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South Africa's Medicines Regulator Proposes New Guidelines to Combat Codeine Abuse

Medical Directory3 min readFrom our archive
South Africa's Medicines Regulator Proposes New Guidelines to Combat Codeine Abuse
Rehabilitation centers have reported a surge in codeine users in recent years. In response, South Africa's medicines regulator, the South African Health Products Regulatory Authority (SAHPRA), has published a draft guideline as part of a broader effort to track suspicious codeine sales. This guideline permits the regulator to request sales data from manufacturers, suppliers, or distributors to monitor the flow of codeine from production to distribution, including clinics, pharmacies, hospitals, and doctor's practices.

Codeine, an opioid found in certain pain relief medicines and cough syrups, is often abused in large doses to achieve a high. The new draft guideline aims to address this misuse by allowing SAHPRA to request detailed sales data from companies and health workers, thereby identifying anomalies in the distribution of codeine.

Previously, health authorities struggled to detect suspicious sales of codeine due to the lack of centralized data. Recreational users could obtain continuous supplies by purchasing from multiple pharmacies, while illicit bulk sales of codeine-based cough syrups contributed to the problem. A recent investigation revealed that a pharmacy group was involved in such illicit sales.

The new guideline, part of the "codeine care initiative," aims to centralize data on all codeine sales nationwide. This initiative will enable SAHPRA to detect irregularities, such as unusually large orders by dispensaries, and flag individuals buying large amounts of codeine from multiple vendors.

The draft guideline comes at a time when codeine addiction rates are soaring in South Africa. Data from drug and alcohol treatment facilities show that admissions for codeine misuse have tripled since 2019. Most rehabilitation centers participate in the South African Community Epidemiology Network on Drug Use (SACENDU), which collects anonymized patient data. According to Professor Nadine Harker, who oversees SACENDU, the increase in codeine-related admissions has been steady and significant. In the first half of 2019, 277 people admitted to SACENDU-linked rehab sites reported misusing codeine, accounting for 3% of all admissions. By the first half of 2023, this percentage had risen to 9%, with 749 people admitted for codeine misuse. Concerns about the easy availability of codeine have been growing. A mid-2010s survey of doctors revealed that 85% were worried about the accessibility of codeine in pharmacies. Long-term use of codeine-based medicines can lead to health complications, including stomach ulcers and liver damage, particularly when combined with substances like paracetamol.

The increase in codeine use is partly driven by trends among young people, who mix codeine-based cough syrups with soft drinks to create a party drug known as "lean." The drug's low price and accessibility contribute to its popularity. Additionally, some individuals use codeine to cope with psychological distress, as evidenced by a 2022 study involving women in rehab centers.

A lack of awareness about the dangers of codeine also plays a role. Many patients do not fully understand the risk of dependence on over-the-counter codeine medicines. Some researchers argue that codeine should be available only by prescription to reduce its misuse.

However, increased regulation may pose challenges, especially for poorer patients needing pain relief. Making codeine prescription-only could also lead to a shift toward accessing opioids on the black market, as seen in other countries.

Researchers agree on the need for public education about the risks of codeine. Pharmacists and medical professionals should engage with patients purchasing codeine and inform them of the potential consequences of misuse.
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