28 Aug Codeine cough syrup Press release
MEDIA RELEASE: Embargo: Immediate release
Pretoria, 2 July 2019 – The South African Health Products Authority (SAHPRA) is aware of the non-medicinal use of codeine-containing medicines and is working with the relevant bodies to combat this misuse.
What is Codeine?
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 authorized 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 licensed 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,” indicates Ms Portia Nkambule, Acting CEO of SAHPRA. On an ongoing basis, the regulatory compliance unit of SAHPRA requests reports of the sales of codeine-containing cough syrups from various suppliers and uses these to identify potentially illicit sales. Inspections are also conducted at pharmacies which have been identified as ordering unusually high volumes of codeine-containing cough syrups.
SAHPRA continues to work with relevant stakeholders such as the South African Pharmacy Council (SAPC), Health Professional Council of South Africa (HPCSA), the Central Drug Authority (CDA) of the Department of Social Development, the South African Police Service (SAPS), the pharmaceutical industry, and also the South African National Council on Alcoholism and Drug Dependence (SANCA). SAHPRA has also conducted awareness campaigns for employers who have reported concerns over employees abusing such products. Complaints should be reported to: SAHPRA in Pretoria via telephone on (012) 842 7609/10 or by email: adr@sahpra.org.za or to the National Adverse Drug Events Monitoring Centre
on (021) 447 1618 or fax: (021) 448 6181. The adverse drug reaction (ADR) reporting form can be accessed via the SAHPRA website at: https://www.sahpra.org.za/documents/12e54dcaADRForms.pdf.
Issued by:
Ms Portia Nkambule
012 842 7582/7583
portia.nkambule@sahpra.org.za
Media Contact:
Mr Yuven Gounden
012 842 7628
083 297 1214
yuveng@sahpra.org.za
For more information:
Mr Jerry Molokwana
076 422 4934
jerry.molokwane@sahpra.org.za