South Africa’s medicines regulator is developing a new set of initiatives to stem the misuse of codeine, found in certain pain relief medicines and cough mixtures and frequently taken by thousands of school children and youngsters to get “high”.
The SA Health Products Regulatory Authority (SAPHRA) communications officer, Nthabi Moloi, said the problem was “of grave concern”.
In response, and in efforts to stem the abuse, the regulatory body is now drafting new guidelines on the drug, which will be available for public comment in June, writes Jesse Copelyn in Spotlight.
Dr Sham Moodley, who chairs a multi-stakeholder forum on codeine misuse, said SAHPRA was considering an initiative requiring all pharmacies and health providers to digitally record the ID numbers of patients buying or collecting codeine.
This information would feed into a centralised computer system used by health workers nationally to flag patients requesting too much of the drug across different dispensers.
Moodley said sales of codeine by manufacturers and wholesalers would also be tracked to ensure companies were not supplying the opioid to unregistered outlets.
The programme, known as the Codeine Care Initiative, has seen a prior iteration which applied only to pharmacies, but this was voluntary, and most pharmacies chose not to take part.
By contrast, the new phase of the initiative would be mandatory and incorporate all role-players in the codeine supply chain, Moodley said.
Asked about the programme, Moloi did not explicitly confirm the details, but said SAHPRA was “engaging with various stakeholders” to review “the current data reporting requirements”.
She said the new draft guidelines would stipulate the information that companies and health authorities would need to provide to SAPHRA when dispensing the drug.
These reporting requirements would first apply to manufacturers, she added, while dispensing points would be “targeted in later phases”.
In large doses, codeine can induce a range of warm, fuzzy, and euphoric feelings, but it can also come with health complications, particularly when used over a prolonged period.
These include confusion, breathing problems, damage to the liver, and gastrointestinal issues, like constipation, bleeding and peptic ulcers.
There is also the risk of death from an overdose.
Codeine-containing cough syrups are a particular target of misuse among youngsters, and frequently mixed with fizzy drinks so that large amounts of the often unpleasant-tasting formula can be downed (a combination known as “lean”).
Research conducted in four township schools in Mpumalanga and the Free State found about a quarter of Grade 10 to 12 pupils had used codeine-based cough mixtures to get high.
Pupils who tried it typically started when they between 15 and 17 and were largely unaware of the side effects.
Deputy director of the Substance Use Programme at the SA Medical Research Council (SAMRC) Professor Nadine Harker said children often used lean “as part of codeine parties” and the drug provided “entertainment and escapism”.
Because codeine has genuine medical applications, users can also become dependent unintentionally.
In one study, patients at rehabilitation centres in South Africa told researchers they began taking codeine-based pills to manage pain after surgery or simply in response to severe headaches and migraines.
However, over time they had come to rely on the drug as an emotional crutch to deal with depression and stress, without realising they were becoming addicted.
Common pills reportedly included Stilpane, Syndol, Myprodol, and Adcodol.
New initiative will not violate privacy
The latest stage of the Codeine Care Initiative will empower health workers to monitor and help these kinds of patients.
Information about the programme was provided to Spotlight by the secretariat of the Codeine Care Forum, which developed the new leg of the project.
The forum includes a range of stakeholders, from manufacturers and private pharmacy groups to universities and professional associations.
The idea came about in the early 2010s when the Pharmaceutical Society of South Africa developed the first stage of the initiative.
Moodley, who chairs the forum, added that as part of this phase, a computer programme was developed to capture the ID numbers of patients buying codeine and generate a warning message on pharmacists’ screens when they were asking for problematic amounts across different pharmacies.
Depending on the specific case, staff could refuse to provide more of the medicine, educate the person, or suggest alternatives.
The programme remained limited to a small number of outlets however, and a 2017 paper found people who worked with drug users doubted its efficacy.
Mariet Eksteen, one of the members of the secretariat, explained part of the problem: “As associations or interest groups, we can’t mandate participation. Only a regulator, in this case SAHPRA, can mandate participation or compliance.”
Anthony Engelbrecht, the IT systems and solutions architect behind the initiative, said the software was deployed in only about 400 to 450 pharmacies.
Many companies were reluctant to come on board as they did not want their “customer information being shared with the potential opposition”.
Another challenge was that initially, the programme wasn’t compulsory for patients.
“So where the patients were concerned about their health, they would give you consent, but where there was a potential for overuse of the codeine they … could refuse to give their ID numbers,” Moodley said.
This changed in 2017 when regulations were published under the Medicines Act, making it mandatory for healthcare providers to capture the ID numbers of anyone buying a medicine scheduled 2 or higher.
Codeine-containing products are scheduled 2 to 6 depending on the dose and whether they contain additional active ingredients (for instance, schedule 2 codeine-containing products must be combined with other substances like paracetamol).
As a result of the 2017 regulations, the legal framework was now in place to implement a Codeine Care Initiative that had more teeth, the secretariat said.
Asked whether it would nonetheless violate patients’ privacy to share their data without consent, Engelbrecht said pharmacists would not be able to log on to the system to find a customer’s details and substance use history.
“There’s virtually no information we actually share. All we’re doing is throwing up warnings to the pharmacist when a person exceeds their allotment,” he added.
Any data that went to SAHPRA would also be anonymised, said Engelbrecht.
“They might ask [for a record of] all the products that pharmacy x has dispensed because they might be doing an audit on that pharmacy – we [would] produce that for them without patient information, without a surname and ID number.”
These details, he noted, could however be handed over if there were a criminal investigation.
Programme to target illegal dealers
Not only would the programme help health workers to stop the accidental or intentional misuse of codeine, but it would also combat the illegal market for the drug, said Moodley.
Legally, the drug can only be sold by a registered pharmacist (including interns) or an assistant under their supervision, yet it appears large quantities are being channelled into illicit or unregistered outlets.
This could be happening for a few reasons, according to Andy Gray, a senior lecturer in pharmacology at the University of KwaZulu-Natal.
“Either it’s theft and diversion at the level of the manufacturers, or it’s theft and diversion at the level of wholesalers.”
Given how much illicit codeine is being found, Gray noted it was unlikely to come from the community pharmacies themselves.
Wholesalers “might be selling into unregulated channels”, he added.
The Codeine Care Initiative could help tackle this issue.
“If you are able to track (sales) from manufacturer all the way to patient … we would then be able to say where the leakage is (happening),” said Moodley.
See more from MedicalBrief archives:
Balancing act between pain relief and addiction in codeine regulation
Cheap, over-the-counter codeine fuels SA schoolchildren’s addiction
Lean – South Africa’s codeine addiction crisis
Nigeria legislates to ban codeine in cough syrup