With the increasing sophistication of clinical trials, the medical world and the better educated general public with easy access to Dr Google is becoming more aware of the potential complications and long-term side effects of chronic pharmaceutical therapy.

Also, with increasing longevity, many people are suffering chronic illnesses and require multiple therapies for relief and treatment of their underlying conditions.

One of the commonest medical problems in modern society is that of chronic pain. It is estimated that around 3 1/2 million people living in Australia suffer some form of chronic pain e.g. arthritis, back pain and headaches.

For many years, the only “go to” painkillers were aspirin and paracetamol. When I started medicine in the 1970s, we were just becoming aware of the pervasive effects of analgesic abuse with the use of Bex and Vincents powders, which, at times, led to chronic kidney failure, if taken regularly.

High dose aspirin therapy and moderate dose paracetamol were the mainstays of therapies for acute pain and in some cases were even used for chronic conditions to alleviate discomfort.

The Therapeutic Goods Administration will be meeting in mid-November to discuss limiting the access to paracetamol. The reason for this is that over the past 12 months in New South Wales and Victoria alone there has been around 7000 cases of paracetamol overdose.

Paracetamol is touted as a gentle to the stomach pain killer but many people do not realize that in doses greater than 2 to 3 g per day, there is a real and definite risk for liver disease.

A small but significant number of people also take a large dose to induce self-harm or potentially even commit suicide. Many groups are pushing for paracetamol compounds to be restricted to avoid people stockpiling the drug and also to try to limit access to stronger doses. Interestingly, over the last 10 years the rates of paracetamol overdose have increased by 98%.

I have attached the proposed amendments to paracetamol access.

Proposed amendments to the Poisons Standard

Option 1: Requirement for paracetamol to be sold in blister packs.

• Option 1A: Solid dose paracetamol (tablets/capsules) should only be available in blister packs for general sale preparations.
• Option 1B: Solid dose paracetamol (tablets/capsules) should only be available in blister packs for general sale and in pharmacies.
• Option 1C: Solid dose paracetamol (tablets/capsules) should only be available in blister packs from all points of purchase.
• Option 1D: All solid dose preparations of paracetamol, including prescription and non-prescription preparations should only be available in blister packs from all points of purchase.

Option 2: Restrictions on paracetamol pack sizes.

• Option 2A: The maximum paracetamol pack size should be reduced to 10 x 500 mg tablets/capsules or 5 individually sachets for general sale preparations.
• Option 2B: The maximum paracetamol pack size should be reduced to 32 x 500 mg tablets/capsules or 16 individually wrapped sachets for pharmacy only preparations

Option 3: Restrictions on purchase of paracetamol packs.

• Option 3A: Allow only one pack to be purchased at a time without a prescription in pharmacies and for general sale.
• Option 3B: Allow only one pack to be purchased at a time without a prescription in preparations for general sale.

Option 4: Prevent display and self-selection of paracetamol from non-pharmacy outlets i.e. require paracetamol to be purchased from behind the counter.

Option 5: Age restrictions on purchasing paracetamol.

• Option 5A: Restrict minimum age of purchase to those 18 years and over in pharmacies and for general sale.
• Option 5B: Restrict minimum age of purchase to those 18 years and over in preparations for general sale.

Option 6: All modified release paracetamol should be rescheduled from Schedule 3 to Schedule 4 (prescription only), without change to maximum pack size.

Reprinted form SMH article-Nov 6^th 2022

Analysis of a study of low-dose aspirin [only 100 mg and not in doses that would alleviate pain] examined 6703 Australians over the age of 70 followed for somewhere between 4 to 6 years in a placebo-controlled trial and found that 1400 of these people required hospitalization for a fall. Those taking low-dose aspirin were 10% more likely to suffer a fall during the trial.

I would suggest the reason for this statistic is not that aspirin increases your risk for falling but it certainly increases your risk for bleeding when you fall and thus necessitating the need for hospitalization.

Regardless, it is important to realize that all forms of pharmaceutical therapy have a potential risk. Even consistent doses of more than four standard 500 mg paracetamol per day may increase the risk for liver damage. Taking a lethal overdose may even induce liver failure.

Aspirin therapy, even in the dose of 100 mg daily, may induce significant gastrointestinal bleeding. The anti-inflammatory, pain relieving doses of 600 mg 2 to 3 times per day, makes the risk for gastrointestinal bleeding very significant.

There are multiple other potential side effects from these very commonly used painkillers, thus the need for medical supervision with anything other than occasional doses.

I'm certainly not in favour of the nanny state controlling all of our behaviors but do believe we need to have a strong debate about the use of all drugs and their potential risks. 

A few years back, all codeine containing pharmaceuticals were taken off the shelf and made prescription only in an attempt to minimize the risk of abuse from a very small proportion of the population. Although there was a reasonable argument to support this act, it meant that many people would have to make a doctor’s appointment to obtain a script for an ibuprofen-codeine combination to relieve acute pain. In my view, this made the busy GP’s life, even busier.

It has been said that “always the needs of the many outweigh the needs of the few”, but this certainly does not appear to be the case with the new legislation around all pain killers. I totally agree that we always need to minimize harm and risk but also feel the need for common sense around the debate when it comes to how we obtain painkillers for the very common conditions of acute and chronic pain.