...is restricting codeine sales even necessary, even if codeine dosages are sub-therapeutic?
It's under 12 months now when in February 2018, codeine in Australia will no longer be available by just asking your pharmacist. It all began in late 2015, when Australia's Therapeutic Goods Administration or the TGA published an interim preliminary finding recommending that all over-the-counter codeine medicines be rescheduled as prescription-only. The TGA was overwhelmed by the public outcry at the foreshadowed restrictions and announced a stay on rescheduling codeine, later announcing in December 2016, that codeine will become prescription-only.
Getting your opiate relief won't be so easy
One of the arguments for restricting codeine availability is its questionable clinical efficacy in managing pain, particularly with dosages of codeine at 8mg and 15mg. The therapeutic benefit can only be achieved at higher dosages, such as with Panadeine Forte (30mg).
The medical community also asserts the need for restrictions in the aim for public safety because of misuse. Australian research published in 2015, showed that between 2000 to 2009, there were 1437 deaths from overdose or intentional self-harm. According to the study, those who had overdosed, 'were more likely to be older, female and have a history of mental health problems; those who had accidentally overdosed were more likely to have a history of substance use problems, chronic pain and injecting drug use.'
Is that reason enough to restrict codeine sales to regular people?
The Pharmacy Guild of Australia claimed that regulating codeine doesn't automatically make the community safer, and claimed a restriction on codeine sales would be disproportionate to the threat of harm.
Restricting access to codeine can also have unintended consequences. The Pharmacy Guild's view was that prescriptions for codeine could overburden doctor clinics, shift attention away from those needing appointments and reduce individual agency when managing pain responsibly. And it could certainly take away the role of community pharmacists advising on safe codeine use.
At the time, the Australian Health Minister was quick to point rescheduling codeine would need to 'balance the needs of patients with those who abuse it'. Implicit in the Minister's comments earlier this year suggest support for expanding the monitoring and reporting system found in Project STOP.
Project STOP helped in stemming sales of pseudoephedrine for illegal methamphetamine manufacture. It's the system that prompts the pharmacist to ask for identification prior to pseudoephedrine sales. The Pharmacy Guild, who as early as 2008 had asked the Australian Government to widen Project STOP to cover codeine, said of the codeine's potential rescheduling that it would add costs to the health system and disadvantage those who currently use codeine.
It should come as no surprise then, that the PGA has begun rolling out MedsASSIST, the new sibling alongside PGA's Project STOP. Who better placed to implement a system that implemented Project STOP and was successful in reducing pseudoephedrine misuse? MedsASSIST may be just the thing pharmacies need to not only combat codeine misuse but other commonly misused pain relievers, such as Nurofen Plus.
Codeine's adverse effects seem limited to an especially compromised or susceptible sub-population. Pharmacists should be given time to implement MedsASSIST.
Looking at the number of people who overdosed on codeine, restricting codeine sales is not necessary, and pharmacists should be given the opportunity to advise on appropriate forms of pain relief before a patient seeks further advice from a doctor.
While the TGA claims that its system isn't directed at denying a person's right to self-manage their pain, it certainly feels like it.