TGA guides pharmacists on codeine

After releasing a fact sheet about codeine changes for consumers in April, the regulatory body has now released one aimed at pharmacists

Pharmacist fact sheet: Talking to your patients about the changes in codeine access argues that the upscheduling decision was made because OTC codeine is ineffective and can be harmful.

“Research shows that current over-the-counter low-dose (<30 mg) codeine-containing products offer little additional pain relief when compared to similar medicines without codeine,” says the TGA.

“Codeine can be harmful. Health risks include tolerance, dependence, addiction, poisoning and, in high doses, even death. In addition, side effects of long term use of combination codeine medicines containing paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs), are also potentially life threatening.”

The TGA says that “Patients respond best when conversations are framed as protecting them from opioid-related harms and when they recognise you have their best interests in mind”.

It says pharmacists should first establish whether the patient’s pain is related to an infection, acute or chronic – helping to guide your recommendation of treatment or referral process.

This includes being aware of over-the-counter medicines available for treating cough, cold and flu symptoms which do not contain codeine, and knowing when to suggest non-pharmacological routes or refer to a doctor.

“Manage expectations – Inform the patient what your scope of practice is and to what extent you can/cannot help them,” says the fact sheet.

“Don’t assume that if someone asks you to assist them with pain that they are looking for medications. You may want to suggest the use of alternative products that are available over-the-counter; discuss non-drug options such as a TENS machine, physiotherapy, complementary medicine (massage, acupuncture), exercise or lifestyle changes; or advise the patient to discuss their pain and cough, cold and flu management options with their GP,” says the TGA.

It suggests online self-management resources to refer your patient to, including: ‘Chronic pain management’ and ‘National support services’ under ‘How and where to get advice’ in the TGA codeine information hub.

Regarding excessive use, the TGA says that “as a pharmacist, a complete diagnosis of substance use disorder (SUD) is outside of your scope of practice and referral to an authorised prescriber is necessary for detox/management.

“However, you will be able to establish if there is a possibility of SUD, such as tolerance or dependence.”

Pharmacy organisations are currently lobbying for the government to implement a model that would see certain limited circumstances in which patients could continue accessing codeine-containing medicines directly through community pharmacies without a prescription.

NSW PSA President Professor Peter Carroll, from the University of Sydney’s Pharmacology department, says low-dose codeine-containing analgesics must remain an OTC therapeutic option for the management of acute, short-term pain.

“Community pharmacists have the knowledge base and competence to counsel patients regarding the effective and safe use of these products, and the vast majority of patients who use the products do so safely and appropriately for short-term use, and are at no risk of becoming dependent on codeine,” he says.

After the changes in February, the TGA says pharmacists can guide patients with acute pain by recommending OTC medicines that do not contain codeine; self-management resources; or refer them to their GP for further diagnosis and treatment.

See the fact sheet here

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  1. William

    I wonder if any of the public servants and so called experts ever read the final documents they generate.
    It is amazing how many times in that it self refers to itself.
    Looks like they only worry about generation voluminous documents rather than referring to useful independent studies to back up their recommendations.

    • Ron Batagol

      If you read all the material that TGA has based its decision on, there is a truckload of research and clinical experience to back up what TGA is doing, in line with what is already occurring in many other overseas jurisdictions, (also in response to research and clinical experience).
      Thus we know low-doses don’t work. In addition, outcomes from using Codeine at therapeutically effective doses, may range from being ineffective to causing toxicity depending on the vastly variable genetic makeup within the community.
      Hopefully, pharmacists, including utilising a Medassist style of monitoring when required, willl still be able to effectively counsel and advise patients, as they have always done for both script medications.
      (BTW even more reasons now with the Codeine schedule change to make ALL packs of NSAID non-script products S3( sadly not likely to happen any tine soon!)

      Sent from my

      • bernardlou1

        Just because there is no evidence that low dose codeine doesn’t work, it doesn’t mean it doesn’t work as the 8 millions transaction recorded through Medsassist
        price otherwise.
        IT was the TGA that has down schedule due CCA ( codeine containing analgesic ) and it’s he same organization that upscheduled it.
        There are better, cheaper and more
        Effective ways to treat acute pain wirhout the need to go to a doctor.

        I wonder why the gov isn’t acting on making Medsassist mandatory and improving the lives of consumers.

        • Ronky

          Actually OTC CCAs were around for a century before the TGA was created in 1989. They were “grandfathered” as existing products.

          Yes, there are for some people some of the time, better, cheaper and more effective ways to treat acute pain wirhout the need to go to a doctor. Codeine is not one of them (or very rarely).
          The reason nobody has made MedsASSIST mandatory is that it plainly is at best of limited effectiveness in limiting codeine misuse.

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