Rehab centres in South Africa have been admitting an increasing number of codeine users in recent years. Now, the country's medicines regulator has published a draft guideline as part of a broader effort to track suspicious codeine sales.
South Africa's medicines regulator - the South African Health Products Regulatory Authority (SAHPRA) - has released a new draft guideline which it says will help stem the misuse of codeine. The opioid, which is found in certain pain relief medicines and cough syrups, is used by some people in large doses to get high.
Under the new draft guideline, the regulator can request sales data (and other information) from manufacturers, suppliers or distributors of any scheduled medicines. This would allow 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", SAHPRA's communications officer, Nthabi Moloi, told Spotlight.
Why is this important? Until now, health authorities have struggled to detect suspicious sales of codeine, which is 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 purchase 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. Following a Carte Blanche investigation flighted last year, SAHPRA confirmed that a pharmacy group was making illicit bulk sales of codeine-based cough syrups. While patients are only allowed to get codeine from a licensed health worker or pharmacist, it's thus no surprise that it can also be found on the black market.
SA's medicines regulator is developing a new initiative to stem the misuse of codeine, an opioid drug which is found in certain pain relief medicines and cough mixtures, but which people also frequently use in large doses to get high.
The new draft guideline aims to tackle both of these problems by allowing SAHPRA to request information from companies and health workers about how much codeine they're producing, selling or dispensing and who it is being provided to. This would "enable SAHPRA to detect anomalies in the distribution of medicines prone to abuse, such as abnormally large orders by dispensaries" Moloi explains.
It is the "first phase", she says, of the codeine care initiative - which is an effort to centralise data on all codeine sales along the entire supply chain nationally. The plan is to ensure that the regulator can flag anything from an individual who is buying large amounts of codeine from multiple vendors to a wholesaler who is selling the drug to illicit dealers.
Codeine rehab admissions triple since 2019
The draft guideline, which is now available for public comment, comes at a time in which rates of codeine addiction are soaring throughout South Africa, according to admissions data from drug and alcohol treatment facilities. Most rehabilitation centres around the country are connected to a programme called the South African Community Epidemiology Network on Drug Use (SACENDU), which collects anonymised patient data from the different centres. Professor Nadine Harker, who oversees this project says "if you look at treatment admissions over time, there has been an increase [in codeine-related admissions] over the years - steadily but definitely".
Indeed, 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. This amounted to 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 uptick, health workers were concerned. In the mid-2010s, a survey of 238 (mostly private sector) doctors was conducted across South Africa. It found that 85% of these practitioners 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 a range of health complications, including stomach ulcers and liver damage (this is 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 a trend among young people, who sometimes mix codeine-based cough syrups with cooldrinks. The combination is often referred to as lean, and has become a popular party drug among high school students. Research shows that codeine's low price and general accessibility is one reason for its popularity. Harker for instance notes that it's often available at home, where kids "can pick it up out of their mom's medicine cabinet".
In other cases, people appear to be relying on the drug not for recreation but to cope with psychological distress. For instance, a 2022 study for which women were interviewed at rehab centres in the Western Cape and Eastern Cape found that many had turned to pharmaceutical products to deal with everything from trauma caused by physical abuse to grief over the loss of a child.
"I just wanted the pain to go away. I wanted my mind to switch off... [the tablets] actually made me dead inside if I can say that," one woman explained.
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". The lack of regulatory control may contribute to this impression: one study at South African rehab centres found that "many participants were of the view that [over-the-counter] codeine-containing medicines were not drug[s] per se due to their free availability to purchase without any real regulations or protocols guiding their sale".
Shouldn't we just make codeine prescription-only?
Currently, the law states that codeine-based pills can be bought over the counter only under specific conditions. For one, they have to contain another active ingredient like paracetamol or ibuprofen, and each pill can contain a maximum of 10 milligrams of codeine. A person can only buy one pack and it must contain at most 5 days' worth of medicine (with no more than 80 milligrams 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 10 milligrams of codeine per teaspoon (the maximum daily dose is 80 milligrams). The bottle itself may not contain more than 100 millilitres of syrup.
Some researchers that spoke to Spotlight argue these restrictions are too lenient, and that codeine should be 'up-scheduled', meaning that it would only be available if a patient has a script, regardless of the dose or combination. By doing this, children may find it harder to get a hold of cough syrups for lean, and people may generally become more aware of the addictiveness of the drug when used over the long-term.
Indeed, there are some studies which have found this approach to be effective in other countries. Research published in the journal Addiction found that when authorities in Australia made codeine prescription-only in 2018, a large poisoning information centre in the country began to receive significantly fewer calls about codeine-related incidents (both from health workers and members of the public).
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But there are also potential downsides to this strategy. For one, as Spotlight has previously reported, increased regulation may make life harder for poorer patients seeking pain relief. This is given that they would have to spend more money 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, notes a third related problem that may occur. "If people do have codeine-dependence and they're unable to access the codeine, they might likely shift to accessing opioids... on the black market".
Scheibe highlights the United States 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 those opioids then people started using heroin," he notes. A 2022 study found that this had taken place among opioid users interviewed in Connecticut, Kentucky and Wisconsin.
Whatever the answer, researchers agree that some basic steps need to be taken to educate the public. Harker says "a lot of awareness raising needs to happen at various levels, for instance at pharmacies". She notes that "when someone purchases 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".
