From 1 February 2018, medicines containing codeine are no longer available without a prescription.
No therapeutic product is ever completely free of risk. Some risks may be known when a medicine is first placed on the Therapeutic Goods Register. Others only become apparent after more people use the products.
In 2010, the Therapeutic Goods Administration (TGA) reviewed the availability of codeine in response to reports of misuse and toxicity. This review resulted in the removal of the pharmacy-only (Schedule 2) listing for codeine-containing analgesics and restricted pack sizes to five days’ supply (Roberts and Nielson 2018).
Codeine is widely used in Australia, often in combination with other medicines. In 2013, more than 27 million packs of codeine-containing analgesic products were supplied by pharmacies, and 56% of these sales were over-the-counter without a prescription (Gisev et al. 2016).
National sales data show that over-the-counter codeine-containing analgesics account for 37% of all opioid purchases in the community (Degenhardt et al. 2016).
Codeine is metabolised to morphine but there is marked variability in each individuals metabolism resulting in considerable differences in analgesic effects. Due to the opioid effects of codeine, people can become dependent with regular use (Roberts and Nielson 2018).
Use of medicines containing codeine, for example for chronic pain, has led to some people becoming addicted to codeine without realising it.
Research shows that current over-the-counter low-dose (<30 mg) medicines containing codeine for pain relief offer very little additional benefit when compared to similar medicines without codeine. The use of such medicines however, is associated with high health risks. Codeine can cause opioid 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 nonsteroidal anti-inflammatory drugs (NSAIDs), are also potentially life threatening (Australian Government Department of Health Therapeutic Goods Administration).
In December 2016, after more than 18 months of consultation, the Australian Government Department of Health TGA made the final decision to reschedule all codeine-containing products to prescription only (Schedule 4).
Submissions to the TGA during the consultation that supported rescheduling included: addiction specialists reporting increasing numbers of people presenting with codeine dependence; pharmacists reporting the challenge of dealing with people demanding codeine; and members of the public speaking of families being devastated by codeine addiction.
These groups identified the ready availability of codeine over the counter as a contributing factor. Those arguing against codeine rescheduling included: people using codeine regularly; people with limited access to GPs; and community pharmacists (Therapeutic Goods Administration 2016).
Through the extensive consultation activities that were undertaken, stakeholders indicated that an education and awareness campaign would be critical for health professionals and consumers to support changes in codeine scheduling.
In May 2017, the Australian Nursing and Midwifery Federation (ANMF) received an invitation to participate on the Nationally Coordinated Codeine Implementation Working Group (NCCIWG), established to inform and educate all affected stakeholders of the upcoming changes to the availability of low-dose codeine containing medicines. The NCCIWG, which continues to meet monthly, includes representatives from state and territory health departments, and peak professional bodies representing consumers, pharmacists, doctors, nurses and midwives. The purpose of the NCCIWG has been to facilitate a coordinated and consistent approach to the drafting and delivery of key messages and education material to all affected stakeholders.
Through the NCCIWG, the ANMF has assisted the TGA to draft the Nurses and Midwives Fact Sheet: Talking to people about changes to codeine access. This document is available through the TGA Codeine Hub at: www.tga.gov.au/codeine-info-hub
People will still be able to access codeine-containing medicines through prescription, if and when they need them, by consulting with a health practitioner with prescribing authority.
Nurse practitioners and midwives with scheduled medicines endorsement are authorised prescribers and can prescribe codeine-containing medicines when appropriate, consistent with their scope of practice.
In some jurisdictions, registered nurses in rural and remote areas can supply codeine-containing medicines in specific circumstances, under protocol.
A list of codeine-containing products previously available over the counter that are still available with a prescription from 1 February 2018 is available at: www.tga.gov.au/community-qa/current-listscheduled-codeine-containingproducts
It is anticipated that pain relief will be a key reason for people seeking prescriptions for codeine or other opioids. As is always the case, the assessment of pain requires a thorough history and examination before any prescribing should occur. It’s possible that a benefit of rescheduling codeine is that it will direct attention to the clinical assessment and management of pain and the risks associated with the use of opioids. Clear messages from health professionals about the relative effectiveness of non-drug options and non-opioid analgesics available over-the-counter may also help address people’s concerns (NPS MedicineWise).
Preparing for the changes to codeine availability in 2018 is as critical for health professionals as it is for people using codeine-containing products. As qualified health professionals and the largest part of the health workforce, nurses and midwives are well placed to discuss the changes to codeine access. Head to the TGA Codeine Hub for all the information you’ll need.
Australian Government Department of Health Therapeutic Goods Administration. Nurses and Midwives Fact Sheet: Talking to people about the changes to codeine access. Available at: www.tga.gov.au/codeineinfo-hub
Degenhardt, L., Gisev, N., Cama, E., Nielsen, S., Larance, B., Bruno R. 2016. The extent and correlates of community-based pharmaceutical opioid utilisation in Australia. Pharmacoepidemiol Drug Saf 25:521-38.
Gisev, N., Nielsen, S., Cama, E., Larance, B., Bruno, R., Degenhardt, L. 2016. An ecological study of the extent and factors associated with the use of prescription and over-the-counter codeine in Australia. Eur J Clin Pharmacol 72:469-94.
NPS MedicineWise. Over-the-counter codeine: changes to supply. [cited 2018 Feb 12]