In its submission to the supplementary consultation on the scheduling of OTC codeine medicines, ASMI supported regulatory options that reduce the risk of codeine misuse, while retaining pharmacy access for the vast majority of consumers who use OTC codeine medicines safely and responsibly.
“ASMI does not support up-scheduling of OTC codeine medicines and instead is proposing a package of targeted measures to reduce the risk of misuse of OTC codeine-containing analgesics, including warning statements, reduced pack sizes and a real-time monitoring system for community pharmacy,” says Deon Schoombie, ASMI CEO.
“We are pleased the TGA is proposing separate regulatory approaches for cold/flu products and OTC codeine-containing analgesics given the lack of evidence of misuse of cold/flu medicines.
“ASMI supports the mandatory inclusion of label warning statements for all OTC medicines containing codeine.
“Label warning statements are an accepted way of mitigating risk by providing consumers with important advice that facilitates appropriate use of the medicine and addresses specific risks.
“Many ASMI member companies have already voluntarily applied label warning statements, but this proposal would harmonise the practice.”
ASMI supports limiting packs of OTC codeine containing analgesics to three days’ supply, says Dr Schoombie.
“This quantity is sufficient to meet the needs of a consumer using the product for acute pain, whilst also ensuring more frequent contact with a health care professional if further pain relief is needed.
“ASMI also supports the introduction of a real time monitoring system for OTC codeine-containing analgesics, and the availability of educational resources for health care professionals and consumers.
“ASMI has been working with a range of stakeholders, notably the Pharmacy Guild, to develop and refine a prototype real-time monitoring system. It will record customer details, information about the supplied product, recent purchases and indications for supply or refusal.
“Information entered into the system will be linked in real time, allowing pharmacists to accurately identify consumers who purchase OTC codeine analgesics at multiple pharmacies.
“Pharmacists will be prompted to provide these consumers with information and advice to assist those who may be having problems with chronic pain, dependence or misuse, and refer them to their GP or pain clinic as appropriate.
In the absence of any evidence of actual or potential misuse of codeine-containing cold and flu products, the case for regulatory intervention has not been made, he says.
“Nevertheless, of the regulatory options proposed by the TGA, ASMI is prepared to accept the reduction of pack sizes in order to maintain the existing Schedule 2 access to these products.”