'For jet lag and insomnia': Psilocybin to be prescribed, melatonin to be sold over-the-counter
Psilocybin will still be an "unapproved medicine" but will be able to be granted under the authority of one specific highly experienced psychiatrist.
Melatonin is a natural hormone that helps induce sleep, and is used to treat insomnia and jet lag, but has been classified as a prescription-only medicine in New Zealand.
It will be available in pharmacies as pills up to 5mg in packs with up to 10 days' supply, or pills up to 3mg. "Modified release doses" - pills, capsules, gels and medical devices which allow the drug to be administered over a specific period - could also be available with dosages of up to 2mg.
No specific date has been set for when the changes will take effect.
Associate Health Minister David Seymour announced the decisions on Wednesday afternoon, noting they were made by MedSafe rather than politicians.
"Certainly I've discussed with some of them ... some of them were very enthusiastic about the melatonin but ultimately they respect that it's a technical decision for MedSafe."
He said melatonin would become available once manufacturers began to export it to New Zealand.
"You'll be able to go to any pharmacy and buy melatonin for jet lag and insomnia just as soon as it's available over the counter in New Zealand. Part of the purpose of my announcement today is to call on the melatonin manufacturers of the world to apply to bring their products into our country," Seymour said.
"When we did this with pseudoephedrine, it was a matter of months before products were on the shelves and I hope we can beat that record.
"Kiwis shouldn't be left counting sheep or desperate for options when other countries are already using these medicines. The government is committed to putting patients first ... this is a commonsense decision that will make melatonin more accessible in New Zealand than in many other countries."
The change for psilocybin was a huge win for people with depression who had tried everything else, Seymour said.
"If a doctor believes psilocybin can help, they should have the tools to try. The psychiatrist involved has previously prescribed psilocybin in clinical trials and will operate under strict reporting and record-keeping requirements."
He said it would initially only be available from one specific psychiatrist, but he hoped more would apply.
"Psilocybin is a medicine that can treat untreatable depression. It was first researched in the 1950s and '60s and more recently there's been extensive research and approvals by the FDA in the United States to be able to use these types of medicines.
"Fair to say it's been driven by people in the profession - there's a lot of people very passionate about this because untreatable depression's an awful thing and there are clinicians who say there's stuff happening in the rest of the world and we need to be part of it."
He had never taken either of them, nor pseudoephedrine.
"No. No I have not inhaled melatonin but maybe I will. I've had some recent issues with jet lag of my own so hopefully in the future I'll be able to," Seymour said.
"I used to go mushroom hunting with my dad as a very small kid, but I don't think we found any."
The melatonin changes were confirmed in regulations gazetted by Medsafe group manager Chris James.
The psilocybin changes were not yet gazetted, but it will mark the first time psilocybin will be legally available in New Zealand outside of clinical trials.
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RNZ News
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Two-month-old Bellamere Arwyn Duncan's death 'must be a turning point', says pharmacist
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"For years, community pharmacies have grappled with operating under this fundamentally flawed funding system, marked by chronic underinvestment and relentless workload pressures. Skilled staff are increasingly difficult to retain, and experienced pharmacists are burning out or leaving the profession altogether. The very people relied upon to be the final checkpoint before a medicine reaches a patient are now overstretched, under-resourced, and unsupported." CAPTION: Bellamere Duncan's parents were given an adult dosage of phosphate by the pharmacy. Photo: Supplied Wong said in healthcare there were multiple layers of safeguards that were meant to save an error from happening. "But when there are gaps in every layer, caused by workload pressures, fatigue, underinvestment or broken systems and those gaps align, the error breaks through." Pharmacists were being asked to interpret complex prescriptions, perform clinical calculations, and provide personalised counselling, often while working under intense pressure and tight deadlines, she said. "In Bellamere's case, it appears the pharmacist had to calculate a specialised paediatric dose and explain a precise paediatric-dosing schedule to the whānau. This is work that requires expertise, care, and time, and yet the pharmacy was reimbursed less than the cost of a cup of coffee. That's not just unsustainable. It's unsafe." She said Bellamere's death "must be a turning point". "It's not just about fixing one pharmacy or one process, it's about fixing the system around pharmacy. "That means investing in safety, funding time to think, check and counsel, and designing a workforce strategy that ensures every community has access to skilled, supported pharmacists." [h ]The medication error In their email to Bellamere's parents the owner of the Manawatū Pharmacy included a summary of what happened. The owner said the pharmacy's standard dispensing process involved intern pharmacists entering each prescription into the dispensary computer. The pharmacy used a dispensing system called Toniq. A technician would then use the information in Toniq and the prescription to identify the medication and put the correct amounts in containers. The labels were then printed out and placed in a basket with the original prescription and the medication. A registered pharmacist would then check the prescription, the labels and the medication itself before it was given to the patient. The owner said the pharmacy received the prescription by email on 1 July from Palmerston North Hospital. The prescription was entered into Toniq by an intern pharmacist. 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She put the original prescription, labels and the medication in a basket on the dispensing bench for the registered pharmacist to check. "Unfortunately, the original label and the warning label was not kept with other items." The registered pharmacist who carried out the final check did not pick up that the medication was for an infant, the owner said. "In addition, it was not identified that this was a new medication. The fact that the warning label was not retained contributed to this error." The owner said the intern pharmacist had been suspended by the Pharmacy Council. The registered pharmacist had taken leave and then resigned. "This person does not intend to return to work in the immediate future," the owner said. The pharmacy was "urgently re-evaluating our dispensing and checking protocols and reinforcing safety checks at every stage". "We are actively recruiting additional staff to help manage our workloads. In addition, we are engaging an independent pharmacist from outside the Manawatū region to conduct a full review of our dispensing procedures and provide further guidance on system improvements." The owner said the pharmacy was "fully co-operating" with investigations being carried out by MedSafe, the Pharmacy Council and the police on behalf of the coroner. The owner signed off the email with "heartfelt apologies and regret". Bellamere's parents Tempest Puklowski and Tristan Duncan said after reading the email they did not blame the intern pharmacist for what happened. "My first initial reaction after reading it was I felt really bad for the intern," Puklowski said. "I don't blame him for the mistakes. I blame whoever was meant to be looking over his shoulder, whoever put him in that responsibility and just left him to it." Puklowski said it should have been picked up that the medication was for a baby. "It just seems like there's something lacking there that could have avoided it being missed or messed up," she said. Duncan said the system "needs to be better". Tempest said she remained "frustrated and angry" about her daughter's death. "It's just an endless sort of questioning of how and where it went wrong, to the point of, yeah, how could it have been avoided? "Obviously, those questions don't do much now, which then brings on the sadness of just knowing that she could still be here if these things were pulled up on initially, if maybe the intern wasn't left just to do the job by themselves. Or if you know something else is put in place, we would've never even gotten it and then we wouldn't be beating ourselves up for giving it to her." Duncan said the past two weeks since Bellamere's death had been "really hard". "Just empty is the only word that really comes to mind," he said. "It's unfair. Just stolen away by a singular document. That's what it comes down to." Puklowski said the couple "don't really know what to do with ourselves really". They were now waiting to see what happened with the multiple investigations that are under way. "I want things to change," Duncan said.
Scoop
5 hours ago
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8 hours ago
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Three staff involved in pharmacy error that led to two-month-old's death
'It just makes no sense that he was left to make up these prescriptions without having someone there with him making sure that he is filling out each one correctly.' RNZ earlier revealed Bellamere Arwyn Duncan died at Starship Hospital on July 19. A Manawatū pharmacy dispensed an adult dosage of phosphate to the 2-month-old's parents. A coroner's preliminary opinion is that she died from phosphate toxicity. The revelations have prompted the Ministry of Health and Health New Zealand to 'urgently' undertake a joint review into the incident with Medsafe visiting the pharmacy to ensure it was safe to continue operating. The Pharmacy Council, which is also investigating, said it was 'clear that an awful error has occurred'. On Friday, the owner of the Manawatū pharmacy emailed Bellamere's parents with a summary of what happened. 'Once again, we recognise the immense impact of our error on you and your family,' the email began. Bellamere Duncan's parents were allegedly given an adult dosage of phosphate by the pharmacy. Photo / Supplied The owner said the pharmacy's standard dispensing process involved intern pharmacists entering each prescription into the dispensary computer. The pharmacy used a dispensing system called Toniq. A technician would then use the information in Toniq and the prescription to identify the medication and put the correct amounts in containers. The labels were then printed out and placed in a basket with the original prescription and the medication. A registered pharmacist would then check the prescription, the labels and the medication itself before it was given to the patient. The owner said the pharmacy received the prescription by email on July 1 from Palmerston North Hospital. The prescription was entered into Toniq by an intern pharmacist. 'This person unfortunately misread the prescribed dosage and entered the prescription dose as '1 tablet twice daily' rather than '1.2 mmol twice daily',' the owner said. The Toniq system then generated an original label for the prescription. 'This includes a warning label with the patient's age, if they are under 18 years old, and if the patient has not been prescribed the medication before. 'The second warning prompts the checking pharmacist to counsel [speak with] the patient or their caregiver about how to take the medication.' The product was supplied in tubes of 20 tablets. The trainee technician printed out three further labels. They were to be placed on the three tubes that were being dispensed. 'This was the trainee technician's first time handling a phosphate product. She was also unfamiliar with the mmol dosage. She did not notice the dosage error as a result. She put the original prescription, labels and the medication in a basket on the dispensing bench for the registered pharmacist to check. 'Unfortunately, the original label and the warning label was not kept with other items.' The registered pharmacist who carried out the final check did not pick up that the medication was for an infant, the owner said. 'In addition, it was not identified that this was a new medication. The fact that the warning label was not retained contributed to this error.' The owner said the intern pharmacist had been suspended by the Pharmacy Council. The registered pharmacist had taken leave and then resigned. 'This person does not intend to return to work in the immediate future,' the owner said. The pharmacy was 'urgently re-evaluating our dispensing and checking protocols and reinforcing safety checks at every stage'. 'We are actively recruiting additional staff to help manage our workloads. In addition, we are engaging an independent pharmacist from outside the Manawatū region to conduct a full review of our dispensing procedures and provide further guidance on system improvements.' The owner said the pharmacy was 'fully co-operating' with investigations being carried out by Medsafe, the Pharmacy Council and the police on behalf of the coroner. The owner signed off the email with 'heartfelt apologies and regret'. 'I don't blame him' Speaking to RNZ on Monday, Bellamere's parents, Tempest Puklowski and Tristan Duncan, said after reading the email they did not blame the intern pharmacist for what happened. 'My first initial reaction after reading it was I felt really bad for the intern,' Puklowski said. 'I don't blame him for the mistakes. I blame whoever was meant to be looking over his shoulder, whoever put him in that responsibility and just left him to it.' Puklowski said it should have been picked up that the medication was for a baby. 'It just seems like there's something lacking there that could have avoided it being missed or messed up.' Duncan said the system 'needs to be better'. Tempest said she remained 'frustrated and angry' about her daughter's death. 'It's just an endless sort of questioning of how and where it went wrong, to the point of, yeah, how could it have been avoided? 'Obviously, those questions don't do much now, which then brings on the sadness of just knowing that she could still be here if these things were pulled up on initially, if maybe the intern wasn't left just to do the job by themselves. Or if you know something else is put in place, we would've never even gotten it and then we wouldn't be beating ourselves up for giving it to her.' Duncan said the past two weeks since Bellamere's death had been 'really hard'. 'Just empty is the only word that really comes to mind,' he said. 'It's unfair. Just stolen away by a singular document. That's what it comes down to.' Puklowski said the couple 'don't really know what to do with ourselves really'. They were now waiting to see what happened with the multiple investigations that are under way. 'I want things to change,' Duncan said. In a statement to RNZ on Friday, Pharmacy Council chief executive Michael Pead said whenever the Pharmacy Council received a notification of an incident, it began an 'initial inquiry' to assess the situation. 'At the start of any inquiry, our focus is on ensuring there is no further risk to public safety. There are many ways to achieve this, including suspension of the pharmacist or pharmacists involved or a voluntary agreement that the individual/s will stop working.' In order to ensure the inquiry into Bellamere's death was 'fair and thorough', and to avoid pre-empting any findings, the council could not provide any further details. 'We can confirm that the Pharmacy Council is comfortable that immediate steps have been taken to prevent the risk of further harm while the enquiry is ongoing.' The medication While in hospital, Puklowski gave Bellamere her drops for Vitamin D. Nurses also administered her phosphate. When they left hospital, they were given some Vitamin D in a little bottle, and a prescription for iron and Vitamin D. The following day, Duncan went to a Manawatū pharmacy with the prescriptions. He was given the iron, but said the pharmacy refused to give the Vitamin D as the staff thought the dosage was 'too high for her age and her weight'. The staff said they would call the neonatal unit and follow up. A few days later, Puklowski received a call from the unit to organise a home care visit. During the call, she was asked if she had any concerns, and Puklowski asked if they had been contacted about the Vitamin D. They had not, and said they would follow up and rewrite the prescription along with a prescription for phosphate. A day after the phone call, on July 2, Duncan went to the pharmacy to collect the medication and came home with just the phosphate. Unbeknown to the parents they had been given an adult dosage of phosphate. The label on the medication directed them to dissolve one 500mg tablet of phosphate twice daily in a glass of water. That evening, they gave Bellamere her first dose of the medicine in her formula water. They would give her three bottles in 24 hours as was recommended. The couple noticed in that period that her eating was off, and thought she was 'extra gassy', Puklowski said. 'She was still feeding fine. She just wasn't maybe going through a whole bottle compared to what she was,' she recalled. Then, the day after she got her first dosage, Bellamere suddenly stopped breathing. Bellamere was taken to hospital and rushed to the emergency department. Once she was stabilised, she was taken to the neonatal unit where she stayed overnight before she was flown to Starship Hospital. The couple had taken a bottle of the medicine with them to Starship Hospital. She gave it to the staff who saw that they had been given an adult dose. The staff then requested the original prescription which confirmed the script had been written with the correct dosage, but somehow the pharmacy had given the wrong dosage, Puklowski said. 'I keep thinking about how much she ended up having and it just makes me feel sick.' Tragically, Bellamere died at Starship Hospital on July 19. On Wednesday, a Ministry of Health spokesperson told RNZ there were a number of investigations under way. 'Medsafe has completed an urgent assessment and is comfortable there is no immediate patient safety issue at the pharmacy. Medsafe will continue to work with Health New Zealand and these findings which will inform the information provided to the coroner. Medsafe is also sharing information with the Pharmacy Council. 'Once these reviews are completed, we will be able to look at next steps.' Health Minister Simeon Brown earlier told RNZ he raised the incident with the Director-General of Health as soon as he was made aware. 'She assured me that there would be an investigation undertaken by both the Ministry of Health and Health New Zealand. That investigation is under way. 'I am advised that this incident has led to Medsafe undertaking an urgent assessment of the pharmacy. A further investigation is being undertaken by the Pharmacy Council, and the death is also the subject of a Coroner's inquest.' Health agencies would provide information to the coroner as needed to support the inquest. 'It is important that the reviews are undertaken, and that the circumstances that led to this incident are understood. I expect that these investigations may propose recommendations, and that these will be reviewed once reports are complete.' - RNZ
