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Codeine upscheduling: what doctors need to know

 

Today’s the day when codeine-containing products can no longer be bought over the counter at pharmacies and legally require a prescription as schedule 4 drugs. Here’s what you need to know about the change:

What is being changed and why?

In 2016 the Therapeutic Goods Administration proposed rescheduling all codeine-containing analgesics to Schedule 4 (prescription only). It received submissions from pain specialists reporting rising levels of codeine dependence and from members of the public whose families had been destroyed by codeine addiction. Although some bodies, notably the Pharmacy Guild of Australia, argued against upscheduling, the TGA eventually decided that codeine-containing products would become Schedule 4 from February 1, 2018.

It cited the likely public health benefits of such a move, based on the evidence of harm due to dependence on easily accessible, over-the-counter products. In 2013 well over half of codeine-containing analgesics in Australia were sold over the counter. From 2014 to 2016, the proportion of people seeking help for opioid addiction rose from 2.7% to 4.6%, and around 150 people a year die from overdose due to opioid overdose per year.

This may not be the TGA’s last move concerning codeine. It is reportedly looking into banning GPs from prescribing strong opioids as a means of addressing misuse and overdose. Other restrictions on the horizon may concern pack sizes, along with a review of indications and label warnings.

Are GPs likely to see an influx of patients seeking codeine products?

This may happen, but it may also take a while for people struggling with codeine addiction issues to come out of the woodwork.

There is some anecdotal evidence of patients stockpiling codeine products in anticipation of restrictions. Self-denial and the stigma attached to addiction may also hinder people from coming forward, and it may be some time before the extent of the problem can be quantified.

What should doctors tell their patients about codeine products?

The TGA says it’s important for GPs to develop practice policies for prescribing analgesics and know when to refer to pain specialists or allied health professionals for alternative therapies.

If you have a patient presenting with pain who has previously self-medicated with over-the-counter codeine products, here are some approaches:

  • Ask open-ended questions about your patient’s pain and don’t presume they’re just after painkillers;
  • Manage expectations: let your patient know that sometimes pain management is a long-term process that requires more than drugs;
  • Tell them that there’s evidence low-dose codeine is no more effective than OTC products without codeine, and that higher-dose codeine is indicated for acute rather than chronic pain;
  • Ensure your practice has a drugs of dependence therapy agreement policy to inform people about the risks of codeine dependency;
  • If you suspect a patient of substance abuse, use this opportunity to organise proper care and consider referral to local drug and alcohol services.

Read more tips and talking points on managing patients who were previously on OTC codeine medication here.

Which OTC painkiller in a post-codeine world?

 

From February 1st next year, all codeine-based pain relief medications will become prescription-only. GPs may get a surge of patients asking for codeine prescriptions, but they will probably also get people asking them for good over-the-counter alternatives to the opioid. So what should they be telling their patients?

According to NPS MedicineWise, the best alternative for the short-term management of acute pain may be an paracetamol/ibuprofen combination pill, of which there are several OTC formulations on the Australian market.

NPS MedicineWise says the best treatment for mild pain is still paracetamol only or non-pharmacological measures, such as ice packs. But when that doesn’t do the trick, paracetamol/ibuprofen may prove more effective, as long as the patient is able to take an NSAID.

Evidence from a number of studies show that for acute pain, the combination is better for analgesia than either drug on its own, although it is not indicated for chronic pain. Paracetamol/ibuprofen has been found to be effective for a variety of pain states, including postoperative pain, dysmenorrhoea and musculoskeletal pain.

A Cochrane review has looked at the combination’s efficacy after wisdom tooth removal and found it better than either paracetamol or ibuprofen on its own for relieving pain six hours after the intervention.

Short-term studies have not identified any safety concerns for the combination other than those already known for the individual components, although one study found an increase in bleeding over 13 weeks, suggesting caution with long-term use.

Paracetamol is relatively safe, although inadvertent overdose is possible, but more precautions are needed with the use of ibuprofen. Lower doses are recommended for older people, and those with kidney disease, a history of peptic ulcers, asthma, high blood pressure or in pregnancy.

Another possible OTC alternative to codeine is diclofenac potassium, which has been shown to be effective in a variety of pain states, including acute lower back pain, tension-type headache, musculoskeletal pain, dysmenorrhoea and dental pain.

For chronic pain, analgesic medicines are only mildly effective and their use is recommended only as an adjunct (paracetamol) to non-pharmacological strategies, or in small doses for a short time (NSAIDs).

Source: NPS MedicineWise

Tensions reach boiling point over codeine changes

 

The row between the Pharmacy Guild and the medical community over the coming upscheduling of codeine products has well and truly boiled over this week, with the Guild accusing doctor groups of “hurling abuse and playing political games”.

Over-the-counter codeine products will become prescription-only as of February next year, in a move by the Therapeutic Goods Administration that has received the support of all main medical associations, including the AMA, RACGP, RACP and Pain Australia.

In its decision, the TGA cited the issue of opioid misuse and addiction as well as the poor additional pain relief offered by codeine compared with other common over-the-counter painkillers.

Over 6 million codeine-containing products, such as Panadeine and Nurofen Plus, are sold every year by pharmacists, who stand to lose up to $120 million in sales once these painkillers are upscheduled.

But the Guild has lobbied hard for a softening of the upscheduling decision. It wants pharmacists to continue to be able to continue supplying over-the-counter codeine products for the temporary treatment of acute pain, with a mandatory requirement for real-time monitoring to identify non-legitimate misuse.

Their argument is that upscheduling of codeine will merely overburden GP surgeries and ER departments, and that in rural and regional areas people will find it hard to see a doctor to get their medication.

The Guild’s intense lobbying efforts appear to be paying off. This month, health ministers from all state and territories, with the exception of South Australia, wrote to federal Health Minister Greg Hunt to express their concern about the new rules.

“Some people managing chronic conditions with codeine medications will deteriorate as they abandon medication due to the out-of-pocket expenses associated with accessing GPs for their prescription,” they wrote.

AMA President Michael Gannon hit back at the “irresponsible and unprincipled lobbying of state and territory governments”, while RACGP President Dr Bastian Seidel pointed to the $340,000 the Guild has donated to the major political parties in the past two years alone.

“They are trying to introduce policy by chequebook by donating large amounts to state and federal parties to gain open access to decision makers,” he said.

But on Wednesday the Guild said it rejected “the outrageous and baseless claim that it is putting the commercial interests of pharmacies ahead of patients in relations to the upscheduling of codeine”.

It said its arguments had been motivated solely by “the need to maintain convenient access for patients who use these products legitimately, and the safeguard of real-time monitoring for at-risk patients with addiction issues”.

It said that “rather than throwing mud”, doctor groups should be taking responsibility for the “very real patient issues that doctors will need to manage” once codeine is upscheduled.

It questioned how overstretched doctors will manage the increase in demand in areas where patients already have to wait long periods before seeing their GP.

At the same time the presidents of five high-profile medical and health consumer associations, including the RACGP and Pain Australia, have written an open letter to all state and territory health ministers, warning that any changes to the TGA’s plan to upschedule codeine will put health and lives at risk.

“The Guild’s proposed alternative model carries a serious risk of increased harms and potentially preventable deaths and cannot be supported by the medical community and consumer advocates,” the letter says.

It also notes the “serious and far-reaching implications” of any state or territory creating exemptions, as it would be “tantamount to walking away from nationally consistent regulation of medicines in this country”.

The European Union, Japan and Canada all require a prescription for codeine-containing products.