On 1 February 2018 the Poisons Standard February 2018 commenced, restricting access to medicines containing codeine.

Australians now require a doctor’s prescription in order to purchase medicines containing codeine, after the Therapeutic Goods Administration (TGA) followed the lead of the United States, Japan, Germany and 23 other nations around the world in restricting access to the opioid drug.

The legislative changes come after lengthy public debate among healthcare providers, pharmaceutical advocacy groups and within the government.

While the decision has attracted some criticism, particularly from consumers, it has been a long time coming and is the latest example of the TGA’s attempt to manage the increase of opioid misuse in Australia.

Background

According to the TGA, Australia currently has the eighth highest usage of prescription opioids per head of population. With increased levels of use, unfortunately, comes increased levels of misuse, the TGA reporting that levels of prescription opioid overdose (including accidental overdose) are at record highs.

Just under three years ago, relevant stakeholders got serious about the issue. In May 2015, an Opioids Roundtable was held in Canberra where discussions included the regulation of opioids and education about opioids.

Increasingly, analgesics containing codeine became a major focus for the TGA, in part due to their popularity and ease of access.

On advice from the Advisory Committee on Medicines Scheduling, in October 2015 the TGA published an interim decision to “up-schedule” codeine to become prescription-only medicine based on the risk of addiction, and adverse events.

The Department of Health published its final decision to up-schedule codeine on 23 March 2017, announcing that the restrictions would apply from 1 February 2018.

The Amendments

The prescribing of medicines is governed by the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard), produced by the TGA.

The regulation of codeine was achieved through the following amendments to the Poisons Standard:

  1. Removing codeine from schedule 2 (Pharmacy Medicine).
  2. Removing codeine from schedule 3 (Pharmacist Only Medicine).
  3. Inserting “Codeine when compounded with one or more other therapeutically active substances” (in dosage units of 30mg or less) into schedule 4 (Prescription Only Medicine).
  4. Inserting “Codeine except when included in Schedule 4” into schedule 8 (Controlled Drug).

Practical Implications

On 1 February 2018 codeine-containing painkillers such as Panadeine and Nurofen Plus, as well as cold and flu products such as Codral and Demazin, disappeared from pharmacy aisles.

Now a schedule 4 drug, patients will only be able to obtain codeine-containing products with a doctor’s prescription.

Further, as a result of the legislative changes, some codeine-containing medications are no longer available.

Following the TGA’s announcement in March 2017, pharmaceutical giant GlaxoSmithKline decided that from February 2018 it would take its products including Panadeine, and Panafen Plus off the Australian market, rather than to move its codeine range to prescription only medicine.

Already substitutes are being advertised to fill the gap in the market, with ad campaigns promoting “double-action” analgesics containing both ibuprofen and paracetamol as the “alternative to codeine” and advertising availability without prescription.

Implications for Healthcare Providers

Aside from the clear implications for pharmacists, general practitioners are likely to see a rise in consultations with patients requiring a prescription to continue their use of codeine-containing medications.

General practitioners unfamiliar with prescribing such products should ensure that they are familiar with the risks associated with the drug.

Time will tell whether the changes will cause consequent pressure on the Government’s Prescription Shopping Programme (PSP) which responds to prescription shopping or “doctor shopping”.

The reasons for the decisions of the Secretary to the Department of Health can be found here.

For the current Poisons Standard, click here.