Associate Professor Betty B. Chaar
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[post_content] => Last year, it was reported that Australian poisons hotlines received almost 1,500 calls about child ingestion of melatonin.
In Western Australia, calls to the poisons hotline about melatonin have nearly doubled from 175 in 2018 to 322 as of August this year, across all age groups – mostly related to gummy products.
In the same month, online health retailer iHerb suspended the sale of melatonin supplements in Australia.
But there are retailers selling these products online, said Sarah Blunden, Professor and Head of Paediatric Sleep Research, CQUniversity Australia.
‘There are a lot of other companies from the United States that sell it,’ she said.
AP investigates what melatonin toxicity looks like, why so many kids are taking it and how pharmacists can help to ensure safe and effective use of medicines for sleep.
Why have calls to poison hotlines about melatonin gummies doubled?
From Prof Blunden’s perspective, the drivers are straightforward.
‘They are not regulated, they've got sugar in them and they taste good,’ she said. ‘Children love them and parents think they're natural. And without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.’
Independent analyses of melatonin gummies have shown large discrepancies between labelled and actual melatonin content.
‘Two research groups – one in Canada and one in the UK – found some had no melatonin at all, and some had up to 400% of what was on the label,’ Prof Blunden said.
‘without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.'
Professor Sarah Blunden
The Therapeutic Goods Administration (TGA) recently conducted its own review, reporting significant variability between products. For example, The Smurfs Kids Gummies Melatonin 1 mg contained 155–170% variation from the labelled amount.
Endogenous melatonin biology is also highly individual, with retinal light-sensing pathways modulating secretion with wide inter-child variability, and there’s no practical clinical assay to map a child’s secretion pattern outside of a research study.
‘A child who’s particularly light-sensitive might have higher endogenous levels at a certain time, and if they then take several gummies, toxicity could be faster and worse,’ she said. ‘That’s why, when they present to ED, it gets labelled as an “overdose,” but we don’t exactly know what that means.’
What are the symptoms of melatonin toxicity?
Common reported effects of melatonin toxicity include headache, dizziness, nausea, and drowsiness.
Children can also experience central nervous system (CNS) effects, including extreme sedation, nightmares and vivid dreams.
‘Parents might see a very drowsy or unwell child and seek care, or they may witness ingestion of multiple gummies and go to the emergency department (ED),’ Prof Blunden said.
Sometimes, toxicity appears fatal.
‘In a review we conducted, two or three deaths of children who had ingested melatonin were reported, but they are not included in many systematic reviews – including ours – because we couldn’t confirm that melatonin was the cause,’ she said.
‘I also found a paper reporting seven infants who died with high levels of exogenous melatonin in the blood, but causation wasn’t established. It’s unknown – and that is really scary.’
Why are so many kids taking melatonin?
Sleep is increasingly recognised as a crucial factor in community health, said Prof Blunden.
‘Traditionally the pillars were healthy eating and exercise,’ she said. ‘But in the last 20 years, sleep has edged in as equally important.’
This shift is especially relevant for Australian parents, who have long encouraged children to sleep alone.
‘Because we've always had that expectation, there have always been issues around children who don't want to sleep by themselves,’ Prof Blunden said.
Controlled crying was previously the standard response for children resisting independent sleep, but now, behavioural sleep medicine recognises melatonin as another option.
‘The increase in dual-working families, the need for children to sleep independently, the broader community conversation about sleep, and greater availability of melatonin for children who are not typically developing has led to the use of melatonin sharply rising,’ she said.
‘I’m on the board of the International Pediatric Sleep Association. And at the last two conferences, physiologists and clinicians said melatonin prescriptions and use have skyrocketed over the last 5 years,’ Prof Blunden said.
Who is melatonin indicated for and at what dose?
In Australia, melatonin is indicated for children aged 2–18 years with neurodevelopmental disorders including:
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[post_content] => New research has indicated that adolescents prefer seeking reproductive health services from pharmacists, but there are barriers to accessing care that must be addressed.
Adolescents face unique and at times greater challenges when accessing sexual and reproductive health (SRH) services than adults, including stigma, limited knowledge, out-of-pocket costs and restrictive legislative frameworks, said SPHERE Research Fellow and lead author of the study Dr Anisa Assifi.
‘Community pharmacies offer a promising, accessible alternative, but only if pharmacists are equipped and supported to meet adolescents’ needs,’ she said.
What are the benefits of pharmacy for SRH?
The review pulled on 25 years’ worth of published research in high-income countries with similar healthcare settings and approaches to care, including Australia and the United States.
Overwhelmingly, adolescents felt they received detailed, high-quality, trustworthy information about contraceptive products from pharmacists.
‘What we found is that adolescents find pharmacy a really accessible and acceptable source of information, and really easy to get into,’ Dr Assifi said. ‘They trusted the pharmacist's knowledge.’
Across Australia, reproductive health is an area pharmacists are increasingly involved in. With scope of practice broadening, pharmacists have been prescribing emergency contraception, resupplying the oral contraceptive pill and dispensing mifepristone/misoprostol (MS-2 Step).
At the same time, barriers to general practice access have increased; declines in Medicare bulk billing rates coupled with long wait times to see a GP have made pharmacy a more favourable setting for seeking reproductive care,
‘You might wait 5–10 minutes to talk to a pharmacist, depending on the pharmacy and location,’ she said.
Despite efforts to improve sex education in schools, Dr Assifi said students may still be missing the information they need.
‘It’s an amazing opportunity for adolescents to talk to a health professional and get accurate information they may not be getting elsewhere.’
What are the barriers to care?
It’s not all roses, with adolescents still frequently experiencing embarrassment and judgement from pharmacists and pharmacy staff when seeking SRH services, alongside stigma related to being sexually active, Dr Assifi said.
‘Many went in expecting to be judged, so it was both their experience and perception that contributed to them feeling judgement.’
Adolescents also questioned whether pharmacists would maintain confidentiality, and were concerned that the layout of large, high-volume pharmacies could make private conversations at the counter difficult.
‘What did come out was that the difference between pharmacy and family planning or GP clinics is that you're in a consultation room, so confidentiality is more maintained,’ she said.
‘False barriers’ were also identified.
‘Sometimes pharmacists were not up to date with guidelines or regulations (e.g. age of access, parental consent, prescription requirements) or they created unnecessary hurdles – saying they didn’t stock a product, or that parental consent was required,’ Dr Assifi said.
‘So even though they were trusted, there were still some issues that would come up where they would block that access.’
When pharmacists were empathetic and non-judgmental, including adjusting their body language and lowering their tone of voice, this made a significant difference to patient experience.
‘Some pharmacists were very good at this and recognised the importance of not being judgmental or making assumptions when interacting with adolescents, recognising that they need to be treated with respect and empathy,’ she said.
What’s pharmacists' perspective?
Most pharmacists found it acceptable to provide contraception to adolescents, including emergency contraception, and felt comfortable counselling this age cohort. However, their acceptability of providing emergency contraception declined as adolescents’ age decreased.
‘Pharmacists felt more comfortable interacting with older adolescents and were looking for further training and support about how to provide appropriate care to an adolescent that meets their needs, including how to interact with them through those discussions and encounters.’
Dr Assifi said more research was required to understand the training and support mechanisms that would better enable pharmacists to provide adolescent-friendly care.
‘Pharmacists, along with any other health professionals, have their own personal belief systems, and we did find in quite a few studies that this made them unwilling or unhelpful to provide care,’ she said.
‘So we need to ensure that if one pharmacist is uncomfortable, another is available to provide the service so adolescents receive appropriate information and sexual and reproductive healthcare.
‘I think it's an injustice to the young person if we can't provide them with the appropriate information and support required of an SRH that they've come to you as a health professional seeking.’
What needs to be considered?
PSA’s Code of Ethics states that in the instance of conscientious objection, pharmacists must ‘inform the patient when exercising the right to decline provision of certain forms of health care based on the individual pharmacist’s conscientious objection, and in such circumstances, appropriately facilitate continuity of care for the patient’.
‘What’s important is ensuring adolescents don’t feel judged or embarrassed when seeking information or services, and that they still receive the care they need,’ Dr Assifi agreed.
‘Adolescent-friendly care isn't simply about mannerisms and the way a pharmacist interacts and talks with a young person. Pharmacy staff and dispensing technicians also need to be involved in how to have these conversations.’
The pharmacy environment also has a role to play. Consultation rooms should be the standard setting for conversations about contraception to take place.
‘The availability of private consultation rooms is a great step forward, and being able to offer that space to a young person to have those conversations in – whether they choose to take it or not – is really important.’
Do not use a paper checklist!!
SPHERE is currently working on further research to identify the impact of the paper form and checklist still used by some pharmacists when supplying emergency contraception.
While the checklist has been found to be a barrier to access, this is likely even more pronounced in adolescents.
‘We don't want young people to feel like their personal information is being taken and they don’t know what's being done with it,’ Dr Assifi said.
‘Alternative ways where a young person can signal or provide that information so it doesn't feel as jarring as saying it across the dispensing counter should be considered.’
PSA’s Non-prescription medicine treatment guideline: Emergency Contraception, found in the Australian Pharmaceutical Formulary and Handbook or PSA Resource Hub, advises pharmacists to ‘Gather patient information in a confidential, respectful and non-judgemental manner. Do not use a written checklist or form because the patient (or third party) can perceive it as a barrier to care’.
[post_title] => Stigma hinders adolescent contraceptive care
[post_excerpt] => Adolescents prefer seeking contraceptive care from pharmacists, says new research. But there are barriers to access that must be addressed.
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[title_attribute] => Stigma hinders adolescent contraceptive care
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[post_content] => When standard needles for vaccination shortchange patient immunity.
Vaccines are most effective when administered using correct technique – this includes injection site positioning, angle of the needle and needle length.
Most vaccines currently available are administered as intramuscular (IM) injections. With the breadth and depth of pharmacist-administered vaccination growing, it’s timely that pharmacists double check their depth.
What needle size should I use for IM injections?
A 25 mm needle is recommended for most people, including from infants to older adults.
There are two exceptions:
For very large or obese people, a longer needle of 38 mm length is recommended.1 With 32% of the Australian population being obese,2 around a third of vaccines likely should be administered using longer needles.
If a needle isn’t long enough, or used at an incorrect angle, the needle may not fully penetrate the deltoid fat pad and therefore be inadvertently administered subcutaneously.
For most vaccines, this risks a higher rate of local adverse events, such as redness, swelling, itching and pain.1,3 This is particularly noted with aluminium-adjuvanted vaccines (such as hepatitis B, dTpa or dT vaccines).2
Concerningly, it is also recognised as reducing immunogenicity.2 For example, Rabipur Inactivated Rabies Virus Vaccine (PCECV) is considered invalid if given subcutaneously.2
It’s hard to tell. There is limited contemporary data – and no Australian data was identified when researching this article.
However, overseas studies suggest 38 mm needles are drastically underutilised4 – with one US study suggesting the wrong length needle was used 75% of the time when administering vaccines to obese people.5
Consult the Australian Immunisation Handbook.1 The ‘Vaccine injection techniques’ section contains advice on inadvertent subcutaneous injection of intramuscular vaccines.
Error reporting to indemnity insurers and state/territory health department systems may also be required.
In the example of the Rabipur rabies vaccine, as a subcutaneous dose is invalid, the dose must be repeated – an undesirable situation given the cost and time-critical regimen for rabies vaccines.
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[post_content] => Tomorrow (Thursday 25 September 2025) is World Pharmacists Day – an annual milestone for the past 16 years that celebrates the pharmacy profession worldwide and amplifies its essential contribution to health systems.
The theme for this year’s World Pharmacists Day, as chosen by the International Pharmaceutical Federation (FIP) is ‘Think Health, Think Pharmacist’.
The theme reflects the vital role of pharmacists both in Australia and internationally, and the need to routinely embed them across all areas of the health system.
Ahead of the day, FIP President, Australia’s Paul Sinclair AM MPS said ‘Think Health, Think Pharmacist’ is more than a campaign – it’s a call to action.
‘Pharmacists are crucial to the safe use of medicines, chronic disease management and public health delivery. Investing in them is investing in stronger health systems,’ he said.
‘As the world faces rising healthcare demands, economic uncertainty, and growing threats like antimicrobial resistance and climate change – pharmacists remain key to ensuring safe, cost-effective, and accessible care.
‘From improving health literacy and delivering vaccinations to ensuring the safe use of medicines, pharmacists are an indispensable part of our health systems, especially in underserved communities.’
Getting involved in World Pharmacists Day
Australian pharmacists can get involved by engaging patients, politicians and stakeholders in conversation. Pharmacists can also champion the profession through social media, including:
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[post_content] => As US regulators flag new warnings, the Therapeutic Goods Administration (TGA) and Australian experts have weighed in on what the evidence shows.
Paracetamol has widely been considered the safest analgesic to relieve fever and pain during pregnancy. Fever higher than 38.9°C for at least 24 hours during pregnancy is linked to higher chances of miscarriage, preterm birth, stillbirth and certain malformations including neural tube defects like spina bifida.
Yet the US Food and Drug Administration (FDA) announced it intends to add a warning label to the medicine, citing a ‘possible association’ between autism in children and the use of acetaminophen (paracetamol) during pregnancy.
This proposed regulation change, along with updated advice given to the American Academy of Pediatrics among other medical groups, follows an announcement from the US President linking acetaminophen (Tylenol) (known as paracetamol in Australia) to autism – calling on pregnant women to avoid it.
Australia’s Chief Medical Officer Micahel Kidd has rejected claims about the use of paracetamol in pregnancy and the risk of developing ADHD or autism. So what are other experts saying?
TGA: ‘safe for use in pregnancy’
Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy, a spokesperson for the TGA told Australian Pharmacist.
‘The use of medications in pregnancy is subject to clinical, scientific and toxicological evaluation at the time of registration of a medicine in Australia,’ the spokesperson said.
‘Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed.’
Paracetamol is still the recommended treatment option for pain or fever in pregnant women when used as directed, the TGA said.
‘Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment.
The spokesperson said that the TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol.
‘When safety signals are identified for a medicine, they are subject to detailed clinical and scientific investigation to confirm that a safety issue exists, and if confirmed, what regulatory actions are most appropriate to mitigate the risk,’ the spokesperson said. ‘The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.’
Australia is not the only nation holding firm; international peer regulators, such as the UK Medicines and Healthcare products Regulatory Agency, continue to advise that paracetamol be used according to the approved Product Information.
In its 2019 review, the European Medicines Agency also determined that the available evidence on paracetamol’s effects on childhood neurodevelopment is inconclusive.
Is there any evidence linking paracetamol in pregnancy with autism?
Some systematic reviews have reported associations between paracetamol use in pregnancy and autism in children – usually prolonged, high-dose use that exceeds recommendations.
Of central interest to the US Government's claim is a 2025 systematic review which made the claim of ‘strong evidence of a relationship between prenatal acetaminophen use and increased risk of ASD in children’.
But the quality of these studies have been subject to significant critical review.
Professor Margie Danchin, a paediatrician and group leader of the Murdoch Children’s Research Institute’s Vaccine Uptake Group, refuted the evidence base, made up of observational studies, linking paracetamol to autism.
‘The cause of fever for the women in those studies is probably what caused the problems later on developmentally for the children, not the fact that they took Panadol for that fever.’
Additionally, Prof Danchin said many of the women who participated in these studies were asked several years postpartum whether they took paracetamol during pregnancy, further undermining accuracy.
More recent and robust studies contradict these claims and support the prevailing evidence that paracetamol is not causally linked to autism or ADHD, the TGA said.
Experts point to a Swedish cohort study as the most persuasive evidence on paracetamol and autism. Published last year, it analysed records for nearly 2.5 million children born between 1995 and 2019, identifying autism diagnoses and verifying whether mothers used paracetamol during pregnancy.
Crucially, the investigators conducted a sibling-comparison analysis, assessing pairs in which one child was prenatally exposed to paracetamol and the other was not. Because siblings share much of their genetics, household environment and maternal health influences, this approach helps isolate the impact of specific factors such as paracetamol.
In the largest study of its kind to date, no association was found between prenatal paracetamol exposure and autism.
Imparting safe and accurate information
Prof Danchin called the claim linking acetaminophen exposure in utero to autism ‘disinformation’.
‘At the moment, the biggest issue at play is trust,’ she said.
The danger of ‘repeatedly repeating myths’ is that it further entrenches them.
‘That sort of repetition becomes very sticky. People hear it all the time, and it becomes harder and harder to counter,’ Prof Danchin said.
However, health professionals should ensure the right messages get across, she said.
When counselling patients on paracetamol use in pregnancy, PSA has advised pharmacists to take the following approach:
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[post_content] => Last year, it was reported that Australian poisons hotlines received almost 1,500 calls about child ingestion of melatonin.
In Western Australia, calls to the poisons hotline about melatonin have nearly doubled from 175 in 2018 to 322 as of August this year, across all age groups – mostly related to gummy products.
In the same month, online health retailer iHerb suspended the sale of melatonin supplements in Australia.
But there are retailers selling these products online, said Sarah Blunden, Professor and Head of Paediatric Sleep Research, CQUniversity Australia.
‘There are a lot of other companies from the United States that sell it,’ she said.
AP investigates what melatonin toxicity looks like, why so many kids are taking it and how pharmacists can help to ensure safe and effective use of medicines for sleep.
Why have calls to poison hotlines about melatonin gummies doubled?
From Prof Blunden’s perspective, the drivers are straightforward.
‘They are not regulated, they've got sugar in them and they taste good,’ she said. ‘Children love them and parents think they're natural. And without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.’
Independent analyses of melatonin gummies have shown large discrepancies between labelled and actual melatonin content.
‘Two research groups – one in Canada and one in the UK – found some had no melatonin at all, and some had up to 400% of what was on the label,’ Prof Blunden said.
‘without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.'
Professor Sarah Blunden
The Therapeutic Goods Administration (TGA) recently conducted its own review, reporting significant variability between products. For example, The Smurfs Kids Gummies Melatonin 1 mg contained 155–170% variation from the labelled amount.
Endogenous melatonin biology is also highly individual, with retinal light-sensing pathways modulating secretion with wide inter-child variability, and there’s no practical clinical assay to map a child’s secretion pattern outside of a research study.
‘A child who’s particularly light-sensitive might have higher endogenous levels at a certain time, and if they then take several gummies, toxicity could be faster and worse,’ she said. ‘That’s why, when they present to ED, it gets labelled as an “overdose,” but we don’t exactly know what that means.’
What are the symptoms of melatonin toxicity?
Common reported effects of melatonin toxicity include headache, dizziness, nausea, and drowsiness.
Children can also experience central nervous system (CNS) effects, including extreme sedation, nightmares and vivid dreams.
‘Parents might see a very drowsy or unwell child and seek care, or they may witness ingestion of multiple gummies and go to the emergency department (ED),’ Prof Blunden said.
Sometimes, toxicity appears fatal.
‘In a review we conducted, two or three deaths of children who had ingested melatonin were reported, but they are not included in many systematic reviews – including ours – because we couldn’t confirm that melatonin was the cause,’ she said.
‘I also found a paper reporting seven infants who died with high levels of exogenous melatonin in the blood, but causation wasn’t established. It’s unknown – and that is really scary.’
Why are so many kids taking melatonin?
Sleep is increasingly recognised as a crucial factor in community health, said Prof Blunden.
‘Traditionally the pillars were healthy eating and exercise,’ she said. ‘But in the last 20 years, sleep has edged in as equally important.’
This shift is especially relevant for Australian parents, who have long encouraged children to sleep alone.
‘Because we've always had that expectation, there have always been issues around children who don't want to sleep by themselves,’ Prof Blunden said.
Controlled crying was previously the standard response for children resisting independent sleep, but now, behavioural sleep medicine recognises melatonin as another option.
‘The increase in dual-working families, the need for children to sleep independently, the broader community conversation about sleep, and greater availability of melatonin for children who are not typically developing has led to the use of melatonin sharply rising,’ she said.
‘I’m on the board of the International Pediatric Sleep Association. And at the last two conferences, physiologists and clinicians said melatonin prescriptions and use have skyrocketed over the last 5 years,’ Prof Blunden said.
Who is melatonin indicated for and at what dose?
In Australia, melatonin is indicated for children aged 2–18 years with neurodevelopmental disorders including:
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[post_content] => New research has indicated that adolescents prefer seeking reproductive health services from pharmacists, but there are barriers to accessing care that must be addressed.
Adolescents face unique and at times greater challenges when accessing sexual and reproductive health (SRH) services than adults, including stigma, limited knowledge, out-of-pocket costs and restrictive legislative frameworks, said SPHERE Research Fellow and lead author of the study Dr Anisa Assifi.
‘Community pharmacies offer a promising, accessible alternative, but only if pharmacists are equipped and supported to meet adolescents’ needs,’ she said.
What are the benefits of pharmacy for SRH?
The review pulled on 25 years’ worth of published research in high-income countries with similar healthcare settings and approaches to care, including Australia and the United States.
Overwhelmingly, adolescents felt they received detailed, high-quality, trustworthy information about contraceptive products from pharmacists.
‘What we found is that adolescents find pharmacy a really accessible and acceptable source of information, and really easy to get into,’ Dr Assifi said. ‘They trusted the pharmacist's knowledge.’
Across Australia, reproductive health is an area pharmacists are increasingly involved in. With scope of practice broadening, pharmacists have been prescribing emergency contraception, resupplying the oral contraceptive pill and dispensing mifepristone/misoprostol (MS-2 Step).
At the same time, barriers to general practice access have increased; declines in Medicare bulk billing rates coupled with long wait times to see a GP have made pharmacy a more favourable setting for seeking reproductive care,
‘You might wait 5–10 minutes to talk to a pharmacist, depending on the pharmacy and location,’ she said.
Despite efforts to improve sex education in schools, Dr Assifi said students may still be missing the information they need.
‘It’s an amazing opportunity for adolescents to talk to a health professional and get accurate information they may not be getting elsewhere.’
What are the barriers to care?
It’s not all roses, with adolescents still frequently experiencing embarrassment and judgement from pharmacists and pharmacy staff when seeking SRH services, alongside stigma related to being sexually active, Dr Assifi said.
‘Many went in expecting to be judged, so it was both their experience and perception that contributed to them feeling judgement.’
Adolescents also questioned whether pharmacists would maintain confidentiality, and were concerned that the layout of large, high-volume pharmacies could make private conversations at the counter difficult.
‘What did come out was that the difference between pharmacy and family planning or GP clinics is that you're in a consultation room, so confidentiality is more maintained,’ she said.
‘False barriers’ were also identified.
‘Sometimes pharmacists were not up to date with guidelines or regulations (e.g. age of access, parental consent, prescription requirements) or they created unnecessary hurdles – saying they didn’t stock a product, or that parental consent was required,’ Dr Assifi said.
‘So even though they were trusted, there were still some issues that would come up where they would block that access.’
When pharmacists were empathetic and non-judgmental, including adjusting their body language and lowering their tone of voice, this made a significant difference to patient experience.
‘Some pharmacists were very good at this and recognised the importance of not being judgmental or making assumptions when interacting with adolescents, recognising that they need to be treated with respect and empathy,’ she said.
What’s pharmacists' perspective?
Most pharmacists found it acceptable to provide contraception to adolescents, including emergency contraception, and felt comfortable counselling this age cohort. However, their acceptability of providing emergency contraception declined as adolescents’ age decreased.
‘Pharmacists felt more comfortable interacting with older adolescents and were looking for further training and support about how to provide appropriate care to an adolescent that meets their needs, including how to interact with them through those discussions and encounters.’
Dr Assifi said more research was required to understand the training and support mechanisms that would better enable pharmacists to provide adolescent-friendly care.
‘Pharmacists, along with any other health professionals, have their own personal belief systems, and we did find in quite a few studies that this made them unwilling or unhelpful to provide care,’ she said.
‘So we need to ensure that if one pharmacist is uncomfortable, another is available to provide the service so adolescents receive appropriate information and sexual and reproductive healthcare.
‘I think it's an injustice to the young person if we can't provide them with the appropriate information and support required of an SRH that they've come to you as a health professional seeking.’
What needs to be considered?
PSA’s Code of Ethics states that in the instance of conscientious objection, pharmacists must ‘inform the patient when exercising the right to decline provision of certain forms of health care based on the individual pharmacist’s conscientious objection, and in such circumstances, appropriately facilitate continuity of care for the patient’.
‘What’s important is ensuring adolescents don’t feel judged or embarrassed when seeking information or services, and that they still receive the care they need,’ Dr Assifi agreed.
‘Adolescent-friendly care isn't simply about mannerisms and the way a pharmacist interacts and talks with a young person. Pharmacy staff and dispensing technicians also need to be involved in how to have these conversations.’
The pharmacy environment also has a role to play. Consultation rooms should be the standard setting for conversations about contraception to take place.
‘The availability of private consultation rooms is a great step forward, and being able to offer that space to a young person to have those conversations in – whether they choose to take it or not – is really important.’
Do not use a paper checklist!!
SPHERE is currently working on further research to identify the impact of the paper form and checklist still used by some pharmacists when supplying emergency contraception.
While the checklist has been found to be a barrier to access, this is likely even more pronounced in adolescents.
‘We don't want young people to feel like their personal information is being taken and they don’t know what's being done with it,’ Dr Assifi said.
‘Alternative ways where a young person can signal or provide that information so it doesn't feel as jarring as saying it across the dispensing counter should be considered.’
PSA’s Non-prescription medicine treatment guideline: Emergency Contraception, found in the Australian Pharmaceutical Formulary and Handbook or PSA Resource Hub, advises pharmacists to ‘Gather patient information in a confidential, respectful and non-judgemental manner. Do not use a written checklist or form because the patient (or third party) can perceive it as a barrier to care’.
[post_title] => Stigma hinders adolescent contraceptive care
[post_excerpt] => Adolescents prefer seeking contraceptive care from pharmacists, says new research. But there are barriers to access that must be addressed.
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[title_attribute] => Stigma hinders adolescent contraceptive care
[title] => Stigma hinders adolescent contraceptive care
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[post_content] => When standard needles for vaccination shortchange patient immunity.
Vaccines are most effective when administered using correct technique – this includes injection site positioning, angle of the needle and needle length.
Most vaccines currently available are administered as intramuscular (IM) injections. With the breadth and depth of pharmacist-administered vaccination growing, it’s timely that pharmacists double check their depth.
What needle size should I use for IM injections?
A 25 mm needle is recommended for most people, including from infants to older adults.
There are two exceptions:
For very large or obese people, a longer needle of 38 mm length is recommended.1 With 32% of the Australian population being obese,2 around a third of vaccines likely should be administered using longer needles.
If a needle isn’t long enough, or used at an incorrect angle, the needle may not fully penetrate the deltoid fat pad and therefore be inadvertently administered subcutaneously.
For most vaccines, this risks a higher rate of local adverse events, such as redness, swelling, itching and pain.1,3 This is particularly noted with aluminium-adjuvanted vaccines (such as hepatitis B, dTpa or dT vaccines).2
Concerningly, it is also recognised as reducing immunogenicity.2 For example, Rabipur Inactivated Rabies Virus Vaccine (PCECV) is considered invalid if given subcutaneously.2
It’s hard to tell. There is limited contemporary data – and no Australian data was identified when researching this article.
However, overseas studies suggest 38 mm needles are drastically underutilised4 – with one US study suggesting the wrong length needle was used 75% of the time when administering vaccines to obese people.5
Consult the Australian Immunisation Handbook.1 The ‘Vaccine injection techniques’ section contains advice on inadvertent subcutaneous injection of intramuscular vaccines.
Error reporting to indemnity insurers and state/territory health department systems may also be required.
In the example of the Rabipur rabies vaccine, as a subcutaneous dose is invalid, the dose must be repeated – an undesirable situation given the cost and time-critical regimen for rabies vaccines.
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[post_content] => Tomorrow (Thursday 25 September 2025) is World Pharmacists Day – an annual milestone for the past 16 years that celebrates the pharmacy profession worldwide and amplifies its essential contribution to health systems.
The theme for this year’s World Pharmacists Day, as chosen by the International Pharmaceutical Federation (FIP) is ‘Think Health, Think Pharmacist’.
The theme reflects the vital role of pharmacists both in Australia and internationally, and the need to routinely embed them across all areas of the health system.
Ahead of the day, FIP President, Australia’s Paul Sinclair AM MPS said ‘Think Health, Think Pharmacist’ is more than a campaign – it’s a call to action.
‘Pharmacists are crucial to the safe use of medicines, chronic disease management and public health delivery. Investing in them is investing in stronger health systems,’ he said.
‘As the world faces rising healthcare demands, economic uncertainty, and growing threats like antimicrobial resistance and climate change – pharmacists remain key to ensuring safe, cost-effective, and accessible care.
‘From improving health literacy and delivering vaccinations to ensuring the safe use of medicines, pharmacists are an indispensable part of our health systems, especially in underserved communities.’
Getting involved in World Pharmacists Day
Australian pharmacists can get involved by engaging patients, politicians and stakeholders in conversation. Pharmacists can also champion the profession through social media, including:
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[post_content] => As US regulators flag new warnings, the Therapeutic Goods Administration (TGA) and Australian experts have weighed in on what the evidence shows.
Paracetamol has widely been considered the safest analgesic to relieve fever and pain during pregnancy. Fever higher than 38.9°C for at least 24 hours during pregnancy is linked to higher chances of miscarriage, preterm birth, stillbirth and certain malformations including neural tube defects like spina bifida.
Yet the US Food and Drug Administration (FDA) announced it intends to add a warning label to the medicine, citing a ‘possible association’ between autism in children and the use of acetaminophen (paracetamol) during pregnancy.
This proposed regulation change, along with updated advice given to the American Academy of Pediatrics among other medical groups, follows an announcement from the US President linking acetaminophen (Tylenol) (known as paracetamol in Australia) to autism – calling on pregnant women to avoid it.
Australia’s Chief Medical Officer Micahel Kidd has rejected claims about the use of paracetamol in pregnancy and the risk of developing ADHD or autism. So what are other experts saying?
TGA: ‘safe for use in pregnancy’
Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy, a spokesperson for the TGA told Australian Pharmacist.
‘The use of medications in pregnancy is subject to clinical, scientific and toxicological evaluation at the time of registration of a medicine in Australia,’ the spokesperson said.
‘Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed.’
Paracetamol is still the recommended treatment option for pain or fever in pregnant women when used as directed, the TGA said.
‘Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment.
The spokesperson said that the TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol.
‘When safety signals are identified for a medicine, they are subject to detailed clinical and scientific investigation to confirm that a safety issue exists, and if confirmed, what regulatory actions are most appropriate to mitigate the risk,’ the spokesperson said. ‘The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.’
Australia is not the only nation holding firm; international peer regulators, such as the UK Medicines and Healthcare products Regulatory Agency, continue to advise that paracetamol be used according to the approved Product Information.
In its 2019 review, the European Medicines Agency also determined that the available evidence on paracetamol’s effects on childhood neurodevelopment is inconclusive.
Is there any evidence linking paracetamol in pregnancy with autism?
Some systematic reviews have reported associations between paracetamol use in pregnancy and autism in children – usually prolonged, high-dose use that exceeds recommendations.
Of central interest to the US Government's claim is a 2025 systematic review which made the claim of ‘strong evidence of a relationship between prenatal acetaminophen use and increased risk of ASD in children’.
But the quality of these studies have been subject to significant critical review.
Professor Margie Danchin, a paediatrician and group leader of the Murdoch Children’s Research Institute’s Vaccine Uptake Group, refuted the evidence base, made up of observational studies, linking paracetamol to autism.
‘The cause of fever for the women in those studies is probably what caused the problems later on developmentally for the children, not the fact that they took Panadol for that fever.’
Additionally, Prof Danchin said many of the women who participated in these studies were asked several years postpartum whether they took paracetamol during pregnancy, further undermining accuracy.
More recent and robust studies contradict these claims and support the prevailing evidence that paracetamol is not causally linked to autism or ADHD, the TGA said.
Experts point to a Swedish cohort study as the most persuasive evidence on paracetamol and autism. Published last year, it analysed records for nearly 2.5 million children born between 1995 and 2019, identifying autism diagnoses and verifying whether mothers used paracetamol during pregnancy.
Crucially, the investigators conducted a sibling-comparison analysis, assessing pairs in which one child was prenatally exposed to paracetamol and the other was not. Because siblings share much of their genetics, household environment and maternal health influences, this approach helps isolate the impact of specific factors such as paracetamol.
In the largest study of its kind to date, no association was found between prenatal paracetamol exposure and autism.
Imparting safe and accurate information
Prof Danchin called the claim linking acetaminophen exposure in utero to autism ‘disinformation’.
‘At the moment, the biggest issue at play is trust,’ she said.
The danger of ‘repeatedly repeating myths’ is that it further entrenches them.
‘That sort of repetition becomes very sticky. People hear it all the time, and it becomes harder and harder to counter,’ Prof Danchin said.
However, health professionals should ensure the right messages get across, she said.
When counselling patients on paracetamol use in pregnancy, PSA has advised pharmacists to take the following approach:
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[post_content] => Last year, it was reported that Australian poisons hotlines received almost 1,500 calls about child ingestion of melatonin.
In Western Australia, calls to the poisons hotline about melatonin have nearly doubled from 175 in 2018 to 322 as of August this year, across all age groups – mostly related to gummy products.
In the same month, online health retailer iHerb suspended the sale of melatonin supplements in Australia.
But there are retailers selling these products online, said Sarah Blunden, Professor and Head of Paediatric Sleep Research, CQUniversity Australia.
‘There are a lot of other companies from the United States that sell it,’ she said.
AP investigates what melatonin toxicity looks like, why so many kids are taking it and how pharmacists can help to ensure safe and effective use of medicines for sleep.
Why have calls to poison hotlines about melatonin gummies doubled?
From Prof Blunden’s perspective, the drivers are straightforward.
‘They are not regulated, they've got sugar in them and they taste good,’ she said. ‘Children love them and parents think they're natural. And without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.’
Independent analyses of melatonin gummies have shown large discrepancies between labelled and actual melatonin content.
‘Two research groups – one in Canada and one in the UK – found some had no melatonin at all, and some had up to 400% of what was on the label,’ Prof Blunden said.
‘without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.'
Professor Sarah Blunden
The Therapeutic Goods Administration (TGA) recently conducted its own review, reporting significant variability between products. For example, The Smurfs Kids Gummies Melatonin 1 mg contained 155–170% variation from the labelled amount.
Endogenous melatonin biology is also highly individual, with retinal light-sensing pathways modulating secretion with wide inter-child variability, and there’s no practical clinical assay to map a child’s secretion pattern outside of a research study.
‘A child who’s particularly light-sensitive might have higher endogenous levels at a certain time, and if they then take several gummies, toxicity could be faster and worse,’ she said. ‘That’s why, when they present to ED, it gets labelled as an “overdose,” but we don’t exactly know what that means.’
What are the symptoms of melatonin toxicity?
Common reported effects of melatonin toxicity include headache, dizziness, nausea, and drowsiness.
Children can also experience central nervous system (CNS) effects, including extreme sedation, nightmares and vivid dreams.
‘Parents might see a very drowsy or unwell child and seek care, or they may witness ingestion of multiple gummies and go to the emergency department (ED),’ Prof Blunden said.
Sometimes, toxicity appears fatal.
‘In a review we conducted, two or three deaths of children who had ingested melatonin were reported, but they are not included in many systematic reviews – including ours – because we couldn’t confirm that melatonin was the cause,’ she said.
‘I also found a paper reporting seven infants who died with high levels of exogenous melatonin in the blood, but causation wasn’t established. It’s unknown – and that is really scary.’
Why are so many kids taking melatonin?
Sleep is increasingly recognised as a crucial factor in community health, said Prof Blunden.
‘Traditionally the pillars were healthy eating and exercise,’ she said. ‘But in the last 20 years, sleep has edged in as equally important.’
This shift is especially relevant for Australian parents, who have long encouraged children to sleep alone.
‘Because we've always had that expectation, there have always been issues around children who don't want to sleep by themselves,’ Prof Blunden said.
Controlled crying was previously the standard response for children resisting independent sleep, but now, behavioural sleep medicine recognises melatonin as another option.
‘The increase in dual-working families, the need for children to sleep independently, the broader community conversation about sleep, and greater availability of melatonin for children who are not typically developing has led to the use of melatonin sharply rising,’ she said.
‘I’m on the board of the International Pediatric Sleep Association. And at the last two conferences, physiologists and clinicians said melatonin prescriptions and use have skyrocketed over the last 5 years,’ Prof Blunden said.
Who is melatonin indicated for and at what dose?
In Australia, melatonin is indicated for children aged 2–18 years with neurodevelopmental disorders including:
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[post_content] => New research has indicated that adolescents prefer seeking reproductive health services from pharmacists, but there are barriers to accessing care that must be addressed.
Adolescents face unique and at times greater challenges when accessing sexual and reproductive health (SRH) services than adults, including stigma, limited knowledge, out-of-pocket costs and restrictive legislative frameworks, said SPHERE Research Fellow and lead author of the study Dr Anisa Assifi.
‘Community pharmacies offer a promising, accessible alternative, but only if pharmacists are equipped and supported to meet adolescents’ needs,’ she said.
What are the benefits of pharmacy for SRH?
The review pulled on 25 years’ worth of published research in high-income countries with similar healthcare settings and approaches to care, including Australia and the United States.
Overwhelmingly, adolescents felt they received detailed, high-quality, trustworthy information about contraceptive products from pharmacists.
‘What we found is that adolescents find pharmacy a really accessible and acceptable source of information, and really easy to get into,’ Dr Assifi said. ‘They trusted the pharmacist's knowledge.’
Across Australia, reproductive health is an area pharmacists are increasingly involved in. With scope of practice broadening, pharmacists have been prescribing emergency contraception, resupplying the oral contraceptive pill and dispensing mifepristone/misoprostol (MS-2 Step).
At the same time, barriers to general practice access have increased; declines in Medicare bulk billing rates coupled with long wait times to see a GP have made pharmacy a more favourable setting for seeking reproductive care,
‘You might wait 5–10 minutes to talk to a pharmacist, depending on the pharmacy and location,’ she said.
Despite efforts to improve sex education in schools, Dr Assifi said students may still be missing the information they need.
‘It’s an amazing opportunity for adolescents to talk to a health professional and get accurate information they may not be getting elsewhere.’
What are the barriers to care?
It’s not all roses, with adolescents still frequently experiencing embarrassment and judgement from pharmacists and pharmacy staff when seeking SRH services, alongside stigma related to being sexually active, Dr Assifi said.
‘Many went in expecting to be judged, so it was both their experience and perception that contributed to them feeling judgement.’
Adolescents also questioned whether pharmacists would maintain confidentiality, and were concerned that the layout of large, high-volume pharmacies could make private conversations at the counter difficult.
‘What did come out was that the difference between pharmacy and family planning or GP clinics is that you're in a consultation room, so confidentiality is more maintained,’ she said.
‘False barriers’ were also identified.
‘Sometimes pharmacists were not up to date with guidelines or regulations (e.g. age of access, parental consent, prescription requirements) or they created unnecessary hurdles – saying they didn’t stock a product, or that parental consent was required,’ Dr Assifi said.
‘So even though they were trusted, there were still some issues that would come up where they would block that access.’
When pharmacists were empathetic and non-judgmental, including adjusting their body language and lowering their tone of voice, this made a significant difference to patient experience.
‘Some pharmacists were very good at this and recognised the importance of not being judgmental or making assumptions when interacting with adolescents, recognising that they need to be treated with respect and empathy,’ she said.
What’s pharmacists' perspective?
Most pharmacists found it acceptable to provide contraception to adolescents, including emergency contraception, and felt comfortable counselling this age cohort. However, their acceptability of providing emergency contraception declined as adolescents’ age decreased.
‘Pharmacists felt more comfortable interacting with older adolescents and were looking for further training and support about how to provide appropriate care to an adolescent that meets their needs, including how to interact with them through those discussions and encounters.’
Dr Assifi said more research was required to understand the training and support mechanisms that would better enable pharmacists to provide adolescent-friendly care.
‘Pharmacists, along with any other health professionals, have their own personal belief systems, and we did find in quite a few studies that this made them unwilling or unhelpful to provide care,’ she said.
‘So we need to ensure that if one pharmacist is uncomfortable, another is available to provide the service so adolescents receive appropriate information and sexual and reproductive healthcare.
‘I think it's an injustice to the young person if we can't provide them with the appropriate information and support required of an SRH that they've come to you as a health professional seeking.’
What needs to be considered?
PSA’s Code of Ethics states that in the instance of conscientious objection, pharmacists must ‘inform the patient when exercising the right to decline provision of certain forms of health care based on the individual pharmacist’s conscientious objection, and in such circumstances, appropriately facilitate continuity of care for the patient’.
‘What’s important is ensuring adolescents don’t feel judged or embarrassed when seeking information or services, and that they still receive the care they need,’ Dr Assifi agreed.
‘Adolescent-friendly care isn't simply about mannerisms and the way a pharmacist interacts and talks with a young person. Pharmacy staff and dispensing technicians also need to be involved in how to have these conversations.’
The pharmacy environment also has a role to play. Consultation rooms should be the standard setting for conversations about contraception to take place.
‘The availability of private consultation rooms is a great step forward, and being able to offer that space to a young person to have those conversations in – whether they choose to take it or not – is really important.’
Do not use a paper checklist!!
SPHERE is currently working on further research to identify the impact of the paper form and checklist still used by some pharmacists when supplying emergency contraception.
While the checklist has been found to be a barrier to access, this is likely even more pronounced in adolescents.
‘We don't want young people to feel like their personal information is being taken and they don’t know what's being done with it,’ Dr Assifi said.
‘Alternative ways where a young person can signal or provide that information so it doesn't feel as jarring as saying it across the dispensing counter should be considered.’
PSA’s Non-prescription medicine treatment guideline: Emergency Contraception, found in the Australian Pharmaceutical Formulary and Handbook or PSA Resource Hub, advises pharmacists to ‘Gather patient information in a confidential, respectful and non-judgemental manner. Do not use a written checklist or form because the patient (or third party) can perceive it as a barrier to care’.
[post_title] => Stigma hinders adolescent contraceptive care
[post_excerpt] => Adolescents prefer seeking contraceptive care from pharmacists, says new research. But there are barriers to access that must be addressed.
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[post_content] => When standard needles for vaccination shortchange patient immunity.
Vaccines are most effective when administered using correct technique – this includes injection site positioning, angle of the needle and needle length.
Most vaccines currently available are administered as intramuscular (IM) injections. With the breadth and depth of pharmacist-administered vaccination growing, it’s timely that pharmacists double check their depth.
What needle size should I use for IM injections?
A 25 mm needle is recommended for most people, including from infants to older adults.
There are two exceptions:
For very large or obese people, a longer needle of 38 mm length is recommended.1 With 32% of the Australian population being obese,2 around a third of vaccines likely should be administered using longer needles.
If a needle isn’t long enough, or used at an incorrect angle, the needle may not fully penetrate the deltoid fat pad and therefore be inadvertently administered subcutaneously.
For most vaccines, this risks a higher rate of local adverse events, such as redness, swelling, itching and pain.1,3 This is particularly noted with aluminium-adjuvanted vaccines (such as hepatitis B, dTpa or dT vaccines).2
Concerningly, it is also recognised as reducing immunogenicity.2 For example, Rabipur Inactivated Rabies Virus Vaccine (PCECV) is considered invalid if given subcutaneously.2
It’s hard to tell. There is limited contemporary data – and no Australian data was identified when researching this article.
However, overseas studies suggest 38 mm needles are drastically underutilised4 – with one US study suggesting the wrong length needle was used 75% of the time when administering vaccines to obese people.5
Consult the Australian Immunisation Handbook.1 The ‘Vaccine injection techniques’ section contains advice on inadvertent subcutaneous injection of intramuscular vaccines.
Error reporting to indemnity insurers and state/territory health department systems may also be required.
In the example of the Rabipur rabies vaccine, as a subcutaneous dose is invalid, the dose must be repeated – an undesirable situation given the cost and time-critical regimen for rabies vaccines.
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[post_content] => Tomorrow (Thursday 25 September 2025) is World Pharmacists Day – an annual milestone for the past 16 years that celebrates the pharmacy profession worldwide and amplifies its essential contribution to health systems.
The theme for this year’s World Pharmacists Day, as chosen by the International Pharmaceutical Federation (FIP) is ‘Think Health, Think Pharmacist’.
The theme reflects the vital role of pharmacists both in Australia and internationally, and the need to routinely embed them across all areas of the health system.
Ahead of the day, FIP President, Australia’s Paul Sinclair AM MPS said ‘Think Health, Think Pharmacist’ is more than a campaign – it’s a call to action.
‘Pharmacists are crucial to the safe use of medicines, chronic disease management and public health delivery. Investing in them is investing in stronger health systems,’ he said.
‘As the world faces rising healthcare demands, economic uncertainty, and growing threats like antimicrobial resistance and climate change – pharmacists remain key to ensuring safe, cost-effective, and accessible care.
‘From improving health literacy and delivering vaccinations to ensuring the safe use of medicines, pharmacists are an indispensable part of our health systems, especially in underserved communities.’
Getting involved in World Pharmacists Day
Australian pharmacists can get involved by engaging patients, politicians and stakeholders in conversation. Pharmacists can also champion the profession through social media, including:
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[post_content] => As US regulators flag new warnings, the Therapeutic Goods Administration (TGA) and Australian experts have weighed in on what the evidence shows.
Paracetamol has widely been considered the safest analgesic to relieve fever and pain during pregnancy. Fever higher than 38.9°C for at least 24 hours during pregnancy is linked to higher chances of miscarriage, preterm birth, stillbirth and certain malformations including neural tube defects like spina bifida.
Yet the US Food and Drug Administration (FDA) announced it intends to add a warning label to the medicine, citing a ‘possible association’ between autism in children and the use of acetaminophen (paracetamol) during pregnancy.
This proposed regulation change, along with updated advice given to the American Academy of Pediatrics among other medical groups, follows an announcement from the US President linking acetaminophen (Tylenol) (known as paracetamol in Australia) to autism – calling on pregnant women to avoid it.
Australia’s Chief Medical Officer Micahel Kidd has rejected claims about the use of paracetamol in pregnancy and the risk of developing ADHD or autism. So what are other experts saying?
TGA: ‘safe for use in pregnancy’
Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy, a spokesperson for the TGA told Australian Pharmacist.
‘The use of medications in pregnancy is subject to clinical, scientific and toxicological evaluation at the time of registration of a medicine in Australia,’ the spokesperson said.
‘Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed.’
Paracetamol is still the recommended treatment option for pain or fever in pregnant women when used as directed, the TGA said.
‘Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment.
The spokesperson said that the TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol.
‘When safety signals are identified for a medicine, they are subject to detailed clinical and scientific investigation to confirm that a safety issue exists, and if confirmed, what regulatory actions are most appropriate to mitigate the risk,’ the spokesperson said. ‘The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.’
Australia is not the only nation holding firm; international peer regulators, such as the UK Medicines and Healthcare products Regulatory Agency, continue to advise that paracetamol be used according to the approved Product Information.
In its 2019 review, the European Medicines Agency also determined that the available evidence on paracetamol’s effects on childhood neurodevelopment is inconclusive.
Is there any evidence linking paracetamol in pregnancy with autism?
Some systematic reviews have reported associations between paracetamol use in pregnancy and autism in children – usually prolonged, high-dose use that exceeds recommendations.
Of central interest to the US Government's claim is a 2025 systematic review which made the claim of ‘strong evidence of a relationship between prenatal acetaminophen use and increased risk of ASD in children’.
But the quality of these studies have been subject to significant critical review.
Professor Margie Danchin, a paediatrician and group leader of the Murdoch Children’s Research Institute’s Vaccine Uptake Group, refuted the evidence base, made up of observational studies, linking paracetamol to autism.
‘The cause of fever for the women in those studies is probably what caused the problems later on developmentally for the children, not the fact that they took Panadol for that fever.’
Additionally, Prof Danchin said many of the women who participated in these studies were asked several years postpartum whether they took paracetamol during pregnancy, further undermining accuracy.
More recent and robust studies contradict these claims and support the prevailing evidence that paracetamol is not causally linked to autism or ADHD, the TGA said.
Experts point to a Swedish cohort study as the most persuasive evidence on paracetamol and autism. Published last year, it analysed records for nearly 2.5 million children born between 1995 and 2019, identifying autism diagnoses and verifying whether mothers used paracetamol during pregnancy.
Crucially, the investigators conducted a sibling-comparison analysis, assessing pairs in which one child was prenatally exposed to paracetamol and the other was not. Because siblings share much of their genetics, household environment and maternal health influences, this approach helps isolate the impact of specific factors such as paracetamol.
In the largest study of its kind to date, no association was found between prenatal paracetamol exposure and autism.
Imparting safe and accurate information
Prof Danchin called the claim linking acetaminophen exposure in utero to autism ‘disinformation’.
‘At the moment, the biggest issue at play is trust,’ she said.
The danger of ‘repeatedly repeating myths’ is that it further entrenches them.
‘That sort of repetition becomes very sticky. People hear it all the time, and it becomes harder and harder to counter,’ Prof Danchin said.
However, health professionals should ensure the right messages get across, she said.
When counselling patients on paracetamol use in pregnancy, PSA has advised pharmacists to take the following approach:
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[post_content] => Last year, it was reported that Australian poisons hotlines received almost 1,500 calls about child ingestion of melatonin.
In Western Australia, calls to the poisons hotline about melatonin have nearly doubled from 175 in 2018 to 322 as of August this year, across all age groups – mostly related to gummy products.
In the same month, online health retailer iHerb suspended the sale of melatonin supplements in Australia.
But there are retailers selling these products online, said Sarah Blunden, Professor and Head of Paediatric Sleep Research, CQUniversity Australia.
‘There are a lot of other companies from the United States that sell it,’ she said.
AP investigates what melatonin toxicity looks like, why so many kids are taking it and how pharmacists can help to ensure safe and effective use of medicines for sleep.
Why have calls to poison hotlines about melatonin gummies doubled?
From Prof Blunden’s perspective, the drivers are straightforward.
‘They are not regulated, they've got sugar in them and they taste good,’ she said. ‘Children love them and parents think they're natural. And without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.’
Independent analyses of melatonin gummies have shown large discrepancies between labelled and actual melatonin content.
‘Two research groups – one in Canada and one in the UK – found some had no melatonin at all, and some had up to 400% of what was on the label,’ Prof Blunden said.
‘without dosage requirements, they might give them one, two or three, and there’s no pharmacist or doctor monitoring the dose.'
Professor Sarah Blunden
The Therapeutic Goods Administration (TGA) recently conducted its own review, reporting significant variability between products. For example, The Smurfs Kids Gummies Melatonin 1 mg contained 155–170% variation from the labelled amount.
Endogenous melatonin biology is also highly individual, with retinal light-sensing pathways modulating secretion with wide inter-child variability, and there’s no practical clinical assay to map a child’s secretion pattern outside of a research study.
‘A child who’s particularly light-sensitive might have higher endogenous levels at a certain time, and if they then take several gummies, toxicity could be faster and worse,’ she said. ‘That’s why, when they present to ED, it gets labelled as an “overdose,” but we don’t exactly know what that means.’
What are the symptoms of melatonin toxicity?
Common reported effects of melatonin toxicity include headache, dizziness, nausea, and drowsiness.
Children can also experience central nervous system (CNS) effects, including extreme sedation, nightmares and vivid dreams.
‘Parents might see a very drowsy or unwell child and seek care, or they may witness ingestion of multiple gummies and go to the emergency department (ED),’ Prof Blunden said.
Sometimes, toxicity appears fatal.
‘In a review we conducted, two or three deaths of children who had ingested melatonin were reported, but they are not included in many systematic reviews – including ours – because we couldn’t confirm that melatonin was the cause,’ she said.
‘I also found a paper reporting seven infants who died with high levels of exogenous melatonin in the blood, but causation wasn’t established. It’s unknown – and that is really scary.’
Why are so many kids taking melatonin?
Sleep is increasingly recognised as a crucial factor in community health, said Prof Blunden.
‘Traditionally the pillars were healthy eating and exercise,’ she said. ‘But in the last 20 years, sleep has edged in as equally important.’
This shift is especially relevant for Australian parents, who have long encouraged children to sleep alone.
‘Because we've always had that expectation, there have always been issues around children who don't want to sleep by themselves,’ Prof Blunden said.
Controlled crying was previously the standard response for children resisting independent sleep, but now, behavioural sleep medicine recognises melatonin as another option.
‘The increase in dual-working families, the need for children to sleep independently, the broader community conversation about sleep, and greater availability of melatonin for children who are not typically developing has led to the use of melatonin sharply rising,’ she said.
‘I’m on the board of the International Pediatric Sleep Association. And at the last two conferences, physiologists and clinicians said melatonin prescriptions and use have skyrocketed over the last 5 years,’ Prof Blunden said.
Who is melatonin indicated for and at what dose?
In Australia, melatonin is indicated for children aged 2–18 years with neurodevelopmental disorders including:
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[post_content] => New research has indicated that adolescents prefer seeking reproductive health services from pharmacists, but there are barriers to accessing care that must be addressed.
Adolescents face unique and at times greater challenges when accessing sexual and reproductive health (SRH) services than adults, including stigma, limited knowledge, out-of-pocket costs and restrictive legislative frameworks, said SPHERE Research Fellow and lead author of the study Dr Anisa Assifi.
‘Community pharmacies offer a promising, accessible alternative, but only if pharmacists are equipped and supported to meet adolescents’ needs,’ she said.
What are the benefits of pharmacy for SRH?
The review pulled on 25 years’ worth of published research in high-income countries with similar healthcare settings and approaches to care, including Australia and the United States.
Overwhelmingly, adolescents felt they received detailed, high-quality, trustworthy information about contraceptive products from pharmacists.
‘What we found is that adolescents find pharmacy a really accessible and acceptable source of information, and really easy to get into,’ Dr Assifi said. ‘They trusted the pharmacist's knowledge.’
Across Australia, reproductive health is an area pharmacists are increasingly involved in. With scope of practice broadening, pharmacists have been prescribing emergency contraception, resupplying the oral contraceptive pill and dispensing mifepristone/misoprostol (MS-2 Step).
At the same time, barriers to general practice access have increased; declines in Medicare bulk billing rates coupled with long wait times to see a GP have made pharmacy a more favourable setting for seeking reproductive care,
‘You might wait 5–10 minutes to talk to a pharmacist, depending on the pharmacy and location,’ she said.
Despite efforts to improve sex education in schools, Dr Assifi said students may still be missing the information they need.
‘It’s an amazing opportunity for adolescents to talk to a health professional and get accurate information they may not be getting elsewhere.’
What are the barriers to care?
It’s not all roses, with adolescents still frequently experiencing embarrassment and judgement from pharmacists and pharmacy staff when seeking SRH services, alongside stigma related to being sexually active, Dr Assifi said.
‘Many went in expecting to be judged, so it was both their experience and perception that contributed to them feeling judgement.’
Adolescents also questioned whether pharmacists would maintain confidentiality, and were concerned that the layout of large, high-volume pharmacies could make private conversations at the counter difficult.
‘What did come out was that the difference between pharmacy and family planning or GP clinics is that you're in a consultation room, so confidentiality is more maintained,’ she said.
‘False barriers’ were also identified.
‘Sometimes pharmacists were not up to date with guidelines or regulations (e.g. age of access, parental consent, prescription requirements) or they created unnecessary hurdles – saying they didn’t stock a product, or that parental consent was required,’ Dr Assifi said.
‘So even though they were trusted, there were still some issues that would come up where they would block that access.’
When pharmacists were empathetic and non-judgmental, including adjusting their body language and lowering their tone of voice, this made a significant difference to patient experience.
‘Some pharmacists were very good at this and recognised the importance of not being judgmental or making assumptions when interacting with adolescents, recognising that they need to be treated with respect and empathy,’ she said.
What’s pharmacists' perspective?
Most pharmacists found it acceptable to provide contraception to adolescents, including emergency contraception, and felt comfortable counselling this age cohort. However, their acceptability of providing emergency contraception declined as adolescents’ age decreased.
‘Pharmacists felt more comfortable interacting with older adolescents and were looking for further training and support about how to provide appropriate care to an adolescent that meets their needs, including how to interact with them through those discussions and encounters.’
Dr Assifi said more research was required to understand the training and support mechanisms that would better enable pharmacists to provide adolescent-friendly care.
‘Pharmacists, along with any other health professionals, have their own personal belief systems, and we did find in quite a few studies that this made them unwilling or unhelpful to provide care,’ she said.
‘So we need to ensure that if one pharmacist is uncomfortable, another is available to provide the service so adolescents receive appropriate information and sexual and reproductive healthcare.
‘I think it's an injustice to the young person if we can't provide them with the appropriate information and support required of an SRH that they've come to you as a health professional seeking.’
What needs to be considered?
PSA’s Code of Ethics states that in the instance of conscientious objection, pharmacists must ‘inform the patient when exercising the right to decline provision of certain forms of health care based on the individual pharmacist’s conscientious objection, and in such circumstances, appropriately facilitate continuity of care for the patient’.
‘What’s important is ensuring adolescents don’t feel judged or embarrassed when seeking information or services, and that they still receive the care they need,’ Dr Assifi agreed.
‘Adolescent-friendly care isn't simply about mannerisms and the way a pharmacist interacts and talks with a young person. Pharmacy staff and dispensing technicians also need to be involved in how to have these conversations.’
The pharmacy environment also has a role to play. Consultation rooms should be the standard setting for conversations about contraception to take place.
‘The availability of private consultation rooms is a great step forward, and being able to offer that space to a young person to have those conversations in – whether they choose to take it or not – is really important.’
Do not use a paper checklist!!
SPHERE is currently working on further research to identify the impact of the paper form and checklist still used by some pharmacists when supplying emergency contraception.
While the checklist has been found to be a barrier to access, this is likely even more pronounced in adolescents.
‘We don't want young people to feel like their personal information is being taken and they don’t know what's being done with it,’ Dr Assifi said.
‘Alternative ways where a young person can signal or provide that information so it doesn't feel as jarring as saying it across the dispensing counter should be considered.’
PSA’s Non-prescription medicine treatment guideline: Emergency Contraception, found in the Australian Pharmaceutical Formulary and Handbook or PSA Resource Hub, advises pharmacists to ‘Gather patient information in a confidential, respectful and non-judgemental manner. Do not use a written checklist or form because the patient (or third party) can perceive it as a barrier to care’.
[post_title] => Stigma hinders adolescent contraceptive care
[post_excerpt] => Adolescents prefer seeking contraceptive care from pharmacists, says new research. But there are barriers to access that must be addressed.
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[post_content] => When standard needles for vaccination shortchange patient immunity.
Vaccines are most effective when administered using correct technique – this includes injection site positioning, angle of the needle and needle length.
Most vaccines currently available are administered as intramuscular (IM) injections. With the breadth and depth of pharmacist-administered vaccination growing, it’s timely that pharmacists double check their depth.
What needle size should I use for IM injections?
A 25 mm needle is recommended for most people, including from infants to older adults.
There are two exceptions:
For very large or obese people, a longer needle of 38 mm length is recommended.1 With 32% of the Australian population being obese,2 around a third of vaccines likely should be administered using longer needles.
If a needle isn’t long enough, or used at an incorrect angle, the needle may not fully penetrate the deltoid fat pad and therefore be inadvertently administered subcutaneously.
For most vaccines, this risks a higher rate of local adverse events, such as redness, swelling, itching and pain.1,3 This is particularly noted with aluminium-adjuvanted vaccines (such as hepatitis B, dTpa or dT vaccines).2
Concerningly, it is also recognised as reducing immunogenicity.2 For example, Rabipur Inactivated Rabies Virus Vaccine (PCECV) is considered invalid if given subcutaneously.2
It’s hard to tell. There is limited contemporary data – and no Australian data was identified when researching this article.
However, overseas studies suggest 38 mm needles are drastically underutilised4 – with one US study suggesting the wrong length needle was used 75% of the time when administering vaccines to obese people.5
Consult the Australian Immunisation Handbook.1 The ‘Vaccine injection techniques’ section contains advice on inadvertent subcutaneous injection of intramuscular vaccines.
Error reporting to indemnity insurers and state/territory health department systems may also be required.
In the example of the Rabipur rabies vaccine, as a subcutaneous dose is invalid, the dose must be repeated – an undesirable situation given the cost and time-critical regimen for rabies vaccines.
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[post_content] => Tomorrow (Thursday 25 September 2025) is World Pharmacists Day – an annual milestone for the past 16 years that celebrates the pharmacy profession worldwide and amplifies its essential contribution to health systems.
The theme for this year’s World Pharmacists Day, as chosen by the International Pharmaceutical Federation (FIP) is ‘Think Health, Think Pharmacist’.
The theme reflects the vital role of pharmacists both in Australia and internationally, and the need to routinely embed them across all areas of the health system.
Ahead of the day, FIP President, Australia’s Paul Sinclair AM MPS said ‘Think Health, Think Pharmacist’ is more than a campaign – it’s a call to action.
‘Pharmacists are crucial to the safe use of medicines, chronic disease management and public health delivery. Investing in them is investing in stronger health systems,’ he said.
‘As the world faces rising healthcare demands, economic uncertainty, and growing threats like antimicrobial resistance and climate change – pharmacists remain key to ensuring safe, cost-effective, and accessible care.
‘From improving health literacy and delivering vaccinations to ensuring the safe use of medicines, pharmacists are an indispensable part of our health systems, especially in underserved communities.’
Getting involved in World Pharmacists Day
Australian pharmacists can get involved by engaging patients, politicians and stakeholders in conversation. Pharmacists can also champion the profession through social media, including:
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[post_content] => As US regulators flag new warnings, the Therapeutic Goods Administration (TGA) and Australian experts have weighed in on what the evidence shows.
Paracetamol has widely been considered the safest analgesic to relieve fever and pain during pregnancy. Fever higher than 38.9°C for at least 24 hours during pregnancy is linked to higher chances of miscarriage, preterm birth, stillbirth and certain malformations including neural tube defects like spina bifida.
Yet the US Food and Drug Administration (FDA) announced it intends to add a warning label to the medicine, citing a ‘possible association’ between autism in children and the use of acetaminophen (paracetamol) during pregnancy.
This proposed regulation change, along with updated advice given to the American Academy of Pediatrics among other medical groups, follows an announcement from the US President linking acetaminophen (Tylenol) (known as paracetamol in Australia) to autism – calling on pregnant women to avoid it.
Australia’s Chief Medical Officer Micahel Kidd has rejected claims about the use of paracetamol in pregnancy and the risk of developing ADHD or autism. So what are other experts saying?
TGA: ‘safe for use in pregnancy’
Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy, a spokesperson for the TGA told Australian Pharmacist.
‘The use of medications in pregnancy is subject to clinical, scientific and toxicological evaluation at the time of registration of a medicine in Australia,’ the spokesperson said.
‘Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed.’
Paracetamol is still the recommended treatment option for pain or fever in pregnant women when used as directed, the TGA said.
‘Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment.
The spokesperson said that the TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol.
‘When safety signals are identified for a medicine, they are subject to detailed clinical and scientific investigation to confirm that a safety issue exists, and if confirmed, what regulatory actions are most appropriate to mitigate the risk,’ the spokesperson said. ‘The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.’
Australia is not the only nation holding firm; international peer regulators, such as the UK Medicines and Healthcare products Regulatory Agency, continue to advise that paracetamol be used according to the approved Product Information.
In its 2019 review, the European Medicines Agency also determined that the available evidence on paracetamol’s effects on childhood neurodevelopment is inconclusive.
Is there any evidence linking paracetamol in pregnancy with autism?
Some systematic reviews have reported associations between paracetamol use in pregnancy and autism in children – usually prolonged, high-dose use that exceeds recommendations.
Of central interest to the US Government's claim is a 2025 systematic review which made the claim of ‘strong evidence of a relationship between prenatal acetaminophen use and increased risk of ASD in children’.
But the quality of these studies have been subject to significant critical review.
Professor Margie Danchin, a paediatrician and group leader of the Murdoch Children’s Research Institute’s Vaccine Uptake Group, refuted the evidence base, made up of observational studies, linking paracetamol to autism.
‘The cause of fever for the women in those studies is probably what caused the problems later on developmentally for the children, not the fact that they took Panadol for that fever.’
Additionally, Prof Danchin said many of the women who participated in these studies were asked several years postpartum whether they took paracetamol during pregnancy, further undermining accuracy.
More recent and robust studies contradict these claims and support the prevailing evidence that paracetamol is not causally linked to autism or ADHD, the TGA said.
Experts point to a Swedish cohort study as the most persuasive evidence on paracetamol and autism. Published last year, it analysed records for nearly 2.5 million children born between 1995 and 2019, identifying autism diagnoses and verifying whether mothers used paracetamol during pregnancy.
Crucially, the investigators conducted a sibling-comparison analysis, assessing pairs in which one child was prenatally exposed to paracetamol and the other was not. Because siblings share much of their genetics, household environment and maternal health influences, this approach helps isolate the impact of specific factors such as paracetamol.
In the largest study of its kind to date, no association was found between prenatal paracetamol exposure and autism.
Imparting safe and accurate information
Prof Danchin called the claim linking acetaminophen exposure in utero to autism ‘disinformation’.
‘At the moment, the biggest issue at play is trust,’ she said.
The danger of ‘repeatedly repeating myths’ is that it further entrenches them.
‘That sort of repetition becomes very sticky. People hear it all the time, and it becomes harder and harder to counter,’ Prof Danchin said.
However, health professionals should ensure the right messages get across, she said.
When counselling patients on paracetamol use in pregnancy, PSA has advised pharmacists to take the following approach:
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
