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Right: Public Health Association CEO Michael Moore: "... sale of codeine products should not be determined by the loss of profit to manufacturers and pharmacists ...".

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Arguments opposing the over-the-counter sale of codeine products

1. Codeine can be highly addictive
For therapeutic users of codeine, the addictive qualities of the drug can be a significant problem.
Inside the body, codeine is partially metabolised to morphine, which can produce feelings of relaxation and euphoria. As a result, some people increase their use of codeine-containing medications.
Australia's Therapeutic Goods Administration (ATG) has stated, ' Low dose codeine-containing medicines are not intended to treat long term conditions, however public consultation indicated that many consumers used these products to self-treat chronic pain. This meant that consumers frequently became addicted to codeine.'
Dr Hester Wilson, a GP and addiction medicine specialist has noted that with some individuals, addiction can occur within days. Dr Wilson has stated, 'I think many of us take a casual approach to painkillers... but up to 50 per cent of people who use opioids for more than a few days have a real risk of becoming dependant.'
Over the past 10 years drug services have reported a tripling of people presenting with codeine dependency.
The addictiveness of codeine means that some people have taken up to 100 tablets a day, which they have collected over the counter from multiple pharmacies. A family who wrote to Australia's Therapeutic Goods Administration (TGA) said their son would drink the entire contents of a 200 millilitre bottle of cough syrup in one sitting several times a week, or alternatively, buy 48-tablet packs of Panadeine Forte or similar pills.

Less dramatic instances of codeine addiction can also be highly debilitating. A Sydney Morning Herald report published on December 31, 2017, noted the situation of Leah O'Dwyer who over the last four months had been able to wean herself off codeine, after she heard her pills would no longer be available over the counter. She went to visit one of her pharmacists and told her: 'I have a problem, please help me.' It was only as she gradually took herself off the drug, transitioning to Panadol and ibuprofen, that she realised how addicted she had become. Ms O'Dwyer said, 'The little voice in my head that said "Just go get some codeine" was there for the entire time.'
In terms of avoiding codeine dependency, it has been noted that doctors are able to prescribe alternate medications for opioid-responsive pain that are less addictive than codeine. Professor Hogg, a Painaustralia? board member and head of pain services at the Royal Melbourne Hospital, has noted that buprenorphine and tapentadol are both opioid medications which are 'less dependence forming' than codeine.

2. The dependency-based use of over-the-counter codeine medications is growing dramatically in Australia
Those who want the over-the-counter sale of codeine products banned in Australia point to the increased incidence of codeine dependency brought about through the use of medications bought without a prescription.
In September, 2017, the Australian Drug Foundation (ADF) released a report titled 'Is there a pill for that?...the increasing harms from opioid and benzodiazepine medication.' It warns, 'At the Alcohol and Drug Foundation, we believe pharmaceutical misuse is Australia's fastest-growing drug problem. The number of people dying after taking codeine has doubled in the past decade...' There are over 5 million over-the-counter sales of Nurofen Plus, Panadeine, Mersyndol and Codral in Australia each year.
The ADF report further noted, ' Some medication misuse is deliberate, for example when people take a pharmaceutical drug for a euphoric or other psychoactive effect. In 2013, over 200,000 adult Australians reported deliberately misusing over - the - counter codeine analgesics.'
The ADF report additionally warned, ' Public alcohol and drug clinics reported a fourfold increase in the number of treatments where codeine was a drug of concern between 2003 - 04 to 2013-14.
An editorial published in Australian Prescriber on January 23, 2017, states, 'The proportion of people seeking opioid substitution treatment for codeine dependence in Australia rose from 2.7% in 2014 to 4.6% in 2016. A study in Sydney reported that codeine was the sole substance used by 39% of patients with a pharmaceutical opioid dependence and 83% of these patients were using only over-the-counter codeine. At a drug dependence unit in South Australia, the annual incidence of codeine dependence requiring intervention increased from 31 people in 2003 to 174 in 2014. The estimated cost of treating 30 patients with codeine-related admissions in one Adelaide hospital was over $1 million.4 In 2013 the National Drug Strategy Household Survey reported that 33% of the people who had misused pharmaceuticals had used over-the-counter codeine-containing analgesics. This increased to 75% in 2016.6.'

3. Codeine medications and codeine-combined medications can result in organ injury or death
Taken beyond the recommended dose, both codeine and medications in which codeine is combined with either paracetamol or ibuprofen can be fatal or cause serious organ injury. There is data to suggest that these products present a similar risk of death as heroin abuse.
There were 1917 recorded deaths involving either over-the-counter products containing codeine or Oxycodone between 2007 and 2011. In the same time period, 1127 people died from heroin abuse.
Royal Australian College of General Practitioners vice-president, Edwin Kruys, has stated, 'Up to 150 Australians are now dying from codeine-related overdoses every year - double the number 10 years ago - and many more people are seeking help for codeine addiction. So it's vitally important that the people affected by the end of over-the-counter sales get appropriate advice on alternative medications and are directed to their GP for further support and advice as necessary.'
A comment and analysis published in The New Scientist on January 3, 2017, noted what it referred to as the 'double whammy' effect, that is, those who over-use combination drugs containing codeine are harmed by both the codeine and the other drug with which the codeine is mixed. The New Scientist report stated, ' When people start taking high doses, codeine can cause severe breathing difficulties. But there is another harmful effect for people who become addicted. Over-the-counter drugs that contain codeine also often contain other drugs like paracetamol (acetaminophen) or ibuprofen, and as a person increases their use of these, they can experience liver, gut or kidney damage.
A recent study found that paracetamol or ibuprofen was involved in 55 per cent of the 1200 codeine-related deaths recorded in Australia between 2000 and 2013.
Michael Vagg, a pain specialist in Geelong, has stated, 'Every hospital in Australia will tell you stories of addiction to such combined drugs. You often see it in young women. Some have to be tube-fed because their guts are so damaged. Others have to go on dialysis because their kidneys are wrecked.'

4. Much of the pressure to retain over-the-counter sale of codeine products comes from groups concerned to protect their profits
Supporters of the banning of over-the-counter sales of codeine products argue that some of those bodies arguing for their continued sale are concerned to preserve their profits.
In November, 2015, Australia's Therapeutic Goods Administration (TGA) agreed to the postponement of a ban in response to lobbying from the Pharmacy Guild, the Pharmaceutical Society of Australia and the Australian Self Medication Industry.
The Royal Australian College of General Practitioners claimed that much of the opposition to the ban was commercially motivated, arguing over-the-counter medications are 'big business and as a result there is likely to be significant pressure to resist rescheduling these medications'.
Similarly, Public Health Association of Australia chief executive, Michael Moore, has urged that the decision to end over-the-counter sale of codeine products should not be determined by the loss of profit to manufacturers and pharmacists or the increased demands on the government health budget to cover Pharmaceutical Benefits payments and Medicare costs.
Mr Moore stated, 'I think there's a fine balance in pharmaceuticals between industry profits and what's the most effective way to deliver pharmaceutical goods to the consumer, it ought not to be just about how that affects industry or jobs.'
The Therapeutic Goods Administration's (TGA) principal medical officer, Dr Tim Greenaway, has explained the decision to ban over-the-counter codeine sales, stating, ' It's important that people realise that the decision's been taken based on safety predominantly and based on the risk of abuse... The decision's been made on the basis of patient safety; the bottom line of pharmacies, for example, is not a consideration that has been taken into account.'
Responding to changed market conditions, the maker of Panadeine products, GlaxoSmithKline, has ceased manufacturing those products, declaring it will pull them from Australia. Other companies are believed to be reformulating popular brands by removing the codeine so they can still be bought over the counter.

5. There are more effective alternative treatments to manage pain
It has been claimed that unprescribed codeine is not a particularly effective pain treatment for chronic pain and that sufferers would be better to get medical advice regarding their pain management. It has also been argued that once codeine is no longer an over-the-counter medication, there are other effective medications available to people to treat short-term pain.
Pain medicine specialist, Dr Michael Vagg, has explained that codeine purchased over the counter was in such low doses that some people may find themselves taking more and more to produce meaningful pain relief. It has been suggested that doing this is a dangerous procedure, not only because it creates a risk of addiction or overdose, but also because it leaves the cause of the pain and other forms of pain treatment unexplored.
Dr Vagg has stated, ' If you have severe acute pain and the simple analgesics are not cutting it, you are better off going to your doctor to get a diagnosis and prescription. With persistent pain, that advice is even more important. Trying to manage long-term persistent pain with lots of doses of short-acting analgesics is not the best approach.'
Dr Chris Hayes, Dean of the Faculty of Pain Medicine (FPM), has advised that anti-inflammatory drugs or paracetamol provide better pain relief without the risk of codeine addiction.
Dr Hayes has stated, 'For acute pain most of the studies show that the combination of paracetamol and anti-inflammatories works as well, if not better, and without the risks of codeine [addiction].' Dr Hayes has further noted, 'In the chronic pain situation, codeine doesn't work well anyway.'
Codeine is a short-acting analgesic that is metabolised very differently by different individuals so that the level of its active constituent, morphine, that is released varies dramatically from one person to another. It generally should be not be used for managing chronic pain. Chronic pain sufferers using codeine often find that they need to take larger and more frequent doses to obtain relief.
Australian Medical Association president, Dr Michael Gannon, has stated, 'For those people who have historically used Panadeine or Neurofen Plus, rather than plain Panadol or plain Neurofen, the evidence shows that for the overwhelming majority of people the combinations containing codeine are no more effective.'
In addition to other medications, chronic pain sufferers can gain relief from psychological techniques; pacing activities; physiotherapy; relaxation techniques such as meditation; and
exercise such as walking, swimming, cycling or tai chi.