The South African Health Products Regulatory Authority (SAHPRA) has released its new draft guideline it hopes will help stem the misuse of codeine, and as part of a broader effort to track suspicious codeine sales, reports Spotlight.
Currently out for public comment, it allows the regulator to request sales data (and other information) from manufacturers, suppliers or distributors of any scheduled medicines, enabling them to track the flow of codeine all the way “from the manufacturer to the dispensary, be it a clinic, pharmacy, hospital, or doctor’s practice”, said SAHPRA’s communications officer, Nthabi Moloi.
Until now, authorities have struggled to detect suspicious sales of codeine, found in both prescription and over-the-counter medicines.
This problem manifests in two ways. For one, recreational users can often get a continuous supply of codeine directly from pharmacies. While people are only permitted to buy a limited amount of the drug, many bypass this simply by buying from different pharmacies. It’s largely impossible to flag these individuals since there is no centralised data on what medicines people buy across vendors (though attempts have been made to address this).
The second issue relates to wholesale supply. After a Carte Blanche investigation flighted last year, SAHPRA confirmed that a pharmacy group was making illicit bulk sales of codeine-based cough syrups.
The guideline will allow SAHPRA to request information from companies and health workers about how much codeine they’re producing, selling or dispensing and to whom it is being provided, making it easier to detect anomalies in the distribution of medicines prone to abuse, like abnormally large orders by dispensaries, according to Moloi.
It is the “first phase”, she said, of the Codeine Care Initiative – an effort to centralise data on all codeine sales along the entire supply chain nationally.
Codeine rehab admissions tripled since 2019
The guideline comes as rates of codeine addiction are soaring throughout South Africa, according to admissions data from drug and alcohol treatment facilities. Most rehabilitation centres are connected to a programme called the SA Community Epidemiology Network on Drug Use (SACENDU), which collects anonymised patient data from the centres.
“If you look at treatment admissions, there has been an increase (in codeine-related admissions) over the years – steadily but definitely,” said Professor Nadine Harker, who oversees the project.
SACENDU’s bi-annual reports show that in the first half of 2019, 277 people who went to SACENDU-linked rehab sites said they had been misusing codeine (3% of all admissions). But by the first half of 2023, this percentage had tripled to 9% – totalling 749 people. (In absolute terms the number slightly less than tripled).
Even before this, health workers were concerned. In the mid-2010s, in a survey of 238 (mostly private sector) doctors across South Africa, 85% of them were worried about the easy availability of codeine in pharmacies.
Part of the concern is driven by the fact that people who use codeine-based medicines over a long time can develop health complications that include stomach ulcers and liver damage (particularly when the medicines contain additional substances like paracetamol). And some people are more vulnerable than others, as genetic factors play a big role in how codeine affects a person.
Why is the problem getting worse?
Part of the spike in codeine use appears to be driven by the trend among young people, who sometimes mix codeine-based cough syrups with cool drinks – often referred to as lean, and a popular party drug among high school students.
Codeine’s low price and general accessibility is one reason for its popularity, and Harker notes that it’s often available at home, where kids “can pick it up out of mom’s medicine cabinet”.
In other cases, people appear to be relying on the drug not for recreation but to cope with psychological distress.
A lack of awareness about the dangers of codeine also seems to play a role: 94% of doctors who were surveyed agreed that patients “do not fully understand the risk of dependence in taking over-the-counter medicines containing codeine”.
Shouldn’t we make codeine prescription-only?
Currently, the law states that codeine-based pills can be bought over the counter only under specific conditions. They have to contain another active ingredient like paracetamol or ibuprofen, and each pill can contain a maximum of 10mg of codeine. A person can only buy one pack and it must contain, at most, five days’ worth of medicine (with no more than 80mg a day). Anything more and a script is needed.
Liquid codeine, like cough syrups, can be bought without a script if it contains no more than 10mg of codeine per teaspoon (the maximum daily dose is 80mg). The bottle itself may not contain more than 100ml of syrup.
Some researchers told Spotlight these restrictions are too lenient, and that codeine should be “up-scheduled” – only available if a patient has a script, regardless of dose or combination. Youngsters might then find it harder to obtain cough syrups for lean, and people may generally become more aware of the addictiveness of the drug when used long-term.
Some studies have found this approach effective in other countries. When authorities in Australia made codeine prescription-only in 2018, a large poisoning information centre received significantly fewer calls about codeine-related incidents (both from health workers and the public).
But there are also potential downsides to this strategy. For one, increased regulation may make life harder for poorer patients seeking pain relief – who would have to pay more for a consultation and prescription if they needed codeine-based painkillers.
Andy Gray, who chairs an advisory scheduling committee at SAHPRA, details a second issue: “I’m not convinced that up-scheduling would solve the issue if what we’re dealing with (in South Africa) is illegal behaviour… If (codeine) is being smuggled out of manufacturers or wholesalers, scheduling is not going to make a difference”.
Dr Andrew Scheibe, a harm reduction researcher at the University of Pretoria, said a third problem may occur. “If people do have codeine-dependence and they’re unable to access the codeine, they might shift to accessing opioids… on the black market.”
Scheibe highlights the US as an example, where prescription opioids like oxycodone and fentanyl have been at the centre of a major drug epidemic. “When they tried to increase restrictions on access to these, then people started using heroin,” he notes.
Whatever the answer, researchers agree some basic steps need to be taken to educate the public.
“A lot of awareness-raising needs to happen at various levels, for instance at pharmacies,” said Harker. “When someone buys codeine over the counter, it’s important for a pharmacist to engage [with them and] make the consequences known to the individual if they use it outside of the dosages indicated… And we don’t do that enough from the medical or pharmacist’s side.”
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See more from MedicalBrief archives:
New SAHPRA guidelines planned to address codeine abuse
Balancing act between pain relief and addiction in codeine regulation
Cheap, over-the-counter codeine fuels SA schoolchildren’s addiction