17 January 2020 - Deborah Wilkes
The South African Health Products Regulatory Authority (SAHPRA) is seeking sales data on codeine-containing medicines as it reviews whether such products should remain available without a prescription.
In a communication to industry, the regulatory agency highlighted the global trend towards reverse-switching codeine-containing medicines from non-prescription to prescription status.
New Zealand’s Medicines Classification Committee recently recommended that “all medicines containing codeine should be classified as prescription medicines” but has not suggested a timeframe (click here to read the News story).
Furthermore, Australia reverse-switched all medicines containing codeine to prescription status on 1 February 2018, and France did the same in July 2017.
Codeine-containing medicines are already restricted to prescription status in many countries including Belgium, Croatia, the Czech Republic, Germany, Greece, Italy, Norway, Portugal, Spain, Sweden and the US.
In the UK, the Proprietary Association of Great Britain (PAGB) recently issued a statement stressing that “OTC products containing codeine are appropriately safe and effective, if used in accordance with the instructions on the pack and patient information leaflet inside”.
The industry association was responding to an edition of the BBC television programme Horizon that looked at the “opioid crisis” in Britain.
"Widespread abuse nationally and gloabally"
SAHPRA said there was “widespread abuse of codeine-containing preparations nationally and globally”. “In South Africa and neighbouring countries,” added the regulatory agency, “the abuse of codeine-containing cough preparations, specifically amongst the youth, is concerning.”
The regulatory agency said it was alleged that the cough preparations registered and available without a prescription in South Africa were finding their way illicitly onto the market in neighbouring countries where such products were banned or only available on prescription.
SAHPRA pointed out there were “safer, more effective alternative products” available without a prescription that did not contain codeine, as well as many non-drug options to treat pain.
“Research has shown that current OTC low-dose codeine-containing medicines for pain relief offer very little additional benefit but high health risks when compared to similar medicines without codeine,” commented SAHPRA.
SAHPRA said there was a “paucity” of data on the sale of codeine-containing medicines at all levels of the supply chain – manufacture, wholesale, distributor and retail.
It has requested manufacturers, wholesalers and distributors to submit sales data – domestic, import and export – for all codeine-containing preparations from January 2018 onwards.