Ireland has a "significant and widespread reliance on codeine containing medicines" and will consider moving from over-the-counter sales to prescription-only, according to internal Department of Health documents.
Irish people spend substantially more than consumers in 30 other countries on well-known codeine containing medicines such as Solpadeine and Nurofen Plus available to buy over-the-counter in pharmacies.
The documents, some of which were redacted, were released to Prime Time under the Freedom of Information Act. They show that proposals to change the method of sale of codeine medicines from over-the-counter to prescription have been put forward.
Preliminary research into such a move is now taking place in Ireland. The reclassification would be in line with an international trend where countries such as New Zealand and Australia have moved to prescription only. In Europe, France reclassified codeine from over-the-counter to prescription-only in 2017, and Estonia did the same in January.
Notes within the Department of Health documents outline how statistics around the sale of codeine products in Ireland "demonstrate how much the public are willing to spend on codeine containing products, thereby highlighting that there is likely a significant and widespread reliance on codeine containing medicines".
Significantly, the documents also "demonstrate how valuable the Irish market is to companies selling codeine containing medicines" and warn that the Department needs to "approach the next steps with caution".
The Irish pharmaceutical industry directly employs over 24,500 people and Ireland is now the largest net exporter of pharmaceuticals in the EU.
The documents obtained by Prime Time also show that sales of codeine containing medicines soared in the three-year period from 2018 to 2021.
Sales of Solpadeine increased by 12% over the three years, with over 2.4 million packs sold in Ireland in 2021. Sales of Nurofen Plus grew by 11.5% between 2018 and 2021, with 1.6 million packs sold.
The overall sales of codeine containing medicines increased by 7.3% in the three-year period. This marked a rise in sales from 4.2 million packs in 2018 to 4.53 million packs in 2021.
Irish people also spend substantially more on codeine painkillers than consumers in other countries.
Behind South Africa, Ireland sold the second-highest amount of over-the-counter codeine medicines over the six years from 2013 to 2019, according to an Oxford University-led analysis of sales in 31 countries.
Furthermore, Ireland had the highest percentage sales per population within 20 EU countries.
Codeine, an opioid medication, is typically used in the treatment of mild to moderate pain. But long-term use can result in physical dependence and addiction.
When combined with paracetamol or ibuprofen, codeine has the potential to cause serious clinical harm if taken in overdose quantities or used for a prolonged period.
Though medicines containing codeine are available over-the-counter under the supervision of a pharmacist, some have suggested that it should only be available with a prescription.
Under the current guidelines, customers should be questioned to determine if a codeine-based painkiller is the most appropriate treatment and asked if they have tried an alternative non-codeine painkiller.
Among other things, they should also be reminded that taking the drug for more than three days can lead to addiction.
Last October Prime Time examined the extent to which pharmacies follow the guidelines around the sale of codeine medicines by sending a researcher into 18 pharmacies – six pharmacies in each of three counties.
Not one of the 18 pharmacies visited adhered to all of the guidelines, which are designed to ensure that codeine medicines are used safely.
Australia reclassified codeine to prescription-only in 2018 and, five years on, Professor Suzanne Nielsen of the Monash University Addiction Research Centre in Melbourne says the overall effect of the move to prescription-only has been positive.
In 2018, the Australian Department of Health advised that over-the-counter codeine sales were responsible for more than 100 deaths per year.
She told Prime Time, "We've seen a halving in the kind of volume of codeine that we're using in Australia. So, a substantial reduction in codeine use, and obviously sales, because it's only prescription.
"We've also seen a reduction in the harms of about the same magnitude. So, about a halving in the number of codeine deaths, about a halving in the number of poisonings. It does seem to have had a very clear positive effect on not only reducing codeine use, but really reducing those harms around codeine."
Professor Nielsen said there was real concern that the move to prescription-only would place an enormous burden on the healthcare system with people flocking to GP and emergency services seeking pain relief.
But there was a small but "manageable" increase in people seeing their GPs and a reduction in people going to emergency departments.
So, what can countries like Ireland learn from the Australian experience over the last five years?
Professor Nielsen said "I would note that there was quite a long lead-in time from when the decision was announced to when it was implemented.
"There was a lot of education for both consumers and for health professionals around alternatives for codeine and how limited the role of codeine was for pain and in particular chronic pain."
"So, I think that's partly to do with why we saw these good outcomes."
The manufacturers of codeine painkillers have said they support all current requirements in place for the safe sale of over-the counter codeine containing medicines.
The documents obtained by Prime Time note that some TDs, members of the public, a prominent consultant nephrologist and the Health Products Regulatory Authority (HPRA) have called for a review of the method of sale and supply of codeine medicines.
They outline that the Pharmacovigilance Risk Assessment Committee (PRAC), a high-level committee of the European Medicines Agency (EMA), advocates prescription-only status for EU member states.
The committee say this "would be the most effective risk minimisation measure in mitigating against harm associated with abuse and dependence of these products containing codeine."
Briefing notes prepared by the Department of Health outline that the department "is committed to working with relevant stakeholders in fully considering any policy changes that may be required regarding the regulation of codeine containing medicinal products.
"Any potential change to the prescription requirements for codeine containing medicinal products must be supported by sufficient evidence. The evolving evidence is being actively monitored by the Department of Health and its agencies."
In a statement issued to Prime Time, the Department of Health said: "The Health Products Regulatory Authority (HPRA), the competent authority for medicines in Ireland, are currently conducting an independent review of the method of sale and supply of codeine-containing medicinal products that are currently available without a medical prescription."
"Following its completion, the Department of Health will engage with the above indicated stakeholders to assess the recommendations made."