New directive aims to reduce abuse • Spotlight

New directive aims to reduce abuse • Spotlight

South Africa’s drug rehabilitation centres have been seeing increasing numbers of codeine users in recent years. The country’s medicines regulator has issued a draft guideline as part of a broader effort to track down suspicious codeine sales.

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

Under the new draft directive, the regulator can request sales data (and other information) from manufacturers, suppliers or distributors of any listed medicine. This would allow them to track the flow of codeine all the way “from the manufacturer to the dispensary, whether that’s a clinic, pharmacy, hospital or doctor’s office,” SAHPRA’s communications manager Nthabi Moloi told Spotlight.

Why is this important? Until now, health authorities have had difficulty detecting suspicious sales of codeine, which is found in prescription and over-the-counter medications. This problem manifests itself in two ways. For one, recreational users can often obtain a continuous supply of codeine directly from pharmacies.. Although people are only allowed to buy a limited amount of the drug, many get around this requirement by simply buying from another pharmacy.p. It is largely impossible to report these individuals because there is no centralised data on what drugs people buy from different suppliers (although attempts have been made to address this problem).

The second issue concerns wholesale supply. Following a Carte Blanche investigation launched last year, SAHPRA confirmed that a pharmaceutical group was illicitly selling codeine-based cough syrups in bulk. Although patients are only allowed to obtain codeine from a healthcare professional or registered pharmacist, it is therefore not surprising that it can also be found on the black market.

The new draft directive aims to address both issues by allowing SAHPRA to request information from companies and healthcare professionals about the amount of codeine they produce, sell or distribute and to whom it is supplied. This would allow SAHPRA to “detect anomalies in the distribution of medicines that could be misused, such as unusually large orders by dispensaries,” Moloi says.

This is the “first phase,” she said, of the Codeine Care initiative, which aims to centralize data on all codeine sales throughout the supply chain nationwide. The goal is to ensure the regulator can flag everything from an individual buying large quantities of codeine from multiple suppliers to a wholesaler selling the drug to illicit traffickers.

Codeine detox admissions have tripled since 2019

The draft guideline, which is now available for public comment, comes at a time when rates of codeine addiction are soaring across South Africa, according to admission data from drug and alcohol treatment centres. Most of the country’s rehabilitation centres are connected to a programme called the South African Community Epidemiology Network on Drug Use (SACENDU), which collects anonymised data on patients at the various centres. Professor Nadine Harker, who is supervising the project, says: “If you look at treatment admissions over time, you see an increase (in codeine-related admissions) over the years – a steady but definite one.”

Indeed, SACENDU’s half-yearly reports show that in the first half of 2019, 277 people who visited SACENDU-related rehabilitation centres reported having misused codeine. This represented 3% of all admissions. But by the first half of 2023, this percentage had tripled to 9%, or a total of 749 people. (In absolute terms, the number has slightly more than tripled.)

Even before the increase, health professionals were already concerned. In the mid-2010s, a survey of 238 doctors (mostly in the private sector) in South Africa found that 85% of these practitioners were concerned about the availability of codeine in pharmacies.

Part of the concern is that people who take codeine medicines over a long period of time can develop a range of health complications, including stomach ulcers and liver damage (particularly when the medicines contain additional substances such as paracetamol). 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?

The rise in codeine use appears to be partly due to a trend among young people, who sometimes mix codeine-based cough syrups with soft drinks. This combination is often referred to as “lite” and has become a popular party drug among high school students. Research shows that codeine’s low price and general accessibility are among the reasons for its popularity. Harker, for example, notes that it is often available at home, where kids “can grab it from their mom’s medicine cabinet.”

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

“I just wanted the pain to go away. I wanted my mind to shut down… (the tablets) actually made me dead inside, if I can say that,” one woman explained.

Lack of awareness of the dangers of codeine also appears to play a role: 94% of physicians surveyed agreed that patients “do not fully understand the risk of addiction associated with taking over-the-counter medications containing codeine.” A lack of regulatory oversight may contribute to this perception: a study of drug treatment centers in South Africa found that “many participants believed that (over-the-counter) medications containing codeine were not medicines in themselves because they were freely available for purchase without any real regulation or protocol governing their sale.”

Shouldn’t we just make codeine available by prescription only?

Currently, the law stipulates that codeine tablets can only be purchased without a prescription under certain conditions. On the one hand, they must contain another active ingredient such as paracetamol or ibuprofen, and each tablet can only contain a maximum of 10 milligrams of codeine. A person can only buy one pack and it must contain a maximum of 5 days’ worth of medication (with a maximum of 80 milligrams per day). Beyond that, 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 should not contain more than 100 milliliters of syrup.

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

Some researchers interviewed by Spotlight believe that these restrictions are too lax and that codeine should be “rescheduled” – meaning that it would only be available if the patient has a prescription, regardless of the dose or combination. Doing so could make it harder for children to get cough syrups for weight loss, and people could become more aware in general of the addictive nature of the drug when used long-term.

Indeed, some studies have demonstrated the effectiveness of this approach in other countries. Research published in the journal Addiction found that when Australian authorities made codeine available only by prescription in 2018, a large poisoning information centre in the country began receiving significantly fewer calls about codeine-related incidents (from both healthcare professionals and the public).

But there are also potential downsides to this strategy. For one, as Spotlight has previously reported, tighter regulation could make it harder for poorer patients to find pain relief. If they needed codeine-based painkillers, they would have to pay more for a consultation and prescription.

Andy Gray, who chairs a planning advisory committee to SAHPRA, details a second problem: “I’m not convinced that planning upwards would solve the problem if we’re dealing (in South Africa) with illegal behaviour… If (codeine) is being smuggled out of manufacturers or wholesalers, planning won’t make any difference.”

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

Scheibe cites the example of the United States, where prescription opioids like oxycodone and fentanyl are at the heart of a major addiction epidemic. “When they tried to increase restrictions on access to these opioids, people started using heroin,” he notes. A 2022 study found that this phenomenon occurred among opioid users surveyed in Connecticut, Kentucky and Wisconsin.

Whatever the answer, researchers agree that there are some basic steps that need to be taken to educate the public. Harker says that “you need to educate the public at different levels, like in pharmacies.” She notes that “when someone buys codeine over the counter, it’s important that a pharmacist comes to them and tells them what the consequences are of using it outside of the recommended dosages… And we don’t do that enough on the medical side or the pharmacist side.”

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