Upcoming Paracetamol Restrictions

A major scheduling change to paracetamol (acetaminophen) has been foreshadowed in Australia, which will affect most of us. Pack sizes are proposed to be markedly reduced, 16 tablets only in supermarkets, retail outlets and 100 tablets in pharmacies, but behind the counter. This is due to the risks for those attempting suicide, but will these actions minimise significant injuries and deaths from suicide attempts?

Will people resort to other methods, or will there still be enough paracetamol at home or available for immediate purchase that they can proceed anyway? Would desperate people just buy multiple smaller packs of 16 with cash in a number of self-serve checkouts, even if there is a credit card lockout at non-pharmacy retailers?
A 100 pack is still proposed to be available as a pharmacist-only behind the counter medicine, which adds to the workload of pharmacists counselling and is only 12-13 days supply for patients with chronic pain at the maximal dose. This is in addition to recent restrictions of 665mg modified release paracetamol tablets (now also behind the counter), which are more difficult to counter in overdose and also, mandating analgesics with codeine are prescription only - so options for mild-moderate pain relief in an ageing population are being further restricted.

Good regulations are those that are understood and effective in most circumstances to reduce adverse outcomes. I am not sure the case has been made that these additional restrictions will achieve their stated aim.

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There has been many reports of increasing incidence of accidental and deliberate overconsumption of paracetamol in recent years.

I remember many years ago that paracetamol was portrayed widely as being safe to take, especially compared to prescription or aspirin based alternatives. Its safety possibly based on usual/recommended doses.

Impression of being safe still exists and may give a false impression that taking a few or more above recommended doses is okay…and then if such dosing isn’t effective, maybe a few more might also work and is okay.

The communication about paracetamol safety in the past has been poor and has possibly contributed to the accidental overconsumption. It may also be challenging to change the beliefs relating to paracetamol safety quickly and why there is now a TGA response to its availability.

Deliberate overconsumption is also a problem and agree that curtailing availability won’t stop ability to accumulate enough paracetamol to case injury or death. It might have some effect if deliberate overconsumption was spontaneous rather than planned. If it was made highly restrictive, such as becoming prescription only, it may only cause those who chose to overconsume to look at alternatives.

The reduction in availability does impact on all consumers of the product, but this needs to be balanced with its potential use by some and its safety. I personally don’t have any issues with the changes or its potential impact, as we are very low consumers of paracetamol. Any changes in relation to availability wouldn’t overly impact on us.

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From my query to government about the matter.

Thank you for your correspondence of 22 November 2022 to the Minister for Health and
Aged Care, the Hon Mark Butler MP regarding proposed plans to limit paracetamol. The
Minister has asked me to reply.

I acknowledge your concerns regarding access to paracetamol.

From 14 September to 14 October 2022, the Therapeutic Goods Administration (TGA), part
of the Department of Health and Aged Care, consulted publicly on a range of options for
new or tightened purchasing and access controls for paracetamol. At this stage, however,
no decision has been made to change access to paracetamol. It is important that our
community retains access to medication for the relief of acute and chronic pain, and none of
the options, if implemented, would result in the removal of supermarket or pharmacy
access to paracetamol.

The consultation was undertaken in response to the publication of an independent expert
report into the risks of self-poisoning with paracetamol that was commissioned by the TGA
following reports of a significant number of deaths from intentional paracetamol misuse.

The report is available at www.tga.gov.au/resources/publication/publications/independent-
expert-panel-report. The report identified an increasing trend in self-poisonings, particularly
among adolescent and young adult females, and included seven (7) recommendations to
reduce the risks associated with this medicine.

The Advisory Committee on Medicines Scheduling (ACMS), an independent committee of
medical specialists and public health advocates, met on 16 November 2022 to discuss the
findings of the independent expert report and the submissions received during the first
round of public consultation. The ACMS considered all factors associated with the possible
changes, including weighing the benefits of paracetamol use to relieve pain against the risks
to public health associated with its deliberate misuse.

The decision maker on any changes is a senior medical officer at the TGA acting as a
delegate of the Secretary of the Department of Health and Aged Care, not the Minister for
Health and Aged Care or the Australian Government. The delegate will consider the advice
of the ACMS, the submissions received during the public consultation, and the independent
expert report before making an interim decision on any changes to the access of
paracetamol. The interim decision is anticipated to be published in February 2023 and will
be available at www.tga.gov.au/resources/publication/scheduling-decisions-interim.

Publication of the interim decision will be immediately followed by another round of
consultation to allow members of the public to provide feedback in relation to the interim
decision before a final decision is made. A final decision is anticipated to be made in April
2023.

Changes, if any, would likely not be implemented until late 2023 or early 2024.

I was not able to identify an interim determination. My personal view is that humans are very clever and if one problem is removed they will replace it with one equal or more effective or sinister. Everyone else pays either through higher prices, reduced and restricted availability, or removal from the market.

A similar issue is pseudoephedrine, about the only truly effective decongestant available. Those with chronic problems have been disadvantaged and drug manufacturers seem to have been only minimally impacted.

If anyone wants to do self harm they are going to do it with paracetamol, a gun, jumping off a building, ‘death by cop’ or whatever. Trying to protect every one from everything they might get into has its own societal consequences. Where the balance is is for each individual. My position might be evident.

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I find this move very hard to understand for several reasons.

  • Death from overdose is not quick and not painless, you die in pain days later from liver failure. Apparently those planning self harm don’t know this as it is fairly popular as a means of suicide nonetheless. Would greater publicity of the risk be beneficial?
  • I don’t know how reducing the pack size for over the counter sales from 20 to 16 is going to matter. It will still be easy enough to shop around and buy enough as it is widely available.
  • Chronic pain is very common in our society, something the readers here would be well acquainted with as the age profile is older than the general population. There needs to be a medication that is cheap, relatively benign and readily available, and paracetamol fits the bill.
  • The cruncher for me is that this is seen as a remedy to intentional self harm, what about treating the causes and the patients with suicidal tendencies rather than trying to make it impractical for people to do it?
    Apparently it has been shown that reducing access to the means of suicide reduces the number of impulse suicides, lack of ready access to firearms comes to mind. Has it been shown that these measures would actually have this effect and that any benefit from restricting it is greater than the harm caused?
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Phil, good comments thank you. I am not sure that the planned restrictions will achieve their stated aim, but will affect many others in the community. Phb, hepatotoxicity and the necessity to limit doses to 8/day (4g) from all sources has been known for many decades and is a mantra from Drs and pharmacists and now commonly required on labels and packs, so the main current issue the ACMS is responding to is the upsurge in poisonings.

The most important thing to do was to restrict the modified release paracetamol due to how difficult it is to clear it from a person’s system, which has already been done.

However, once the decision is made, I foresee there will be an outcry from many consumers who have to use paracetamol for chronic pain, who up to every 12-13 days will be waiting for a pharmacist to give them a pack of 100 of a product that they have been on for months and years.

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It seemed ridiculous to me that I can walk into a supermarket and buy any number of paracetamol packs (20 for $0.80), yet when I call into a chain pharmacy, I have to present to the back counter where a pharmacy assistant will attempt to up-sell me to a branded product.

My own small part-time pharmacy, where he knows his customers by name, will sell me 100 tabs at $3, but still gives me the “talk”. Restricting supply to a time-line will cause problems where this pharmacy (the only one in town) is only open 4 mornings a week. After noon on Thursday, you have to wait till 7am Monday.

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The fact that only 16 are available in a supermarket pack is easily overcome by buying 2 packs or going from one supermarket to another as like the example at Redbank Plains shopping centre where there is Woolies, Coles, a pharmacy, and an ALDI so in that case at least 4 packs could be purchased within 5 minutes as long as the lines at checkouts weren’t long.

So the idea that this will reduce the impact is a bit farcical as is its naivety.

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Many government actions are often more about seen to be doing something even if it is just moving chairs on the deck. It allows government to respond ‘positively’ when questioned …to reduce the potential for negative publicity by not seen to be doing anything.

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The changes seem to have be generated by studies showing that proportionally high level of females aged 12 to 19 intentionally self-poison with paracetamol. Further details are available from a report, see link on this page.

As is the case with a lot of controls, they inconvenience many in the hope of benefitting a few. Given the age demographic of those worse affected, hopefully the suggested limitations are a good chance to reduce the number of self-poisonings.

Here is a media release containing links to further documents.

Reading the Executive Summary of the report, I don’t think it clearly supports this interim decision and proposed course of action, i.e. recent purchases of packs are usually not the cause:

"These studies found that most paracetamol self-poisonings in all age groups are impulsive but with suicidal intent. It is common for these individuals to have repeated episodes of self-harm. Over half the time, the paracetamol taken in intentional self-poisoning was present in the home. Only around 10% reported recently purchasing paracetamol (usually on that day); 1 or 2 packs were purchased. "

…and there is no evidence that this approach has worked overseas:

"Due to the limited availability of published data, we were unable to identify clear trends between the level and means of access controls on paracetamol, and the incidence of poisoning, morbidity and mortality, between jurisdictions. "

… but strangely it then says this:

"Our literature review noted that reduction in pack size has been found to reduce deaths from poisonings by about a third, although effects may be less for non-lethal outcomes. "

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Thanks @Glenn61 but that makes me even more cynical with such as ‘be required to be in blister packaging’. That raises prices for packaging as well as creates waste. How many people bent on self harm might be stopped by opening blister packs? True, it might give them a few extra minutes to think about what they are doing?

My basis for being irritated about the pack mandate is that the TGA has no interest in long term meds being randomly packaged and sold in either 30s or 28s because it seems all too hard to mandate one or the other. Each year the GP has to issue an extra script for those in 28s to get multiple meds in sync and ease of management yet a speculative ‘maybe’ seems to get attention.

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Three more things that seem to be noticeable from the underlying review on which the interim decision is based. The upswing was mainly during the worst of Covid restrictions in 2020 and 2021 and in 12-19 year old females - will this continue after long-term lockdowns have ended?? Also, the main danger is the ingestion of modified release or ingestion of 25g of paracetamol or more (i.e. 50 immediate release tablets).

Also there are recommendations in the report, which for some reason are not proposed to be implemented:

Recommendation 2: Pack number limits (p.123)
Most (~95%) sales of paracetamol tablets involve the purchase of 1 or 2 packs. Making this the maximum number of packs that can be purchased in one transaction would almost certainly reduce home stockpiles, and likely also reduce the number of very large overdoses, which have much higher morbidity and risk of death. Such restrictions would also inconvenience relatively few people. Purchasing limits on many pharmaceutical agents and other items have been widely used and shown to be implementable in the recent COVID-19 pandemic.

Recommendation 4: Age restrictions (p.124)
There is research from Denmark (Morthorst et al., 2020) showing that an 18+ age restriction on the purchasing of over-the-counter non-opioid analgesics resulted in a significant decrease in non-opioid analgesic poisonings among 10-17 year-olds. Given that paracetamol self-poisoning is most common among adolescents and young people, an age restriction on paracetamol and similar over-the-counter non-opioid analgesics should be considered. However, any effect of such restrictions would be modest, as most paracetamol ingested in self-poisoning is already purchased and present in the home. Moreover, whereas scheduling based on the age for whom medicines are indicated is common, it would need to be determined whether scheduling based on the age of the person to whom a medicine is sold in real time is feasible.
(if continued to be sold in supermarkets, certain meds could be placed at the front with the tobacco products? so as they don’t go to anyone under the age of 18?)

and ibuprofen is safer in overdose so maybe this is a better product for supermarkets?:
Substitution and OTC analgesics (p.127)
Ibuprofen is much less toxic in overdose but has more adverse drug effects in therapeutic use. Aspirin is roughly equally toxic in overdose to paracetamol but is much less commonly used as an analgesic, and it also has more adverse drug effects with therapeutic use. Were the access to paracetamol following this report changed, an overall shift in the preferred over-the-counter analgesic may not be desirable. However, our review of the literature does not indicate that method substitution is likely.

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Looking at the statistics and toll on the community, it’s difficult to understand how the proposed changes will create better outcomes. There are many significant factors in why self harm is occurring. Partially restricting access to paracetamol we nearly all use at some time without issue suggests over-reach. Especially given the diversity of feedback the TGA has received in the public submissions.
Published responses for Public consultation on proposed amendments to the Poisons Standard (paracetamol) - ACMS, November 2022 - Therapeutic Goods Administration - Citizen Space

The views range from numerous everyday users requesting no change to some declared medical professionals agreeing with restrictions including to only over the counter sales.

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But that is usually the problem. The government provides no justification on the basis of how many lives will be saved v. how many customers will be inconvenienced. It becomes a real “somebody think of the children” argument from the government.

With respect, I object to that. I personally won’t be affected at all but that doesn’t mean I don’t have any issue with the (hypothetical) changes!

I think the OP nails it:

so options for mild-moderate pain relief in an ageing population are being further restricted

With an ageing population and more and more people on long term pain relief for that or other reasons, there is a serious non-monetary cost to making life even more difficult for them. It will require these people to be more organised and many people are not.

In the context of non-prescription behind-the-counter medicines, it’s important to distinguish between

  • medicines that are behind the counter but don’t require any interaction other than asking for them and getting a cursory interrogation from the person behind the counter, and
  • medicines that require presenting a Medicare card in addition to the previous.

If a Medicare card is required then it is used for centralised monitoring, so that shopping from one pharmacy to another should be impossible, but increases the burden on pharmacies. (Of course that’s more surveillance …)

Indeed. I too have contacted the relevant part of government to at least express my objection to the mooted change.

Presumably if the government actually goes ahead with this then supermarkets will be obliged to limit a purchase to 1 pack. Supermarkets have shown themselves through the pandemic to be capable of implementing pack limits.

It isn’t obvious though that you can’t just go in a loop: buy a pack, go through checkout, put in car i.e. even with only one supermarket available (particularly as many supermarkets allow self serve now but I guess “restricted items” could be blocked from self-serve checkouts, with future software changes?) Just don’t use your (Woolworths) Everyday Rewards Card or (Coles) Flybuys Card.

Another challenge is that paracetamol is very widely available in people’s houses. Hands up anyone who has zero paracetamol packs at home!

So if a 19-year-old female is determined to commit suicide using paracetamol then presumably when visiting grandma she can just “borrow” grandma’s legitimate stash of pain relief.

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Maybe worth pursuing. Require the pack to say: Overdose on paracetamol is a crap way of committing suicide. (Not in those words necessarily.)

However that does highlight that overdose on paracetamol is a way of committing suicide i.e. it’s advertising.

So would it save more lives than it costs?

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Maybe a mandatory printed statement on the paracetamol outer pack, such as - “overdosage can cause lifelong liver problems”*

It’s less about stopping people who extensively plan a suicide, and more about people who have spurs of the moment.
content warning, suicide

When people plan to commit suicide, hanging is one of the more regular choices that results in a completed suicide. People who take an overdose of medications often have a managed mental health condition that results in occasional strong mood swings. During those swings, people generally don’t do things like go out and buy tools to undertake suicide. They just reach for whatever is available, such as paracetamol.

Currently, people have large quantities of paracetamol in their home because it’s easy to buy in this format. Example: “I sprained my ankle so I’ll buy a 50 pack because it’s cheaper per pill.” When someone in the home has a rough patch, it’s an easy thing to reach for. If that’s a 16 pack instead, you remove a way that person can hurt themselves before their mood improves.

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I just had a thought, if the government negotiated with industry for a good price and put 24 and 50 packs on the PBS then the price per pill would drop to near what it is for the 100 pack, so people would be less encouraged to get an excessively large pack. Secondly, GPs could then prescribe a lesser quantity, which would be useful with short term pain, so they won’t have the rest of the pack lying around after. It may be that adolescents reach for the parents’ packs and this may be a source for them?
They could also put a 50 or 100 pack of ibuprofen 200mg on the PBS, so it is lying around rather than a large pack of paracetamol…
However, this requires the PBS to be on board, which is a separate branch to the TGA in Health with a separate leadership structure, unfortunately.

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I knew a gent many years ago who had a ‘spur of the moment’ in the USA. He bought a gun and killed himself hours later. Paracetamol? I cannot imagine that would be a choice for an effective ‘spur of the moment’ so I’ll not debate that possibility.

People do all sorts of things on ‘spur of the moment’ from assault to a large gambling punt to a holiday trip to buying a new vehicle to abandoning a family to ghosting a relationship to name it. Not all are equal in affect. Should they all or any be covered in ever more legislation and restrictions and what is the litmus test to add them to the list at ‘page 1 thousand’? Not intended to be flippant, just reality that it is impossible to stop people from doing a wrong thing every time and in the situations cited here access to mental health support and a less angry society seems more effective, although the latter may be beyond reach.

As an analogy some may reject, many road rules are predicated on the basis that every vehicle will crash so the rules protect all of them. In reality those who do crash may or may not care about any of the voluminous rules.

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Do we really understand the circumstances. It’s only human to think the cause is something we can control, rather than something we can not.

There is some history of self harm within the extended family. No paracetamol was required. It has touched 3 generations and 11 lives. One could ban farm dams and pebbles, ropes, railway locomotives or … All exceptionally tragic loses at one time or another over several generations. There are many avenues, opportune or presumptive. And certainly great personal pain and grief for those who are left behind.

I’ll say what I think. It’s an ill considered response that will disproportionately affect all with an uncertain outcome for those at risk of self harm. If instead the effort went into providing support to treat the underlying causes in the community and individually, perhaps we’d not be so readily distracted from the greater need.

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