The 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, says a not-for-profit organisation committed to raising public awareness of prescription medication addiction.
The TGA recently deferred its decision on whether to upschedule these medicines. A final decision will not take place before June 2016 and if OTC codeine is upscheduled, this will not occur until 2017. Since the interim decision was published, there were 127 public submissions, of which 113 did not support the upscheduling proposal.
Stakeholders including the Pharmacy Guild are now working on a real-time monitoring system for OTC codeine sales in order to combat addiction and misuse problems.
But according to ScriptWise, 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.
ScriptWise CEO Bee Mohamed says that 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,” she says.
“Any ongoing review needs to be conducted sooner rather than later, and agreement between medical, pharmacy and patient support groups must be achieved,” Mohamed says.
“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,” she says.
“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,” says 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.”
According to the AIHW, painkillers and analgesics are the most commonly misused pharmaceuticals.
“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,” Mohamed says.
“We know there’s been a 15-fold increase in PBS dispensing of opioid painkillers in the last two decades, with approximately 7.5 million annual opioid sales, 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,” says Mohamed.
“Reports reveal people who are dependent on non-prescription, OTC compound codeine analgesics can take between 30 to 60 tablets per day, placing their lives at risk.”
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.”