The recent TGA decision to defer the rescheduling of codeine-containing OTC medications conflicts with rising codeine analgesics misuse, its devastating consequences and the recognition that opioid misuse is a public health concern.

Further, the TGA’s own acknowledgement of low dose codeine efficacy, genetic variances in codeine metabolism and established misuse side-effects from combination OTC products, gives little credence to the notion of further delay for ongoing review.

According to ScriptWise CEO, Ms Bee Mohamed, while ScriptWise agrees with the need for a holistic and comprehensive approach to prevent spiraling codeine analgesic misuse, further delays will only serve to undermine an already challenging situation.

“While we support the implementation of a real-time monitoring system, we have very real statistics today which require immediate solutions.

“Any ongoing review needs to be conducted sooner rather than later, and agreement between medical, pharmacy and patient support groups must be achieved,” Ms Mohamed said.

“A coordinated approach is not only pivotal to preventing prescription or OTC medication addiction and overdose, but also for ensuring treatment options are made available to patients at-risk of addiction.”

Sydney-based Addiction Medicine Specialist, Dr Hester Wilson, says from a medical point-of-view, the efficacy of codeine itself as an analgesic is questionable, and there are high risks associated with misusing combination products.

“There is a two-fold issue with codeine in OTC products. Firstly, it increases dependency on the medication, which leads to people exposing themselves to higher than recommended levels of NSAIDS or paracetamol, leading to gastrointestinal bleeding and liver damage respectively.

“At very low doses, such as those found in combination OTC analgesics, there is very little evidence for codeine benefit above its NSAID and paracetamol co-compounds, with many studies showing efficacy only in higher, prescription-only combinations,” said Dr Wilson.

“Further, we know many people can’t metabolise codeine. This means codeine, which is a ‘prodrug’ and therefore not active, isn’t broken down to the active drug. Hence it doesn’t relieve pain. Others, however, are ultra-rapid metabolisers to the active drug, and as a result, see rapid breakdown to morphine, which can lead to serious respiratory depression and even death.”

With the marked increase in pharmaceutical opioid use associated with chronic pain over the last decade, national figures show painkillers and analgesics are the most commonly misused pharmaceuticals.1

Estimates suggest approximately 10 per cent of patients with chronic, non-malignant pain who use opioids long-term, become dependent on their medications.2

“To date, there remains no official way to keep track of opioids, benzodiazepines or OTC codeine sales and health professionals are unable to identify individuals who are at risk of developing dependency on such medicines,” Ms Mohamed said.

“We know there’s been a 15-fold increase in PBS dispensing of opioid painkillers in the last two decades,3 with approximately 7.5 million annual opioid sales,3 however, tracking people buying OTC analgesics is not a simple task, with many of them shopping from multiple pharmacies.

“Studies also indicate about three-quarters of OTC codeine abusers do not seek help for their dependence,so many of these people remain hidden from health professionals,” said Ms Mohamed.

“Reports reveal people who are dependent on non-prescription, OTC compound codeine analgesics can take between 30-to-60 tablets per day,5 placing their lives at risk.”

Dr Christian Rowan, Addiction Medicine Specialist, Brisbane, says irrespective of rescheduling delays, opioid misuse remains a public health issue requiring a multifaceted approach.

“People who have developed dependency, first and foremost, need access to evidence-based treatments.

“Whether people have recognised dependency themselves based on the number of tablets they’re taking, or by signs of physical or psychological harm, or whether their dependency is identified by a family member,  friend, or a treating health professional, ensuring people get access to treatment is vitally important,” Dr Rowan said.

“Real-time monitoring is required across all jurisdictions for both OTC and prescription opioids.

“Further, increasing access and treatment options for people with dependency is needed not only in urban, but also regional and rural communities,” said Dr Rowan.

“Together with maintenance treatment, other pharmaco-therapeutic options and psychological therapies, people can recover from opioid dependency.”

Ms Mohamed says working with Government and GPs to identify and overcome restrictions impeding access to opioid dependency treatment is paramount.

“It’s common to have several discussions with a patient before GPs agree to treat them with opioid substitution therapy, and it can often take three-to-six months from first contact, to time of first treatment.

“We need an immediate, collective effort from Government, medical and pharmacy professionals as well as the pharmaceutical industry, to ensure consumers are aware and informed about the devastating consequences of misusing these medications, and to seek the professional help, that will ultimately save their lives.”


  1. [Last accessed Nov, 2015].
  2. Medicine Today Supplement. Prescription opioid misuse – Contemporary challenges. 2015. Available at: [Last accessed Nov, 2015].
  3. Blanch B, Pearson SA, Haber PS. An overview of the patterns of prescription opioid use, costs and related harms in Australia. Br J Clin Pharmacol 2014 Nov;78(5):1159-66. doi: 10.1111/bcp/12446.
  4. Nielsen S, Cameron J, Pahoki S. Over the counter codeine dependence. Turning Point Alcohol & Drug Centre Victoria. 2010. Available at [Last accessed Nov, 2015].
  5. Frei MY, Nielsen S, Dobbin MD, Tobin CL. Serious morbidity associated with misuse of over-the-counter codeine-ibuprofen analgesics: a series of 27 cases. Med J Aust 2010;193:294-6.