to their doctor.
In a statement to RNZ, chief coroner Judge Marshall said: "I acknowledge some concerns with my findings in the epilepsy joint inquiry, and urge people to read in its entirety to understand the conclusions.
"While the evidence does not clearly link the brand switch to the seizures that led to the deaths, some useful observations have arisen during the inquiry.
"These include the need for an improvement in communication between health professionals and epilepsy patients, the benefits of establishing a national dispensing database available to all pharmacists, and the lack of a formal system in New Zealand to comprehensively monitor therapeutic equivalence between different brands of drugs.
"My thoughts go out to the families of the deceased at this time."