[The Conversation]

The TGA Is Considering Paracetamol Restrictions Due To Poisonings – But What Does That Mean For Consumers?​

Paracetamol is Australia’s most widely used pain medicine, with 65 million packs sold across the country in 2021. It is available everywhere from toilet vending machines, to convenience stores, supermarkets, and pharmacies.

The Therapeutic Goods Administration (TGA) is now undertaking a public consultation into access to paracetamol in the community due to concerns about poisonings, especially among young people.

What is paracetamol and what is it used for?​

Paracetamol (commonly marketed as Panadol, Panamax or Dymadon) is a medicine used to treat pain and reduce fever.

Outside of pharmacies, paracetamol is available in packs of up to 20 tablets (or capsules), while pharmacies stock packs of up to 100 tablets and a range of formulations, including liquids and suppositories. Paracetamol’s wide availability and low cost make it a convenient option for people to self-treat pain without a doctor’s appointment or prescription.


At therapeutic doses, paracetamol is considered safe for most people, with few side effects when used as directed.

However, it can be dangerous at high doses, resulting in acute liver toxicity, which in severe cases may lead to death. Although there are treatments to reverse paracetamol overdose, they need to be given within 2-8 hours to be most effective.

Why is the TGA reviewing paracetamol access?​

The TGA is concerned about harm from paracetamol poisoning, particularly intentional overdoses among young people, which have been seen in Australia as well as internationally. In response, the TGA requested an independent expert report to support its review of paracetamol access.

The report found that between 2007 and 2020, there were 40–50 deaths each year in Australia from paracetamol poisoning. From 2009 to 2017, hospital admissions due to paracetamol poisoning increased from 8,617 to 11,697. They decreased to 8,723 in 2019–20.

Around 80% of these admissions were due to intentional self-poisoning, with young people aged between 10–24 years accounting for 40–50% of these incidents. Hospitalisations among young people due to intentional overdoses from any medicine also increased over this period. Calls to Australian Poisons Information Centres about self-poisonings involving paracetamol also increased over the last decade.

It is important to note that the number of harmful events is low compared to the amount of paracetamol sold in Australia. For every million packs of paracetamol sold, there were 100 hospital admissions for intentional self-poisoning, three hospital admissions for liver injury, and less than one death. And in recent years, both unintentional and intentional self-poisoning admissions per million packs of paracetamol sold have been decreasing.

More paracetamol involved in intentional self-poisoning was already in the home. Shutterstock​

How might paracetamol access change?​

The expert panel made several recommendations including:

• limiting pack sizes
• introducing purchase limits
• requiring a prescription to purchase higher amounts and modified-release products (such as Panadol Osteo)
• requiring a prescription for people under 18.

Additional measures being considered include changes to packaging and how paracetamol is displayed in stores. At the moment, there are no recommendations to make all paracetamol products prescription-only or to restrict their sale to pharmacies only.

Many of these strategies are focused on reducing potential harm by limiting the amount of paracetamol available. The change to pack sizes available outside of pharmacies would bring Australia in line with countries such as Denmark, Ireland and the United Kingdom. These countries have had restricted pack sizes (maximum 10–16 tablets) for sale outside pharmacies for many years and have seen reductions in hospital admissions and deaths. Poisonings among people aged 10–17 years also went down in Denmark after age restrictions were introduced in 2011.

The expert report found most cases of self-poisoning involve medicines already present at home. So the benefits of these measures may be limited. But limiting pack sizes may help to reduce the overall quantity of medicines available in the home and the risk of fatal poisoning.

The expert panel also recommended better follow-up care after self-poisoning events. Developing preventative strategies and increasing mental health support is vital to address the drivers of intentional self-poisonings more broadly.

What next?​

Ready access to paracetamol allows people to conveniently self-treat their pain at minimal cost and without visiting a health professional. Reduced paracetamol availability may prompt people to switch to using other pain medicines, such as ibuprofen, which carries its own risks and may not be suitable for everyone.

Although limiting harms due to paracetamol poisoning is important, at the same time, the TGA will need to ensure paracetamol remains accessible to those in need. By keeping paracetamol on the shelves of supermarkets and pharmacies in reduced pack sizes, the TGA will be aiming to strike a balance between accessibility and safety.

The biggest potential impact for people living with chronic pain would be brought about by reducing larger pack sizes currently only available in pharmacies (such as those containing 50–100 tablets) and making modified-release paracetamol products prescription-only.

Media personality Prue MacSween has spoken out against the proposal telling the TGA to 'get out of our lives'.

The expert report notes that at 665 mg, the modified-release formulation in particular is linked to larger overdoses. As these products are currently only available from pharmacies, authorities would need to show how these changes would significantly reduce harm, without overly burdening people in pain.

However, as people are aware, paracetamol is used by many for a variety of other medical needs.

Actor Magda Szubanski offered a suggestion.

'Maybe people with chronic pain-who rely on things like Panadol Osteo just to get through the day-could have some kind of medical certificate?' she wrote. 'Instead of added pain burden & cost of constant GP appointments to get scripts?' she wrote.

Lorraine Burchell, who has chronic pain issues, said 20 tablets a day wasn't enough for her.

'As a someone with chronic pain managed by physical therapy and paracetamol 4 x day, I will be affected by this,' she wrote.

'Prior to taking paracetamol regularly I was frequently incapacitated, needing codeine based meds and having MRI to investigate. Now my pain is managed. 20 tabs = 2.5 days.'

Invisible Disabilities Australia raised the point that sufferers across the country already face difficulties seeing a GP.

'Asking people with cancer, pensioners, and some of the eight million people with chronic conditions to get scripts for Panadol is outrageous,' they said.

'We already have a shortage of GP appointments.'

The TGA's advisory committee on Medicines Scheduling will meet on November 16 to consider the proposed changes to the sale of paracetamol.

This article was first published on The Conversation, and was written by Natasa Gisev, Clinical pharmacist and Scientia Senior Lecturer at the National Drug and Alcohol Research Centre from UNSW Sydney, Ria Hopkins PhD Candidate, National Drug and Alcohol Research Centre from UNSW Sydney

Later edits were made by the SDC team.

 

[TrishT]

The TGA is Taking an easy approach to a long standing problem with impacts that that will effect many more people than their so called target group.
Those that use these drugs for self harm need better, age/generation appropriate mental health access and Drug Health education included in schools and universities.
What happens to those that have long term chronic pain illness, or pain from
Accidents, major surgery. This board has short sighted uncaring/uneducated ideas.
what will happen to those who live with life long chronic pain. They will have an even poorer quality of life with enduring chronic pain, unable to manage many functions of daily activities, unable to active in the community or at times unable to work. Sadly the majority in this group are usually mid to elderly aged citizens, not considered worthwhile by the body of decision makers. Getting into a GP is almost impossible now, add getting a script for Panadol would make it impossible.
we would see an increase in suicide in this age group, not to mention depression and further degeneration in their health status.
Pain is real, it can be long term and lead to further long term issues than the illness itself. Pain needs to be addressed, by a a number of well thought out means/methods/therapies.
The TGA has not looked at long term outcomes of this decision, or even possible
alternate solutions. Living Beings feel pain. Stop being draconian, puritanic, short sighted, short thinking authoritarian nanny decision makers and start being Progressive thinking, long term solution thinkers.

 

[Janmf]

They are just making it harder and harder for us oldies who rely on Panadol Ostio for at least some relief.

 

[Thecheesequeen]

I take Panadol Osteo for osteoarthritis and it would be a major inconvenience to be only allowed to buy 20 at a time. I’m in the country and it’s a significant outing to get to a chemist. This proposal is like using a sledgehammer to crack a nut.

 

[June E]

The TGA Is Considering Paracetamol Restrictions Due To Poisonings – But What Does That Mean For Consumers?​

Paracetamol is Australia’s most widely used pain medicine, with 65 million packs sold across the country in 2021. It is available everywhere from toilet vending machines, to convenience stores, supermarkets, and pharmacies.

The Therapeutic Goods Administration (TGA) is now undertaking a public consultation into access to paracetamol in the community due to concerns about poisonings, especially among young people.

What is paracetamol and what is it used for?​

Paracetamol (commonly marketed as Panadol, Panamax or Dymadon) is a medicine used to treat pain and reduce fever.

Outside of pharmacies, paracetamol is available in packs of up to 20 tablets (or capsules), while pharmacies stock packs of up to 100 tablets and a range of formulations, including liquids and suppositories. Paracetamol’s wide availability and low cost make it a convenient option for people to self-treat pain without a doctor’s appointment or prescription.


At therapeutic doses, paracetamol is considered safe for most people, with few side effects when used as directed.

However, it can be dangerous at high doses, resulting in acute liver toxicity, which in severe cases may lead to death. Although there are treatments to reverse paracetamol overdose, they need to be given within 2-8 hours to be most effective.

Why is the TGA reviewing paracetamol access?​

The TGA is concerned about harm from paracetamol poisoning, particularly intentional overdoses among young people, which have been seen in Australia as well as internationally. In response, the TGA requested an independent expert report to support its review of paracetamol access.

The report found that between 2007 and 2020, there were 40–50 deaths each year in Australia from paracetamol poisoning. From 2009 to 2017, hospital admissions due to paracetamol poisoning increased from 8,617 to 11,697. They decreased to 8,723 in 2019–20.

Around 80% of these admissions were due to intentional self-poisoning, with young people aged between 10–24 years accounting for 40–50% of these incidents. Hospitalisations among young people due to intentional overdoses from any medicine also increased over this period. Calls to Australian Poisons Information Centres about self-poisonings involving paracetamol also increased over the last decade.

It is important to note that the number of harmful events is low compared to the amount of paracetamol sold in Australia. For every million packs of paracetamol sold, there were 100 hospital admissions for intentional self-poisoning, three hospital admissions for liver injury, and less than one death. And in recent years, both unintentional and intentional self-poisoning admissions per million packs of paracetamol sold have been decreasing.

View attachment 6775
More paracetamol involved in intentional self-poisoning was already in the home. Shutterstock​

How might paracetamol access change?​

The expert panel made several recommendations including:

• limiting pack sizes
• introducing purchase limits
• requiring a prescription to purchase higher amounts and modified-release products (such as Panadol Osteo)
• requiring a prescription for people under 18.

Additional measures being considered include changes to packaging and how paracetamol is displayed in stores. At the moment, there are no recommendations to make all paracetamol products prescription-only or to restrict their sale to pharmacies only.

Many of these strategies are focused on reducing potential harm by limiting the amount of paracetamol available. The change to pack sizes available outside of pharmacies would bring Australia in line with countries such as Denmark, Ireland and the United Kingdom. These countries have had restricted pack sizes (maximum 10–16 tablets) for sale outside pharmacies for many years and have seen reductions in hospital admissions and deaths. Poisonings among people aged 10–17 years also went down in Denmark after age restrictions were introduced in 2011.

The expert report found most cases of self-poisoning involve medicines already present at home. So the benefits of these measures may be limited. But limiting pack sizes may help to reduce the overall quantity of medicines available in the home and the risk of fatal poisoning.

The expert panel also recommended better follow-up care after self-poisoning events. Developing preventative strategies and increasing mental health support is vital to address the drivers of intentional self-poisonings more broadly.

What next?​

Ready access to paracetamol allows people to conveniently self-treat their pain at minimal cost and without visiting a health professional. Reduced paracetamol availability may prompt people to switch to using other pain medicines, such as ibuprofen, which carries its own risks and may not be suitable for everyone.

Although limiting harms due to paracetamol poisoning is important, at the same time, the TGA will need to ensure paracetamol remains accessible to those in need. By keeping paracetamol on the shelves of supermarkets and pharmacies in reduced pack sizes, the TGA will be aiming to strike a balance between accessibility and safety.

The biggest potential impact for people living with chronic pain would be brought about by reducing larger pack sizes currently only available in pharmacies (such as those containing 50–100 tablets) and making modified-release paracetamol products prescription-only.

Media personality Prue MacSween has spoken out against the proposal telling the TGA to 'get out of our lives'.

The expert report notes that at 665 mg, the modified-release formulation in particular is linked to larger overdoses. As these products are currently only available from pharmacies, authorities would need to show how these changes would significantly reduce harm, without overly burdening people in pain.

However, as people are aware, paracetamol is used by many for a variety of other medical needs.

Actor Magda Szubanski offered a suggestion.

'Maybe people with chronic pain-who rely on things like Panadol Osteo just to get through the day-could have some kind of medical certificate?' she wrote. 'Instead of added pain burden & cost of constant GP appointments to get scripts?' she wrote.

Lorraine Burchell, who has chronic pain issues, said 20 tablets a day wasn't enough for her.

'As a someone with chronic pain managed by physical therapy and paracetamol 4 x day, I will be affected by this,' she wrote.

'Prior to taking paracetamol regularly I was frequently incapacitated, needing codeine based meds and having MRI to investigate. Now my pain is managed. 20 tabs = 2.5 days.'

Invisible Disabilities Australia raised the point that sufferers across the country already face difficulties seeing a GP.

'Asking people with cancer, pensioners, and some of the eight million people with chronic conditions to get scripts for Panadol is outrageous,' they said.

'We already have a shortage of GP appointments.'

The TGA's advisory committee on Medicines Scheduling will meet on November 16 to consider the proposed changes to the sale of paracetamol.

This article was first published on The Conversation, and was written by Natasa Gisev, Clinical pharmacist and Scientia Senior Lecturer at the National Drug and Alcohol Research Centre from UNSW Sydney, Ria Hopkins PhD Candidate, National Drug and Alcohol Research Centre from UNSW Sydney

Later edits were made by the SDC team.

What a load of rubbish ! If I was going to commit suicide I’d hardly use Panadol ! Much easier ways if I were serious. Also how many people can afford to go to the Dr for a script for a simple pain such as a headache. Plus half the time you can’t get in for a week! Big Brother raising his fist again in my opinion GRRRRRRR.

 

[Ricci]

I have given up on Panadol as it doesn't even touch the edges of my daily pain but I understand it is a necessary part of life for many. I tried last Thursday to make an appointment to see my doctor, I managed to snag a cancellation and will be going this Friday other than that the next available one was for the following Thursday, luckily it's nothing desperate that I need, just a quarterly Diabetic checkup but it's a terrible situation when it's two weeks or more before you can see the doctor.
If they do indeed put limits on purchasing Panadol what's to stop you going from supermarket to supermarket to chemist etc. to get your supply other than the inconvenience?

 

[Liz]

Why not just put panadol in chemists only. Forget about the script as trying to get into doctors is so hard these days. As a person who relies on panamax, I am not going to the doctor every week or two weeks just to get panamax. If young people chose to try and self harm, more education is needed and stricter supervisions on buying paracetamol for under 18's. I don't think that it should be in supermarkets anyway.

 

[Sloopy]

Nailed it, Ricci. Those of us with chronic pain issues have already had to cope/adapt following the changes in regulation of opiates because some people did the wrong thing. I used to be able to get a total of almost 6 months' worth of medication prescriptions in one doctor's visit. After the regulations changed, that became 4 weeks. Due to staffing shortages and the closure of one of the practices in town, it is now a 6-week booking time for an appointment. They claimed that this change in regulations was either because people inevitably required higher doses (I had managed to reduce my usage to the minimum available and then remained on that dosage for 8 years) or they were selling them on to people who were using them illegally. Due to a combination of gastric illness while away from home and being unable to get a new supply I was without them for over a week. I decided to live without them if I possibly could, and have done so. However, my quality of life has decreased and my pain has increased. I now rely on a combination of paracetamol and ibuprofen, which is not as effective as the opiates were, and long-term use of paracetamol has its own drawbacks. I will not personally be affected by this change, as I keep my use low, but I do know people who will find it very difficult, especially those in regional/rural areas who may only have one place they can buy them.

 

[Rob44]

It would be more appropriate to ban alcohol, which does far more damage than paracetamol to young people. Or for that matter, cars and motorcycles.

 

[odgersbarb]

Nailed it, Ricci. Those of us with chronic pain issues have already had to cope/adapt following the changes in regulation of opiates because some people did the wrong thing. I used to be able to get a total of almost 6 months' worth of medication prescriptions in one doctor's visit. After the regulations changed, that became 4 weeks. Due to staffing shortages and the closure of one of the practices in town, it is now a 6-week booking time for an appointment. They claimed that this change in regulations was either because people inevitably required higher doses (I had managed to reduce my usage to the minimum available and then remained on that dosage for 8 years) or they were selling them on to people who were using them illegally. Due to a combination of gastric illness while away from home and being unable to get a new supply I was without them for over a week. I decided to live without them if I possibly could, and have done so. However, my quality of life has decreased and my pain has increased. I now rely on a combination of paracetamol and ibuprofen, which is not as effective as the opiates were, and long-term use of paracetamol has its own drawbacks. I will not personally be affected by this change, as I keep my use low, but I do know people who will find it very difficult, especially those in regional/rural areas who may only have one place they can buy them.

Chemist's already only allow you to buy 1 package of Panadol osteo. I too suffer chronic pain and need this to help me through the day and also am a pensioner.

 

[LadyMoonlight]

Chronic pain and paracetemol/panadol do not belong in the same sentence for goodness sake. A person in chronic pain needs a doctor's script for something that actually works, like panadeine or panadeine forte.

 

[JayKay]

I am unable to take analgesia like Panadol, Nurofen etc as they cause severe epigastric pain for me.
I too suffer unbearable chronic pain every minute of every day, but I just have to pretend it's not there, despite tears often streaming down my face involuntarily.
The possibility of overdosing on Panadol is not great, however, the possibility of liver complications from long-term usage is quite high.
It's good to be reminded.
A card or letter with an exemption to restricted quantities sounds like an effective way to overcome the limitations.

 

[Shirlgirl]

The TGA Is Considering Paracetamol Restrictions Due To Poisonings – But What Does That Mean For Consumers?​

Paracetamol is Australia’s most widely used pain medicine, with 65 million packs sold across the country in 2021. It is available everywhere from toilet vending machines, to convenience stores, supermarkets, and pharmacies.

The Therapeutic Goods Administration (TGA) is now undertaking a public consultation into access to paracetamol in the community due to concerns about poisonings, especially among young people.

What is paracetamol and what is it used for?​

Paracetamol (commonly marketed as Panadol, Panamax or Dymadon) is a medicine used to treat pain and reduce fever.

Outside of pharmacies, paracetamol is available in packs of up to 20 tablets (or capsules), while pharmacies stock packs of up to 100 tablets and a range of formulations, including liquids and suppositories. Paracetamol’s wide availability and low cost make it a convenient option for people to self-treat pain without a doctor’s appointment or prescription.


At therapeutic doses, paracetamol is considered safe for most people, with few side effects when used as directed.

However, it can be dangerous at high doses, resulting in acute liver toxicity, which in severe cases may lead to death. Although there are treatments to reverse paracetamol overdose, they need to be given within 2-8 hours to be most effective.

Why is the TGA reviewing paracetamol access?​

The TGA is concerned about harm from paracetamol poisoning, particularly intentional overdoses among young people, which have been seen in Australia as well as internationally. In response, the TGA requested an independent expert report to support its review of paracetamol access.

The report found that between 2007 and 2020, there were 40–50 deaths each year in Australia from paracetamol poisoning. From 2009 to 2017, hospital admissions due to paracetamol poisoning increased from 8,617 to 11,697. They decreased to 8,723 in 2019–20.

Around 80% of these admissions were due to intentional self-poisoning, with young people aged between 10–24 years accounting for 40–50% of these incidents. Hospitalisations among young people due to intentional overdoses from any medicine also increased over this period. Calls to Australian Poisons Information Centres about self-poisonings involving paracetamol also increased over the last decade.

It is important to note that the number of harmful events is low compared to the amount of paracetamol sold in Australia. For every million packs of paracetamol sold, there were 100 hospital admissions for intentional self-poisoning, three hospital admissions for liver injury, and less than one death. And in recent years, both unintentional and intentional self-poisoning admissions per million packs of paracetamol sold have been decreasing.

View attachment 6775
More paracetamol involved in intentional self-poisoning was already in the home. Shutterstock​

How might paracetamol access change?​

The expert panel made several recommendations including:

• limiting pack sizes
• introducing purchase limits
• requiring a prescription to purchase higher amounts and modified-release products (such as Panadol Osteo)
• requiring a prescription for people under 18.

Additional measures being considered include changes to packaging and how paracetamol is displayed in stores. At the moment, there are no recommendations to make all paracetamol products prescription-only or to restrict their sale to pharmacies only.

Many of these strategies are focused on reducing potential harm by limiting the amount of paracetamol available. The change to pack sizes available outside of pharmacies would bring Australia in line with countries such as Denmark, Ireland and the United Kingdom. These countries have had restricted pack sizes (maximum 10–16 tablets) for sale outside pharmacies for many years and have seen reductions in hospital admissions and deaths. Poisonings among people aged 10–17 years also went down in Denmark after age restrictions were introduced in 2011.

The expert report found most cases of self-poisoning involve medicines already present at home. So the benefits of these measures may be limited. But limiting pack sizes may help to reduce the overall quantity of medicines available in the home and the risk of fatal poisoning.

The expert panel also recommended better follow-up care after self-poisoning events. Developing preventative strategies and increasing mental health support is vital to address the drivers of intentional self-poisonings more broadly.

What next?​

Ready access to paracetamol allows people to conveniently self-treat their pain at minimal cost and without visiting a health professional. Reduced paracetamol availability may prompt people to switch to using other pain medicines, such as ibuprofen, which carries its own risks and may not be suitable for everyone.

Although limiting harms due to paracetamol poisoning is important, at the same time, the TGA will need to ensure paracetamol remains accessible to those in need. By keeping paracetamol on the shelves of supermarkets and pharmacies in reduced pack sizes, the TGA will be aiming to strike a balance between accessibility and safety.

The biggest potential impact for people living with chronic pain would be brought about by reducing larger pack sizes currently only available in pharmacies (such as those containing 50–100 tablets) and making modified-release paracetamol products prescription-only.

Media personality Prue MacSween has spoken out against the proposal telling the TGA to 'get out of our lives'.

The expert report notes that at 665 mg, the modified-release formulation in particular is linked to larger overdoses. As these products are currently only available from pharmacies, authorities would need to show how these changes would significantly reduce harm, without overly burdening people in pain.

However, as people are aware, paracetamol is used by many for a variety of other medical needs.

Actor Magda Szubanski offered a suggestion.

'Maybe people with chronic pain-who rely on things like Panadol Osteo just to get through the day-could have some kind of medical certificate?' she wrote. 'Instead of added pain burden & cost of constant GP appointments to get scripts?' she wrote.

Lorraine Burchell, who has chronic pain issues, said 20 tablets a day wasn't enough for her.

'As a someone with chronic pain managed by physical therapy and paracetamol 4 x day, I will be affected by this,' she wrote.

'Prior to taking paracetamol regularly I was frequently incapacitated, needing codeine based meds and having MRI to investigate. Now my pain is managed. 20 tabs = 2.5 days.'

Invisible Disabilities Australia raised the point that sufferers across the country already face difficulties seeing a GP.

'Asking people with cancer, pensioners, and some of the eight million people with chronic conditions to get scripts for Panadol is outrageous,' they said.

'We already have a shortage of GP appointments.'

The TGA's advisory committee on Medicines Scheduling will meet on November 16 to consider the proposed changes to the sale of paracetamol.

This article was first published on The Conversation, and was written by Natasa Gisev, Clinical pharmacist and Scientia Senior Lecturer at the National Drug and Alcohol Research Centre from UNSW Sydney, Ria Hopkins PhD Candidate, National Drug and Alcohol Research Centre from UNSW Sydney

Later edits were made by the SDC team.

I feel extremely sad for the people who have died as a result of paracetamol overdose however, in comparison to the massive number of Australians who use it regularly and safely and benefit from it , the number of deaths is extremely small.
In comparison to so many other countries in the ‘free world’ in my opinion Australia is so over regulated that it has become harmful to our ability to learn how to make common sense decisions for ourselves.
Please please Australian government get a grip and let our young ones learn how to make informed decisions for themselves.

 

[RobD]

In my previous professional life, I witnessed the slow, painful death of a young person in intensive care with liver failure, she had intentionally overdosed on paracetamol. Just one example of the many overdoses witnessed in my four plus decade career. I witnessed physical and psychological dependence upon paracetamol in many people, not just for pain relief. It does happen!
Paracetamol is toxic to your liver! Too many people rely upon this chemical, as the one and only go to medicine, without realising just how dangerous it is! Unintentional overdose does happen, as well as intentional.
As a retired professional nurse, I am all for regulation!

 

[jlc]

The TGA Is Considering Paracetamol Restrictions Due To Poisonings – But What Does That Mean For Consumers?​

Paracetamol is Australia’s most widely used pain medicine, with 65 million packs sold across the country in 2021. It is available everywhere from toilet vending machines, to convenience stores, supermarkets, and pharmacies.

The Therapeutic Goods Administration (TGA) is now undertaking a public consultation into access to paracetamol in the community due to concerns about poisonings, especially among young people.

What is paracetamol and what is it used for?​

Paracetamol (commonly marketed as Panadol, Panamax or Dymadon) is a medicine used to treat pain and reduce fever.

Outside of pharmacies, paracetamol is available in packs of up to 20 tablets (or capsules), while pharmacies stock packs of up to 100 tablets and a range of formulations, including liquids and suppositories. Paracetamol’s wide availability and low cost make it a convenient option for people to self-treat pain without a doctor’s appointment or prescription.


At therapeutic doses, paracetamol is considered safe for most people, with few side effects when used as directed.

However, it can be dangerous at high doses, resulting in acute liver toxicity, which in severe cases may lead to death. Although there are treatments to reverse paracetamol overdose, they need to be given within 2-8 hours to be most effective.

Why is the TGA reviewing paracetamol access?​

The TGA is concerned about harm from paracetamol poisoning, particularly intentional overdoses among young people, which have been seen in Australia as well as internationally. In response, the TGA requested an independent expert report to support its review of paracetamol access.

The report found that between 2007 and 2020, there were 40–50 deaths each year in Australia from paracetamol poisoning. From 2009 to 2017, hospital admissions due to paracetamol poisoning increased from 8,617 to 11,697. They decreased to 8,723 in 2019–20.

Around 80% of these admissions were due to intentional self-poisoning, with young people aged between 10–24 years accounting for 40–50% of these incidents. Hospitalisations among young people due to intentional overdoses from any medicine also increased over this period. Calls to Australian Poisons Information Centres about self-poisonings involving paracetamol also increased over the last decade.

It is important to note that the number of harmful events is low compared to the amount of paracetamol sold in Australia. For every million packs of paracetamol sold, there were 100 hospital admissions for intentional self-poisoning, three hospital admissions for liver injury, and less than one death. And in recent years, both unintentional and intentional self-poisoning admissions per million packs of paracetamol sold have been decreasing.

View attachment 6775
More paracetamol involved in intentional self-poisoning was already in the home. Shutterstock​

How might paracetamol access change?​

The expert panel made several recommendations including:

• limiting pack sizes
• introducing purchase limits
• requiring a prescription to purchase higher amounts and modified-release products (such as Panadol Osteo)
• requiring a prescription for people under 18.

Additional measures being considered include changes to packaging and how paracetamol is displayed in stores. At the moment, there are no recommendations to make all paracetamol products prescription-only or to restrict their sale to pharmacies only.

Many of these strategies are focused on reducing potential harm by limiting the amount of paracetamol available. The change to pack sizes available outside of pharmacies would bring Australia in line with countries such as Denmark, Ireland and the United Kingdom. These countries have had restricted pack sizes (maximum 10–16 tablets) for sale outside pharmacies for many years and have seen reductions in hospital admissions and deaths. Poisonings among people aged 10–17 years also went down in Denmark after age restrictions were introduced in 2011.

The expert report found most cases of self-poisoning involve medicines already present at home. So the benefits of these measures may be limited. But limiting pack sizes may help to reduce the overall quantity of medicines available in the home and the risk of fatal poisoning.

The expert panel also recommended better follow-up care after self-poisoning events. Developing preventative strategies and increasing mental health support is vital to address the drivers of intentional self-poisonings more broadly.

What next?​

Ready access to paracetamol allows people to conveniently self-treat their pain at minimal cost and without visiting a health professional. Reduced paracetamol availability may prompt people to switch to using other pain medicines, such as ibuprofen, which carries its own risks and may not be suitable for everyone.

Although limiting harms due to paracetamol poisoning is important, at the same time, the TGA will need to ensure paracetamol remains accessible to those in need. By keeping paracetamol on the shelves of supermarkets and pharmacies in reduced pack sizes, the TGA will be aiming to strike a balance between accessibility and safety.

The biggest potential impact for people living with chronic pain would be brought about by reducing larger pack sizes currently only available in pharmacies (such as those containing 50–100 tablets) and making modified-release paracetamol products prescription-only.

Media personality Prue MacSween has spoken out against the proposal telling the TGA to 'get out of our lives'.

The expert report notes that at 665 mg, the modified-release formulation in particular is linked to larger overdoses. As these products are currently only available from pharmacies, authorities would need to show how these changes would significantly reduce harm, without overly burdening people in pain.

However, as people are aware, paracetamol is used by many for a variety of other medical needs.

Actor Magda Szubanski offered a suggestion.

'Maybe people with chronic pain-who rely on things like Panadol Osteo just to get through the day-could have some kind of medical certificate?' she wrote. 'Instead of added pain burden & cost of constant GP appointments to get scripts?' she wrote.

Lorraine Burchell, who has chronic pain issues, said 20 tablets a day wasn't enough for her.

'As a someone with chronic pain managed by physical therapy and paracetamol 4 x day, I will be affected by this,' she wrote.

'Prior to taking paracetamol regularly I was frequently incapacitated, needing codeine based meds and having MRI to investigate. Now my pain is managed. 20 tabs = 2.5 days.'

Invisible Disabilities Australia raised the point that sufferers across the country already face difficulties seeing a GP.

'Asking people with cancer, pensioners, and some of the eight million people with chronic conditions to get scripts for Panadol is outrageous,' they said.

'We already have a shortage of GP appointments.'

The TGA's advisory committee on Medicines Scheduling will meet on November 16 to consider the proposed changes to the sale of paracetamol.

This article was first published on The Conversation, and was written by Natasa Gisev, Clinical pharmacist and Scientia Senior Lecturer at the National Drug and Alcohol Research Centre from UNSW Sydney, Ria Hopkins PhD Candidate, National Drug and Alcohol Research Centre from UNSW Sydney

Later edits were made by the SDC team.

This is an inadequate response to a gigantic problem of inadequate pain relief. Reality is that it is now a long wait to see a G.P. even longer if you are under a specialist. These increasingly strict rules appear designed to protect doctors from accusations of over prescribing and less about helping with pain relief. Dealing with constant pain causes many problems including a restriction of normal life such as exercise shopping going out. A lack of pain relief stopping sleep and rest has a big input into mental health isolating a person from their normal life. Your study admitted a lowering of overdoses and other reasons for unwanted hospitalisation. Please stop treating the public as less important than studies please give us back our choice to ease our pain. Jenny Crowd

 

[Sandgroper]

In my previous professional life, I witnessed the slow, painful death of a young person in intensive care with liver failure, she had intentionally overdosed on paracetamol. Just one example of the many overdoses witnessed in my four plus decade career. I witnessed physical and psychological dependence upon paracetamol in many people, not just for pain relief. It does happen!
Paracetamol is toxic to your liver! Too many people rely upon this chemical, as the one and only go to medicine, without realising just how dangerous it is! Unintentional overdose does happen, as well as intentional.
As a retired professional nurse, I am all for regulation!

I have been reminded that when visiting Bali later this year, Paracetamol must be declared and only a small amount allowed.

 

[Loren]

Chronic pain and paracetemol/panadol do not belong in the same sentence for goodness sake. A person in chronic pain needs a doctor's script for something that actually works, like panadeine or panadeine forte.

Not when you're allergic to codeine and can't take anything stronger than paracetemol due to chronic kidney disease

 

[Ashmenou]

The TGA is Taking an easy approach to a long standing problem with impacts that that will effect many more people than their so called target group.
Those that use these drugs for self harm need better, age/generation appropriate mental health access and Drug Health education included in schools and universities.
What happens to those that have long term chronic pain illness, or pain from
Accidents, major surgery. This board has short sighted uncaring/uneducated ideas.
what will happen to those who live with life long chronic pain. They will have an even poorer quality of life with enduring chronic pain, unable to manage many functions of daily activities, unable to active in the community or at times unable to work. Sadly the majority in this group are usually mid to elderly aged citizens, not considered worthwhile by the body of decision makers. Getting into a GP is almost impossible now, add getting a script for Panadol would make it impossible.
we would see an increase in suicide in this age group, not to mention depression and further degeneration in their health status.
Pain is real, it can be long term and lead to further long term issues than the illness itself. Pain needs to be addressed, by a a number of well thought out means/methods/therapies.
The TGA has not looked at long term outcomes of this decision, or even possible
alternate solutions. Living Beings feel pain. Stop being draconian, puritanic, short sighted, short thinking authoritarian nanny decision makers and start being Progressive thinking, long term solution thinkers.
i am a retired RN, Bachelor of Nursing, With multiple qualifications and over 34 years experience in General, Paediatric in Burns and Cranio Facial areas, Geriatric, Psychiatric and Community Nursing, Duty Nurse Manager in a major state Hospital and Nurse Practitioner Development standards Project Manager with a role in State and National Projects As a State Project Manager in this Project.

I total agree

 

[Ashmenou]

What a load of rubbish ! If I was going to commit suicide I’d hardly use Panadol ! Much easier ways if I were serious. Also how many people can afford to go to the Dr for a script for a simple pain such as a headache. Plus half the time you can’t get in for a week! Big Brother raising his fist again in my opinion GRRRRRRR.

Well said

 

[Wendy]

I take panadol osteo and can get 2 packs at a time.
Recently when I was in the UK my cousin said they can only get it on prescription.