The South African Health Products Regulatory Authority (SAHPRA) is reviewing the scheduling status of codeine following the growing use of the non-medicinal use of codeine-containing medicines.
Codeine is classified as an opioid. Opioids are narcotics with a known potential for dependence. Codeine is administered in liquid or solid form (tablet/capsule), either alone or in combination with other active pharmaceutical ingredients. When used under the direction of a health professional, codeine-containing combination medicines are a relatively safe way to treat minor pain or suppress non-productive coughs. Codeine can also cause euphoriant effects, which reinforce continued use.
Codeine therefore poses a risk of developing tolerance and eventually dependence.
Codeine is an internationally controlled substance in terms of the 1961 Single Convention on Narcotics, and its use is monitored by the International Narcotics Control Board. In order to import or export such products, a permit must be issued by SAHPRA. Codeine-containing cough syrups are regulated in terms of Schedule 2 and Schedule 3 to the Medicines Act. Unless prescribed by an authorised prescriber, these products can only be sold by a registered pharmacist, or a post-basic pharmacist’s assistant under the personal supervision of a pharmacist, at a licenced pharmacy.
SAHPRA is aware of illicit sales of codeine-containing cough syrups through other outlets and is working on the means to monitor suppliers of these products. Various industry bodies have been requested to provide data relating to Codeine to SAHPRA. Complaints should be reported to: SAHPRA in Pretoria via telephone on (012) 842 7609/10 or by email: email@example.com or to the National Adverse Drug Events Monitoring Centre on (021) 447 1618 or fax: (021) 448 6181.