New guidelines aim to curb abuse • Spotlight

South African rehabilitation centres have been seeing an increasing number of codeine users in recent years. Now the country’s medicines regulator has released draft guidelines as part of a wider effort to track suspicious codeine sales.

South Africa’s medicines regulator, the South African Health Products Regulatory Authority (SAHPRA), has released new draft guidelines it says will help curb codeine abuse. The opioid, which is found in some painkillers and cough syrups, is used by some people in high doses to get high.

Under the new draft guidelines, the regulator can request sales data (and other information) from manufacturers, suppliers or distributors of any scheduled medicine. This would allow them to track the flow of codeine “from the manufacturer to the point of sale, whether it’s a clinic, pharmacy, hospital or doctor’s office,” SAHPRA communications officer Nthabi Moloi told Spotlight.

Why is this important? Until now, health authorities have had trouble detecting suspicious sales of codeine, which is found in both prescription and over-the-counter drugs. This problem manifests itself in two ways. First, recreational users can often receive continuous supplies of codeine directly from pharmacies. Although people are only allowed to buy a limited amount of the drug, many bypass this limit by simply buying it from different pharmaciesS Tagging these individuals is virtually impossible because there is no centralized data on what medications people are buying from different vendors (although there have been attempts to address this problem).

The second issue concerns wholesale supplies. Following a Carte Blanche investigation last year, SAHPRA confirmed that a pharmacy group was illegally selling codeine-based cough syrups in bulk. While patients can only obtain codeine from a licensed healthcare professional or pharmacist, it is not surprising that it can also be found on the black market.

The new draft guidelines aim to address both of these issues by allowing SAHPRA to request information from companies and healthcare professionals about how much codeine they are producing, selling or dispensing and to whom it is being supplied. “This would enable SAHPRA to detect anomalies in the distribution of medicines susceptible to abuse, such as abnormally large orders placed by outlets,” Moloi explains.

It’s “phase one,” he says, of a codeine custody initiative — an effort to centralize data on all codeine sales across the supply chain at a national level. The plan is for the regulator to flag everything from someone buying large quantities of codeine from multiple suppliers to a wholesaler selling the drug to illicit dealers.

Codeine addiction treatment admissions have tripled since 2019

The draft guidelines, now available for public consultation, come at a time when rates of codeine addiction are rising rapidly across South Africa, according to data on admissions to drug and alcohol treatment centres. Most rehabilitation centres across the country are affiliated with a programme called the South African Community Epidemiology Network on Drug Use (SACENDU), which collects anonymised patient data from a range of centres. Professor Nadine Harker, who oversees the project, says: “if you look at treatment admissions over time, there has been an increase (in codeine-related admissions) over the years – steady but definite.”

Indeed, SACENDU’s half-yearly reports show that in the first half of 2019, 277 people who went to SACENDU-affiliated rehabilitation centres said they had abused codeine. This represented 3% of all admissions. However, in the first half of 2023, this figure had tripled to 9% – a total of 749 people. (In absolute terms, this figure has increased by slightly less than threefold.)

Even before this increase, health workers were concerned. In the mid-2010s, a survey of 238 doctors (mostly from the private sector) across South Africa found that 85% of them were concerned about the easy availability of codeine in pharmacies.

Part of the concern is that people who use codeine-based drugs for a long time can develop a range of health complications, including stomach ulcers and liver damage (especially when the drugs contain additional substances such as acetaminophen). And some people are more susceptible than others, because genetic factors play a large role in how codeine affects a person.

Why is the problem getting worse?

Part of the increase in codeine use appears to be due to a trend among young people who sometimes mix codeine-based cough syrups with cold drinks. This combination is often referred to as lean and has become a popular party drug among high school students. Studies suggest that codeine’s low price and widespread availability are among the reasons for its popularity. Harker, for example, notes that it is often available at home, where children “can get it from mom’s medicine cabinet.”

In other cases, people appear to be turning to the drug not for recreation but to cope with psychological distress. For example, a 2022 study that interviewed women in rehabilitation centres in the Western Cape and Eastern Cape found that many had turned to pharmaceuticals to cope with everything from the trauma of physical abuse to the grief of losing a child.

“I just wanted the pain to go away. I wanted my mind to shut down… (the pills) were basically killing me internally, if I may say so,” one woman explained.

Lack of awareness of the dangers of codeine also appears to play a role: 94% of doctors surveyed agreed that patients “do not fully understand the risk of addiction in taking over-the-counter medicines containing codeine.” A lack of regulatory control may contribute to this impression: one study in South African rehabilitation centers found that “many participants felt that (over-the-counter) medicines containing codeine were not medicines per se due to their free availability without any real regulations or protocols governing their sale.”

Shouldn’t we just make codeine a prescription-only drug?

The law currently states that codeine-based tablets can only be purchased over the counter under certain conditions. First, they must contain another active ingredient, such as acetaminophen or ibuprofen, and each tablet can contain a maximum of 10 milligrams of codeine. A person can only buy one pack, which must contain a maximum of five days’ worth of the drug (no more than 80 milligrams per day). For larger quantities, a prescription is required.

Liquid codeine, like cough syrups, can be purchased without a prescription if it contains no more than 10 milligrams of codeine per teaspoon (the maximum daily dose is 80 milligrams). The bottle itself cannot contain more than 100 milliliters of syrup.

Products like Gen-payne, Myprodol and Stopayne contain small amounts of codeine – usually in combination with other painkillers like acetaminophen or ibuprofen. (Photo: Towfiqu Barbhuiya/Unsplash)

Some researchers Spotlight spoke with say these restrictions are too lenient and that codeine should be “prescribed later,” meaning it would be available only if a patient has a prescription, regardless of the dose or combination. As a result, it may be harder for children to get their hands on weight-loss cough syrups, and people may generally become more aware of the drug’s addictive effects when used over a long period of time.

Indeed, there are some studies that have shown the effectiveness of this approach in other countries. The study, published in the journal Addiction found that when authorities in Australia allowed codeine to be available only by prescription in 2018, the country’s major poisoning information centre began receiving significantly fewer calls about codeine-related incidents (from both healthcare workers and members of the public).

But there are potential drawbacks to this strategy. First, as Spotlight has previously reported, increased regulation could make life harder for poorer patients seeking pain relief, since they would have to spend more money on a consultation and prescription if they needed codeine-based painkillers.

Andy Gray, chairman of SAHPRA’s advisory planning committee, puts the second problem forward: “I’m not convinced that extending the deadline would solve the problem if we’re dealing with illegal behaviour (in South Africa)… If (codeine) is being smuggled in from manufacturers or wholesalers, extending the deadline won’t make any difference.”

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Dr. Andrew Scheibe, a harm reduction researcher at the University of Pretoria, notes a third, related problem that can occur. “If people are addicted to codeine and don’t have access to codeine, they’re likely to turn to opioids… on the black market.”

Scheibe cites the United States as an example, where prescription opioids like oxycodone and fentanyl have become the center of a major drug epidemic. “When they tried to increase restrictions on access to these opioids, people started using heroin,” he notes. A 2022 study found that this was happening 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 that “a lot of awareness-raising needs to happen at different levels, like in pharmacies.” He notes that “when someone buys codeine without a prescription, it’s important for the pharmacist to engage (with them) and inform them of the consequences if they use it beyond the recommended doses… And we don’t do that enough on the medical side or the pharmaceutical side.”

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