Pain physicians are floating the idea that low-dose tramadol could be down-scheduled to meet a need for moderate analgesia in the wake of Australia’s OTC codeine ban.

Victorian pain physician Dr Michael Vagg says talk in pain medicine circles has centred around which medications could be appropriate contenders to replace  low-dose codeine, with tramadol being seen as the “obvious” frontrunner.

As a non-opioid with only weak affinity for opioid receptors, tramadol has lower risk for addiction and misuse than codeine – though it does carry a higher risk of interactions with other medicines, Dr Vagg says.

“We don’t have a lot of data for low-dose tramadol preparations so those studies would need to be done, but what I know from a lot of experience is that there are patients who will respond to low dose tramadol and if that’s done responsibly that’s not an unreasonable thing to consider,” he told the limbic.

However he emphasised this was his personal view not that of the Faculty of Pain Medicine, of which he is a spokesperson.

“If you are looking at what companies could do to replace over the counter codeine, pushing for a down-scheduling of lower dose tramadol, if they have appropriate evidence of safety and efficacy would be the obvious thing I would imagine they would do.”

“If you had a 25 mg tramadol [tablet] you could get over the counter in packs of ten say, I think you could make a case that if it was done responsibly that might be a useful thing.

The rationale for tramadol replacing codeine comes down to the different mechanisms of action, says Dr Vagg.

“When you actually look at the pharmacology of the drugs codeine is a very weak opioid as far as pain relief goes, (however) it actually has strong opioid effects at other receptors not to do with pain and that’s why it remains a significant addiction risk.

“But tramadol has such a weak opioid action that it actually has a breakdown product which is responsible for most of the opioid-like actions of the drug, it’s reasonably understood that low doses of tramadol would have a lower addiction potential than low doses of codeine, because it’s a completely weak opioid in all respects.”

Current guidance suggests that those looking for an OTC substitute for low dose codeine opt for a combination of paracetamol and ibuprofen.

Dr Vagg said this was a reasonable approach.

“The Faculty is aware that there are some studies that suggest the combination of ibuprofen and paracetamol is superior to over the counter strength of codeine containing preparations of either drug… It’s not what you would say is overwhelming evidence but it’s reasonable robust evidence that gives you confidence that using that instead of codeine based ones does not leave the patient worse off.”

Meanwhile the Faculty of Pain Medicine has raised concerns about the inappropriate use of sustained-release opioids in the management of acute pain.

The concerns related particularly to in-hospital acute pain management and day surgery where there have been several recent instances of severe harm to patients with sustained release opioids including two deaths, according to Dr Vagg.

“One example of one of the near misses was where opioid-naïve patients have been sent home from orthopaedic day surgery with fentanyl patches,” said Dr Vagg.

“In pain management off-label use is relatively common,” Dr Vagg concludes. “But it does require the prescriber has an appropriate justification and in the case of sustained release opioids in acute pain we are trying to make the point this is not a well justified reason for going off label.”

Dr Vagg did not have any declarations of interest.