The Health and Disability Commissioner wants answers from Pharmac and a national MP is calling for an inquiry, after four people died following an epilepsy drug brand switch.
RNZ has learned two complaints have been laid with the Health and Disability Commissioner alleging Pharmac breached patient rights to be treated with respect, to make informed choices and to give consent.
"This matter raises significant issues and I will be following this up with Pharmac," commissioner Anthony Hill told RNZ. "It is important that patients have the information they need to make informed choices, including understanding the risks and benefits of treatment options."
Pharmac pulled funding from the Lamictal and Arrow brands of lamotrigine on 1 October and was switching up to 11,000 people to the generic version, Logem, in a bid to save $30 million.
Many patients had no idea their medicine was being changed until they looked at their pills, felt unwell, began having seizures or heard about the change from the media.
MedSafe warned Pharmac against the switch, saying it posed significant safety issues, but advised the drug buying agency that if it went ahead, all patients should see a GP before switching and vulnerable patients should see a specialist.
Pharmac rejected the specialist recommendation and was concerned about the idea of giving patients a lot of information. Minutes from one Pharmac sub-committee meeting read: "Members considered that there was a risk of causing unnecessary anxiety about the change if too much emphasis was placed on the change and that caution should be taken with the amount of information provided to patients upfront."
Four deaths and 50 adverse reactions have been reported to the Centre for Adverse Reactions Monitoring over suspicions they were linked to the brand switch.
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Following reports of the deaths and under pressure from Epilepsy New Zealand, Pharmac backed down on the brand switch on Friday, announcing it would make it easier, in most circumstances, for people to obtain funding to stay on their preferred medicine. They could do this by talking to their doctor and applying via the exceptional circumstances process.
Pharmac has received 409 applications, 309 of which have been received since the agency's announcement on Friday. Pharmac said it had brought in extra resource to process them.
But the U-turn has not stopped the questions. National's health spokesperson Michael Woodhouse, who was previously restrained in his criticism of Pharmac's handling of the switch, is now calling for a full ministerial inquiry into the decision.
"They should have nothing to fear from an inquiry, but the reversal and the number of adverse events that we have heard about since October 1 certainly makes me think that the public are owed an explanation about the original decision and the change in that decision."
Mr Woodhouse is also questioning whether aggressive brand switches - where branded drugs are often replaced with generics - have been forced on Pharmac through lack of funding.
"They are being sweated financially and I think they're being forced into making cost saving decisions that, maybe, with greater resourcing they would have been able to find other priorities for that investment."
Arabella Gubay, who has a four-year-old daughter with epilepsy and has been an advocate for patients forced to switch brands, said Pharmac chief executive Sarah Fitt and the agency's board needed to resign.
"I think it's time for them to go. If this was a business, a company, ignoring the advice of a safety regulator, and pushing forward with a risky decision and four lives were potentially lost, and hundreds of lives were ruined, they would stand down."
Documents obtained under the Official Information Act show that prior to the brand switch, Pharmac thought it could use the lamotrigine change to research the "nocebo effect" - when a patient suffers side effects brought on by a perception their medicine is inferior.
Pharmac said it would "consider futilising the lamotrigine brand change as an opportunity to get real world experience on whether counselling on the nocebo effect alters the acceptance of a brand change using lamotrigine as the pharmaceutical for this research".
Epilepsy New Zealand chief executive Ross Smith said he was aware of complaints to the Health and Disability Commissioner over the lack of information given to patients and believed there would be more.
"People feel that their rights under the under the act have been breached and one of those is about consent," he said. "We're not surprised there's a lot of very, very upset and angry people in the epilepsy community about how this has been handled."
Pharmac said it could have done more to reassure and inform people about Logem and would be looking at how it could work more closely with prescribers.
But the agency said it had taken precautions ahead of the switch, including offering resources to health professionals, making leaflets that could be given to patients, and creating an exceptional circumstances process to allow people to apply to remain on their original medication if they had good reason to.
The agency stressed Logem worked in the same way as the Arrow and Lamictil brands of lamotrigine for most people, and patients should not stop taking it. If people had concerns, they should speak to their prescriber about options.