Rationale for TGA decision

3. Rationale for TGA decision

The TGA decision was based on an extensive review of evidence and consultation. The rationale for rescheduling included:

  • There is a lack of evidence that codeine in low doses provides any more pain relief than medicines that do not contain codeine.
  • There is extensive evidence of harm caused by the overuse and abuse of over the counter codeine-containing medicines.
  • Codeine demonstrates marked variability in its metabolism to morphine in different individuals, with the potential for severe toxicity in ultra-rapid metabolisers at recommended doses. This applies to medicines intended for treating coughs and colds, and those intended for the treatment of pain.
  • Low-dose codeine is capable of producing dependence at recommended doses and, in overdose, respiratory depression and reduced level of consciousness and death.
  • The medicines combined with codeine in OTC combination medicines, such as paracetamol and ibuprofen, can cause significant harms when overused. Over use of paracetamol is associated with liver damage and overuse of ibuprofen is associated with gastrointestinal perforation and kidney damage.
  • Low dose codeine is intended for the short term relief of acute pain only; however their availability over the counter has seen a significant increase in their long term use for the self-treatment of chronic pain despite these medicines being intended for the short term relief of pain only.  This can lead to patients inadvertently becoming addicted to codeine.
  • The risks associated with unregulated codeine use, such as dependence, toxicity and death, are too high.
  • The use of and harms from opioid analgesics in Australia increased considerably from 2001with the over the counter availability and affordability being suggested as one of the main driving factors for this.
  • The availability of safer and effective analgesics for temporary relief of pain (such as combination paracetamol-ibuprofen).
  • Substantial health economic benefits will result from the rescheduling, $5.3 billion nationally over 10 years. (2)

Further information regarding the TGA decision is available at www.tga.gov.au/scheduling-decision-final/scheduling-delegates-final-decision-codeine-december-2016.

Further information regarding the health economic benefits is available at www.tga.gov.au/publication/economic-modelling-and-financial-quantification-regulatory-impact-proposed-changes-codeine-scheduling.

4. Chronic pain and the use of OTC CACCs

Chronic pain is an important public issue. One in five Australians will suffer chronic pain in their lifetime, with up to 80 per cent missing out on treatment that could improve their quality of life (12).

Access Economics estimated that chronic pain costs the Australian economy $34 billion a year in 2007 and was the nation’s third most costly health problem (13).

The National Pain Strategy recognises the importance of a whole-of-system response to pain to improve quality of life for people with pain and their families, and to minimise the burden of pain on individuals and the community (12).

Individuals take OTC CACCs for many reasons. These include for the relief of acute pain, chronic non-cancer pain, or cancer-related pain; and for reasons other than relieving pain, such as for intended intoxication.

Most people taking OTC CACCs will be at low risk of harm, with infrequent use within the recommended dosage range for the relief of short term pain.

Despite this some individuals may develop a pattern of use over time that increases the risk of harms.

These harms include codeine dependency which can occur within the recommended dosage range of CACCs. Frequent use of OTC CACCs within the recommended dosage frequency can lead to dependency over time regardless of the reasons for use. (14)

Some individuals taking CACCs will have a pattern of use associated with a higher risk of harm. Misuse can be defined as consumption outside of acceptable medical guidelines, medical direction or indication; when self-medicating at higher doses and for longer than recommended; or for intoxicating purposes. (14)

Studies of codeine dependent individuals identify three patterns of use of OTC CACCs:

  1. Regular use within recommended therapeutic doses, despite limited effectiveness to treat underlying medical condition.
  2. Recreational codeine use without a medical reason, including time-consuming extraction of codeine from CACCs.
  3. Daily use exceeding recommended therapeutic doses, often very high doses and at risk of severe harms. (15,16)

There are many published case reports and series including individuals who have experienced serious harm(s) who are taking large amounts of OTC codeine-ibuprofen analgesics of up to 90 tablets a day (15,17-22).

A web-based study of 800 people in Australia who self-reported OTC CACC use found a higher proportion of women and higher proportion of unemployed compared to the general population.

Seventeen per cent of individuals taking OTC CACCs were assessed as dependent on codeine. Individuals taking OTC CACCs who were assessed as dependent on codeine were more likely to be younger, have lower levels of employment and education, report chronic pain, have poorer overall health and mental health compared to individuals not dependent on codeine.

Additionally, those individuals dependant on codeine were more likely to have sought help for a previous alcohol and other drug problem than those not dependent on codeine. There was no difference between the codeine dependent and non-dependant individuals in the proportion that had ever used illicit drugs. (18)

5. Extent of OTC codeine containing medicine sale and related harms in Tasmania

There are an estimated 380 000 to 460 000 packets of OTC CACCs and 120 000 to 145 000 packets of OTC codeine containing cough and cold medicines sold each year in Tasmania. This is on average more than one packet per year per person in Tasmania.

Between 12-17 per cent of people buying OTC CACCs are likely to be dependent on codeine and at risk of serious harms (2,18).

The National Drug Strategy Household Survey 2013 reported “pain-killers/analgesics” were the most commonly misused pharmaceutical drug for non-medical purposes, misused by 3.3 per cent of Australians aged 14 years or older, with one third of misuse involving OTC CACCs (23).

Modelling based on these findings and reported national data, estimates that over 5 000 Tasmanians are taking OTC codeine medicines for non-medical purposes and these people are likely to be dependent on codeine and at risk of serious harms.

This averages out to about 30 customers per pharmacy and eight patients per GP in Tasmania. These numbers may be higher, as codeine use is higher in regional and rural areas, and in populations of lower socio-economic status (24).

There is evidence that opioid dependence arising from the use of OTC CACCs is an increasing problem (25). A study of clients admitted to a New Zealand and an Australian detoxification unit in 2010 found that 8% of new attendees received care for a dependence on OTC CACCs (22). Anecdotal evidence from the Tasmanian Alcohol and Drug Service is that around 10 per cent of their clients present as a consequence of a dependence on OTC codeine containing analgesics.

Serious complications are common in people who are dependent on OTC CACCs. A study of the patients attending the Drug and Alcohol Services of South Australia over a five year period with primary codeine dependence who abused OTC CACCs found that 87 per cent of those abusing ibuprofen-codeine containing analgesics experienced serious complications; including gastrointestinal blood loss or perforation, anaemia and kidney damage.

Of the 60 patients abusing ibuprofen-codeine containing analgesics identified, two deaths occurred. (17)

A recent study conducted at the Royal Adelaide Hospital (590 beds) identified 99 admissions involving 30 patients over five years with harms associated with OTC CACCs.

Surgery was required for 13 per cent of admissions and intensive care was required for 10 per cent of admissions. The mean length of stay per admission of was six days. The average cost per admission was $10 183. (21)

Coding of the reason for emergency department presentation or hospital admission in Tasmania does not allow specifying harms related to OTC CACCs. As a result it is difficult to reliably determine clearly the burden on our hospitals related to OTC CACCs.

Despite this, Tasmanian gastroenterologists report they are seeing ongoing cases of significant gastrointestinal morbidity related to the overuse of OCT codeine-ibuprofen combination analgesics.