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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