Patients using codeine-based painkillers or cough suppressants will soon need a prescription from their doctor, if the recommendations of an interim report are put in place.
The Federal Government’s medicines regulator, the Therapeutic Goods Administration (TGA), has been considering whether to reclassify drugs such as Neurofen Plus or Panadine Extra because of the risk of harm, addiction or overdose.
The interim report from its Advisory Committee on Medicines Scheduling recommends making codeine-based products prescription only from June next year.
The report lists the risk of a severe adverse reaction, misuse or abuse, and the “relative lack of efficacy compared to safer products”.
“There is also a lack of evidence of any benefit of codeine over placebo in the relief of cough, making the risk/benefit profile for this indication unfavourable,” the report said.
The Australian Medical Association said it backed the TGA to make an appropriate decision.
“The evidence is the key to making the decision here — it’s not about anyone’s interests other than the patient,” AMA vice-president Dr Stephen Parnis told the ABC’s AM program.
He said patients suffering from chronic pain needed a treatment plan that was much more comprehensive than just over-the-counter medicines.
“One of the issue about the use of codeine is that it should only be used, if over-the-counter, for short-term pain relief, and yet it appears from the evidence that it’s used for longer term relief,” he said.
“The other issue is that there might be more suitable alternatives to be used, such as anti inflammatories combined with paracetamol, which don’t carry that risk of harm,” Dr Parnis said.
Codeine products ‘come in handy’ for patients
But the Pharmacy Guild of Australia said codeine products did make a difference, and making them prescription-only would increase the workload for doctors and force up Medicare costs.
“The majority of people do use these quite safely and wisely,” guild president George Tambassis told AM.
“They do look after the pain of a lot of people out there that perhaps paracetamol and aspirin and maybe the anti-inflammatories that we’ve also got to choose [from] in terms of our recommendations do not.
“So I can’t agree with some of the data that they may have access to because at the pharmacy level we do find these products do come in handy for a lot of patients out there.”
The guild has been calling for a real-time monitoring system to help pharmacists make sure patients are using the drugs correctly.
A similar system is already in place to keep track of the drug pseudoephedrine, which can be used to make illicit drugs.
“If we pick up on these people that are either using these products too much or it’s obvious that they’re addicted to them, we’ll deal with that if we have the data in front of us,” Mr Tambassis said.
‘No evidence to date of any abuse’
The industry body representing manufacturers of over-the-counter medicines says it strongly supports such a monitoring system.
The Australian Self Medication Industry (ASMI) said the recommendation in the interim report to reschedule codeine-based cough suppressants was particularly baffling.
“Because there’s been really no evidence to date of any abuse of those medicines, so that was really a surprise decision,” ASMI CEO Deon Schoombie told AM.
“Scheduling we believe is a very blunt instrument and also there’s absolutely no guarantee, by moving it into prescription-only medicine, that that will address the risk [of addiction or misuse].”
He said it was “totally unrealistic” for the industry to make the proposed changes by the suggested deadline of June next year.
“The plans for the 2016 cough/cold season are already underway in terms of product orders, printing of labels, etc, so the logistics around that is quite complex and complicated,” Mr Schoombie said.
The TGA will accept submissions about the interim report until October 15, before it makes a final decision in late November.